Presentation
MDD22 - Medical Device Human Factors Testing: To IRB or Not to IRB? That is the Question.
DescriptionINTRODUCTION
This presentation is motivated by what was becoming a frequent debate and a point of confusion among our consulting team and clients: Do medical device human factors (HF) usability studies need Institutional Review Board (IRB) review? As consultants, we nearly always suggest to our clients that their HF studies need IRB review and include this activity in our description of services. Oftentimes, however, our clients push back and ask why they need one. When we point them to the relevant FDA regulations on this topic to justify why IRB review is needed for their studies, they frequently remain unconvinced and struggle to understand how the content relates to their testing. We then find it difficult to answer their questions to their satisfaction. After repeatedly encountering this challenge, we decided to roll up our sleeves and deeply investigate applicable regulations to determine once and for all whether HF studies need IRB review. 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 will share during this presentation.
HF is in a gray area; it lives at the intersection between psychology and clinical research. Consequently, on the surface, which guidance documents and regulations apply to HF studies are unclear. Current guidance documents, including the Informed Consent guidance published this year [1], can pose more questions than they answer.
When we asked our colleagues whether an IRB review is needed for HF studies, we found that large differences exist in opinion and understanding. These differences tended to be strengthened by educational and professional backgrounds, with some people arguing one end of the extreme that IRB review is needed for all studies involving human subjects and others arguing the other end of the extreme that no HF studies need IRB review; rather, it should only be performed for clinical trials. Regardless of which side of the debate our colleagues are on, none were able to reference resources or guidelines that clearly supported their argument as it pertains to HF. The more research we did and the more people we spoke with about this topic, the muddier the answer to our question became. In fact, over a series of thoughtful conversations with one of our regulatory consultants, we witnessed her move from thinking IRB review is not needed to starting to believe that it is, during which time she admitted to her confusion about the current regulations and which ones apply to HF studies.
Because we like a challenge and finding an answer to this question was becoming an obsession, we persevered, dug into more research, and organized our findings. We developed an IRB Decision Tree that maps the important decision points and paths to determine whether IRB review is needed. Because following the regulations and the Tree requires understanding how to define terms such as “clinical investigation” and if research results are “generalizable,” our Tree defines what these terms mean so users have the information they need to make an appropriate choice. Now, we finally feel that we have made some sense of this complicated topic! Given how unexpectedly difficult it has been to answer this seemingly simple question, we decided that the Decision Tree is the perfect tool to bring to our HF community. The research done to create this Tree has led us to conclude that all HF studies involving FDA-regulated medical devices require IRB involvement. We look forward to discussing this with the community.
PURPOSE
To help our colleagues determine if IRB review should be involved for their HF studies, our presentation will offer a well-researched IRB Decision Tree that details all the potential factors to consider. Following the Decision Tree pathways will help with understanding which regulatory bodies to consider, how the primary regulatory bodies differ, and where we believe medical device HF studies fall within each regulation. Our presentation aims to provide the community with the tools and understanding they need to determine if their research should undergo IRB review and why. We hope this content sparks discussion and potentially motivates changes in regulations to more clearly include or exclude HF studies.
THE IRB DECISION TREE FOR HF STUDIES
After introducing our colleagues to the IRB roles and responsibilities and the purposes of IRB review, our presentation will focus on detailing the IRB Decision Tree. Based on our research, the Tree presents five general steps to determine whether HF studies need IRB review.
Step 1: Determine whether the institution’s internal policies require HF studies to undergo IRB review. If they do, then the answer is easy! Simply skip the rest of the steps and have an IRB review the study. If, however, they do not, then steps 2-5 should be completed.
Step 2: Establish which organizations and regulations are relevant. All regulatory bodies have their own guidelines that explain when IRB review is required. So, the next step in the Decision Tree is to determine which organization(s) and regulation(s) are relevant for the study by answering (1) who is funding or supporting the research; (2) who is regulating the research. Our Tree involves three regulatory organizations that are most relevant to our work in HF: the FDA, the Department of Health and Human Services (HHS), and the National Institute of Health (NIH). In our presentation, we will walk through the Decision Tree paths for each of these three organizations.
