Why We Have An IRB
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History
Unfortunately, history has revealed many prominent examples of research involving questionable and immoral ethics and practices. As these atrocities were disclosed, ethical codes and regulations were developed. The two most well-known catalysts for these changes were the Nazi War Crimes Tribunal and the Tuskegee Syphilis Study.
Nuremburg Code
Following World War II, leading Nazi doctors were brought to justice before the International Military Tribunal at Nuremberg. Twenty doctors were charged with War Crimes and Crimes Against Humanity. The Nuremberg trial of doctors, which began in 1946, revealed evidence of sadistic human experiments conducted at the Dachau, Auschwitz, Buchenwald and Sachsenhausen concentration camps. Subsequently, in 1947, the Nazi War Crimes Tribunal issued the Nuremberg Code, which was the first internationally recognized code of research ethics. (hhs.gov)
Tuskegee Syphilis Experiment
In 1932, the Public Health Service, working with the Tuskegee Institute, began a study to record the
natural history of syphilis in hopes of justifying treatment programs for blacks. The study initially
involved 600 black men - 399 with syphilis, 201 who did not have the disease. The study was conducted
without the benefit of patients' informed consent. Researchers told the men they were being treated
for "bad blood," a local term used to describe several ailments, including syphilis, anemia, and fatigue.
The men were never given adequate treatment for their disease. Even when penicillin became the drug of
choice for syphilis in 1947, researchers did not offer it to the subjects. Although originally
projected to last 6 months, the study actually went on for 40 years. In July 1972, an Associated
Press story about the Tuskegee Study caused a public outcry that led the Assistant Secretary for
Health and Scientific Affairs to appoint an Ad Hoc Advisory Panel to review the study.
The panel found that the men had agreed freely to be examined and treated. However, there was no evidence that researchers had informed them of the study or its real purpose. In fact, the men had been misled and had not been given all the facts required to provide informed consent.
Establishment of the National Commission
These cases led some people to conclude that researchers should not be allowed to conduct studies involving humans without some ethical oversight.
By Congressional mandate, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was established in 1974 to make recommendations for the conduct of research involving humans. It was determined that the IRB was one mechanism by which human subjects could be protected. Oversight for the system of protection for research participants was assigned by law to the Secretary of the Department of Health and Human Services (DHHS). DHHS set as a goal: high quality research accompanied by high standards of research ethics.
The DHHS regulations are intended to implement the basic ethical principles governing the conduct of human subjects research. These ethical principles are set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (the "Belmont Report").
The Belmont Report
The Belmont Report sets forth three basic ethical principles for the conduct of human subjects research:
- Respect for persons involves recognition of the personal dignity and autonomy (right to choose) of individuals, and special protection of those persons with diminished autonomy. This principle requires obtaining informed consent from all potential research subjects (or their legally authorized representatives).
- Beneficence requires that researchers protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm. Research-related risks must be reasonable in light of expected benefits.
- Justice requires that the benefits and burdens of research be distributed fairly.
Belmont Report Link: Belmont Report
The Office for Human Research Protections (OHRP)
At the federal level, the Office for Human Research Protections (OHRP) has responsibility, delegated by the Secretary of the Department of Health and Human Services (DHHS), for promulgating, implementing, and overseeing regulations for the protection of human subjects (45 CFR 46) when research involving human subjects is conducted or funded by any component of DHHS.
OHRP coordinates the oversight of human subjects protection within other federal departments and agencies. OHRP is located in the United States Department of Health and Human Service's Office of Public Health and Safety.
Federal Regulations
There are many federal regulations which govern the conduct of research on human subjects. Depending on the research, regulations may overlap.
The "Common Rule" Code of Federal Regulations (45 CFR 46)
In the early 1980's, revised regulations for the conduct of research with humans were published, entitled "Federal Policy for the Protection of Human Subjects" Title 45 Code of Federal Regulations Part 46, commonly referred to as the "Common Rule".
The ethical principles of The Belmont Report are embodied in these regulations; taken together, The Belmont Report and 45 CFR 46 articulate the minimal ethical and legal obligations of those who conduct or support research involving human subjects.
Among other things, these regulations require that our institution adhere to the principles of The Belmont Report and set forth in writing, policies and procedures for protecting the rights and welfare of human subjects.
The Food and Drug Administration (FDA) Regulations
The U.S. Food and Drug Administration (FDA), through the Office of Health Affairs, has developed its own set of regulations on the protection of human subjects (Title 21, Parts 50 and 56 of the Code of Federal Regulations).
These regulations apply to any clinical trial that involves an investigational drug, biological product, or other device that is regulated by the FDA under the Food, Drug, and Cosmetics Act -- regardless of whether or not the trial receives federal funding. If a trial is supported by the Department of Health and Human Services and involves an FDA-regulated drug or device, then it is subject to both organizations' regulations.
Health Insurance Portability and Accountability Act (HIPAA)
The Health Insurance Portability and Accountability Act (HIPAA) of 1996 is a broad federal law, only part of which is intended to protect the privacy of healthcare information. It is divided into three parts: portability; accountability; and administrative simplification.
There are several sets of HIPAA regulations. The most important regulations for research are the privacy regulations, often referred to as the Privacy Rule. The Privacy Rule is similar to existing human subject protection regulations (the Common Rule and FDA regulations) but has some unique features.
Where research is concerned, the Privacy Rule protects the privacy of the individually identifiable health information, while at the same time, ensuring that researchers continue to have access to medical information necessary to conduct vital research. (This is covered further in Module 4.)
Comparison of Regulations
| "The Common Rule" HHS Protection of Human Subjects Regulations Title 45 CFR Part 46 | FDA: Protection of Human Subjects Regulations Title 21 CFR Parts 50 and 56 | HIPAA Privacy Rule | |
|---|---|---|---|
| Overall Objective | To protect the rights and welfare of human subjects involved in research conducted or supported by HHS. | To protect the rights, safety and welfare of subjects involved in clinical investigations regulated by FDA under 21 U.S.C. 355(i) and 21 U.S.C. 360g(j). | Establishes a federal standard of privacy protections for most individually identifiable health information by establishing conditions for its use and disclosure by certain health care providers, health plans, and health care clearinghouses. |
| Applicability | Applies to human subjects research conducted or supported by HHS. | Applies to research involving products regulated by FDA. Federal support is not necessary for FDA regulations to be applicable. When research subject to FDA jurisdiction is federally funded, both the HHS Protection of Human Subjects Regulations and the FDA Protection of Human Subjects Regulations apply. | Applies to HIPAA-defined covered entities, regardless of the source of funding. |