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[October 15, 2020] Effort Commitment Guidance for Federal Proposals
Effective January 5, 2001 through a Presidential Review Directive and clarification memo M-01-06 issued by the Office of Management and Budget (OMB), it is expected that “most Federally-funded research programs should have some level of committed faculty (or senior researchers) effort, paid or unpaid by the Federal government. This effort can be provided at any time within the fiscal year (summer months, academic year, or both).” The clarification memo also states that, “...Some types of research programs...do not require committed faculty effort, paid or unpaid by the Federal government...”

Further, the National Institutes of Health (NIH) Grants Policy Statement notes that “zero percent” effort or “as needed effort” is not an acceptable level of involvement for key personnel. Therefore, in preparing proposals and in allocating effort after award, all PIs and key personnel (not including Other Significant Contributors) must include some level of committed effort on most sponsored research activities. Some exclusions apply (see EXCLUSIONS below).  Any programs that do not cover key personnel salary expenses as a matter of policy do not qualify as an exclusion (instead, effort must be cost shared). Any effort devoted by these individuals that is above the committed effort amount is considered uncommitted effort. Other contributing personnel must be included in the proposal reflecting their effort contributions to the project.

PIs must quantify effort commitments (e.g., a percentage of time, dollar amount of salary, number of months, etc.) in the proposal. These commitments are paid from (1) the sponsor and/or (2) other, non-federal sources. The effort commitments must be fulfilled within each year of the award.

The minimum amount of effort committed to a specific sponsored research activity should be no less than 1 percent of the key personnel’s university effort. Beyond this minimum, the specific amount of effort committed to a particular grant should be based on the PI’s estimate of the effort necessary to meet the technical goals and outcomes of the project. If you have questions, about minimum levels of effort, or converting hours to percent efforts, please contact your Sponsored Programs Officer. In addition, NIH institutes may have minimum effort requirements for some grant mechanisms, see details in the National Cancer Institute Notice.

EXCLUSIONS
Some federal and federal flow-through sponsored programs do not require a minimum level of committed effort by PIs and key personnel and therefore are not subject to this policy. The following are excluded from the requirements set forth above.
NOTE: This list is not all-inclusive. Contact your Sponsored Programs Officer with questions.
•    Equipment and instrumentation grants
•    Mentor effort on doctoral dissertation, fellowship, scholarship awards, training grants, and resident research experiences
•    Specific purpose awards such as travel grants, outreach programs, workshops, and conference support grants
•    National Science Foundation (NSF) Research Experiences for Undergraduates (REU).
•    NIH supplements (For the PI, committed effort must be present on the parent grant supporting the supplement.)
•    NIH Other Significant Contributors as cited in the agency’s SF424 Application Guide
•    Non-federally funded clinical research/trial/treatment – On a case-by-case basis, where PI oversight related to research is expected to be very minimal, it may be appropriate to budget less than one-percent effort.

[September 17, 2020] What is the NIH viewing window for electronic applications?
Applicants who submit at least two days in advance of the deadline have two business days to view their assembled application in the eRA Commons. This viewing window enables applicants to verify that their application is viewable correctly and, if not, to work with an institutional Signing Official to reject, modify, and resubmit it. However, any modifications or corrections must be completed PRIOR to the due date. Applicants are strongly advised to submit early and to allow enough time for an adequate review in order to ensure the successful submission of their applications. In general, OSPA will only reject and resubmit applications for reasons such as missing documents, illegible figures, and validation warnings. More>> [Faculty, Postdocs and Resadmin 9/17/2020] 
 
[August 20, 2020] What is Responsible Conduct of Research (RCR)? Responsible conduct of research is defined by NIH and others as the practice of scientific investigation with integrity (NOT-OD-10-019). RCR involves the awareness and application of established professional norms and ethical principles in the performance of all activities related to scientific research. More>> [Faculty, Postdocs and Resadmin 8/20/2020] 

[August 20, 2020]  Who is required to take Responsible Conduct of Research (RCR) training on campus? The current institutional requirement is that all pre- and post-doctoral appointees on NIH funded NRSA programs must attend a Responsible Conduct of Research Course in the first year of their appointment (Tri-Institutional RCR Course). In addition, all first year Graduate Fellows and third year Biomedical Fellows must attend, so that they are trained in ethical considerations from the outset of their graduate education.  Additionally, The NSF requires institutions to verify that undergraduate students, graduate students, and post-doctoral researchers supported by NSF to conduct research have received training in the responsible and ethical conduct of research (RCR). The Dean's Office oversees the RCR training requirement on campus. More>>  [Faculty, Postdocs and Resadmin 8/20/2020]  


[Febuary 27, 2020] What information should be included in the Project Summary/Abstract and Project Narrative sections of my NIH application? The Project Summary/Abstract should outline the broad, long-term goals and specific aims of the project and its biomedical relevance, as well as describe the research design and methods for achieving the project objectives.  This section is limited to 30 lines of text; figures should not be included. Investigators should describe the benefits of their proposed research to public health in their Project Narrative section of their NIH application. This section should be succinct – no more than 2-3 sentences long - and in plain language. If the application is funded, both sections will be viewable to the public in the NIH RePORTER, and any proprietary or confidential information should be excluded.  More>> [Faculty, Postdocs and Resadmin 2/27/2020] 

[January 23, 2020] Record Retention Requirements Most sponsored projects have legal requirements as to how long project records must be retained. These guidelines also recognize the substantial physical and fiscal resources required to retain technical, clinical, financial and other records (contact your Sponsored Programs Officer for assistance).

