PrintOverview
The Standing Committee on the Use of Human Subjects in Research serves as the Institutional Review Board for all the "University Area" schools, including the Faculty of Arts and Sciences, the Harvard Graduate School of Education, the John F. Kennedy School of Government, the Harvard Law School, the Harvard Business School, the Harvard Graduate School of Design, the Harvard Divinity School, and the Radcliffe Institute for Advanced Study.
The Committee's primary charter is the Statement of Policies and Procedures Governing the Use of Human Subjects in Research Under the Faculty of Arts and Sciences (voted by the President and Fellows of Harvard College, 22 September 2003), "The Vote." In addition, for research with external funding, any procedures for protecting human subjects stipulated by the funding agency must be followed. Investigators with questions about review requirements are urged to consult the Committee office.
The mere fact that a research project requires review does not mean that there will likely be any problem, so long as the project is thoughtfully designed and proper consideration is given to the rights and welfare of the research subjects. Conversely, proposing a project that has been determined to be exempt from the requirements of committee review does not relieve the investigator of any responsibilities relating to the research subjects; equal care must still be taken to ensure that subjects experience no harm to themselves or to their legitimate interests. If a research project includes some elements that may be exempt and some that may not, the more conservative judgment will obtain and a full application should be submitted to the committee for review.
This flowchart highlights some of the questions that must be asked to help you anticipate whether a project should be submitted to the CUHS for review. Regardless of whether the chart indicates review may be required, final determination of exemption must be made by someone other than the investigator , so if your project involves collecting data about or interacting with living individuals, you should consult with the committee staff about whether an application for approval need be submitted.
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Definitions
A. Research means a systematic investigation designed to develop or to contribute to generalizable knowledge. A research investigator may be faculty, student, or staff. The intent of the project need not be to generate results for publication.
B. Human subject means a living individual about whom an investigator conducting research obtains data through intervention or interaction, or identifiable private information.
- Intervention includes both physical procedures for data gathering (venipuncture, EEG recordings, etc.) 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, as well as information that has been provided for specific purposes by an individual, and which the individual can reasonably expect will not be made public (for example, a school or medical record or a loan application). Private information must be individually identifiable—that is, 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.
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Flowchart
If the flowchart indicates that research may be exempt from the requirement for IRB review, you must confirm this exemption with the Committee Staff before proceeding with the project.
