Medical School NIH Research Proposal Review Checklist...provides a quick reference to address the most common mistakes in proposal prepara on. Research Administrators are encouraged

Ques ons? [email protected]

This checklist serves as a reference guide for Medical School departments/units when

reviewing NIH research grants (in FORMS‐E) prior to rou ng for approval. This document

provides a quick reference to address the most common mistakes in proposal prepara on.

Research Administrators are encouraged to review NIH research proposal submissions using

this tool in order to make the Medical School’s sponsored project review process more

efficient. Using this checklist should reduce review ques ons during rou ng.

Ques ons & comments are welcome. Please email to the Grant Review & Analysis Office

([email protected]). Future itera ons based on feedback are expected.

Check here for updates!

Medical School

NIH Research Proposal

Review Checklist

Version 2.2

April, 2018

GRANT REVIEW & ANALYSIS



Review Checklist

Using the Checklist

Symbols

In this document, you will find text bubbles in two colors:

Medical School will review for accuracy and data integrity as part of the rou ng process

Departments/units are responsible to ensure accuracy and will not be re‐reviewed by

the school. Departments may also wish to review yellow bubbles are to ensure fewer ques ons

about the form content in the rou ng and review process.

indica ng useful informa on (included in green boxes); and

Helpful ps (included in gray boxes)

Abbrevia ons

GR&A = Grant Review & Analysis, the Dean’s Office Review step.

Dept = Any administra ve home department / unit / center

Suggested Steps

You may wish to compare the review applica on side by side with this document.

Open 424 applica on in eRPM. Click on Edit/View Grant Applica on in the le panel.

Align this checklist next to the applica on so that the two windows are side by side.

Compare the reviewed page to the corresponding page in this checklist. At a minimum, verify all

the fields with blue bubbles are correctly filled out.

Repeat with the fields of the Proposal Approval Form (PAF) and PAF Summary in eRPM.

You may wish to keep the 424 applica on window open. Some fields in the PAF

will be compared against those in the applica on.

Use of the document is most effec ve a er the project team has completed the en re NIH 424 research applica-on and PAF and is using the informa on to review the packet prior to rou ng. This is not intended to be a re-

placement of the sponsor direc ons and specific sponsor requirements for all sec ons of the applica on.

GRANT REVIEW & ANALYSIS


Applicant Iden fier = PAF #; do not leave out leading 0s.

Previous Grants.gov ID: Dept: Leave blank. GR&A will complete if applica on is submi ed >1x.

The contact is automa cally populated. Verify your ORSP

Project Representa ve’s contact info here.

Confirm this is no earlier than the earliest start date allowed by NIH. Start dates must be in the future or the Grants.gov system will error. For Renewals: Confirm no date overlap with current grant.

Confirm PI informa on is the same as shown in the PAF.

SF424 R&R Cover Page ‐ Page 1 New applica on: blank Renewal/Resubmission/Revision: Use Previous NIH grant # ‐> 2 le ers + 6 numbers

Always Applica on when first routed by Dept. GR&A will change if applica on is submi ed >1x

Verify

Complete. Refer to NIH Glos‐

sary for defini ons.

Verify

Page 1

Many fields prepopulate

when the 424 is created or informa on

from the PAF is copied into the 424. It is always good to read over

the fields to be sure nothing is

accidentally replaced.


Review Checklist GRANT REVIEW & ANALYSIS


Total must match the sum on R&R BUDGET— Cumula ve Budget page, Sec on K.

Unless the federal program requires a specific

match, don’t enter cost sharing amount.

Make sure the box is checked. If non‐faculty PI, assurance statement should also be signed an uploaded to the PAF.

NOT‐OD‐16‐008: Requests for assignment should not be included in Cover Le er. Use Assignment Request Form instead. What can be included: Refer to SF424 guide for most up‐to‐date

SF424 R&R Cover Page ‐ Page 2

The contact is automa cally populated. Verify it is completed.

Frequently required proposal documents and data can be found on the ORSP website.

Page 2

Make sure the total equals line a + b.

GR&A manually replaces the ORSP email address with GR&A if they will submit.




List all other par cipa ng organiza ons, sites, or contribu ng en es (subcontracts, VA, etc.) here.

R&R Project/Performance Site Loca on(s)

Never check this box.

Verify

Work with subcontract organiza on(s) to ensure accuracy.

If the UM VA is the sole loca on, then VA is the Primary Loca on.

