Single IRB Request
Single IRB FAQs
Single IRB Policy
Supplemental Form – Enrollment of Adult Participants with LARs
Determining if IRB Approval is Needed
Purpose The purpose of this policy is to outline the definitions of ‘research’ and ‘human subjects’ and the CRC IRB procedure for determining when projects do and do not require IRB review and approval. Policy Activities that meet the federal definition of ‘human subjects’ at 45 CFR 46.102(e) and ‘research’ at 45 CFR 46.102(l) require […]
IRB Submission Timelines
If your study has a deadline or specific time constraint, please give yourself and the IRB enough time to complete the review. Contact the IRB if you have questions or concerns about your deadline. Submissions for Full Board Review New research projects requiring full board review are added to a meeting agenda when the IRB […]
Working with Human Subjects
The Charles River Campus (CRC) Institutional Review Board (IRB) is responsible for reviewing and approving […]
HHS and FDA Regulations Compared
NIH and Certificates of Confidentiality
On October 1, 2017, the National Institutes of Health (NIH) updated its policy for issuing Certificates of Confidentiality. Certificates of Confidentiality are issued by the NIH, and they protect the privacy of research participants enrolled in biomedical, behavioral, clinical, or other research. With limited exceptions, researchers may not disclose names or any information, documents, or […]