NSF: Writing Budget Justifications

A budget justification is the narrative that accompanies your NSF budget and can be up to 5 pages in length. This is where investigators validate and explain the dollar amounts they requested in their line-item budget. Justifications explain pay rates and outline equipment, materials, and supplies requests. Investigators should ask themselves if their budget justifications are answering these questions;

  1. Why are these requested funds needed?
  2. How does each item in the budget help meet the proposed deliverables?
  3. How were these requested funds estimated?

The first place to start before writing any budget justification is the PAPPG. In addition to all the picky details provided there, here are three general pieces of advice that typify budgets that meet little resistance when it comes time to fund your project. The best budget justifications tend to have these things in common:

Use of Parallel Formatting with the Budget Pages

The absolute best way to organize and format your budget justification is to use the same letter and number system used in the budget template. This also helps your Program Officer locate specific items and amounts.

Using Senior Personnel as an example, your budget template will look something like this;

budget just.png

Then your budget justification for this exciting, cross-disciplinary proposal should follow this order;

A. Senior Personnel

  1. Pomona Sprout- Principal Investigator, # months’ work/year, list specific responsibilities and explain how she arrived at this calculation.Year 1 $$$$, Year 2 $$$$, Year 3 $$$$, Year 4 $$$$
  2. Indiana Jones- Co-Principal Investigator, # months’ work/year, list specific responsibilities and explain how he arrived at this calculation.Year 1 $$$$, Year 2 $$$$, Year 3 $$$$, Year 4 $$$$

Salaries: Time and Rates

For all personnel, show what amounts you are asking for and state how you calculated those salary amounts. Give a monthly breakdown and include any fringe rates.

If you are requesting more than two months’ salary for any senior personnel, clearly justify that the rationale fits into one of these two categories:

  1. the person has a soft money position, or
  2. the project scope requires buying out of teaching time.

Section G. Other Direct Costs

Section G is often where confusion happens. The best way to avoid confusion is to start in the PAPPG. It clearly defines which costs should live in lines G1-G6. Some key points to keep in mind are;

  • Do not include funds for Materials and Supplies under Participant Support Costs (section F), even if those items will be used by students or other trainees. List them under G.1.
  • Section G.3 (Consultant Services): If you are using the consultant category, Program Officers may request additional information as to each individual’s expertise, primary organizational affiliation, normal daily compensation rate, and number of days of expected service.
  • Section G.5 (Subawards): For each subaward, a budget and budget narrative need to be prepared and submitted. Please make sure that the subaward budgets list the subawardee institution and PI (and not the information of the lead proposal again).
  • Section G.6 (Other Direct Costs – Other) is a catch-all category that will always attract scrutiny, so especially for this section be sure to be explicit about what you’re requesting, why, and how much it will cost. Also,
  • Graduate student tuition goes in G.6. Other.

In Conclusion

Justify everything. Assume nothing. If necessary, clarify the NSF budget guidelines with your Authorized Organizational Representative prior to submitting a proposal. This is especially important for rare or unusual expenditures, such as foreign subawards or consultancies or salary requests beyond two months for any senior personnel. It’s also important for normal expenditures like travel.

For example, don’t just write, “I need $8000 for international travel to go to two meetings in Europe.” PIs should use an airfare estimator and show the breakdown of costs.

Again, make sure your Program Officer understands how you came up with the total number you’re requesting in each category. There’s no harm in adding a table to show calculations. And this may seem obvious, but make sure the numbers in the budget justification match the numbers in the budget.

Finally, if most of your work is off-campus, check with your Authorized Organizational Representative about whether the off-campus indirect cost rate applies. Different institutions have different policies on when the off-campus rate is appropriate.

For additional tips on preparing an award budget, visit the MCB blog.

Original post by DEB Science Staff 8/23/19

How do I get an ORCHID iD?