Step 3: Classify the Research. According to HHS and the NIH, activities must undergo IRB review before beginning any research activity if they meet the definitions of “research” and “human subject” [2]. Per the FDA, protection of human subjects applies to “clinical investigations” [3]. Our research has revealed that determining whether HF studies meet these different definitions is not a trivial process. We will break this process down and discuss how we navigated this step and classified HF studies by referencing the relevant regulations themselves.
Steps 4 and 5: Determine whether the research could be exempt (Step 4) or eligible for expedited review (Step 5). Depending on the regulations referenced, different considerations should be made when determining whether HF studies are eligible for expedited or exempt from IRB review. We will walk our colleagues through how to navigate these differences using our Decision Tree.
WHY IS KNOWING THE ANSWER TO THE IRB QUESTION IMPORTANT?
Failing to get IRB review and approval when it is needed could result in the FDA deciding not to consider any of the study’s data or information when they are considering supporting an application for a research or marketing permit [4]. It could also result in an increased risk of violations to participants’ rights and welfare. These serious consequences provide even more reason to align on an answer to the IRB question!
SUMMARY
We will conclude our presentation by stating our viewpoint that IRB involvement is needed for all HF studies involving FDA-regulated medical devices. Given this conclusion, we would like to discuss with the community their reactions, experiences, potential confusion points, and the prevalence of possible consequences of not getting IRB review for HF studies.
We hope that this presentation will take a step toward achieving more clarity to the answer of: To IRB or not to IRB? That is the question for medical device HF researchers.
REFERENCES
[1] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices
[2] https://irbo.nih.gov/confluence/display/ohsrp/Step+1 and https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts-2018/index.html
[3] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=50&showFR=1#:~:text=%28a%29%20This%20part%20applies%20to%20all%20clinical%20investigations,biological%20products%20for%20human%20use%2C%20and%20electronic%20products.
[4] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=56&showFR=1
This presentation is motivated by what was becoming a frequent debate and a point of confusion among our consulting team and clients: Do medical device human factors (HF) usability studies need Institutional Review Board (IRB) review? As consultants, we nearly always suggest to our clients that their HF studies need IRB review and include this activity in our description of services. Oftentimes, however, our clients push back and ask why they need one. When we point them to the relevant FDA regulations on this topic to justify why IRB review is needed for their studies, they frequently remain unconvinced and struggle to understand how the content relates to their testing. We then find it difficult to answer their questions to their satisfaction. After repeatedly encountering this challenge, we decided to roll up our sleeves and deeply investigate applicable regulations to determine once and for all whether HF studies need IRB review. 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 will share during this presentation.
HF is in a gray area; it lives at the intersection between psychology and clinical research. Consequently, on the surface, which guidance documents and regulations apply to HF studies are unclear. Current guidance documents, including the Informed Consent guidance published this year [1], can pose more questions than they answer.
When we asked our colleagues whether an IRB review is needed for HF studies, we found that large differences exist in opinion and understanding. These differences tended to be strengthened by educational and professional backgrounds, with some people arguing one end of the extreme that IRB review is needed for all studies involving human subjects and others arguing the other end of the extreme that no HF studies need IRB review; rather, it should only be performed for clinical trials. Regardless of which side of the debate our colleagues are on, none were able to reference resources or guidelines that clearly supported their argument as it pertains to HF. The more research we did and the more people we spoke with about this topic, the muddier the answer to our question became. In fact, over a series of thoughtful conversations with one of our regulatory consultants, we witnessed her move from thinking IRB review is not needed to starting to believe that it is, during which time she admitted to her confusion about the current regulations and which ones apply to HF studies.
Because we like a challenge and finding an answer to this question was becoming an obsession, we persevered, dug into more research, and organized our findings. We developed an IRB Decision Tree that maps the important decision points and paths to determine whether IRB review is needed. Because following the regulations and the Tree requires understanding how to define terms such as “clinical investigation” and if research results are “generalizable,” our Tree defines what these terms mean so users have the information they need to make an appropriate choice. Now, we finally feel that we have made some sense of this complicated topic! Given how unexpectedly difficult it has been to answer this seemingly simple question, we decided that the Decision Tree is the perfect tool to bring to our HF community. The research done to create this Tree has led us to conclude that all HF studies involving FDA-regulated medical devices require IRB involvement. We look forward to discussing this with the community.
