Genetic testing ethics – consent forms becoming incomprehensible

Following my recent article on ethical guidelines for informed consent in genomic studies, a group of scientists met at the Translating ESLI conference in Cleveland to debate this whole ethical argument. This issue is particularly critical for genome-wide association studies and in establishing and using large biobanks.

It was universally acknowledged that consent forms are difficult to read for participants who do not have reading skills beyond middle school or high school, for example. As a result, these paticipants may be unaware of what exactly the research could mean to them.

Laura Beskow, a researcher at Duke University’s Institute for Genome Sciences and Policy worked with the Association of American Medical Colleges to start a working group on informed consent issues and what concerned participants.

Participants advised of a number of important questions that consent forms should answer regarding the use of their samples.:

1. Do the forms specify the nature of the research, and is consent for an indefinite period of time?

2. What kinds of confidentiality are participants granted, particularly in an environment of increasing large-scale genetic information-sharing for various studies?

3. Can and when particpants withdraw their specimens?

4. Will they have access to the results of particular findings related to their genetic information?

5. If participants are ever contacted by researchers wanting to use their samples for other studies, it must be crystal clear why they were contacted.

These studies present significant new challenges for consent and participation, including questions about the management and protection of personal information, the return of findings to individuals and to groups, and the potential commercial use of information and tissues that were donated for research.

Elaine Warburton www.geneticsandhealth.com