research ethics

Incidental Findings: It’s My DNA, and I Want to Know if Something is Wrong With it.

by Ryan J. Connell, UMN Law Student, Joint Degree Program Fellow, MJLST Staff

Thumbnail-Ryan-Connell.jpgAs genetic research continues to develop, researchers are more apt to make incidental discoveries in the course of the research on a subjects DNA. Susan Wolf, Founding Chair of the University of Minnesota’s s Consortium on Law and Values in Health, Environment & the Life Sciences, points out in her article “The Role of Law in the Debate over Return of Research Results and Incidental Findings: The Challenge of Developing Law for Translational Science,” that, with this development, there is a serious question that must be asked, but that the law does not really answer: do researchers have to report these incidental findings to the subject?

Is this something that necessarily must be addressed by the law? I think so. Researchers need guidance on this front. Right now if a researcher finds something that may or may not have adverse health consequences for a subject the researcher must balance competing interests. What if they do disclose the risk? Is a pure researcher qualified to evaluate medical risks? The researcher could be very wrong in their analysis; could a subject who was told that they might be at risk for a serious health problem, but was not, hold a researcher liable for emotional stress? On the other hand, if a researcher comes across some potential risks and does not tell the subject, and the subject suffers as a result, should the researcher be liable?

I think the answer to this problem lies in waivers. Before people make themselves subject to research they should sign a waiver to either not hold a researcher liable for any incidental findings reported, or agree to not receive any information about any incidental findings.

This really should be the patient’s decision. Some geneticists think that it is better not to let people know if they have a risk for Huntington’s disease, or Alzheimer’s disease because there are no interventions. Likewise some geneticists feel that they would only report a risk of cancer if it is specifically requested.

From my point of view, if my genes are used for research and the researchers find that I am at risk for something, I want to know. I don’t care if there is nothing that I can do about it; I should know about it. My personal view is not shared however, some feel like they want to contribute to research, and then they don’t want to be bothered again.

This is a complicated issue with no clear solution. How do you feel? Do you want a researcher to tell you if they think you are at risk? Would you hold a researcher liable if they mistakenly told you that you were at risk for a horrible disease? Or would you be more likely to hold a researcher liable for not telling you that you were at risk for a disease? Do you think a waiver, or some other agreement is necessary between a researcher and a subject before any research is conducted?