Improvements to Inclusion Data Reporting and Management

May 31, 2014

A new system for reporting and managing your clinical research inclusion data is on its way. Currently, grantees report on sex/gender, race, and ethnicity information as required by NIH’s policy on the Inclusion of Women and Minorities in Clinical Research, ….

Is it True That There are Special Requirements for Addressing FCOI in Clinical Research?

May 30, 2014

Yes. In any case in which HHS determines that an NIH-funded clinical research project’s purpose is evaluating the safety or effectiveness of a drug, medical device, or treatment, and that intervention has been designed, conducted, or reported by an investigator with a conflicting interest that was not managed or reported by the grantee organization as … Continue reading “Is it True That There are Special Requirements for Addressing FCOI in Clinical Research?”

Who Do the Revised 2011 Financial Conflict of Interest (FCOI) Regulations Apply To?

May 30, 2014

As described in the 2011 revision, FCOI regulations apply to each institution applying for or receiving NIH grant or cooperative agreement funding, and to investigators who are planning to participate or are participating in NIH-supported research. However, this regulation does not apply to Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) Phase I applicants and recipients.

It’s important to remember that the regulatory definition of “investigator” is not limited to ….

July 4, 2014: NIH Closed for Federal Holiday

May 30, 2014

NIH (including help desks) will be closed Friday, July 4, 2014 (Independence Day). If a postmark/submission date falls on this federal holiday, the application deadline is automatically extended to the next business day.

New Efforts to Maximize Fairness in NIH Peer Review

May 29, 2014

We want you to know NIH is working on multiple fronts to get to the bottom of unexplained racial disparities in R01 grant funding and to maximize fairness in NIH peer review. Since the problems and the solutions are bigger than NIH, we have reached out to the scientific community and other concerned citizens for help. Now armed with a team of experts and a set of new initiatives, we’d like to tell you about our efforts to address this important issues –- particularly an exciting opportunity for you to submit your input. ….

Changes to the Biosketch

May 22, 2014

We’re set for a major change in how you portray your body of work when applying for NIH funds. With strong support from NIH leadership, we will be rolling out a new biosketch format. The new NIH biosketch emphasizes your accomplishments instead of just a list of publications, which, as previously discussed, we questioned as the best way to showcase your scientific contributions. ….

More on Addressing Sex Differences in Pre-clinical Studies

May 16, 2014

You likely saw the recent Nature policy article, in which NIH Director Francis Collins and NIH Office of Research on Women’s Health Director Janine Clayton discussed ways that NIH is addressing sex differences in research. As our understanding of science evolves, so do our policies that govern research. This commentary cites several studies that highlight the need to further consider sex differences in preclinical research and describes how NIH will enact new policies to expand the consideration of sex differences in research studies using animal models and cells. The article generated quite a buzz in the community, and I wanted to take this opportunity to explain the roll out of our implementation plan. ….