All research projects involving human subjects must secure approval from an Institutional Review Board (IRB). The purpose of an IRB review is to assure, both in advance and by periodic audit, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in a research study. To accomplish this purpose, IRBs review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of subjects participating in clinical research.
To begin to screen and enroll subjects into a clinical trial, the study must:
- Be approved by our designated IRB;
- Have finalized a formal contract with the sponsor; and
- Include an agreed upon budget with defined payment terms and conditions.
The OCT is the final gateway to the multiple processes that must be engaged and completed.
In order to initiate the process of activating a clinical trial, the OCT needs to be notified of your intent. This is done via completion of a formal STUDY ACTIVATION form. Click here to download the file .
For a new study protocol application:
- If your trial is industry-sponsored, submit your protocol with the STUDY ACTIVATION FORM to OCT@montefiore.org or OCT@einstein.yu.edu;
- When submitting your request to the OCT, your Department Chair’s signature is required to both inform and get approval for your research;
- Submit your protocol to the Einstein-Montefiore IRB, if applicable.
- For more information regarding initial submission of Clinical Trial Studies, contact:
Either the IRB staff or the OCT can help you determine your protocol requirements. There are two paths for IRB approval: either through our institutional IRB (www.einstein.yu.edu/irb) or BRANY's (http://www.branyirb.com/).
The OCT will help investigators holding or needing an IND or IDE at any stage of an investigation. Specifically, the IND/IDE assistance program will:
- assist in determination of a requirement for an IND or IDE.
- provide education to PIs regarding regulatory responsibilities of INDs or IDEs.
- provide guidance in the preparation and submission of an IND or IDE.
- provide regulatory assistance during FDA inspections of clinical trials.
Albert Einstein Cancer Center Protocol Review Committee
The Protocol Review Committee (PRC) is part of the Albert Einstein Cancer Center (AECC), and serves to scientifically review all human subject cancer or cancer-related protocols to align their priority with the institutional missions. This review is intended to complement, but not duplicate, IRB review.
Department of Radiology Review
The Radiology Review Committee reviews studies involving radiology resources that are part of clinical research, especially those that fall outside of routine “standard of care” and are either to be billed to a sponsor or involve research that details specific imaging requirements for radiology.
Clinical Research Center (East and West campuses)
The Clinical Research Centers (CRCs) on each campus provide a research-only environment for clinical encounters that are part of clinical studies. Investigators are encouraged to use these facilities for subject visits, blood drawing, and non-invasive procedures. Certain fees may apply and should be planned for in budgeting. Administrative review by the ICTR Protocol Review Committee for all industry-sponsored protocols is required.
Institutional Biosafety Committees (IBCs)
Established under the NIH guidelines of research involving recombinant DNA molecules to provide local review and oversight of nearly all forms of research that involves biological materials (e.g., infectious agents) and other potentially hazardous agents (e.g., carcinogens).
Department of Pharmacy Involvement
Commonly, clinical research involved participation of the Department of Pharmacy either for the storage, preparation or dispensing of drugs. Such participation must be planned for in advance, and appropriate fees included in study budgets.
The research pharmacists of Montefiore are:
Additional Programmatic Oversight
Investigators must check with their respective department chairs and division directors to see if there are additional review mechanisms in place.