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Registry and Biorepository Bulletin
Brought to you by Genetic Alliance Registry & BioBank
September 30 2011 Issue #19
NETS Resource

NETS, Navigating the Ecosystem of Translational Science, is an interactive model of drug development intended to educate and empower individuals to get involved in translational science. Designed by Genetic Alliance, the model offers a more realistic and nuanced view of drug development than the traditional pipeline model. By grouping related processes into five different “neighborhoods,” NETS shows the general order of drug development while demonstrating its flexibility. NETS also provides toolkits of definitions, resources, and educational materials to disease advocacy organizations and basic researchers who want to become more involved in the drug development process.

Watch Introduction to NETS and How to Use NETS.

Biobank Governance

At Genetic Alliance’s Annual Conference Evolving Models of Biobank Governance session, presenters discussed a number of biobank governance models. Kelly Edwards, Ph.D., associate professor of bioethics at University of Washington, presented on commonly held assumptions about biobank governance whose re-evaluation could lead to better biobanking results for both participants and researchers. While identifiers are frequently stripped from specimens and information to assure privacy, Dr. Edwards suggested that doing so without allowing a means for re-identification actually hurts participants by preventing them from being able to receive results if appropriate, and precludes researchers from obtaining any necessary follow-up information. She also proposed the need for a more dynamic and collaborative model of informed consent to replace the limited offerings of a one-time, all-purpose informed consent agreement. The current structure often limits a participant’s ability to direct his or her information on an ongoing basis, and eliminates the possibility for using data for purposes not included in the initial consent. This is particularly important given evolving and unforeseeable future uses of biobank specimens.

Adaptive Governance for Genomic Biobanks

Scientists suggest four general principles that are necessary for informing sustainable and effective governance of biobanks in a recent paper published in Social Science Medicine. These four principles are: recognition of research participants as a collective body, trustworthiness, adaptive management, and fit between the nature of a particular biobank and the specific structural elements of governance adopted. The authors apply these four principles in a case study on BC Generations Project, a population-scale biobank. In doing so, the authors aim to create an adaptive governance approach that protects participant interests while promoting effective translational health sciences.

Read the article.

Better Provenance for Biobank Samples

A key determinant in the success of personalized medicine is the quality of biobank specimens and the data used to derive them. In a recent report published in Nature, 125 manuscripts were analyzed to determine if information about the biospecimens used was provided, and if so, if the specimen data was sufficient. More than half of the manuscripts did not provide any information regarding the biospecimens used in research, and four from 2009 contained insufficient specimen data. This lack of quality control results in unreliable information in scientific publications. Since leading journals are influential in defining publication criteria, the authors suggested that all journals should insist on complete details of the biobank specimens used to preserve the quality and reliability of publications. Biobankers can help this effort by collecting complete information on their samples that can be used in publications.

Read the article.

Request for Public Comment

The Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) are inviting public comments on the joint draft guidance document, “Guidance on Exculpatory Language in Informed Consent.” The document provides guidance on the regulatory prohibition of the inclusion of exculpatory language in informed consent and includes examples of language that the OHRP and FDA consider acceptable and unacceptable. This document has significant implications for biomedical research and biobanks, as it would affect the language of the informed consent document. Comments are due by November 7, 2011

Submit your comments.

ANPRM Comment Deadline Extended

The deadline to submit comments on the proposed changes to the Common Rule has been extended to October 26, 2011. (This is also referred to as Advanced Notice of Proposed Rulemaking (ANPRM) for Revisions to the Common Rule.) Over the summer, the government began the process of proposing major changes to the rules that govern research involving human subjects. 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.

Read the request for comment.