Chapter 3 - Human Subject Research and the Authority and Jurisdiction of the University of Pittsburgh Human Research Protection Office and IRB
The University of Pittsburgh IRB is required to review and approve all research activities, within its jurisdiction, involving human subject research prior to its implementation. All studies approved after January 21, 2019 will be required to comply with the Revised Common Rule.
Clinical Investigation [FDA – 21 CFR 56.102(c)]: Any experiment that involves a test article and one or more human subjects and that is either subject to requirements for prior submission to the FDA under section 505(i) or 520(g) of the Act, or is not subject to requirements for prior submission to the FDA under these sections of the Act, but the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for research or marketing permit. The terms “research,” “clinical research,” “clinical study,” “study,” and “clinical investigations” are deemed to be synonymous for purposes of this part (21 CFR 50.3(c) and 21 CFR 56.102(c)
Clinical trial: A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
Generalizable: Knowledge that may be justifiably transferred or extrapolated to a broader population or situation than from which it was initially derived.
Human Subject (DHHS)
- Pre-2018 [45 CFR 46.102(f)]: A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through interaction or intervention with the individual or (2) private, identifiable information.
- Post-2018 [45 CFR 46.102(e)(4)]: A living individual about whom an investigator (whether professional or student) conducting research (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens, or (2) obtains, uses, studies, analyzes, or generates private identifiable information or identifiable biospecimens.
- Intervention includes both physical procedures by which information or biospecimens are gathered (for example venipuncture) and manipulation of the subject or the subject’s environment that are performed for research purposes.
- Interaction includes communication or interpersonal contact between investigator and subject.
Human Subject (FDA) [21 CFR 56.102(e)]: An individual who is or becomes a participant in research, either as a recipient of a test article or as a control. A subject may be either a healthy individual or a patient (21 CFR 50.3(g) and 21 CFR 56.102(e)). For clinical investigations involving medical devices, the results of which are intended to be submitted later to, or held for inspection, by the Food and Drug Administration as part of an application for a research or marketing permit, human subject also means a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A subject may be in normal health or may have a medical condition or disease.
- Pre-2018 (45 CFR 46.102(f): The identity of the individual subject is or may readily be ascertained by the investigator or may be associated with the information.
- Post-2018 (45 CFR 102(e)(5-6): 1) Private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information; and/or 2) A biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
- Pre-2018 (45 CFR 46.102(f): Any information that an individual can reasonably expect will not be made public, and any information about behavior that an individual can reasonably expect will not be observed or recorded.
- Post-2018 (45 CFR 46.102(e)(4): Information about a behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
- Pre-2018 [45 CFR 46.102(d)]: A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”
- Post-2018 [45 CFR 46.102(l)]: A systematic investigation, including research development, testing, and evaluation, designed to contribute to generalizable knowledge. The following is deemed not to be research:
- Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or risk factors, patterns in diseases, or increases in injuries from using consumer product(s). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health including natural or man-made disasters.
- Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
- Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense or other national security missions.
- Secondary research involving non-identifiable newborn screening blood spots.
Systematic Investigation: An activity that involves a prospective plan which incorporates data collection, either quantitative or qualitative, and data analysis to answer a question.
Guidance concerning activities that may not require IRB oversight is located on the IRB website.
Authority Granted to Human Research Protection Office (HRP) and IRB through the Institution
The University Chancellor has delegated authority, through the Vice Chancellor for Research Conduct and Compliance (the designated Institutional Official), to the University of Pittsburgh HRP, including the Institutional Review Board (IRB) to oversee all research activities falling under the Human Research Protection Program (HRPP) of the University of Pittsburgh.
Authorities Granted to the IRB by Federal Regulation
The nine IRB committees listed on the University of Pittsburgh’s Federal-Wide Assurance (FWA00006790) are appropriately constituted administrative bodies established to protect the rights and welfare of human subjects recruited to participate in research activities. In accordance with the Federal Policy regulations (45 CFR 46) of the Department of Health and Human Services (DHHS) and the applicable regulations (21 CFR 50, 56) of the Food and Drug Administration (FDA), the IRB has the authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by the policy, including exempt research activities under 45 CFR 46.104 for which limited IRB review is a condition of exemption (45 CFR 46.104(d)(2)(iii) and (d)(3)(i)(C). Exemptions at (d)(7) and (d)(8) are not included because Broad Consent is not being implemented.
- Research activities approved by the IRB are subject to further appropriate review and approval or disapproval by the Institutional Official of the University of Pittsburgh and by officials of the UPMC. However, those officials may not approve human subject research to be conducted within their institution if such research has not received prior approval from the IRB.
- Unresolved questions or issues between the IRB and investigators will be referred to the Institutional Official for additional discussion. Comments and recommendations of the Institutional Official will be considered by the IRB in its subsequent decision to approve or disapprove the proposed research protocol.
The IRB has the authority to determine that a project submitted by an investigator does not meet the regulatory definition of human subject research under 45 CFR 46.102(e)(1) and 46.102(l) and 21 CFR 56.102(f).
The IRB has the authority to require progress reports from investigators and to conduct continuing reviews of approved human subject research studies at intervals appropriate to the degree of risk.
The IRB has the authority to approve prospectively all modifications to previously approved research protocols and/or informed consent documents; the only exception being a protocol deviation that may be necessary to eliminate an apparent immediate hazard to a given research subject.
The IRB has the authority to observe or have a third party observe the conduct of approved human subject research studies, including the informed consent process.
The IRB has the authority to suspend, or terminate the approval of, human subject research activities that are not being conducted in accordance with the IRB’s requirements or have been associated with unexpected serious harm to subjects.
The IRB has the authority to place restrictions on human subject research activities.