Page 3




Scenarios in sec-ons 3, 4, 5 are

unusual. Contact the

GR&A Office for help!

If Yes: Upload a document tled Foreign Jus fica on

Narra ve: 2 to 3 sentences

If “Human Subjects” is “Yes”, this standard # is required.

If “Vertebrate Animals” is “Yes”, this standard # is required.

R&R Other Project Informa on

If interna onal collabora on, all countries should be listed.

Facili es and Equipment available at all

performance sites should be included.

Page 4

Abstract: 30 lines or less



Include PMCID in cita ons.


Mandatory for all PD/PI(s) — Verify login name on ORSP website. Typos may cause submission failure. Verify ins tu onal affilia on and role.

No effort may be reflected in the Research Sup‐port sec on. Click here for format, instruc ons and samples.

Use Display Order func on to assign a specific order, so that

all PD/PIs are first, followed by others in alphabe cal order of last name.

Have Mul ple PD/PIs? Don’t forget the Mul ple PD/PI Lead‐ership Plan on PHS 398 Research Plan form.

R&R Senior/Key Person Profile

Page 5

Posi on/Title (e.g., Professor), not Project Role (e.g., PD/PI).




Not mandatory for non‐PD/PI. Not recommended to include for non‐PD/PI as it may cause Grants.gov system errors.

R&R Senior/Key Person Profile, Con nued

No effort may be reflected in the Research Sup‐port sec on. Click here for format, instruc ons and samples.

No effort may be reflected in the Research Support sec on. Click here for format, instruc ons and samples.

Page 6



Mandatory for all PD/PI(s) — Verify login name on ORSP website. Typos may cause submission failure. Verify ins tu onal affilia on and role.


If Yes: Cell line code should be listed. It is composed of 4 numbers (eg., 0004).

If “Vertebrate Animals” is “Yes” on R&R Other Project Informa on form, this sec on must be answered.

PHS 398 Cover Page Supplement , Part I

Yes = Uncommon! If you think you may have income, contact the GR&A Office.

Page 7

If, income is expected, complete

SF424 Cover Page, p2 #15d




PHS 398 Cover Page Supplement, Part II

Page 8



Answer this sec on ONLY when Type 2 Submission, i.e. Renewal, or Resubmission of renewal.

Complete this item only when transferring a grant to UM from another organiza on (more common).

Complete this item only when changing the PD/PI during a proposal submission (not common).


Only the primary applicant organiza on selects Project.

Start Date is the same as that in R&R Cover Page 1, item 12.

The Month field must be > 0 or Grants.gov will error. If truly no effort, use 0.01 CM.

R&R Budget ‐ Sec on A & B

Base Salary: must match University ins tu onal base salary (not full‐ me rate) or NIH salary cap; OR you may leave the field blank.

List only UM person‐nel with effort on this page.

Headcount of people in each

category.

Any lis ng in Budget Jus fica on

of effort must match.

Page 9

Project Role must EXACTLY match that in R&R Senior/Key Person Profile form.

Click here for examples of calendar month calcula on.

OR call the GR&A office for help with par al appointments.




Equipment defini on: > 1‐yr life me AND cost ≥ $5K

Par cipants are trainees from outside UM. Click here for full defini on. This sec on is NOT for subject fees or any costs related to U‐M affiliated personnel. Generally, this sec on will only be used if specified listed in the Request for Appli‐ca on (RFA) and will be used in the Medial School infrequently. GR&A is happy to answer ques ons as budgets are developed.

R&R Budget ‐ Sec on C, D & E

Be careful to specify by category (domes c vs. foreign) in budget categories and Budget Jus fica on.

Page 10




This # must be manually entered. See Sub‐contract Sec on, for the text bubble next to Sec on I, for calcula on instruc ons.

See the next page for sample calcula ons.

Budget should reflect details in the Budget Jus fica on. Make sure #s in Budget Jus fica on are consistent with those in this budget form. In modular budget, include Addi onal Narra ve Jus fica on if there are varia ons in # of modules requested.

Review Best prac ce: Start with jus fica on and be able to

generate budget details, OR be “direc onally correct” if there are not details.

Make sure these two #s are correctly reflected on PAF, 3. Budget, Budget and Time Period, item 3.7.

Page 11

R&R Budget ‐ Sec on F ‐ L



Graduate tui on should be entered here in Other, not in Sec on E.


