Skip to main content Skip to navigation
Washington State University
*This site is still under construction. We will be updating periodically*

Regulations and Ethics

Summary of relevant regulations and ethical principles

The Belmont Report

The WSU HRPP and IRB adhere to the principles of The Belmont Report, the ethical foundation for conducting research with human subjects. Published in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, the report identifies 3 core principles that must underlie all human subjects research. These principles apply to all human subjects research regardless of “Exempt” or “Non-Exempt” status.

Respect for Persons

Individuals should be treated as autonomous agents and persons with diminished autonomy should be protected.

A researcher must employ safeguards to maintain a person’s maximum exercise of autonomy while protecting that person from detrimental effects of choices. Sometimes, this means excluding the person from participating in decisions that affect the person. In order to ensure respect for persons, participation in research must be informed and voluntary (e.g. an informed consent process must still be included). The informed consent process must provide enough information to ensure the participants’ full understanding of risks/benefits, as well as emphasizing the voluntary nature of participation.

Beneficence

Do not harm.

Beneficence justifies conducting research that benefits society at large even if no likely benefit exists for individual participants — for example, finding better ways to treat childhood diseases justifies involving children in research. Assess risk appropriately in terms of nature and scope, systematic assessment, minimizing risks and maximizing benefits.

Justice

Equals should be treated equally.

In selecting subjects, do not offer beneficial research opportunities only to certain populations and possible negative participation experiences to others. Use fair and reasonable inclusion and exclusion criteria. Are certain people being included or excluded for a reason related to the research objectives, or merely due to convenience? Those who are most likely to benefit from the potential outcomes of the research should equally share the burden of participation

Other ethical guidelines

Nuremberg Code

During the Nuremberg War Crime Trials, the Nuremberg code was drafted as a set of standards for judging physicians and scientists who had conducted biomedical experiments on concentration camp prisoners. This code became the prototype of many later codes intended to assure that research involving human subjects would be carried out in an ethical manner.

Declaration of Helsinki

Preamble of the Declaration of Helsinki:

1. The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

The Declaration is intended to be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs.

2. Consistent with the mandate of the WMA, the Declaration is addressed primarily to physicians. The WMA encourages others who are involved in medical research involving human subjects to adopt these principles.

Washington state laws and agency rules

Revised Code of Washington (RCW)

Washington Administrative Code (WAC)

Federal regulations and guidelines

Code of Federal Regulations

Title 45

U.S. Department of Health and Human Services

Part 46: Protection of Human Subjects (also known as the Common Rule)

U.S. Food and Drug Administration
U.S. Department of Health and Human Services

Title 34

U.S. Dept. of Education

National Institutes of Health

Guidelines for the Conduct of Research Involving Human Subjects (pdf)

Office for Human Research Protections

U.S. Department of Education

U.S. Food and Drug Administration

Federal oversight agencies

Health Insurance Portability and Accountability Act (HIPAA)

U.S. Department of Health and Human Services

Health Information Privacy

Methods for De-identification of PHI (pdf)

National Institutes of Health