How do you approach underserved communities for collaboration in your health research? With humility and flexibility, says Dr. Katherine Tossas, a cancer epidemiologist and Director of Catchment Area Data Access and Alignment at Virginia Commonwealth University (VCU) Massey Cancer Center. As part of our People of Precision Health Podcast, Vibrent Health recently interviewed Dr. Tossas in her work engaging communities and catchment areas in cancer research as it relates to health disparities.  

As a native Puerto Rican, she has used her experience to develop some incredibly useful perspectives and approaches in approaching underserved communities. Some of these included sharing resources with communities, not having preconceptions about communities, understanding the limitations of research data in telling the full story, and more. 

Collaborating With an Indigenous Community to Study Their Cancer Rates 

At the start of our interview, Dr. Tossas mentioned The Chickahominy TRUTH Project, a powerful example of how the interplay between community engagement and research can make an impact with underserved populations—particularly indigenous populations. “TRUTH is an acronym we created together with the Chickahominy indigenous community that represents Trust, Research, Understand, Teach, and Heal,” Dr. Tossas said. “Trust came first because of the loss of trust that many underrepresented communities have acquired over time in health care and health research that we need to earn back by collaborating and developing the program together.” 

Initially, the project came as a concern that the Chickahominy tribe was experiencing high rates of cancer. As an epidemiologist, Dr. Tossas helped them to draw a map of incidence across the community and to investigate the epidemiology of the specific cancers in it. She found that there was in fact a significant cluster of cancers in the community more than what could be expected. 

In partnering with the community to do the research, Dr. Tossas’s team has given community members training related to IRBs and qualitative interviewing. Research staff and community members visit the community as a dyad to do interviews about cancer risk perceptions, health care knowledge, et cetera, as well as conducting safety tests to the community’s well water. “By the end of the project, we hope to give the results to the community, so that they can decide what to do,” Dr. Tossas said.  

Learn more about the Chickahominy Truth Project Here:

Engaging Under-Represented Communities Means Sharing Resources and Staying Humble 

When it comes to engaging communities in research, Dr. Tossas discouraged study teams from seeking to ‘empower’ communities, and instead approaching them in order to align with them. She said that as a researcher, “my job is to align with the community’s power, to stand alongside them so that they make decisions as to what to do.” 

She also stressed the importance of cultural humility and flexibility when engaging with communities. When researchers come with an idea and funding to a community, there is immediately a power differential that needs to be acknowledged and redistributed for fair collaboration. Hence the need for humility. One way to redistribute power, Dr. Tossas said, is by sharing resources. While not a popularly held belief in the research community, she believes in equal financial resources sharing with communities, alongside the conventional approach of sharing intelligence.  

Humility also means coming in with few or no assumptions as to a community’s shared identity or attitudes. Dr. Tossas remarks how her research team explored the spiritual aspect of how the Chickahominy community attributed causes of cancer. The research team had initial questions that were informed by animistic practices common in many indigenous communities, which did not accord with the traditional Christian practices adopted by the Chickahominy community over time. “It was a great moment of humility where we had to be flexible in adapting our initial assumptions about the community,” she said. Humility was also important as it related to bringing community members in as part of a dyad to help researchers engage and interview other community members. 

Watch the full podcast here: 

Health Disparities Research Demands Respect and a Shift in Thinking 

Dr. Tossas remarked that health disparities research is a legitimate science with the same scientific rigor of translational, clinical, and basic research. She said, “There are metrics that have been validated, there are methodologies, and grounding frameworks that demand respect.”  

She highlighted that in really collaborating with a community, the value that it can bring to research can be unexpected, and that researchers need to be ready for anything. As an example, Dr. Tossas was recently asked to present on emergent themes in the data of the TRUTH study alongside the Chickahominy community, who presented before her. “I had no need to present, because they shared what I’m seeing on the data as well,” she said. “Data is valuable to researchers in certifying that a problem exists and ways to change outcomes, but the community intelligence is equally valuable.” 

For that matter, she pointed to the need for a paradigm shift around how health disparities researchers decide what data is or is not. While researchers design questions to illuminate correlations in certain areas, she reflected that this is to the neglect of other areas that may inform what the data and thus what the results are in a study. And while qualitative scientists focus on words and quantitative researchers focus on numbers, she said, “there’s a lot of data that is simply ‘information’ that isn’t captured.” She mentioned that early in her career, she did a study evaluating performance of a cancer center that had a huge gap in data simply because her surveys and other data capture methods couldn’t account for structural inefficiencies and equipment deficits. Again, this is where flexibility and humility present themselves as viable approaches in community engagement and health disparities research. 

Defining Catchment Areas Can Hold Cancer Centers Accountable to Communities 

Dr. Tossas mentioned her upcoming Catchment Area Data Conference as the first of its kind to discuss cancer center catchment area analytics. In the last ten years, Dr. Tossas remarked, cancer centers have been pushed from the National Cancer Institute to define the catchment areas where their patients come from as a way to define how they are allocating their money and serving their communities. The conference, in service of this effort, seeks to further support national efforts to develop tools and methods designed to define catchment areas and inform what research, outreach, and clinical services cancer centers perform to hold these institutions accountable. 

Attend the Catchment Area Data Conference – Beyond Definition conference from December 7-9, 2023 in Richmond Virginia: 

Digital Methods Can Improve Community Engagement 

In closing, Dr. Tossas highlighted to value that technology collaborators like Vibrent bring to the table in the digital methods we use to help researchers measure how researchers engage communities and collect the data vital to their projects. Technology, she said, is vital to help researchers improve their methodologies, and to help them share lessons learned on a research software platform like Vibrent’s in a way that is easily systematized, maximizing the benefit of data for many research teams instead of one. Ultimately, she says, technology has the potential to increase the impact that researchers have on communities.  

The post Community Engagement Paves the Way for Reducing Health Disparities in Cancer Research: An Interview with Dr. Katherine Tossas  appeared first on Vibrent.

Above all, finding ways to notify participants in an automated way, structuring surveys and forms for organization and clarity, properly educating participants when it comes to certain data collection activities, and integrating external data sources easily are some of the ways you can aim for more efficient data collection. 

Structure case report forms for easy completion 

When it comes to case report forms, it’s important to think early on how you want the information to be structured and make sure that forms can be filled out easily. Since the purpose of a case report form is to capture safety and efficacy data, designing the form to ensure ease of use and accuracy is paramount to capturing data effectively. 

• While open field text can be the better option for certain queries that require nuanced information, drop downs and other predefined fields give data more structure and can reduce entry errors.  
• You should always strive to collect what is necessary, seeking to avoid collecting data that ultimately does not serve the aims of the study. It’s also important to capture the most important information first and use a logical order to the form’s questions. 
• Be sure to provide clear instructions, and if necessary, to provide definitions for terms. This can help when you are employing ancillary research support staff to do telephone interviews of participants to collect data.  
• A modern, user-friendly electronic data capture (EDC) system can be helpful when creating electronic case report forms (eCRFs) because they can automatically validate data, reduce transcription errors, and provide real-time data access. Good EDCs also allow for dynamic forms that can add in tooltips to define complex terms, and branching logic so that forms add in additional questions/parameters as needed. 

Educate and notify for remote patient monitoring 

Digital methods are incredibly useful for remote patient monitoring in helping you educate and notify participants. And with the right solution in place, you can integrate wearable data into your data collection for remote monitoring and make the experience mobile-friendly. 

• Setting up automatic notifications to remind participants to report measures eliminates the need for your teams to manually communicate to participants.  
• Alternatively, allowing participants to schedule convenient times of the day to receive notifications may help to spur even better compliance for your trials. 
• Education is important when participants are required to take specific measurements that require detailed instructions. A good example is blood pressure.Consider utilizing video and other visuals to help participants learn how to take accurate measurements so that data can be correctly reported.  
• Wearables can help automatically monitor participants, sending data to your electronic data capture system at regular intervals. Remember to ask to use participants’ wearable device data in your consent process. It’s also important to make wearable connectivity easy for participants so they can quickly and easily begin sending data from their devices to your study team without support. (read more about how to best integrate wearable data into your studies here.) 
• Lastly, mobile friendliness is important especially for study populations that are constantly on-the-go. Smartphones allow for the reporting of data measurements wherever a participant may be so long as they have the measurement devices with them, like a blood pressure monitor. Here are some examples of smartphone apps we have designed for mobile data collection. 

Find ways to easily verify treatment compliance 

Ensuring that participants comply with treatments in your clinical trials is, like remote monitoring, a matter of reminding them. It also warrants verification in some instances. While you want to be sure you can notify participants in an easy and automated way to keep up with their treatments, you also want to find a way to make sure they are confirming they complied with the treatment protocol. 

• One easy way of course is to have them reply ‘Yes’ or ‘No’ when, say, sending an automated SMS message asking them if they complied with treatment that day.  

• You can also send push notifications if you are utilizing an app to capture data via a participant’s smartphone to verify treatment compliance. 
• In certain cases, more verification is needed. For instance, some populations may be incentivized financially to participate in a decentralized clinical trial without wanting or caring enough to adhere to the treatment. In this case, study teams may want to use photo verification where a participant takes a picture in real-time to verify their adherence. 

Make symptom management surveys simple for participants 

Symptom management is also about notification, but it is more nuanced when it comes to getting the right responses from participants. Offering automated notifications for daily, weekly, or monthly symptom tracking can help your study staff by reducing their time filling out measures manually. It’s important of course to make sure your surveys follow best practices so that participants can understand and answer questions easily. 

Documenting symptom management in an EDC also allows you to automate care triaging in the case of adverse events, serious adverse events, or persistent symptoms. Since monitoring symptoms over time can show significant increases in specific symptoms, you can set up triggers to alert nurses or other care staff who can follow up with participants individually as they experience these events. In this case, you can also trigger notifications back to patients to share information with them to help them manage their symptoms, and to notify them if a nurse or clinical staff will be in touch with them. 

Wearables are also highly valuable in managing symptoms that are easily trackable values like heart rate, respiration rate, and so on.   

Word and structure ePRO surveys clearly 

Getting participants to answer electronic patient reported outcomes (ePROs) like surveys or ecological momentary assessments correctly is all about organizing and wording the questions in a way that makes sense to the participants. You have to consider the age and general health literacy of the populations you are engaging when creating the survey or choosing the right instruments to use.  

• Remember to strive for a diverse range of questions to keep it interesting and avoid survey fatigue. 
• We also suggest limiting the number of questions per page, and in general to strive for as simple a format as possible.  
• Breaking larger surveys into segments can also be helpful to prevent survey fatigue. 
• Consider adding interactive elements such as tool tips to define complex terms and media if needed to visually describe a concept.  
• Lastly, it’s important to seek feedback on your surveys early and often, and if possible, to engage a survey methodologist to help you design your surveys for optimal performance. 

Integrate with EHR, genomics, and wearable data 

By integrating EHR, genomics, and wearables data you are simultaneously unlocking opportunities for more data and insights, but it’s important to integrate them carefully. First of all, it’s important to make sure you are properly consenting participants to collect these data.  

Platforms like Vibrent’s allow you to give participants the ability to connect their EHR and wearable data to the study, and to order genomics kits directly from sequencing providers. These are done through integrations which allow the data to be accessed by study teams. The data, especially EHR, needs to be harmonized so that all data points fit together in a way that makes sense to the study. While some EHR data points are easily harmonized with software like Vibrent’s, we recommend mapping dispersed datasets using a data dictionary according to FL7/FHIR standards.  