$280,460 ‐ $5,000 ‐ $0 ‐ ($48,750 ‐ $25,000) ‐ $0 ‐ $20,000 ‐ $0 ‐ $0 = $231,710

Total Direct Cost

Equipment

Research Pa ent Care costs (Recruitment/reten on fees are NOT eligible.)

Renova ons Total Subcontract

(a er 1st $25K)

Tui on Par cipant Support Lease

Let’s Take the Applica on in Year 1 as an Example

Page 12



Total Direct ‐ Equipment ‐ Par cipant Support ‐ Each SubK ( > $25K) ‐ Renova ons ‐ Tui on ‐ Research Pa ent Care ‐ Lease

$$ in Sec on G

$$ in Sec on C $$ s in Sec on F

For EACH subcontract, locate the $$ in R&R BUDGET, SUBAWARD, BUDGET PERIOD 1, Sec on I.

If ≤ $25K, use “$0” as you have not yet met the excluded amount.

If > $25K, calculate “$$ ‐ $25K” and use the $$ difference as your excluded amount.

Add up the excluded $$ across ALL subcontracts. Plug the sum to the formula above.

If you do not reach $25K for any given subcontract, instead start excluding in a subsequent year

when the cumula ve total costs reach $25K.

$$ in Sec on E

How to Calculate Modified Total Direct Costs (Indirect Cost Base)


Make sure this # is correctly reflected

on R&R Cover Page 2, item 15a.

R&R Budget ‐ Cumula ve Budget

Make sure these #s are correctly reflected

on PAF, 3. Budget, Budget and Time Period

Page, item 3.7.

Numbers on this page are automa cally calculated. If individual

budgets are correct, the cumula ve budget is correct.

Page 13




Only Senior/Key Persons from the subcontract or‐

ganiza on should be listed on the subaward pages.

Make sure correct Budget Type is selected.

R&R Budget, Subaward ‐ Sec on A & B

Make sure each Subaward budget period matches the UM project’s.

Page 14




R&R Budget, Subaward ‐ Sec on C, D & E

Subcontracts have similar budget issues to UM. They need reviewed, but remember

Other ins tu ons have different financial rules than UM.

Their ins tu onal official signs off to ensure their budget follows local requirements.

Usually you are reviewing for $$ accuracy (do 2 trips @ $500 each = $1,000?) v. how cost

items are treated (Should they recover F&A on travel?).

If anything raises a red flag, ask the ins tu onal contact!

Page 15




Interna onal subaward: indirect cost rate is limited to 8%.

R&R Budget, Subaward ‐ Sec on F ‐ L

Under the Uniform Guidance, each subcontractor SHOULD

have a nego ated rate agreement. If they don’t, UM may

offer 10%. Contact Grants Office for any ques ons/devia ons.

Budget should be produced from Budget Jus fica on. Make sure #s in Budget Jus fica on are consistent with those in this budget form.

Add the $$ in Sec on K of ALL subawards (for the corresponding period).

Enter the sum to UM Budget page, item F5.

Page 16




R&R Budget, Subaward ‐ Cumula ve Budget

Numbers on this page are automa cally calculated. If individual

budgets are correct, the cumula ve budget is correct.

Check this # against the executed ins tu onal le er of commitment.

Make sure this # is correctly copied and pasted to PAF, 3. Budget, 3.11

Subcontracts, for the corresponding subcontract.

Page 17




For Resubmission & Revision only and limited to 1 page

Limited to 1 page

Click here for page limits specified by NIH.

1. Required if “Vertebrate Animals” is “Yes”.

3. Required if more than one PD/PI. Elaborate all PIs’ roles and plan for resolving conflicts.

Examples

NOT-OD-17-035: Applica ons will be withdrawn and not reviewed if

they are submi ed with appendix materials that are not specifically

listed in this No ce or the FOA as allowed or required.

Appendix: Eligible documents: Blank consent forms, blank surveys, and FOA‐specified items.

7. Required, in order to implement Rigor and Transparency policy (NOT‐OD‐16‐011); if not applicable, add a brief statement indica ng so. Recommend 1 page; NIH FAQs

6. Required, if

≥ $500K in direct costs in any year/required by FOA ‐> Data Sharing Plan; or

sharing Model Organisms; or

Genome Wide Associa on studies

5. Consultant le ers: Include hourly rate & # of hours; no % effort!

PHS 398 Research Plan

Page 18

4. Ins tu onal Approvals required prior to rou ng.



Required for renewals.


