Presentation
MDD23 - The Role of Institutional Review Boards in Human Factors Research
DescriptionInstitutional Review Boards (IRB) were established over four decades ago in response to major reports of unethical treatment of human research subjects. International recognition of the need for guidelines when conducting human subject research emerged following the Nuremberg trials, where the unethical medical experimentation by Nazi doctors during World War II came to light. The international community responded with the creation of the Neuremberg Code in 1945, followed by the Declaration of Helsinki in 1964. During this period in the United States, public disclosure of the Tuskegee Syphillis Study, in which 300 black men were left untreated for syphillis despite the availability of antibiotics, prompted Public Law 93-348. This ultimately led to the publication of the Belmont Report, which established three general ethical principles to be applied to human research, (1) beneficence, (2) respect, and (3) justice.
Although IRB review typically is not required for simulated-use human factors studies, there are situations in which IRB review is beneficial to both the researcher and the participants even when there is not clinical use of a medical device or combination product. IRB review can ensure that participants are adequately informed of the research procedures and risks prior to their participation. By ensuring that participants are aware of the requirements for their participation during the recruiting and informed consent process, researchers may then reduce the risk that participants withdraw from the study after being recruited.
IRB review is particularly important when working with vulnerable populations such as children, pregnant women, or people with reduced cognitive abilities such as patients with Alzheimer’s disease. Special considerations need to be taken when designing recruiting screeners, Informed Consent Forms, and Moderator’s guides to ensure the participant’s safety.
The purpose of this presentation is to discuss the importance of engaging an IRB for ethical review of human factors studies. This presentation will cover topics including (1) history of IRB review, (2) when to submit research for IRB review, (3) special populations in research, (4) and designing an Informed Consent Form.
Although IRB review typically is not required for simulated-use human factors studies, there are situations in which IRB review is beneficial to both the researcher and the participants even when there is not clinical use of a medical device or combination product. IRB review can ensure that participants are adequately informed of the research procedures and risks prior to their participation. By ensuring that participants are aware of the requirements for their participation during the recruiting and informed consent process, researchers may then reduce the risk that participants withdraw from the study after being recruited.
IRB review is particularly important when working with vulnerable populations such as children, pregnant women, or people with reduced cognitive abilities such as patients with Alzheimer’s disease. Special considerations need to be taken when designing recruiting screeners, Informed Consent Forms, and Moderator’s guides to ensure the participant’s safety.
The purpose of this presentation is to discuss the importance of engaging an IRB for ethical review of human factors studies. This presentation will cover topics including (1) history of IRB review, (2) when to submit research for IRB review, (3) special populations in research, (4) and designing an Informed Consent Form.
Event Type
Poster Presentation
TimeMonday, March 254:45pm - 6:15pm CDT
LocationSalon C
Digital Health
Simulation and Education
Hospital Environments
Medical and Drug Delivery Devices
Patient Safety Research and Initiatives