Conclusion 

Optimizing digital data collection for efficiency is not always a straightforward process and can take some time for you and your research teams to experiment with different methodologies and different ways of engaging your participants. Remember that different studies can call for different strategies, and it’s important to consider what data is necessary to your study and start there. From that point, finding a good case for nice-to-have data that will further help you accomplish your aims, and figuring out a way to collect that data in as easy a manner as possible can be beneficial to gleaning deeper insights from your studies. 

Overall, it’s important to find ways to automate your communication with participants to collect data more easily, to structure information for optimal clarity and organization, and to consider integrating datasets in a way that is easy for your study teams to manage. You may choose to do this work with internal resources, or partner with a company like Vibrent Health who can offer tools and expertise designed to allow you to collect more data with a higher quality with less work from your team. 

Looking to collect other kinds of data? Reach out to us with your questions and to see what’s possible.  

The post How to Use Digital Methods for Data Collection and Remote Monitoring in Clinical Trials  appeared first on Vibrent.

How do we address the barriers to cancer research participation among patients, especially underrepresented populations? How do we create partnerships with underserved communities to foster more trust, greater recruitment, and better retention rates among these populations? 

In our most recent People of Precision Health podcast episode, we sat down with Porscha Johnson, PharmD, CPGx to address these questions. 

Currently, Dr. Johnson leads Northside Hospital’s genomic oncology advisory board and has been developing their precision oncology program. She specializes in cancer pharmacogenomics to understand how patient genetics informs their response to medications. In addition to overseeing a team of oncology pharmacists and focuses on educating her patients about therapeutic treatments for cancer. 

A lack of genomics literacy is the primary obstacle to optimized cancer care 

When pointing to the biggest obstacle to optimizing care, Dr. Johnson cited a lack of understanding, saying, “Genomic literacy has been the most challenging obstacle to overcome not just for our providers, but for patients and caregivers as well.” She remarked that providing advocacy resources to educate these different groups as succinctly as possible on things like the difference between genetics and genomics, how certain testing impacts health and life insurance as well as people’s jobs, as well as how much control people have over their healthcare data can empower them to move forward in the care journey. 

Cancer studies should be considered as a first-line resource for patients 

For many in the cancer care continuum and even beyond, there’s been the view that suggesting a clinical trial to a patient is a last-ditch effort. “It’s not at all; it’s actually included in the standard-of-care guidelines and should be spoken about from the very beginning of a patient’s care journey,” Dr. Johnson said. When having these conversations around participation in cancer studies alongside more conventional treatment avenues. For this, Dr. Johnson noted above all the importance of creating an open and safe environment where patients feel supported. 

Community approaches can address cultural disparities and underrepresentation in research 

To address underrepresentation of minority groups in clinical studies, Dr. Johnson recommends engaging with community organizations to leverage the trust of community leaders and to tailor culturally relevant recruitment strategies to target populations. Establishing partnerships that prioritize inclusivity such as with historically black colleges and universities (HBCUs) can be a proving ground for establishing the benefits of active participation in studies. Actively listening to community concerns can move the needle on participation rates from underrepresented populations. Recognizing the impacts of social determinants of health and how disparities in housing, transportation, historical discrimination and a general fear of the unknown are also key to educating the medical community to address care more empathically. 

Understanding cultural barriers to improve retention rates 

Aside from racial/ethnic and cultural barriers, there are barriers as it relates to socioeconomic status, age, as well as gender identity that may play a role in discouraging participation or neglecting to address the needs of specific populations. The hope is that addressing these barriers from a more culturally informed and trauma-aware perspective can help to improve retention rates. But this is data that, Dr. Johnson notes, must be collected and analyzed in health systems willing and ready to address inherent disparities in order to prove the impact of these improvements. 

Incentivizing partnership with participants means showing how they contributed 

In describing how to overcome some of the more significant barriers to participation, Dr. Johnson cited the slogan “nothing about us without us” as a principle whereby underrepresented groups need to be actively involved in the design of research studies and in the creation/testing of medicines that address their populations’ needs. “Having a patient advisory board or focus group can help researchers and clinicians to understand what challenges or concerns that potential participants have,” Dr. Johnson said. 

Dr. Johnson pointed out that collaboration with patient advisors and focus groups needs to be an end-to-end approach. “Before you even begin to recruit, you need to make sure that the literacy, comfortability, and willingness to help their community is there with focus groups of patient advisory boards,” she said. And the momentum needs to be kept throughout the clinical trial development, the research process, and at the study’s closeout to understand what went well and what warrants improvement. It is also important, she noted, to tell the patient advisors how they contributed to the overall results of recruitment, retention, and the ultimate outcomes of the study. 

Watch the full podcast here:

Diverse providers can help to foster greater inclusivity and trust among underserved populations 

Among the concerns around participation, data privacy and stigmatization loom large for underrepresented populations. For that matter, she mentions that many underrepresented people don’t feel comfortable relaying their financial issues or childcare issues with a provider at hand because the provider may not look like them or represent the same or a similarly marginalized community. This, Dr. Johnson highlights, demonstrates a greater need for a diverse medical workforce and research teams more specifically. She points to her experience, saying, “As a black female, I’m a double minority. And I believe my experiences there as well as my leadership role can contribute to a more inclusive and welcoming environment for people to talk with me and lower their guard within the medical community and the broader clinical trials space.”  

Addressing specific barriers to research participation with specific solutions 

Again, she stresses that health literacy is an important barrier, which needs to be addressed by introducing and explaining the clinical benefits of participation in research as well as some of the more abstract benefits such as benefitting one’s family and community by contributing to equitable research opportunities. Language barriers are a frequent issue that can be addressed by translating consent forms and clinical trial packets. 

Transportation issues can be addressed with vouchers by working with ridesharing services such as Uber or Lyft, or taking a more hybrid/decentralized approach to studies to decrease the amount of time and money participants spend traveling to clinical sites. In terms of encouraging participation from populations that are farther away from cancer centers, a mobile clinic unit or a hub-and-spoke model may be appropriate to allowing them to come into a satellite hospital or clinical site that is closer to them. “Meeting patients physically where they’re at may be a way to address some of those barriers,” Dr. Johnson said.  

Ultimately, Dr. Johnson feels it is important to address to patients the potential that the clinical benefits of experimental interventions may well outweigh the risks and have the potential to provide greater safety and efficacy than what is already available as the current standards of care.  

Utilizing digital methods for greater engagement and data insights 

Dr. Johnson espoused the great promise that digital methods hold in the research space, citing interactive platforms like websites where people can speak to care navigators in real time to address their needs and challenges. She addressed the great opportunity for social media to serve as a platform for recruiting and educating potential participants for trials and research.  

She mentioned the promise of smartphone apps to give access to genetic and other test results that patients can then easily share with their providers and as a platform for feedback and engagement from participants. For instance, if a participant chooses to withdraw consent and end their participation with a study, apps and digital platforms could serve as an easy resource to understand any challenges that research teams could help mitigate to retain participants.  

Digital platforms also allow for the delivery of patient advocacy materials such as videos that serve as empowering educational materials for patients and their caregivers. They also allow, she said, the ability to easily pre-screen patients into trials, and to serve as data repositories for patients’ genomic and genetic results, and for patients, caregivers, and clinicians to search for research studies or newly approved targeted therapies. 

AI is already proving to help with a lot of these processes, particularly around the administrative side of research to assess and strategize for quality improvement processes for better study feasibility or overall clinical outcomes. “Most importantly,” she said, “I think this technology affords us the possibility to better report on the demographics of a trial and to make that data publicly available to promote transparency and accountability, thereby mitigating trust among underrepresented communities.”  

The future of precision medicine is already here 

In speaking to integrating genomics into cancer treatment, Dr. Johnson notes that the future of precision medicine is already here—it’s the headwinds to these novel solutions that stand to erode with time. She remarks that this is largely due to the lack of awareness around the patterns that professionals in the field have managed to show around how genomics and genetics play a role and what clinical applications have arisen from these discoveries. 

“Some of these have been very unknown significance, but recently we’ve seen these insights become prognostic or pathogenic. In many cases, you can now bypass the standard of care or trial-and-error via preventative screening or more targeted therapies,” she said. Her ultimate goal to realize the integration of precision medicine into cancer care would be universal biomarker testing, but the hurdle for many patients involves having comprehensive insurance coverage. But Dr. Johnson notes that there are many organizations that provide grant funding or assistance for these testing mechanisms that unlock more informed treatment decisions. 

She also reiterates the value of bringing research to patients away from traditional academic research organizations and cancer centers into more community-based approaches like mobile clinic units. This involves eliminating the stigma of community-based care as an inferior option to centers of excellence.  “There are just as good if not greater providers in the community setting because they want to serve those people in the communities disproportionately affected by disadvantage,” she said.  

Ultimately, Dr. Johnson notes the value of genomics and genetics not just in cancer care but in cardiology, pain management, and other clinical areas. She firmly asserted that in 10 years, patients will be able to easily access germline testing and other tests, which will be fully integrated into EMR systems and have garnered the trust of care providers, policymakers, and insurance carriers.  

Subscribe to our People of Precision Health podcast on your favorite platform: 

• Simplecast 
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The post Addressing Barriers to Cancer Research Participation for Underserved Populations  appeared first on Vibrent.

Currently, FDA describes its requirements for informed consent in its regulations on Protection of Human Subjects  (21 CFR part 50).  

The FDA distinguishes in this latest guidance that informed consent is not the act of merely obtaining a signature. It is the process of making sure potential participants understand the research, as well as their role in it. The agency also notes that a big part of informed consent means giving prospects ample opportunity to ask questions of investigators and their study team to gain adequate knowledge and confidence in participating in the study. This is also seen as an ongoing process whereby participants should be able to ask questions throughout the study to support their informedness. 

Recruitment is considered a vital part of the consent process. The agency’s reasoning here is that recruitment conveys the initial information that potential participants use to gauge their interest in the study. As such, the information provided in initial recruitment advertisement needs to be minimal while serving this purpose of generating interest.  

One of the main potential risks identified by the FDA is that of undue coercion. As such, the agency recommends that investigators do not overstate the benefits of a particular treatment or diagnostic tool being studied, and do not make unsubstantiated claims to this or any other effect to spur consent. Conversely, the agency does not consider any sort of incentive, whether financial or otherwise, to be considered undue influence, unless under some overt or covert threat of withholding it. 

Overall, the consent form should contain information presented in language that an average person can understand. If medical or scientific terms are used, they must be explained. Exculpatory language that waives participants of their legal rights is prohibited. 

Eight basic elements of consent 

The FDA defined eight basic elements of consent: 

Description of clinical investigation 

The consent form should note that participation is for research purposes, and while preliminary data may exist, the study is investigational, observational, or experimental in nature. The description should contain a list of procedures done in the study, what typical elements of clinical care may be included or excluded as part of the study, how the participants will be involved, how long the study will be for participants, and what may be involved in follow-up from the initial study timeframe.  

Risks and discomforts 

Any reasonably foreseeable risks or discomforts must be documented in the consent (sidenote: video consent can be considerably useful for this). Procedures or tests that may carry risks or discomfort must be documented, especially those with considerable risk for morbidity and/or mortality. ‘Risks’ entails not just physical harm, but also the possibility of unintended disclosures of private/sensitive information of participants.   

