Statement of policies and procedures governing the use of human subjects in research at Harvard University
Elected by the President and Members of Harvard College on September 22, 2003
Harvard University adheres to the ethical principles for research involving human subjects set out 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 Research Human Subjects [the “Belmont Report”] ]). The Minimum Standard is established by Department of Health and Human Services regulations at 45 CFR 46 (the “General Rule”). Harvard University has additional provisions beyond this Standard that help meet the highest expectations of performance and oversight by investigators, Institutional Review Boards (IRBs), and the university. The following policies and procedures describe these expectations.
guidelines
Research that exposes human subjects to an unreasonable risk of harm must not be conducted.
Subjects should not be exposed to any risk that is practically avoidable without compromising the research design.
Persons intending to carry out research involving human subjects must be qualified through experience and/or training to ensure the well-being of their research subjects.
The investigators under whose auspices the research will be conducted have the primary responsibility for determining whether subjects may be at risk of harm. In making this determination, investigators will seek advice from the appropriate IRB. Principal Investigators also have the primary responsibility for protecting subjects from harm through their participation in a study. All other study participants have this responsibility.
Each IRB will have the power to review, approve or deny and establish terms for conducting research involving one or more human subjects in accordance with the policies described in this document. In addition to membership requirements established by federal law and regulation, each IRB's membership is selected based on its ability to credibly represent the diverse perspectives of subjects, investigators, and society at large. In appropriate circumstances, the IRB seeks the advice of others who are uniquely qualified to represent the views of a particular professional group. CEP members cannot participate in the approval of projects in which they are involved or have conflicting interests.
While the typical topics covered by the IRBs that oversee human research at different faculties vary widely, IRB Chairs meet as needed to ensure that similar topics are treated similarly throughout the university.
Investigators should explain the research objectives, procedures to be followed, and potential risks and benefits to subjects prior to participation. Researchers may not use individuals as subjects unless they are satisfied that they or others legally responsible for their well-being voluntarily consent to participate and understand the consequences. Investigators will generally also obtain consent from individuals who are legally unable to consent to participate. The IRB may waive some or all of these requirements only if it is satisfied that the research could not otherwise be conducted, that the potential value of the research outweighs the subject's outrage, and that the subject will not suffer further harm from the investigation • risky participation. Where appropriate, the IRB may also require that participants receive additional information about the study after participation.
The researchers respect the privacy of the subjects. They protect confidential information provided to them and inform participants in advance of any limitations on their ability to ensure that information remains confidential.
Participants will not be forced to participate by any means or circumstances that could impair their ability to make their own decisions.
Researchers must be concerned with fair selection of subjects, taking into account the research purposes, the environment in which the research is conducted, and any special vulnerabilities of the target population.
It must be made clear to subjects that they can withdraw from active participation in the research at any time and without prejudice to their legitimate interests. Subjects who express a desire to withdraw must be able to do so immediately.
A researcher must disclose the source of research support to a subject who requests it.
Faculty who commission or supervise student research projects and exercises are responsible for ensuring that students are able to adequately ensure the well-being of subjects.
Researchers may indicate their position at Harvard, but may not claim that the research is sponsored by the university or any university department, unless there is express agreement with the appropriate administrative bodies.
Minutes
An investigator who intends to conduct, direct or supervise research involving human subjects must ensure that the research is conducted in accordance with the policies and procedures set out herein and that the relevant IRB has been informed of any existing knowledge of the risks involved.
Regardless of funding source, all research that meets the definition of research involving human subjects under the Common Rule is reviewed in accordance with the standards contained therein and any other applicable laws or regulations.
Whether or not the common rule requires review, proposed research involving human subjects must be submitted to the IRB for review and approval, or for determination of an exemption, if the research poses more than minimal risk to participants, or if the investigation contains:
Procedures that may physically harm the subjects;
Procedures that deprive subjects of necessary or customary resources;
hypnosis or exceptionally high mental stress;
The use of people unable to give their free and informed consent, including minors, prisoners and people with reduced intellectual capacity;
Explicit or implicit deception of subjects about aspects that may be important to them;
The use of subjects that are available because they require the investigator's professional services;
Activities that may be illegal or violate applicable ethical standards.
Each IRB develops guidelines for investigations involving subjects who do not meet the definition of investigation under the Common Rule or the conditions set forth in Part C of these Procedures. Guidelines should provide the procedures to be used for the review and approval of such studies. Investigations in this category may include, for example, those designed to train individuals in investigative techniques, such as B. Student assignments assigned during classroom lessons or other educational programs.
Investigators must submit their plans for the use of human subjects to the appropriate IRB in the form and schedule established by that IRB to ensure the proper conduct of its activities. IRB approval is normally limited to the specific research plan submitted to the IRB. Admission is limited to one year. If the investigation lasts longer than one year, a new application must be approved. Extensions to the designated time that subjects participate and schedule changes that subjects may find significant require additional approval from the IRB.
When investigators identify an adverse change in a subject's health or behavior that can be attributed to a study, or identify new risks that may arise from the subject's participation in that study, they must decide whether to continue or discontinue the study immediately. In either case, report the incident to the IRB immediately. Regardless of the investigators' decision to discontinue the study, the IRB will independently decide whether discontinuation of the study is appropriate and, if so, under what conditions it may be resumed. Study participants should be informed of any knowledge gained during the course of the research that may relate to their willingness to continue participating.
This Statement of Policies and Procedures is distributed annually to all faculty and administrative staff who may have responsibility for studies involving human subjects. In turn, they take appropriate steps to ensure that their students and staff are aware of the content.