Policies for Grant Submissions

The type of paperwork needed is determined by the research category, (i.e., preclinical, animal, or human). Consult the MSSM Research Web site, www.mssm.edu/research.html, for the best information available. There are separate submission instructions and forms for BRANY (Biomedical Research Alliance of New York) studies. These are available on the BRANY web site, www.BRANY.com.

Most research in the Department of Obstetrics, Gynecology, and Reproductive Science is human subject research. This category of submission requires the completion of IRB (Institutional Review Board) paperwork, as well as GCO (Grants and Contracts Office) paperwork. GCO is not the same as the IRB.

The Department needs to catalog all IRB/GCO submissions. The greatest level of scrutiny is reserved for funded projects where the PI (Principal Investigator) is a member of the Department of Obstetrics, Gynecology, and Reproductive Science. The Medical School has mandated that departments have increasing responsibility for all investigator research within their department. This includes financial, ethical (for example, good clinical practice and conflicts of interest), and the successful completion of trials (for example, managing competing enrollments).

Types of Research Submissions

• Non-Funded Research
• Funded Research – PI is not in the Department of OB-GYN
• Funded Research – PI is a Member of the Department of OB-GYN

Study Continuation Procedures

1. Submit study continuation forms to the IRB in a timely manner.
2. For non-competitive grant renewals, yearly IRB and GCO paperwork should be submitted six weeks in advance. Investigators are strongly encouraged to submit GCO and IRB paperwork simultaneously. Prior to submission, the renewal budget should be reviewed with the Grants Manager and Administrator.
3. A copy of the IRB re-approval letter should be submitted to the Grants Manager for the departmental files.

Frequently Asked Questions

• Do I need to submit a finalized and complete extramural application for Divisional and Departmental approval and signature?
  The Department prefers to review a finalized and complete application; however, the scientific narrative may be preliminary. All administrative and budget pages (i.e. extramural application face page, first year budget, entire proposed budget, budget justification, other support pages, etc.) must be finalized.
• If my Division Director is away, who will approve and sign off on my Research Application?
  Please check with your Administrator for the alternate signatories in your Division. Also, please plan ahead and communicate with your Division Director in advance of the application deadline.

Forms

• Non-Funded Research Submission Checklist
• Funded Research – PI is not in the Department of OB-GYN Submission Checklist
• Funded Research – PI is a Member of the Department of OB-GYN Submission Checklist

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