The Biosketch

For most NIH applications and non-competing renewals, biosketches are required for all personnel listed in the Senior/Key Personnel section of the proposal. The biosketch may not exceed 5 pages. Make sure that the most recent biosketch format page is used.  Please note that section D) Research Support has been removed.  In the most recent format, research projects may be described in section A) Personal Statement.  

• Check out https://grants.nih.gov/grants/forms/biosketch.htm for the most current biosketch format pages, instructions and samples.
• Looking for a tool to help you develop your biosketch? With SciENcv you can automatically format your biosketch according to NIH requirements, or easily transform an existing biosketch from one format to another (e.g., old NIH format to new NIH format, NIH format to NSF format).
• Review answers by NIH to Frequently Asked Questions (FAQs) regarding biosketches.

Other Support

• NIH Other Support Format Pages, Instructions and Samples. New format required for due dates on/after January 2022 (NOT-OD-21-073)
• Reminders of NIH Policies on Other Support and on Policies related to Financial Conflicts of Interest and Foreign Components
• See NIH Other Support for Medical School tools and resources to aid faculty and research administrators in complying with the implemented NIH requirements for disclosure of activities and research support.

In most cases Other Support is requested by NIH prior to award (Just-in-Time) and is required for key personnel as defined in the application. There is no page limit for Other Support.

Other Support includes all resources available in support of an individual’s research endeavors regardless of whether there is monetary value and regardless of whether the activity is based at U-M. Other Support reporting now includes agreements outside U-M, in-kind contributions, and copies of agreements with entities outside the US.  The revised Other Support format also includes a new attestation statement and the requirement for digital signature. 

If the support is provided under a consortium/contractual arrangement or is part of a multi-project award, indicate the project number, PD/PI, and source for the overall project, and provide all other information for the subproject only. 

NIH Career Development (K) applications require Modified Other Support documents for Mentors and Co-Mentors. See K Career Development Instructions.

• For Mentored applications, mentors and co-mentors are to provide information on their research support that is relevant to the candidate’s research.
• 3-page limit per attachment
• Do not include information on “percent effort/person months” or on “overlap”.
• For active and pending projects, provide the total award amount for the performance period. 
• Must be electronically signed by mentors. Signatures are not required as part of Admin Shell but need to be signed prior to Finalization. See NIH Other Support FAQs.

Renewals, also referred to as Competing Continuations, are by NIH’s definition, requests for assistance to extend for one or more additional budget periods a project period that would otherwise expire. Renewal applications compete under peer review for funds - usually with other renewal applications, revised (supplemental), and new applications. Also referred to in the NIH naming convention as a "Type 2". 

In layman’s terms Renewals are when you are applying for the next iteration or cycle of funding to continue your existing research project.

Proposed increases in budget are allowed over the current award period. The NIH institutes and Centers may set budgetary guidelines and may impose caps (generally 10 to 20%). If a previously awarded modular proposal increases costs and becomes categorical, this is acceptable. Please see your institute’s website for specifics. 

Although the application is a continuation of an ongoing project, you are still encouraged to create a full cost budget based on the new specific aims, before settling on the application budget. If the institute does impose budgetary caps, review your options for budget handling with your department. As always, not being able to "afford" the budget may result in a narrowing of the specific aims instead of department support.

Remember to:

• Check the Funding Opportunity Announcement (FOA) to verify that your institute is accepting renewal applications or if there are new restrictions/expectations on applying (for instance, change of due dates by institute)
• Choose Renewal as the type of application (SF424 Cover Page #8) if this is the first submission of this renewal
• Choose Resubmission as the type of application (SF424 Cover Page #8) if this is a Resubmission of a Competing Continuation – see "Resubmissions" below
• Include the 2 character institute code and 6 digit project number (CA123456) in the Federal Identifier field (SF424 Cover Page #4a)
• Answer the Inventions and Patents question (#3) on the PHS 398 Checklist page of the SF424 application
• Include the Inclusion Enrollment Report, if the application involves clinical research

A Resubmission is an application previously submitted and peer reviewed, not funded, and now being resent for consideration. Applicants must make significant changes to the application and can only resubmit once after the summary statement is available.  

Further information from the NIH is available in their Notice (NOT-OD-09-003). Please note that while NIH information is included here, most of these principles are applicable to resubmissions for any sponsor.

The NIH will accept only a single amendment to the original application (called a resubmission application). There is a suffix in its application identification number:

1 R01 CA123456 01 A1

Any second resubmission will be administratively withdrawn and not accepted for review.

