A Proposed HHS Regulation and NIH Policy to Further the Impact of Clinical Trials Research

November 19, 2014

Clinical trials play a vital role in transforming scientific research into medical interventions to improve human health. Transparency about the clinical trials underway and their subsequent results ensure potential participants can make informed decisions about potential trial participation and know how their participation may have helped others. …. Today, the Department of Health and Human Services (HHS) announced proposed regulations to implement the clinical trial reporting requirements established by the Food and Drug Administration Amendments Act (FDAAA) of 2007. …. Importantly, today NIH also announced a proposal to apply these same proposed requirements to all NIH-funded clinical trials, whether subject to FDAAA or not. The proposed policy would require that every NIH-funded clinical trial be registered ….

Better Research Trainee Data through Streamlined Reporting Processes

November 17, 2014

Training of the next generation of biomedical scientists is a core responsibility of NIH and its partner grantee institutions.The NIH Advisory Council to the Director‘s Biomedical Research Workforce Working Group recommended that NIH should “develop a simple and comprehensive tracking system for trainees” as part of the broader challenge of gathering better biomedical workforce data. Unambiguous identification of NIH trainees was an absolutely critical first step in establishing the ability to examine contributing factors that lead to various post-training careers. Accordingly we started collecting information in this way by requiring that all post-doctorates and all graduate and undergraduate students listed in a grantee’s progress report have an eRA Commons ID (as of 2009 and 2013, respectively). The next important step is developing a system to automate the capture of trainee data that has long been provided by extramural institutions in their training grant applications. ….

Due Date Accommodations for Investigators Responding to the West Africa Ebola Outbreak

October 31, 2014

The Ebola outbreak in West Africa is the largest Ebola outbreak in history. NIH appreciates the humanitarian assistance being provided by NIH-supported program directors and principal investigators who travel to West Africa to participate in emergency response activities. As described in NIH Guide Notice NOT-OD-15-010, we have made accommodations to provide additional time for application submission and grant-related reporting for these investigators. ….

New System for Reporting Inclusion Data Is Live

October 30, 2014

NIH’s new system for reporting and managing your inclusion data is now here. The Inclusion Management System allows grantees to use the eRA Commons to report sex/gender, race, and ethnicity information as required by NIH’s policy on the Inclusion of Women and Minorities in Clinical Research. ….

Retention Rates for First-Time R01 Awardees

October 28, 2014

We have seen increased interest in the biomedical workforce by Congress and especially by our community. From our end we’ve in particular observed heightened attention to how the dynamics of the workforce impact researchers in the early stages of their careers. So the topic definitely deserves our continued attention and I thought in light of this it’d be a good time to share some of NIH’s analyses on one specific aspect of this that my office has been closely examining. ….

A Pause in Funding Certain Types of Gain-of-Function Research

October 17, 2014

The White House announced today that U.S. government agencies will institute a pause in the funding of new “gain-of-function” research on influenza, SARS, and MERS viruses that could increase the pathogenicity or transmissibility to mammals …. During this funding pause, the government will carry out a deliberative process to assess the risks and benefits of such studies and will develop a new Federal policy regarding the funding of this research. ….

Defining the Dual Role of Graduate Students and Postdocs Supported by Research Grants

October 10, 2014

Back in 2012 I blogged about what kinds of activities are allowable as part of the official duties of postdoctoral fellows supported by NIH research grants. At the time, NIH received a number of inquiries asking us if certain activities such as participating in seminars, attending meetings, or engaging in other activities designed to expand … Continue reading “Defining the Dual Role of Graduate Students and Postdocs Supported by Research Grants”