The role of the Program for the Protection of Human Subjects (PPHS) is to safeguard the rights and welfare of all human subjects who participate in research projects conducted by the Icahn School of Medicine at Mount Sinai (ISMMS). In compliance with Federal law and institutional policy, all research projects involving human subjects or human material must be reviewed and approved by an Institutional Review Board (IRB). The School’s program supports five IRBs at this time.
The general criteria for IRB approval of human research are:
- The risks to subjects are minimized as much as possible
- The risks to subjects are reasonable in relation to anticipated benefits
- The informed consent is adequate
- Where appropriate, the research plan makes provisions for the safety of the subjects during the data collection process
- Where appropriate, there are adequate provisions to protect the privacy of subjects and maintain confidentiality of data
- Appropriate safeguards are included within the study to protect the rights and welfare of the vulnerable subjects
The PPHS is the oversight body for all research involving human subjects at ISMMS. If you have any questions, always feel free to call us.
The IRB is charged with review and approval of all research protocols being conducted at the Icahn School of Medicine and The Mount Sinai Hospital (MSH), or by those employed by or acting on behalf of the School and MSH, with the aim of protecting the rights and welfare of human subjects enrolled in these research protocols. The regulations governing the IRB procedures developed as a result of reports produced by several commissions which examined the use of human subjects in research—in particular, the Belmont Report.
The Belmont Report, prepared by the National Commission for the Protection of Human Subjects of Biomedical and Biobehavioral Research in 1978, formulated three basic ethical principles that must be adhered to in the conduct of research involving human subjects. These are:
- Respect for persons: recognition of the autonomy and personal dignity of each individual and provision of special precautions to protect vulnerable subjects
- Beneficence: potential benefits of participation in research must be maximized while potential harms must be minimized
- Justice: the benefits and risks of research participation must be distributed fairly within the general or subject population
Following this, various legal codes were developed to specify, more precisely, actions that must be taken to ensure adherence to these principles. In particular, human research at ISMMS is governed by Federal Regulations (FDA, 21CFR50 and 21CFR56; DHHS, 45CFR46) in addition to applicable state and city codes. The responsibility for protecting the rights and welfare of human subjects in research has been delegated to IRB at each institution conducting federally sponsored research.
All proposals for conducting research on human subjects must be reviewed and approved by the IRB before they can be initiated, regardless of funding source. Certain types of research may be exempt from IRB review. The Icahn School of Medicine has assured the federal government, through Federal Wide Assurances (FWA #00005656, FWA#00005651), that it will comply with all applicable regulations.
The IRB staff will be happy to discuss any questions that you have with regards to complying with these policies.