Accordingly, the agency recommends describing ways in which personal health information and personally identifiable information will be secured/protected to the best of the study team’s ability, while disclosing limitations to these efforts. While all possible risks don’t need to be described, it’s important to provide some detail on how the most likely risks may impact participants. Probability as well as reversibility can be considered in these risk disclosures. 

Benefits  

Reliable information on potential benefits to the participants as well as others (such as patients with a particular condition) can be described. The FDA cautions against overly optimistic benefits or descriptions of benefits. If there are no direct benefits, this must be clearly stated. Payments/incentives/reimbursement are not considered benefits as part of the consent process. 

Alternative procedures or treatments 

Participants must be made aware of the care or treatments they could receive in place of participating in the study. If there is more than one alternative, there should be language indicating that investigators can follow up with the participant to describe these in more detail. If additional treatments or procedures become available during the course of the treatment, this may warrant the updating of the consent document. The document can also refer patients to their primary care doctor or another healthcare professional to discuss alternatives in more detail. 

Alternative considerations are also in play when considering participation in other research studies. The consent process should also detail whether participation In other studies affects a person’s ability to participate in the study for which the consent process is intended.  

Confidentiality 

The consent process should describe the measures by which confidential information will be safeguarded. The FDA maintains the right to inspect confidential information as it pertains to the research without permission and holds this right per stipulations set forth in the Health Insurance Portability and Accountability Act (HIPAA).  

Compensation and medical treatment in event of injury 

If a study poses any significant risks, it’s important to disclose any compensation and medical treatments available should injury occur. If no compensation is available, the informed consent should specify this, while also making it clear that this does not require the person to waive any legal rights. 

Contact information 

The consent form should have information on who to contact for questions regarding the study, the participant’s rights, as well as who to contact in case of injury as a result of the study activities. It should include names, telephone numbers, and email addresses. The FDA advises against listing a study contact for participant’s rights as it may discourage participants from seeking out information from biased parties, and instead recommends contact information for a member of the study’s IRB office. It should also disclose who to contact in the case of an emergency, including 24-hour contact information where applicable. Correct contact information should be provided to participants as it gets updated. 

Voluntary participation 

Participants must be informed of their right to stop participation at any time, and that their participation is completely voluntary. Should the research require special procedures to ensure safe, secure withdrawal from the study, these procedures must be outlined in the consent. The consent document should clarify if the information the participants provide during their course of the study will remain part of the study’s database or not. 

Additional elements of informed consent 

The FDA defines six additional elements of informed consent: 

• Unforeseeable risks 
• Involuntary termination of subject participation 
• Additional costs to subject 
• Consequences of subject’s decision to withdraw 
• Providing significant new findings to subjects 
• Number of subjects 

Documentation of consent 

A document containing the signature of a participant and the date is required for the consent process, and digital signatures and documents can be used provided they are in accordance with 21 CFR Part 11, which regulates the use of electronic records and signatures.  

Alternative methods for obtaining consent 

While paper consent is the traditional form of obtaining consent, other methods can be used. Technologies for obtaining consent must be discussed with the study’s appropriate IRB, or investigators can contact the FDA for advice as needed. If written consent is required, consent may not be obtained via telephone. The general guidance suggests that any alternative method for consent is adequate if it allows for the “adequate exchange of information and documentation, and a method to ensure the signer of the consent form is the person who plans to enroll as a subject in the clinical investigation or is the legally authorized representative (LAR) of the subject.”  

If a telephone conversation is used to provide information to the participant or their LAR for the consent process, there must be a means obtaining signature. This can be done by email, fax, or via a secure web address. Another way to ensure signature is for participants to bring in a signed copy of the form to their next scheduled visit to the research site. The signed consent form must be maintained as part of a participant’s case history per 21 CFR 312.62(b) and 812.140(a)(3), and the participant/LAR must receive a copy of their form per 21 CFR 50.27(a). While the copy provided to participants does not need to be signed, it is recommended per these guidelines. 

Forms for documentation of informed consent 

A document provided to the participant, or their LAR, should either contain all the information regarding the consent, or be a short form summary and acknowledgement of an oral explanation of the entire consent documentation. All IRBs need to approve of the written form of the oral summary to be stated exactly as written to potential participants.  

IRB responsibilities for informed consent 

The FDA maintains that institutional review boards review all consent materials to request modifications and approve/disapprove of the materials. This includes advertisements and other recruitment materials. 

The central responsibility for review boards is to ensure that materials are compliant with 21 CFR part 50, and to ensure that participants are well-informed of their rights as it pertains to the study in question. They must ensure that consent materials minimize the incidence of undue coercion. 

As far as content, IRBs should consider whether to disclose sources of funding for the study, the adequacy and appropriateness of all wording in the consent materials to facilitate informedness, supplemental media to inform understanding, and the use of standardized language as it relates to their institution. As far as form, they should weigh how well alternative forms of consent that differ from face-to-face interactions such as telephonic interviewing supports informedness. By extension, investigators should also consider these factors. 

IRBs have the authority to observe (or have a third party observe) the consent process to ensure adequate compliance with their guidance as well as with regulatory requirements. They may also interview participants to ensure the consent process ensures adequate informedness. If any information or element of the consent materials and process is updated, IRBs need to be able to review these materials in a timely manner. Small administrative changes such as telephone numbers or typographical errors do not require re-approval, however, IRBs should be sent an updated copy on consent forms for their records. The FDA recommends that IRBs have a way of keeping track of up-to-date forms so that previously approved forms are not used in the consent process.  

Clinical investigator responsibilities for informed consent 

According to the guidance, “the clinical investigator is responsible for protecting the rights, safety, and welfare of subjects during a clinical investigation, and for ensuring that, unless an exception applies, legally effective informed consent is obtained from each subject or the subject’s LAR before that subject takes part in the clinical investigation.” The informed consent must meet all federal, local, and state requirements—in addition to what the FDA may require.  

The clinical investigator must inform their IRB of the consent process and materials they will use, as well as who will conduct the consent discussion. They are required to obtain IRB approval for the clinical investigation, the consent form, and any other information given to participants before beginning the consent process. They must obtain approval from their respective IRB for revisions to the consent material or process that may affect the willingness of participants to continue in the study or for prospects’ willingness to initially consent. The IRB will determine whether investigators need to inform previously enrolled participants of the new information and whether the research team should obtain consent to further continue in the study. 

Clinical investigators have the authority to delegate the responsibility of the consent discussion to their study staff members. In which case, the FDA expects these staff to be adequately educated, trained and experienced to perform this activity. Whoever is delegated to obtain informed consent should have adequate knowledge of the investigation and be able to address concerns or questions from participants pertaining to the study. An investigator should have a detailed plan for supervising and training staff as it relates to informed consent and other study processes. The investigator remains responsible for all tasks delegated to their team as it relates to obtaining legally effective, informed consent. 

Investigators also need to consider whether to disclose financial relationships/interests. This includes things like sources of funding or funding arrangements. As such, special measures can be considered to mitigate financial conflicts of interest such as having unbiased individuals involved in the consent process or using independent monitoring of the consent process. 

The sponsor’s responsibilities for informed consent 

A sponsor generally gives investigators a standard consent form that can be adapted for local site needs. They should provide any updates of this standard form to investigators to ensure that these forms are up-to-date across sites. Sponsors should work closely with a study’s investigator to ensure IRB approval and should provide a copy of their form—approved by the sponsor’s IRB—to the investigator. 

When review from local IRBs result in substantial modifications to the consent form, the FDA expects the sponsor to share these revisions with all investigators and their IRBs. These revisions should be shared with a central IRB if there is one, and central IRBs can also address local issues as needed. Medical device studies may call for additional considerations. 

The FDA’s responsibilities for informed consent 

Sponsors may be required to submit different materials as it pertains to drug or device studies. The FDA does not require sponsors to submit consent materials for review for all types of investigations. The agency will generally assess the adequacy of the content, most notably as it relates to the communication of foreseeable risks or discomfort to participants. The FDA reserves the right to require revisions to consent materials that they find to be misleading, inaccurate, or incomplete insofar as it would make participant consent inadequate or otherwise non-compliant with 21 CFR part 50. 

The FDA’s review does not substitute for an IRB’s review and approval of the consent form and processes. New drug and biologics do not require the submission of consent materials to the FDA, except in instance where it is deemed necessary to evaluate study safety. If consent forms call for specific exceptions from requirements, these are reviewed on a case-by-case basis. 

Medical device studies that require an IDE application require the submission of all forms and materials in the process for consent. The FDA reviews the consent to ensure it complies with 21 CFR part 50 and sends a letter citing any deficiencies to the sponsor. The study may not begin until the sponsor corrects the deficiencies. If an IRB calls for substantial changes to the informed consent document after IDE approval, the sponsor is required to obtain additional approval from the FDA prior to implementing these changes in their study.  

Summary of the FDA’s latest informed consent guidance 

Overall, here is the FDA’s latest thinking on informed consent: 

• Recruitment materials are considered a part of the consent process.
• The FDA primarily looks for undue influence and unsubstantiated claims.
• The main purpose of informed consent is to make sure participants are informed of their rights and understand the study, its activities, and what participants need to do as part of the study. 
• Substantial updates that affect people’s willingness to participate should be made and approved by the IRB before being implemented.

When creating and implementing your informed consent, you should follow these FDA guidelines: 

• Describe foreseeable risks to patient safety and confidentiality and any potential discomforts.
• Don’t be overly optimistic when explaining benefits.  
• Discuss alternative treatments and research. 
• Provide contact information for participant rights, study details, emergencies, and injuries.
• Explain how confidential information will be safeguarded .
• Make it clear that participation in your study is completely voluntary and participants can withdraw at any time. 
• Document participant or LAR consent via paper or digital signature. 
• Give participants/LARs a copy of the consent, preferably signed. 
• Maintain signed copies of consent forms for recordkeeping. 

An IRB’s responsibility for informed consent includes: 

• Reviewing and approving/disapproving all consent forms to ensure informedness, disclosure of participants’ rights, disclosure of risks, minimize any undue coercion, and disclosure of financial conflicts. 
• Determining appropriateness and adequacy of wording in consent forms and the use of alternative forms of obtaining consent such as telephonic interviewing or electronic consent. 
• Evaluating the effectiveness of supplemental media such as consent videos to ensure informedness.  
• Ensuring standardized institutional language is in the informed consent form or discussion. 
• Reviewing changes to the consent form and process throughout a study to ensure timely implementation of updates. 
• Observe (directly or via a third party) or conduct interviews with participants to confirm that consent materials/process foster adequate understanding.  

For informed consent, a clinical investigator’s responsibility is to: 

• Ensure that staff who conduct the process are adequately trained and experienced. 
• Protect the rights, safety, and welfare of subjects during a clinical investigation. 
• Obtain legally effective, informed consent from participants or their LARs. 
• Meet local, state, federal, FDA, and IRB requirements regarding informed consent. 
• Obtain approval from their IRB for the initial consent form and process, as well as any updates during the course of the study. 
• Consider the disclosure of financial relationships/interests. 

A sponsor’s main responsibility for informed consent Is to: 

• Maintain and distribute a standard, up-to-date consent form for use across studies/sites/investigators. 

As far as informed consent, the FDA can: 

• Call for revisions to consent materials that they find to be misleading, inaccurate, or incomplete insofar as it would make participant consent inadequate or otherwise non-compliant with 21 CFR part 50. 

Need help with your informed consent process or language for your IRB?  

