2012 Webinar: Data Sharing in Genomics Research

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Overview

During this webinar, the following topics were discussed: the current state and evolution of data sharing policy, including other relevant developments in federal policy; IRB issues, best practices, and informed consent; and results from a randomized study of consent for data sharing conducted at Baylor College of Medicine.

Data sharing is a tenet of research traditionally expressed through publication and the opportunity for others to review, critique, and attempt to reproduce scientific findings. Data sharing has also increasingly become standard practice as a means to promote resource sharing across the research community.

Genomics research, in particular, is built on principles of rapid and broad data sharing through community resources. Since 2008, NIH-funded genomics studies have shared information through the database for Genotypes and Phenotypes (dbGaP), the NIH database designed to archive and distribute data from genome-wide association studies (GWAS).

Policies for genomic data sharing are likely to be relevant to anyone collecting biospecimens for future research. However, many institutions don’t know what those policies are, how to comply with them, how to address them, or how to discuss them in consent forms and consent processes.

For pre-existing studies, determining whether data sharing is consistent with the original consent remains a challenge. Many older consent forms do not explicitly address data sharing, and consequently, it can be challenging to know how to assess them.  In addition, genomic science is advancing rapidly and the issues relevant to data sharing are evolving along with it. During this transitional time, there is great uncertainty about how to deal with genomics and genomic data.

During this webinar, the following topics were discussed:

  • The current state and evolution of data sharing policy, including other relevant developments in federal policy
    • e.g issues under discussion by the Presidential Commission for the Study of Bioethical Issues: privacy vs. access; individual vs. societal benefit
  • IRB issues, best practices, and informed consent
  • Results from a randomized study of consent for data sharing conducted at Baylor College of Medicine, including:
    • Preconceptions and evolving opinions on controlled access and open-access data release
    • Changes in preferences following changes in data sharing options

Audience

Those conducting or reviewing genetic and genomic research that is or may be governed by data sharing policies.

Faculty

Laura Lyman Rodriguez, PhD
Laura Lyman Rodriguez is the director of the Office of Policy, Communications, and Education at the National Human Genome Research Institute (NHGRI), National Institutes of Health (NIH). Dr. Rodriguez works to develop and implement policy for research initiatives at the NHGRI, as well as trans-NIH programs.  Dr. Rodriguez has been with NHGRI since 2002 and served in multiple capacities during her tenure with the Institute. Prior to coming to NIH, she was a senior program officer at the National Academies Institute of Medicine where she was the study director for a project examining the federal system for protecting human research participants.

Dr. Rodriguez has provided leadership for many of the policy development activities pertaining to genomic data sharing and the creation of the database for Genotypes and Phenotypes (dbGaP) at the NIH. She has spent time in the legislative arena as an American Association for the Advancement of Science (AAAS) Congressional Science Fellow working on national science policy issues and K-12 math and science education, and with the Office of Public Affairs at the Federation of American Societies for Experimental Biology covering federal funding issues and various topics in bioethics. Dr. Rodriguez received her BS with honors in biology from Washington and Lee University in Virginia, and earned a PhD in cell biology from Baylor College of Medicine in Texas.

Amy McGuire, JD, PhD
Amy McGuire is associate professor of medicine and medical ethics and associate director of research for the Center for Medical Ethics and Health Policy at Baylor College of Medicine. Her research focuses on legal and ethical issues in genomics.  She is currently studying participant attitudes toward genomic data sharing, investigators’ practices and perspectives on the return of genetic research results, ethical issues in human microbiome research, and ethical and policy issues related to the clinical integration of genomics.  Her research is funded by the NIH-NHGRI and the Cancer Prevention and Research Institute of Texas. Dr. McGuire received her BA in psychology, summa cum laude, from the University of Pennsylvania, her JD, summa cum laude, from the University of Houston, and her PhD in medical humanities from the Institute for the Medical Humanities at the University of Texas Medical Branch.

Certificates of Attendance

Certificates of Attendance were made available at the conclusion of the webinar. To access the certificate, you must first complete the online evaluation. Such certificates are useful for obtaining continuing education (CE) credits (not Continuing Medical Education credits) from professional associations. Note that guidelines concerning CE credits may differ, and you should consult the appropriate professional association representative for further guidance.

CE Credit for Certified IRB Professional (CIP®) Recertification
Webinar participants holding the CIP credential who wish to apply credits from this webinar toward CIP recertification may submit the Certificate of Attendance they received upon completing the online evaluation as documentation of their participation. Participation in this 90-minute webinar counts as 1.5 CE credit hours.

For recertification by CE, CIPs must complete 30 documented hours of continuing education. At least 15 of the 30 hours must either carry credits issued by a recognized accrediting body or have received advanced recognition from the Council for Certification of IRB Professionals (CCIP). Credits from PRIM&R webinars have received such advance recognition, and may be counted towards these 15 hours.

Additional information about CIP recertification can be found here.