Does Research on Medical Practices (ROMP) create additional risks?
There are risks associated with usual medical care. When usual medical practices are studied, does this introduce more risk to patients? For example, the risk of a breach to patient confidentiality may be slightly higher when health systems share patient information with each other.
In the ROMP Ethics Study, we are exploring people’s attitudes about the following questions:
- Are the risks different when randomization is used to select the medication versus doctors making an arbitrary choice (because they do not have enough information to really know whether one medication works better than the other)?
- Are patients harmed who got the medication that was eventually found to be not as good as the other medication? Is the harm different if the medication was prescribed as part of Research on Medical Practices versus simply prescribed by the doctor? And are the risks different if only medical records were reviewed, as compared to if the patients were randomized?
- Are the risks different depending on the severity of the medical condition? What if the medical condition is more severe than, say, high blood pressure, or what if the medications have serious side effects?
- Are the risks different depending on how randomization is done?For example, does it make a difference whether the doctor and patient know which medication the patient is taking? Are the risks different when the randomization is done so that all patients in one place (e.g., in one hospital) receive the same medication?
Read some of the ethical issues related to letting patients know about Research on Medical Practices.
- Feudtner C, Schreiner M, Lantos JD. Risks (and benefits) in comparative effectiveness research trials. New England Journal of Medicine. 2013; 369: 892-894.
- Gross CP, Krumholz HM, Van Wye G, Emanuel EJ, Wendler D. Does random treatment assignment cause harm to research participants? PLoS Medicine. 2006; 3: 800-808.
- Magnus D, Caplan AL. Risk, consent, and SUPPORT. New England Journal of Medicine. 2013; 368: 1864-1865.