Consent & Conversation in Population-Based Research

PredictER's Peter H. Schwartz will be presenting the Walter C. Randall Lecture in Biomedical Ethics at the annual Experimental Biology meeting of the American Physiological Society, to be held in New Orleans, April 18-22, 2009. Dr. Schwartz's talk, Consent and Conversation in Population-Based Genetic Research, will take place on Tuesday, April 21st at 2:00 p.m. Additional information is available here.


Abstract: The future of research into the human genome depends on the creation of massive biobanks, databases that combine phenotypic information about individuals (such as their medical history) with genetic information and biologic samples collected from them. Some of the most important biobanks will involve the participation of thousands or millions of people, representing a broad swath of an entire community. But signing up such large numbers raises serious challenges for traditional ideas of consent by research subjects. We need to formulate a new model of ethical research that relies on a conversation with a community rather than just informed consent by individuals.

Amy Lewis Gilbert

Patient Attitudes Toward Genotyping: Willingness to Donate

The November 2008 issue of Obstetrics & Gynecology included an article addressing an Indiana University study which sought to ascertain the willingness of women to donate DNA specimens. The article, “Patient Attitudes Toward Genotyping in an Urban Women’s Health Clinic” (David M. Haas, Jamie L. Renbarger, Eric M. Meslin, Katherine Drabiak, and David Flockhart), acknowledges the great promise of the emerging fields of genotype association studies and pharmacogenetics, which will theoretically allow for targeted medical interventions, personalized drug therapies and the more efficient allocation of healthcare resources. The study compared women’s willingness to donate DNA specimens via blood and saliva collection, and looked at several other factors to confirm the findings of previous studies regarding which of those factors predicate a willingness to donate. The authors found that more women are willing to donate DNA using saliva than blood, and that higher levels of education (college and beyond) and greater knowledge of genes and DNA increase women’s willingness to donate.

So how do these findings translate into ethical practice? How will they inform the future collection of samples for both medical and research purposes? It seems that researchers and practitioners should bear in mind that less-invasive methods of DNA procurement are preferred, and that education about purpose and use be stressed during the informed consent process. When asked about the translational implications of this study, Dr. Eric Meslin, co-author and Director of the Indiana University Center for Bioethics, said: “the key to success in any biobanking effort lies in the scientific community’s ability to both acquire and maintain the public’s trust. Informed consent may be evidence of the public’s willingness to permit specimens to be used for research, but consent should never be confused with the public’s willingness to trust science to do the right thing.” -Amy Lewis Gilbert

Personalized Therapeutics at IU

In August 2008, the Indiana University Department of Medicine’s Division of Clinical Pharmacology began a new series of compelling seminars that may be of great interest to those involved in predictive health research ethics. The Personalized Therapeutics Seminar series commenced on August 5th with a presentation on the FDA’s Sentinel System for Post-market Drug Safety Surveillance given by Barbara Evans, J.D., Ph.D. from the Health Law and Policy Institute at the University of Houston Law Center. Additional speakers this fall, all from the Indiana University School of Medicine, have included Dr. Noah Hahn presenting on the Indiana University Cancer Biomarker Study, Dr. David Haas addressing PREGMED and the search for individualized pharmacotherapy in pregnancy, Dr. Zeruesenay speaking about emerging in vivo phenotyping methods and Dr. Tatiana Foroud addressing the results of whole genome association studies and how they may change our approach to medicine. The next seminar, entitled Personalized Therapeutics in Breast Cancer: A Model for Translating Pharmacogenomics, will be presented Dr. David Flockhart, Chief of the Division of Clinical Pharmacology, on September 9th. All seminars in this series are held on Tuesdays from 12:00pm – 1:00pm, in room W7120 on the 7th floor of the Wishard Myers Building.

For a complete schedule, please see: http://medicine.iupui.edu/clinpharm/PMG/PT_Seminars.asp [link edited 9-18-09]



Amy Lewis Gilbert