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You may recall from one of my previous blogs that there are policy challenges in balancing the sharing of valuable research data with the protection of the participants whose data is being shared. The NIH Office of Science Policy is taking a leading role in ensuring that genomic data is shared in a responsible way.

Under the NIH Genomic Data Sharing Policy, institutions must indicate the appropriate use of genomic data, including any limitations on the distribution and use of that data.  In order to assist institutions in recognizing potential data use limitations (DUL), NIH created several resources for investigators.  These include Points to Consider in Developing Effective Data Use Limitation Statements as well as a set of Standard Data Use Limitations.  However, even with these resources, there is still the possibility for multiple interpretations which may cause time delays and additional costs when trying to share genomic data.

This raises some interesting questions: could time delays and cost burdens be reduced if the conditions of potential data use and sharing were clearly communicated at the time the data is generated? What are the variations in the designation of data conditions, and what does that landscape look like, domestically and internationally? To begin to address these questions, OSP staff collaborated with members of the Global Alliance for Genomics and Health to a set of “Consent Codes” that could be used to assign genomic datasets to standardized data use groups in order to allow a consistent interpretation for the appropriate secondary use of vital genomic data.  As described in a recent article in PLOS Genetics, the consent codes should help in avoiding the introduction of unnecessary new restrictions on data use, while at the same time facilitating research with the greatest amount of data available.

The issue of genomic data sharing highlights the importance of international collaboration as well as the delicate balance between the broad sharing of valuable research and ensuring the protection of participants.  OSP will continue to develop resources on genomic data sharing while evaluating the existing policy landscape to ensure that researchers have appropriate access to data while simultaneously making sure that the data is not inadvertently or deliberately misused.

Posted by Dr. Carrie D. Wolinetz, May 2, 2016

In one of my first blog posts, I mentioned that the Office of Science Policy (OSP) works with various stakeholders within and outside of NIH to develop policies that promote progress in the life sciences. These stakeholders can be local, state, federal, and international partners, research institutions, private companies, as well as non-governmental organizations. Building and fostering collaborative relationships with these groups gives NIH the opportunity to join forces with other experts and better use the biomedical research enterprise to improve public health, lengthen life, and reduce illness and disability.

Here, I want to spotlight a specific collaborative relationship that OSP has facilitated in recent years with the Patient-Centered Outcomes Research Institute (PCORI). Congress established this independent, nonprofit, non-governmental organization through the Patient Protection and Affordable Care Act of 2010. PCORI supports comparative effectiveness research, which is  aimed at improving the quality and relevance of available clinical evidence. These findings will help patients, care givers, advocates, policy makers, and public health officials make better health care decisions.  With their charge defined, Congress encouraged PCORI to work with NIH to manage the funding and conduct of research when needed and appropriate.

OSP works with the various NIH Institutes and Centers (ICs) to help encourage information-sharing and professional consultation with PCORI when a need arises. When these interactions lead to an opportunity for a collaborative research activity, OSP serves a central role at NIH to ensure that collaborations run smoothly and efficiently, from the earliest phases of concept development and throughout the life of the supported research. Specifically, OSP facilitates the agreements between the ICs and PCORI that establish the operational framework for the proposed collaborations. As such, OSP led the NIH efforts to develop this framework, which ensures that collaborative projects follow the policies of both organizations and provides guidance on initiative development, legal affairs, financial management, communications, and extramural activities.

Two formal NIH-PCORI research collaborations are now underway. For these activities, PCORI provided the research funding and the NIH ICs administered the resulting initiatives. The operational framework developed by OSP continues to facilitate communication between both organizations during these initiatives. The first of these joint projects, in 2014, was the National Institute on Aging Falls Injuries Prevention Partnership. This $30 million, five-year project supports a clinical trial to test individually tailored care plans in order to help reduce serious fall injuries, a common source of disability and death among the elderly. Another major collaboration involves the National Heart, Lung, and Blood Institute and National Institute of Neurological Disorders and Stroke jointly administering the Hypertension Disparities Reduction Program Partnership. This $23 million program is supporting two activities—awards announced in September 2015—performing randomized trials comparing evidence-based approaches for improving hypertension control in high-risk populations.

Collaborations like these represent exciting opportunities to address complex real-world public health issues. This important research has the potential to generate information that will help patients and care givers make better informed health care decisions. To this end, OSP will continue working with our colleagues at PCORI and leveraging similar approaches to collaborate with other like-minded organizations supporting biomedical research.