Educating and protecting clinical research participants

Episode # 103
Uploaded: July 16, 2012
Running Time: 3:02

CROWN: From the National Institutes of Health in Bethesda, Maryland, this is CLINICAL CENTER RADIO.

The goal of clinical research is to develop our scientific knowledge and improve health care. The people who participate in clinical research are a key part of making this possible. These volunteers are not only incredibly valuable, but also protected, says Dr. Christine Grady, chief of the Clinical Center's Department of Bioethics.

GRADY: Well certainly (it's) important for people to understand what they're being asked to do before they decide whether or not they want to do it just out of respect for people's ability to make decisions about their own lives. So that's really the basis of informed consent, in so many ways. It's to say, you know, people make choices about their lives; this is one choice they can make along the way. So we want to be clear what it is they are choosing.

CROWN: Dr. Grady and her team in the Department of Bioethics spend a great deal of time thinking about the safety of patients and the ethics of research. She says there are many ways to educate research participants about the potential benefits and risks of studies – a key part of the entire process.

GRADY: When people are invited to participate in research, there is a strong belief that it should be their choice based on their understanding of what the study is about, and what the risks and benefits of the study are. It's a process of giving people information about the study in a variety of ways. Sometimes it's discussions with people. Sometimes it's written pamphlets or information. Sometimes it's videos.

CROWN: Dr. Grady adds that it's normal for potential participants to have lots of questions during the informed consent process. In fact, it's encouraged.

GRADY: How much time is it going to take? How many times do I have to come into the clinic or how much time do I have to spend in the hospital? What are the kinds of procedures you're going to do? What are the kinds of interventions I'm going to have? Also people are, of course, very interested in what kind of risks there might be; discomforts they might experience…and what kinds of benefits they might get from being in the study.

CROWN: Potential research volunteers should also know that studies have to pass several reviews before they are even allowed to recruit patients.

GRADY: The research studies that are being proposed, not just at the NIH but in most institutions where they are doing research, are carefully reviewed and carefully vetted for their ethics before anyone gets invited to participate.

CROWN: To learn more about participating in studies at the NIH Clinical Center, go online to clinicalcenter.nih.gov/recruit. From America's Clinical Research Hospital, this has been CLINICAL CENTER RADIO. In Bethesda, Maryland, I'm Ellen Crown, at the National Institutes of Health, an agency of the United States Department of Health and Human Services.

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