IRB Process Simplified: Speedy Guidance on Completing the Application Form
Navigating the IRB Approval Process at Princeton University
Conducting human subjects research at Princeton University requires approval from the Institutional Review Board (IRB). Here's a guide to help you navigate the application process, ensuring your research adheres to ethical principles and protects participants' rights.
Planning Ahead
To ensure a smooth process, submit your IRB application at least eight weeks before the planned study start, especially during summer months to accommodate review and required revisions.
Understanding Risk Levels
The IRB prioritizes minimal risk studies for expedited review, while those posing greater than minimal risk undergo full review at the scheduled monthly meetings.
Completing the Application
Provide clear, thorough responses on the form, aligning your protocol with ethical principles such as respect for persons, beneficence, and justice (per the Belmont Report).
Preparing for Revisions
Expect that the IRB will likely require you to revise your submission before approval.
Informed Consent Details
Your application should explain how you will obtain informed consent and protect participants’ rights and privacy.
Contact Information
Include a way for participants to contact the IRB regarding concerns.
Consulting Resources
Review the Princeton Research Integrity & Assurance website for deadlines, templates, and guidance. Contact the IRB office early if you have questions.
Protecting Confidentiality
The Confidentiality section of the IRB form is designed to protect participants' Personal Identifiable Information. Confidentiality measures may include storing papers and media securely, using passwords, locking computers, encrypting files, and deleting confidential data after the study is concluded.
Attaching Supporting Documents
The IRB form at Princeton includes a section for attaching supporting documents, such as a human consent form, interview guides, survey questionnaire, and potentially more.
Timing Submissions
If a student is pressed for time and believes the Board will need to convene about their proposal, they can time their submission accordingly.
Revisions and Approval
If the status of a submission is "Approve Pending Revisions," students should work with their adviser to make final modifications and re-submit the form.
Patience is Key
Remember, the IRB review process can take time, so students are advised to be patient.
Navigating eRIA
A Quick Reference Guide is available for navigating eRIA, the system used for IRB submissions.
Independent Research Opportunities
At Princeton, students are given opportunities to conduct independent research, including traveling to other countries. It's possible to find a classmate to work with through the document.
Templates for Human Consent Form
The human consent form can be downloaded and modified from a template.
Extensive IRB Form
The IRB form at Princeton is extensive, with 15 sections to fill out. However, with careful planning and attention to detail, navigating this process can lead to valuable research experiences.
[1] Princeton University Office of Research and Project Administration. (n.d.). IRB. Retrieved from https://orpaservices.princeton.edu/irb/
[2] Belmont Report. (1979). National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
[3] Office for Human Research Protections. (2019). The Common Rule: What it is and why it matters. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/the-common-rule/index.html
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