Research Volunteers - Know Your Rights
Ask Some Key Questions before Participating in Research.
Feb 13, 2009
The following article is the first in a series on understanding your rights as a U.S. research volunteer such as the right to privacy, confidentiality, and proper informed consent. The focus on this article is asking the right questions at the study site.
One of the hardest things to do in medical research is to recruit research volunteers, and some studies will pay a nice fee for your participation. If you decide to volunteer, you are to be applauded for helping the advancement of medical research. But don't forget to protect your rights at the same time. Ask some key questions and be informed.
Was This Study Approved by the IRB OR Ethics Committee?
In a research or medical setting, IRB approval is the norm. The first thing you should ask when you visit the study site is, "was this study approved by an Institutional Review Board (IRB) or Human Studies Ethics committee?" The answer should be a fast "yes" because the government mandates IRB review on studies under Food and Drug Administration (FDA) oversight or if the study is funded by a federal grant.
May I Read the Consent Form?
Usually, you shouldn't have to ask this question, but consent is the cornerstone of human research practice. If you are not given a consent form to participate in a research study, you should ask for one. Consent is a concept more than a form, and many a well-meaning participant has flipped to the signature line without reading it or asking questions. Some of these forms are quite lengthy, but don't let that stop you from reading it. Ask questions if it isn't clear. The consent form must tell you about the study, why the study is being done, and it must also outline the risks. The form must never say you give up your rights if you participate. You should also be able to find phone numbers for the scientist who heads the study or someone you can call if you have more questions.
What are the Risks of Participation?
Risk will be described in the consent form. A consent form that says there are no risks is questionable. Studies of new medicines often list the risk of death, so read carefully. Find out what happens if you get hurt. Some companies pay for injuries if the study turns out to be harmful. Ask if emergency treatment is available if case the study procedures make you sick.
What are My Costs for Participation?
Speaking of costs, the consent form should mention your out of pocket expenses. If it doesn't, ask the research study coordinator, nurse or doctor to explain the expenses. Sometimes the compensation section of a consent form can be confusing. The study should point out what you get for "free" and what you don't. If it is a drug study, some pharmaceutical companies provide the drug for free, but other "treatment" expenses can hit your own pocket. Simply find out what is covered before you sign.
Above all, make the entire visit a "consent process" for yourself. If you feel rushed, slow down. Ask the study nurse or doctor to go over the consent form with you and ask some key questions. Once you feel comfortable, sign on the dotted line and feel good about helping the medical community meet the needs of medical science. At the same time, feel good about being an informed study volunteer.
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