What are some of the issues have occurred in the past regarding consent and genetic studies?

Next week, the TIDES Event will take place in Providence, Rhode Island.  This week, we're revisiting some of the speaker interviews we conducted to prepare for the event. Today we look at the interview with Bertha deLanda, CIP - IRB/SCRO Panel Manager, Research Compliance Office at Stanford University.  She will be presenting Informed Consent and Genetic Research as a part of the Nucleic Acids Technologies for Molecular Diagnostics Workshop.

Today, Bertha answers the question:
What issues have occurred in the past regarding consent and genetic studies?

Well, unfortunately there are many examples of how both subjects and researchers and the general public are affected by mishaps and compliance issues that are very current. Havasupai Tribe for example, contributed their blood samples in the hopes of finding out more about the high incidence of pervasive diabetes within their population. The consent forms that the researchers obtained contained very vague language, which was reviewed by the IRB and found – at the time – to be adequate. However, the vagueness and terms and the lack of communication regarding the consenting process really caused downstream legal issues when the tribe later discovered that their samples were being used for other research that they objected to.

Also, there is the case of newborns being tested via blood spots in Texas where parents sued the institutions involved for not disclosing that this material would be stored indefinitely for undisclosed research purposes and without the plaintiff’s knowledge or consent.

Unfortunately, we have many other examples of situations where informed consent didn’t meet the standard of adequacy by the public eye. Since we depend on subjects providing samples as volunteers in order to continue our research, we must look at these past issues in order to avoid them in the future. I’ll touch on these examples during my talk and provide examples of consent forms to help delineate these points.

Read the rest of Bertha's interview here.

If you would like to learn more about this topic, join Bertha next week, May 12-15, 2014, in Providence, Rhode Island for the TIDES event. As a reader of this blog, when you register to join us and mention code XB14180BLOG, you can save 20% off the standard rate. Have any questions? Reach out to Jennifer Pereira.

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