Tag: and Emerging Biotechnology

It is almost universally acknowledged that life science research is fundamentally important and is the basis for advances in medicine, agriculture, environmental quality and a strong national economy.  However, over the past several years, the U.S. Government has recognized that some information generated by important life science research could be misused by those with the intent of harming public health or other aspects of national security.  This is the dual use dilemma: good science could be put to bad uses.

The NIH Office of Science Policy, in association with its Federal partners, has been actively involved in the discussion of how to best address research with this potential, known as ‘Dual Use Research of Concern, or (DURC).  In recent years, the U.S. Government has issued two policies on the oversight of DURC, both with the goal of preserving the benefits of important life sciences research while minimizing the risk that such research could be misused to cause harm.  The first Policy was issued in March 2012 and required Federal departments and agencies to review their life science research portfolios to determine if any research projects had potential DURC implications.

The second U.S. Policy, United States Government Policy for Institutional Oversight of Life Sciences DURC, was issued in September 2014.  The institutional policy outlines the procedures for the oversight of DURC at the local level and describes the responsibilities of Principal Investigators and research institutions.  The institutional policy must be implemented by institutions subject to its scope by September 24, 2015.

In advance of the implementation date, the White House Office of Science and Technology Policy and the National Institutes of Health are co-hosting a public workshop to discuss and solicit feedback from the community on the implementation of the institutional policy.  The workshop will take place at the NIH on July 22, 2015, and will include a series of panels where institutional representatives will share their experiences, challenges, and innovative practices in identifying research which is subject to the policy, developing risk mitigation plans, and raising awareness and educating about DURC.  The event will also feature an interactive case study that will highlight issues that investigators and institutions need to consider when determining whether research is subject to the policy.  This is a unique opportunity for the research community to provide feedback on the policy, and I hope stakeholders will take advantage of it and will come to share their thoughts.

I hope to see you on the 22nd!  In the meantime, you can contact staff in the NIH Office of Science Policy with questions about DURC by emailing DURC@od.nih.gov.

We’re all familiar with the analogy that policy development is akin to sausage making:  you don’t want to see how it’s made.  NIH takes a somewhat different approach in that we not only hope stakeholders will join us in the kitchen as policies are developed; we also seek out your suggestions for improving the recipe.

In Dec 2014, NIH posted the draft “Policy on the Use of Single Institutional Review Board (IRB) for Multisite Research” for public comment.  (You may recall Dr. Sally Rockey’s RockTalk post discussing the draft policy.) As a result, OSP received, reviewed, and analyzed 167 comments submitted by individuals, entities affiliated with academic institutions, patient advocacy groups, IRBs, private healthcare and research organizations, tribal nations, and the general public.  Public Comments on the Single IRB Policy are available on the OSP website.

While the vast majority of comments (~70%) support the use of a single IRB for multi-site research studies, commenters across all demographics also provided very thoughtful recommendations, questions, and concerns. These comments were broad in scope and expressed differing, often conflicting, opinions for NIH to consider.  Going back to the sausage-making analogy, if one commenter suggests that you double the amount of cayenne pepper and another one calls for it to be eliminated, you obviously can’t follow both suggestions but it’s clear that the “cayenne pepper issue” may warrant further discussion.

One such issue made clear by the comments received is the strikingly dissimilar understanding of the roles and responsibilities of the site or institution conducting human subjects’ research and the responsibilities of the reviewing IRB with regard to the protection of human subjects.  It’s important to keep in mind that through this draft Policy, NIH doesn’t suggest that the primary responsibility for the protection of human subjects may be relinquished by the local investigator or institution; rather, the policy attempts to streamline one component of human research protections, the IRB regulatory review.

While the regulations (at 45 CFR part 46.114 and 21 CFR part 46.114, for those policy wonks following along at home) have always allowed for reliance on an external IRB for multi-site research, recent support from the Office of Human Research Protections (OHRP) (2010 letter) and FDA (2006 guidance) have helped to reduce the fear of regulatory liability when relying on a single IRB.