The post What Researchers Need to Know About the Latest FDA Informed Consent Guidance  appeared first on Vibrent.

Your website or digital experience is not participant-friendly 

These days, people who participate in digitally-enabled health research are subject to many types of experiences online. Shopping apps, online dating, accessing their medical records, scheduling appointments, and ordering food are just some of the many ways people are using their smartphones and computers to engage digitally with various products and services. Whether you know it or not, your research interests in engaging potential participants are competing with these digital experiences. And most if not many of these experiences are fine-tuned for optimal user experience. Is your digital research experience on par with these experiences? 

Potential participants may be put off from engaging with your consent materials if your website portrays a potentially frustrating or lackluster user experience. It could be stale, uninspiring graphics, or clunky writing, or a lack of buttons that call your prospects to specific actions—like signing up for the study. In a recent research paper, we showed that by creating a website with good user experience, we were able to convert 20.9 percent of vistiors into consenting participants.  

Need help building an effective recruitment website? 

Your website and accompanying study materials may not be mobile-friendly. Or your study may not provide clear details on who to reach out to on your research team to ask questions. All of these can cause your recruits to abandon your study immediately and not look back. 

So it’s important to consider how your messaging and the design of your digital recruitment materials and study materials reflects the modern user experience that many people expect. Any inkling that your website looks or feels outdated to the average research participant could be enough to reflect poorly on your study and discourage enrollment and completion of consent materials. 

Your consent form is too complicated or unclear 

Often, research teams are more focused on writing materials and consent documentation that serve their interests. They focus on conforming to state rules around consent, and for explaining the study in the way that they, as researchers, understand. But writing materials based on a researcher’s understanding of their research is quite different than writing study materials that reflect the average participant’s understanding of what that research might entail. 

To that end, it’s important to take the time to write and rewrite consent materials to adapt them for an audience who may lack health literacy. When in doubt, it’s always helpful to consult a focus group or an advisory board of patients or people who may participate in your study as it relates to your target population and demographics. A test audience, however small, can tell you if your materials are too hard to understand. If you can rewrite your consent documents so that potential participants can more easily get what you are studying and how you will conduct your research, it’s less likely that you will lose prospects to unclear or complicated explanations. You’ll suffer less abandonment at point of consent. 

Your consent process takes too much time 

It’s easy to see that any process that seems too lengthy or complex may compel people to abandon the consent process early. If a prospective participant has to read and sign multiple documents, or if there are too many steps in the process, you can easily turn them off from the study.  

There may be a way to either break the process into simpler steps, or to do away with unnecessary tasks or information. The key is to avoid redundant information wherever possible. Do you repeat information? Is there a way to reduce the repetition? In terms of breaking the process down, have you considered paginating your consent form? Digital health research platforms like Vibrent’s allow for the breaking down of information into smaller pages, hence the term ‘pagination’. This is especially important for being able to have potential participants digest your consent form in bits and pieces. And doing so allows for people to focus on key information and retain it more easily. 

Participants need to be reminded 

Sometimes life gets in the way. If a potential participant is consenting remotely for your study and gets interrupted, they should be able to easily return to the process. But what if they forget? Digital health research has evolved to the point where it’s easy to monitor who has completed consent after initial enrollment, and who hasn’t. 

For that matter, being able to remind prospects that they have yet to complete the consent process is a powerful tool for avoiding non-completion or total study attrition. It’s easy in this modern digital world for people to quickly lose interest in participating in a study. But in having the ability to send out reminders via text message or email to complete a consent form, it’s more likely that you can retain participants at this initial step. Even more important is fruther in the study when you are collecting data on these consented participants. If they forget to complete a survey, you can easily remind them. Being able to remind participants of an uncompleted milestone helps to foster engagement—whether it’s in the consent process or beyond. 

Need a robust health research platform to improve your success with eConsent? 

You aren’t incorporating best practices for diversity recruitment and engagement 

When it comes to digital health research, the opportunity to recruit diverse participants across ethnicity, race, age, and other demographics is plentiful. However, you stand to lose recruits when information is not presented in a way that addresses various demographics’ general concerns. For one, privacy and confidentiality can be of utmost concern to many participant demographics where trust is key to engaging these populations. It’s also important to use graphics and imagery that are representative of the diverse demographics you wish to recruit and consent for your studies. For example, a consent video, when showing how research will be conducted, should depict an ethnically diverse sample of participants in its animations.  

Technology is also a factor when it comes to consenting a diverse group of participants. People who are socioeconomically disadvantaged lack access to broadband internet and are more often using their smartphones to engage with digital health studies. For aging populations, many are not specifically comfortable with technology, and may benefit from versatile approaches like a computer-assisted telephone interview tool that consents them over the phone. 

You aren’t incorporating other eConsent best practices 

There are a number of other considerations that research teams need to be aware of when they create their electronic informed consent process and content. Planning up front and engaging your IRB early on are two important factors to make sure that you create consent content that is adherent to things like state regulations, and according to the standards that your institution considers heavily. 

Video consent and digital consent call for numerous best practices to follow aside from just writing for your audience and breaking up your content into digestible fragments.  

Overall, digital health research needs to be reflective of the modern digital age. EConsent has to adapt to modern best practices for user experience and in its messaging so that it can be clearly understood by a wide range of participants who may lack health literacy. You also need to be able to address values that different patient populations tend to hold as it relates to things like privacy and confidentiality. And above all, you need to meet participants where they’re at as it relates to technology—otherwise they won’t be able to participate. 

Ready to consent more participants? 

The post Why People Don’t Consent in Your Studies  appeared first on Vibrent.

So, how do you write a consent video script? Here in this blog, we explain some of the best practices you and your study team can utilize to write an effective video script for your digital consent that compels action from potential participants and fosters understanding. 

Use language to fit for your participant population 

In order to connect with as many potential participants as possible, it’s important to avoid overly clinical terms. This is because literacy in areas like health care or research is not universally high among populations. 

For instance, a 2003 survey from the National Center of Educational Statistics found that only 53% of the US population possess intermediate health literacy. A more recent study by the Kansas Behavioral Risk Factor Surveillance System has shown that while health literacy is increasing, it’s still not universal, with Kansas residents reporting ‘less than high’ literacy at 67 percent in 2012, and 51 percent in 2018.  

If you are looking to recruit specific populations, it’s important to understand their literacy needs. Several studies show that race, ethnicity, age, education level, economic status, health status, cognition, and non-English speaking populations are all factors that affect levels of health literacy. It’s also worth noting the commonly shared values that populations hold to connect with them through your consent video to build trust. 

Keep the tone of the video script conversational 

Maintaining a conversational tone in your eConsent video script may be challenging, but it’s essential for making it more engaging and accessible. Remember to balance some of the more clinical aspects of your video script with a friendly, approachable, and relatable tone. Conversational tone implies being able to use everyday language that your audience can understand. It also helps to simplify your script, which makes for an easier flow to the consent video. You can always rewrite the script and substitute more complex terms and words for shorter, simpler words that fulfill the same purpose. 

Be sure to address your consenting participants with language like “you” and “we” to make the tone more relatable and to help them easily understand how they will participate in the study. Real life examples are another way to help build understanding for specific concepts. If you are having trouble making complex concepts more relatable, try using metaphors or analogies. The more familiar the analogies/metaphors, the better. If concepts are too complex for your participant audience, be sure to break down complex concepts into smaller components. Or you may consider whether certain concepts are central to a participant’s required understanding to properly consent and omit them altogether.  

Need help producing an eConsent video or writing a script? 

Give prospects good reasons for participating 

Overall, you want to convince prospects that it’s worth their time participating. So it’s great to emphasize the benefits. Different benefits may be more important to different populations, so it’s important to understand how your population thinks. 

Some potential benefits include: 

• Contributing to the health of future generations: this is especially relevant to elderly populations who want to ‘pay it forward’ and leave behind something of value while they had the time to do it. 
• Contributing to the health of your racial or ethnic community: it’s important here to emphasize that people in underserved populations can contribute to insights and medical breakthroughs that are better tailored to the genetics of people from similar backgrounds. Since much research in the past has been comprised of majority white, male participants, it’s important to highlight the value of participation of diverse populations to these populations. 
• Contributing to medical breakthroughs for a particular condition or set of conditions: this can be especially important for people living with the medical conditions that are being studied, people with family members with the condition, or those with a known genetic predisposition for a particular disease/set of diseases. 
• Receiving standard-of-care or cutting-edge treatment: if your study gives participants access to treatments at little or no cost, it’s worth highlighting this incentive. 
• Receiving genetic test results or other medically actionable insights: if your research program involves getting a free screening for certain medical conditions, or genetic testing that screens for predispositions or a more general idea of a person’s health, it’s worth highlighting the potential benefits that come with these insights. 
• Access to insightful research findings: participants may have access to the results and findings of your research, which can provide insights into their health or condition. 

It’s important to highlight the benefits or participation towards the end of your video as people are closer to making an informed decision on whether to study or not. Alternatively, you can use it in the beginning of the script to gain their curiosity for learning more about the study. 

Keep the video short 

Avoid writing a long script. Participants will generally get distracted if your video is longer than three minutes. Based on our experience creating consent videos, we have found anywhere between a minute and a half to two minutes is an ideal length help maintain attention. 

In order to figure out the timing of your script, simply read it out and time yourself. Remember to leave space for natural pauses, which will allow for the video’s content to be more easily digestible to your consenting audience and help you gauge the video’s run length. Remember, consent videos don’t need to contain all the information necessary for consent, since they are often intended as supplementary aids to learning and comprehension. Also, animations in your video can help to add further context to help make your video more concise and effective in explaining your study in less time. 

Give an overview of your study and what it aims to accomplish 

This one is pretty self-evident. It’s important to state the main goal of your study. While in many cases you will want to avoid some of the less significant questions you aim to address. State the questions you want to answer in simple terms. Be sure to explain the types of people you are aiming to recruit. Or you could explain why the participants themselves are being selected to participate. This part of your script might also be a good opportunity to introduce your study team to briefly explain how each of them will be involved. 

Provide information regarding study activities  

How will your participants be involved, and what is your study team doing over the course of the research? It’s important to explain how long the study will take, what sort of procedures may be involved, as well as some of the risks and potential benefits. As always, make sure participants are well aware of their rights, specifically as it relates to their right to stop participating at any time they choose for any reason. This is a great area to consult with your IRB when you are submitting various materials for your informed consent process, as it relates to eConsent or otherwise.   

Explain how their data will be used, accessed, and kept secure 

Give a high-level description of what the data they provide will be used for, who will have access to it, and how the data will be kept secure. More specifically, how will their personal health information (PHI) and personally identified information (PII) be used/stored? What rights do they have per these data? As previously explained, data privacy and confidentiality are valued among many populations, so it’s important you address this in an easily graspable way. 

End the video with a compelling call to action 

A call to action is a marketing term defined as a short phrase using a verb to compel a specific action from your audience. In this case, a call to action can be used to compel potential participants to: 

• Continue enrollment 
• Contact study staff (if they have specific questions) 
• Agree to participate 
• …and so on. 

Summary of how to write an informed consent video script 

To write a clear, concise, compelling consent video script for your research study, consider the following: 

• Do not use overly clinical language 
• Keep the tone of the video script conversational 
• Give prospects good reasons for participating 
• Keep the video short; 1:30-2:00 is ideal to maintain attention 
• Give an overview of your study and what it aims to accomplish 
• Provide information regarding what activities a participant is agreeing to when they join 
• Explain how their data will be used, accessed, and kept secure 
• End the video with a compelling call to action 

To learn more about eConsent video best practices, read our blog:  

How to Create an eConsent Video that Builds Participant Trust: An Interview with a Health Research Project Manager 

To learn more general eConsent best practices, read our blog: eConsent Best Practices 

Need access to a team of eConsent experts and technology for eConsent? 