If you are not familiar with the ORCID iD, ORCID stands for Open Researcher and Contributor ID.  This is a unique personal digital identifier that distinguishes every researcher and is a global effort for adoption by the scientific community.  Eventually the ID will allow you to link your eRA Commons account to various other resources to reduce your administrative burden. Currently for NIH, your ORCID iD will link to your eRA Commons account so that publications can be easily associated with your grants.

Starting in October 2019, ORCID iDs will be required for new appointees to institutional training grants and other awards who make appointments through xTrain.

When a 2271 appointment form is submitted for Training and Institutional K awards, eRA systems will check to ensure that the ORCID iD is present in the Personal Profile associated with the Commons IDs listed in the form.  Starting this month, a warning will be issued if the ORCID iD is not present.  This warning will be switched to an error in October of 2019 and must be cleared to successfully submit the new appointment.

How do you get an ORCID iD, you ask? Well, that is very easy.  Logging into eRA Commons, you can go to your Personal Profile. Just under your name and your listed eRA Commons roles, you will find a link to create your ORCID iD. Following that link to ORCID.org, you will be able to register and link your Commons account to your ID. See steps and screenshots in the ORCID topic in the eRA Commons online help.

For more information, see Guide Notice NOT-OD-19-109.

Original post on NIH eRA Items of Interest — July 2019

Now Available in Research.gov: Support for Collaborative Proposals with Subawards and New SPO/AOR Email Notification

Important message from NSF:

We are very pleased to announce that as of June 24, 2019, the research community can prepare and submit full, research collaborative proposals with subawards in Research.gov. This is in addition to the existing capability (since April 2018) to prepare and submit full, research non-collaborative proposals in Research.gov. Since that initial release just over a year ago, the National Science Foundation (NSF) has implemented several enhancements to the site, including additional flexibilities for PDF uploads, support for PDFs generated from LaTeX source documents, and compliance checks for fonts and font sizes. Future enhancements to the Research.gov proposal system will allow the preparation and submission of separately submitted collaborative proposals from multiple organizations.

Compared to FastLane, our grants management system launched in 1994, the Research.gov proposal system is much easier to use and provides proposers with faster document uploads and the ability to quickly create and update documents. We encourage you to try the new system, and we are confident that you will agree that this next generation grants management system is more efficient and less burdensome than FastLane.

Also, as of June 24, 2019, a new email notification functionality was implemented to generate Sponsored Project Office (SPO)/Authorized Organizational Representative (AOR) email notifications when Principal Investigators (PIs) enable proposal access to SPOs/AORs. A similar email notification is available in FastLane, and we are excited to add the capability in Research.gov.

Modernizing Proposal Preparation and Submission

NSF’s modernization of its FastLane system continues with the goal of improving the user experience to prepare and submit NSF proposals, while also reducing administrative burden for both proposers and NSF staff. As capabilities are migrated from FastLane to Research.gov, the system features will expand until it eventually replaces FastLane for proposal preparation and submission.

While proposers can still prepare and submit collaborative proposals with subawards as well as full, research non-collaborative proposals in FastLane, we encourage the research community to use the new Research.gov proposal system because as NSF continues to enhance the new system incrementally, your vital feedback is being incorporated during the development process.

Preparing and Submitting Proposals in Research.gov
Here’s some of the current Research.gov features that proposers are enjoying:

  • Integrated compliance checks for fonts, margins, and line spacing;
  • Real-time compliance feedback and alerts, so proposers know a proposal section is compliant before moving on to another section;
  • Specific checks on the budget screens and for Collaborators and Other Affiliations (COA) uploads;
  • A few seconds to upload documents versus 30-90 seconds for each document upload in FastLane; and
  • Embedded relevant sections of the Proposal & Award Policies & Procedures Guide (PAPPG) and video job aids, so proposers don’t have to go to multiple sites to access guidance and tools.

Initiating a Proposal in Research.gov
By answering a few questions in the five-step proposal wizard, Research.gov customizes the set-up process and compliance rules for the proposal being created. In addition, the proposal wizard dynamically drives the proposal sections that are required on subsequent screens.

