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As of January 21, 2019, studies initiated on or after that date are expected to comply with all Revised Common Rule requirements for the remainder of the study including:
1) removal of the requirement for Institutional Review Boards (IRBs) to review grant applications and contract proposals related to research (see NOT-OD-19-055)
2) a new requirement for clinical trial informed consent documents to be posted on a public federal government website;
3) changes to categories of research that qualify for an exemption;
4) removal of the requirement for annual IRB reviews for certain categories of research.
Please see NOT-OD-19-050 for reference.
NOT-OD-19-056 Clarifies for the community that information regarding institutional commitment to ensuring that proper policies and oversight are in place to prevent discriminatory harassment and other discriminatory practices is to be included in the same letter with the information about the applicant institutional commitment to the planned program. Separate letters are not required.
OER launched a new version of the human subjects protections website. The new approach greatly simplifies finding information about the protection of human subjects (we hope!), provides updated information on the revised human subject regulation (Common Rule), and integrates more closely with the main NIH Grants and Funding site.
Looking to search the NIH Guide by for FOAs where you are the issuing organization? The search now allows for that, and the export to Excel feature captures issuing vs participating organization for your convenience.
Fy19 funding levels will generally be issued at the commitment level on notice of award, NRSA stipends will increase by ~2%, meritorious ESI R01 equivalent applications will be prioritized, salary limits are set at Exec. Level II ($189,600). See NOT-OD-19-031
As of January 2019, NIH is shifting its approach to the use of the R15 activity code. The name, AREA, will be reserved for grants to undergraduate-focused institutions that do not receive substantial funding from NIH. NIH will also offer R15 opportunities to support graduate schools of arts and sciences and health professional schools. We will be calling this the Research Enhancement Award Program (REAP). Another change involves having institutions verify eligibility upon application submission rather than NIH issuing an ineligibility list. (NOT-OD-19-015) Also see related Open Mike blog.
Input is sought on the draft report and proposed recommendations to reduce the administrative burden associated with research activities with laboratory animals while maintaining protections and scientific integrity. (NOT-OD-19-028) The draft is available at https://olaw.nih.gov/sites/default/files/21CCA_draft_report.pdf. Also see related Open Mike blog
New parent funding opportunity announcement (FOAs) for R01, R21, K99/R00, K01, K02, K08, K23, K24, K25 activity codes will be issued in late November to accommodate basic science experimental studies involving humans for participating institutes and centers. Applications must contain studies that meet both the NIH definition of a clinical trial and the definition of basic research. This includes studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. See NOT-OD-19-024.
Effective January 1, 2019, NIH will require SBIR/STTR grant recipients to submit the Life Cycle Certifications within the I-RPPR and the F-RPPR. Previously we did not previously require recipients to submit the actual certifications, they just had to complete and maintain them within their official files. See NOT-OD-19-025.
To maximize public benefit from genomic information generated through NIH-supported research in a manner consistent with current scientific and ethical considerations, and to promote of scientific advances while protecting research participants’ privacy interests, NIH is updating its data management procedures under the Genomic Data Sharing Policy to allow unrestricted access to genomic summary results from most NIH-supported studies for health or research purposes. See NOT-OD-19-023. Also see related blog.
Effective October 1, 2018, NIH will implement the new final regulations of the Bayh-Dole Act. The new regulations will apply to all NIH new (including renewals) and continuation awards beginning on or after October 1, 2018. The Bayh-Dole Act permits funding to retain ownership of the inventions made under federally funded research grants or contract programs, while also giving the government a license to practice the Subject Invention. See NOT-OD-18-233.
A ‘Direct-to-Phase II’ SBIR award is a Phase II award issued to a small business that did not receive a Phase I award for that research/research & development. Recent legislation has re-instated this SBIR Direct Phase II provision through Fiscal Year 2022 and NIH is re-implementing the SBIR Direct-to-Phase II program. The prior program had specific SBIR Direct-to-Phase II funding opportunity announcements (FOAs). These will not be needed now. The transition to FORMS-E allows NIH to track SBIR Direct-to-Phase II applications using a new check-box on the SBIR/STTR Information Form for Direct Phase II. See NOT-OD-19-019.
