Office of
Research and Creative Scholarship

IRB Resources

The Belmont Report and the Federal Regulations  are the two most important federal documents that Institutional Review Boards must follow.

The two most important federal documents that Institutional Review Boards must follow are the Belmont Report and the Federal Regulations. 

In 1974, the United States Government passed the National Research Act, which set up the National Commission for the Protection of Human Subjects of Behavioral and Biomedical Research and lead to the development of the Intuitional Review Board system and the codes of rules related to their structure and function and to some extent the general requirements of ethical concerns of informed consent, risk to benefit ratio and documentation issues.     Ethicists from various research files on the commission reviewed historically relevant ethical codes and statements like the Helsinki Declaration and modern day cases of abuses like the Tuskegee Syphilis Study.  The commission’s report, named after the conference center where they met, came to be known as “The Belmont Report.”

The Belmont Report

The report outlines three basic ethical principles that underlie the United States regulations.  These principles are:  Respect for Persons, Beneficence and Justice.

Respect for Persons concerns protecting a person’s autonomy and treating people with respect.  It provides the basis for the requirement of obtaining informed consent from research participants.

Beneficence requires maximizing benefits for the research project while minimizing risks to the research subjects.

Justice ensures reasonable, non-exploitative and well-considered procedures are administered fairly (the fair distribution of costs and benefits).

Federal Regulations

Federal regulations for the protection of human participants in research have been adopted by several federal agencies and have thus come to be known as the “Common Rule.”  The Belmont Report is the basis for the regulations.  The Department of Health and Human Services (DHHS) regulations are found at 45 CFR 46.

OHRP

The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).  OHRP helps ensure this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and social-behavioral research.  This link will take you to more resources http://www.hhs.gov/ohrp/index.html

NIH Training

Beginning January 1, 2013, applications for approval by the Andrews University Institutional Review Board (IRB) require the inclusion of certificates of completion for the National Institute of Health Training. Principal and co-investigators listed on the IRB application must complete the training in human subjects protections at https://www.andrews.edu/services/research/research_compliance/institutional_review/training-education.html or  http://phrp.nihtraining.com/users/login.php  and upon completion you will be able to secure your certificate.  For applications submitted by student researchers, a certificate of completion for the faculty research advisor should also be included.

 Formation en éthique de la recherche (FER)

Course on research ethics in French.  International Development Program cohort students who speak French can take their training here.  Only students meeting the said criteria are allowed to take the training in French. 

DIDACTICIEL EPTC 2: FER

Le didacticiel EPTC 2. Formation en éthique de la recherche (FER) http://www.ger.ethique.gc.ca/fra/education/tutorial-didacticiel/

Supplementary Resources

  • Videos: Educational resources on a variety of topics, such as research misconduct and the protection of human subjects.
  • Participating in Research: The rights of those participating in research.
  • Presentation Materials: Resources to assist with putting together an appropriate presentation in conjunction with IRB criteria.
  • Standard IRB Definitions: A list of common words used in IRB documents and their definitions.