Icahn School of Medicine at Mount Sinai: Program for the Protection of Human Subjects

Mount Sinai Medical Center

Icahn School of Medicine at Mount Sinai is a leading institution in medical and scientific training, biomedical research and patient care. Working in close partnership with the Mount Sinai Hospital, Icahn School of Medicine serves one of the most diverse and complex patient populations in the world. Mount Sinai is also home to an array of leading research institutes, centers, and laboratories, all of which work toward rapidly translating advances in basic science into innovative patient care.

Program for the Protection of Human Subjects

Mount Sinai’s Human Research Protection Program is a major component of the research done at Mount Sinai. The program provides a comprehensive system to ensure the protection of the rights and welfare of subjects in Human Research. The Program for the Protection of Human Subjects (PPHS) is a key component of Mount Sinai’s efforts to ensure human subject protections. It supports our researchers in assuring the ethical conduct of research and compliance with federal, state and institutional regulations and provides a professional office staff to assist both investigators, participants, and five Institutional Review Boards (IRBs).

An IRB is a diverse, independent committee comprised of a minimum of 5 individuals whose job is to review, approve and monitor human subjects research. 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. An IRB has the authority to require progress reports from investigators, to oversee the conduct of a study, and to suspend or revoke its approval of ongoing research. IRBs have the following tasks:

• Reviewing of study documents to ensure protection of the rights, welfare, and well-being of human subjects who participate in research conducted by faculty, staff, and students at Mount Sinai,

• Ensuring that all approved research complies with the three Belmont Principles: Respect for persons, Beneficence, and Justice,

• Assessing the risks and benefits of research, and making sure that risks are minimized and justified by potential benefits of the research,

• Ensuring that privacy and confidentiality of subject information is maintained and safeguarded,

• Ensuring that informed consent is adequately obtained, and procedures to obtain consent for research are just and equitable,

• Supporting high quality research,

• Collaborating with researchers, staff, and IRB professionals,

• Complying with applicable state and federal privacy laws.

Our goal is to support Human Subjects Research at the Mount Sinai Medical Center, and to help continue Mount Sinai's pioneer breakthroughs and achievements in research while protecting human subjects and adhering to federal rules and regulations.