Y'all complain about the IRB, but every time a bad study/paper gets published everyone is like where was the IRB??!?! So, a tweetorial about the history of IRBs to remind us why they are so critical, and to remind you I'm a complete academic nerd.

Scientific research, while critically important to the advancement of public health, has also posed some troubling ethical questions.

The Nuremberg Code, created after 1946 criminal proceedings against German’s conducting experiments on concentration camp prisoners without consent, was 1st international document advocating for voluntary participation & informed consent for research.

It stated ‘The voluntary consent of the human subject is absolutely essential.’

Then in 1964, the World Medical Association established recommendations (declaration of Helsinki) to guide doctors in research involving human subjects. The Declaration governs research ethics is the basis for Good Clinical Practices used today.

Declaration of Helsinki included:

Research with humans should be based on results from lab & animal experiments
Protocols should be reviewed by independent committee prior to initiation
Informed consent is necessary
Research should be conducted by qualified individuals
Risks should not exceed benefits

Another critical turning point in development of consensus for guidelines for ethical research was the Tuskegee Syphilis Study (1932–1972). 600 Black men, 400 of whom were infected with syphilis, were monitored for 40 yrs.

Subjects received medical exams, but were not told about their disease and did not receive a proven cure (penicillin) when it became available in the 1950. Researchers even intervened to prevent treatment when other physicians diagnosed syphilis.

The study sparked a wide-scale public outrage and the US government had to close it in 1973.

Due to the publicity of this study, in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was created.

One of their tasks was to identify fundamental ethical principles in conducting research involving human subjects, and to develop guidelines to assure that research is conducted in accordance with those principles.

The Belmont Report, published in 1979, attempts to summarize the basic ethical principles identified by the Commission.

Core basic ethical principles governing human subjects research:
1. respect for persons (protecting autonomy & obtaining informed consent)
2. beneficence (maximizing benefits & minimizing risks)
3. justice (fairness in the distribution of the benefits & burdens of research).

With The Belmont Report as foundation, HHS and the FDA revised existing human subjects regulations. Guidelines around this time also included requirement for group ethics review and the term “institutional review board” was introduced. FDA began to require an IRB in 1981.

The Federal Policy for the Protection of Human Subjects or the “Common Rule” was published in 1991.

It's the baseline standard of ethics by which any government-funded research in US is held; nearly all US academic institutions hold their researchers to these statements.

Currently, DHHS Office of Human Research Protections (OHRP) is responsible for monitoring compliance with the Common Rule. Research institutions that receive DHHS funds need to provide OHRP assurance they will comply with fed regulations, including at least one registered IRB.

IRBs require at least 5 members of various backgrounds, including at least one scientific member, one nonscientific member and one unaffiliated (community) member.

IRBs are also often tasked with responsibilities beyond those required by federal regulation, including review of COIs, compliance with privacy regulations, & training of investigators.

They are also responsible for making research staff submit one billion forms. #yourewelcome