Each clinical trial proposal must pass through a series of reviews before it is approved to be opened for recruiting.
First, a full study protocol undergoes Primary Department Review by the primary department of the Primary Investigator (PI), and also by the secondary department if there is a Co-PI in a secondary department. The protocol documents required for submission for Primary Department Review are as follows:
- Final and current protocol (draft protocols are not allowed)
- Appendices (if applicable)
- Drug diary (if applicable)
- Questionnaires (if applicable)
- Investigator’s Brochure(s) (if applicable)
Protocol Manuals (if applicable: drafts are accepted if the study is industry-funded)
- Laboratory Manual
- Imaging Manual
- Pharmacy manuals
- EKG manuals
- Protocol Face Sheet
- Materials for patients
- External budget template and sponsor contact information (if industry-funded)
The Research Council reviews study proposals for scientific merit and priority before submission to the Institutional Review Board (IRB) as well as existing studies for progress. The Research Council is comprised of two groups that meet bi-weekly on alternate weeks. Submissions must be received nine days before the meeting date.
The Institutional Review Board/Privacy Board is responsible for protecting the rights and welfare of human participants in accordance with federal and state regulations, as well as with institutional SOPs. The IRB reviews all human subject research under the OneMSK platform and monitors ongoing research. The IRB is comprised of two groups that meet biweekly on alternate weeks.
The Human Research Protection Program (HRPP) provides oversight to the IRB and continuing education and guidance to MSK investigators and research staff. MSK has a Federal Wide Assurance (FWA) with the Office of Human Research Protections (OHRP) in order to certify compliance with the regulations set forth in 45 CFR 46, 21 CFR parts 50, 56, 312 and 812 and the Privacy Rule in 45 CFR parts 160 and 164.
FWA Number: FWA00004998 (expiring 5/20/2019)
IRB A Registration Number: IRB00000273 (expiring 9/28/19)
IRB B Registration Number: IRB00009377 (expiring 9/28/19)