04/21/23 LSUHSC-NO ORS Training Series 1

LSU School of Medicine-New Orleans (LSUSOM-NO) is the provider of Continuing Medical Education for this activity. The planning and presentation of all LSUSOM-NO activities ensure balance, independence, objectivity and scientific rigor.

The LSU School of Medicine-New Orleans designates this educational activity for a maximum of 1.5 AMA PRA Category 1 Credit(s) ™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

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Disclosure

I do not have any relationship(s) with commercial interests.

A commercial interest is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients.

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When in Doubt, Route!

Processing Grant Applications and Contracts

Welcome

– Presenter:• Nicole G. Hammill, MBA• Coordinator of Grants and Development• Office of Research Services

– 433 Bolivar Street, Room 206E, New Orleans, LA 70112– Nbarro@lsuhsc.edu– (504) 568-4970 tel– (504) 568-8808 fax

– http: http://www.lsuhsc.edu/administration/academic/ors/grants_contracts_processing.aspx

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Office of Research ServicesDirector:

Dr. Kenneth E. Kratz

Staff:

Nicole G. Hammill – Pre-award (Grants and Contracts)Rose Castay – IACUC and IBCDyan Melson – IRBLynn Arnold – IRBAmy Tassin – IRB Anissa McDougle – Conflicts of Interest

Responsibilities:

• Pre-award, sponsored project activity; this includes evaluation and routing for signatures all grant applications, research agreements, and clinical trial agreements.

• Conflict of Interest Program based upon Chancellor’s Memorandum #35 “Individual and Institutional COI in Sponsored Projects”. 

• The AAHRPP “Fully Accredited” Human Research Protection Program and Institutional Review Board (IRB) which provides oversight for the protection of human subjects participating in research. 

• The Institutional Animal Care and Use Committee (IACUC) which provides oversight for the welfare of animals used in research.

• The Institutional Bio-safety Committee (IBC) which in collaboration with the Office of Environmental Health and Safety provides oversight of bio-safety issues and recombinant DNA research.

Helpful Administrative Information

• Most of the numbers, dates, names, and titles commonly needed for the completion of grant applications can be found here:

http://www.lsuhsc.edu/administration/academic/ors/docs/Helpful_Administrative_%20Information.pdf

Updated frequently!

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Agenda

Who should route materials?

What should be routed?

When should materials be routed?

Where do routed materials go?

Why should materials be routed?

How should materials be routed?

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Who?Develops Materials?

PIs, with assistance from:Business ManagersAssistant Business ManagersOther Departmental Administrative Personnel

Signs Materials?

PIsFellows (if applying for fellowship grant)Business ManagersDepartment HeadsDeans*

*Office of Research Services personnel are authorized to sign on behalf of the SoM Dean; all other schools (SoN, SoAH, SoGS, SoPH, SoD) should have their Dean sign.

Is Responsible for the Contents?

Persons who sign the routing sheet agree to the items contained within the routing sheet – including accuracy of materials and various certifications.

Read the routing sheet!

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What?Grant Applications (new, resubmissions, renewals, transfers, revisions [aka “supplements”])

Progress Reports

Just-in-Time Submissions

Clinical Trial Agreements

Research Agreements

Grant Award Agreements

Confidentiality Disclosure Agreements

Material Transfer Agreements (Note: these should be routed to the Office of Technology Management)

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What? (continued)Subcontracts

Amendments (to any type of agreement noted above)

Major changes to personnel or scope requiring sponsor approval

Second no-cost extension requests

Relinquishing statements

Carryover requests

Application withdrawal requests

…And Many More!

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What? (continued)Ask Yourself:

Is Institution making a commitment to receive funds, perform work/services, or share costs?

Is Institution certifying, verifying, or representing anything?

Is anyone’s signature required by the sponsor?

Is financial information of any kind being provided to a non-LSUHSC-NO entity?

Will the Office of Research Services need to submit anything electronically?

Could export controls issues arise?

