Ìý(Note: OLPM sections on this page may be cited following the format of, for example, "UNH.VIII.F.1.1". These policies may be amended at any time, do not constitute an employment contract, and are provided here only for ease of reference and without any warranty of accuracy. See OLPM Main Menu for details.)
1.ÌýÌý Preamble
1.1ÌýÌý The University of New Hampshire (UNH) recognizes its responsibility to produce and disseminate knowledge in accordance with its mission of research, teaching, and public service. When non-human models are insufficient, use of human subjects in research is an integral aspect of scholarly activity at UNH. UNH recognizes its ethical and legal responsibilities to provide a mechanism to protect individuals involved as subjects in research conducted under the auspices of UNH. Accordingly, to protect the rights and welfare of every human subject involved in research activities, UNH maintains a policy on the use of human subjects in research. UNH strives to ensure that all members of its community understand and adhere to this policy.
2.ÌýÌý Definitions
2.1ÌýÌý Assurance: Federalwide Assurance of Protection for Human Subjects.
2.2ÌýÌý Human Subject: A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
2.3ÌýÌý Institutional Official: The individual designated by the UNH President to ensure that research involving human subjects conducted under the auspices of UNH is in compliance with all applicable laws and regulations. This individual is the Senior Vice Provost for Research.
2.4ÌýÌý Institutional Review Board for the Protection of Human Subjects in Research (IRB): The committee established by the UNH President to oversee the use of human subjects in research conducted under the auspices of UNH.
2.5ÌýÌý Research: A systematic investigation (including research development, testing, or evaluation), designed to develop or contribute to generalizable knowledge.
2.6ÌýÌý The Belmont Report: The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research report titled Ethical Principles and Guidelines for the Protection of Human Subjects of Research.
3.ÌýÌý Statement of the Policy
3.1ÌýÌý All UNH research activities proposing to involve human subjects must be reviewed and receive written, unconditional approval from the IRB before commencing. This applies to all research activities conducted under the auspices of UNH involving human subjects regardless of discipline or whether or not the activities are funded. In addition, all research activities involving human subjects must be conducted in accordance with:
3.1.1ÌýÌý Federal, state, and local laws and regulations applicable to use of human subjects in research. These include, but are not limited to, Federal Policy for the Protection of Human Subjects, Title 45 Code of Federal Regulations Part 46; Food and Drug Administration (FDA) Regulations for Human Subjects Protections, Title 21 Code of Federal Regulations Parts 50 and 56; and, the principles set forth in "The Belmont Report"; and
3.1.2ÌýÌý UNH policy as set forth in the Assurance.
4.ÌýÌý Applicability. This policy is applicable to any research activity:
4.1ÌýÌý Sponsored by UNH, or
4.2ÌýÌý Conducted by or under the direction of any employee, student, or agent of UNH in connection with his or her UNH responsibilities, or
4.3ÌýÌý Conducted by or under the direction of any employee, student, or agent of UNH involving the use of any UNH property or facility, or
4.4ÌýÌý Conducted by or involving any individual or institution working with UNH as part of a collaboration, subgrant, or subcontract.
5.ÌýÌý Examples. Examples of activities involving the use of human subjects covered by this policy include, but are not limited to:
5.1ÌýÌý Research involving surveys or questionnaires, administered in person, by mail, or via the telephone or electronically, designed to elicit information about individuals, including behaviors, experiences, attitudes, or beliefs.
5.2ÌýÌý Research involving interviews or focus groups designed to elicit information about individuals, including behaviors, experiences, attitudes, or beliefs.
5.3ÌýÌý Educational practices or tests conducted for research purposes.
5.4ÌýÌý Research involving program evaluation.
5.5ÌýÌý Research involving observation of public behavior.
5.6ÌýÌý Research involving the collection and/or study of data, documents, records, or biological, pathological, or diagnostic specimens, including voice or image recordings, medical, academic, or court records, and, invasive and noninvasive clinical procedures.
5.7ÌýÌý Clinical studies of drugs and medical devices.
6.ÌýÌý Effective Date
6.1ÌýÌý The requirements of this policy have been in effect since the execution of UNH's first Assurance on April 21, 1980.
7.ÌýÌý Administration of Policy
7.1ÌýÌý The Institutional Official is responsible for the administration of this policy and its procedures as set forth in the Assurance. Approval by the UNH President is required to amend this policy.
8.ÌýÌý Enforcement
8.1ÌýÌý The Institutional Official is responsible for enforcing this policy. Violations of this policy fall under the purview of the Assurance.
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Reference:
UNH Federalwide Assurance of Compliance for the Protection of Human Research Subjects atÌý/sites/www.usnh.edu/files/media/olpm/docs/unh/fwa-update-190118.pdf
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