Understanding the Nature and Purpose of the IRB
Federal regulations and Yale policy require that human subjects research must be reviewed and approved by a committee called an Institutional Review Board (IRB) to ensure that the research is ethical and does not expose the research participants to unnecessary risk of harm. There are four IRBs at Yale registered under a Federalwide Assurance (FWA) approved by DHHS for projects involving human subjects:
- Two Human Investigation Committees (HIC I, HIC II) for the School of Medicine.
- The Human Subjects Committee (HSC) (serving the Faculty of Arts and Sciences and the Schools of Management, Forestry and Environmental Studies, Law, Divinity, Art, Architecture, Drama, and Music).
- The Human Subjects Research Review Committee (HSRRC) for the School of Nursing.
The membership and operations of the Yale IRBs are governed by federal regulations and Yale policy. A University-wide IRB Operations Manual and individual committee guides and policies for each IRB set forth the policies and procedures of the IRBs. These policies and procedures ensure that the IRBs operate in accordance with applicable regulations and guidance issued by OHRP and other agencies. Federal regulations do not affect any applicable state or local laws that provide additional protection for human subjects.
Human Subjects Research Defined
The regulatory definition of "human subjects research" requires investigators to be familiar with the individual definitions of both "Research" and "Human Subject."
Research:
"Research means a systematic investigation, including research
development, testing and evaluation, designed to develop or contribute to
generalizable knowledge. Activities that meet this definition constitute
research for purposes of this [45 C.F.R. 46] policy, whether or not they
are conducted or supported under a program that is considered research for
other purposes. For example, some demonstration and service programs may
include research activities."
(45 CFR 46.102(d))
Human Subject:
"A human subject is a living individual about whom an investigator
(professional or student) conducting research obtains 1) data through intervention
or interaction with the individual, or 2) identifiable private information."
(45 CFR 46.102(f))
Activities that Meet the Regulatory Definition of Research
The following activities are included in the scope of human subjects research:
- Physical procedures;
- Manipulation of the subject's environment;
- Interviews, surveys, and other forms of communication;
- Gathering information about individuals that was collected for purposes other than a specific research study (e.g., medical or school records);
- Obtaining bodily materials such as cells, blood or urine, tissue, organs, hair, and nail clippings even if the investigator did not collect these materials; and
- Access to medical records and data through medical information systems.
In addition, an organization is considered "engaged in research" if any of the following conditions apply:
- The organization's employees or agents are intervening or interacting directly with research subjects or prospective research subjects for research purposes and such activity does not qualify for exemption under 45 CFR 46.101(b).
- The organization's employees or agents are obtaining or assessing individually identifiable information or biomaterials about or from subjects or prospective subjects for research purposes and such activity does not qualify for exemption under 45 CFR 46.101(b).
- The organization is the prime recipient of a DHHS award to conduct non-exempt research (even if none of the research will be conducted at the organization or by any of its employees). Engagement of Institutions in Research
If an organization proposes to conduct research as defined above, the protocol must be submitted to an IRB for review and approval before any research with human subjects may be initiated. If the research involves one or more Yale researchers (and includes a Yale principal investigator), the organization may be an appropriate candidate to become a Yale RA. Once an organization completes the requirements to become a Yale RA and Yale approves the RA Application, the RA can submit its protocol(s) to the Yale IRB(s) for review, and Yale will serve as the organization's "IRB of record." If it is appropriate for your organization to apply to become a Yale RA, please continue to Roles and Responsibilities.
