Information for IRB Members Being Interviewed by AAHRPP
Thank you for your participation in Utah State University's upcoming AAHRPP Site Visit! The Association for the Accreditation of Human Research Protection Programs (AAHRPP) is an international, independent, nonprofit organization that reviews and accredits an institution's human research protection program (HRPP). The HRPP is made up of three primary areas: the institution itself, its IRB, and its researchers. Long regarded as the gold standard, AAHRPP accreditation demonstrates commitment to quality research programs.
The Human Research Protections Office has provided AAHRPP with a written description of USU's policies, procedures, and resources. AAHRPP Site Visitors will conduct virtual interviews on October 1st and 2nd, 2026, to ensure those policies and procedures are being followed. We expect questions to be focused on regulatory and ethical issues related to research with human participants, but questions may also relate to your perception of the HRPP and IRB. Please be timely, honest, and respectful during your time with the site visitors. While the Human Research Protections Office will hold one-on-one preparation sessions, this page will also provide an overview of what to expect.
Please reach out if you have any questions during this preparation process! We're excited and proud to show AAHRPP the thoughtful analysis and discussion held by our IRB members.
General Questions (These questions will likely be asked no matter your role)
- What training have you received? Do you know how to access it? Do you know if the IRB considers you up-to-date?
- Know what constitutes a conflict of interest and understand how conflicts of interest are managed at USU
- Where are protocols submitted?
- What is AAHRPP Accreditation, and why is it important? Understand the Accreditation process (Step 1: Application; Step 2: Revisions based on application; Step 3: site visit; Step 4: recommendation to the Council)
- What standards does USU use to review protocols? (Belmont Report, Common Rule)
IRB Member Questions
You are specifically being interviewed as a member of USU's Institutional Review Board. Here is a summary of AAHRPP's emphases within your membership and potential questions:
- What does the IRB do?
- Clearly describe your role and responsibilities in supporting the protection of human research participants
- Understand and describe the ethical aspects, purpose, and value of your work as an IRB member
- Know where to obtain answers to ethical/regulatory questions
- Know the process for noncompliance reporting
- Know your training requirements, the training requirements of researchers, and what materials exist as resources for you and for researchers at USU
- Describe the training you have received as an IRB reviewer. Do you receive continuing education?
- Know IRB terminology (protocol, exempt, expedited, Full Board/Convened IRB, noncompliance, reportable events, informed consent, etc.)
- What do you do when you have a conflict of interest as an IRB member?
- Does the IRB review Conflict of Interest Management plans?
- What is the IRB Evaluation process?
- Understand the Belmont Report Principles and the Common Rule and how those are applied to research at USU
- What other laws and policies does the IRB consider?
- Information on HIPPA, FERPA, PPRA, and the European Union General Data Protection Regulation Guidance can all be found within the "Laws, Regulations, and Codes" section of "Guidance Documents"
- What is the IRB's reputation on campus?
- Do you think the IRB's workload is fair and reasonable?
- If you have concerns about anything occurring on the IRB, what do you do?
- Do you think the resources supporting the IRB are adequate?
- Do you think the institution prioritizes the work of the IRB?
- Do you feel as though the support exists for your role as a member of the IRB?
- Do you feel like the IRB is kept adequately independent from other institutional pressures?
Understanding of the Human Research Protection Program as a whole
While you are representing the IRB in the accreditation interview, it is important that you understand the other two domains within the protection of human research participants
- Where do you fall within USU’s HRPP?
- Who is the Institutional Official and what is she responsible for?
- Lisa Berreau, the Vice President for Research, is the current Institutional Official
- Be familiar with USU HRP Policies and Procedures
- What is the mission of USU's HRPP? (To protect the rights and welfare of human research participants who are included in the university's research activities)
Review Standards and Processes
- What other laws and policies does the IRB consider?
- What is governed by FDA regulations? (Utah State University does not review under the FDA regulations, but it governs human subjects research involving drugs and devices)
- What is ethical research to you?
- If you wanted more training on laws and policies, where would you go?
- What is your process for reviewing a study? Do you utilize guidance or written checklists?
- What is the process for scientific review at USU? How do you receive notifications about scientific review?
- What are the Expedited and Exempt review categories? When are they used?
- What does it mean for research to be "exempt"? How does this differ from a project that is not human subjects research?
- What is continuing review, and when is it necessary?
- Do you know what should NOT be a part of the IRB's review?
- What is the role of the Community Member on the IRB? Are their contributions welcomed and valued?
- What is the difference between privacy and confidentiality?
- What are some additional mechanisms you might request as a reviewer for a protocol that involves a vulnerable population?
- What are the different levels of risk associated with research studies? Who determines the level?
- What are concerns you most frequently note in your review?
- What is the difference between an adverse event, an unanticipated problem, and noncompliance?
- How do you handle participant complaints?
- How do you handle complaints about the IRB from your colleagues?
- To whom do you go for help on regulatory or ethical issues as a Board Member?
- Do you know all of the requirements of informed consent? Generally speaking, what are you looking for in an informed consent document?
- What is the difference between a waiver of informed consent and a waiver of documentation of informed consent?
- How can a person obtain information about human research protections at USU?
- What should be disclosed to participants regarding conflicts of interest?
Interview Tips
- If you don't know the exact answer to a question, you can always respond by knowing where to find the answer to their question (Kuali, the IRB/HRPP website, or our SOPs)
- Answer questions directly. If you do not understand a question, you may ask them to rephrase it
- If a question is not related to your role, let the interviewers know
- Site visitors may not be familiar with USU terms and acronyms--you might be asked for more information when describing your process