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Tips for Writing Successful IRB Protocols for Human Subjects Research

An Institutional Review Board (IRB) is responsible for the protection of the rights, privacy and welfare of all participants in human subjects research. It is guided by federal regulatory requirements and has the authority to review, approve, modify or disapprove research protocols.

People believe it is difficult to get IRB approvals for studies that involve human subjects. But your IRB application and approval process can go smoothly if you follow these tips. Each tip introduces critical elements of IRB review and components of the IRB operations and review processes; however, this list does not represent the policy of any specific IRB committee. We hope you find it useful.

  1. Know the rules - Be informed:  Complete relevant IRB trainings for interacting with human participants. IRB committees in most institutions require successful completion of these trainings before applications are considered. Also, before making an application, gather as much information as possible about your IRB guidelines, requirements and application process relevant to your type of research.
  2. Be considerate and patient: IRBs have liaisons or individuals who process applications they receive from researchers. It is critical that you establish a considerate and patient relationship with them because they can help you navigate through the requirements of your institutions IRB. They can also help upcoming researchers become familiar with the intricacies of the IRB process.
  3. Be very detailed: Your protocol must provide detailed description of whom you will recruit to participate, how you will recruit them, why you are recruiting the participants you are recruiting, and when you will recruit them. If your recruitment tactics (as described in your protocol) eventually vary slightly during the actual implementation of your research, you can always file an amendment.
  4. Have summaries of your protocol handy: Prepare a six (6) page mini-write-up of the entire study including: a short introduction, the objective of the study, a short justification of where the study fits in existing academic literature, a description of participants, a run-down of the methodology and a short description of expected results. Summarizing your protocol can help you clearly present the objectives and process throughout the course of the research.
  5. Complete all required forms: Investigators conducting research that involves human subjects are required to complete certain human participant protection forms: These may include consent forms, assent forms, a participant debriefing form, and anonymity assurance for data that are quantitative or qualitative. Completing these forms will demonstrate that you are dedicated to the care of the participants of your study.
  6. Know and work with your IRB schedule:  Applications that involve very little intrusiveness can be processed relatively quickly, but those that involve more moderate participant intrusiveness could take much longer to process. In any case, knowing when the IRB committee meets and how often could determine how long your IRB application process will take.
  7. Pay attention to details: Your IRB may have the specific instructions for submitting applications and forms to them (number of copies, formatting, appendices, etc.). Make sure you pay attention to these details - submit ALL documents according to specifications to avoid delays.
  8. Respond promptly. When you receive your application back, respond to the IRB committee as quickly as possible. It is better to get the application back as soon as possible while the application is still fresh in the minds of members of the committee.
  9. Be thankful. When your application is finally approved, thank the IRB liaison and ask him/her to please thank the committee on your behalf. 
  10. Comply with all requests from the IRB to provide updates on your research if asked and submit any progress reports if requested.

 

We encourage you to share your experiences with developing IRB protocols using the comment box below. Let us know:

  • What challenges you faced and how you overcame those challenges,
  • Tips of your own that could help others develop successful IRB protocols.
  • Any questions you have about IRBs, or answers to the questions of others.
Date: 
Wednesday, October 1, 2014

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