Presentation
MDD30 - To IRB or Not to IRB? That is the Question. Survey Results From Our HF Community
SessionPoster Session 1
DescriptionBACKGROUND. Last year, we presented a poster titled “Medical Device Human Factors: To IRB or Not to IRB? That is the Question,” which was motivated by the large differences in opinion about whether IRB oversight is needed for medical device human factors (HF) usability research. Specifically, some of our HF colleagues argue one end of the extreme that IRB review is needed for all medical device HF usability studies that involve human subjects, whereas others contend that none of these studies require IRB review. These contrasting viewpoints prompted us to dig into the FDA documentation and other research to understand whether IRB oversight is needed for medical device HF usability testing to comply with the Agency’s regulations.
We were not prepared for the ambiguity that we found; HF is in a unique regulatory space, so much so that even some regulatory personnel are unsure about the need for IRB review of HF studies. This ambiguity, however, informed our decision to create a well-researched IRB Decision Tree that we shared in our poster to provide our community with the tools and understanding they need to determine if their research should undergo IRB review and why. Our conclusion from the IRB Decision Tree is that IRB involvement is likely needed for all HF studies involving FDA-regulated medical devices. Presenting our poster confirmed that this is a hot topic and subject of debate among the HF research community.
OUR IRB SURVEY. In an effort to clarify the reasons why so many differing perspectives exist for whether medical device HF research requires IRB oversight, we conducted a survey. The survey asked our community to report approximately what percentage of the medical device usability research they conduct have undergone IRB review, for what reasons they did not get IRB review for this research (if applicable), and what value IRB oversight brings to research. It also asked respondents questions about their educational and professional backgrounds to better understand whether deciding to get IRB oversight is influenced by these areas.
IMPORTANCE. The results of our survey will continue to shed light on what spurs differences in opinion and understanding of whether IRB oversight is needed for medical device HF usability research. Such insights will help to inform next steps as a community toward education and alignment on this topic.
FINDINGS. This survey will remain open until we need to print our poster in March. Thus far, the results confirm the wide variety in whether IRB review is conducted for medical device HF research: some respondents reported getting IRB oversight for 0% of their research, others indicated getting it for 10-50% of their research, some for 70-80% of their research, and several for 100% of their research.
All of the respondents who work in higher-education organizations reported getting IRB oversight for 100% of their research, whereas the frequency varied between 0-100% across respondents who work for a for-profit business. Furthermore, the percentage of medical device usability research that has undergone IRB review does not appear to depend on company size.
The most prevalent reason for not getting IRB for medical device usability research is that the research is not a clinical investigation as defined by the FDA. Notably, this result is consistent with the fact that the FDA regulations about IRB review tend to be written for clinical trials/clinical studies rather than for medical device HF research. Other common reasons provided for not getting IRB oversight are that participants are not placed at psychological risk, participants are not placed at physical risk, the research does not capture biometric data, and the research does not involve a control group vs. intervention group.
Respondents most frequently reported that the value an IRB brings to research is ensuring physical safety (i.e., protects the participant from potential physical harm). Other commonly reported values are liability safety (i.e., it decreases liability risk), informed consent (i.e., it helps to guarantee that the research is designed to support or inform individuals of their rights as human participants), data privacy (i.e., helps to ensure the protection and privacy of data). and psychological safety (i.e., protects participants from psychological harm).
CONCLUSIONS. Taken together, the results from this survey validate that the amount of medical device HF studies that undergo IRB review drastically varies (from 0-100%) among those in our community. Given that respondents tended to think that that IRB oversight is not needed for this research because it is not a clinical investigation and that the value of the IRB is to protect participants from physical harm speaks to ambiguity of the current FDA regulations on IRB oversight; these regulations tend to discuss this topic with clinical research in mind and do not clearly indicate how they apply – if at all – to HF. Indeed, some respondents indicated that getting IRB oversight is required for medical device HF research and meets FDA regulations. The findings emphasize the need to enhance clarity in the regulations to increase FDA submission compliance and success, in addition to ensuring the protection of the rights and welfare of human participants when needed.
We were not prepared for the ambiguity that we found; HF is in a unique regulatory space, so much so that even some regulatory personnel are unsure about the need for IRB review of HF studies. This ambiguity, however, informed our decision to create a well-researched IRB Decision Tree that we shared in our poster to provide our community with the tools and understanding they need to determine if their research should undergo IRB review and why. Our conclusion from the IRB Decision Tree is that IRB involvement is likely needed for all HF studies involving FDA-regulated medical devices. Presenting our poster confirmed that this is a hot topic and subject of debate among the HF research community.
OUR IRB SURVEY. In an effort to clarify the reasons why so many differing perspectives exist for whether medical device HF research requires IRB oversight, we conducted a survey. The survey asked our community to report approximately what percentage of the medical device usability research they conduct have undergone IRB review, for what reasons they did not get IRB review for this research (if applicable), and what value IRB oversight brings to research. It also asked respondents questions about their educational and professional backgrounds to better understand whether deciding to get IRB oversight is influenced by these areas.
IMPORTANCE. The results of our survey will continue to shed light on what spurs differences in opinion and understanding of whether IRB oversight is needed for medical device HF usability research. Such insights will help to inform next steps as a community toward education and alignment on this topic.
FINDINGS. This survey will remain open until we need to print our poster in March. Thus far, the results confirm the wide variety in whether IRB review is conducted for medical device HF research: some respondents reported getting IRB oversight for 0% of their research, others indicated getting it for 10-50% of their research, some for 70-80% of their research, and several for 100% of their research.
All of the respondents who work in higher-education organizations reported getting IRB oversight for 100% of their research, whereas the frequency varied between 0-100% across respondents who work for a for-profit business. Furthermore, the percentage of medical device usability research that has undergone IRB review does not appear to depend on company size.
The most prevalent reason for not getting IRB for medical device usability research is that the research is not a clinical investigation as defined by the FDA. Notably, this result is consistent with the fact that the FDA regulations about IRB review tend to be written for clinical trials/clinical studies rather than for medical device HF research. Other common reasons provided for not getting IRB oversight are that participants are not placed at psychological risk, participants are not placed at physical risk, the research does not capture biometric data, and the research does not involve a control group vs. intervention group.
Respondents most frequently reported that the value an IRB brings to research is ensuring physical safety (i.e., protects the participant from potential physical harm). Other commonly reported values are liability safety (i.e., it decreases liability risk), informed consent (i.e., it helps to guarantee that the research is designed to support or inform individuals of their rights as human participants), data privacy (i.e., helps to ensure the protection and privacy of data). and psychological safety (i.e., protects participants from psychological harm).
CONCLUSIONS. Taken together, the results from this survey validate that the amount of medical device HF studies that undergo IRB review drastically varies (from 0-100%) among those in our community. Given that respondents tended to think that that IRB oversight is not needed for this research because it is not a clinical investigation and that the value of the IRB is to protect participants from physical harm speaks to ambiguity of the current FDA regulations on IRB oversight; these regulations tend to discuss this topic with clinical research in mind and do not clearly indicate how they apply – if at all – to HF. Indeed, some respondents indicated that getting IRB oversight is required for medical device HF research and meets FDA regulations. The findings emphasize the need to enhance clarity in the regulations to increase FDA submission compliance and success, in addition to ensuring the protection of the rights and welfare of human participants when needed.
Event Type
Poster Presentation
TimeMonday, March 314:45pm - 6:15pm EDT
LocationFrontenac Foyer
Digital Health (DH)
Simulation and Education (SE)
Hospital Environments (HE)
Medical and Drug Delivery Devices (MDD)
Patient Safety and Research Initiatives (PS)