CC Bioethicist Co-Authors JAMA Paper on What Physician-Investigators Owe Patients Who Participate in Research

Episode # 50
Uploaded: December 15, 2010
Running Time: 5:35

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

In the arena of clinical research, the relationship between the patient and investigators is not the same as the typical doctor/patient relationship. In the typical relationship, the patient visits the health care provider with the ultimate goal of finding relief from a condition or disease. In the clinical research setting, the patient is told at the outset that his or her participation is not primarily directed at treating or curing the patient. The goal is to learn more about the condition or disease, to add to the body of medical knowledge. The patient's informed consent about this fact is a necessary and vital part of the patient screening process. Still, there are safeguards within the clinical trial scenario that the patient should expect from his or her physician-investigator, according to Dr. Frank Miller, Senior Bioethicist at the National Institutes of Health Clinical Center.

MILLER: It's kind of easy to confuse medical care with clinical research because they both involve patients in need of treatment and if its what's known as a randomized trial, patients would be enrolled in a clinical research study in which treatments are being given to them and being tested -- an experimental treatment being compared with a standard treatment or being compared with a placebo control. You've got physicians in both settings, you've got patients in need of treatment in both settings, so one might think that the obligations of physician investigators in clinical research would be the same as the obligations of physicians in medical care but I think that would be making a basic mistake.

SCHMALFELDT: Dr. Miller co-authored a paper on the subject, published in the October 6, 2010 issue of the Journal of the American Medical Association. That paper focuses on how the close connection between clinical research and patient care, coupled with the need for research to be conducted by physician-investigators with patients who participate in research, makes it difficult to appreciate how the ethical obligation of investigators differ from those of physicians.

MILLER: In clinical research you are often recruiting patients who are sick, and so you have some obligations… say not to make them worse. You have obligations to carefully screen them so they won't be placed at excessive risks of harm for going in the study. You have to closely monitor them so there is a protective function that you have. You don't, I believe, really have an obligation to make them better. When you are in research that's not what you are trying to do you aren't trying to make the individual patient better, but you certainly don't want to harm them. But there is also an obligation to promote valuable science, and there is a tension between protecting research participants and promoting science, and that's where a lot of the ethical problems lie.

SCHMALFELDT: Dr. Miller said trust between the investigator and patient in a clinical trial is key.

MILLER: Trust is really central, it's obviously central in medicine. You go in the doctor's office, you take off your clothes, it's a stranger, you have to trust that they are going to have your personal well being in mind. Some of that definitely carries over into the research setting. You're going into a study as an individual lay person you aren't going to understand a lot about the risks of the treatments that are being studied, the risks of the research procedures. You have to trust that the investigators know what they are and that they've carefully selected them so that people will not be placed at serious risk of harm. You have to trust that what they are telling you about the study is the truth. You have to trust that you will be monitored in a careful way so that if problems come up, you know people will stop doing something which is potentially harmful and take care to stabilize the condition of the research subject.

SCHMALFELDT: Understanding the risks and agreeing to take part in clinical research is, no matter how you cut it, a valiant decision to make. Without the brave, well-informed people who volunteer for clinical trials, medical investigators would be severely limited in their ongoing search for the treatments and cures that can improve the overall human condition and quality of life. For more information about bioethics at the NIH Clinical Center or if you're interested in learning more about any of the 1,500 clinical trials and studies performed here, log on to http://clinicalcenter.nih.gov. From America's Clinical Research Hospital, this has been CLINICAL CENTER RADIO. In Bethesda, Maryland, I'm Bill Schmalfeldt at the National Institutes of Health, an agency of the United States Department of Health and Human Services.

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