A reminder that if a recipient institution initiates a research misconduct investigation, it must take any necessary steps to:
- protect the scientific integrity of the project;
- protect human participants, live vertebrate animals and the environment;
- ensure the proper expenditure of funds and, if appropriate, continuation of the project during the investigation; and
- provide reports to the HHS Office of Research Integrity
Importantly, when a recipient institution finds, learns, or suspects that falsified, fabricated, or plagiarized information has affected the integrity of NIH-supported research, the institution must immediately provide information on the affected research to the NIH Office of Extramural Research – Research Integrity. The recipient institution must also work with NIH IC staff to assess any effects of the allegation or finding on the ability to continue the project, as originally approved by NIH. See NOT-OD-19-020.
The revised NIHGPS is applicable to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2018. This revision supersedes October 2017 GPS as a standard term and condition of award. Previous versions of the NIHGPS remain applicable as a standard term and condition for all NIH grants and cooperative agreements with budget periods that began prior to October 1, 2018. See NOT-OD-19-021.
Announces the launch of a new eRA system to manage human subjects and clinical trials information. HSS will replace the existing Inclusion Management System (IMS) and will be used by NIH staff, grant applicants, and recipients as of June 9, 2018.
Note that grantees are required to complete any in-progress enrollment records by June 8. If they are working on their RPPR on or before June 8, they will be unable to submit any in-progress inclusion data until the entire RPPR is submitted. In this situation, they should plan to submit the entire RPPR by June 8 or wait until June 9 to enter inclusion data in the new system. Records that have not been submitted by June 8, 2018 will not be available in the Human Subjects System and will need to be re-entered. For more information please see NOT-OD-18-179.
For training videos and other resources, see the eRA intranet page on HSS.
Establishes stipend levels for FY18 Kirschstein-NRSA awards for undergraduate, predoctoral, and postdoctoral trainees and fellows and announces increases in the institutional allowance for postdoctoral trainees and fellows. For more details please see NOT-OD-18-175.
Details policies on FY 2018 funding levels, NRSA stipend levels, how we are prioritizing applications from early stage investigator (ESI) principal investigators, 2018 salary limits, and more. For more details please see NOT-OD-18-180.
Transition from Inclusion Management System to New Human Subjects System (HSS) as of June 9, 2018
Additional Awards Eligible for PA-18-586 Research Supplements to Promote Diversity in Health-Related Research (Admin Supp)
Ruth L. Kirschstein National Research Service Award (NRSA) Stipends, Tuition/Fees and Other Budgetary Levels Effective for Fiscal Year 2018
OER is launching a new eRA system to manage human subjects and clinical trials information. This Human Subjects System (HSS) will replace the existing Inclusion Management System (IMS) and will be used by NIH staff, grant applicants, and recipients as of June 9, 2018. To learn more, see our:
Clarification of NIHs Policy Regarding a Change in Program Directors/Principal Investigators Status
Update on Additional Awards that Permit Eligibility for K01, K08, K23, and K25 Career Development Awards
Career Award (K) Policy Update: Temporary Adjustments to Percent Effort or Part-Time Institutional Appointment
Career Award (K) Policy Update: Concurrent Support from a Mentored K Award and a Research Grant
Financial Conflict of Interest: Investigator Disclosures of Foreign Financial Interests
NOT-OD-18-133 Beginning with RPPRs due on or after October 1, 2019 and applications submitted for due dates on or after January 25, 2020, NIH anticipates that it will mandate that required training data tables submitted with T32, TL1, T90/R90, and T15 applications and progress reports be created via the xTRACT system. Learn more about xTRACT.
NOT-OD-18-128 This notice clarifies application instructions to be clear the human subject form is not available in most training grant application packages (except for D43 and K12) and indicates that, while not required, applicants can provide additional information regarding potential or current involvement of appointed trainees in human subjects research in the Proposed Training section of the Program Plan attachment on the PHS 398 Research Training Program Plan form.
Unfortunately, the FORMS-E application instructions are not quite accurate. As this notice indicates, most training grant applicants that answer “yes” for human subjects do not need to provide additional information. If they choose to they can put addition information regarding potential or current involvement of appointed trainees in human subjects research in the "Proposed Training" section of the Program Plan. See NOT-OD-18-128
Please help us spread the word to applicants. NOT-OD-18-126
This notice reminds all participants in the NIH peer review process of possible consequences that may ensue and actions that the NIH may take in response to a breach of integrity in peer review. See NOT-OD-18-115.
If you missed in, you may be interested in the Open Mike blog post about a recent peer review issue.
Do you work on R&D contracts involving human subjects? If so, learn about the requirements for contract officers, contract officer representatives, contractors and others on a new intranet page dedicated to this topic.
Revises NIH policy and guidelines on the Inclusion of Children. Changes to the policy include (1) the applicability of the policy to individuals of all ages, including children and older adults; (2) clarification of potentially acceptable reasons for excluding participants based on age; and (3) a requirement to provide data on participant age at enrollment in progress reports. The policy applies to competing grant applications for due dates on or after January 25, 2019. Ongoing, non-competing awards will not be expected to comply with this policy. For R&D contracts, the policy will apply to all solicitations issued on or after this effective date. See NOT-OD-18-116
NIH is removing the funding pause on the provision of new or continuation funding for gain-of-function research projects. NIH will continue to accept applications for research projects including studies that are reasonably anticipated to create, transfer or use enhanced potential pandemic pathogens and will identify meritorious research applications meeting the scope of the HHS P3CO Framework for a multidisciplinary, department-level review prior to any funding decision. See
Interested in “playing” with a sample FORMS-E application package to become familiar with the new application forms including the PHS Human Subjects and Clinical Trials form? You’re in luck! eRA has provided a non-production ASSIST sandbox. See attached instructions for creating accounts and using the sandbox and FORMS-E test opportunities representing various grant programs.
Unfortunately, we are unable to provide production credentials to allow you to check out actual published FOAs in ASSIST. This Grants.gov “How Do I Preview Forms in a Grant Application” video, which only runs 53 seconds, details steps you can take to preview (in a read only format) the forms posted for a specific production FOA.
Program officials should help PIs understand that these outcomes should:
- Be written for the general public in clear and concise language
- Be suitable for dissemination to the general public
- Not include proprietary, confidential information or trade secrets
- Not be more than half a page
See NOT-OD-18-103 for more info.
Encourage applicants to submit early to allow time to work through any unforeseen issues! See NOT-OD-18-009
It was reported that Grants.gov was experiencing technical issues impacting applicants’ ability to access application packages, submit, check status of a submission and access their website today. These issues impacted NIH’s ability to process applications and some features in ASSIST. It appears that service to Grants.gov has been restored and NIH is now processing all submitted applications. These issues may have been related to a wider Internet issue. If you get questions, please advise applicants that if any issues with Federal systems impact the ability to submit on time to NIH due dates, the applicant must document the issue with the eRA service desk by the application deadline. See dealing with system issues.
The new version is applicable to all NIH grants and cooperative agreements with budget periods beginning on or after October 1, 2017. Previous versions of the NIHGPS remain applicable as a standard term and condition for all NIH grants and cooperative agreements with budget periods that began prior to October 1, 2017. See NOT-OD-18-005
To protect the credibility of published research, authors are encouraged to publish papers arising from NIH-funded research in reputable journals. Look for an upcoming Open Mike blog on this topic. See NOT-OD-18-011.
Provides information about upcoming funding opportunity announcements and explains support for independent clinical trials and clinical trial research experience for these applicants. See NOT-OD-18-001
NIH will be issuing these announcements in November 2017 for applications targeting due dates on or after January 25, 2018. NOT-OD-18-010
Guidance for applicant and grantee institutions in the U.S. Virgin Islands and Puerto Rico. See NOT-OD-18-002
These notices detail the additional review criteria that NIH will apply for clinical trial applications for due dates on or after January 25, 2018, and applications in which trainees, fellow, or career development awardees propose to gain research experience in an ongoing clinical trial led by a mentor or co-mentor. The review criteria for clinical trials page is also available on the extramural staff intranet.
Consistent with NIH practices over the last decade, NIH will issue non-competing research grant awards at a level below that indicated on the most recent Notice of Award (generally up to 90% of the previously committed level). Upward adjustments to awarded levels will be considered after FY 2018 appropriations are enacted. See NOT-OD-17-124.
Reminding the community that when delays occur because the applicant or recipient organization is officially closed due to a natural disaster or other emergency, the NIH will consider accepting applications late, on a case-by-case basis, in certain circumstances. See NOT-OD-17-113
This notice announces additional review criteria that NIH will apply to clinical trial applications for research projects submitted to due dates on or after January 25, 2018. See NOT-OD-17-118
Language in published FOAs (with the exception of clinical trial FOAs and parent announcements) with due dates after January 25 is being updated to reflect clinical trial allowability, FORMS-E, and select other information. Updates will be completed by October 6. See NOT-OD-17-114
The NIH Policy on the Use of a sIRB for Multi-Site Research becomes effective for applications with due dates on and after January 25, 2018. This public webinar addresses the implementation of the NIH Single IRB Policy, how to write the single IRB plan, and how to request an exception. See NOT-OD-17-120
This notice provides additional detail on the special considerations being given to impacted institutions, including: information on late application submissions, post-submission materials, salary payments, and financial and progress reporting. See NOT-OD-17-111
As you continue to reach out to your grantees and contractors about the clinical trial changes, remember to refer back to the Clinical Trial Communications Toolkit for the latest versions of resources. Corrections have recently been made to fix typos on presentations and the flier, and we continue to update the resources regularly.
Newly added: Presentation on NIH Clinical Trial Reforms. Why the Changes?
To increase the protection of privacy of research participants, as of October 1, 2017, NIH funded researchers who are who are collecting identifiable, sensitive information as part of their NIH funded research will automatically be issued a CoC as part of the term and condition of their award. There is no need for them to apply for a CoC. Compliance with the privacy protections afforded by the CoC is also a term and condition of award. All research that was commenced or ongoing on or after December 13, 2016 and is within the scope of this policy is issued a Certificate through this policy. See NOT-OD-17-109
See: Open Mike Blog on the Updated Case Studies to learn about the types of topics that got further clarified (yes, case study 18 is one of them!)
Expect these resources to continue to evolve as we get additional feedback and questions.
This notice announces a new policy implementing special funding consideration for early and mid-career (early established) investigators. See policy summary below. This policy supersedes previous notices on new and early stage investigators. We anticipate that ICs will seek to fund other more senior investigators who are new to the NIH system through specific programs as well as select pay. Read more in the Open Mike blog on the policy and Open Mike blog on Data on Trends According to Career Stage. Note that NIH’s website on new investigators has been replaced with Early Stage and Early Investigator Policies (there is a redirect from the old page to the new one). See NOT-OD-17-101 for more information.
When delays occur because the applicant or recipient organization is officially closed due to a natural disaster or other emergency, the NIH will consider accepting applications late. Read more about NIH responses to natural disasters in the Open Mike blog on Monitoring the Impact of Hurricane Harvey on Research. See NOT-OD-17-106
Since clinical trial-related materials will be required in the new PHS Human Subjects and Clinical Trials Information Form, they will no longer be allowed in the Appendix for due dates on or after January 25, 2018 unless specifically stated as required in the funding opportunity announcement. See NOT-OD-17-098
This notice clarifies and updates the guidance on full-time training. See NOT-OD-17-095
This notice describes when it is allowable for a recipient institution to supplement the NIH salary contribution on K awards. See NOT-OD-17-094
The NIH Fiscal 2017 eRA End of Year deadline dates have been established. Wednesday, September 27, is the last day to release FY 2017 awards, supplements and revisions for additional funds in IMPAC II. The End of Fiscal Year Grants Calendar and Frequently Asked Questions are now posted on the Resources page. For additional reference, visit the new NIH–wide Combined Year-end Communications SharePoint Site.