Then Ask Us!

Remember: PIs are not authorized to make commitments on behalf of the institution!

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What? (continued)

Exceptions:

Expenditure contracts are handled through your Dean’s office. Contact:

School of Medicine: Mary Lapworth, Daniela Schmidt and/or Richard Buhler

School of Public Health: Scott Dessens

School of Allied Health: Joseph Lassalle

School of Nursing: Marsha Bennett

School of Dentistry: Mary Gerry

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What? (continued)

Exceptions:

Intramurally funded grants do not need to be routed. Examples include:

The School of Medicine’s “Research Enhancement Fund”

The Neuroscience Center’s “COBRE III Pilot Projects”

The Louisiana Cancer Research Consortium’s “Bridge, Competitive Advantage, and Seed Fund” Awards

But when in doubt, ask!

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What? (continued)

Exceptions:

Some Pre-Applications do not need to be routed. Examples include:

NIH Letters of Intent

Susan G. Komen for the Cure Letters of Intent

But Some Pre-Applications do need to be routed. Examples include:

Board of Regents Notices of Intent

Department of Defense Pre-Applications (if budget amount is requested)

But when in doubt, ask!

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What? (continued)

Exceptions:

Some Post-Submission Materials do not need to be routed. Examples include:

Biographical sketches (e.g., change in senior/key personnel due to the hiring, replacement, or loss of an investigator)

Letters of support or collaboration resulting from a change in senior/key personnel due to the hiring, replacement, or loss of an investigator

News of an article accepted for publication (a copy of the article should not be sent)

News of a professional promotion or positive tenure decision for any Program Directors/Principal Investigators and Senior/Key Personnel

But when in doubt, ask!

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What? (continued)

Exceptions:

But some Post-Submission Materials do need to be routed. Examples include:

Revised budget page(s) (e.g., change in budget request due to new funding or institutional acquisition of equipment)

Adjustments resulting from natural disasters (e.g., loss of an animal colony)

Adjustments resulting from change of institution (e.g., PD/PI moves to another university)

But when in doubt, ask!

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What? (continued)

For Grant Applications and Related Materials:

List and templates available at:

http://www.lsuhsc.edu/administration/academic/ors/grants_contracts_processing.aspx

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What? (continued)

For Contracts and Related Materials:

Procedures Listed Here:

http://www.lsuhsc.edu/administration/academic/ors/docs/procedures_for_processing_agreements_contracts.pdf

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What? (continued)

Tour of the Routing Sheet

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1. When your paperwork arrives at ORS, it’s logged in by ORS staff.

2. More than one may apply (example: a research project that’s a drug study).

3. More than one may apply (example: a subcontract on a clinical trial agreement).

4. Remember the difference between a grant (which implies it’s already been awarded) and a grant application (which implies it’s not yet been awarded).

5. More than one may apply (example: a resubmission of a renewal application).

1

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4

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6 7 8 9

10 11 12

6-7. This is the person who will serve as the “Contact PI” for work performed at LSUHSC-NO (not necessarily the PI of the project in the case of our being a sub-applicant/awardee). Note: Last name first!

8. If this is an existing project, insert the PeopleSoft project/grant number (example: 149740170A).

9. If this proposal is to be submitted electronically, either by the PI or by the ORS, check “yes”.

10-11. This is the person who will serve as the additional PI on a Multi-PI application. Do not list co-investigators here. Note: Last name first!

12. If this proposal is to be submitted electronically by the ORS, check “yes”. If “yes” is not checked, we will assume that it requires no action on our part and will not schedule time to be available to submit your proposal.

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13. Information for Contact PI. Example: Medicine/Infectious Disease/School of Medicine. This is the department to which an account number will be assigned if award is made.

14-16. The more ways to get in touch with the PI, the better.

17-20. Information for additional PI.

21-24. The Administrative Contact is the person to whom inquiries about the paperwork may be directed, and who will be copied on all related correspondence. Usually this is the business manager or grants/contracts coordinator.