The post How to Write an Engaging, Informative eConsent Video Script  appeared first on Vibrent.

During our latest podcast Improving Surveys for Higher Completion Using Skillful Methodology, we sat down with our in-house Survey Methodologist Megan Ruxton, PhD to help us understand what makes a good survey. Here in this blog, we recap some examples she told us of why participants lie or provide inaccurate information. And we address some potential solutions that you and your research teams can use to mitigate bad data into your health research studies. 

Watch the full podcast episode here: 

Trolls and bots that intentionally lie 

In the era of digital health research—as in in all things digital, you may encounter bots or survey trolls that are purposely providing bad data or inaccurate answers to throw off the reliability of a study’s measures. Luckily, technology like two-factor authentication, CAPTCHA and other verification techniques can screen out trolls and bots so that data quality is not extensively affected. More recently, Ruxton explained that her colleagues in survey methodology are studying and incorporating machine learning to identify and mitigate fraudulent or otherwise inaccurate responses. And while there is not a solution to completely mitigate this possibility for research teams, digital health research platforms like Vibrent’s can vastly reduce the likelihood of trolls and bots with security best practices and the latest proven opt-in methods.  

Shame around sensitive topics 

Ruxton goes on to say that there is a generational or cultural gap often where many older participants aren’t comfortable sharing certain health information they consider to be private. This could be information they may just not know, like family medical history, or something they’re simply too ashamed to admit. “It may be that you’re asking a generation that just doesn’t talk about sensitive topics,” Ruxton added. A good example may be health research surveys asking about sexual history or history of sexually transmitted infections, or an emotionally difficult health experience such as miscarriages.  

The key in these situations is to be able to build trust with participants. You and your teams can find ways to preface these kinds of sensitive topics with guidance about the purpose of the question, trigger warnings, or to perhaps use a computer-assisted telephone interviewing (CATI) tool to conduct a live call with a person to give reassurance or support when navigating potentially upsetting questions around medical history. Surveys can also work up to more sensitive topics so that participants don’t feel blindsided with particularly intrusive questions. 

Researchers asking the wrong question

There may be the issue that researchers are simply asking the wrong question. “Either someone doesn’t know the correct answer and is either not providing a response or giving you their best guess, or they’re interpreting the question in a way you don’t intend them to,” Ruxton explained. 

Or the question’s wording could have multiple interpretations. “This is where it’s advantageous to have multiple eyes on a survey to see how people may be interpreting your questions. Maybe you’re asking something in a way where respondents think they’re giving you the right answer, but it’s not quite what you meant,” Ruxton said. 

Employ skillful methods and build trust 

While bots and trolls are purposely lying, most respondents are not providing inaccurate data intentionally. When mitigating the risk of inaccurate data, it’s key to employ skillful methodologists who can help you word questions and structure health research surveys and questionnaires in a way that fosters trust and clarity for respondents. And in order to avoid the chance of some data trolls or bots, having a technology provider who can help you screen out these kinds of fake participants with the latest digital best practices helps to ensure higher data quality than working with outdated or ineffective polling platforms.  

Looking for a skilled services team with best-in-class technology to improve your survey data? 

The post Top Three Reasons Why Health Research Survey Participants Lie  appeared first on Vibrent.

As a result of our work at Vibrent Health in helping clients design and implement eConsent technology and processes, we’ve managed to learn and adapt some best practices that could be useful to you and your research teams looking to adopt this efficient digital method.  

Differences between eConsent and Paper Consent 

Before we begin to offer eConsent best practices, here are some critical differences between eConsent and paper consent. 

• Accessibility and convenience: Paper consent is usually done in person but can be mailed to participants who are far away from sites or lack appropriate transit. eConsent on the other hand can be completely remote, which creates accessibility and convenience for patients. 
• Record-keeping: Paper consent is prone to data entry errors since it must be manually filed. Even if a digital copy is produced, this requires scanning the paper copy which can be time intensive for study staff scanning every consent form. eConsent is automatically stored and organized for easy tracking, including things like date it was signed, IP addresses, and other information that can be important to establish a compliant audit trail. 
• Flexibility: eConsent is also highly flexible to account for things like sub-studies, different languages, tailored content for different demographics and populations, while paper consent typically possesses far less versatility without creating and managing multiple versions manually. 

Make these vital decisions up front 

In creating eConsent content and processes, you first have to think several steps ahead of simple execution. Here are some vital things to consider up front. 

• Language translation: For one, translation has to come early on in the conversation. How many languages do you want to translate? Will other elements of your study need to be translated? Do you want to consider localization for different sites to account for geographic variations in dialect? 
• State regulations: State laws can create complexity for studies being conducted in many areas of the country. The same goes for international studies – you need competent guidance to ensure you are complying with the legal obligations that states can have. 
• IRB requirements: You will want to gather not just the typical requirements for traditional consent, but the additional specifications that IRBs ask for when creating digital consent. 
• eConsent video script: If you’re going to create a consent video, the trick is to make sure you write the script early on. It will likely change alongside the consent document. Video production can take a long time, so you want to do this up front. 
• Other media: Also consider other media or interactive elements you want to include up front. Think of ways to build trust and give prospective participants an inclusive, informative, easy process. 
• Organization of consent: How will you organize and structure your content? Getting the flow right is important in phase one of your consent creation. 
• Customization for different populations: Like translation, you want to think about the demographics you will target for your study and how you will customize content to fit their general needs and psychology. It may be worth using language to build trust with prospective participants from under-represented groups who may harbor mistrust or distrust of clinical research. 
• Stakeholder engagement: All of this can certainly be overwhelming to a team of researchers who may not know where to find certain information or how to complete some of these list items. Video is a clear example of that. So it’s important to think about the kind of expert stakeholders you need to partner with to get these things done. 

Research and follow state regulations 

State regulations are important to understand up front. Here are some kinds of information that laws typically call for when it comes to digital consent. 

• Patient bill of rights: A patient bill of rights has to be included in consent forms in Illinois and California, for instance. This is because it needs to be clear as to what information research participants have a right to request, and what they are allowed to do. 
• Confidentiality, right to withdraw: States may also require specific language be included around things like confidentiality, the purpose of the study, and a patient’s right to withdraw at any time. California is a great example of this, and they have quite an exhaustive list of what consent forms need to say and how they say it. 
• Legal consent age: There can be variation across states as to what age that research participants can legally consent. Make sure you have a clear picture of this, because the implications of improper consent could have dire consequences on your ability to do research. 

Understandably, interpreting and complying with state regulations can be tricky and perhaps time-intensive. Finding an expert or a team of experts can help you navigate a multi-state consent process with a sense of ease and security. 

Want to partner with eConsent experts?  

Submit the right materials to the IRB 

What are the materials you need to submit to an IRB for eConsent? There is some overlap between traditional and electronic consent, but we want to stress some differences. 

• Video script: If you are creating video, sending a script is a must. 
• Multimedia and interactive features: Document how interactive features will help increase patient understanding and garner support when needed. 
• Knowledge check questions: Submit your knowledge check questions and answers, along with any branching logic to show how prospective participants will be corrected if they answer each question correctly or incorrectly. 
• Data safeguards: Provide information on data safeguards to explain how you will keep participant data secure and private. 
• Overview of the process: And be sure to describe an overview of how your consent process will work. A good best practice we have observed is submitting a workflow graphic like the one on this slide to show what exactly happens when a participant end-user takes a specific action. 
• Technical information: In addition to data security and privacy, it’s also important to show how the digital infrastructure works. A good example is to explain how digital signatures will be recorded. 
• Risk assessment: Be sure to address questions such as: how will you assess and avoid risks? How will you mitigate them when they happen? How will you collect and store data? 
• Digital support: Another really important thing to explain is how you will support participants in the process should they become lost or confused. However,  any automated or digital support should not replace meaningful interaction with study staff. This is because it’s so important to build trust directly with participants as well as digitally. 

Read our blog IRB Approval for eConsent: What to Include in Your Protocol for a more in-depth look at what you need to submit to institutional review boards for digital consent. 

Integrate intuitive communication tools and processes 

Another best practice for eConsent is to consider integrating intuitive communication tools and processes that make eConsent an easier process for people who want to participate in your study. 

• Encourage participation/interaction: You can also use communication tools like reminders and bi-directional messaging so that participants are encouraged to reach out to study staff. 
• Send reminders: You can use communication tools to segment participants based on whether they have completed their consent, or completed certain surveys. This is great for reminding participants to complete consent and other study milestones. 
• Self-service portal: one way you can do this is by creating a comprehensive self-service portal where participants can go online to sign, view, and withdraw consent at any time, change their communication preferences so they are notified in the manner they want to be, a dashboard where they can view the items they’ve completed in the study to show their progress, and to offer them a way to easily schedule appointments with research staff. 
• Communication preferences: If participants have access to a portal that allows them to indicate their communication method of preference, they will receive a reminder via that method such as email, SMS, or an in-app notification. 

Follow eConsent video best practices 

• As a result of our time at Vibrent Health creating many consent videos for our collaborators, we have learned many best practices you can incorporate when creating them for your studies. 
• Plan ahead: Get your script written and then approved by the IRB. Get on board with a video team early so they have enough time to create it before your study starts. 
• Optimize length: As far as length, eConsent videos that are three minutes or less tend to be the right amount of time. Three minutes or less ensures optimal comprehensibility without sacrificing some detail. 
• Consider visuals: You want to consider your visuals carefully. Animation can quickly show how participation in the study works, and it can easily explain complex concepts. 
• Don’t use stock video: We caution against using stock video because it’s often too vague and doesn’t always convey what you want to participants. Animated video is often a better choice to illustrate complex topics in a way that is easy to understand for a non-scientific audience. 
• Be efficient: Make sure your visuals are created to make your script length an optimal length. The key is to use visuals for efficiency and avoid too much language. 
• Represent diversity: Visuals should always be representative of the populations you aim to recruit, and also account for underrepresented groups as well. 
• Use text: Closed captioning and translations (when applicable) help participants to follow along with the video and optimize comprehension. 
• Assess your audio: Narrators of videos should have a friendly, informational tone, and be representative of the communities you want to recruit and engage for your study. 
• Write for your audience: Use specific messaging that resonates with your target population and diverse populations. The script itself should help cultivate a delightful, informative experience, and to do that, we recommend gaining as much feedback as you can from people who aren’t necessarily involved in your study. 
• Be flexible and accessible: Always be mindful that not everyone can view the video, so you will want to plan accordingly. If participants can’t or don’t want to view the video, give them the option to read the transcript instead as a requirement of completing the consent process. 
• Ensure comprehension with knowledge checks: Knowledge checks are the hallmark of great eConsent because they ensure that participants understand what they are agreeing to. But it needs to be done right. 
• Define objectives: Getting clear on what you want participants to learn up front can easily help you formulate your questions. 
• Vary question types: In order to keep participants engaged during the knowledge check, use a variety of question types to make it interesting. 
• Be clear and concise: Make sure questions are clear and concise to avoid confusion and reduce the likelihood of incorrect responses. 
• Focus on important concepts: You want to make sure the knowledge check focuses on the right concepts that are key to understanding the study consent. 
• Provide immediate feedback: Knowledge checks should be able to provide immediate feedback to patients as to whether they successfully answered the question or not. 
• Optimize difficulty: Make sure that the knowledge check you create is in the ‘goldilocks zone’ between so difficult that few prospects pass, and so easy that it doesn’t adequately check participant knowledge. 
• Randomize questions: While not entirely necessary, we suggest randomizing questions to avoid logical progression of questions, and to keep it interesting. 
• Time limit: Consider creating a time limit if you want to ensure patients are not cheating or to motivate them to finish the knowledge check quickly. 
• Test it out: We always recommend pilot testing the knowledge check to be sure it works. 
• Adjust as needed: As your consent process and language evolves, you can evaluate how your needs for the knowledge check changes and update it accordingly. 

