Guidance for Completing IRB Submission Form: Useful Insights for a Smooth Process
At Princeton University, the process for Institutional Review Board (IRB) approval for human subject research is an essential step to ensure participant safety and ethical conduct. Here's a guide to help you navigate this process.
Submitting Your Study Protocol
To begin, submit a complete study protocol outlining research methods, risks, and protections for human subjects. It's important to include a detailed protocol, consent forms, descriptions of risk minimization measures, documentation of informed consent processes, any recruitment materials or study instruments, and compliance with privacy and data security protections.
Review Timeframes
Most minimal risk studies are reviewed within ten business days, while higher-risk studies are reviewed during monthly IRB committee meetings. The IRB recommends investigators plan for about eight weeks to secure approval, as there may be required revisions before final approval.
Compliance and Confidentiality
The IRB expects compliance with federal regulations governing human subject research and adherence to ethical principles protecting participant rights and welfare. Confidentiality is a crucial component of the IRB form, designed to protect Personal Identifiable Information. The form requires the names of people involved in the study, including the Principal Investigator.
Confidentiality and Data Security
Confidentiality means only the researchers will have access to participants' identifiable information, not anonymity where not even the researchers can identify participants. Confidentiality measures may include storing papers and media securely, using passwords, locking computers, encrypting files, securely transferring information, and deleting confidential data after the study is concluded.
The IRB Form
The IRB form is extensive, containing 15 sections and can be intimidating. Section N of the IRB form requires the attachment of any supporting documents, such as the human consent form, interview guides, survey questionnaire, and potentially more. A downloadable and modifiable human consent form template is available.
Responding to Revisions
If the status is "Approve Pending Revisions," final modifications should be made and the form re-submitted. If time is a concern and the Board is expected to convene about a proposal, the submission can be timed accordingly.
Student Principal Investigators
Students are not eligible to be Principal Investigators (PI) in studies at Princeton; the JP or Thesis Adviser should be listed as the PI.
IRB Approval and Beginning Research
Conducting the study can begin once the form is approved. It's crucial to remember that conducting research without prior IRB approval is considered noncompliance and must be reported according to Princeton IRB policy.
Seeking Assistance
If needed, assistance can be sought from an adviser or directly contacting the IRB. A Quick Reference Guide is available to help navigate eRIA.
In summary, at Princeton University, you must submit your human subject research for IRB review well in advance of your planned start (at least 8 weeks recommended), complete all required documentation, respond to any revision requests, and wait for formal approval before beginning research activities involving human participants.
[1] Princeton University Office of Human Research Protection, IRB Policy #207: Principal Investigator Obligations. (n.d.). Retrieved from https://www.princeton.edu/~oohrp/docs/policy/207.pdf
- For a junior student at Princeton University, the transition from a junior paper to a senior thesis involves the submission and IRB approval process, which requires a comprehensive study protocol, detailing research methods, risks, and protections for human subjects, as well as learning about confidentiality and data security measures.
- In the realm of education-and-self-development, the process of conducting a senior thesis that involves human subjects requires understanding the importance of learning from the IRB review, which ensures participant safety and ethical conduct, and involves submitting a complete study protocol, responding to revisions, and adhering to principles of confidentiality and data security for approved studies.
