Tag: Biosecurity

Ensuring Continued Responsible Research with Non-Human Primates

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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://www.nal.usda.gov/programs/awic) 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 , 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 website.  Comments 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

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Protecting Data, Promoting Access: Improving Our Toolbox

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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

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Building a Better Biomarker Glossary

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Precise and clear communication across biological and clinical research disciplines supports efficient translation of results from basic research into applied therapeutics and interventions. Both the NIH and FDA are keenly interested in working together to help the biological and clinical research communities speak a common language, so that research results can be clearly understood by both groups.

This is especially true in considering the vocabulary used to describe measures of health, disease, or physiological processes. For example, “biomarkers,” “surrogate endpoints,” and “clinical outcome measures” are widely used in published research findings.  The terms above mean different things; in order to build a solid foundation of research for precision medicine (and medicine in general), it is important that researchers are communicating consistently and that the wider community understands what published results actually mean.  Inconsistent terminology undermines the strength of these tools.

We’d like to share a new resource focused on biomarkers, endpoints, and other related tools that we hope will assist researchers in the development of their research plans and reporting of research  findings. Earlier this year, the NIH and FDA published an open access textbook: the Biomarkers, EndpointS, and Other Tools (BEST) Resource.  BEST was developed by evaluating an extensive array of definitions — drawing from FDA guidance documents; the scientific literature; the 2010 Institute of Medicine study on the Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease; and a 2015 Brookings Institution meeting with academic and private sector stakeholders.

If your work involves the use of biomarkers or clinical outcomes, we hope you take a look at this resource and consider using it in a variety of contexts – reading and writing manuscripts, discussing your ideas with colleagues, and planning the next steps in your research. The glossary is intended to be a living document, with the goal of adding more terms and definitions based on your feedback. We welcome you to email the joint FDA-NIH Biomarker Working Group with your suggestions – including proposed edits. This input will be used by the Working Group to inform future editions of this glossary.

For additional perspectives on this resource, please see the recent JAMA article or blog in the FDA Voice.

Many thanks to Pamela McInnes, Lisa McShane, and Holli Hamilton of NIH for their contributions to this blog.

Dr. Mike Lauer is the NIH Deputy Director for Extramural Research and blogs about NIH research funding policies and data at his blog, Open Mic.

Posted by Dr. Carrie D. Wolinetz, April 18, 2016

Dr. Mike Lauer
NIH Deputy Director for Extramural Research
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NIH-FDA Draft Clinical Trial Protocol Template: Stakeholder Feedback Needed!

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In the recently released NIH-Wide Strategic Plan (FY 2016-2020), the agency declared our commitment to “fostering approaches to enhance the speed and efficiency with which [clinical] trials are conducted.” On March 17, we unveiled a piece of that ongoing effort for input from stakeholders: a draft clinical trial protocol template released in today’s Guide to Grants and Contracts.

Developed jointly by NIH and the Food and Drug Administration (FDA), the protocol template  provides a standard format with instructional and sample text that NIH funded investigators can use when preparing protocols for phase 2 or 3 clinical trials that require an Investigational New Drug application (IND) or Investigational Device Exemption (IDE) application.

The agencies’ goal in developing the template is to ensure investigators prepare protocols that are organized consistently and contain all the information necessary to enable efficient and timely review.   The draft template is consistent with guidance on protocol development found in the International Conference on Harmonisation (ICH) E6 Good Clinical Practice.  A copy of the draft template as well as instructions on how to comment can be viewed on the NIH OSP Website.

We encourage stakeholders to submit comments on the utility of the template and the clarity of the accompanying instructional guidance.  We would specifically welcome feedback from investigators, investigator-sponsors, institutional review board members, and any other stakeholders who are involved in protocol development and review on the readability and clarity of the instructions contained in the template.  Stakeholder feedback will be critical when NIH and FDA consider the next steps in this process.

Posted by Dr. Carrie D. Wolinetz, March 18, 2016

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