Tuesday, May 6, 2014

What is the main challenge with the informed consent process as it relates to genetic research process?

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 shares her thoughts on the question:

What is an IRB and what do they have to do with the consenting process?

Well, in IRB or Institutional Review Board, it is the independent ethics review board that’s responsible for reviewing, approving, continuing with or rejecting any research that involves either human subjects or their identifiable private health information. It is composed of at least five individuals, one who must be an unaffiliated or public member, one who must be a non-scientist and other members who are doctors, lawyers, teachers, businessmen, etc. Because my panel also oversees studies that involve stem cell research, my panel includes BioE Thesis and researchers with a strong stem cell background. Also, sometimes when necessary, a panel member who is experienced in assisted reproductive technology. 

My background is in the genetics research field. Many of the PCR drug technologies I was involved with were genetic research-based. Their purpose was to diagnose, treat, identify or even, in some cases, cure diseases so that they would inevitably go to human clinical trials. Therefore, before writing a protocol that involves work with human samples, the scientists and researchers should do their best to avoid the pitfalls and retrospective issues that can occur when consenting, potential participants or their samples.

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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