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25

26

27

28

25.This question is asking who the Sponsor of the project is. The Sponsor is the entity from whom the money is originating. Example: NIH-NIDDK.

26. If we are a sub to another entity, list who the prime applicant is. Example: Tulane. Sometimes it’s not immediately obvious who the Sponsor of a project is, as opposed to the Prime Applicant/Awardee. Read documents carefully for clues, such as a grant award number (1R01CA121999-01A1, for example, tells us that the Sponsor is the National Cancer Institute), or a project title. “Johns Hopkins Study of USDA’s Policies” hints that USDA is the Sponsor, while Hopkins is the Prime Applicant/Awardee.

27.This is the drop-dead date at which the materials must be delivered to the Sponsor.

28.This is the drop-dead date at which the materials must be delivered to the Prime Applicant, if they are transmitting the application to the Sponsor. You may additionally, but not alternatively, list this date.

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29 30

29.The Funding Opportunity Announcement #, or “FOA”, assists our office in ensuring that you have met all of the requirements for submission. Time permitting, we will review the FOA prior to reviewing your application to check for compliance with the instructions. We also need to know the FOA so that we can see if there is anything unique/trackable about the source of funds, such as the Affordable Care Act or ARRA, on which we are required to report.

30. If this is an existing project, it will likely have a grant award number or contract number assigned to it. That number should be listed here. For progress reports and revisions (aka “supplements”), list the anticipated grant award number (example: 3R01CA121999-01A1S1 would be the anticipated supplement award number for 1R01CA121999-01A1).

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31.List the title of the project. Helpful hint: NIH grant applications have a character limit of 200, including spaces.

32.Examples include “R01”, “Grant-in-Aid”, “Research Scholar Grant”, etc. We are asking for the mechanism, as defined by the sponsor, through which funds will be awarded. Therefore, showing “grant”, “contract”, etc. would not be correct. Not every sponsor has assigned names for its award mechanisms; if that is the case, this field should be left blank.

33.Keywords are available via a drop-down list. Routing sheets without keywords will be returned without review, or held until keywords are provided.

34.On this line, we need to know the location(s) where any clinical trial will be performed.

3132 33

34

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35

3637

35.On this line we want the signature(s) and title(s) of someone at the performance site(s) (e.g., Ochsner Hospital), where the clinical trial will be conducted. This person will typically be the Chair of the “Research Review Committee” or its complement at the performance site. For some private hospitals this person may be an administrator. The purpose of this requirement is to assure that the performance site is aware of the project and has an opportunity to provide input on their part of the clinical trial budget.

36. If the paperwork is associated with a clinical trial, this question must be answered; if yes, contact your school’s contracts management office. For definitions of “personal, professional, or consulting services”, see http://www.lsuhsc.edu/administration/supplychain/personal_professional_consulting_services.aspx.

37. If the paperwork is associated with a clinical trial, this question must be answered; if yes, contact supply chain management.

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38 39 40 41

42 43 44 45

38. Note that sometimes a “budget year” may not be 12 months long. Example: a grant that is being transferred from another institution in the middle of its

funding period.

39-41. See cells H53, H54, and H55 of budget template.

42. Show the entire funding period, including the first year.

43-45. See cells M53, M54, and M55 of budget template.

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46. Different types of personnel have different fringe benefit rates. See budget template and http://www.lsuhsc.edu/administration/accounting/fa_fringe.aspx.

47. The routing sheet will be updated when F&A rates change. To confirm current F&A rates, see: http://www.lsuhsc.edu/administration/accounting/fa_fringe.aspx.

48. Note that, for your convenience, an explanation of what constitutes Modified Total Direct Costs (MTDC) is provided.

49. If the sponsor is being charged for IRB review (typical with clinical trials), check “yes”.

50. Remember that the IRB fee is not charged to federal sponsors.

51. Check “N/A” to the IRB fee question if the project does not involve human subjects.

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48

49 50 51

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52. Sometimes, a sponsor is unable or unwilling to pay our full, federally-negotiated F&A rate. If this is the case, you must provide an explanation.

