March 19, 2008

What You Should Know About Clinical Trials

Responding to our recent post about clinical trials, a commenter mentioned informed consent and the questions women should ask before agreeing to participate in a trial. This is a timely topic today, with a CNN article asking, Did Tuskegee damage trust on clinical trials?,” as current protections for research subjects have really only been in place for a few decades (the history of women’s inclusion in trials is a topic for another day).

To understand your rights with regard to volunteering for a study, it may help to know a little bit about the process and guidelines for clinical research. Prior to conducting a study, researchers typically must submit their research plan to an institutional review board, or IRB. This board is charged with monitoring the trial and making sure the rights and welfare of the subjects are protected, and that the Belmont Report principles of respect for persons (individual autonomy and informed consent), beneficence (maximizing benefit to subjects while minimizing risk), and justice are honored. This presentation on ethical principles for human subjects research is a good introduction to the topic.

The IRB is also in charge of making sure the informed consent process is in place and adequate. An informed consent process should give you information on the research procedure, its purpose, risks and anticipated benefits, alternative procedures, and make it clear that you can ask questions and withdraw from the study at any time (you always have this right). It should also convey this information in a way that you can comprehend, and your consent should be obtained in a way that makes it truly voluntary for you (i.e., there is no coercion, undue influence, or punishment for not participating). The National Cancer Institute offers this guide to understanding informed consent.

The National Institutes of Health, a major funder of clinical trials in the United States, offers this list of questions you should ask when deciding whether to participate in a trial, and the National Cancer Institute offers a more comprehensive list of questions to have answered. These questions focus on the purpose of the study, possible risks and benefits, personal concerns, costs, and other topics; you should review this list and remember that you have every right to have these questions answered before volunteering for a study.

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