How should patients be informed about Research on Medical Practices?
There is no consensus among researchers, physicians, and bioethicists about the most appropriate way to inform patients about Research on Medical Practices.
In the ROMP Ethics Study, we are exploring people’ attitudes about the following questions:
- When reviewing medical records for research, should the patient be asked to sign a written agreement? Written agreements take additional time for the patient and the doctor. Sometimes it is not possible to obtain written agreement. Requiring written agreements can sometimes effect who participates in research, which may bias the results of a study. As a result, some argue that other approaches should be considered. Is it enough to get verbal permission or to give patients general information (like a brochure)? These two approaches are quicker and don’t slow the pace of research as much as written agreement, but the patient may not fully understand the information presented briefly in an in-person presentation.
- Suppose your doctor would like to randomize you to one of two medications because she does not know which is best. What are acceptable ways to let you know about this randomization? Is it enough that the doctor discusses this with you and gets your verbal permission? Or, would you prefer to sign a written agreement after she discusses the research with you? If all of the patients in the clinic will be randomized to get the same medication, is it acceptable to notify patients with general information only?
- Who should ask patients for their permission? We do not know who is in the best position to talk with patients about research participation. Should it be your doctor or the researcher? Sometimes the doctor is the one conducting the research; sometimes these roles are filled by different people. You might have a closer relationship with your doctor and trust her recommendation—but then again, you might feel pressured. Even if the researcher tells you the study is really important, you might not worry about saying no to him because you do not have an ongoing relationship with him.
- If you knew that there were other patients giving the health system advice (such as asking if the study were really necessary), would you be more likely to find it acceptable to get only general information? Some health systems have a community advisory board to help review the research plan and make recommendations about how to notify patients. Would this affect how you feel about Research on Medical Practices taking place at your doctor’s office?
Read some of the ethical issues related to risks in Research on Medical Practices.
- Faden RR, Beauchamp TL, Kass NE. Informed consent, comparative effectiveness, and learning health care. New England Journal of Medicine. 2014; 370: 766-768.
- Kim SYH, Miller FG. Informed consent for pragmatic trials—the integrated consent model. New England Journal of Medicine. 2014; 370: 769-772.
- Macklin R, Shepherd L. Informed consent and standard of care: What must be disclosed. American Journal of Bioethics. 2013; 13: 9-13.
- Wendler D. What should be disclosed to research participants. American Journal of Bioethics. 2013; 13: 3-8.