Beginning in the 1930s, researchers working in Tuskegee, Alabama with African-American men with syphilis failed to offer those men penicillin as treatment for their disease even though research had determined that penicillin cured syphilis as early as the 1940s. This unethical research continued until 1972. As a result of this lack of ethical behavior in research as well as other unethical research conducted by the Nazis and others, the federal government in 1974 passed the National Research Act which governs ethical behavior in research. One of the outcomes of that Act is the establishment of Internal Review Boards or IRBs on college campuses as a result of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
IRBs act as governing bodies to ensure human and animal research is conducted in an ethical manner. The IRB is tasked with guiding faculty and student research design so that all research on human and animal subjects occurs in a manner that is free of possible abuses. Included in its duties, the IRB must review study protocols and determine if they meet ethical standards .
Of course, in addition to the federal requirements, we as Christians should go above and beyond the minimum to make certain all human and animal subjects are treated with the utmost respect and compassion, just as the Lord Jesus Christ does.
To speed up the approval process on IRB submissions, applicants should make certain to do the following:
- Students must get faculty approval prior to submitting an IRB request.
- Submit and fully complete the appropriate faculty consent forms.
- Review the sample consent forms (link) to be certain that all essential components are included in your consent.
- In your application for approval, be sure to clearly outline what will happen in your study. Include what research question you will be answering and what the study participants will be asked to do, as well as how you will analyze the data. Briefly give a rationale for the study — one of the areas the IRB considers when approving research is the value of the study in comparison to the time that individuals will be asked to give in order to participate in it.
- Researchers should be certain that the consent form is written in understandable language, avoiding discipline-specific jargon if at all possible.
- If you are using surveys, include any available reliability and validity information for the instrument. If the study is a pilot study, note that in your application.
- Provide the survey/interview tool being used in the research.
- Think carefully about any potential risks to your subjects (the first instinct is to put “none known” but assess your study carefully before noting that). Consider: psychological or emotional risks for delving into certain topics, risks to privacy, any physical or other risks. If you note that there could be some risk, note clearly what steps will be taken to safeguard from those risks. If you put “none” on your application when asked about risks, then you shouldn’t have to note any safeguards.
- Be certain that the start date on your application reflects awareness of the processing time required. Start dates should NOT predate the application, or be for the date of application or the week of application. It is best to plan for two weeks to a month for lead time for the application to be considered, before planning to actually collect data.
For further information on the IRB approval process, visit the IRB page on the ORSP website at http://www.acu.edu/academics/orsp/institutional.html.
A member of the church of Christ had a major positive impact on the men affected by the Tuskegee syphilis study. Learn more about him at this link: Who is Fred Gray