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The Importance of Research Compliance

Posted on December 2, 2011

Yonette Thomas (bio) stresses the importance of research compliance when dealing with human subjects, animals, and even tissue.


Well, research compliance is, in part, about ethics, but it's also about responsible conduct of research, which is very important. So, as a researcher, you have to be mindful of the subjects you are using in your research, whether they be human or animal. And, interestingly enough, even if they're tissue.

And what do I mean by that? So most people -- the majority of researchers -- do human subjects research, and you have to go to an Institutional Review Board, or an IRB. Most people hear the acronym IRB, and they're like, "Uhhhhh. The IRB." But the IRBs play a role in helping us to stay on the right side of human research protection. So consent agreements, assent forms.

It's very important that you recognize the importance of protecting subjects, people who may not understand why they're part of a study, and you need to make them aware of what the study's about, why they're in, what the risks and benefits are.

With regard to animals, you know, we have to be mindful of the humane aspects of working with animals. So levels of pain -- how are you modulating pain? So you'll have an institutional Animal Care and Use Committee that will have oversight over your research. You will have to prove to them that you are following all the regulatory guidelines required to protect animal subjects.

When you're using cell lines or other tissue, they don't come out of nowhere. They either come from human beings or animals. So you have to follow certain guidelines related to the use of that material, the protection of the individuals from whom you got that material -- or animals -- and also the long-term use. So people have to know what are you going to be using their data for in the long term, if they're humans? So there are all these guidelines, and biohazards is part of it. You have to be sure if you're using viruses that the researcher is protected and the community, your lab, people in your labs, you're not exposing people to viruses.

So research compliance is a very important part of the life of an institution, the life of a researcher, and the life of subjects.

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Excerpted from an interview with the researcher conducted at the 2011 NHSN Conference held in Miami, FL.


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