Protecting Human Research Participants
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Therefore, distorting, falsifying, or misinforming research participants for the purpose of manipulating different reactions is highly unethical, and the values that research ethics rely on including integrity, accuracy, and objectivity are always violated. The Milgram Experiment on Obedience and the Stanford Prison Experiment are examples of two of the most intriguing and widely discussed social psychology experiments that have violated the basic principles of research ethics involving human subjects.
The resulting public outrage led to the appointment of an ad hoc advisory panel by the Department of Health, Education and Welfare (which later was split into the Department of Education and the Department of Health and Human Services [HHS]) to review the study and develop recommendations to ensure that such experiments would never again be conducted. The principle of justice may arise in decisions about inclusion and exclusion criteria for participation in research and requires investigators to question whether groups are considered for inclusion simply because of their availability, their compromised position, or their vulnerability — rather than for reasons directly related to the problem being studied.
While the reasons for enrolling in a research study may be many, patients expect that their safety will be looked after carefully, and do not expect to be hurt by their participation. But sometimes harm does come to research participants, and researchers must be sure the patient has given a truly informed consent, realizing the potential risks as well as the potential benefits of the research. Everyone in research is responsible for human subject protection. Institutional Review Boards (IRB) are unique in that this is their sole reason for existence.
Failure of IRBs to provide appropriate review and oversight can lead to severe consequences, as can abrogation by the investigator to place the well-being of the subjects as the primary responsibility in any research protocol. Understanding how we arrived at the current approach and some of the failures that directed this course can support efforts to continually reevaluate and improve the safety of subjects who are willing to participate in research activities.
Heller J. New York Times. July 26, 1972.
Mahoney M. R., Sargent D. J., O'Connell M. J., Goldberg R. M., Schaefer P., and Buckner J. C. (2005). Dealing With a Deluge of Data: An Assessment of Adverse Event Data on North Central Cancer Treatment Group Trials. J Clin Oncol. 2005