Awarded Applications:
•    Federal awards - Retain records for 3 years after submission of the final fiscal status report (annual or, if annual is not required, competitive segment) or after final payment under a Federal contract. If any litigation, claim, or audit is started before the expiration of the 3-year period, the records must be retained until all litigation, claims or audit findings involving the records have been resolved and final action taken. Record retention under Federal grants is governed by 2 CFR 200.  Record retention under Federal contracts is governed by the Federal Acquisition Regulation, specifically FAR 52.215-2.
•    State and other governmental awards – A number of these awards require that records be retained for six (6) years. It is recommended that all records for projects funded under State/governmental awards (MOUs, grants, agreements) be retained for 6 years.
•    Other awards - If the sponsor or award document does not specify a specific time period to retain project records, follow the Federal contract requirement (retain for 3 years after final payment under the award).
[Faculty, Postdocs and Resadmin 1/28/2020]


[December 17, 2019] Extending PI Eligibility on an NIH K99/R00 application The eligibility rules for the K99/R00 Pathway to Independence Award application state that the applicant must have no more than 4 years of Post-Doctoral Experience at the time of application.  However, leave for pressing personal or family situations of generally less than 12 months duration, such as family care responsibilities, disability or illness, or active military duty, is not included in the 4-year eligibility limit.  Also, time spent conducting postgraduate clinical training that does not involve research is not considered as part of the 4-year research training eligibility limit.
Since one of the most common reasons for extension request involve childbirth, NIH will approve an extension of eligibility for one year for childbirth. Men, those adopting children, and same-sex partners of individuals can also apply for an extension.  Potential K99 applicants are encouraged to discuss their individual situation with an NIH Institute or Center Scientific Program Contact before applying. [Faculty, Postdocs and Resadmin 12/17/2019]

[November 26, 2019] How is federal science funding impacted by a continuing resolution? When Congress fails to pass an appropriations bill by the end of the federal fiscal year (September 30), it can pass a continuing resolution (CR) to provide budget authority for federal agencies to continue operating until regular appropriations are enacted. Under a CR, policy provisions from the previous fiscal year’s appropriations legislation are continued and funding is provided at a level equal to or slightly lower than was enacted in the previous fiscal year. We are currently under a CR, which expires December 20.

During a CR, Federal sponsors:
•    Can make only a limited number of new grant awards
•    May fund existing awards at a reduced level until the budget passes
•    Must fund existing programs
•    Is prohibited by law from launching new initiatives or activities outside the scope of the existing authorization

More>> [Faculty, Postdocs and Resadmin 11/26/2019]

[October 24, 2019] How do I submit a request for controlled access data? The Office of Sponsored Programs Administration (OSPA) processes and administers Data Access Requests that require institutional certification.  To ensure all required data security concerns are addressed, investigators should complete a data security questionnaire, which will be evaluated by RUIT. Investigators should also provide IRB approval for their project, or IRB determination that no IRB approval is required. These forms, along with a  Data Access Routing Form and the data access request itself, are submitted to OSPA for review and submission.  Please see our Data Access Request page for more information. [Faculty, Postdocs and Resadmin 10/24/2019]

[September 19, 2019] NSF to require new biosketch format in 2020
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 sketches, and is encouraging its use to prepare a biographical sketch for inclusion in proposals to NSF.

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 Proposal & Award Policies & Procedures Guide (PAPPG), anticipated effective date 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 formats will be posted on the NSF website when the PAPPG is issued.

Multiple training resources are available on the SciENcv website. The following website resources may be of assistance in preparing a biographical sketch using the SciENcv format:
SciENcv Background
YouTube Video: SciENcv Tutorial
YouTube Video: Integrating with ORCID
SciENcv Help
 
[Faculty, Postdocs and Resadmin 9/25/2019]

[September 10, 2019] NIH, CDC, and AHRQ to require ORCID iDs for certain PD/PIs and Appointees beginning October 1, 2019
ORCID (Open Researcher and Contributor IDentifier) iDs are unique, persistent digital identifiers that distinguish individual investigators and can be used to connect researchers with their contributions to science over time and across changes of name, location, and institutional affiliation.  These free identifiers are assigned and maintained by the non-profit organization ORCID.

