July 8, 2013
By Tom Varricchione, VP of Clinical & Regulatory Affairs
Deciphering U.S. FDA and HHS regulations and agency guidance regarding human research protection makes clear the need for protecting the safety and privacy of participants but leaves unclear whether Institutional Review Board (IRB) approval is needed for Human Factors and Usability Studies. Conservative organizations adopt a default position of seeking IRB approval for all human factors and usability research which they perform, but there are categories of such research that remain exempt from the requirement for IRB approval. In addition to interpreting the nuances of the regulations, determining the level of risk a study poses to participants is a determining factor in whether IRB approval is required as well as the type and extent of review and documentation required for the study. For this reason we have developed the following 3-step ‘Quick Start Guide’ for conducting research with human subjects.
Step 1: Assess research needs and potential risk at time of study design.
Assessing risk is not limited to just the potential for physical injury to a participant. It is important to assess other risks such as the risk of psychological harm (e.g. stress, embarrassment), privacy risks (unintentional disclosure of sensitive, private information) and regulatory risk (e.g. whether study results will be submitted to or are subject to inspection by FDA). We also assess whether there are business risks associated with the planned research, not for reasons of complying with regulations but to ensure that our business as well as our client’s will be adequately protected.
Note: Risk assessment should ideally occur during proposal development.
Step 2: Draft Appropriate Study Documents based on identified risk level
When assessing risk in the human subject research we use the following four categories “No/Very Low Risk”, “Low Risk”, “Non-Significant Risk” and “Significant Risk”. It is deemed that each study fits into one of these categories based upon interpretation of the regulations and the risk assessment perform as an early activity. It is important to note that each of these categories carries its own unique documentation needs.
Based on the level of risk determined, documentation can be as informal as a one page synopsis and a verbal informed consent for studies deemed No/Very low risk to an HSR protocol, FDA and IRB submissions, Informed Consent Form, Eligibility Form, Material Safety Documentation, Subject Name/ID log, Device accountability log, adverse event form, data capture forms for studies wherein the level of risk is categorized as significant.
Step 3: Determine Appropriate Persons to Sign Off on Study Documents Based on Identified Risk Level
Approval signatures again vary based on the same four categories of risk referenced in Step 2. In cases where risk is deemed No/Very Low Risk the study need only be signed off on by a research lead whereas a study design deemed to carry significant risk needs the signatures of a senior management sponsor, client, IRB and the FDA.
Human research protection is an integral part of all research activity and we don’t want to short circuit efforts in that regard which is why we use this risk assessment and study categorization process to help us determine the level of internal and, when deemed necessary, external review needed for a planned study, as well as the type and extent of documentation needed. This process, however, also helps us streamline the controls and resources needed to ensure that protection while meeting business needs.
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 21 CFR 56.110 and 45 CFR 46.101