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Federal Agency Updates

General Federal Agency Updates

JHU Update on NIH policy on Foreign Involvement: January 17, 2019

NIH has recently provided clarification of their foreign collaboration policies as follows:

I. Foreign Other Support must be disclosed to NIH in advance, by including it in the Just‐in‐Time Other Support submission on a new or renewal award, or updated in the annual RPPR, or submitted by letter to the awarding office and thereafter included in the RPPR.  For example, “Visiting scientist, name, degree, role on project, supported by institution, country, for the period of __/__/____ to __/__/____. “

II. Foreign Involvement, requiring NIH Prior Approval, only applies to NIH work scope performed in a foreign location, either funded by the NIH grant or by other sources, domestic or foreign.  Continued collaboration (e.g., research data generation, data analysis, etc.) by a foreign supported scientist or student, who had previously been visiting the grantee institution and reported as Other Support, upon their return to their foreign home institution, would require NIH prior approval for foreign involvement.

III. Foreign personal payments received by a funded investigator, including, stipends and honorariums, must be disclosed to JHU via eDisclose and evaluated by the institution for COI under the PHS regulations and JHU policies. Additionally, sponsored or reimbursed travel must be disclosed when the value received from a single foreign entity reaches or exceeds $5,000 during a twelve month period.


Changes in the NIH Management of Genomic Summary Results Access Policy (12/7/2018):

The NIH recently announced changes in the NIH Management of Genomic Summary Results Access Policy (available at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-023.html) , which will permit unrestricted download of genomic summary results data by third parties from the NIH Database of Genotypes and Phenotypes (“dbGaP”). Please note these changes apply to the sharing of summary results only and do not impact requirements for sharing of individual-level data.

For new NIH funded studies that will collect genomic data that is subject to the NIH Genomic Data Sharing Policies, all JHU Institutional Review Boards (“IRBs”) have developed new template language for informed consent documents to inform research participants about the further dissemination of genomic summary results data.  Investigators should make certain that they are using the most current template language for new or on-going studies subject to the data-sharing requirements.

For studies that have already deposited data into dbGaP, the NIH has acknowledged that this change in policy may heighten the privacy risks to subjects for studies that are particularly sensitive; including studies involving populations from isolated geographic areas, populations with rare traits, or populations with stigmatizing traits.  The NIH has given institutions until May 1, 2019, to designate, through the Institutional Certification process under dbGaP, whether any studies previously submitted will be designated as “sensitive” by the institution and which therefore should be maintained as controlled access only.  Johns Hopkins University IRBs have convened a small group of internal experts to develop a consistent rubric to review already deposited studies and will be communicating with impacted investigators directly about any further action required.  Investigators who have been contacted by their program officers, or who have questions about an existing study, may contact the relevant IRB office with questions about their particular study.


Revision of the NSF Award Terms and Conditions: Regarding NSF Notice 144 (10/21/2018):

On October 21, 2018, a new grant term will be incorporated into all new NSF awards, and into any funding amendments made to existing NSF grant awards.  This new grant term and condition is part of NSF’s efforts to ensure that research and training environments are free of sexual and other forms of harassment; a goal that Johns Hopkins University shares.  The new grant term requires any NSF funded institution to notify NSF, through a secure, confidential portal, of all final determinations by the institution that an NSF funded PI or co-PI has engaged in sexual harassment, or other forms of harassment in violation of federal law, and to notify NSF when certain administrative leaves or other administrative actions with respect to an NSF funded PI or co-PI are taken.  More information on the new grant term is available on the NSF website: https://www.nsf.gov/od/odi/harassment.jsp.


NIH single Institutional Review Board (IRB) requirement (1/25/2018):

Effective January 25, 2018 the NIH requires that all grant applications for domestic, multi-site, non-exempt human subject research studies include a proposal for the use of a single IRB (“sIRB”) to review the research for all participating domestic sites. The Bloomberg School of Public Health IRB, the School of Medicine IRB, and the Homewood IRB are working together to address the new NIH requirement for sIRB. When sIRB services are required by a Sponsor, and a JHU PI wants JHU to serve as the study’s sIRB, the School of Medicine IRB will review all requests for sIRB services, and if approved, will serve as the University’s sIRB for all divisions. JHU has signed on to the SMART IRB Reliance agreement, and investigators are urged to make sure that their collaborators have either signed on to this form of reliance agreement, or are willing to sign on.

  • All Planning Phase and New Applications that involve Hopkins as the reviewing sIRB must submit a “Reliance Request” through an on-line SOM IRB query portal available on this page: http://www.hopkinsmedicine.org/institutional_review_board/about/reliance_agreement.html. Reviewers will evaluate and act on the request.
  • Bloomberg School of Public Health (JHSPH) and Homewood investigators preparing grant submissions and new applications that propose relying on an external sIRB should contact the JHSPH (irboffice@jhu.edu) or Homewood IRB for further guidance.

All other reliance requests will be managed by the IRB associated with the PI’s division.

NIH Updates

02/19/2019     NIH Policy on Foreign Components

06/09/2018     Transition from Inclusion Management System to New Human Subjects System (HSS)


05/09/2018     Ruth L. Kirschstein National Research Service Award (NRSA) Stipends, Tuition/Fees and Other Budgetary Levels Effective for Fiscal Year 2018

05/01/2018      Clarification of NIH’s Policy Regarding a Change in Program Director’s/Principal Investigator’s Status


04/30/2018      Update on Additional Awards that Permit Eligibility for K01, K08, K23, and K25 Career Development Awards


01/25/2018      NIH single Institutional Review Board (IRB) requirement goes into effect


11/17/2017      Revised NIH Grants Policy Statement

11/17/2017     Guidance on Exceptions to the NIH Single IRB Policy

11/17/2017     Guidance on Implementation of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research 

11/17/2017     Publication of the Revised NIH Grants Policy Statement (Rev. October 2017) for FY 2018 

11/17/2017     Implementing a New Human Subject and Clinical Trail Information Form 


10/13/2017    New Certificate of Confidentiality guidelines from NIH


06/09/2017   NIH Appendix Update

The agency is taking this update seriously, and will withdraw your application from consideration if you violate the policy. Please review your application and ensure that any included appendices fall within the new policy.


05/31/2017    NIH Authentication of Key Biological and/or Chemical Resources

05/30/2017   NIH Additional Change to the NIH/AHRQ/NIOSH Policy on Post-Submission Materials


NSF Updates

 

 

1/31/2019      NSF Resumption of Operations: Grant and cooperative agreements policy and systems information site (1/28/2019):

A Resumption of Operations at NSF page has been developed that includes Important Notice No. 145, Resumption of Operations at the National Science Foundation, dated January 28, 2019, as well as supplemental guidance that addresses grant and cooperative agreement-related policy and systems issues. This page will continue to be updated as new information becomes available.

Policy-related questions regarding resumption of operations at NSF may be addressed to policy@nsf.gov.

11/17/2017      NSF Agency Specific Requirements to the Research Terms and Conditions 

11/01/2017     Revised  NSF Proposal and Award Policies and Procedures Guide (PAPPG) (NSF 18-1) The new PAPPG will be effective for proposals submitted, or due, on or after January 29, 2018.


10/01/2017    Implementation of the RTCs for NASA and Department of Commerce


 

Federal Demonstration Partnership (FDP)

The Federal Demonstration Partnership (FDP) shares monthly presentation with recent updates from all federal agencies. Visit their webpage to access this month’s update presentation and their archives from previous meetings.

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