We are updating our application forms to FORMS-E for due dates of Jan 25, 2018 and beyond. FORMS-E includes a brand new form. Check it out using the resources below.
· Video tour of the new Human Subjects and Clinical Trial Information form on YouTube. - public
· Preview of FORMS-E Grant Application Form Changes - public
· Annotated Form Set for NIH Grant Applications - FORMS-E Series - public
· Draft Instructions for the Human Subjects and Clinical Trial Information form - staff only
You can! Federal RePORTER is a searchable database of science award information that enables studies of the portfolio of federal science investments. While it is currently updated annually, its database of ~900,000 projects from 17 agencies is a great resource. See the attached presentation given at the EPMC meeting this week to learn more!
Effective June 30, 2017, all SBIR/STTR Phase II final reports must be submitted through the eRA Commons using the Final RPPR rather than the Final Progress Report. See NOT-OD-17-085
This notice makes final what was previously interim guidance. Direct salary support is limited to Executive Level II of the Federal Executive pay scale. The Executive Level II salary was previously set at $185,100, and increased to $187,000 effective January 8, 2017. See NOT-OD-17-087
NIH is extending the effective date of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research to January 25, 2018. The policy will apply to all competing grant applications for due dates on or after January 25, 2018. For R&D contracts, the policy will apply to all solicitations issued on or after this effective date. See NOT-OD-17-076
Establishes stipend levels FY 2017 Kirschstein-NRSA awards for undergraduate and predoctoral trainees and fellows. See NOT-OD-17-084
Effective June 23, 2017, NIH will implement the requirement that foreign NGOs that agree not to perform or actively promote abortion as a method of family planning, or provide financial support to any other foreign non-governmental organization that conducts such activities, will remain eligible for global health assistance funding. See NOT-OD-17-083
Loan repayment programs have been announced for application period September 1 through November 15 (see NOT-OD-077 through NOT-OD-081).
Revision: Ruth L. Kirschstein National Research Service Awards (NRSA) Predoctoral Stipends, Training Related Expenses, Institutional Allowance, and Tuition/Fees Effective for Fiscal Year 2017
This notice provides the limitations on the use of funds on NIH grant, cooperative agreement, and contract awards for FY 2017. See NOT-OD-17-075 for more information.
NIH recently announced the Next Generation Researchers Initiative to enhance funding to early-stage and mid-career investigators and help stabilize and strengthen the biomedical research enterprise. This initiative shifts NIH’s approach away from the Grant Support Index to more directly support early-stage and mid-career investigators. We will be developing FAQs and issuing updated policies in the near future. In the meantime, learn more through:
NIH Director’s Statement
Next Generation Researchers Initiative Web Page
Presentation to the Advisory Committee to the NIH Director
In April NIH announced that we will be moving to Forms-E for application submissions targeting due dates of January 25 and beyond.
- This week we walked the IC eSubmission Liaisons through the details of the form changes, timing of how the new forms will roll out, as well as the latest changes at Grant.gov etc. See the meeting summary for a detailed view of what is happening.
- If you are not yet familiar with the new Human Subjects and Clinical Trial Information Form and want to get a feel for it, check out the annotated form.
We thought you might be interested in this video of a presentation given by Dr. Mike Lauer, NIH Deputy Director for Extramural Research, at the recent NIH Regional Seminar, in which he shares his thoughts about applying a scientific approach to understanding NIH’s extramural program.
Dos and don’ts for the authentication plan for applicants proposing the use of established key biological and/or chemical resources. NOT-OD-17-068
Failure to submit complete and accurate progress and financial reports may affect future funding to the organization and may result in a delay of continued support. For more information see NOT-OD-17-074
Now citations to issued patents are allowable post-submission materials. For more information see NOT-OD-17-066.
Help us get the word out about the NIH Regional Seminar in Baltimore. Its a great way for investigators and administrators newer to NIH to learn the process and policies behind getting and managing NIH funding. See NOT-OD-17-073 for more information.
Request for Information on the Development of the FY 2019 Trans-NIH Plan for HIV-Related Research