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The ISBER Science Policy Committee represents the perspectives of the ISBER membership and the Society on policy issues related to biological and environmental repositories. Relevant activities include, among other things, communicating to and soliciting input from the membership on emerging science policy issues and providing analysis of policies and regulations that may affect the biorepository community. Policy statements and projects related to these issues may stem from the interests of committee members or may be developed in response to requests for public comment through formal or informal rulemaking or policy development processes.
Since its formation in August 2011, the ISBER Science Policy Committee has submitted a variety of formal responses on ISBER's behalf, all of which can be found on the ISBER website at http://www.isber.org/?page=SciPolComm. The most recent responses include:
1. The July 8, 2013 response to the U.S. Presidential Commission for the Study of Bioethical Issues Request for Comments on Issues Related to Incidental Findings
This request was for public comment on the ethical, legal, and social issues raised by incidental findings (e.g., information revealed as a result of testing that was not its intent) that arise from genetic and genomic testing, imaging, and testing of biological specimens in the clinical, research, and/or direct-to-consumer contexts. The Commission was particularly interested in public comment regarding:
• The likelihood of incidental findings and related case studies; • What, if anything, patients, participants, and/or consumers should be told about incidental findings resulting from large-scale genetic testing, imaging, and testing of biological specimens before tests are conducted; • Any duties or ethical obligations that clinicians, researchers, and direct-to-consumer companies might have to actively look for certain incidental findings; • Best practices, methods, and mechanisms for determining when and how incidental findings should be returned to patients, participants, and/or consumers; • The acceptability of holding back information such as establishing "no return" policies, or stipulating in advance that no incidental findings will be returned; and, • Any best practices or recommendations regarding incidental findings that apply regardless of the type of test or context. See the link below for ISBER's response to the request for comments:
http://c.ymcdn.com/sites/www.isber.org/resource/resmgr/documents/isber_presidential_commissio.pdf
2. The March 4, 2013 response to the European General Data Protection Regulation Proposal as provided by the European Parliament and the Council of the European Union, (Brussels, 4 December 2012) The European Commission plans to unify data protection within the European Union (EU) with a single law, the A proposal for such a regulation was released on January 25, 2012, and the changes, if adopted, will impact organizations inside as well as outside the EU if they process personal data of EU residents. The anticipated adoption date is some time in 2014, and the regulation is planned to take effect in 2016 after a transition period of 2 years. See the link below for ISBER's comments:
http://c.ymcdn.com/sites/www.isber.org/resource/resmgr/ISBERSPCResponsetoESBBPrivac.pdf
3. At the time of writing this article, the Committee was preparing a response to the Draft NIH Genomic Data Sharing (GDS) Policy that can be found at http://www.federalregister.gov/a/2013-22941j, with a deadline of November 20th for comments. The pdf version of the NIH Draft is available at: https://s3-amazonaws-com-443.web.bisu.edu.cn/public-inspection.federalregister.gov/2013-22941.pdf. The submitted response can be found on the ISBER website at http://www.isber.org/?page=SciPolComm.
Involvement of the ISBER membership is critical to the Science Policy Committee's success. Sci Pol wishes to encourage participation and respond to areas of importance at a global level. To that end, the Committee continues to work to encourage and increase the involvement of ISBER members as well as experts outside the ISBER community in the following ways:
• ISBER members and non-members alike have the ability to submit documents for review and topics for discussion to the entire Sci Pol Committee, and to interact with other members by contacting Sci Pol members directly (see Table 1). • ISBER members are strongly encouraged to respond to requests for input from the Science Policy Committee as it prepares to formulate responses on ISBER's behalf.
The ISBER Science Policy Committee welcomes and encourages input regarding topics of policy and regulatory-related importance as well as methods for increasing expert involvement. Please feel free to contact one of its Co-Chairs or any of the Committee Members at your convenience. Links and references supporting your suggestions are highly encouraged, and contact information is requested to ensure timely follow-up.