Q&A – The New Normal: Considerations for Restarting Research
In a recent webinar, Advarra IRB and research compliance experts discussed key areas to consider as we look to ramp up research in the COVID-19 pandemic’s “new normal.” Presenters discussed challenges such as how to communicate with stakeholders, how to prioritize the research portfolio, and ways to ensure compliance and participant and staff safety. Due to time constraints we weren’t able to answer all audience questions during the Q&A period, so our experts have answered some of the most popular questions in this blog.
Note: IRB policies vary; please contact your IRB regarding any specific questions.
Q: How should participants be consented via phone or email?
A: There is no prohibition on consenting by phone or by email. If not consenting in person, you must be able to verify the identity of the individual with whom you are communicating, provide an opportunity to answer questions, and assure that the informed consent form (ICF) is signed and returned. For more information, see question 11 in FDA Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Public Health Emergency.
Q: Do you have any guidance on witness to signatures when consent is conducted over the phone or email?
A: When using a witness in the consent process, it is best practice to have an objective, unbiased individual serve as witness. The witness should attest that the prospective participant received the consent, that the individual had an opportunity to have questions answered, and that the individual stated he/she signed the document and would return it.
Q: Should research participants be notified—or consent be sought from them—if a sponsor requests all participants’ COVID-19 test results be provided as part of the study data/case report form (CRF) for a non-COVID-19 study?
A: Yes, if the data is going to be part of the research data set, then the protocol and ICF should be amended, and participants should be notified and sign the amended ICF.
Q: What are your thoughts about keeping studies open that can be conducted virtually?
A: From a site perspective, the program’s entire portfolio should be assessed and various factors considered. The purpose of research is to answer a scientific question, which requires quality and complete data collection. At the same time, the participant and staff safety must be considered. If safety cannot be maintained or the scientific question can no longer be answered, then the study likely needs to be paused or suspended. If the study is almost complete and procedures can be done virtually, then there is likely a compelling reason to keep it open.
Consider include the organization’s scientific priorities, the needs of the patient population(s) served, the ease of research conduct, the ability to move procedures virtually, and the study’s status. Additionally, the statistical analysis plan and possibly the data analysis plan will need to be amended to reflect changes in what data is collected and how it is collected. For additional ideas, review Advarra’s Restart Your Research eLearning module.
Q: Do you have any suggestions for multisite study recruitment during this time?
A: Modes of recruitment can be specific to the research participant population and should be considered study by study. Take into account the participants’ age, socioeconomic status, technologic ability, and requested interaction with recruitment. Broadly speaking, different generations have different skills with technology tools. Depending on socioeconomic status and/or age, access to or use of cell phones (especially smartphones) may be limited. People may have the ability to answer phone calls or answer basic surveys online but may not interact well with uploading documents or pictures. Not all people are active on social media. The study may target minors which is a sensitive group to reach online. Security access on their devices may prevent them from being able to access sites or videos.
Q: Any suggestions for assessing participants’ technology access to be able to virtually participate in a study?
A: As discussed above, consider the participant population’s demographics. Certain populations may be more or less comfortable with electronic tools for virtual study conduct. Also consider geographic and socioeconomic factors for your site’s community and the target participant population; not everyone has regular, reliable high-speed internet access.
Q: Can IRBs require that sites/sponsors implement safety processes to decrease the risk of COVID-19?
A: An IRB has jurisdiction over the research. If the safety procedures are not specific to the research with data collected about those safety procedures, it is unlikely the IRB has authority to require general safety precautions.
Q: If patients must be screened for COVID-19 per hospital standards when coming for clinical trial-specific visits only, could this be reimbursed by sponsors?
A: This is worth discussing/negotiating with the sponsor, particularly if the person is only coming to the site for the clinical trial visit. If the participant is expected to cover the cost of the testing, then it should be disclosed in the ICF; that could impact people’s willingness to participate. Also consider to what extent the COVID-19 testing cost is covered by the local/regional health authority. If the jurisdictions provide testing at no cost (including coverage for facilities and practitioner time), it wouldn’t be appropriate to have the sponsor cover the cost.
Q: If the sponsor requires COVID-19 results be reported in an ongoing study, should participants be consented or reconsented?
A: Yes, if the data will be part of the research data set, and this is not part of the original protocol and ICF. The protocol and ICF should be amended, and participants should be notified and sign the amended ICF.
Q: Can you provide any budget-proof strategies around restarting research (e.g., adjusting costs for remote modalities vs the “old normal”)?
A: We suggest evaluating budgets as research resumes. Consider costs associated with additional technology, time, training, etc., and open conversations with the sponsor to help account for those costs. Also ask the organization’s/program’s administration and IT teams if existing technologies already exist that can be applied where possible, and find out whether multiple departments/units can combine efforts to spread the implementation impacts (and increase effectiveness). Think about organization/program-wide answers rather than study-specific answers.
Sponsors may recommend certain technologies, which may be the best solution—but if a technology is already in place that will speed transition to a remote/virtual environment, make sure it will meet study’s needs. Example: A sponsor may be able to provide “X” communication solution for conducting video visits. But if your organization already has solution “Y” in place (including IT vendor assessments, compliance assurances, policies, and processes), it may be better to tell the sponsor about that available technology so research can continue.
Q: Could confidentiality issues arise if participants being screened according to university-wide procedures answer COVID-19 screening questions that are reported to local public health authorities?
A: The screening procedure, which presumably is being conducted as part of research, should include information regarding privacy and confidentiality protections.
Q: Who should sites/sponsors consult with to determine if e-signature is legal in their setting?
A: Electronic systems used to generate electronic signatures on clinical trial records, including ICFs, during the COVID-19 public health emergency must comply with the requirements outlined in FDA regulations at 21 CFR part 11 (Part 11) when applicable. Compliance with Part 11 should be discussed with your technology team and potentially your legal department. Depending on the systems being used, your technology team will help identify if the necessary steps and documentation are in place. If you use a commercial off-the-shelf solution, the vendors may be able to provide sponsors and other regulated entities with information regarding Part 11 compliance. See FDA Guidance Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers for more information.
To find out more about ways sites, institutions, sponsors, and CROs can address the challenges of research in the current health crisis, watch the webinar The New Normal: Considerations for Restarting Research.