Several groups including the National Cancer Institute Central IRB (CIRB), Clinical & Translational Science Awards (CTSA) program, and NeuroNext have laid a strong foundation and continue to develop an infrastructure that reduces redundancy and inefficiency in IRB review and approval of multisite research with the goal of bringing promising new treatments to patients more quickly. We look to build on this foundation and the lesson learned in order to address issues of trust and communication between sites/institutions and single IRBs that may be external to their organization.

Cognizant of the diversity of public opinion and logistical challenges involved in operationalizing the draft Policy, we are using the public comments to identify issues that may warrant additional guidance during a transition period after the Policy is effective prior to the required date of full compliance.

Thank you to all who shared your thoughts and perspective through the Public Comment process.  Your input is invaluable as NIH moves forward with this important policy – stay tuned as we continue to tweak the recipe…

The NIH Office of Science Policy (OSP) is part of the Office of the Director of NIH. Our primary purpose is to advise the NIH Director on biomedical research policy issues that are of significance to the agency, the research community, and the public, as well as to work with stakeholders within and outside of NIH to develop policies that promote progress in the life sciences. OSP is organized into three divisions – the Office of Biotechnology Activities, the Office of Clinical Research and Bioethics Policy, and the Office of Scientific Management and Reporting. Collectively, they represent a wide range of policy issues relevant to the mission of NIH. But, what does OSP do exactly? I’ve outlined a few of our key functions below:

Policy Development: OSP is frequently the incubator for policies that are ultimately implemented through the terms and conditions of grant awards funded by NIH. For example, NIH issued the NIH Genomic Data Sharing (GDS) Policy to facilitate data sharing while ensuring data are used in a way that respects the privacy and wishes of participants.  Research with genomic data increasingly demands resources that only cloud computing platforms can provide, OSP collaborated with cloud computing experts to develop appropriate best practices that support use of this technology.  The GDS Policy is part of a broader effort by NIH to increase access by researchers, clinicians, and the public to the results of NIH-funded research.

Other areas in which OSP plays a critical role in policy development include the protection of human research subjects, the conduct and reporting of clinical research and clinical trials, privacy and confidentiality in research, stem cells and regenerative medicine, biosecurity, biosafety, genetic testing, health services research, and sharing of and access to research results. Working closely with other agencies and the NIH Institutes and Centers, as well as the research community, OSP crafts the policies that facilitate research advancement and responsible conduct of research.

Review of Emerging Technologies: In some instances, OSP is directly involved in creating the policies related to oversight and review of research involving cutting edge or novel biotechnologies. An example is the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, which have become a national biosafety standard and have been used as a model for the development of biosafety standards in many other countries. In fact, this year is the 40th anniversary of the Asilomar conference at which the NIH system of oversight of recombinant DNA research was established.  OSP also oversees the activities of the National Science Advisory Board for Biosecurity (NSABB) which provides advice to the U.S Government on biosecurity matters.  In addition, OSP staff play a vital role in the USG’s implementation of the new United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern.

On an ongoing basis, OSP considers whether an emerging field of science, such as embryonic stem cells, genome editing, or gene drives might need new policies to facilitate progress or address bioethical or safety concerns. This might take the form of a workshop to consider the state of the science – such as a recent examination of genomic editing technologies – or the sponsorship of a National Academies study or the creation and implementation of guidance, like the NIH Guidelines for Human Stem Cell Research.

Measuring the Outputs of Research Investment: Connecting the line between research advances and health outcomes is not easy.  Research results may take years to implement into public health practice, and one vein of research may have implications for many different aspects of health.  In addition, as the largest biomedical research agency in the U.S., it is important to ensure that our federal partners, Congress, and the public are aware of NIH’s myriad research activities.  OSP works across NIH to report on the full range of NIH’s activities, coordinate NIH’s interactions with its many important partners and to analyze NIH’s contributions to the improved health of the nation.

But wait, there’s more… As you can see from this snapshot, we tackle a diverse topics of high importance, not only to the scientific community, but to society at large. Truthfully, the activities of OSP are too numerous to capture in a single blog post – it’s an exciting place to be a part of!

In the coming months I will be sharing more information with you about some of the key initiatives of the Office of Science Policy and how our programs contribute to the mission of the NIH as well as the broader goals of promoting scientific research and using the discoveries to improve public health.  In the meantime you can find additional details about our office on the web at http://osp.od.nih.gov/.  We invite you to contact us at any time!