December 2006 It is the policy of the Organization that applications for the conduct of human subject research shall be assigned to an IRB for review. Procedures for assignment are governed by written review agreements, contractual terms, or internal guidelines issued by the IO. The possible assignments to an IRB are as follows: - One of the five JHM IRBs in Baltimore
- Bloomberg School of Public Health IRB
- MedStar Research Institute
- NCI CIRB and NCI Pediatric CIRB
- National Institute on Aging (NIA) IRB
- National Institute on Drug Abuse (NIDA) IRB.
Written review agreements determine assignment to BSPH, MedStar Research Institute, the two NCI CIRBs, NIA, and NIDA. Research applications that are not funded, that are federally funded or funded through a non-profit organization, or that are commercially funded but may qualify for an expedited review process or as exempt research may be assigned to the JHM IRBs. Assignment information will be made available to researchers on the IRB website. Updates to assignment information shall be made by the IO and provided to researchers as needed. In September 2002, a policy was adopted for new protocols submitted to the JHM IRBs on which an IRB member is the PI (or a family member or a significant other is a PI). In such cases, the review will be assigned to a JHM IRB on which the PI does not serve. In September 2005, the policy on assignment was amended for applications on which a former IRB chair or IRB member is the PI. For a period of two years after service as an IRB member or chair, new applications will not be assigned to the JHM IRB on which the PI had served as a member or chair. Once assigned to an IRB, that IRB will continue to review the protocol unless the protocol is transferred (see Policy 103.14 “Transfer of Protocol Among JHM IRBs”) or an emergency arises. |