On Jan. 30, 2015, President Barack Obama announced a Precision Medicine Initiative that would include assembling one million volunteer participants whose genetic information will be studied to help advance understanding about how to harness the power of genomics to improve health. Those participants would join thousands already enrolled or being recruited to join other research studies.
"The contribution of research participants to medical advances cannot be underemphasized, and the choice to play this important role must be thoughtfully considered and fully informed," said Laura Lyman Rodriguez, Ph.D., director of the Division of Policy, Communications, and Education (DPCE), at the National Human Genome Research Institute (NHGRI). "As genomics research extends throughout biomedical and clinical research, it is especially important that we provide participants with clear information about the issues relevant to genomic research participation, so that they have the right tools to understand and make decisions about their contribution to any research activities."
Informed consent is the basic and primary tool through which investigators communicate with each potential study participant and is vital to ensuring that the research purpose, any risks and possible benefits, or other implications of participation are understood. Informed and voluntary agreement to participate in genomics research is fundamental from an ethical and legal standpoint.
An online Informed Consent Resource (ICR) introduced in 2009 by the National Human Genome Research Institute (NHGRI) has helped thousands of researchers navigate the informed consent process. To date, the ICR has been accessed online by more than 45,000 visitors from four continents. Now, the ICR has been updated to keep pace with advances in genomics over the past several years.
An NHGRI team with expertise in genomics research, bioethics and policy contributed to the recent ICR update. NHGRI also obtained input from more than 20 external experts including clinicians, bioethicists, genomic researchers, genetic counselors and institutional review board members with non-scientist participant advocates.
"Over the past five years, dramatic progress in our understanding of the genome, changes in research approaches and an evolving cultural and policy landscape have contributed to new considerations for consent in genomic research," said Kate Saylor, health science policy analyst in NHGRI's Policy and Public Analysis Branch, part of DPCE. "All of these changes have called for updates to the online tool."
The updated ICR explores a range of important topics for researchers, including the scope of consent, sample and data storage, return of results, research involving children, and privacy and confidentiality. It also includes examples and information to guide researchers through the complex consent issues that arise in genetic and genomic research.
"We hope that the online resource will continue to stimulate a dynamic dialogue with investigators, institutional review board members and the broader research community," said Derek Scholes, Ph.D., chief of NHGRI's Policy and Program Analysis Branch.
According to Amy McGuire, J.D., Ph.D., Leon Jaworski Professor of Biomedical Ethics and director of the Center for Medical Ethics and Health Policy at Baylor College of Medicine, "The NHGRI ICR provides both Institutional Review Boards and investigators valuable guidance on the elements of informed consent that ought to be considered when designing genomic studies and discussed with potential participants of genomic research. The model language that is provided can help to control unjustified variation in consent documents, which will help to facilitate future research."
For more about the ICR, go to: http://www.genome.gov/informedconsent
For feedback or suggestions, send email to: informedconsent@mail.nih.gov
