Tag Archives: Clinical Research

FASEB Supports Draft NIH Policy to Streamline Multi-Site Clinical Trials

A draft policy released by the National Institutes of Health (NIH) on December 3, 2014 signifies a positive step towards streamlining the clinical trial process. The Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research promotes the use of a single IRB of record for domestic sites of multi-site… Read More »

FASEB Provides Feedback on Informed Consent Considerations for Comparative Effectiveness Research

By Anne Deschamps The Federation of American Societies for Experimental Biology (FASEB) recently submitted comments on the Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care published by the Office for Human Research Protections (OHRP) in response to the 2013 OHRP compliance oversight investigation into the Surfactant, Positive Pressure, and Oxygenation… Read More »

HHS and NIH Propose to Expand and Enforce Data Reporting Through ClinicalTrials.gov

By Yvette Seger Citing data revealing that 30 percent of a sample of 400 clinical trials had not published or deposited results in the ClinicalTrials.gov database, the National Institutes of Health (NIH) and the U.S. Department of Health and Human Services (HHS) issued separate notices on November 19 announcing plans to enforce the sharing and… Read More »

NIH Requests Comments on Draft Policy for Using Single Institutional Review Board for Multi-Site Clinical Research Activities

By Yvette Seger Seeking “to enhance and streamline the process of Institutional Review Board (IRB) review and reduce inefficiencies so that research can proceed without compromising ethical principles and protections,” the National Institutes of Health (NIH) released a draft policy to promote the use of single IRB review for multi-site clinical research. In the request… Read More »

FDA to Host Workshop on Proposed Framework for Oversight of Laboratory Developed Tests

By Yvette Seger Earlier this fall, the Food and Drug Administration (FDA) released a proposed framework for regulatory oversight of laboratory developed tests (LDTs), a category of in vitro diagnostic devices intended for clinical use and designed, manufactured, and used within a single laboratory. Intended to reflect the changing landscape for the development and clinical… Read More »

Office for Human Research Protections Issues Draft Guidance on Disclosing Risks in Standard of Care Research

By Yvette Seger On October 24, the Office for Human Research Protections (OHRP) within the Department of Health and Human Services (HHS) released Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care for comment. It resulted from discussions in the research community related to the 2013 OHRP compliance oversight investigation of the… Read More »

FASEB Comments on Proposed NIH Policy to Balance Sex in Animal and Cell Studies

By Anne Deschamps The Federation of American Society for Experimental Biology (FASEB) has submitted comments to the National Institutes of Health (NIH) on a pending policy to balance sex in preclinical research. FASEB called for NIH to provide clear guidelines for the review of research proposals, to be transparent regarding the types of research eligible… Read More »