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Each year the National Science Foundation and the National Institutes of Health issue updated guidance for proposals and awards. These documents serve to provide proposal and award process guidance for the assistance programs of the agencies. View the complete  and the . Below are highlights of some of the significant changes for each agency's guidance as it relates to proposal development and submission. For full details, reference the respective guides.

NSF Notable Changes for Proposals

The National Science Foundation (NSF)’s 2019 Proposal and Award Policies and Procedures Guide (PAPPG) is effective for proposals submitted on or after January 29, 2019. Following are changes that PIs need to be aware of as they prepare their proposals.

International Campuses of U.S. Institutions and Foreign Organizations

• The policy surrounding subawards to these entities has not changed, but institutions will now need to check a box on the proposal coversheet and provide a justification in the Project Description section as to why involvement of international subawardees is necessary.

Biosketch Synergistic Activities

•  This area of the biographical sketch is limited to five distinct examples only. PIs should not provide lists of examples under one heading.

Conference Proposals

• New coverage has been added to the conference proposal section to require submitters to have a policy or code of conduct that addresses sexual and other forms of harassment and that includes a “clear and accessible means of reporting violations” and that is disseminated to conference attendees prior to the conference and made available at the conference.
• See also NSF Announces New Measures to Protect Research Community from Harassment.

Responsible Conduct of Research

• The PAPPG incorporates additional, strengthened coverage of NSF’s policies on responsible conduct of research and research misconduct. The NSF Office of Inspector General is starting to peruse proposals as they come in for how research conduct is addressed.�� The additional language in the 19-1 PAPPG includes:
  • NSF's RCR requirement applies to the breadth of research disciplines that the Foundation funds. The training provided should be effective and must be appropriately tailored to the specific needs and circumstances at each institution. Accordingly, it is the responsibility of each institution to determine the content, focus and the delivery method for the RCR training.��While training plans are not required to be included in proposals submitted to NSF, institutions are advised that they are subject to review, upon request.
  • NSF will not tolerate research misconduct in proposing or performing research funded by NSF, in reviewing research proposals submitted to NSF, or in reporting research results funded by NSF. Allegations of research misconduct are taken seriously and are investigated by NSF’s Office of the Inspector General (OIG). OIG refers completed investigations of research misconduct to NSF for action. Upon findings of research misconduct, NSF will take appropriate action against individuals or organizations.

Reminders

• RAPID, EAGER and RAISE proposals are not eligible for reconsideration.
• Equipment proposals and conference proposals greater than $50,000 must include Collaborators and Other Affiliations information.
• The Collaborators and Other Affiliations table must be used.�� See below for a link to the template.

PI Checklists that include the PAPPG requirements can be found at:

• NSF Proposal Documents PI Checklist - FastLane
• NSF Proposal Documents PI Checklist - Research.gov

Also see OCG's forms page for NSF approved Biosketch, Budget Justification, Current and Pending Support and Collaborator and Other Affiliations templates, as well as a .��

Note that the templates are NOT paginated; if using Fastlane to submit, please add page numbers to each document, if using Research.gov, omit the page numbers.

NIH Notable Changes for Proposals

The items below cover the planned updates to NIH application instructions, review criteria language, and select Parent Announcements for research grant applications submitted for due dates on or after January 25, 2019.

Updates to Submission Requirements (see ):

incorporates the following changes to submission requirements:

Research Strategy

• Significance: Under “Significance,” the term “rigor of the prior research” has replaced the term “scientific premise.”
• Approach: New language notes “Describe plans to address weaknesses in the rigor of the prior research that serves as the key support for the proposed project.”
• Above changes also apply to Career Development applications.

Human Subjects and Clinical Trials Information

• Inclusion of Women, Minorities, and Children: This section has been updated to provide a link to the , in place of the former policy specifically addressing the inclusion of children.
• Clarified instructions for Career Development Award and Fellowship applicants who are proposing to gain clinical trial research experience.
• Added instructions about grouping Study Records.
• Clarified instructions for delayed onset studies.
• Now includes modified text regarding exemption numbers 7 and 8 in question “1.a. If YES to Human Subjects” within the Project Information Form.

Fellowship Applications

• Updated and clarified instructions under the “Applicant’s Background and Goals for Fellowship Training” section to provide a timeline of the proposed research training, professional development, and other activities planned during the fellowship.
• For fellowship applicants proposing to gain clinical trial research experience, instructions for the “Sponsor and Co-Sponsor Statements” section have been updated to include guidance on how the sponsor should document leadership of the clinical trial and describe the respective roles and responsibilities of the sponsor and the applicant.

Research Training Program Plan Form

• Added language in the “Proposed Training” section of the “Program Plan” to provide guidance to applicants who choose to provide a description of opportunities for trainees to be involved in human subjects research.
• Added instructions under the ”Letters of Support” section about including a letter that describes the institutional commitment to ensuring that proper policies, procedures, and oversight are in place to prevent .

Career Development Awards

• For applicants proposing to gain clinical trial research experience, instructions for the “Plans and Statements of Mentor and Co-Mentor(s)” section have been updated to include guidance on how the mentor should document leadership of the clinical trial and describe the respective roles and responsibilities of the mentor and the applicant.

Updates to Scored Review Criteria

Reviewers will be asked to consider the revised review questions summarized below. All FOAs with due dates on or after January 25, 2019 will be updated with the revised language (or link to revised language). Scored Review Criteria includes the following revised review questions:

• Significance: “Is there a strong scientific premise for the project?” has been revised to “Is the prior research that serves as the key support for the proposed project rigorous?”
• Approach: New language has been added: “Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project?”
• Approach: Question revised to ask “If the project involves human subjects and/or NIH-defined clinical research, are the plans to address: 1) the protection of human subjects from research risks, and 2) the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (exclusion) of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?” (Bold denotes the change to original question).
• Protections for Human Subjects: Statement revised to state “For research that involves human subjects but does not involve one of the [six] categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects…” (Bold & ���ٲ����������������word denotes the removed word).
• Inclusion of Women, Minorities, and Individuals Across the Lifespan: Statement revised to state “When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed.” (Bold denotes the change to original question).

New Parent Announcements

NIH has released the new parent announcement funding opportunities for proposal submissions due on or after January 25, 2019. Some NIH Institutes and Centers (IC) will not be participating in specific parent announcements, so please ensure that the requested IC is participating prior to applying.

NIH has also introduced new funding opportunities for . These specific funding opportunities are for studies that meet the definition of basic research and are also subject to clinical trials policies based on the .

The new Program Announcements of note are as follows, with more available on NIH’s page:

• : Research Project Grant (Parent R01 Clinical Trial Not Allowed)
• : Research Project Grant (Parent R01 Clinical Trial Required)
• : NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required)
• : NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)
• : NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required)
• : NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required)
• : NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed)