Summary Table of Changes to Instructions

Attachment 8 - Summary Table of Changes to Instructions

PHS 398, 2590, 2271, 3734, and HHS 568

General Changes	Justification
Restructuring of instructions for consistency with the SF424(R&R) and PHS398 component Instructions where possible. Numerous clarifications provided; redundancies removed; references updated	Ease of reference and use, less confusing to applicant community.
PHS 398 Grant Application
Research Plan reorganized to mirror SF424(R&R) Application Guide instructions.	Consistency with SF424(R&R), less confusing to applicant community.
Delete modular budget instructions and form from the PHS 398. Modular budget remains as PHS 398 Component Form and in SF 424 (R&R) instructions.	Mechanisms submitted on paper 398 do not use modular budget forms.
Addition of requirement for DUNS registration for subaward/consortium organizations.	Required by Federal Financial Accountability and Transparency Act (FFATA).
Addition of requirement for Central Contractor Registration (CCR) for applicant organization.	Required by FFATA.
Revised instruction for justification for foreign applicant or component.	Consistency with NIH policy on research involving foreign institutions.
Replace decision table for human subjects research with narrative text.	Replace confusing instructions with clearer text.
Provide suggested cover letter format.	Greater consistency and facilitation of applicant requests for specific Institute/Center and Scientific Review Group assignment.
Replace table of Standard Postmark/Submission Dates, Review and Award Cycles with url to current web page.	Point applicant toward current and up-to-date information.
Human subject and vertebrate animal research plan instructions modified to address indefinite plans in these areas.	Provide guidance to applicants with indefinite plans at the time of application.
398 Part I, 7. Career Development Awards
Term mentor used in place of sponsor.	More accurate description of relationship.
Instruct candidates to include membership on Federal Public Advisory Committees in Biographical Sketch.	Ensure that candidate receives credit for membership on Federal Public Advisory Committees during review process.
Clarification that description of career development program related activities should be addressed for any performance site.	Ensure information submitted describes complete program related activity plan, regardless of site.
Clarification that future career plans should be addressed.	Necessary to determine if proposed career goals are related to mission initiatives.
Clarification that mentor should address plan for transitioning candidate to independence.	Necessary for successful transition of candidate.
Clarification that certain non-mentored candidates should address plan for providing mentoring to new investigators.	Emphasize that certain programs require a plan to provide mentoring for new investigators.
Clarification of the need to describe relationship between candidate's and mentor's research.	Necessary to determine appropriateness of mentor’s research with regard to candidate’s career goals.
398, Part I, 8. Institutional Research Training Awards Including NRSA
Instructions and forms renamed "Institutional Research Training Application Including Ruth L. Kirschstein-NRSA Application."	Acknowledge that NRSA training awards are a subset of institutional training awards.
Expand minority recruitment and retention plan to diversity recruitment/retention plan (add disability and disadvantaged background as categories).	Implement NIH diversity recruitment and retention policy.
Add suggestion that instruction in Responsible Conduct of Research (RCR) address peer review, collaboration, and mentor/mentee relationship.	Important areas for trainee education.
Provides guidance on PD/PI Leadership Plan for training program if FOA permits multi-PD applications.	Clarification that a training grant multiple PD leadership plan should address how it will benefit the training program and the trainees, and that not all mentors should be designated PD status, except in unusual cases.
Provide fillable format tables, examples of completed tables, and detailed instructions for completing tables.	Promote consistent NIH-wide approach to training program data.
398, Part II, Instructions for Preparing the Protection of Human Subjects Section of the Research Plan
Human subject definitions moved to Part III.	Place all definitions in the same section.
Changes to scenarios: All 6 human subjects exemptions are provided in one scenario, and corresponding instructions modified accordingly. New scenario "Delayed Onset Human Subjects Research" incorporated.	Less confusing to applicants. Provide instructions on addressing indefinite plans for including human subjects.
398, Part III, Policies, Assurances Definitions
Updated, and editorial and clarifying changes.
PHS 2590 Progress Report
Maximum length of progress report narrative expanded from 2 to 4 pages for training/career development awards.	Awardees need additional space since the progress report covers both research and research training plans.
Specific guidance for programs that include a requirement to become a mentor.	Assist program with monitoring.
Replace use of Human Subject Inclusion Enrollment Report for reporting trainee diversity with a Trainee Diversity Report.	Less confusing for applicant.
PHS 2271 Statement of Appointment
Revised to implement previously approved use of form for Career Award appointees and to enable the use of the form for Research Education appointees.	Enable broader use of form.
Add definitions for NRSA, non-NRSA, Career Development and Research Education awards, and trainee, scholar and participant.	Reflect use of form for different mechanisms.
Add instructions for completing disability and disadvantaged background questions.	Implement NIH diversity recruitment and retention policy.
Add "Other, clinical" and "Other, nonclinical" to Fields of Training list.	Provide option for fields of training not included on the list.
HHS 568 Final Invention Statement
Delete requirement for two signatures.	Institution official is the only signature necessary.
HHS 3734 Relinquishing Statement
No change

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