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Overview

Federal and state regulations and institutional guidelines and policies govern human subject research. These regulations and guidelines exist to protect the rights and welfare, including privacy/confidentiality rights, of all human research subjects. The Institutional Review Board (IRB) is a committee of scientists/doctors and non-scientists whose charge is to oversee the safety and protection of human subjects in research based on those 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 US Food and Drug Administration (FDA) regulated research. FDA regulations 21 CFR 312 and 21 CFR 812 govern research involving drugs and devices, respectively.

Please be aware that 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.

Also, per federal guidance, IRBs are required to review the grant proposal for a study to ensure that the protocol is within the scope of the grant. Information is also available online about NIH “just-in-time” IRB review.

“Vulnerable Populations”

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) 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 OHRP IRB Guidebook specifically addresses “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.

Informed Consent

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 investigators write 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. Those regulations allow for a waiver or alteration of the requirement for a signed ICF in certain minimal risk studies and when the principal risk is a breach of confidentiality. The FDA does not permit waivers of documentation of consent (see 21 CFR 50.23, 50.24). Please also note that a waiver of parental permission is not allowed for any FDA regulated research. 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.

International Research

The Tufts MC/TUHS IRB must review all human subject research conducted by researchers at the institutions, including when Tufts MC/TUHS researches conduct international research. When international research is conducted, both the Tufts MC/TUHS IRB and the foreign site’s IRB/ethics committee must approve the research before the study begins. Researchers should consult the OHRP 2012 edition of the International Compilation of Human Subject Protections , which lists approximately 1,100 laws, regulations, and guidelines on human subject protections from 101 countries. Many of the listings include web addresses, allowing researchers to link directly to the law, regulation, or guideline of interest.

Please call the IRB office if you are planning to conduct international research and someone will help guide you. Please note: When Tufts MC/TUHS receives a federal grant to conduct research on the ground in a foreign nation, the convened Tufts MC/TUHS IRB may be required to review the study even if all human subject interactions will occur at a foreign site.