Chapter 1 - Ethical and Regulatory Mandates to Protect Human Research Participants

Ethical Foundation for Human Subject Protections

The University of Pittsburgh is committed to ensuring that all human subject research1 in which it is engaged2 is conducted in accordance with the ethical principles stated in the Belmont Report. The Belmont Report, published in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, provides the ethical foundation for the federal regulations for the protection of human research subjects. All University personnel involved in the conduct and oversight of human subject research must abide by the fundamental principles set forth in the Belmont Report which include:

Respect for Persons

Individuals should be treated as autonomous agents afforded the right to make decisions for themselves. Those with diminished autonomy (e.g. minors, prisoners, persons who are mentally disabled) are entitled to additional protections. Application of this principle requires that human subjects are enrolled into research studies only under the conditions of effective informed consent. This involves a process in which participation in the research is acknowledged by the research subject (or by a legally authorized representative) as a voluntary act free from coercion or undue influence from the investigator or members of the research team. Exceptions to this informed consent requirement must be outlined in the federal regulations and subsequently approved by the University of Pittsburgh IRB.


The research study must be designed and implemented so as to maximize possible benefits and minimize possible harms. Application of this principle involves a risk/benefit analysis in which the risks to subjects must be reasonable compared to the potential for benefit either to subjects directly or to society. Risk evaluation must include the consideration of both the probability and magnitude of harm, including psychological, physical, legal, social, and economic harm.


The possibility for benefits and the potential burdens of the research should be equitably distributed among the potential research subjects. Application of this principle requires the close scrutiny of the enrollment process to ensure that particular classes (welfare patients, racial and ethnic minorities, or persons confined to institutions) are not selected for their compromised position or convenience to the research investigator.

1Under the University of Pittsburgh’s policies and procedures, an activity is human subject research if it is either (1) human research that is subject to FDA regulation or (2) human research that is subject to DHHS regulations. Activities are human research that are subject to FDA regulations when they meet the FDA definition of “research” and involve one or more “human subjects” as defined in FDA regulations. Activities are human research that are subject to DHHS regulations when they meet the DHHS definition of “research” and involves one or more “human subjects” as defined in DHHS regulations (45 CFR §46.102(f)).

2"Engaged in the conduct of the research" shall be defined in accordance with current Office of Human Research Protection (OHRP) guidance.



Regulatory Mandates

The IRB and the research community adhere to the following regulations and policies for human subject research activities:

  1. The Federal Policy regulations for the protection of human research subjects (45 CFR Part 46; Subpart A also known as the “Common Rule”), as well as all additional subparts outlined in 45 CFR 46.  Although the University of Pittsburgh has chosen to "uncheck" the box on its FederalWide Assurance, all regulatory requirements are applied across studies with minor exceptions as outlined in other sections of this document.  Where this occurs, equivalent protections are included.
  2. When research involves articles subject to regulation by the FDA, the FDA regulations for the protection of human subjects (21 CFR Parts 50) and Institutional Review Boards (21 CFR Parts 56).
  3. Where applicable, other federal, state and local regulations regarding research involving human subjects.
  4. The provisions of the Federal Wide Assurance Agreements (FWA) for the University of Pittsburgh (FWA #00006790), UPMC (FWA #00006735), UPMC Cancer Centers (FWA #00003338), UPMC Children’s Hospital of Pittsburgh (FWA #00000600), and Magee Women’s Research Institute (FWA #00003567).

When making determinations concerning the rights and welfare of human subjects participating in research studies, the IRB will also refer to current guidance available on OHRP’s website, the FDA's Information Sheets for IRBs and Clinical Investigators; and to other interpretative directives, information documents and guidance materials disseminated by OHRP, DHHS, the National Institutes of Health (NIH) the FDA and other federal agencies (e.g., Office of Civil Rights).

version 12.9.2015