Federal and state regulations and institutional guidelines and policies govern research that involves human subjects. These regulations and guidelines exist to protect the rights and welfare of all human research subjects. The Institutional Review Board is an administrative entity whose charge is to oversee the implementation of, and conformity with, these regulations and guidelines as they apply to individual research studies.
If an investigator is engaged in research, IRB review and approval is required.
45 Code of Federal Regulations (CFR) 46 specifically addresses the protection of human study subjects as promulgated by the Department of Health and Human Services (DHHS). 45 Code of Federal Regulations (CFR) 46 encompasses research conducted under DHHS, National Institutes of Health (NIH), and the Office for Human Research Protections (OHRP). 21 CFR 50 and 21 CFR 56 are the general regulations that govern FDA regulated research. 21 CFR 312 and 21 CFR 812 govern Research involving drugs and devices, respectively.
The CFR recognizes specific groups of persons as vulnerable populations. Included among the vulnerable populations identified in federal laws are pregnant women, fetuses, and neonates, prisoners, and children.
Additionally, the Commonwealth of Massachusetts General Laws (MGL) also address experimentation on human research subjects. Specifically, MGL Chapter 112, Section 12J addresses research conducted on human fetuses. This is commonly referred to as the Massachusetts Fetal Research Statute.
While there are no specific federal regulations addressing research involving incompetent or cognitively impaired persons, the highest of ethical standards should be abided by when conducting research with this vulnerable population of people. The IRB Guidebook from the OHRP specifically addressed "special classes of subjects," including fetuses and human in vitro fertilization, women, children and minors, prisoners, the terminally ill, the elderly, minorities, students, employees, and the cognitively impaired.
Specific federal regulations dictate the required elements of informed consent. 21 CFR 50 and 45 CFR 46 specify these regulations. The IRB has developed templates to help you write your informed consent forms (ICF).
A waiver or alteration of informed consent can be requested in accordance with 45 CFR 46.116(d) and 45 CFR 46.117. To help determine if your research qualifies for a waiver or alteration of informed consent consult the Human Subject Decision Charts.
Private third party payors, i.e., health insurance, generally follow the guidelines established for the federal Medicare program, but they are not mandated to do so.
The previous National Institutes of Health (NIH) grants policy stated that research involving human subjects was required to have IRB approval at submission or within 60 days of application receipt. As of January 2001, IRB approval is not required prior to NIH peer review of an application.
