Oct 16th, 2018 January 2019

NIH – Open During Gov’t Shutdown Both NIH and Grants.gov remain operational during the current partial federal government shutdown. NIH will continue to issue Notices of Award. Since NIH has an appropriation, payments are being made to grantees. www.nih.gov/all/2019/01/07/nih-operational-during-partial-federal-government-shutdown/

[Footer] NIH - Implementation of the Final Rule on the Federal Policy for the Protection of Human Subjects (Common Rule) The effective date for the amended regulation is January 21, 2019. It applies to studies initiated on or after this date, and ongoing studies that voluntarily transitioned to the Revised Common Rule. Key changes that may impact NIH studies include the following: NIH will no longer require Institutional Review Boards (IRBs) to review entire grant applications and contract proposals related to research. The IRB must continue to review and approve the research protocol for all NIH-supported non-exempt human subjects research studies;

[Footer] NIH will require clinical trial informed consent documents to be posted on a public federal government website; NIH will no longer require annual IRB reviews for certain categories of research; NIH is implementing changes to exemption codes. Applicants should take note of changes to categories of research qualifying for exemption and take care to select the appropriate category. www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index

NIH – New PI Resubmissions NIH will no longer offer a special deadline for new investigator resubmission applications. This change goes into effect starting with R01 applications submitted for due dates on or after January 25, 2019. Since 2007 NIH had provided new investigators the option of submitting R01 A1 resubmission applications for consecutive review cycles (“next round resubmission”) thinking it would enable new investigators to potentially resubmit applications more rapidly. It didn’t. www.grants.nih.gov/grants/guide/notice-files/NOT-OD-19-053

NIH – eRA Commons RPPR Changes What’s Changed? There is now a two-step submission process for inclusion enrollment data updates made during the RPPR process – one submission via ASSIST for the inclusion data and a separate submission for the full RPPR file. Investigators will enter their inclusion enrollment updates via ASSIST in the Human Subjects and Clinical Trial form. When completed, they need to update the ASSIST file status to “Ready for Submission” and route to their Signing Official for submission prior to the submission of their full RPPR. 2) Once the SO then submits the updated HSCT form, the RPPR can be completed and submitted as usual. Who’s Affected? All principal investigators submitting RPPR files with 2018 inclusion enrollment updates submitted since the June 9, 2018 launch of the Human Subjects System (HSS).

NIH – Anti-Discrimination Letter & NRSA Fellowship Changes [Footer] NIH – Anti-Discrimination Letter & NRSA Fellowship Changes Beginning for applications submitted for due dates on or after January 25, 2019, institutional training grant applications (T15, T32, T34, T35, T36, T37, T90/R90, TL1, TL4) must include a letter that describes the institutional commitment to ensuring that proper policies, procedures, and oversight are in place to prevent discriminatory harassment and other discriminatory practices. This letter should be included with other Letters of Support on the PHS 398 Research Training Program Plan form. www.nexus.od.nih.gov/all/2018/11/09/new-application-requirements-for-institutional-training- grants-letter-of-institutional-commitment-to-harassment-and-discrimination-protections/ Kirschstein National Research Service Award (NRSA) stipend levels, tuition/fees, and training related expenses have been increased for 2019. www.grants.nih.gov/grants/guide/notice-files/NOT-OD-19-036

NSF – Closed During Gov’t Shutdown [Footer] NSF – Closed During Gov’t Shutdown No new NFAs are being issued but proposals are being accepted pursuant to existing deadlines. FastLane, Grants.gov, and Research.gov are available, but proposals will not be processed until operations resume. No new grants, cooperative agreements, or Continuing Grant Increments (CGIs) will be awarded. No payments will be made during a lapse in appropriations. Responses to any inquires are deferred until shutdown is over. Principal Investigators (PIs) will be able to submit annual and final project reports and Project Outcomes Reports via Research.gov. NASA, NOAA, USDA, NIST, and NEH are also closed. www.nsf.gov/shutdown/grantees