Existing guidance
Little official guidance exists on responding to IFs, let alone during HF studies. As an example, the Food and Drug Administration (FDA) refers to the Code of Federal Regulations (CFR) for regulations and law applicable to human subjects research (21 C.F.R. 2020, Part 50), yet the CFR does not mention IFs. Our own search for organizations in the United States, European Union, and United Kingdom that govern or advise on human subjects research does reveal some guidance, protocols, and recommendations on dealing with IFs (see Resources for a list of what we found). However, no consensus currently exists regarding how to best handle IFs. Additionally, because the existing guidance focuses primarily on medical and psychological research, the approach for addressing IFs in HF research is still undetermined; this is in part because how IFs appear during HF research is generally different from how they appear in medical or psychological research. Fortunately, because HF research falls under the umbrella of human subjects research, we can consider how other fields suggest responding to IFs and apply suggestions to HF research.
Recommendations
First, attempt to eliminate the possibility of IFs occurring. Avoiding IFs, if feasible, is ideal. If eliminating the possibility of IFs is not feasible, consider the following recommendations:
Get advice.
Consider any IF-related best practices provided by your institution/organization and provided by the legal entity overseeing your research (e.g., IRB). Other strategies for responding to IFs can be implemented in absence of, or in addition to, these best practices.
Plan for IFs.
- Determine the potential for IFs at the outset of test planning.
- Identify IFs that are not harmless (i.e., IFs that could potentially lead to harm).
- Ensure all project stakeholders (e.g., clients, third-party researchers) agree on the approach to responding to IFs.
Determine how you will respond to IFs.
- Develop a script for responding to IFs, and ensure the script receives approval from the IRB and from project stakeholders.
- Consider when and how to incorporate participant preferences, such as whether participants want to be informed of any IFs.
- Consider participant confidentiality requirements (e.g., General Data Protection Regulation [GDPR]) and any limitations that might impose on IF reporting.
Act appropriately during the study.
- Before a session begins (e.g., in the informed consent form), inform participants that you might discover something about their health of which they might be unaware, and describe the implications (e.g., the potential need to follow up with a doctor).
- Enable participants to opt in or out of learning information related to an IF before their session begins (e.g., in the informed consent form).
- If you encounter an IF during a study, remain calm to help keep participants at ease.
- Do not address IFs until after all study activities are completed to avoid compromising the data.
- Follow the protocol and script you developed for responding to IFs.
- Inform participants of the facts and how to proceed.
- Do NOT give any medical advice of any type; HF researchers are not qualified to do so.
- Encourage participants to direct any questions about the IF to a doctor.
- At the end of the study session, remind participants of the contact information for the study so that they can reach out with any questions.
Resources
Below is a list of the resources we found when searching for existing guidance:
- Recommendations on Reporting Incidental Findings from the United States Department of Health and Human Services
- Managing incidental findings and research results in genomic research involving biobanks and archived data sets from Genetics in Medicine
- Incidental findings in research with human participants: Ethical challenges for psychologists from the American Psychological Association Committee on Human Research
- Guidance Note for Researchers and Evaluators of Social Sciences and Humanities Research from the European Commission
- Framework on the feedback of health-related findings in research from the Medical Research Council
Ruben Post and Alexandra Benbadis are Senior Human Factors Specialists at Emergo by UL's Human Factors Research & Design division.
Learn more about HF testing for medical devices:
- HFE user research support for medical devices and IVDs
- Medical device and product evaluation and usability testing
- Webinar: Human factors engineering for medical devices