The Protection of Human Subjects
The most important consideration in research at Baystate Medical Center (BMC) is the protection of human subjects. Federal and State Law and Regulations mandate an Institutional Review Board (IRB) at institutions where research involving human subjects is taking place. By federal regulation the IRB is a subcommittee of the Governing Board of the institution.
No research involving the use of human subjects may be undertaken without first being reviewed and approved by the institutional IRB. All research involving the use of human subjects must meet the highest of ethical standards. Generally speaking, the concerns are of the IRB are:
- Will each research subject be adequately informed of the nature of the research.
- What is going to be done to them
- An evaluation of what the risks and benefits are to the subject
- Aware they can withdraw at any time without prejudice to their care
- Do any of the researchers have a conflict of interest, e.g. a financial interest, in the research?
These issues are addressed through an IRB approved Informed Consent Document, which is signed by both the researcher and the subject at the time of enrollment. The IRB is required to review on-going studies and has the regulatory authority to halt or suspend studies that are no longer considered to be in the best interest of the subjects involved.
Federal Regulations & Oversight
Federal oversight is provided by the Office for Human Research Protections (OHRP) within the Office of the Secretary DHHS. BMC's IRB is registered with OHRP. OHPR has assigned Federal Wide Assurance (FWA) number 00004355 to BMC's IRB.
Historically, the ethical considerations go back to the Nuremberg Code of 1947 and the Declaration of Helsinki of 1964 (revised 1975). The current body of federal regulations stems from the Belmont Report (NIH 1979). The regulations are found at 45CFR Part 46 (National Institutes of Health) and 21CFR Parts 50, te seq. (Food & Drug Administration).
Violation of these regulations has serious individual and institutional consequences.