Mount Sinai's Institutional Review Board (IRB) is a critical component of the institution's research infrastructure, responsible for reviewing and approving research studies involving human subjects. The IRB ensures that research is conducted in accordance with federal regulations, institutional policies, and ethical standards. In this article, we will provide a simplified overview of the Mount Sinai IRB process, highlighting key steps and requirements for researchers.
Introduction to Mount Sinai IRB
The Mount Sinai IRB is comprised of multiple boards, each with its own area of expertise and responsibility. The IRB reviews research studies to ensure that they meet the requirements of the Belmont Report, which outlines the principles of respect for persons, beneficence, and justice. The IRB also ensures that research is conducted in compliance with federal regulations, including those set forth by the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA).
Step 1: Determining IRB Review
Before submitting a research study for IRB review, researchers must determine whether their study requires IRB approval. The Mount Sinai IRB uses a decision tree to guide this process, which involves assessing the level of risk associated with the research, the type of research being conducted, and the population being studied. Researchers can use the IRB’s online decision tree tool to determine whether their study requires IRB review.
| Study Type | IRB Review Required |
|---|---|
| Exempt Research | No |
| Expedited Research | Yes, but expedited review process |
| Full Board Review | Yes, full board review required |
IRB Submission Process
Once a researcher has determined that their study requires IRB review, they must submit their study for review through the Mount Sinai IRB’s online portal. The submission process involves uploading required documents, including the research protocol, informed consent document, and any other relevant study materials. Researchers must also complete an online application, which provides detailed information about the study, including the study design, methodology, and potential risks and benefits.
Step 2: Pre-Review
After submission, the IRB conducts a pre-review to ensure that the study is complete and ready for review. The pre-review process involves checking the study for completeness, accuracy, and compliance with IRB policies and procedures. Researchers may be contacted during the pre-review process to clarify or provide additional information.
IRB Review
Once the study has passed pre-review, it is assigned to an IRB board for review. The IRB review process involves a thorough evaluation of the study to ensure that it meets the requirements of the Belmont Report and federal regulations. The IRB reviews the study to ensure that it is scientifically valid, that the risks and benefits are reasonable, and that the rights and welfare of participants are protected.
- Scientific validity
- Risks and benefits
- Participant rights and welfare
- Informed consent
- Privacy and confidentiality
Step 3: IRB Decision
After completing the review, the IRB makes a decision regarding the study. The IRB may approve the study, require modifications, or disapprove the study. Researchers are notified of the IRB’s decision and provided with feedback and guidance on any required modifications.
What is the purpose of the Mount Sinai IRB?
+The purpose of the Mount Sinai IRB is to review and approve research studies involving human subjects to ensure that they are conducted in accordance with federal regulations, institutional policies, and ethical standards.
What types of research require IRB review?
+Research studies that involve human subjects, including exempt research, expedited research, and full board review research, require IRB review.
How long does the IRB review process take?
+The IRB review process typically takes several weeks to several months, depending on the complexity of the study and the level of review required.