A lengthy hiatus after the initial submission may be marked by significant advances in the scientific field and the comments of the reviewers may no longer be relevant. Therefore, a resubmission application must be submitted within 37 months after the date of receipt of the initial New or Renewal application (see NOT-OD-10-140). After 37 months, you may submit a New application.

Remember to:

• Include the 2 character institute code and 6 digit project number (CA123456) in the Federal Identifier field (SF424 Cover Page #4a) on the SF424
• Choose Resubmission (even if it’s a Competing Continuation/Renewal as the type of application (SF424 Cover Page #8) on the SF424
• Update key personnel (add or remove people accordingly) - and make sure all current key personnel are on the PAF to comply with all FCOI requirements
• Update Ongoing/Completed section of the Biosketches (including publications and PMCID#s)
• Update Human/Animal approvals
• Review the space and resources listed for accuracy
• Review the specific aims to evaluate whether there has been a change since last submission that warrants budget adjustments
• Review the budget in terms of current costs to evaluate whether amounts (e.g. salaries, equipment quotes) have changed and require a rebudget
• Review the revised justification for consistency with the revised budget
• Obtain updated letters of support (including consultant letters) and subcontract agreement forms
• Ensure referees update their letters of reference for Career Development Awards
• Include the Introduction to Application attachment (typically limited to 1 page)
• Mark the scientific changes by bracketing, indenting, or changing the typography rather than underlining or shading
• Communicate the turn down of the previous submission in eRPM (if that hasn’t already been done)

Career Development or K Awards are intended to provide individual and institutional research training opportunities to candidates in various career stages including Undergraduate, Graduate/Clinical Doctorate, Postdoctoral/Residency, Early Career and Established Investigator to further develop their careers. The NIH Career Development Awards are focused in five general areas: Mentored, Transition/Early Stage, Mid-Career and Enhancement/Further Development.

NIH Career Development Award applications are subject to the general K Award Career Development Instructions.  The Funding Opportunity Announcement (FOA) will include specific instructions needed for your application submission.  Remember that the FOA instructions always supersede the application instructions.  Note that institutes may have different program requirements for the FOA. The FOA will have a link to a “Table of IC-Specific Information, Requirements, and Staff Contacts”. The information will be helpful in determining requirements for the chosen institute.

See the NIH K Kiosk to view Current Funding Opportunities. The NIH K Kiosk also contains helpful information for use in preparing career development applications such as the various types of K awards and a Career Development Wizard to help you select the appropriate career award type.

Additional Resources

Grant Services & Analysis provides a list of the components that we need for review. See our Routing Medical School Proposals page for specifics.

The NIH’s Table of Page Limits notes by activity code what the page limits are for each of those documents where page limits are enforced.

NRSA Individual Fellowship (F) Awards are available to support predoctoral, postdoctoral and senior fellows in becoming future highly trained, independent research investigators. 

NIH fellowship applications are subject to the general F Award Fellowship Instructions. The Funding Opportunity Announcement (FOA) will include specific instructions needed for your application submission. Remember that the FOA instructions always supersede the application instructions. Note that institutes may have different program requirements for the FOA. The FOA will have a link to a “Table of IC-Specific Information, Requirements, and Staff Contacts”.  This information will be helpful in determining requirements for the chosen institute.

Additional Resources

Grant Services & Analysis provides a list of the components that we need for review. See our Routing Medical School Proposals page for specifics.

The NIH’s Table of Page Limits notes by activity code what the page limits are for each of those documents where page limits are enforced.

Institutional Research Training Grants, or T Awards, are subject to the general guidelines of the Program Announcement (PA). However, certain mechanisms may only be offered by specific institutes. The NIH’s T Kiosk page is a resource that may be helpful in detailing requirements for the chosen mechanism/institute. Keep in mind that not all institutes accept applications during each cycle, so please read the FOA carefully and check the T Kiosk page for more information.

Helpful Links:

The Office of Graduate and Postdoctoral Studies (OGPS) web-site provides information regarding pre-award for Training Grants Preparation.

M-Factir (FACulty and Trainee Information Resources)– UM Tool to facilitate in the preparation of NIH Training Grant Tables.

Grant Services & Analysis provides a list of the components that we need for review. See our Routing Medical School Proposals page for specifics.

The NIH Page Limits notes by activity code what the page limits are for documents where page limits are enforced.

The cover letter serves as a direct communication between the Principal Investigator (PI) and the Center for Scientific Review (CSR).  It will not be shared with peer reviewers.  It provides the PI with a chance to communicate key administrative information or place a request. In some instances, it is required.

