Human subjects research

All research involving human subjects must comply with applicable policies for the protection of human subjects. “Research” here is defined to be a “systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge.” That include theses and dissertations.

Human subjects guidelines and approval mechanisms have developed in response to past and continuing abuses of people through research studies. Yet there is much debate about whether the mechanisms are sufficient to prevent these abuses or necessary in the way they’re implemented.

Many people dread the review process. I don’t relish IRB review myself, but I have actually found it be useful, because it requires me to think through the various aspects of a research project and to seriously examine the risks and benefits to the participants. Most of the questions on the IRB forms are ones you should answer in any case, such as “who is involved”, “what will they be asked to do?”, “are you including minors?”, or “which procedures are important enough for the research that their use outweighs the possible risks to the people who are helping you with the study?”

References

Schrag, Zachary M. (2009). How talking became human subjects research: The Federal regulation of the social sciences, 1965–1991. Journal of Policy History, 21(1) 3-37.

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