Month: June 2015

In the OSP Kitchen – Single IRB for Multisite Research Policy

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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…

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Burden of Disease and NIH Funding Priorities

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Co-Authored by Carrie Wolinetz and Sally Rockey

Recently, many voices have asked how NIH considers public health needs when setting funding priorities. The quick answer is that public health needs are a critical factor in our decision making-in addition to scientific merit, portfolio balance, and budgetary considerations. But the question of how one measures public health need, as it turns out, isn’t as simple as you might think.

Public health needs are not only reflected by how many people have a particular disease, but also by the burden of disease – the impact of a health condition as measured by mortality, morbidity, financial cost, and other indicators. Different diseases can impose vastly different kinds of burdens. Some diseases may cause premature death, while other chronic conditions may cause long-term disability and impose a great emotional and monetary toll for patients, family members, and society. Many diseases vary widely in the severity of symptoms, the acute vs. chronic nature of the disorder, treatment strategies, and health outcomes. A thousand people with influenza, for example, is not equivalent to a thousand people with headaches. To further complicate matters, identifying affected individuals can be challenging; diagnosing certain psychiatric disorders is far different than diagnosing diabetes. Current disease burden may not necessarily predict future disease burden. Consider the potential burden that the recent Ebola epidemic may have created had it not been contained. And finally, NIH will invest in research on certain diseases that are close to a cure, to propel us towards the ultimate goal of eradication.

Clearly, there can be no “one size fits all” approach to measuring and comparing the burden across different diseases. Nevertheless, we wanted to look at a few possibilities for depicting the relationship between disease burden and NIH funding. Thus, NIH’s Office of Extramural Research and Office of Science Policy collaborated on an exploratory analysis, which you can see on our new burden of disease page on RePORT. This page illustrates how NIH funding levels relate to U.S. and global deaths and disability-adjusted life years (DALYs)—a measure that quantifies the number of healthy years of life lost due to morbidity or premature mortality caused by disease. This analysis comes with several caveats, however, and more information can be found via the methodology link on the disease burden page.

We think you’ll find these data and we hope this analysis contributes to the conversation of advancing public health through scientific research. That being said, disease burden can’t be the only factor in setting funding priorities. NIH is also committed to funding research into rare diseases, which affect a smaller component of the population, thus skewing burden measures. Much of the NIH portfolio involves basic research, which seeks to understand the basic biological processes involved in both health and disease. Basic research doesn’t neatly map onto the burden of a single disease or condition, especially for areas such as genetics or pediatrics. Many of the projects from NIH’s basic research portfolio produce findings that can have implications for the cause and treatment of a variety of diseases, and can be applied across several fields.

As NIH sets its priorities, it’s important that we monitor the public health landscape for unmet needs and emerging challenges, so that the research we support translates into meaningful health benefits. Scientific disciplines mature at different rates, and not all areas are equally ripe for major scientific progress. For example, advances in imaging technologies and tools for mapping connections between neurons now allow us to study the brain and the diseases that affect it in a way that would not have been possible a decade ago. Investing the same amount of money into two different areas can generate very different returns for increasing scientific knowledge and advancing human health. Getting the most out of NIH’s research investment means making smart investments, which come from a deep understanding of the scientific landscape. So while we’re looking forward to using these analyses as a jumping off point for a larger conversation about priority setting, NIH believes that a process that includes multiple measurements of public health needs, but is also informed by scientific opportunity, allows us to fund the best science.

Dr. Sally Rockey is the NIH Deputy Director for Extramural Research and blogs about NIH research funding policies and data at her blog, Rock Talk.

Sally Rockey
NIH Deputy Director for Extramural Research
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Everything You Wanted to Know About OSP (But were afraid to ask…)

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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!

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