If you have not done so already, we invite you to initiate a proposal in Research.gov by following the steps outlined below:

  • Open Research.gov and click “Sign In” located at the top right of the screen;
  • Enter your NSF ID and password and click “Sign In;”
  • From the Research.gov “My Desktop” page, click “New! Prepare Proposals (Limited proposal types)” in the “Prepare & Submit Proposals tile” or go to this option from the top navigation bar by selecting the “Prepare & Submit Proposals” tab and clicking on “New! Prepare Proposals (Limited proposal types);”
  • Select the “Prepare Proposal” option in the “Prepare New Proposal” tile on the left side of the Proposal Preparation page; and
  • Follow the five-step proposal wizard to set up the proposal.

After completing the initiation steps, you are ready to complete all required and optional sections

Submitting Feedback
NSF wants to hear from you! To submit feedback about the new Research.gov Proposal Preparation and Submission Site:

  • Go to the Research.gov Feedback page;
  • Choose “Other” under the Site Area dropdown menu;
  • Include your feedback in the Comments or Suggestions field; and
  • Click Submit when you are ready to send your feedback to NSF.

Training Resources and Additional Information

Please share this information with your colleagues. If you have IT system-related questions, please contact the NSF Help Desk at 1-800-381-1532 or rgov@nsf.gov. Policy-related questions should be directed to policy@nsf.gov.

Original post by NSF 6/26/2019

NSF-approved Biographical Sketch Format

Please be advised that the National Science Foundation (NSF) has designated the National Institutes of Health’s SciENcv (Science Experts Network Curriculum Vitae) as an NSF-approved format for submission of biographical sketch(es) and is encouraging its use to prepare a biographical sketch for inclusion in proposals to NSF.

In accordance with the current Proposal & Award Policies & Procedures Guide (PAPPG) (NSF 19-1), a biographical sketch (limited to two pages) is required for each individual identified as senior personnel on a proposal, and a separate biographical sketch PDF file, or other NSF-approved format, must be uploaded in FastLane for each designated individual (see PAPPG Chapter II.C.2.f.). These biographical sketch and file format requirements also apply to NSF proposals submitted through Research.gov and Grants.gov.

Use of an NSF-approved format aims to reduce administrative burden and improve efficiencies by providing proposers with a compliant and reusable way to maintain this information for subsequent proposal submissions to NSF, while also ensuring that the information is submitted in a searchable composition.

Beginning with the next iteration of the PAPPG (expected to be implemented in January 2020), NSF will only accept PDFs for biographical sketches that are generated through use of an NSF-approved format. A description of NSF-approved format(s) will be posted on the NSF website when the PAPPG is issued. A draft version of the PAPPG was published in the Federal Register for public comment. The deadline for submitting comments is COB July 29, 2019.

Multiple training resources are available on the SciENcv website. The following website resources may be of assistance to proposers preparing a biographical sketch using the SciENcv format:

You are encouraged to share this information with your colleagues. If you have IT system-related questions, please contact the NSF Help Desk at 1-800-381-1532 or rgov@nsf.gov. Policy-related questions should be directed to policy@nsf.gov.

Original post by NSF 6/17/2019

NIH Guidance on Salary Limitation

Please see the important two notices from NIH regarding salary limitation:

1.) Guidance on Salary Limitation for Grants and Cooperative Agreements FY 2019

Notice Number: NOT-OD-19-099

Key Dates: Release Date: April 17, 2019

Related Announcements: None

Issued by: National Institutes of Health (NIH)


Since 1990, Congress has legislatively mandated a limitation on direct salary for individuals under NIH grant and cooperative agreement awards (referred to here as a grant).  The mandate appears in The Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 (Public Law 115-245), signed into law on September 28, 2018, which provides authority for NIH to incur obligations for FY 19.

The Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019, restricts the amount of direct salary to Executive Level II of the Federal Executive pay scale.  The Office of Personnel Management has recently released new salary levels for the Executive Pay Scale.  Effective January 6, 2019, the salary limitation for Executive Level II is $192,300.