Create an easy, gratifying participant experience 

How do you create an easy, gratifying experience for participants? Here are some best practices to follow. 

• Think like a participant: Find out what demographics in your population tend to value, and find ways to speak to those values in your consent process and content. 
• Address fear/mistrust: You want to be sure to address fear and lack of trust when possible. One way you can do this in your recruitment and consent materials is by incorporating testimonials from actual trial participants. This is especially helpful for underrepresented groups who may harbor a lack of trust in clinical research. 
• Consider structure/design: Consider how your information is delivered by being deliberate in your design. Do you want to paginate portions of your consent to break up your content? Or do you want to incorporate it in one page for a continuous scroll? Will participants be using mobile or consenting primarily by tablet in-clinic? 
• Leverage primacy/recency effects: Make sure you take advantage of the primacy and recency effects, which basically means you present the most important information first and last, but not in the middle, because the beginning and end is where people retain the most information. 
• Summarize: A brief summary, especially with bullet points, is a great tool for ensuring clarity and comprehensibility of the consent. 
• Optimize detail: You want to consider how much detail you want to convey, and when brevity is more important. 
• Revise: Remember to think about ways to revise your consent. Can you cut elements out? Can you shorten it in some way? What will the typical participant need to understand? 
• Test your audience: Interviewing participants and researchers can help you to see if the consent process and content actually makes sense to them. 
• Think of the total experience: Being able to seamlessly flow prospects from initial recruitment into consent and study participation is part and parcel of a great participant experience. This is because it really should be that easy for participants. Having a participant portal for self-service that patients can navigate to from your study recruitment website makes this very easy. 

Don’t neglect participant engagement after consent 

eConsent is just the tip of the iceberg when it comes to engagement. Remember to follow these rules beyond the initial consent process with participants. 

• Keep them engaged: You want to find ways to keep participants engaged using regular touchpoints, especially in long studies. 
• Plan for reconsent/dynamic consent: It’s always a good idea to plan for reconsent, or to consider ongoing or dynamic consent. This means putting language in your consent that takes into account the possibilities of follow-up studies or sub-studies that come with your protocol design. 
• Seek consent for recontact: If you plan on possibly contacting patients for reconsent or ongoing consent, we highly encourage you to prime participant expectations in the initial consent so that they are not surprised when they are being given additional forms to complete, or the consent language or process has changed in a dramatic way. 

Conclusion 

eConsent continues to gain adoption and as a result has made an increasing impact on how participants engage with research studies. But we think there’s more to it that simply just doing it, and we’ve learned a lot of important lessons. There are far more nuances beyond this quick guide to eConsent. 

Want to partner with eConsent experts?  

Summary of best practices for eConsent 

• It’s important to think about stakeholders to bring in for things like video, IRB submission, state regulations and so forth. Making key decisions up front is key to ensuring a successful consent in the end. 
• Find out which states you will be consenting patients in so that you can fulfill the legal requirements for each one. 
• Compile the right materials to submit to your IRB, including the nitty gritty of how your digital consent works and how it ensures comprehension. 
• Think of intuitive ways and tools to communicate to participants so that you’re able to keep them engaged. 
• Be deliberate and plan ahead for your consent video, and think about how the video can best convey the information to foster informedness. 
• Create and test your knowledge checks to be sure they aren’t too difficult or too easy, and so that they are engaging. 
• You need to think like a participant and incorporate the right functionality and tools into your eConsent content and process so that it’s a gratifying, easy experience. 
• And remember, don’t neglect engagement after consent. Build in language that allows for reconsent or dynamic consent if you need to, and let participants know if consent for follow up studies may be required in the future. 

The post eConsent Best Practices  appeared first on Vibrent.

Improving participant engagement is all about adopting best practices and more efficient technology and processes. In this FAQ, we will seek to address some of these best practices and digital methods to ensure you and your research team are taking advantage of tested approaches to increasing participant engagement in your research studies.  

If you don’t see a question you want to ask below, please email us at info@vibrenthealth.com. 

How can I improve the recruitment process to consent more participants into my research study? 

Attracting more participants requires using a multi-channel approach to find the right participants and communicate in a way that these populations understand and can appreciate. 

Relying on only in-person recruitment or flyers will greatly reduce your study’s ability to consent enough participants. Beyond these traditional methods, you will need to add digital channels and methods to your plan. 

Using ads and regular social media posts targeted to the demographics you want to recruit is key to finding the right audience using digital methods. Secondly, utilizing a community approach will help you to reach specific demographics as well as building a more personal rapport between research institutions/team members and potential participants. Find community organizations and events you can collaborate with to tap into their networks and to engage more directly with your target populations. 

It’s also extremely important when writing messages to attract participants to think like the populations you want to recruit. Use messages that resonate with your participants. For instance, older generations may respond well to the benefit of contributing to the health of future generations. Minority populations who have a strong sense of community may respond well to the idea that they are contributing to the health of their race/ethnicity and thus helping to preserve their culture. For that matter, it is also important to reach out to the communities that you wish to engage for your studies. 

Lastly, in addition to using social media, it’s important to leverage other digital tools that can help to market your study to potential participants. Tools like study websites are incredibly helpful in explaining how studies work. Recruitment video can be a powerful tool for the recruitment and consent process. Working with experts in developing these kinds of digital media can help you to scale your recruitment more quickly and easily. 

In summary, to recruit more participants for a study: 

• Use targeted advertising and social media to reach your intended audience. 
• Collaborate with community organizations or institutions to tap into their networks. 
• Clearly communicate the benefits and significance of the study to potential participants. 
• Leverage other digital tools like study websites and video to easily explain your study. 

What are some effective strategies to retain participants throughout the entire duration of the study? 

Retention strategies hinge especially on maintaining open and transparent communication with participants. This is especially true in long-term studies that may include a genomics element. It’s important to provide regular updates on the study progress and its outcomes. This may entail providing return of information regarding the participant or the study in general. Of particular importance in your communication is to give participants choices in terms of the mediums in which you communicate such as SMS, email, newsletters, phone calls, etc. Providing participants the opportunity to indicate how they want to be contacted can help to give them the power to communicate the way they want to with the study team. It may also be important to include a community element or involve family members in your study to encourage ongoing participation. 

Additionally, you can encourage participants to continue the study by emphasizing the impact of their participation. You can also retain participants by offering incentives or rewards for their continued participation. This could look like offering gift cards when participants complete important study milestones.  

To sum it up, to retain participants through the end of your study: 

• Provide regular updates on the study progress and outcomes. 
• Give participants valuable return of results or return of information. 
• Communicate using mediums that participants prefer. 
• Utilize community and family involvement to help remind participants. 
• Offer incentives or rewards for continued participation. 
• Maintain open and transparent communication channels with participants. 

How do I create a participant-friendly informed consent process that encourages more individuals to participate? 

Essentially, implementing informed consent in your study requires you to make it easy for participants to understand and retain information about your study and how it may affect them. This allows you to build ample trust with your participants early in the study.  

 Be sure to use clear and simple language in your informed consent documents. Use video, infographics, and forms of interactive multimedia like knowledge checks to help participants to easily learn about your study and demonstrate their understanding. Additionally, give your participants ample time to review the information to make their decision. 

This is why electronic consent can be a great tool to encourage participation in your study, because it allows for participants to review consent documents on their time and to access them digitally for further review. If you’re looking to implement eConsent, we recommend working with a digital consent provider who can help you navigate regulations and various technological and ethical considerations when submitting materials to your IRB.  

To encourage participation in your study through your informed consent, be sure to: 

• Use clear and simple language in your informed consent documents. 
• Consider presenting information in alternative formats (e.g., videos, infographics). 
• Allow participants sufficient time to review the information and make their decision. 
• Work with an eConsent solution provider that helps you navigate ethical, legal, and technological complexity easily. 

What are some creative and engaging ways to present study information and instructions to participants? 

Study teams need to consider adapting modern digital approaches that most potential participants are used to seeing in their everyday lives. Video content, interactive online modules like knowledge checks, explanatory graphics and clear, concise writing resonates with potential participants and helps them better understand your study. Gamification elements showing progress and achievement of study milestones helps keep things transparent and can motivate participants to carry forward with study activities like filling out surveys. When it comes to writing, utilize storytelling techniques, testimonials, as well as words and phrasing that prospects can relate to when they’re deciding to participate or not. 

So when finding creative and engaging ways to present study information and instructions to participants, you can: 

• Use multimedia content, such as videos or interactive online modules. 
• Employ gamification elements to make the process enjoyable and interactive. 
• Utilize storytelling techniques to make the study purpose relatable. 

Are there specific incentives or rewards that have been shown to increase participant engagement without compromising the integrity of the study? 

Yes, there are specific incentives or rewards that have been shown to increase participant engagement in studies without compromising study integrity. These incentives are carefully designed to encourage participation while minimizing potential biases or undue influence on participants. Here are some examples: 

• Financial Compensation: Providing fair monetary compensation for participants’ time and effort is a common incentive. It ensures that participants are appropriately compensated for their contribution without creating undue pressure to influence their responses. 
• Gift Cards or Vouchers: Offering gift cards or vouchers for popular stores or online platforms can be an effective way to incentivize participation. This provides participants with the freedom to choose something they like without introducing bias. 
• Donations to Charity: Instead of providing direct compensation to participants, some studies offer to make a donation to a charity of the participants’ choice. This approach can appeal to participants who are motivated by altruism. 
• Access to Study Findings: Offering participants access to study results or a summary of findings can be a powerful incentive. People often appreciate being informed about the outcomes of research they contributed to. 
• Personalized Feedback: Providing individualized feedback or insights to participants based on their responses can be a compelling incentive, especially in studies related to self-assessment or personal development. 
• Entry into a Raffle or Prize Draw: Entering participants into a raffle or prize draw for valuable items (e.g., electronic gadgets) can motivate them to participate without directly influencing their responses. 
• Participation Badges or Certificates: Issuing digital badges or certificates to acknowledge participants’ involvement and contribution can be rewarding, particularly in online studies. 
• Public Recognition: With participants’ consent, researchers can acknowledge their contributions publicly, such as on a study’s website or in research publications. This recognition can be gratifying for some participants. 
• Return of Genetic Results: Knowledge is power. In studies that require genomics or other testing, its especially beneficial for participants to gain insights into their health, their genetics, or their family genetic history. Results don’t necessarily have to be actionable for participants.

It’s crucial to strike a balance between motivating participation and ensuring the integrity of the study. Researchers must be transparent about the incentives provided and avoid offering rewards that could lead to biased or untruthful responses. Lastly, it’s important to gain approval from your institutional review board (IRB) as to what type of incentives you plan to use. 

