Society Hosts Key Diabetes Stakeholders, Senator Daschle to Discuss 2015 Outlook
On December 4, Endocrine Society hosted a meeting of the Diabetes Advocacy Alliance (DAA) to discuss recent legislative and regulatory advances in diabetes and how to achieve greater success through our collective work. Former Senate Majority Leader, Tom Daschle (pictured), provided a unique perspective at this meeting on opportunities to affect change in the 114th Congress, remarking that Democrats and Republicans will likely be further polarized but that there are several potential areas for bipartisanship. Th ese issues include the repeal of the flawed sustainable growth rate formula, reimbursement for telehealth, and extending coverage of the National Diabetes Prevention Program to the Medicare population. The Society looks forward to continuing to advocate on behalf of these important issues and in working with the DAA to affect change together.
Draft NIH Policy Promotes Use of Single IRB for Multi-Site Studies
On December 3, the National Institutes of Health (NIH) announced a draft policy for the “Use of a Single Institutional Review Board (IRB) for Multi-Site Research.” The new policy establishes the expectation that multi-site NIH-funded domestic studies will make use of a single IRB of record, rather than multiple local IRBs. Comments on the proposed policy will be collected by the NIH until January 29, 2015.
The Endocrine Society has consistently advocated for the use of single IRBs for multi-site studies in an effort to increase efficiencies while maintaining high standards for the protection of human research subjects. The Society is enthusiastic about the proposed policy and will develop comments to ensure that the final policy remains broadly consistent with the Endocrine Society’s position statement on Central Institutional Review Boards. To ensure that the Society captures your perspective on the policy, we encourage interested members to submit their comments to Joseph Laakso, associate director for Science Policy at [email protected] by January 22.
— Joe Laakso is associate director, Science Policy, for the Endocrine Society. For more information, go to: www.nih.gov/about/reporting-preclinical-research.htm.
Alarmed that the results of nearly a third of its funded clinical trials go unreported, the National Institutes of Health (NIH) has proposed new policies and requirements for the registration of NIH-funded clinical trials and subsequent reporting of clinical trial data on the clinicaltrials.gov website.
The new policy would require that all NIH-funded awardees conducting clinical trials are expected to ensure that their NIH-funded clinical trials are registered and summary results, including adverse event information, are submitted to ClinicalTrials.gov in accord with the timelines that will be set forth at ClinicalTrials.gov. Investigators who fail to comply with the new rule may face strict enforcement actions, including loss of funds or grant termination as appropriate.
The Endocrine Society supports the goal of ensuring that data from clinical trials achieve the maximum benefit to society while minimizing administrative burdens on researchers. The Society will provide feedback to the NIH on the proposed rule and continue to keep members informed as the new policies are implemented. For more information on the new regulations and opportunities to comment, please see the Clinical Trials Registration and Results Submission docket at regulations.gov. If you have any thoughts or concerns regarding the new policy that the Endocrine Society should include in formal comments, please send your input to Joseph Laakso, associate director for Science Policy at [email protected].
Congress Passes Funding Bill;
NIH Receives $150 Million Increase
During an unusual weekend session, on December 13 the U.S. Senate finally passed a government funding bill for the remainder of the 2015 fiscal year passed earlier by the House of Representatives. High drama ensued in the Capitol as a small group of conservatives tried to block debate on the bill by raising concerns with President Obama’s immigration policy, forcing a marathon weekend session. Ultimately, the bill passed included mostly fl at funding for most health agencies, however, the National Institutes of Health (NIH) received an increase of $150 million as a result of the increased advocacy from the research community. Th e Society thanks all members who contacted Congress; your voice was heard. A complete analysis of the legislation is available on endocrine.org. Below are highlights of importance to the Society:
National Institutes of Health (NIH) —
The bill provides $30.3 billion, an increase of $150 million in base funding and $238 million in Ebola-related research.
National Diabetes Prevention Program (NDPP) —
The bill provides support for the NDPP that encourages collaboration among federal agencies, communitybased organizations, employers, insurers, healthcare professionals, academia, and other stakeholders to prevent or delay the onset of type 2 diabetes among people in the United States.
Clinical Trials —
The agreement expects the NIH to review its policies and to make changes to ensure appropriate minority participation in clinical trials.
Commitment to New and Early-Stage Investigators —
The NIH is directed to develop a new approach with actionable steps to reduce the average age at which an investigator first obtains R01 funding. Further, the agreement requests the NIH review the grant success rates for early-stage investigators in their first two grant submissions to consider whether the grant applications submitted by all early-stage investigators should compete against other early-stage investigators instead of all submissions.
Women’s Health Research —
The agreement supports the NIH’s recent shift toward achieving balance between females and males in preclinical research and encourages the NIH to ensure this applies to experimental models used for basic science research and that both males and females are used to investigate diseases that affect men and women. It is recommended that the NIH expand its current policies to require NIH-funded investigators to prominently indicate the sex of their experimental model in their grant application and progress reports. Further, those investigators should be required to report, and when appropriate, analyze their data by sex as part of the grant progress reporting and in all published results derived from NIH funding. The NIH is encouraged to require investigators to use valid experimental design, including consideration of sex, as a biological variable in relevant research on animals, cells, and human subjects. The agreement also states that grant proposals that include adequate numbers of women and men be given priority in funding decisions, when appropriate.
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