Institutional review board
History of IRB
The need for research guidelines to protect human subjects emerged following the Nuremberg trials, where abuses of WWII came to public attention. These efforts were expanded in 1964, leading to a code of ethics formulated in the 1964 Declaration of Helsinki. National Institutes of Health required approval from a review panel as early as 1953, followed by a set of regulations from the United States Public Health Service in 1966. By 1974 further revision of rules led to establishment of institutional review boards at hundreds of institutions that received federal funding for research.
Levels of review
Each campus has its own review procedures, but generally there are three levels of review. New faculty members need to check with their campus IRB committee to learn about the specifics of their process. The three levels are: full board, expedited, and exempt, determined by the nature of the protocol, level of risk to human subjects, and the subject population.
Timeline for review
Before any research can begin, a research proposal must be approved by the IRB. It is extremely important to factor the time this process takes into the research proposal / implementation timeline. Generally exempt and expedited reviews take less time than a full review, but the review committee members have full schedules of their own, and therefore need plenty of time to review, convene if necessary, and make decisions about each proposal submitted from the campus. Some campuses convene the committee once a month, and therefore a missed meeting would delay the review process by another month.
Review process
Each campus may vary, but review generally entails multiple committee members reading a proposal with specific guidelines in mind. It is common for the committee to send back a proposal for revision, requiring additional review once the changes have been made. Many campuses offer sample forms that have already been reviewed by legal counsel. New faculty members will save time and effort by utilizing these existing templates for consent and other forms, since all forms must be reviewed by the IRB. By using the samples provided, the chances of proposals getting through the IRB process more cleanly increases. It is critical to check with your campus to determine the appropriate procedures to use.
History of IRB
History of IRBs
Human Subjects Division, University of Washington, composed by the Fordham University Center for Ethics Education
This historical view of IRB provides context for today’s process of careful review of research by peers. This site was a source for the "History of IRB" text on this page.
Sample IRB Process
For Researchers
The Office of Human Research Ethics, University of North Carolina, Chapel Hill
This site goes in great detail about the IRB process, definitions, various types of review, required training, and consent, among other issues.
Ethics of IRB
Research Ethics: The Tuskegee Syphilis Study
Tuskegee University
This site outlines one of the most horrendous examples of research carried out with disregard to basic ethical principles.
Ethics Case Studies
Stoerger, S. (2003). Adaptation of web pages created for the Office of the Chancellor for Research,
University of Illinois, Urbana-Champaign
This individual has collected links to dozens of actual case studies in many disciplines, including anthropology, art, bioethics, business, history, journalism, plagiarism, research resources, sociology, and more.
Case Studies
Paul V. Galvin Library, Illinois Institute of Technology. This site offers famous cases of ethical misconduct as well as links to a number of websites with collections of research ethics cases in the areas of sciences including bioethics and biomedical engineering.
Resources for Teaching Research Ethics
Poynter Center for the Study of Ethics and American Institutions,. Indiana University Bloomington
This website provides resources including case studies that effectively immerses students in the subject, and provides opportunities to discuss the possible alternative actions that could have avoided ethical problems.
