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Registry and Biorepository Bulletin
Brought to you by Genetic Alliance Registry & BioBank
August 26 2011 Issue #18
Proposed Changes to Common Rule

The government is proposing major changes to the rules that govern research involving human subjects, the New York Times reports. Officials say the changes will strengthen protections and reduce red tape while addressing the new research climate that has developed since the guidelines were last updated in 1991. Proposed changes include requiring consent before DNA or tissue is used in follow-up studies, requiring that any study conducted at an institution receiving government funding abide by the guidelines, and allowing a single IRB to approve studies for multiple sites. The process is still at an early stage, and the government is asking for public comment.

articleand request for comment.

Relationships between Biobanks and Contributors

At Genetic Alliance’s Annual Conference, Relationships Between Biobanks and Their Specimen Contributors: How Organizational Approach Might Matter workshop, presenters discussed a number of biobank models and the philosophies behind them. A major topic of debate was the appropriate approach to handling personal information. John Conley, Ph.D., J.D., a researcher at UNC, spoke on the potential benefits of giving genetic information the same legal status as a trade secret . Conley believes that concerns of biobank participants, including how long their specimens would be stored, what they would be used for, how their privacy would be ensured, and what kind of compensation they would receive, are the same as those addressed in a trade secret contract. He envisions replacing informed consent, which Conley considers “legally ambiguous” and decreasingly meaningful due to the unforeseeable future of genetics, with a formal contract outlining the terms of the donation. Wendell Fortson, Ph.D., founder of the African Ancestry Biobank, presented on the “member-driven model.” The African Ancestry Biobank will center its governance on member feedback and needs. This will be achieved by soliciting member input before enacting any new policies, offering a staffed support center, and regularly reaching out to members to inform them of upcoming research opportunities. Daniel Vorhaus, J.D., presented on a biobank that opts for nearly complete openness, in contrast to conventional concerns about privacy. The Personal Genome Project offers deidentified data of all participants on its website. The goal is to follow 100,000 individuals for 25 years, collecting specimens and genetic, medical and environmental information. In addition to providing researchers with a universally available longitudinal data set, the Personal Genome Project hopes to track the effect of the project on participants.

Optimizing Participation in Genetic Research

A recent BioMed Central Blog post discussed a study that shows that site of enrollment can influence rates of participation in genetic research. Since many genetic and medical research projects rely on the donation of blood or tissue samples, optimal recruitment of participants is an important consideration. Published in Genome Medicine, the study discusses how genetic research traditionally has relatively low numbers of participants when compared with non-genetic studies. David Lanfear and colleagues sought to determine which factors are associated with low or high rates of patient participation, and found that the site of recruitment was more important in predicting consent than factors such as patient age, gender, or education level. The study concludes that differences in how personnel at particular sites of recruitment interact with patients and present information can impact patients’ willingness to participate in research. In another study published in Genome Medicine, Gert Helgesson suggests that we can improve participation rates by improving training, standardizing enrollment processes, and considering ethical issues. These studies have the potential to inform future recruitment strategies and improve research quality.

Read the post.

Rare Disease-HUB

The Office of Rare Diseases Research (ORDR) at the NIH has introduced Rare Disease-HUB (RD-HUB), an improved biospecimens/biorepositories website. The website is a portal for researchers to locate and inquire on the availability of specimens from existing biorepositories around the world and will let researchers check whether the specimens they are looking for are available before contacting the repository. RD-HUB will also provide links to best practices for specimen collection, models and templates for informed consent, ethical and legal guidelines for handing human subject material for research and treatment, and other useful information. Although RD-HUB includes common diseases, its primary focus will be on rare diseases. ORDR hopes to facilitate global collaboration and interaction among researchers and the scientific community, and is inviting biorepositories to share their inventory. 

Upcoming Events

Join Genetic Alliance for our 25th Anniversary Celebration on September 22, 2011, in Washington, DC, featuring a museum-quality Innovators Exhibit that highlights innovation from the genetics, health, and advocacy community. Music, snacks, and drinks – not to mention great company – will keep the innovations coming throughout the night and beyond.