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Research Ethics Consultation Service (RECS)

Genomic research is one of the most complex and rapidly evolving fields of biomedical science. Current genomic and information technology have raised new questions about participant protections and about the responsibilities of investigators and IRBs regarding collection, storage, and sharing of human genetic specimens and data related to or derived from these specimens. The purpose of the Research Ethics Consultation Service (RECS) is to provide an opportunity for discussion of ethical and social issues related to the conduct of human studies involving genetic or genomic questions, methods and applications. Issues may include “nuts and bolts” procedural questions, study design and implementation, and dissemination of research results from the basic sciences to clinical and population based research. Conceptual and policy-related issues, particularly when new guidelines are issued from NIH, will also be addressed by the service. Our function is strictly educational and/or advisory. It is hoped that this service will fill gaps in knowledge and, when appropriate, facilitate communication between investigators, administrators, and oversight authorities (e.g., IRB).

Services

General education: Offer education sessions of relevance to the IRB and investigator community at UNC; respond to general calls, questions, and concerns about ethical or policy aspects of conducting research with a genetics or genomics component.

Project-specific education: Identify and address ethical or policy issues specific to a particular project or program. Assist researchers and others throughout the research process

Feedback on IRB and grant applications: Prior to submitting IRB and/or grant applications, the service will assist researchers by reviewing relevant sections with ethical or social implications, and facilitate investigator communication with the IRB when requested.

Resources: Maintain a current database with relevant literature, educational materials, and policy documents to help investigators and others identify issues and clarify questions.

*Click here for NIH GWAS Data Sharing Policy: References*

Topics and Issues

Relevant topics and might include, but are not limited to: subject recruitment, biobanking, return of study results or incidental findings to subjects or their physicians, sharing data with other investigators, the consent form and process, privacy and confidentiality of genetic information, dissemination of research data, and secondary and future use of data and specimens. We provide education to individuals or groups, and often in consultation with the IRB, assist in addressing identified questions or concerns.

For more information or to request a consult:

Please contact us at RECS@unc.edu or call us at 919-843-3658.

Click here to download the RECS Intake Form.

RECS Team

Lynn Dressler, Dr. P.H.
Assistant Professor, Division of Pharmaceutical Outcomes and Policy
Associate Director for Policy and Ethics, Institute of Pharmacogenomics and Individualized Therapy (IPIT)
UNC School of Pharmacy
919-966-9480

Nancy King, J.D.
Professor, Department of Social Sciences and Health Policy
Director, Program in Bioethics, Health, and Society
Wake Forest University School of Medicine

Janell Markey, M.S.
Coordinator, Research Ethics Consultation Education Service
Research Assistant, Division of Pharmaceutical Outcomes and Policy, UNC School of Pharmacy
Research Specialist, Lineberger Comprehensive Cancer Center
919-843-3658

The Center for Genomics and Society is supported by the ELSI Research Program of the National Human Genome Research Institute of the National Institutes of Health, Grant Number P50HG004488.