NSF and NIH News

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National Science Foundation (NSF)

July 11, 2019: Dear Colleague Letter: Research Protection.

May 20, 2019: Effective Practices for Data. Open science can be further advanced by two effective data practices: use of persistent IDs for research data, and use of Data Management Plan (DMP) tools that create machine-readable DMPs. Penn State is affiliated with DMPTool.

January 28, 2019: 2019 NSF proposal and award guidelines, PAPPG, take effect. See https://www.nsf.gov/pubs/policydocs/pappg19_1/index.jsp. All proposals submitted to NSF starting January 28, 2019 must adhere to the new guidelines.

August 29, 2018: External peer reviews are important to the decision-making process and a crucial source of feedback to PIs. NSF encourages reviewers to watch the orientation video, “The Art and Science of Reviewing Proposals.” (NOTE: The video will only play on Internet Explorer.) 

April 2018: revised Collaborators and Other Affiliations Information Template. Also please see Collaborators and Other Affiliations Form FAQ (pdf).

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National Institutes of Health (NIH)

August 5, 2019: Early Stage Investigator (ESI) Extension Request Process Moving to eRA Commons. Beginning on August 22, 2019, investigators will be able to request an extension of their ESI eligibility directly through eRA Commons via an ESI Extension request button in the Education section of their personal profile. For step-by-step instructions, review the video tutorial ESI Status Extension Request on the eRA Videos page.

July 25, 2019: Consolidated Notice on NIMH Clinical Trials Policies.

July 11, 2019: Clarifying Long-Standing NIH Policies on Disclosing Other Support. See also: Reminders of NIH Policies on Other Support and on Policies related to Financial Conflicts of Interest and Foreign Components.

July 10, 2019: Requirement for ORCID iDs for Individuals Supported by Research Training, Fellowship, Research Education, and Career Development Awards Beginning in FY 2020.

June 28, 2019: Project Summary/Abstract and Project Narrative: What’s the Difference and What to Include.

May 13, 2019: The Do’s & Don’ts of Hyperlinks in Grant Applications.

April 17, 2019: NIH Salary Cap update.

March 29, 2019: For Clinical Trials, NIH Releases Protocol Template for Behavioral and Social Sciences Research Involving Humans (NOT-OD-19-092)

March 25, 2019: Inclusion of Women, Minorities, and Children. Applicants should include a rationale for the age range of study participants and justification for age-based exclusion in this document (Section 2.4). The document will continue to have the heading “Inclusion of Women, Minorities, and Children” until the next forms update. See instructions under Inclusion of Children in the application guide. More questions on the Inclusion Across the Lifespan policy? Check out its FAQ page

February 15, 2019: Update to the NIH/AHRQ/NIOSH Policy on Post-Submission Materials.

January 25, 2019: New Protection of Human Subjects website. On the new Protection of Human Subjects site, you can find useful information about proposing and conducting NIH extramural research involving human subjects, including policies, regulations, training, resources, and updated information on the revised human subject regulation.

December 19, 2018: Revision: NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects

December 7, 2018 and November 26, 2018: Update to General Application Guide. See Significant Changes effective January 25, 2019

November 27, 2018: Ruth L. Kirschstein National Research Service Award (NRSA) Stipends, Tuition/Fees and Other Budgetary Levels Effective for Fiscal Year 2019

July 3, 2018: The NCATS Trial Innovation Network – A Resource Supporting High Quality and Cost Effective Clinical Trials Available to You”

Human Subject Research Changes at NIH Effective since January 25, 2018:

First, familiarize yourself with the new PHS Human Subject and Clinical Trial Information form (pdf example with annotations).

Some NIH Institutes no longer accept parent announcements for clinical trials and will announce their own solicitations. Be sure to check the announcement for your target institute.

Second, answer these four questions about your current or proposed research:

1)    Does the study involve human participants?

2)    Are the participants prospectively assigned to an intervention?

3)    Is the study designed to evaluate the effect of the intervention on the participants?

4)    Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

If the answer to all four questions is Yes, then your proposed research meets the NIH definition of a clinical trial. The definition encompasses a wide range of trial types: mechanistic, exploratory/developmental, pilot/feasibility, behavioral, and more.

Need more help determining whether your study would be considered by NIH to be a clinical trial? After reading information on the NIH website and walking through the decision tree, contact your NIH program official or the scientific point of contact listed on the funding opportunity announcement to which you are applying.

The Penn State IRB office will assist in your determination and would prefer to be involved early in the submission planning process, especially if your proposal includes a clinical trial or a Single IRB (SIRB).

Third, familiarize yourself with NIH policy changes related to enhancing stewardship of clinical trials.

NIH has made a number of policy changes to improve the stewardship of clinical trials across the life cycle of the trial. We encourage you to familiarize yourself with all that is changing, including:

  • The requirement to apply to an FOA that specifically allows for the submission of clinical trial applications.
  • Good Clinical Practice training expectations for NIH staff, grantees, and contractors effective January 2017.
  • Use of a single IRB for non-exempt, multi-site clinical trials for application due dates on/after January 25, 2018.
  • Expanded ClinicalTrials.gov registration and reporting to include all NIH supported clinical trials.

January 12, 2018: Updated Appendix Policy.

March 24, 2017: Citing interim research products in applications, proposals and reports

March 2, 2017: Update and Clarification: NIH Continuous Submission Policy

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