For awards issued in those years that were restricted to Executive Level II (see historical record of salary cap link below), including competing awards already issued in FY2019, if adequate funds are available in active awards, and if the salary cap increase is consistent with the institutional base salary, grantees may rebudget funds to accommodate the current Executive Level II salary level.  However, no additional funds will be provided to these grant awards.

For a historical record of the salary cap, including effective dates, see: https://grants.nih.gov/grants/policy/salcap_summary.htm

Inquiries: Questions about specific awards may be directed to the Grants Management Specialist identified on the Notice of Award.


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

Notice Number: NOT-OD-19-036

Key Dates: Release Date: November 27, 2018

Related Announcements: NOT-OD-18-175

Issued by:
National Institutes of Health (NIH)
Agency for Healthcare Research and Quality (AHRQ)
Health Resources Services Administration (HRSA)


This Notice supersedes NOT-OD-18-175 and establishes stipend levels for fiscal year (FY) 2019 Kirschstein-NRSA awards for undergraduate, predoctoral, and postdoctoral trainees and fellows, as shown in the tables below. In addition, the Training Related Expenses and the Institutional Allowance for postdoctoral trainees and fellows have been increased. The Training Related Expenses and Institutional Allowances for predoctoral trainees and fellows and the Tuition and Fees for all educational levels remain unchanged. This Notice reflects the Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 ( Public Law 115-245), signed into law on September 28, 2018.

The budgetary categories described in this Notice apply only to Kirschstein-NRSA awards made with FY 2019 funds. All FY 2019 awards previously issued using NOT-OD-18-175 will be revised to adjust funding to the FY 2019 levels. Appointments to institutional training grants that have already been awarded in FY 2019 must be amended to reflect the FY 2019 stipend levels once the training grant award has been adjusted by the NIH. Amended appointments must be submitted through xTrain in the eRA Commons. Retroactive adjustments or supplementation of stipends or other budgetary categories with Kirschstein-NRSA funds for an award made prior to October 1, 2018 are not permitted.

Effective with all Kirschstein-NRSA awards made on or after October 1, 2018, the following annual stipend levels apply to all individuals receiving support through institutional research training grants or individual fellowships, including the Maximizing Access to Research Careers (MARC) and Building Infrastructure Leading to Diversity (BUILD) programs.

Undergraduates in the MARC and BUILD Programs: For institutional training grants (T34, TL4), two stipend levels may be used for undergraduate candidates: Freshmen/Sophomores and Juniors/Seniors.

Career Level Stipend for FY 2019 Monthly Stipend
Freshmen/Sophomores $9,360 $780
Juniors/Seniors $13,104 $1,092

Predoctoral Trainees and Fellows: For institutional training grants (T32, T35, T90, TL1) and individual fellowships (F30, F31), one stipend level is used for all predoctoral candidates, regardless of the level of experience.

Career Level Years of Experience Stipend for FY 2019 Monthly Stipend
Predoctoral All $24,816 $2,068

Postdoctoral Trainees and Fellows: For institutional training grants, (T32, T90, TL1) and individual fellowships (F32), the stipend level for the entire first year of support is determined by the number of full years of relevant postdoctoral experience when the award is issued. Relevant experience may include research experience (including industrial), teaching assistantship, internship, residency, clinical duties, or other time spent in a health-related field beyond that of the qualifying doctoral degree. Once the appropriate stipend level has been determined, the trainee or fellow must be paid at that level for the entire grant year. The stipend for each additional year of Kirschstein-NRSA support is the next level in the stipend structure and does not change mid-year.

Career Level Years of Experience Stipend for FY 2019 Monthly Stipend
0 $50,004 $ 4,167
1 $50,376 $ 4,198
2 $50,760 $ 4,230
3 $52,896 $ 4,408
4 $54,756 $ 4,563
5 $56,880 $ 4,740
6 $59,100 $ 4,925
7 or More $61,308 $ 5,109

Senior Fellows (F33 only): The stipend level must be commensurate with the base salary or remuneration that would have been paid by the institution with which the individual is permanently affiliated when the award is issued, but cannot exceed the current Kirschstein-NRSA stipend limit set by the NIH for those with 7 or more years of experience. The level of Kirschstein-NRSA support will take into account concurrent salary support provided by the institution and the policy of the sponsoring institution. NIH support does not provide fringe benefits for senior fellows.

Relevant Policies
Current stipend levels are to be used in the preparation of future competing and non-competing NRSA institutional training grant and individual fellowship applications. They will be administratively applied to all applications currently in the review process.

NRSA support is limited to 5 years for predoctoral trainees (6 years for dual-degree training), and 3 years for postdoctoral fellows. The NIH provides eight levels of postdoctoral stipends to accommodate individuals who complete other forms of health-related training prior to accepting a Kirschstein-NRSA supported position. (The presence of eight discrete levels of experience, however, does not constitute an endorsement of extended periods of postdoctoral research training).

It should be noted that the maximum amount that NIH will award to support the compensation package for a graduate student research assistant remains at the zero level postdoctoral stipend, as described in NOT-OD-02-017.

Tuition and Fees, Training Related Expenses, and Institutional Allowance for Kirschstein-NRSA Recipients

The NIH will provide funds for Tuition and Fees, Training Related Expenses, and Institutional Allowance as detailed below. The amounts for tuition do not change but the Training Related Expenses and the Institutional Allowance for postdoctoral trainees and fellows are increased by $1,000.

A. Tuition and Fees

Undergraduate and Predoctoral Trainees and Fellows: For institutional training grants (T32, T34, T35, T90, TL1, TL4) and individual fellowships (F30, F31), an amount per predoctoral trainee or fellow equal to 60% of the actual tuition level at the applicant institution, up to $16,000 per year, will be provided. If the trainee or fellow is enrolled in a program that supports formally combined, dual-degree training (e.g., MD/PhD, DO/PhD, DDS/PhD, AuD/PhD, DVM/PhD), the amount provided per trainee or fellow will be 60% of the actual tuition level, up to $21,000 per year.

Postdoctoral Trainees and Fellows: For institutional training grants (T32, T90, TL1) and individual fellowships (F32, F33), an amount per postdoctoral trainee or fellow equal to 60% of the actual tuition level at the applicant institution, up to $4,500 per year, will be provided. If the trainee or fellow is enrolled in a program that supports postdoctoral individuals in formal degree-granting training, an amount per postdoctoral trainee or fellow equal to 60% of the actual tuition level at the applicant institution, up to $16,000 per year, will be provided.

B. Training Related Expenses on Institutional Training Grants

For institutional training grants (T32, T35, T90, TL1), these expenses (including health insurance costs) for predoctoral and postdoctoral trainees will be paid at the amounts shown below for all competing and non-competing awards made with FY 2019 funds.

• Predoctoral Trainees: $4,200
• Postdoctoral Trainees: $10,850

C. Institutional Allowance for Individual Fellows

This allowance for predoctoral and postdoctoral fellows will be paid at the amounts shown below for all competing and non-competing awards made with FY 2019 funds.

Institutional Allowance for individual fellows (F30, F31, F32, F33) sponsored by non-Federal Public, Private, and Non-Profit Institutions (Domestic & Foreign, including health insurance):

• Predoctoral Fellows: $4,200
• Postdoctoral Fellows: $10,850

Institutional Allowance for individual fellows (F30, F31, F32, F33) sponsored by Federal and For-Profit Institutions (including health insurance):

• Predoctoral Fellows: $3,100
• Postdoctoral Fellows: $9,750


Please direct all inquiries to:

See Frequently Asked Questions Related to NRSA Tuition, Fees, and Health Insurance Policies: https://grants.nih.gov/training/nrsa_tuition_q&a.htm .

Specific questions concerning this notice or other policies relating to training grants or fellowships should be directed to the grants management office in the appropriate NIH Institute or Center, AHRQ, or HRSA.

General inquiries concerning NRSA stipend and tuition policies should be directed to:

Division of Biomedical Research Workforce
Office of Extramural Research
Website: https://researchtraining.nih.gov
Email: NIHTrain@mail.nih.gov

System Enhancements in Grants.gov

New system enhancements released on March 18th from Grants.gov are focused on bringing more convenience to the Grants.gov applicant experience.

Grants.gov has already highlighted changes to how grant forecasts will be displayed, making them easier to identify.  There are also a handful of other updates in Release 17.0, including the use of a mobile number when resetting a forgotten password and the ability to view the system privileges associated with an account profile.

Add Your Mobile Number to Your Account

When registering, Grants.gov users will soon have the option to add a U.S.-based mobile phone number to their account as a means to reset a forgotten password.

Users who registered before March 18 will likewise see a one-time pop up invitation to add a mobile number to their account.

Option to Add Your Mobile Phone Number

Please note: the mobile number will only be used by Grants.gov during the password reset process.

Know What Privileges Are Associated With Each Profile

Applicants will soon have the ability to view the privileges associated with each of their account profiles. This added convenience will take the guesswork out of trying to determine what privileges one has been assigned.

View Role Privileges

To view the privileges associated with a specific profile, users will go to the My Account page and click on the Manage Profiles tab.  Under the action column, a View Privileges link will pop open a list of privileges for each profile associated with an organization.

You can learn more about what each privilege does on the Grants.gov Roles & Privileges page.

Additional Enhancements

There are a few other changes that applicants can expect to see when they log into their account after March 18:

  • Applicants will be able to sort a list of their workspaces by Closing Date, making it easy to prioritize form work.
  • Applicants subscribed to a funding opportunity announcement (FOA) will be able to receive notifications from the grantor when changes are made to Related Documents and/or Links in the FOA. (Note: This is an optional feature that some grantors may choose not to use.)
  • Applicants will be able to filter workspace activity column data by keyword.

Original post by Grants.gov on 3/6/2019

New Effective Date for the Revised NSF Proposal & Award Policies & Procedures Guide (NSF 19-1)

Due to the recent lapse in appropriations, implementation of the revised NSF Proposal & Award Policies & Procedures Guide (PAPPG), (NSF 19-1) was postponed. NSF is pleased to announce that the revised PAPPG will now be effective for proposals submitted, or due, on or after February 25, 2019.  Significant changes include:

  • Addition of Research.gov as an option for proposal preparation and submission, and proposal file updates;
  • Revision of eligibility standards for unaffiliated individuals;
  • Specification that conference proposals over $50,000 and all equipment proposals must include the Collaborators and Other Affiliations information in the proposal submission;
  • Revision of resubmission guidelines for NSF programs that accept proposals at any time;
  • Implementation of NSF’s policy on sexual harassment and other forms of harassment, or sexual assault;
  • Specification that proposers are required to have a policy or code-of-conduct that addresses sexual harassment, other forms of harassment, and sexual assault, and that includes clear and accessible means of reporting violations of the policy or code-of-conduct.  This policy or code-of-conduct must be disseminated to conference participants prior to attendance at the conference as well as made available at the conference itself;
  • Emphasis on the importance of training faculty in the responsible and ethical conduct of research;
  • Incorporation of existing patent policy into the PAPPG.  This policy was previously implemented by regulation at 45 CFR 650; and
  • Numerous clarifications and other changes throughout the document.

You are encouraged to review the by-chapter summary of changes provided in the Introduction section of the PAPPG.

To learn about the changes in the revised PAPPG (NSF 19-1), please view the latest NSF Proposal & Award Policy Update webinar.

While this version of the PAPPG becomes effective on February 25, 2019, in the interim, the guidelines contained in the current PAPPG (NSF 18-1) continue to apply.  NSF will ensure that the current version of the PAPPG remains on the NSF website, with a notation to proposers that specifies when the new PAPPG (including a link to the new Guide) will become effective.