53. Additionally, documentation from the sponsor about the F&A rate must be attached to the materials that are routed. This documentation can come from the funding opportunity announcement (FOA) or the sponsor’s web site. An e-mail from the sponsor is not sufficient. An example, from the American Cancer Society’s RSG FOA: “The maximum award is for 4 years and for as much as $200,000 per year (direct costs), plus 20% allowable indirect costs.”

54. If LSUHSC-NO is willing to accept the reduced F&A rate as described above, Sponsored Projects will sign off here.

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53

54

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55.The abstract will be reviewed by ORS to determine if approval from Radiation Safety is required. See: http://www.is.lsuhsc.edu/safety/radiation.aspx

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56. The abstract will be reviewed by ORS to determine if the project involves human subjects.

It is your responsibility to insert the most current approval/reapproval date and number, which will be checked against our databases.

Note that the individual project IRB approval number is not the same as our federal-wide assurance (FWA) number. For projects involving human subjects, it may be possible to amend an existing approved protocol to include the new sponsor and a different title. Contact the ORS for further information.

If the ORS makes changes/corrections to this section of the routing sheet, please make a note of them for future reference.

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57. The abstract will be reviewed by ORS to determine if the project involves animal research. It is your responsibility to insert the most current approval/reapproval date and number, which will be checked against our databases. Note that the individual project IACUC approval number is not the same as our animal welfare assurance number.

For projects involving animals, if the IACUC protocol is already associated with a funded grant, it cannot be used for anything else. It is “locked” to that grant until the funding agency closes the award. The NIH rules state that one cannot have concurrent multiple submissions for the same project (changing titles does not make the project different), thus an IACUC protocol cannot be used for concurrent multiple submissions of federal grant applications. If the PI has an approved IACUC and he does not have an active NIH grant, he can submit a grant application with his IACUC approval if the specific aims/research design match the IACUC protocol. If there are minor differences between the grant application and the existing IACUC protocol, it may be possible to amend the IACUC approval. Amendments should only be requested for work that the PI will perform in that IACUC approval as described in the grant application. Once amended, the PI must adhere to the revision approved by the amendment whether the grant is awarded or not. The purpose of an existing approved IACUC protocol should be that the PI is attempting to secure funding related to the IACUC protocol. If trying to secure funding for a new study that will be done in addition to the current approved IACUC, the PI should submit a new IACUC application. There are very rare exceptions that the IACUC will allow multiple funding on a single IACUC, and these are approved on a case-by-case basis.

If the ORS makes changes/corrections to this section of the routing sheet, please make a note of them.

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58. On October 1, 2008, it became mandatory that all principal investigators with research projects requiring IRB and/or IACUC approval/re-approval must submit an application to the LSUHSC-NO Institutional Biosafety Committee (IBC). This requirement applies to all projects, including survey or chart review studies (this will confirm that the project is exempt from further IBC review).

The form is available at the Office of Research Services web site at http://www.lsuhsc.edu/administration/academic/ors/ibc.aspx. Please follow the instructions closely when completing the application. An electronic version of this application must be sent to IBCoffice@lsuhsc.edu, and a hard copy of the last page must also be sent to: IBC Office, 433 Bolivar Street, Room 206, New Orleans, LA 70112.

Because of this requirement, the IBC approval question should not be marked “not applicable”. It should either include the IBC approval date and number, note that the project has been confirmed as exempt from further IBC review, or be marked “pending”.

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59.As indicated in this notice: http://grants.nih.gov/grants/guide/notice-files/not-od-08-033.html, it is now a requirement that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine’s PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. This policy refers only to publications associated with/resulting from NIH funding.

Obviously, this question should be answered when submitting an NIH progress report (“non-competing continuation”), renewal (“competing continuation”), and revision (“competing supplement”), not when submitting a new grant application.

