Need for a wider view of autonomy in epidemiological research

doi:10.1136/bmj.c2335

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Mats G Hansson, professor of biomedical ethics

¹Centre for Research Ethics and Bioethics, Uppsala University, Department of Public Health and Caring Sciences, PO Box 563, SE-751 22 Uppsala, Sweden

Mats.Hansson{at}crb.uu.se

Accepted 11 April 2010

Review bodies put great importance on informed consent, but Mats Hansson argues that their narrow view of autonomy could be harming patients’ interests

Ethical review boards and data controllers in several countries require explicit and specific informed consent from patients for observational and epidemiological studies as well as for interventional studies. However, evidence is emerging that such strict interpretation of consent is introducing selection bias and reducing response rates.1 2 3 4 5 By diluting the strength of scientific studies, this approach is denying patients access to the best medical knowledge. Using a real case, I argue that review bodies should adopt a wider view of consent.

Current approach

Several ethical guidelines have been drawn up with the explicit purpose of making informed consent the general rule for all types of study. A recent example is the ethical guidelines from the Council for International Organizations of Medical Sciences, which states:

”For all epidemiological research involving humans the investigator must obtain the voluntary informed consent of the prospective subject or, in the case of an individual who is not capable of giving informed consent, the permission of a legally authorized representative in accordance with applicable law. Waiver of individual informed consent is to be regarded as exceptional, and must in all cases be approved by an ethical review committee unless otherwise permitted under national legislation that conforms to the ethical principles in these Guidelines.”6

However, strict interpretation of consent requirements is lowering the scientific value of studies, limiting their capacity to provide new medical knowledge that would be beneficial for patients. Iversen and colleagues report how requirement of informed consent for linkage to a cancer registry seriously hampered epidemiological research.1 Ward and colleagues had a similar experience with a UK nested case-control study of Creutzfeldt-Jakob disease,2 and the requirement …