Overview

Human subjects research comprises a broad spectrum, from testing of new drugs and therapeutics to surveys and questionnaires (in person or online), observation studies, and research with human tissues or data about human beings. It may or may not include direct contact with people.

The Department of Health and Human Services (HHS) defines a “human subject” as follows:

(f) Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains

(1) Data through intervention or interaction with the individual, or
(2) Identifiable private information.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

Anyone performing human subjects research at Harvard, including faculty, staff, and students, must obtain the requisite approvals (see below) prior to beginning the project, regardless of funding source..

External Oversight

Federal

The Office for Human Research Protections (OHRP), part of HHS, has oversight of all federally funded research. HHS regulations for the use of human subjects in research are covered by 45 CFR 46, also known as the “Common Rule.” Subpart A of the Common Rule lists the basic protections required for all human research subjects. The regulations also call for additional protections for pregnant women, human fetuses and neonates (Subpart B), prisoners (Subpart C), and children (Subpart D). (These regulations are also aggregated into a single PDF.)

Any institution engaged in federally-funded, non-exempt human subjects research must have an OHRP-approved Federalwide Assurance (FWA), which states that it will comply with the Common Rule (45 CFR 46.103).

Research regulated by US Food and Drug Administration (FDA) is covered by 21 CFR:
part 50: protection of human subjects
part 312: investigational new drug application (IND)
part 812: investigational device exemptions (IDE)

HHS and FDA regulations are similar but not identical. Both, however, require an institution to have an Institutional Review Board (IRB), a committee that reviews research protocols to ensure that the human subjects who take part in the research are protected. Research may not start until the IRB has either approved the research protocol or has determined that the research is exempt from IRB review (or is not human subjects research).

Other

The Association for the Accreditation of Human Research Protection Programs (AAHRPP) “offers accreditation to research organizations that provide comprehensive protections to research participants. The accreditation process is voluntary, peer-driven, and educational.” The FAS, HMS, and HSPH human research protection programs are accredited by AAHRPP.

Harvard Policies, Procedures & Guidance

Harvard has three IRBs that oversee human research activities.

FAS/University area: Committee on the Use of Human Subjects in Research (CUHS), administered by FAS Research Administration Services (FAS RAS)
HMS/HSDM: Committee on Human Studies (CHS), administered by the Office for Research Subject Protection
HSPH: Institutional Review Board (IRB), administered by the Office of Human Research Administration (OHRA)

School- and IRB-based policies are consistent with the university-wide Statement of Policies and Procedures Governing the Use of Human Subjects in Research at Harvard University. Harvard’s IRBs are the first line of contact for any human-research-related question:

Note: Human subjects research may require approvals beyond that given by the IRB:

• Research that involves the use of biological, chemical, or radioactive materials in humans may require the approval or signoff from the appropriate area in Lab Safety or may require a Material Transfer Agreement (MTA) to obtain those materials.
• Research performed in collaboration with another institution may require approvals from the collaborating institution.
• Use of stem cells require the review and approval of the Embryonic Stem Cell Research Oversight (ESCRO) Committee.
• Research that involves vertebrate animals may require Institutional Animal Care and Use Committee (IACUC) approval (see Animal Research and IACUCs).
• Research must comply with the University’s Research Data Security Policy.
• Some research involving patients and/or medical information may require compliance with HIPAA.

Multi-center research may be eligible for the Common Reciprocal Reliance Agreement, which can allow investigators who are conducting a mutli-center clinical study to request that participating IRBs rely on the review of one center's IRB. Please see the Harvard Catalyst’s cede review website for more information.

Effective January 1, 2011, researchers should be aware of the new Financial Policy on Human Subjects Payments.