What the IRB Reviews

The CHS reviews mostly social and behavioral research with a wide array of participant populations, and also reviews a number of clinical studies that are undertaken at Harvard facilities or elsewhere where review by the CHS is necessary.

The CHS uses the definitions found in the Department of Health and Human Services (45 CFR § 46) and FDA regulations (21 CFR § 50.3 and 56.102), as outlined below. The CHS must review and approve (or grant an exemption to) all “research involving human subjects,” which is defined by an activity that meets definition of “research” and involves “human subjects” under the DHHS or FDA regulations. Under these definitions the following activities may also be human studies research: program evaluations, curriculum studies, surveys, questionnaires, specimens and data analysis.

When in doubt, call the CHS office!

Definitions

The CHS uses the following definitions set forth in DHHS regulations 45 CFR § 46.102 and FDA regulations 21 CFR § 50.3 and 56.102:

1. Research as defined by DHHS regulations is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
2. Research subject to regulation , and similar terms are intended to encompass those research activities for which a federal department or agency has specific responsibility for regulating as a research activity, such as IND requirements administered by the FDA. It does not include research activities which are incidentally regulated by a federal department or agency solely as part of the department's or agency's broader responsibility to regulate certain types of activities whether research or non-research in nature (for example, Wage and Hour requirements administered by the Department of Labor).
3. Human subject as defined by DHHS regulations means a living individual about whom an Investigator (whether faculty, staff or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
4. Research Involving Human Subjects: means an activity that meets the DHHS definition of “research” and involves “human subjects” as defined by DHHS, or that meets the FDA definition of “research” and involves “human subjects” as defined by the FDA.
5. 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.
6. Private information includes information about behavior that occurs in a context in which an individual could 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.
7. Minimal Risk: The regulatory definition of "minimal risk" is the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

For those studies involving clinical investigations, the CHS uses the FDA’s definitions (set forth in 21 CFR § 56.102 (23)) as follows:

1. Clinical investigation or research defined FDA regulations means any experiment that involves a test article and one or more human subjects, and that either meets the requirements for prior submission to the FDA under section 505(i) or 520(g) of the Federal Food Drug and Cosmetic Act (i.e. 21 U.S.C. 355(i) or 360j(g)), or does not meet the requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. The term does not include experiments that meet the provisions of part 58 (i.e. 21 CFR Part 58, “Good Laboratory Practice for Nonclinical Laboratory Studies”), regarding nonclinical laboratory studies. The terms research, clinical research, clinical study, study, and clinical investigation are deemed to be synonymous. In addition:
   1. An experiment is subject to the requirements for prior submission to the FDA under section 505 (i) of the Food, Drug and Cosmetic Act when it involves any use of a drug other than the use of a marketed drug in the course of medical practice,
   2. An experiment is subject to the requirements for prior submission to the FDA under section 520(g) of the Food, Drug and Cosmetic Act when it involves the evaluation of the safety or effectiveness of a medical device.
2. Human subject as defined by FDA regulations means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject is also an individual on whose specimens a medical device is used.
3. Test article means any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the Food and Drug Act or under sections 351 or 354-360F of the Public Health Service Act.
4. Investigator means an individual who actually conducts a clinical investigation (i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject) or, where an investigation is conducted by a team, the responsible leader of that team.

Additional Information
IRB Guidelines
Policies and Procedures
Modes of Review

Updated: 04-Sep-2007

Office for Research Subject Protection:
About | Animal | COMS | ORSP home
Committee on Human Studies (FWA00007071):
Forms | Guidelines | Contact Us | Human Studies Home
For questions or comments about this website, please email: orsp@hms.harvard.edu