FO Title: Copy & paste the tle from the FOA; do not enter the project’s tle.

FO Number: Copy & past the number from the FOA.

PHS Assignment Request Form

Page 19



Awarding Component: Read the FOA; make sure the selected I/C par cipate(s) in the funding opportunity.


The informa on is auto‐populated from the R&R

Other Project Informa on form; if edi ng is needed,

go to Other Project Informa on page.

PHS Human Subjects and Clinical Trials Informa on

Page 20



Study Record: If human subjects are to be involved in the project, create one study record for each study.

Delayed Onset Study: Human subjects research is an cipated within the period of award but definite plans for this involvement cannot be described in the applica on.


Study Record: PHS Human Subjects and Clinical Trials Informa on

Sec on 1

Page 21



Study Title: Each study tle should be unique.

Clinical Trial Ques onnaire: If the four answers are all “Yes”, the study is deemed an NIH clinical trial.



Sec on 2

Page 22



Eligibility Criteria: List inclusion and exclusion criteria as bullet points.

Inclusion Narra ve: To merge FORMS‐D two inclusion files (Women & Minori es + Children).



Sec on 3

Page 23



sIRB Plan: Mandatory for domes c sites of mul ‐site studies where each site will conduct the same protocol involving non‐exempt human subjects research funded wholly or in part by NIH (NOT‐OD‐18‐004 ).

If not clinical trials, you should stop here.



Sec on 4, Part I

Page 24



Interven on: Each interven on used should be added to each record. Thus, if there are two arms with different interven ons, be sure to include both.

Primary Purpose: If “Device Feasibility” is selected, note clinical trials for this purpose are not considered “applicable clinical trials”.

Study Phase: If behavioral studies, select “Other” and list N/A below as shown.



Sec on 4, Part II

Page 25



Dissemina on Plan: A new document; read the SF424 instruc ons carefully and address all the required points. Sample language is available at the end of the checklist (page 34).

Outcome Type

Primary & Secondary: The results will be required to be reported to ClinicalTrials.gov.

Other & Exploratory: The results are not required for repor ng.

The word “use” is approximately equivalent to “evaluate” as defined at ClinicalTrials.gov.



Sec on 5

Page 26



Refer to the FOA for specific instruc ons.

Please contact Diane Wilson ([email protected]) at

Regulatory Affairs for ques ons on ClinicalTrials.gov.

A achments Non‐Clinical

Trials Clinical Trials

2.4 Inclusion of Women, Minori es, and Children Yes Yes

2.5 Recruitment & Reten on Plan Yes Yes

2.7 Timeline Yes Yes

3.1 Protec on of Human Subjects Yes Yes

3.2 sIRB Plan, if “Yes” to Q3.2 Yes Yes

3.3 Data and Safety Monitoring Plan Op onal Yes

3.5 Overall Structure of the Study Team Op onal Yes

4.4 Sta s cal Design & Power No Yes

4.7 Dissemina on Plan No Yes

Required A achments in the Study Record Form


PAF Summary ‐ Print Version

Make sure Project Long Title EXACTLY matches the tle in the applica on on R&R Cover Page 1, item 11.

This sec on must reflect all faculty PLUS for sponsors following Financial Conflict of Interest (FCOI) requirements all Inves gators (any role with the word Inves gator, PD/PI, Co‐I, Research Inves gator, Mentor) & those listed as Key Personnel .

PA‐18‐345

Campus deadline = Sponsor published deadline. If a weekend or holiday, roll to the next work day!

Required Med School field. Refer to Medical School’s deadline calculator.

Page 27

A Proposal Approval Form (PAF) should reflect what is being sent to the sponsor. All infor‐

ma on on the PAF should match and reflect what is in the proposal. Even if par ally com‐

ple ng the PAF prior to filling out the 424, a cross check back through the PAF is necessary to

verify that the final informa on is represented.




PAF ‐ Page 2

Includes students regardless of whether they are receiving compensa on.

If they are funded in this project, check if this is reflected in the R&R Budget

form or Budget Jus fica on.

Mandatory in Medical School.

Check against the applica on (budget, le er of support, etc.).

PAF Summary ‐ Print Version, Con nued

Page 28



Check against the applica on (R&R Other Project Informa on, item 1), including Yes/No answers and Approval Date (if applicable).

