Wednesday, January 6, 2010

Patient Safety in Clinical Trials: IRB Approval

How safe is it to participate in clinical research trials?

Last week, I talked about the lengthy process for approving protocols for animal research. Well, for humans, it’s a whole new ball game. Not shockingly, there is an even more extensive set of rules regulating the approval of protocols for human research. This approval is overseen by the Institutional Review Board (IRB). Depending on the extent of your research question, IRB-approval can delay the implementation of your research trial for years.

As you might imagine, the regulations for the use of humans in research are quite extensive. There are firm checks in place throughout the entire process that makes it extremely safe for volunteers to participate. And, there are personnel available to talk to you at length about the safety measures in place for each trials.

To learn more about participation, or to search the trials available if you are interested in volunteering, please see the following resources:
Center for Information and Study on Clinical Research
Society for Women’s Health Research
NIH Office on Women’s Health
NIH Office of Minority Health and Research
FDA Information Sheet

This is Part 7 of 13 in our From Ideas to Treatments series.
Part 1 - From Ideas to Treatments
Part 2 - Basic Research: It Starts with an Idea
Part 3 - You're an Animal!
Part 4 - Can I care about animals and do research too?
Part 5 - Regulations for Animal Research
Part 6 - Clinical Research Trials
Part 7 - Patient Safety in Clinical Trials: IRB Approval
Part 8 - Recruitment
Part 9 - Health Disparities in Clinical Research
Part 10 - A Brief History of Inclusion Policies
Part 11 - Breaking News: Women and Men are Different
Part 12 - Including Minorities in Clinical Trial Research
Part 13 - Bringing From Ideas to Treatments Home

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