The Icahn School of Medicine at Mount Sinai (ISMMS) Institutional Review Board (IRB) is committed to providing high quality, comprehensive education and training for its IRB members regarding human research protections, federal regulations, and local IRB policies and procedures.
Definition of an IRB:
- An independent committee comprised of a minimum of 5 individuals, whose job is to review, approve and monitor research trials.
- Responsible for reviewing everything from a study’s protocol and informed consent form to its advertising, with the sole purpose of protecting its volunteers.
- Responsible for ensuring that all approved research complies with these three ethical principles: respect for persons, beneficence, and justice.
- Maintains a review process that is responsive to the concerns of all involved. Federal regulations require that the IRB membership reflect experience, expertise, and diversity in academic, research, and professional background; racial and cultural heritage; and a sensitivity to community views and preferences.
- Has authority to require progress reports from investigators, to oversee the conduct of a study, and to suspend or revoke its approval of ongoing research.
- Has authority to approve, to require modification of, and to disapprove proposed human subjects research.
IRB Member Requirements & Responsibilities
- Required to complete the Collaborative IRB Training Initiative (CITI) certificate and attend an orientation from the Program for the Protection of Human Subjects (PPHS) Office before starting their active service. This orientation includes an overview of the Federal regulations (45 CFR 46 , 21 CFR 50 and 21 CFR 56) established to protect human research subjects and other documents/materials pertaining to the protection of human research subjects at ISMMS. The IRB Office staff provides continuing education and support to all IRB members.
- Responsible for reviewing all assigned materials prior to the IRB meeting, sending in their reviews in a timely fashion, attending all scheduled IRB meetings, and participating in IRB discussions. In general, there are about four to six hours of preparation involved for each meeting.
- Responsible for making sure that the research maintains a sound scientific design, that study-related risks have been minimized to the greatest extent possible, that the research presents a reasonable risk/benefit ratio, informed consent is appropriately obtained, vulnerable subjects are protected, privacy and confidentiality are maintained, and the safety of all study participants is carefully safeguarded throughout the course of study.
- Attends IRB meetings in order to observe the presentation and discussion of the submissions to the IRB; the meeting usually runs about two and a half hours and the preparation time depends on the volume of projects on the agenda (usually four to six hours).
- Expected to attend at least 10 out of the 12 monthly board meetings for the board to which they have been assigned.
If you are interested in being a member of one of our IRBs, contact the PPHS office for more information.