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Use of Human Subjects in Research

Statement of Policies and Procedures Governing the Use of Human Subjects in Research at Harvard University

As voted by the President and Fellows of Harvard College, September 22, 2003

Harvard University is guided by the ethical principles regarding research involving human subjects set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Ethical Principles and Guidelines for the Protection of Human Subjects of Research [the “Belmont Report”]). The minimum standard is set by the Department of Health and Human Services regulations at 45 CFR 46 (the “Common Rule”). Harvard University has additional provisions beyond that standard, which help to establish the highest expectations for performance and oversight by investigators, Institutional Review Boards (IRBs), and the University. The following policies and procedures outline these expectations.

Policies

  1. Research that exposes human subjects to the unreasonable risk of harm shall not be conducted.

  2. Subjects must not be exposed to any risk that can practicably be avoided without impairing the research design.

  3. Individuals who propose to conduct research involving human subjects must be qualified by experience and/or training to safeguard the well-being of the subjects of their research.

  4. Investigators under whose aegis research is to be conducted have primary responsibility for determining whether subjects might be exposed to a risk of harm. In making this determination, investigators shall seek advice from the appropriate IRB. Principal investigators also have primary responsibility for protecting subjects from being harmed by their participation in a study. All others involved in the study share this responsibility.

  5. Each IRB shall be authorized to review and to approve or disapprove, and to state conditions for, the conduct of any research involving a human subject or subjects, in accordance with the policies outlined herein. In addition to membership requirements stipulated by federal laws and regulations, the membership of each IRB shall be chosen with a view to its ability to represent credibly the varying perspectives of subjects, investigators, and society at large. In appropriate circumstances, the IRB shall solicit advice from others who are especially qualified to represent the views of a particular subject population. IRB members shall not participate in the approval of projects in which they are involved or have a conflicting interest.

  6. Although the typical issues dealt with by IRBs that oversee human subject research in different Faculties differ greatly, the Chairs of the IRBs shall confer as needed to assure that similar issues are treated similarly across the University.

  7. Investigators shall explain to subjects, prior to their participation, the objectives of the research, the procedures to be followed, and the potential risks and benefits. Investigators shall not use individuals as subjects unless satisfied that they, or others legally responsible for their well-being, consent to participation freely and with understanding of the consequences. Ordinarily, investigators shall also obtain the assent of subjects who are not legally capable of consenting to participation. The IRB may waive some or all of these requirements only when persuaded that the research could not practicably be conducted otherwise, that the potential value of the research outweighs the indignity to the subject, and that the subject risks no other harm in participating. If appropriate, the IRB may also stipulate that additional information about the study will be provided to subjects after their participation.

  8. Investigators shall respect the privacy of subjects. They shall protect confidential information given them, advising subjects in advance of any limits upon their ability to ensure that the information will remain confidential.

  9. Subjects shall not be induced to participate by means or in circumstances that might affect their ability to decide freely.

  10. Investigators shall address the equitable selection of subjects, taking into account the purposes of the research, the setting in which the research will be conducted, and any special vulnerabilities of the subject population.

  11. It shall be made clear to subjects that they are free to withdraw from active participation in the research at any time and without prejudice to their legitimate interests. Subjects who indicate a desire to withdraw shall be allowed to do so promptly.

  12. An investigator shall disclose to a subject, upon request, the source of support for the research.

  13. Instructors who assign or supervise research projects and exercises conducted by students are responsible for ensuring that the student is qualified to safeguard adequately the well-being of the subjects.

  14. Investigators may indicate their position at Harvard, but shall not represent that the research is sponsored by the University or a department within the University except by explicit arrangement with appropriate administrative authorities.

Procedures

  1. An investigator proposing to conduct, direct, or supervise research involving human subjects shall make certain that the research is consistent with the policies and procedures stated herein, and that the appropriate IRB has been informed of existing knowledge of any risks involved.

  2. Regardless of funding source, all investigations that meet the definition of research involving human subjects as specified in the Common Rule shall be reviewed according to the standards therein, as well as any other applicable laws or regulations.

  3. Whether or not the Common Rule mandates review, proposed research involving human subjects must be submitted to the IRB for review and approval, or determination of exemption, if the research presents more than minimal risk to subjects or if the research involves any of the following:

    1. Procedures that might harm the subjects physically;

    2. Procedures that deprive the subjects of necessary, or accustomed, resources;

    3. Hypnosis or unusual degrees of mental stress;

    4. The use of subjects who are not able to give free and informed consent, including minors, prisoners, and individuals of diminished mental capacity;

    5. Explicit or implicit deception of the subjects in any aspect likely to be significant to them;

    6. The use of subjects who are available because they need the investigator’s professional services;

    7. Activities that may be illegal, or are likely to offend prevailing standards of morality.

  4. Each IRB shall develop guidelines for investigations involving human subjects that do not meet the definition of research as specified in the Common Rule or the conditions elaborated in part C of these Procedures. The guidelines should provide procedures to be employed for the review and approval of such studies. Investigations in this category might include, for example, those designed to train individuals in research techniques, such as student exercises assigned during the course of classroom instruction or other pedagogical programs.

  5. Investigators shall submit their plans for using human subjects to the appropriate IRB in the form, and according to the timetable, established by that IRB to ensure orderly handling of its business. IRB approval is ordinarily limited to the specific research plan submitted to the IRB. Approval shall be for a definite period of time up to one year. A new application must be approved for research continuing for more than a year. Extensions of the specified time that subjects participate, and changes in plan that subjects might consider significant, require further IRB approval.

  6. If investigators detect an adverse change in the health or behavior of a subject that may be attributable to a study, or if they identify new risks that may result from subject participation in that study, they shall exercise judgment as to whether to suspend the study immediately. In any event, they shall immediately report the incident to the IRB. Regardless of the investigators’ decision about whether to suspend the study, the IRB independently shall determine whether suspension of the study is in order, and, if so, under what conditions it may be resumed. Study participants must be informed of any findings developed during the course of the research that may relate to their willingness to continue participation.

  7. This Statement of Policies and Procedures shall be distributed annually to all faculty and administrative officers who might bear responsibility for studies involving human subjects. They, in turn, shall take appropriate steps to assure that their students and staff associates are aware of its contents.

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