Statement of Authority and Purpose
1. IRB Review of Research
All research involving human subjects (as defined below), and all other activities, which even in part involve such research, regardless of sponsorship, must be reviewed and approved by the Institution's IRB(s). No intervention or interaction with human subjects in research, including recruitment, may begin until the IRB has reviewed and approved the research protocol. Specific determinations as to the definition of "research" or "human subjects," and their implications for the jurisdiction of the IRB under Institutional policy are determined by the IRB.
It is the IRB's purpose and responsibility to protect the rights and welfare of research subjects. The IRB reviews and oversees such research to ensure that it meets well-established ethical principles and that it complies with federal regulations at 45 CFR 46 and 21 CFR 50 and 56, that pertain to human subject protection, as well as any other pertinent regulations and guidelines, such as the Good Clinical Practice (GCP) Guideline (E6) of the International Conference on Harmonisation.
According to federal regulations, the activities that require IRB review include any activities involving the collection of data through intervention or interaction with a living individual, or involving identifiable private information regarding a living individual must be reviewed by the IRB. Specific activities that require IRB review include, but are not necessarily limited to, the following:
- Any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration (FDA) under relevant investigational drug or medical device provisions of the Food, Drug, and Cosmetic Act, or experiments that need not meet the requirements for prior submission to the FDA, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit.
- Collection of data about a series of standard procedures or treatments for dissemination or generalization.
- A patient's care of assignment to intervention is altered for research purposes in any way.
- A diagnostic procedure for research purposes that is added to a standard treatment.
- Systematic investigation involving innovative procedures or treatments; for example, if a physician plans to collect information about the innovation for scientific purposes or will repeat the innovation in other patients in order to compare it to the standard treatment.
- Emergency use of an investigational drug or medical device. Note that when emergency medical care is initiated without prior IRB review and approval, the patient may not be considered a research subject, and data generated from such care cannot be included in any report of a research activity.
- Human cell or tissue (genetic tissue) research that typically involves repositories that collect, store and distribute human tissue materials for research purposes. However, human cell and tissue repositories activities do not require IRB review if material submitted to the repository satisfies both of the following conditions: (1) The material, in its entirety, was collected for purposes other than submission to the repository (e.g., the material was collected solely for clinical purposes, or for legitimate but unrelated research purposes, with no "extra" material collected for submission to the repository); and (2) The material is submitted to the repository without any identifiable private data or information about the living individual (i.e., no codes or links of any sort may be maintained, either by the submitter or the repository) that would permit access to identifiable private data or information about the living individual from whom the material was obtained.
- Investigator-initiated research, where an investigator both initiates and conducts, alone or with others, a clinical trial. In the case of investigator-initiated studies, it is the investigator's responsibility to keep the IRB informed of unanticipated non-serious research-related events and unanticipated serious adverse events and other unexpected findings that affect the risk/benefit assessment of the research, even if the event occurred at a location for which the Institution's IRB is not the IRB of record. The IRB recommends that an independent data safety monitoring board (DSMB) review all reportable adverse events and the DSMB reports are forwarded to the IRB in addition to individual reports.
- Student-conducted research, which includes all activities that meet the definition of research with human subjects and that are conducted by students for a class project or for work toward a degree, must be reviewed by the IRB. These activities include: (1) All master's theses and doctoral dissertations that involve human subjects; and (2) All projects that involve human subjects and, for which, findings may be published or otherwise disseminated.
- Case studies, such as when a series of subject observations are compiled in such a way as to allow possible extrapolation or generalization of the results from the reported cases. Such activity constitutes research that must be reviewed by the IRB. Additionally, this type of activity must always be reviewed by the IRB when there is intent to publish or disseminate the data or findings.
A. Governing Principles
1. IRB Review of Research
2. Failure to Submit a Project for IRB Review