How can I ensure that my research study is culturally sensitive and inclusive to encourage participation from diverse populations? 

If you want to encourage participation from diverse populations, cultural sensitivity is important. You can involve representatives from the target populations you wish to recruit in your study design process to ensure they agree with various elements of the study. You can also consider translating study materials into relevant languages if necessary. And lastly, it’s important to understand different cultural norms and traditions as it relates to your research. Incorporating that understanding is key to your research study recruiting and retaining a culturally, ethnically, and racially diverse population. 

To ensure your research study encourages participation from diverse populations: 

• Involve representatives from the target populations in the study design process. 
• Translate study materials into relevant languages if needed. 
• Respect cultural norms and traditions throughout the research process. 

What role does communication play in maintaining participant engagement, and what are some best practices for maintaining regular contact with participants? 

It’s important to maintain regular communication, especially in long-term studies, to keep participants informed and engaged. Using regular touchpoints of communication helps to remind study participants of their role in the study and can remind them therefore to keep up with their participation. It is highly encouraged to use a mix of communication channels, or to give participants the ability to indicate communication preferences so that you can reach out to them using email, SMS, phone calls, newsletters or in other ways that meet participants where they’re at.  

To engage participants over the course of a study, particularly a long one, be sure to: 

• Regular communication to help keep participants informed and engaged. 
• Use a mix of communication channels (e.g., emails, phone calls, newsletters). 
• Provide updates on study progress and express appreciation for their participation. 

Are there any technologies or digital tools that have proven effective in enhancing participant engagement in research studies? 

Digital tools and technologies can increase participation by allowing for more convenience and accessibility as well as serving as an empowering and connecting experience. For example, online communities or discussion boards where participants can interact and share experiences fosters connection and community support. Mobile apps help to make the completion of study-related activities easier, and can help remind participants to complete surveys and other forms. Virtual meetings or webinars can increase engagement by speaking to the management of a condition or another relevant topic. Feedback sessions or other interactive events can encourage participants to let study teams know about their experiences with different aspects of the study. This can encourage a two-way communication between researchers and the people they study to increase the quality of studies and ultimately the quality of the data. 

Having study websites that help recruit participants and have easy-to-remember domain names are instrumental in recruiting and keeping participants involved in your study. Study portals can be used in place of, or in tandem with mobile applications so that participants can easily access study materials, fill out surveys, and easily obtain return of results. Online study portals and apps can also give participants more control over how they receive communication, and gives them the ability to connect wearable devices as well as their electronic health records to the study, thus prov 

Some technologies or digital tools that are effective in creating participant engagement in studies are: 

• Online forums or discussion boards for participants to interact and share experiences. 
• Mobile apps for study-related tasks and reminders. 
• Virtual meetings or webinars for engagement and feedback sessions. 
• Study portals for easy access to surveys, study materials, and return of results. 

How do I address potential barriers to participation and engagement that participants may face during the course of the study? 

Participation in studies has many aspects that researchers don’t even think about. It can be helpful for researchers to conduct a preliminary survey, a pilot test with a small group of participants, or interviews that could help identify potential barriers from potential participants or target study populations. Since one common barrier is time, offering flexible study schedules or locations can help accommodate participants as they navigate busy or atypical schedules. Creating study materials and engagement opportunities that are accessible to populations with disabilities are especially important. Text-to-speech, captioning for graphics and video, ensuring readability of text, accounting for text size, color, and contrast are some of many accessibility considerations. Also, if you plan to recruit many non-English speakers, translation is important to ensuring comprehension and thus quality data. 

Support and resources can also address practical challenges such as childcare, or financial and other support for particularly financially vulnerable populations to help them with transportation and other expenses. Remember that many participants find privacy concerns to be a barrier to participation. Find a way to safeguard protected health information and personally identifiable information they provide in the study and inform participants and prospects of these safeguards.  

In addition to ensuring support in face of these barriers, maintain two-way communication channels so that participants can address additional concerns as the study progresses. If you notice engagement dropping from participants, reach out to see if there’s anything you can do to understand the reasons behind it and make necessary adjustments.  

In order to address potential barriers to participation in a study, think to: 

• Conduct a preliminary survey, a pilot test, or interviews to identify potential barriers. 
• Offer flexible study schedules or locations to accommodate participants’ needs. 
• Account for accessibility using standard best practices like captioning. 
• Translate materials if a good portion of your population does not speak English well. 
• Provide support and resources to address practical/financial challenges. 
• Address privacy concerns early and often. 
• Encourage two-way communication to address barriers as they become apparent. 

What are some ethical considerations when implementing strategies to increase participant engagement? 

Before you consider implementing particular ways of improving participant engagement, it’s important to obtain informed consent that ensures participants are fully aware of their rights and so you have the right to re-contact them. Secondly, when considering ways to engage, be sure to protect participant privacy and confidentiality throughout the study. Lastly, engagement comes in many forms, and it may include monitoring for any signs of participant distress and reaching out to participants to give them access to appropriate support and resources that can help.  

If you have any other concerns regarding the ethics of your study, seek the trusted guidance of your institutional review board (IRB) or a trusted technology provider who can help you navigate the ethical nuances of digital engagement. 

When implementing participant engagement strategies, consider the ethical implications by seeking to: 

• Obtain informed consent and ensure participants are fully aware of their rights. 
• Protect participant privacy and confidentiality throughout the study. 
• Monitor for any signs of participant distress and provide appropriate support. 
• Seek guidance from your IRB or from a technology provider to navigate digital ethics. 

Are there any potential risks associated with increased participant engagement, and how can they be mitigated? 

Engaging and communicating with participants carries with it certain inherent risks that can be mitigated with effective approaches. For one, you can overburden or annoy participants with excessive communication or tasks, which can stress out participants or cause them to lose interest in your study. Potential data security and privacy risks may also arise if you are using digital tools. It’s important to work with technology providers and services to ensure robust data protection measures are in place to prevent leaks of protected health information and personally identifiable information. It’s also important to identify these risks early on to your IRB along with risk mitigation measures you can take to safeguard participant data. 

Risks associated with engaging participants in studies and ways to mitigate them include: 

• Overburdening participants with excessive communication or tasks. Find a balance between too much and too little communication. 

• Potential data security and privacy risks if using digital tools. Ensure robust data protection measures by partnering with knowledgeable technology providers and services teams. 

What steps can I take to ensure that participants remain motivated and interested in my research objectives? 

Keeping participants motivated to continue in studies can be challenging, especially if there are demands on their time, finances, and other aspects of their lives. It may be important to find regular touchpoints of communication to remind participants of the potential impact their contribution will have on the research, and how the research can be used to help other people in the future. These touchpoints can also be used to gather feedback from participants about what needs to be done to improve their experience in the study.  

Utilizing a comprehensive digital solution for case management and in managing and contacting different lists of participants based on study milestone completion and demographics can be instrumental to maintaining contact with different participants more easily without having to email individual participants. This kind of software also gives participants more freedom in scheduling appointments and providing data such as surveys and wearable data. Digital health research software can also give participants automated reminders to complete consent forms, surveys, and other study milestones. 

To ensure that participants remain motivated and interested in your research objectives: 

• Highlight the potential impact and relevance of the research. 
• Recognize and acknowledge participants’ contributions regularly. 
• Create a sense of community among participants, if possible. 
• Seek and integrate feedback if you notice a drop in participation. 
• Make it easy for your research team to maintain contact through a modern digital research solution. 

How can I use feedback from participants to continuously improve engagement strategies during the study? 

Finding ways to gather feedback regularly can give you ongoing insight into how to engage your participants better. Find a way to act on feedback promptly to show you care about participants and their experiences in the study. Once you implement changes, find a way to communicate these changes to participants to make sure they know you hear them. 

Adding a question to gain feedback at the end of data collection surveys could be one way to continuously make sure you are improving your study. It will also give you greater insight into how participants think, so you can create better studies in the future. If digital solutions like REDCap are serving as a roadblock to creating a better study with improved engagement, consider working with software that provides a more comprehensive, effective, user-friendly set of tools and a better experience for participants.  

If you want to use feedback to continuously improve your engagement strategies in your study, find ways to: 

• Conduct regular feedback surveys or focus groups to gather insights. 
• Act on participant feedback promptly to show responsiveness. 
• Implement changes based on feedback and communicate the improvements. 
• Add study feedback questions into your data collection surveys and procedures. 
• Consider digital software that gives your team robust tools for improving participant experience. 

Are there differences in participant engagement based on the type of research study (e.g., qualitative vs. quantitative, clinical trials vs. surveys)? 

Your research can dictate how you engage with participants. Some study types require more tailored approaches than others. For instance, qualitative research may involve more interactive discussions, while surveys can often focus on clarity and brevity. Clinical trials will involve more in-clinic testing and may require more trust to be built from clinicians since investigational drugs could alter the course of a participant’s health indelibly. Studies with a longitudinal survey component may require more communication touchpoints to keep participants engaged over time.  

Regardless of study types, a digital software that addresses data collection and patient engagement can vastly increase the abilities of research teams to keep their studies going, recruit participants and keep them engaged to ensure adequate data size and quality.  

Things to keep in mind when considering differences in engagement strategies across different studies: 

• Yes, different study designs may require tailored engagement approaches. 
• Qualitative studies may involve more interactive discussions, while surveys may focus on clarity and brevity. 
• Robust digital research software is important to improving engagement and thus data quality. 

What are some common mistakes researchers make that may hinder participant engagement, and how can I avoid them? 

Participant engagement can be tricky, but there are a few common mistakes researchers make to increase the chances of disengagement. For one, if participants aren’t given consistent, regular communication or feedback throughout the study, it’s easy for their interest to wane. Secondly, if study procedures or tasks become too complex, participants can get easily frustrated or distracted. This results in decreased compliance, or a total dropout from the study. When researchers fail to recognize and appreciate participants’ efforts, then participants may end up feeling taken for granted, which can decrease the motivation to continue or engage as fully as they could. 

Lastly, researchers often fail to acknowledge the role that technology plays in providing a good participant experience. Participants are interacting with technology all the time and expect consumer-grade digital experiences that are mobile friendly, use clear and concise phrasing, and incorporate user experience best practices. 

Common mistakes researchers make to hinder participant engagement in studies are: 

• Lack of communication or feedback to participants during the study. 
• Complexity in study procedures and tasks. 
• Failing to recognize and appreciate participants’ efforts. 

How can I involve participants in the dissemination of research findings to maintain their interest and investment in the study? 

There are many ways to disseminate research findings in ways that participants find enjoyable and increases their motivation in the study activities. You can organize participant-centered dissemination events or conferences. You can share study outcomes and publications with participants directly—this includes digital methods that allow you to give participants easy access to return of results. In some cases, studies have involved participants in writing blogs or articles related to the research! 

To involve participants in the dissemination of your research findings and further motivate them: 

• Organize participant-centered dissemination events or conferences. 
• Share study outcomes and publications with participants directly. 
• Involve participants in writing blogs or articles related to the research. 

What are the key considerations for creating user-friendly surveys and questionnaires to boost response rates and engagement? 

Be sure to use clear, unambiguous language in questions. Keep surveys concise and focused on relevant topics. And If you want to identify any issues or areas of improvement, pilot test the survey with a small group of potential participants or other researchers if you can. If you can, work with a services team with expertise in creating surveys and designing electronic data capture systems that capitalize on best practices in both of these areas. 