The letter should include any of the following information that is applicable:

• Application title
• Funding Opportunity Number & Title (PA/PAR/RFA)
• A statement that you have attached required approval documentation for the type of application being submitted (e.g. direct annual budgets exceeding $500,000) – and append the approval to the cover letter
• List of Referees including name, departmental affiliation, and institution for fellowship and Mentored Career Development Awards
• If you have a late submission, circumstances surrounding the late submission, including:   
  • Continuous Submission - if you are submitting under continuous submission this must be referenced (note: a list of those individuals eligible to submit under continuous submission can be found by clicking the link above)
  • Special Review Panel - if you are submitting late because you did a special review this must be stated along with the dates of service to the review
• Change/Corrected Application (meaning it was submitted and pulled back then resubmitted after the deadline) - the exact same cover letter as was submitted in the original application with only the reason for the late change/corrected application added (if no letter was originally submitted, then only the title, funding opportunity, and statement; no additional information may be included)
• Explanation of any subcontract budget components that are not active for all budget periods (optional)
• If submitting a video as part of your application, information must be included on the cover letter.
• If the proposal will generate large-scale human or nom-human genomic data, a statement must be on the cover letter. For additional information see NIH GDS Policies.

Remember…

• Attach the cover letter in “21) Cover Letter Attachment” field, not to the “20. Pre-application field” which is directly above the cover letter field.
• Requests for an awarding component assignment are done through the optional PHS Assignment Request Form. This is no longer a part of the cover letter.  PHS Assignment Information website
• List of individuals that you are not comfortable having on the review panel is now part of the PHS Assignment Request Form. 
• Ensure that the PA referenced in the Cover Letter matches the PA on the Cover Page of the application
• Confirm that the title referenced in the Cover Letter matches EXACTLY the title on the application Cover Page, as well as the Long Title on the PAF

Additional Resources

See the NIH 424 Instructions, for more details on the Cover Letter including the suggested format.

This information is used to assess the capability of the organizational resources available to perform the research proposed. Identify the facilities and environment to be used. 

Note:

• Only describe resources directly applicable to the proposed work
• If multiple performance sites, describe each site

SPECIAL CONSIDERATIONS

Scientific Environment Success Statement:

• Include a statement of the scientific environment in which the research will be done contributes to the probability of success (e.g., institutional support, physical resources, and intellectual rapport).
• Discussion of ways in which the proposed studies will benefit from:
  • Unique features of the scientific environment
  • Subject populations
  • Useful collaborative arrangements

Early Stage Investigators:

• Describe institutional investment in the success of the investigator, e.g., resources for classes, travel, and training.
• Institutional support such as:
  • Career enrichment programs
  • Assistance and guidance in the supervision of trainees involved with the ESI’s project
  • Availability of organized peer groups
  • Logistical support such as administrative management and oversight and best practices training
  • Financial support such as protected time for research with salary support – NOTE: be cautious as to not create cost sharing by quantifying financial assistance

Biohazards/Dangerous Substances:

• Describe any special facilities used for working with biohazards or other potentially dangerous substances.

Essentially, the budget justification should explain all of the expenses included in the budget. The requested information varies depending on whether you are using the modular or categorical budget format.

Modular Budget Format

The budget justification accompanying a modular budget should be comprised of three separate documents:

1. Personnel Justification: List all personnel, including name, role, number of person months devoted to the project (indicate academic, calendar, and/or summer) and activity to be performed on the project. Do not provide individual salary information. Since the modules should be a reasonable estimate of costs allowable, allocable, and appropriate for the proposed project, you must use the current salary cap when estimating the number of modules. No other items should be listed on the Personnel Justification.
2. Consortium Justification: Provide an estimate of total costs (direct plus facilities and administrative) for each year, rounded to the nearest $1,000. When more than one consortium is involved, provide this estimate for each. List the individuals/organizations with whom consortium or contractual arrangements have been made, along with all personnel, including effort (in person months) and roles on the project. Do not provide individual salary information. Indicate whether the collaborating institution is foreign or domestic. While only the direct cost for a consortium/contractual arrangement is factored into eligibility for using the modular budget format, the total consortium/contractual costs must be included in the overall requested modular direct cost amount.
3. Additional Narrative Justification: This justification should be included if the requested budget requires any additional justification, such as variations in the number of modules requested, or explanation of exclusions applied to the F&A base calculation.

Categorical Budget Format

Use the budget justification to provide the additional information requested in each budget category and any other information the applicant wishes to submit to support the budget request. The following budget categories must be justified, where applicable: equipment, travel, participant/trainee support and other direct cost categories (other expenses). 

When justifying personnel, ensure each participating individual’s name, role, person months devoted to the project (indicate academic, calendar, and/or summer), and activity to be performed are included. 

