MSM Policy and Guidelines
The MSM IRB Guidelines, Policies and Procedures document reflects the intention and obligation of Morehouse School of Medicine (MSM) to protect, to the fullest extent possible, the safety, autonomy, dignity and privacy of individuals who have volunteered to be human research subjects in studies conducted by Morehouse School of Medicine. The principles and requirements reflected in the document are derived from ethical and legal authority expressed in the Belmont Report, the World Medical Association Declaration of Helsinki, the Nuremberg Code, Title 45 Code of Federal Regulations Part 46, and Title 21 Code of Federal Regulations Parts 50 and 56, as well as contemporary advisory opinions and standards issued by federal regulatory agencies charged with protection of human subjects in research.
The purpose of the IRB guidelines and policies is to provide MSM investigators with essential information and an educational resource that can be used in the preparation and submission of research proposals, including informed consent forms, for review by the IRB. The guidelines are also designed to provide information on the ethical and legal duties of investigators during the conduct of human subjects research. These guidelines serve as an official governance document for human subjects research at MSM.
Office for Human Research Protections (OHRP): The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP helps ensure this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and behavioral research.
FDA Human Subjects Research Regulations: The FDA is an agency within the Department of Health and Human Services. The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
Code of Federal Regulations (CFR)
Food and Drug Administration, Protection of Human Subjects (CFR Title 21, Part 50): This part applies to all clinical investigations regulated by the Food and Drug Administration
Food and Drug Administration, Institutional Review Boards (CFR Title 21, Part 56): This part contains the general standards for the composition, operation, and responsibility of an Institutional Review Board (IRB) that reviews clinical investigations regulated by the Food and Drug Administration
Department of Health and Human Services, Protection of Human Subjects (CFR Title 45, Part 46): This policy applies to all research involving human research subjects conducted, supported or otherwise subject to regulation by any federal department or agency. This includes research conducted by federal civilian employees or military personnel, as well as research conducted, supported, or otherwise subject to regulation by the federal government outside the United States.
Other Related Regulatory Documents
The Belmont Report
Prepared by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research on April 18, 1979. This report summarizes the basic ethical principles (respect for persons, beneficence and justice) that should underlie the conduct of biomedical and behavioral research involving human subjects. It also outlines guidelines which should be followed to assure that such research is conducted in accordance with those principles.