Legal requirements to protect human subjects apply to a much broader range of research than many investigators realize.
In addition to covering traditional biomedical studies, legal obligations to protect human subjects also apply, for example, to research that uses:
- Human
beings to test devices, products, or materials
that have been developed through research.
- Data collected through intervention or interaction with individuals.
Intervention includes not only physical procedures, but also manipulation of a subject's environment and some observations
- Private information that can be readily identified with individuals, even if the information was not collected specifically for the study in question. Examples include student records and medical records.
- Bodily materials such as cells, blood or urine, tissues, organs,
hair, and nail clippings even if you did not collect these materials (such research may be considered Exempt if materials are not personally identifiable and if the materials were collected prior to the initiation of the research project).
- Studies conducted to gain generalizable knowledge about categories or classes of subjects, such as Vanderbilt employees, students, and/or patients. This includes a doctoral dissertation and a master's thesis.
- Human beings to evaluate environmental alterations, for example, weatherization options or habitat modifications.
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What is the definition of "Research"? Research
means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
What is an IRB (Institutional Review Board)? An IRB is a board
or committee established in accordance with 45 CFR 46, to review proposed human subject research. At Vanderbilt, the IRB has four different committees: three that review health sciences/biomedical research and one that reviews social/behavioral research.
Types of IRB Review:
- Standard
- review of proposed research at a convened meeting where a
valid quorum of IRB members is present.
- Expedited
- review of proposed research by the IRB Chair or a designated
voting member or group of voting members, rather than by the
entire committee. Federal rules permit Expedited review for
certain kinds of research involving no more than minimal risk
and for minor changes to previously approved research.
- Exempt
- exempt from the requirement for IRB approval when it is determined that research does not involve human subjects as defined in 10 CFR 745 and/or the only involvement of human subjects is in one of the categories listed under 45 CFR 46 Section 101(b)(1)-(6) and 21 CFR 56.104(d). Human subjects regulations do not apply to exempt projects. Any research project involving human subjects thought to be exempt must be submitted to the IRB or other authority according to local procedures for determination of exempt status
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According to our binding commitment (FWA#00005756), all research activities involving human subjects, regardless of sponsorship, must be reviewed by the IRB if one or more of the following apply:
- The research is sponsored by Vanderbilt University
- The research is conducted by or under the direction of any employee,
faculty, staff, student, or agent of Vanderbilt University,
using any property or facility of Vanderbilt University
- The research involves the use of Vanderbilt University's non-public
information to identify or contact human subjects or prospective
subjects.
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