Include in the justification any significant increases or decreases from the initial year budget. Justify budgets with more than a standard escalation from the initial to the future year(s) of support. Also use this section to explain any exclusions applied to the F&A base calculation.

If the application includes a subaward/consortium budget, a separate budget justification is submitted for that budget.

Remember

Fringe Benefits/Inflation: It is acceptable to list the fringe benefit rate used, but not to say that X% was used as it is “University policy.” It is also acceptable to note that an annual X% inflation was used in preparing the budget, but again not that it is “University policy.” The University has no formal policies in place regarding neither the fringe benefit rate to be used nor the inclusion of inflation.

0 Calendar Months: When listing consultants in the budget justification people sometimes note “0 calendar months” as the effort of the consultant. While we understand the effort of the individual may be minimal, we advise against listing “0 calendar months.” The listed activity to be performed for the project/role generally insinuates some, although small, portion of effort. Therefore, from an effort reporting compliance perspective listing 0 calendar months isn’t necessarily accurate. As an alternative we suggest leaving this field blank for those consultants or to list that the consultant is “unpaid.”

GSRAs: When listing GSRAs sometimes the salary requested on the budget may appear incorrect, even when it is accurate. The following sentence may be added to the justification for clarification:

• “GSRAs have a .5 FTE appointment at the University and the base salary reflects the reduced appointment.”

In addition to this statement, if the PI feels compelled to explain the employment arrangement in the justification, there are a few options that are approved by the Medical School:

• “X will devote 6 calendar months, which is equal to full time research effort for a GSRA.”
• “X will spend his full university appointment, which, under GSRA contract, is 6 calendar months.”
• “X will devote 100% of her appointment to this project. Under University of Michigan policy, GSRAs are contracted appointments of 6 calendar months.”

For information on budgeting GSRAs see the Frequently Asked Questions section and view “The Budget/Justification Issues" header.

UM/VA Joint Appointments: When justifying faculty with a joint UM/VA appointment follow the instructions below:

1. Indicate the months proposed. (# of months at the UM as reflected on the MoU worksheet * % of University Effort) Example: 3 months at the UM * 50% UM effort = 1.5 calendar months
2. Indicate that there is a joint appointment with the VA, but all effort charged to the proposal comes from the University of Michigan (you may have additional time from the VA appointment reflected and no dollars recovered).
3. Indicate that a Memorandum of Understanding is on file.

Example language to use: “Dr. X will have 1.5 months devoted to this project. He also has a VA appointment, however all effort on this project will be from the University appointment. A MoU is on file describing the relationship.”

When a subcontract is included the “Consortium/Contractual Arrangements” must be attached to the SF424. The NIH states that this document should explain the programmatic, fiscal, and administrative arrangements to be made between the applicant organization and the consortium organization(s) (otherwise known as the subrecipient(s)).

Further, the University requires specific information as well. The University prefers the use of the “Letter of Commitment to Establish a Subrecipient Agreement” form, as this form captures all of the information the University needs to see. This form should be completed and uploaded to the PAF in the subcontracts section. **This form can also be used to fulfill the NIH Consortium/Contractual Arrangements document requirement**

However, at a minimum the following must be uploaded to the PAF in the subcontracts section in order to submit an application:

• PHS Face Page (printed and signed) AND
  • Inclusion of language similar to the UM form in a cover letter, institutionally signed, OR
  • A separate statement from an institutional official by email, OR
  • Certification of inclusion in the Federal Demonstration Partnership Clearinghouse

Further, when submitting a categorical budget a full budget and justification will need to be obtained from the subcontract sites.

We also recommend that you ask for the following as a best practice for good and orderly work and to make the process of issuing the award easier:

• Biosketch for all Key Personnel for their site
• Facilities & Other Resources
• Budget (even if not sent to the sponsor – to provide a basis of negotiation at the time of award)
• Budget Justification
• Copy of their F&A Negotiated Rate OR a link to their website (in case questions come up)

Lastly, if consortium/contractual activities represent a significant portion of the overall project, it must also be explained as to why the applicant organization, rather than the ultimate performer of the activities, should be the grantee. The explanation should also be uploaded to the Consortium/Contractual Arrangements field on the SF424.

Multiple PI Leadership Plans should address the following administrative processes and PI responsibilities:

• Roles/areas of responsibility of the PIs
• Fiscal and management coordination
• Process for making decisions on scientific direction and allocation of resources
• Data sharing and communication among investigators
• Publication and intellectual property (if needed) policies
• Procedures for resolving conflicts

Please note, the NIH does not recognize the term “Co-PI,” so please ensure that it is not referenced in this document.

For more information on this document visit the NIH’s website where you can also find acceptable examples.