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 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.
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
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/
These following videos are educational and cover a variety of topics from the protection of human subjects to avoiding research misconduct. We recommend that you watch as many as you can.
Is an interactive movie about integrity in research that can have long-term consequences. It addresses avoiding research misconduct, mentorship responsibilities, handling of data, responsible authorship, and questionable research practices.
The interactive video educates clinical and social researchers on the importance of appropriately protecting research subjects and avoiding research misconduct.
The video educates researchers on obtaining legally effective informed consent, determining capacity to consent, using legally authorized representative, and meeting the regulatory requirements for the process of informed consent.
Additional protections for certain vulnerable subjects, including pregnant women, children, and prisoners