Check against the applica on (R&R Other Project Informa on form,

item 2), including Yes/No answers and Approval Date (if applicable).

If Yes, make sure Select Agent Research file is upload‐

ed in the applica on (PHS 398 Research Plan, item 10).

Check against Project Summary/Abstract in the

applica on (R&R Other Project Informa on, item 7).


PAF ‐ Page 3

Click here for Space FAQs. Quick Reference for UMHS Space: List space details (building & room) OR List as “Adequate Space” and for each line: Indicate Medical School or Hospital space. If hospital, further list whether Hosp Clinic or Hosp Office. Remember for Hosp/Clinic, CDA must approve (email or sign PAF).


Page 29



Check against the applica on (R&R Cover Page 1, item 12).

Check against the applica on (R&R Budget ‐ Cumula ve Page, Sec on G & H).

Check against the applica on (R&R Budget ‐ Sec on F ‐ L, BUDGET PERIOD 1, Sec on G, H, I).

Check against the applica on.

Check amount against the applica on R&R BUDGET, SUBAWARD ‐ Cumula ve Budget, Sec on K.

Also check against the ins tu onal le er of commitment.

If mul ple subawards, the total costs of EACH subaward should be checked.

If modular budget, each year’s exclusions should be listed in the Comments field.

The IDC rate should be the same for the Project and Budget lines (IDC rate on the 1st day of the project).

This # is auto‐populated.

When any resources are listed in the proposal without a financial source and will be covered by UM, they should be listed here, with the exact $ values.

If any non‐UM organiza ons are listed in the proposal as providing a financial resource.

When any UM resources are listed in the proposal without a specific $ value.

The IDC rate should be the same for the Project and Budget lines (IDC rate on the 1st day of the project).

All ins tu onally signed le ers of commitment are required prior to rou ng the PAF for review.

When one or more unit(s) of U‐M make(s) a commitment to provide a resource if the project is fund‐ed, but the arrangement is not referenced in the proposal and has not been shared with the sponsor.


PAF ‐ Page 5

Not a required School field; but if completed, it must

match the applica on (R&R Budget ‐ SECTION A&B,

BUDGET PERIOD 1 form, Sec on A).

Make sure PI has signed.


Page 30

Since the NIH applica on (unless via ASSIST) is linked to the PAF, proposal documents

do not need to be uploaded if already in the SF424. If there are uploads, please be

sure to capture the most recent version of the applica on for consistency purposes.




PAF ‐ Page 6

Review the details of the ORSP instruc ons.


Page 31



For all DHHS, including NIH, applica ons, check “Yes”.

12.20.2017

Dissemination Statement for NIH Clinical Trials Form E

NOTE: This language would only be appropriate for grants submitted with proposed trials for which the UM Principal Investigator is the initiator of the trial and there is no other IND/IDE holder for an investigative drug or device. An alternate version is provided below for UMCC (Cancer Center) trials. If you have a situation that seems more complex, than that described above, please contact Diane Wilson at [email protected] or [email protected] (link sends e-mail).

As Responsible Party, I will share information about this/these trial(s) via timely registration, updates, and results reporting in ClinicalTrials.gov in accordance with NIH policy.

The informed consent documents used for this/these trial(s) will include statements to inform participants that information about the trial will be posted in ClinicalTrials.gov.

The University of Michigan’s Human Research Protections Program (HRPP) Operations Manual is the primary location where rules, policies, practices, and guidance pertaining to the University’s HRPP are provided, including Section 11 (H) which addresses the requirements to register trials and report results. Compliance with these provisions is monitored by designated components of the UM HRPP.

*****************

CANCER CENTER VERSION:

I commit to working with the University of Michigan Cancer Center to share information about the trial(s) that will start under this grant via timely registration, updates, and results reporting in ClinicalTrials.gov in accordance with NIH policy.

The informed consent documents used for these trials will include a statement to alert participants that the trial will be posted in www.ClinicalTrials.gov.

The University of Michigan’s Human Research Protections Program (HRPP) Operations Manual is the primary location where rules, policies, practices, and guidance pertaining to the University’s HRPP are provided, including Section 11(H) which addresses the requirements to register trials and report results. Compliance with these provisions is monitored by designated components of the UM HRPP.

mailto:[email protected]

mailto:[email protected]

Documents

Medical School NIH Research Proposal Review Checklist...provides a quick reference to address the most common mistakes in proposal prepara on. Research Administrators are encouraged