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Top Policy Changes

Newest entries appear at the top of the list. For other NIH Guide policy notices, see Special Announcements.

Improvement of Reproducibility and Inclusion of Sex as Biological Variable in Applications and Progress Reports, June 23, 2015

Beginning with applications due January 25, 2016, PIs will have to demonstrate strong scientific premise, rigorous experimental design, and consideration of sex and other biological variables in the Research Strategy section of their applications. Reviewers will factor this information into their overall impact scores.

PIs will also have to include an attachment in the Other Research Plan sections to authenticate their key resources. Reviewers will not factor this information into their overall impact scores.

Further, PIs will report on sex differences in their progress reports and publications.

For more information and links to resources that explain NIH's intent and expectations, read the June 9, 2015 Guide notices:

NIH will provide instructions for applicants and reviewers later this year.

Applicant Responsibilities to Maintain Integrity of NIH Peer Review, June 23, 2015

NIH expects all participants in the application process to respect and protect the integrity of peer review. This includes investigators and officials from institutions applying for NIH support and other people named in an application.

Therefore, effective immediately, those application participants:

  • Should not contact reviewers on the study sections evaluating their applications for information about the review or attempt to influence the review outcome. Instead, they should contact the scientific review officer (SRO) for review information.
  • Should not send information directly to reviewers on the study sections evaluating their applications. Instead, they should follow the post-submission materials instructions outlined in the July 23, 2010 Guide notice and related notices.
  • Should not attempt to access information related to the review in secure NIH computer systems.

That said, NIH staff understand that application participants and reviewers often continue professional interactions while an application is under review.

Application participants should notify their SROs if reviewers contact them about reviews or applications.

For more information, including possible consequences for violating these rules, see the June 18, 2015 Guide notice.

NIH Approves Cloud Storage and Analysis for Genomic Data, April 14, 2015

Investigators and institutions may use cloud-based services to store and process data from NIH-designated repositories that fall under the auspices of NIH's Genomic Data Sharing (GDS) policy.

When requesting data from a repository, they need to identify their service provider and describe how they plan to use the service.

Institutions assume responsibility for any misuse or security breach. For details, read the March 27, 2015 Guide notice.

NIH’s Dual Use Research of Concern (DURC) Expectations for Institutions, January 26, 2015

Institutions have until September 24, 2015, to establish the necessary infrastructure to come into compliance with the federal Policy on Dual Use Research of Concern (DURC), including establishing a standing Institutional Review Entity (IRE).

Starting on that date, an IRE must assess research conducted by the institution, identify DURC as described in the Policy, and assess the benefits and risks.

If an IRE determines that NIH-funded research has DURC potential, the institution must notify the grants management official or contracting officer listed on the award within 30 days. Additionally, institutions and investigators will work with NIH to develop an appropriate risk mitigation plan to guide the conduct and communication of research determined to be DURC.

For more information on how this policy applies to grants and cooperative agreements specifically, see the November 21, 2014 Guide notice.

NIH Simplifies Policy for Late Application Submission, January 15, 2015

Under a new simplified policy for late application submission, NIH will consider accepting a late application within a two-week window of the application due date if there is a valid reason. Now, request for applications and program announcements (PAR) with special due dates will also have this two-week window, with a few exceptions.

NIH does not give permission in advance for a late submission, but if a principal investigator has a valid reason, he or she should provide an explanation in the cover letter submitted with the late application.

This new policy is effective for due dates on or after January 25, 2015. The policy will not be applied retroactively.

For more information, including reasons for why late applications might or might not be accepted, read the December 17, 2014 Guide notice and the January 8, 2015, NIAID Funding News article “New Policy on Late Applications.”

Policy on Shared Animal Welfare Concerns, December 4, 2014

Institutions that report serious adverse events to NIH's Office of Laboratory Animal Welfare (OLAW) may receive a citation from USDA's Animal Care (AC), with whom OLAW shares concerns and issues that are of interest to both agencies.

AC cites the facility depending on whether a reported incident meets or does not meet any of four criteria, e.g., it did not cause serious adverse effects.

For full details, read the December 1, 2014, Guide notice.

New Biographical Sketch Format, December 1, 2014

NIH announced a new biosketch format and instructions, posted at SF 424 (R&R) Forms and Applications. The new format is required for due dates on or after May 25, 2015. Applicants can start using the new format now.

The new format extends the page limit from four to five pages. It allows researchers to describe up to five of their most significant contributions to science, along with the historical background that framed their research. Investigators can outline the central findings of prior work and the influence of those findings.

For more information, see the December 5, 2014 Guide notice and the December 17, 2014, Funding News article "New Format for Biographical Sketches."

Funding Pause for Gain-of-Function Research on Influenza, SARS, and MERS, November 24, 2014

NIH will not release new funding for gain-of-function research on influenza, SARS, and MERS viruses that could be reasonably anticipated to increase the pathogenicity or transmissibility in mammals by the respiratory route. NIH made this decision in accordance with the White House announcement Doing Diligence to Assess the Risks and Benefits of Life Sciences Gain-of-Function Research.

NIH encourages grantees already working on gain-of-function research, which could be subject to the terms of the announcement, to voluntarily pause their research.

During the pause, the government will reassess the risks and benefits of such research and develop a new policy for it.

For more information, read the following:

NIH Issues Genomic Data Sharing Policy, September 18, 2014

Investigators and grantee institutions will soon have new requirements for research that will generate large-scale genomic data or use genomic data for secondary studies.

These new requirements go into effect starting with competing applications due January 25, 2015, or later. Training and fellowship applications are excluded from this policy.

Read the August 27, 2014 Guide notices:

Visit NIH's Genomic Data Sharing site for more details, guidance, sample documents, and related resources.

Last Updated August 24, 2015

Last Reviewed August 24, 2015