Regulatory Charge & Governing Principles of the IRB

Regulatory Charge

The University of Minnesota’s IRB was established to protect the rights and welfare of human research subjects. The IRB is charged with ensuring that those individuals participating in research are not subject to undue or inappropriate risks, that participation remains a voluntary right, and that the conduct of research is upheld as a privilege.

The IRB was formally established in the early 1970s as the Committee on the Use of Human Subjects in Research though research committee minutes in IRB archives date back to 1960. The current Board of Regents' Policy on "Research Involving Human Subjects" was adopted on July 8, 1994

The basis for the Regents' policy and the IRB charge is found in the Code of Federal Regulations (CFR). See Federal & University Regulations, Ethical Codes.

The CFR requires that each institution engaged in the conduct of research involving human subjects provide a written assurance of compliance with the requirements set forth in those regulations. This document is referred to as a FederalWide Assurance of Protection for Human Subjects (FWA).

Governing Principles

The IRB’s authority is founded in and guided by many sources, including regulatory statutes, institutional policies, ethical canons, and members’ own perceptions of community and professional standards. See Federal Regulatory and Guidance Documents below.

While interpretive differences between these governing principles may exist, it should be noted that regulations offering the most stringent guidelines for the protection of human subjects are followed. Furthermore, these principles are to be upheld without regard to whether the research is subject to federal regulation, with whom the research is conducted, or the source of support for the research.

Federal Regulatory Documents

The IRB’s foundation and primary charge are supported in the Code of Federal Regulations. These regulations include, but are not limited to, the following:

Office for Human Research Protections (OHRP)

45 CFR 46 - Protection of Human Subjects

U.S. Food and Drug Administration (FDA)

21 CFR 50 - Protection of Human Subjects

21 CFR 54 - Financial Disclosure by Clinical Investigators

21 CFR 56 - Institutional Review Boards

21 CFR 312 - Investigational New Drug Application

21 CFR 812 - Investigational Device Exemptions

Office for Civil Rights (OCR), within Health & Human Services (HHS)

National Standards to Protect the Privacy of Personal Health Information

Guidance Documents

Nuremberg Code

Events of history have engendered the development of the current federal regulations regarding the use of human subjects in research. The Nuremberg Trials following World War II brought to the attention of the scientific community the need for guidelines for research with human subjects.

Those trials, in which 26 Nazi "scientists" were tried for crimes against victims of the Holocaust, resulted in the international adoption of the "Nuremberg Code" in 1949. The basic principles of the Nuremberg Code serve as the cornerstone for modern regulations.

Those principles emphasize a profound respect for the voluntary nature of human subjects’ participation, the idea of true informed consent, and the personal ethical responsibilities of the investigator to ensure human welfare.

Nuremberg Code

Belmont Report

The IRB uses the Belmont Report as one of its ethical guides. This report, published April 18, 1979, is the product of National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The report provides the most succinct description of the mandate for review of research involving human subjects.

All other federal and local regulations and guidelines concerning the use of human subjects in research are based on the following fundamental elements as excerpted from the Report:

• Respect for Persons. According to the Belmont Report, "Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy. Persons are treated in an ethical manner by respecting their decisions and protecting them from harm."
  
  A critical component of respecting the persons involved in research is the informed consent process. This process includes a discussion of the research project between the potential subject and the investigator, and the signing of the consent form.
  
  IRB implementation: The IRB reviews all consent forms to ensure that the process includes all of the essential elements of informed consent and the IRB carefully examines recruitment methods to ensure a respectful process.
• Beneficence. According to the Report, "The term ‘beneficence’ is often understood to cover acts of kindness or charity that go beyond strict obligation. In this document (and the field of human subjects protection), beneficence is understood in a stronger sense, as an obligation. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: 1) do no harm; and 2) maximize possible benefits and minimize possible harms."
  
  IRB implementation: The IRB assesses the risks and benefits of all research involving human subjects. At times, this review includes scrutiny of the scientific merit of a study to determine that in fact, the potential benefits do outweigh the risks.
• Justice. The Report challenges the researcher to examine the questions of justice and right. "Who ought to receive the benefits of research and bear its burden? This is a question of justice in the sense of ‘fairness in distribution’ or ‘what is deserved." The selection of research subjects must be scrutinized in order to determine whether some classes (e.g. welfare patients, racial or ethnic minorities, or persons confined to institutions) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied."
  
  IRB implementation: The IRB reviews the involvement of subjects and determines that the identification of potential subjects, the means of recruitment, and the selection of individual subjects to be entered into a study represent the fair and equal distribution of risks and benefits to all persons.

Belmont Report

Declaration of Helsinki

A product of the World Medical Association, the Declaration of Helsinki charges the investigator with the responsibility of engaging in only well-informed, proper scientific research with regard for the welfare of the human subject, the risks potentially borne by the subject, and the fair representation of possible benefits.

Originally adopted in June of 1964 and most recently amended in October of 2000, it further emphasizes maintaining the care and well-being of the subject before the needs of the research.

Declaration of Helsinki

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