Associated award terms and conditions (including RTC NSF Agency Specific Requirements, GC-1, and FL-26) will also be effective for proposals submitted or due, on or after, February 25, 2019. Cooperative Agreement Conditions (CA-FATC) and CA-FATC Modifications and Supplemental terms and conditions are effective for new awards and funding actions to existing awards beginning on February 12, 2019.

If you have any questions regarding these changes, please contact the NSF DIAS/Policy Office at policy@nsf.gov.

Original post by NSF dated 2/14/2019

NSF: Update Regarding Resumption of Operations

Important revisions have been made to the Resumption of Operations at NSF page on the NSF website, including identification of new deadline dates for specific solicitations and Dear Colleague Letters. This NSF page will continue to be updated as new information becomes available.

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

NSF: New Resumption of Operations Information

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 by NSF as new information becomes available.

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

Reminder of NIH Policy Changes

For your convenience, here is a roundup of recently announced changes impacting grant application submission for due dates on or after January 25, 2019.

NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects (NOT-OD-18-116)

Individuals of all ages are expected to be included in all NIH-defined clinical research unless there are scientific or ethical reasons not to include them. Applications for research involving human subjects must address the age-appropriate inclusion or exclusion of individuals in the Inclusion of Women, Minorities, and Children section of the proposed research project.

Review Criteria Updates (Fellowship – NOT-OD-18-227; Research – NOT-OD-18-228; Career Development – NOT-OD-18-229)

NIH has updated application instructions and review criteria addressing rigor of prior research (formerly scientific premise); inclusion reporting and requirements; and protections for human subjects.

Recently published opportunities have the updated review criteria in the body of the announcement. Opportunities posted prior to the change have a link to the notice containing updated criteria at the top of the Application Review Information section.

Changes to the NIH Academic Research Enhancement Award (R15) Program (NOT-OD-19-015)

The R15 activity code is rebranded as “NIH Research Enhancement Award” and going forward will include two programs:

  • Academic Research Enhancement Award (AREA) for Undergraduate-Focused Institutions
  • Research Enhancement Award Program (REAP) for Health Professional Schools and Graduate Schools

An institution letter verifying eligibility with the criteria listed in the funding opportunity announcement is required with each application and the ineligible institution list will no longer be maintained.

The NIH Academic Research Enhancement Award (AREA) Parent Announcement, PA-18-504, expires January 8, 2019 and will not be reissued.

Reinstatement of NIH SBIR Direct-to-Phase II Authority (NOT-OD-19-019)

Direct-to-Phase II is now an option for the SBIR Omnibus opportunities (see NOT-OD-19-019 for exceptions).

Other targeted SBIR opportunities issued by NIH Institutes and Centers have reinstated the Direct-to-Phase II option on an opportunity-by-opportunity basis.

New Funding Opportunity Announcements Targeting Basic Experimental Studies with Humans (NOT-OD-19-024)

NIH has issued new R01 Parent Announcements identified as Basic Experimental Studies with Humans. These opportunities focus on applications that propose clinical trials that also meet the definition of basic research. Pay close attention to participating Institutes and Centers and any restrictions posted in the Related Notices section of each opportunity. Applications proposing basic experimental studies involving humans may also be submitted to opportunities which allow clinical trials.

Harassment and Discrimination Protections in NIH Training Applications (NOT-OD-19-029)

The Letters of Support section of institutional training (T) applications must include a letter on institutional letterhead signed by a key institutional leader that describes the institutional commitment to ensuring that proper policies, procedures, and oversight are in place to prevent discriminatory harassment and other discriminatory practices.

NIH Implementation of the Final Rule on the Federal Policy for the Protection of Human Subjects (Common Rule; NOT-OD-19-050)

Several provisions in the Revised Common Rule resulted in changes to NIH policies and procedures. From an application submission perspective, the most notable changes are:

  • Changes to categories of research qualifying for exemptions (FAQs)
  • Use of new exemptions 7 and 8, when applicable

Application Instruction Updates

The application form instructions found on the How To Apply – Application Guide page include clarifications and policy updates (see Significant Changes).

Original post by NIH Staff on 1/8/2019