Guidelines for human subject research

Various organizations have created guidelines for human subject research for various kinds of research involving human subject research and for various situations.

Nuremberg Code

In the early 1940s in Germany doctors conducted Nazi human experimentation on unwilling test subjects; one way of describing the procedures could be to call it medical torture. After the Allied Forces won World War II, United States authorities who held the Nuremberg Palace of Justice used that building to host the Doctors' Trial in which Nazi researchers were charged with crimes against humanity for unethical research practices. After the Subsequent Nuremberg Trials many people felt compelled to create laws to codify some research guidelines to protect research participants and define acceptable relationships between researchers and research participants.

In 1949 the Nuremberg Code was published to be a set of guidelines to guide researchers who work with human subjects. Among the points of the code are the following concepts: participants must continually give their voluntary consent, the study must have the goal of producing good for society, and considerations must be taken to protect participants from even the remote possibility of injury.

Declaration of Helsinki

In 1964, the World Medical Association published a code of research ethics, the Declaration of Helsinki. It was based on the Nuremberg Code, focusing on medical research with therapeutic intent. Subsequently, medical professionals and researchers began requiring that research follows the principles outlined in the Declaration. This document was one of the milestones towards the implementation of the institutional review board (IRB) process.^[1]

Belmont Report

The Tuskegee syphilis experiment was an experiment begun in 1932 by the United States Public Health Service. The design of the experiment involved recruiting 400 poor black people with syphilis and tracking their health. In the 1940s penicillin was identified as standard treatment for syphilis, but the purpose of the experiment was to track long-term syphilis and researchers did not inform the participants that they could be cured. In 1972 press reported on the study to public outrage for disregard of the health of the participants. The study was influential in shaping public perceptions of research involving human subjects.

After the press exposed the study, the US Congress appointed a panel that determined that the study should be stopped immediately and that the oversight of human research was inadequate. The panel recommended that federal regulations be designed and implemented to protect human research subjects in the future. Subsequently, the National Research Act of 1974 led to the creation of the Common Rule, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, and the Office for Human Research Protections

All of these reactions led to the 1979 creation and publishing of the Belmont Report. This report identifies respect for persons, beneficence, and justice as ethical principles which must underlie human subject research.

APA Ethics Code

The American Psychological Association (APA) has a documented ethics code pertaining to the practice of psychology and associated research. This document contains guidelines for the use of deception in research. For members of the APA, these are hard requirements levied against their membership. They are also requirements for any research project conducted, funded, or managed by the APA.^[2]

Research funded by the United States government

Title 45 Code of Federal Regulations, Part 46 (45 CFR 46) is the primary set of Federal regulations regarding the protection of human subjects in research and is often referred to as the Common Rule.^[3][4] It defines the laws, criteria for exemption, as well as definition and formulation of institutional review boards, though some agencies have established their own implementation of this code that supersedes portions or all of 45 CFR 46. The Department of Defense uses CFR 46 but has different exemption criteria. The Food and Drug Administration also applies a modified code that is associated with research into development of any food, drug, or medical devices.

The code establishes what is required to be considered research activities, and for participants to be considered human subjects of research. The definitions are written as such to include situations where the human is the subject of the experiment, their environment is manipulated by the researchers, and data regarding their responses are collected. If the project does not meet these definitions (or there is minimal risk to participants) then the project is exempt from IRB review and the requirements of informed consent. Generally this decision is made and documented by an IRB. The common rule also provides definitions regarding whether institutions are engaged in research, interaction between investigators and subjects, what an intervention is, and what information subjects can expect to remain private.

References

1. Shamoo, A.; Irving, D. (1993). "Accountability in research using persons with mental illness". Accountability in Research 3 (1): 1–17. doi:10.1080/08989629308573826. PMID 11659726.
2. "Ethical Principles of Psychologists and Code of Conduct". American Psychological Association. 2010-06-01. Retrieved 2011-06-01.
3. "Regulations". Office for Human Research Protections. Retrieved 1 June 2011.
4. "Human Subjects Research (45 CFR 46)". Office for Human Research Protections. Retrieved 1 June 2011.