In October 2019, the requirement for ORCID identifiers will be incorporated into the appointment process for trainees, scholars, and participants supported by institutional research training, career development, and research education awards that require appointments through the xTrain system, including the following:    

            T03, T15, T32, T34, T35, T37, T42, T90/R90, TL1, TL4, TU2, K12/KL2, R25, R38, RL5, RL9

At the time of appointment, the xTrain system will check whether appointees have ORCID iDs and appointments will not be accepted for agency review unless an ORCID iD is linked to the individual's eRA Commons Personal Profile.   

Beginning with receipt dates on or after January 25, 2020, the requirement for ORCID identifiers will be enforced at the time of application for individual fellowship and career development awards, including the following: 

F05, F30, F31, F32, F33, F37, F38, F99/K00, FI2, K01, K02, K05, K07, K08, K18, K22, K23, K24, K25, K26, K38, K43, K76, K99/R00

eRA system validations will check whether applicants have ORCID iDs and applications will not be accepted unless an ORCID iD is linked to the PD/PI's eRA Commons Personal Profile. 

At this time, prospective applicants for individual fellowship and career development awards are encouraged to follow the ORCID link from their Personal Profiles in the eRA Commons , where they can either link their eRA profiles to existing ORCID accounts or create ORCID profiles and link them back to the eRA Commons.  Similarly, PD/PIs of institutional research training, career development and research education awards are urged to begin alerting potential appointees to do the same. [Faculty, Postdocs and Resadmin 9/10/2019]

[March 26, 2019] Has your project plan changed since you got your grant?
In general, the PD/PI (Program Director/Principal Investigator) may make changes in the methodology, approach, or other aspects of the project objectives. However, the grantee must obtain prior approval from the sponsor for a change in scope.

A change in scope is a change in the direction, aims, objectives, purposes, or type of research training, identified in the approved project. The grantee must make the initial determination of the significance of a change and should consult with OSPA to see if a change of scope request is needed. This should be done as soon as the PD/PI realizes that their project has changed. Waiting until the time of Progress Report may cause delay of funding.

Potential indicators of a change in scope include, but are not limited to, the following:
•    Change in the specific aims approved at the time of award.
•    Shift of the research emphasis from one disease area to another.
•    Application of a new technology, e.g., changing assays from those approved to a different type of assay.
•    Substitution of one animal model for another.
•    Change from the approved use of live vertebrate animals.
•    Change from the approved involvement of human subjects that would result in an increased risk. This includes:
o    An addition or change that would result in changing the overall human subjects or clinical trial designation of the award from No to Yes;
o    The new inclusion of subject populations that are covered by additional regulatory protections under 45 CFR 46;
o    Any change to the study protocol that would increase the risk level for subjects;
o    New information indicating a higher level of risk to participants than previously recognized for a study intervention, procedure, or pharmacological treatment.
•    A clinical hold by FDA under a study involving an IND or an IDE.
•    Transfer of the performance of substantive programmatic work to a third party through a consortium agreement, by contract, or any other means. For NIH awards, prior approval is always required if the third party is in another country.
•    Change in other senior/key personnel not specifically named in the award notice/agreement.
•    Significant rebudgeting, whether or not the particular expenditure(s) require prior approval. This may differ depending on the terms of your specific award.
[Faculty, Postdocs and Resadmin 3/26/2019]

[January 23, 2019] NIH Biosketch formatting warning The NIH has been growing more stringent with their review of biosketches during the peer review process. They have been issuing warning letters regarding errors within biosketches, reminding investigators that applications are required to comply with the guidelines for all attachments. As a reminder, the following are the rules for NIH biosketches:
•    Complete each section (A - Personal Statement; B – Positions and Honors; C – Contributions to Science; D – Research Support or Scholastic Performance)
•    Include no more than 5 contributions to science with no more than 4 citations per contribution
•    Ensure that, if you include the optional link to a full list of your published work, the URL is .gov (i.e., a site such as My Bibliography)
•    Refrain from including information, such as preliminary data, that belongs elsewhere in the application
•    Follow NIH guidance on font type, font size, paper size, and margins (see Format Attachment instructions)
•    Limit the length of your biosketch to 5 pages or less

Failure to follow the policy means NIH may withdraw your application from consideration (NOT-OD-15-095). [Faculty, Postdocs and Resadmin 1/23/2019]


Joint Tips with Other Departments
[April 18, 2019] Rita & Frits Markus Library/OSPA: Could noncompliance with the NIH Public Access policy impact your funding?
Yes, the NIH can delay the processing of non-competing continuation awards if publications arising from those awards are noncompliant with the NIH Public Access policy. Publications should be reported in the annual Research Performance Progress Reports (RPPR), final reports and renewal applications. NIH's My NCBI is used to report publications. Contact the Rita & Frits Markus Library for assistance with the Public Access process. [Faculty, Postdocs and Resadmin 4/18/2019]


 
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