Ensuring Continued Responsible Research with Non-Human Primates

Research with animals, including non-human primates, has enabled the development of treatments and cures for a host of devastating diseases and conditions in humans, and continues to revolutionize our understanding of health and disease.  Because non-human primates are anatomically, physiologically and behaviorally similar to humans, they are particularly valuable for answering some of the most complex questions germane to human health.  These research models have been instrumental to significant scientific and medical advances such as deep brain stimulation to treat Parkinson’s disease, experimental vaccines aimed at preventing the spread of Ebola virus, developing the polio vaccine, and new strategies that improve organ transplant survival today.  Non-human primate research retains a critical position in the biomedical research enterprise.

Equally important to their scientific value is upholding the highest possible standards of animal welfare, including ensuring that a proposed animal model is appropriate to the research and with an expectation of scientific rigor for every experiment. These precepts have been codified in research policy for many decades (https://awic.nal.usda.gov/government-and-professional-resources/federal-laws/animal-welfare-act) and are a central value of all biomedical research funded by the National Institutes of Health (NIH). NIH remains confident that the oversight framework for the use of non-human primates in research is robust and has provided sufficient protections to date. However, we believe that periodically reviewing agency policies and processes ensures that this framework evolves in a manner consistent with emerging scientific opportunities and public health needs.

Toward this end and in response to Congressional interest (refer to Page 72), the Office of Science Policy is taking the lead in planning a workshop on September 7th, 2016 that will convene experts in science, policy, ethics, and animal welfare.  Workshop participants will discuss the oversight framework governing the use of non-human primates in NIH-funded biomedical and behavioral research endeavors.  At this workshop, participants will also explore the state of the science involving non-human primates as research models and discuss the ethical principles underlying existing animal welfare regulations and policies.  NIH is committed to ensuring that research with non-human primates can continue responsibly as we move forward in advancing our mission to seek fundamental knowledge and enhance health outcomes.

The workshop will be broadcast live and archived for future viewing on the NIH Videocast websiteComments regarding the workshop may be submitted online in advance of and during the workshop for consideration. Please save the date, and stay tuned for more information, including a detailed agenda.


Posted by Dr. Carrie D. Wolinetz, May 24, 2016

Protecting Data, Promoting Access: Improving Our Toolbox

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