PURPOSE
To help our colleagues determine if IRB review should be involved for their HF studies, our presentation will offer a well-researched IRB Decision Tree that details all the potential factors to consider. Following the Decision Tree pathways will help with understanding which regulatory bodies to consider, how the primary regulatory bodies differ, and where we believe medical device HF studies fall within each regulation. Our presentation aims to provide the community with the tools and understanding they need to determine if their research should undergo IRB review and why. We hope this content sparks discussion and potentially motivates changes in regulations to more clearly include or exclude HF studies.
THE IRB DECISION TREE FOR HF STUDIES
After introducing our colleagues to the IRB roles and responsibilities and the purposes of IRB review, our presentation will focus on detailing the IRB Decision Tree. Based on our research, the Tree presents five general steps to determine whether HF studies need IRB review.
Step 1: Determine whether the institution’s internal policies require HF studies to undergo IRB review. If they do, then the answer is easy! Simply skip the rest of the steps and have an IRB review the study. If, however, they do not, then steps 2-5 should be completed.
Step 2: Establish which organizations and regulations are relevant. All regulatory bodies have their own guidelines that explain when IRB review is required. So, the next step in the Decision Tree is to determine which organization(s) and regulation(s) are relevant for the study by answering (1) who is funding or supporting the research; (2) who is regulating the research. Our Tree involves three regulatory organizations that are most relevant to our work in HF: the FDA, the Department of Health and Human Services (HHS), and the National Institute of Health (NIH). In our presentation, we will walk through the Decision Tree paths for each of these three organizations.
Step 3: Classify the Research. According to HHS and the NIH, activities must undergo IRB review before beginning any research activity if they meet the definitions of “research” and “human subject” [2]. Per the FDA, protection of human subjects applies to “clinical investigations” [3]. Our research has revealed that determining whether HF studies meet these different definitions is not a trivial process. We will break this process down and discuss how we navigated this step and classified HF studies by referencing the relevant regulations themselves.
Steps 4 and 5: Determine whether the research could be exempt (Step 4) or eligible for expedited review (Step 5). Depending on the regulations referenced, different considerations should be made when determining whether HF studies are eligible for expedited or exempt from IRB review. We will walk our colleagues through how to navigate these differences using our Decision Tree.
WHY IS KNOWING THE ANSWER TO THE IRB QUESTION IMPORTANT?
Failing to get IRB review and approval when it is needed could result in the FDA deciding not to consider any of the study’s data or information when they are considering supporting an application for a research or marketing permit [4]. It could also result in an increased risk of violations to participants’ rights and welfare. These serious consequences provide even more reason to align on an answer to the IRB question!
SUMMARY
We will conclude our presentation by stating our viewpoint that IRB involvement is needed for all HF studies involving FDA-regulated medical devices. Given this conclusion, we would like to discuss with the community their reactions, experiences, potential confusion points, and the prevalence of possible consequences of not getting IRB review for HF studies.
We hope that this presentation will take a step toward achieving more clarity to the answer of: To IRB or not to IRB? That is the question for medical device HF researchers.
REFERENCES
[1] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices
[2] https://irbo.nih.gov/confluence/display/ohsrp/Step+1 and https://www.hhs.gov/ohrp/regulations-and-policy/decision-charts-2018/index.html
[3] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=50&showFR=1#:~:text=%28a%29%20This%20part%20applies%20to%20all%20clinical%20investigations,biological%20products%20for%20human%20use%2C%20and%20electronic%20products.
[4] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=56&showFR=1
Event Type
Poster Presentation
TimeTuesday, March 264:45pm - 6:15pm CDT
LocationSalon C
Digital Health
Simulation and Education
Hospital Environments
Medical and Drug Delivery Devices
Patient Safety Research and Initiatives