Appendix 5: Advice to Student Researchers

Before You Start Your IRB Application

Complete the online training at the National Institutes of Health’s Office of External Research, “Protecting Human Research Participants” (http://phrp.nihtraining.com/users/login.php) – this is REQUIRED

Key Issues to Consider When Preparing Your Application

Description of the Project

  • The protocol narrative is critical to the IRB understanding your research question(s), methodology, and engagement of human participants in your investigation. As such it is critical to adequately and fully describe the purpose of your proposed research and what risks participants may encounter as well as the benefits.

  • If you are using instruments, include citations for their validity (if appropriate) and what level of training is required to administer and interpret these instruments. If you are using oral interviews please provide a script. If you are asking open ended questions, please provide a list of the seed questions.

  • Project Timelines and Dates -- be sure to allow sufficient time for obtaining signature approvals, permission letter(s) from school districts or other entities, and IRB review and approval. Protocols should have the specific start and end dates of the research project, not semester starting and ending dates.

Informed Consent Documents

  • Informed consent documents should be personable and informative to allow participants to decide if they want to be part of the study. Contact names and contact information should be on all consent forms: for instance, the researcher, the faculty sponsor if appropriate, and the IRB office administrator. This allows multiple contacts in the event that parents, participants or agency heads have questions concerning the proposed research.

  • If you wish to have the IRB waive the requirement for signed written and/or verbal informed consent, be sure to address the reason you are requesting the waiver. See [link needed] for guidance. Tools for developing informed consent documents may be found on the IRB Forms page.

  • If you are using deception in any way, please address why and describe how you will debrief the subjects.

  • Finally, be sure to include that you are a Trinity College student and that the information obtained will be used for your honors thesis, senior exercise, or other research project. It is required that an unsigned copy of the informed consent be given to the participant to keep, whereas the researcher keeps a signed copy.

For additional guidance, see Reviewer Checklist (Appendix 8)