The study idea sounds straightforward: ask a few questions, collect the responses, and look for a pattern. Then you open the institutional research guidance and discover several steps you hadn't planned for.
The handbook urges new faculty to learn the human research protection process early. Start by talking with the office responsible for your project. A training certificate and authorization for a particular study are different things.
1. What determination does this project need?
Describe the purpose, participants, recruitment, and information you plan to collect or use. Follow your institution's process for determining whether the activity is human subjects research and which review or exemption pathway applies. Don't choose a category simply because the project seems small.
HHS guidance explains that institutions usually rely on their human research protection or IRB office to help make these determinations.
2. Which training applies to this team?
Ask what investigators and other team members need to complete and how completion is documented. Confirm the requirements for your role and project. Training helps prepare you for the work; it doesn't by itself establish that a study can begin.
3. What materials should I prepare?
Ask about the protocol, recruitment language, consent or information materials, instruments, data handling, and any other required documents. Keep the descriptions consistent. A change in what participants will do should be reflected wherever it matters in the submission.
Give yourself time to respond to questions and revisions before promising a recruitment date.
4. When may the proposed activities begin?
Get a clear answer through the applicable institutional process. For nonexempt human subjects research requiring IRB review, HHS states that approval is needed before that research begins. Other determinations and institutional procedures still need to be handled correctly.
Keep the relevant decision and approved materials with the study records.
5. What happens if the plan changes?
Ask how changes in recruitment, instruments, procedures, or data use should be handled. Learn the reporting and amendment processes that apply. Don't assume an earlier determination covers every later version of the project.
Make the project summary consistent before asking for guidance
Read your proposed recruitment message, participant instructions, instruments, and data plan together. Do they describe the same activities? If one says responses are anonymous while another asks for identifying information, flag that inconsistency for the responsible office rather than guessing which wording will be acceptable.
Be clear about what has been decided and what remains a proposal. If you're considering two ways to recruit, describe both as options and ask what information is needed to assess them. Don't present an uncertain arrangement as settled simply to make the summary look complete.
Keep the office's response with the relevant version of the plan. A useful question record identifies the issue, the guidance received, and the next step required through the institutional process. This preparation doesn't replace a determination or approval. It makes the consultation more concrete and reduces the chance that different documents quietly describe different studies.
Before your next planning meeting, write a plain-language project summary and send it through the appropriate consultation route. Resolving these questions early can help you design a more realistic timeline and a clearer participant experience.
Adapted from The New Faculty Handbook by Zafer Unal, pp. 76-77. Further guidance: HHS overview of independent review and investigator responsibilities.
