Guiding through IRB Submission Process: Essential Advice on Completing the Form
Conducting research involving human subjects at Princeton University requires adherence to a rigorous approval process by the Institutional Review Board (IRB). Here's a step-by-step guide to help you navigate this process effectively.
The IRB Approval Process
- Pre-Submission Requirements: Before submitting your research protocol, ensure it aligns with the ethical principles outlined in the Belmont Report, which includes respect for persons, beneficence, and justice.
- Submission Timelines: The IRB strongly recommends allowing at least eight weeks for study approval. During the summer, additional time may be required.
- Review Process: Most studies that pose minimal risk are reviewed within ten business days. Studies that may pose greater risk are reviewed once a month by the IRB.
- Revisions and Approval: Most studies require revisions before approval. Researchers should be prepared to address any ethical concerns raised by the IRB.
Requirements for IRB Approval
- Protocol and Consent Forms: Prepare a comprehensive study protocol and informed consent forms that clearly outline the risks and benefits of the study. Participants must provide informed consent before participating.
- Informed Consent Process: Ensure that participants understand the study's purpose, potential risks, benefits, and their rights as participants. This includes the right to withdraw at any time without penalty.
- Minimal Risk Assessment: If the study involves minimal risk, it may be eligible for expedited review.
- Documentation and Reporting: Maintain detailed records of the study, including participant recruitment, data collection, and any ethical issues that arise during the research process. The IRB may require periodic updates or additional reviews.
- Compliance with IRB Policies: Ensure that all research activities comply with the IRB's policies and federal regulations. Non-compliance must be reported to the IRB.
Additional Considerations
- Confidentiality: Protect Personal Identifiable Information by storing papers and media securely, using passwords, locking computers, encrypting files, and deleting data after the study is concluded.
- Template for Consent Form: You can download and modify a template for the human consent form.
- IRB Responsibility: Princeton's Institutional Review Board is responsible for reviewing any research involving human subjects to ensure participant safety.
- Revisions: If your submission receives the status "Approve Pending Revisions," work with your adviser to make the final modifications and re-submit your form.
- Navigating eRIA: If you're having problems navigating eRIA, there's a Quick Reference Guide available.
- Timing Submissions: If you're pressed for time and believe the Board will need to convene about your proposal, time your submission accordingly.
- The IRB Form: The form requires 15 sections to be filled out, which can be intimidating.
- Confidentiality vs. Anonymity: Confidentiality does not mean that not even the researchers will be able to identify participants (anonymity).
- Working with a Classmate: You can find a classmate to work with through the document.
- Supporting Documents: The IRB form requires the attachment of supporting documents, such as the human consent form, interview guides, survey questionnaire, and potentially more.
- IRB Review: Only about 1% of submissions need to be reviewed by the Board.
- Confidentiality and Protection: Confidentiality is an important component of the IRB form, designed to protect Personal Identifiable Information.
By following these guidelines, researchers can navigate the IRB approval process effectively and ensure that their research involving human subjects meets the necessary ethical standards.
A junior paper can be a preliminary research work that requires IRB approval for ethical standards, following the Belmont Report principles and the IRB approval process outlined. In contrast, a senior thesis may undergo a more rigorous review process if it poses greater risk, as the project evolves into a substantial piece of self-development and learning in an individual's educational journey, often employing online education and learning methodologies.
