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.

Definitions:

Research (DHHS): A systematic investigation, including research development, testing and evaluations, designed to develop or contribute to generalizable knowledge [45 CFR 46.102(d)].

  • Systematic Investigation: An activity that involves a prospective plan which incorporates data collection, either quantitative or qualitative, and data analysis to answer a question.
  • Generalizable: Knowledge that may be justifiably transferred or extrapolated to a broader population or situation than from which it was initially derived.

Research (FDA): 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).

Human Subject (DHHS): 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. Intervention includes both physical procedures by which data 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. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public. Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects ([45 CFR 46.102(f)].

Human Subject (FDA): 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.

Guidance concerning activities that may or may not be overseen by the human research protection program such as classroom research, quality assurance/improvement, case reports, program evaluation, and innovative practice is located on the IRB website (http://www.hrpo.pitt.edu/Guidance).

Authority Granted to the Human Research Protection Office (HRPO) and IRB through the Institution

The University Chancellor has delegated authority, through the Vice Provost for Research Conduct and Compliance (the designated Institutional Official), to the University of Pittsburgh Human Research Protection Office (HRPO), 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 seven IRB committees listed on the University of Pittsburgh’s FederalWide Assurance (FWA00006790) are appropriately constituted administrative bodies established to protect the rights and welfare of human subjects (including patients) 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 to, or disapprove all research activities involving human subjects that fall under its authority.

  • 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.
     
  • In addition, investigators may also utilize the Dispute Resolution process through the Office of Clinical Research (http://www.clinicalresearch.pitt.edu/IRSServices/IRBDispute). Through this process, the Associate Vice Chancellor for Clinical Research, Health Sciences and the Vice Provost for Research Conduct and Compliance will evaluate the concerns raised by the investigator and determine what subsequent actions, if any, should be taken to address the issues and/or minimize the likelihood of their recurrence.

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(f) 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, but not less than once per year. Research studies qualifying for “exempt” status in accordance with 45 CFR 46.101(b) will not be subject to continuing review.

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.

 

version 12.9.2015