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Research INKlings

October 2011


Final Rule on Financial Conflict of Interest Regulations NIH is committed to preserving the public’s trust that the research supported is conducted without bias and with the highest scientific and ethical standards. The agency believes that strengthening the existing regulations on managing financial conflicts of interest is key to assuring the public that NIH and the institutions we support are taking a rigorous approach to managing the essential relationships between the government, federally funded research institutions and the private sector. Health and Human Services (HHS) has issued a final rule in the Federal Register that amends the Public Health Service (PHS) regulations on Responsibility

of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought and Responsible Prospective Contractors. NIH Guide Notice – This publication announces the Final Rule on Financial Conflict of Interest Regulations Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought and Responsible Prospective Contractors.

Summary slides that describe the major changes to the 1995 regulations on Financial Conflict of Interest (FCOI) - Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding is Sought. Summary of Major Changes - Table summarizing major changes between the 1995 regulation and the 2011 regulation.

Summary Slide Set for the revised 2011 FCOI Regulation -

NIH stroke prevention trial has immediate implications for clinical practice Dr. Marc Chimowitz, Neuroscience Endowed Chair, stroke prevention trial results was published in the online first edition of the New England Journal of Medicine. This nationwide clinical trial has shown that patients at a high risk for a second stroke who received intensive medical treatment had fewer strokes and deaths than patients who received a brain stent in addition to the medical treatment. SAMMPRIS is the first stroke prevention trial to compare intracranial stenting with medical therapy and to incorporate intensive medical management into the study design. Read the full NIH Press Release.

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Geriatrics and Clinical Gerontology Policies: Regarding Investigator-Initiated Applications for Large Clinical Trials Investigators considering submitting applications for clinical trials for which support through NIA’s Division of Geriatrics and Clinical Gerontology (DGCG) is desired, and whose direct costs to NIA would exceed $2 million in any project year, are asked (but are not required) to send a brief concept proposal, describing the rationale for the trial and its aims, design, and costs to DGCG staff designated at the end of this Notice. These procedures for submitting R34 applications for potential investigator-initiated trials, are described in detail on NIA’s Clinical Research Study Investigator Toolbox. More detailed information related to this policy is available from the NIH NOT-AG-11-009.

NIAID Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases (RCE) Program Webinar The National Institute of Allergy and Infectious Diseases (NIAID) will hold a public information session (Town Hall meeting) and Webinar on November 1, 2011 in Bethesda, MD at 9:00 AM Eastern Time to discuss future plans for the NIAID Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases (RCE) Program. NIAID program staff will describe current RCE research activities and accomplishments, outline preliminary plans for the evolution of the Program, and gather feedback from the research community regarding future directions. More information will be posted on the NIAID website regarding the webinar soon.

MUSC Clinical Data Warehouse for Research The Medical University announces the initial rollout of the Clinical Data Warehouse (CDW) for research, providing University faculty investigators an efficient mechanism to request and receive both de-identified and Institutional Review Board (IRB) approved clinical data to enhance research productivity. The CDW contains secure electronic clinical data from the OACIS Clinical Data Repository, including patient demographics, ICD-coded diagnoses and procedures, laboratory test results, and for inpatient admissions, nursing documentation and medications ordered and administered. The CDW will continue to evolve as we receive feedback and consider ongoing programmatic improvements.

The CDW, as part of the larger Enterprise-wide Data Warehouse (EDW), was developed in partnership with the Office of the Associate Provost for Research, the Office of the Chief Information Officer (OCIO), the South Carolina Clinical and Translational Research Institute (SCTR), and the Medical University Hospital Authority (MUHA). Dr. Jihad Obeid, Associate Director of the SCTR Biomedical Informatics Program, is the Principal Investigator on the IRB protocol that permits its use for research as described on the CDW website. This project was supported in part by SCTR with Clinical and Translational Science Award (CTSA) funding, NIH/NCRR Grant number UL1 RR029882, as well as the Medical University Hospital Authority, and the Office of the Chief Information Officer.

SCTR Announcements Biomedical Imaging — 2011 SCTR Fall Scientific Retreat Research in Autism Spectrum Disorders - 2011 SCTR Fall Scientific Meeting

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Revised Multiple Program Director(s)/Principal Investigator(s) After several years of experience with the multiple-PD/PI model, NIH has determined that there are legitimate circumstances under which it would be in the best interest of an active project to change either from a multiplePD/PI model to a single-PD/PI model, or from a single-PD/PI model to a multiple-PD/PI model, and that peer review of the new leadership team and Leadership Plan may not be essential in these cases. This Notice (NOT-OD-11-118) amends the NIH policy to allow post award PD/PI changes with the prior approval of the Grants Management Officer (GMO). It is anticipated that such requests will be rare. Requested changes must be accompanied by a

strong scientific justification related to the funded project. Prior Approval Requirements are described in the NIH Grants Policy Statement under Section 8.1.2. Changes may not be implemented by the grantee without the approval of the GMO and the receipt of a revised Notice of Award acknowledging the change.

NIH as part of the prior approval request.

A grantee may only convert a single PD/PI award to a multiplePD/PI award if the Funding Opportunity Announcement (FOA) explicitly allowed multiplePD/PIs to be proposed at the time of the competing application. All listed PD/PIs must be registered in eRA Commons with a PD/PI Role; and the Commons User Name must be provided to the

Should anyone have questions concerning any of this information, please contact your assigned Grants Administrator in ORSP, or call 792-3838 for assistance.

Note that adding a PD/PI prior to initial peer review is allowed in limited circumstances as detailed in the NIH Policy on Post-Submission Application Materials (NOT-OD10-115). The multiple-PD/PI web page and FAQs are updated to reflect this revised policy.