To create user-friendly surveys, always: 

• Keep surveys concise and focused on relevant topics. 
• Use clear and unambiguous language in questions. 
• Pilot test the survey with a small group to identify any issues. 
• Work with experts in survey methodology and digital survey software. 

How can I strike a balance between obtaining valuable data and respecting the time and effort of participants? 

Striking a balance between obtaining valuable data and respecting the time and effort of participants is a perennial issue in research. Structuring your data collection processes to minimize patient/participant burden and avoiding fatigue is key. This can be done by using proven digital data collection methods to minimize the amount of time participants need to be at a site for in-person appointments. Also, be sure to offer incentives that reflect the value and length of time of the participants’ efforts. 

If you want to strike a balance between obtaining valuable data from participants and respecting their time, think to: 

• Design efficient data collection processes. 
• Utilize proven digital methods to minimize participant burden. 
• Offer meaningful incentives that reflect participants’ efforts. 

What are some successful examples of participant engagement strategies from other research studies that I can learn from? 

Many study teams don’t seek to understand how other studies and institutions are successfully improving their engagement from participants. There are many studies that have adopted proven strategies with the help of efficient digital methods that drastically reduce their time and effort recruiting and engaging participants. Researchers can benefit from reading existing literature and reaching out to colleagues in the field to understand ways they can increase their chances of success in engaging participants. 

Here are some case studies where institutions and study teams are utilizing best practices and efficient, comprehensive software tools that improve engagement: 

To find successful examples of patient engagement strategies: 

• Engage with other researchers or attend conferences to learn from their experiences.
• Read case studies and literature that details the success of various digital methods and engagement best practices.  

The effectiveness of participant engagement strategies can vary depending on the specific context and study population. However, there are many benefits to adopting best practices that have proven successful across many different studies and research contexts. The key is to connect with other researchers, and to comb literature and case studies that show the effectiveness of participant engagement strategies as they relate to challenges particular to your study protocol, the populations you study, and in achieving your study program’s aims.  

It’s important to continuously assess and adapt your approach. This can be based on participant feedback during your study, or in looking at sensible approaches that incorporate the latest proven methods. Ultimately, the depth of insight your research uncovers is driven by the quality of your data. You need to successfully engage participants and drive optimal value for your research and its impact on human health. 

Don’t see a question you want to ask? Email us at info@vibrenthealth.com. 

The post Frequently Asked Questions on Increasing  Participant Engagement in Research Studies appeared first on Vibrent.

IRBs play a vital role in ensuring ethical and legal compliance for health research teams. This article explores the various requirements for eConsent that your IRB will likely expect to understand when reviewing your study’s scientific protocol. 

The Importance of an IRB Related to Consent 

IRBs pay special attention to the consent process for research participants because of their mandate to ensure the ethical conduct of research involving human subjects. This mandate spans a few different objectives: 

Protecting participant rights 

Informed consent is a fundamental ethical principle in research. This means, at its core, that research participants have control and autonomy over making decisions about whether they participate in research. IRBs seek to ensure your research program will adequately inform participants about your aims, any potential risks and benefits that come with participation, and their rights as it pertains to the study. 

Ethical responsibility 

The consent process serves as a safeguard against potential abuses or violations of participants’ autonomy, dignity, privacy, and confidentiality. IRBs ensure that researchers obtain valid and voluntary consent, minimizing the potential for exploitation or harm. 

Informed decision-making 

IRBs stress the importance that participants have a comprehensive understanding of the research in which they are consenting to participate. By reviewing consent documents and processes, IRBs assess that the information provided to participants is accurate, complete, and comprehensible. This enables participants to make informed decisions based on an understanding of the study’s purpose, procedures, potential risks and benefits, and alternatives. 

Risk-benefit assessment 

IRBs assess the potential risks and benefits associated with research protocols to determine whether the study is ethically justifiable. The consent process allows participants to weigh the potential risks alongside the potential benefits of a study to make an informed decision about their involvement. IRBs review consent forms and processes to ensure that participants are adequately informed about the nature and magnitude of the risks and benefits involved. 

Protecting vulnerable populations 

Certain groups, such as children, individuals with cognitive impairments, or those with limited decision-making capacity, are considered vulnerable in research settings. IRBs pay particular attention to the consent process for these populations to ensure that their rights and interests are protected. Special considerations, such as obtaining assent from children or utilizing appropriate proxy decision-makers, are taken into account by IRBs when reviewing the consent process. Assent is defined as a willingness to participate in research by persons who are not old enough to express informed consent but are old enough to understand how they will participate in the research, what the research aims to study, and any possible risks or benefits. Informed consent must always be obtained from a participant’s parent or legal guardian in addition to the participant’s assent. 

Legal and regulatory compliance 

IRBs operate within legal and regulatory frameworks that require the protection of human subjects in research. This includes national and state regulations. Compliance with these regulations is crucial to ensure the integrity and credibility of research findings. By overseeing the consent process, IRBs ensure that research protocols adhere to applicable regional, local, and federal laws and regulations, many of which accord with international ethical guidelines. 

Research integrity 

IRBs aim to uphold a high standard for integrity in the research programs they oversee. A robust consent process ensures that participants have a clear understanding of their rights, the study’s purpose, and what is expected of them. This fosters trust and cooperation between researchers and participants, maintaining the credibility and reliability of the research endeavor. 

What to Submit to an IRB for eConsent 

So, what do you need to include in your research protocol to satisfy the IRB’s expectations? Let’s explore some of the most likely components you’ll need to address. And if you’re already feeling a bit overwhelmed, let us help you figure it out.  

Overview of the eConsent Process 

A research protocol should begin with an overview of its eConsent process. This includes its purpose and its importance for the study. Questions that IRBs often ask for this component are: What are the benefits for the use of digital methods to acquire patient consent? Is there any scientific aim for using eConsent in place of traditional paper consent?  

In this section, you should summarize the overall process, explain specific steps in the process, and define expectations of the participant at each step. Some of our collaborators use workflow diagrams or detailed explanations for this portion. Here is an example for an eConsent workflow:

Aims of the Research Program  

Any IRB will expect to understand the research study via its specific objectives and aims. Objectives are broad statements that describe the desired outcomes of the study, whereas aims are more detailed, measurable, and focused objectives that serve as milestones within the research process. These objectives and aims should align with the research questions and/or hypotheses. 

If you’re concerned about your IRB’s willingness to support the use of electronic consent, be sure to emphasize the benefits of using eConsent to achieve the objectives and aims more specifically. 

Special Considerations in eConsent for Your Patient Population 

You will already be describing your target participant population, but if there are special considerations for accessibility or multi-language support, you should include that detail.  

For example, you may need to provide consent forms in multiple languages, ensuring comprehension by participants from diverse backgrounds. Additionally, it should be accessible to individuals with disabilities, incorporating features like screen reader compatibility and adjustable font sizes. If you have a population such as elderly patients who may lack access to or comfort with technology, explain how flexible your eConsent process is to help them along the way.

Materials for eConsent  

Your IRB will likely require review of the materials, screens, and content that participants will review during the consent process – whether on paper, or through digital methods. For eConsent, you will need to share materials with the IRB that can include: 

• An overview of the eConsent module and its purpose. 
• The screens that the participants will see during the process. 
• The eConsent video, or transcript of the video, that accompanies the process. 
• Any evaluation questions used for participant comprehension checks. 
• Data collected during consent.  
• How you plan to collect signatures (like a digital signature). 

Participant Comprehension and Informedness  

As explained above, the IRB wants to ensure that patients and participants are fully informed and can maintain decisional autonomy about their participation in research programs.  

This could involve comprehension quizzes, knowledge assessments, or interactive elements like AI chatbots embedded within the eConsent platform. Explain how these components will be designed to assess or otherwise increase participants’ understanding of key study information. 

Data Security and Privacy for eConsent  

Understanding how you will secure and protect participant data is critical to IRBs and research teams alike. Ensure you explain the details about how your eConsent platform addresses things that include: 

• Data Protection Measures: Describe the specific measures that will be implemented to ensure the security and privacy of participant data during the eConsent process. This could include encryption of data during transmission and storage, access controls (who on your team can access what data), secure server infrastructure, firewalls, and other technical safeguards. 

• Compliance with Data Protection Regulations: Emphasize the commitment to comply with relevant data protection regulations, such as the General Data Protection Regulation (GDPR) or Health Insurance Portability and Accountability Act (HIPAA), depending on the jurisdiction and the nature of the study. Explain how the eConsent process will adhere to the requirements and principles outlined in these regulations. 
• Data Storage and Retention: Outline the procedures for storing and retaining participant data collected during the eConsent process. Specify the duration for which the data will be retained and the mechanisms in place to ensure secure storage and prevent unauthorized access or disclosure. You may also want to outline the procedures for securely disposing of participant data once it is no longer needed.  
• Anonymization and De-identification: Explain how participant data will be anonymized or de-identified to protect privacy. Describe the techniques or methods that will be used to remove or encrypt personally identifiable information (PII) to ensure that data cannot be linked back to individual participants. 
• Data Sharing and Transfer: If there are plans to share or transfer participant data, provide details about the procedures in place to ensure secure data sharing and transfer. This may involve secure data transfer protocols, data sharing agreements, or anonymization processes before sharing the data with external parties. 
• Researcher Access and Data Use: Address how researcher access to participant data will be controlled and monitored. Explain the mechanisms in place to ensure that only authorized researchers have access to the data and that access is limited to what is necessary for the purposes of the study.  

This part of your protocol can create stress for many researchers. Managing the data and privacy necessary for recruitment in multiple states, for example, can become confusing. We can help you figure it out and provide example material if you plan to collaborate with Vibrent to deliver eConsent.  

Technical Infrastructure for the eConsent Platform  

If you’re planning to work with Vibrent to deliver eConsent, we have comprehensive language and materials we can share to explain the technical infrastructure that will protect your participants and you in the process. 

If you aren’t, you’ll need to make sure you share enough information for the IRB to make a clear decision about whether the platform you’ve chosen is robust enough. This could include: 

• Detailed architecture diagrams 
• How data is managed and housed 
• Privacy protection  
• Security credentials 

How the Research Study Will Assess Risk Associated with Digital Methods  

Conduct a thorough risk assessment specific to the eConsent process and describe any potential risks or challenges associated with using electronic methods for obtaining informed consent from your participants. Discuss the steps taken to mitigate these risks and protect participant rights. 

Approach for Supporting Participants through eConsent 

To promote participant engagement and address potential concerns or queries, you may need to explain to the IRB how your eConsent experience will provide support during the consent process.  

The eConsent platform should provide a way for participants to seek assistance, including email addresses and telephone numbers of your principal investigator or study staff, or online chat support, staffed by trained personnel. Likely, you’ll also want to include FAQs and help sections to address common participant queries and provide additional guidance. 

If you plan to provide a way for participants to provide feedback on their eConsent experience, enabling continuous improvement of the process, explain that as well. 

Describing eConsent to the IRB Doesn’t Have to Be Stressful 

Compiling and submitting this information to an IRB can be stressful. But making sure that patients and participants are protected in your study is truly important. 

If you’re concerned about submitting your eConsent process and materials to your IRB, we can help. We have materials that you can use if you’re planning to collaborate with us on your study. 

If not, and you’re interested in exploring a collaboration, request a pilot, and we can work together to make eConsent a painless part of your study. 

The post IRB Approval for eConsent: What to Include in Your Protocol  appeared first on Vibrent.