Submitting a new IRB protocol takes time and it is easy to forget why some policies exist in the first place. Let’s briefly take a look back at the origins of the modern IRB. This historical accounting prioritizes brevity over depth, but I provided some external links for anyone interested in reading more about these events.
IN THE BEGINNING
During the twentieth century, biomedical and behavioral researchers often used their “best judgment” as a standard of ethical practice. However, without clear guidance a person’s “best judgment” could vary widely. The modern IRB grew out of concerns about questionable practices in biomedical and behavioral research studies. One of the most infamous studies was brought to light during The Nuremberg Trials.
THE NUREMBURG CODE
The Nuremberg Trials occurred in 1945 and 1946 and was named after Nuremberg, Germany where the trials took place. These trials exposed heinous human experiments conducted by Nazis on concentration camp prisoners during World War II. The Nuremberg Code emerged in 1947 outlining ten guiding principles for research with human subjects.
The Nuremberg Code debunked the “best judgment” approach to research with human subjects and delineated rules for legal and ethical practices when conducting human experiments.
Several online sources exist that present the full text of The Nuremberg Code. To paraphrase:
The Nuremberg Code emphasizes respect and protection for all human life, consent from participants prior to study commencement, voluntary participation, high level experimenter qualifications, and avoidance of undue and intentional harm or suffering to participants.
Inspired by The Nuremberg Code the U.S. National Institutes of Health issued its own guidelines in 1966 called the Policies for Protection of Human Subjects.
POLICIES FOR THE PROTECTION OF HUMAN SUBJECTS
In 1972, six years after the release of the Policies for Protection of Human Subjects, the U.S. Public Health Service Syphilis Study at Tuskegee made news headlines. The study, begun in 1932 at the Public Health Service and Tuskegee Institute, collected data recording the evolution and lifespan of syphilis, a sexually transmitted disease, in hopes of developing treatment programs for African Americans.
After public dismay, it became apparent that some subjects might have agreed to participate in the Syphilis Study without a clear understanding of the study’s purpose, its intent, and risks. Additionally, some researchers withheld syphilis treatment from a group of subjects. Further, subjects were not always given adequate information to make an informed choice to join in the study and it was unclear if they could quit the study freely and without penalty.
The breach in ethics during the Syphilis Study prompted the U.S. government in 1974 to adopt the Policies for Protection of Human Subjects as the official guidelines for research with human subjects.
The official guidelines provided special protection for those deemed especially vulnerable to ethical lapses in research practices. These vulnerable populations included pregnant women and fetuses, prisoners, and children. (The current list of vulnerable populations also includes cognitively impaired persons, minorities, economically and/or educationally disadvantaged individuals and subjects with AIDS/HIV+).
Later, the Belmont Report, published in the Federal Register in 1979, and created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, summarized the ethical principles and guidelines for research with human subjects.
By design the Belmont Report and the Common Rule protected human subjects at a wide span of research entities including universities, hospitals, research laboratories, and libraries across the country.
Specifically, the Belmont Report offers guidelines for evaluating differences between research and practice and helps determine whether a project required IRB review and approval.
- The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research defines practice as “interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success.”
- Furthermore, the commission defines research as “an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge.”
Projects falling under the commission’s definition of practice are not considered human subjects research and do not require IRB review or approval. This distinction between practice and research is important information for students new to IRB.
The Belmont Report specifies three guiding ethical principles that inform the work of IRB administrators—respect for persons, beneficence, and justice.
- RESPECT FOR PERSONS: People are autonomous decision-makers. For persons incapable of such self-determination additional protections should apply.
- BENEFICENCE: Do no harm onto others.
- JUSTICE: Balance benefits and risks and take precautions for vulnerable populations.
The Belmont Report establishes criteria to evaluate proposed research projects. For example, the report specifies that IRBs ensure:
- Informed consent clarity so participants have adequate information to make an informed decision about participating in the research.
- Safeguards are in place to make participation voluntary.
- Information is age-appropriate, easy to read, and understandable by potential subjects.
- Extra precautions and considerations are established for protecting vulnerable populations.
Of utmost importance for IRB reviewers is balancing risks and benefits. Risks may include physical, mental, emotional, legal, or social distress and harm. While not all research studies directly benefit participants, IRB administrators still consider the risks to benefits ratio overall.
Lastly, subject recruitment and selection is important for IRB administrators under the Belmont Report. Recruitment must be fair and free of preferential treatment and precautions must be taken when recruiting vulnerable populations.
Though the origins of IRB practices are rooted in a grim past, modern protocols are in place to prevent the reemergence of such egregious ethical violations. These past unfortunate circumstances created clear, diligent, and just guidelines implemented by IRB administrators on a daily basis to support vital research and protect human subjects.