Regulation changes, new grant tools and including sex in research

New regulations and guidelines have been proposed for e-cigarettes, IACUCs and the inclusion of sex as a variable in research. NIH is developing a new grant-searching tool and hosting grant-writing webinars.

By Kelly Dunn, PhD

E-cigarette Regulation

Currently, e-cigarettes do not fall under the jurisdiction that was granted to the U.S. Food and Drug Administration (FDA) by the Family Smoking Prevention and Tobacco Control Act (2009), which permitted the FDA to regulate the sale of cigarettes and smokeless tobacco but did not broaden the FDA's purview to include all nicotine-based products. The FDA has proposed an amendment that would expand the scope of the Tobacco Control Act to include all tobacco-based products, including cigars and electronic cigarettes (e-cigarettes) and has scheduled a public workshop titled “E-Cigarettes and the Public Health” on Dec. 10-11 to collect information from scientific and medical experts, as well as other stakeholders, regarding the impact of regulating e-cigarettes under the Tobacco Control Act. On Aug. 8, the APA joined 23 other groups to urge the FDA to officially regulate e-cigarettes as tobacco products. E-cigarettes are already under similar regulation in Europe.

New Website To Search for Federally Funded Grants

The National Institutes of Health (NIH) is developing a website that will enable you to search for research grants that are supported by both NIH and other federal agencies (including the Environmental Protection Agency, National Aeronautics and Space Administration, the National Science Foundation, the Department of Veteran's Affairs, etc.). The website looks similar to the NIH Reporter website that is currently used to search for NIH-funded projects. It is titled the Federal RePORTER and though it is still being tested, it is available now online for early use. The website will add several new features beyond those available with NIH Reporter, including graphical visualizations of search results (such as plotting results on a map of the U.S.) and the ability to download images and summaries into Powerpoint and Excel. These features support a major goal of the project, which is to provide a method for demonstrating the national and global value of federally-funded research.

Proposal to Make Sex a New Biological Requirement in Research

The NIH has been soliciting opinions from researchers and other stakeholders regarding a new potential requirement to consider sex as a biological variable in the design and analysis of NIH-funded research involving animals and cells. This was outlined in a Nature commentary. Requests for comments closed on Oct. 24, 2014, so expect the results and a final decision to be forthcoming.

Changes to IACUC Regulations

On Aug. 26, 2014, the NIH issued significant changes regarding the use of animals in research, specifically related to Institutional Animal Care and Use Committees (IACUC's) regulations. See a summary of the changes.

NIH to Provide Grant-Writing Webinars

NIH will be hosting free webinars to support grant development. The webinars will be presented by experts from the Center for Scientific Review and will cover 4 different kinds of grant mechanisms (Fellowship Awards, R01's, R15's, Small Business Grants). The webinars began on Nov. 4, 2014; see more details and instructions for registration.