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60. If renovations, alterations, or other changes to the LSUHSC-NO physical plant are required, sign-off from the Associate Vice-Chancellor, Property & Facilities Management is required. ORS will secure this signature as appropriate.

61. This commonly-misread item refers to patent rights, not patient rights. If patent rights are involved, they may need to be protected before the application is submitted to the sponsor. ORS will secure the signature from the Office of Technology Management as appropriate.

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62. Please review these assurances and certifications, as well as the ones that appear above them on the routing sheet. Everyone who signs is responsible for these.

63. The PI signs here; this field cannot be signed by proxy except in extraordinary circumstances. Contact the ORS for more information.

64. The NIH requires fellowship applicants to sign the routing sheet. See: http://grants.nih.gov/grants/guide/notice-files/not-od-09-007.html.

65. The Business Manager signs here; this field cannot be signed by proxy except in extraordinary circumstances. Contact the ORS for more information.

66. The Department Head signs here; this field cannot be signed by proxy except in extraordinary circumstances. Contact the ORS for more information.

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67 68

67. The ORS is authorized to sign on behalf of the Dean of the School of Medicine only. All other schools (SoGS, SoAH, SoN, SoPH, and SoD) must secure the signature of their dean.

68.Sponsored Projects signs here.

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When?For all grant applications (paper and electronic):

At least 10 working days in advance of an application deadline, PIs should provide to the Office of Research Services the materials discussed previously.

For electronic grant applications:

At least 5 working days in advance of an application deadline, PIs should transmit to the Office of Research Services a complete electronic submission.

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When?

• Monthly reports are provided to the Vice Chancellor for Academic Affairs regarding the timeliness (or lack thereof) of paperwork and electronic file submissions to the ORS!

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Where?For PAPER Grant Applications and Related Materials:

1. Principal Investigator reviews and signs

2. Business Manager reviews and signs

3. Department Head reviews and signs

4. Dean reviews and signs (SoPH, SoAH, SoN, SoD, SoGS only)

5. Departmental Representative delivers to Office of Research Services

6. Office of Research Services logs receipt, performs detailed review, communicates with Principal Investigator and Business Manager as needed, signs, logs transmission to Sponsored Projects

7. Sponsored Projects performs budget review, communicates with Principal Investigator and Business Manager as needed, signs, delivers to Office of Research Services

8. Office of Research Services logs receipt from Sponsored Projects, and logs transmission to Authorized Organization Official

9. Authorized Organization Official signs

10. Office of Research Services picks up and logs receipt from Authorized Organization Official, notifies Principal Investigator and Business Manager

12. Departmental Representative picks up from Office of Research Services

13. Principal Investigator submits application to sponsor

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Where? (continued)For ELECTRONIC Grant Applications and Related Materials:

Follow steps 1-12 (see previous slide), then:

14. Principal Investigator e-mails or otherwise transmits electronic file to Office of Research Services

15. Office of Research Services performs detailed review of electronic file and communicates with Principal Investigator and Business Manager about required corrections, if any

16. Principal Investigator makes all required corrections and transmits electronic file back to Office of Research Services

17. Office of Research Services, acting on behalf of Authorized Organizational Official, submits application

18. Office of Research Services sends all confirmation e-mails to Principal Investigator and Business Manager

Note: Investigators should make themselves available until ALL confirmations are received!

19. Principal Investigator follows all instructions received in confirmation e-mails to ensure successful submission

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Why? Required by sponsor Required by state auditors Required by federal regulations Potential Conflicts of Interest must be evaluated (see:

http://www.lsuhsc.edu/administration/academic/ors/conflict_of_interest.aspx)

Information must be reviewed for compliance in a variety of areas (IRB, IACUC, IBC, Radiation Safety, Conflict of Interest, etc.)

We may need to review the Funding Opportunity Announcement (FOA) to ensure our (and your) rights to intellectual property are protected

Data is needed for reportsTo dean

To chancellor

To LSU systems office

Budget is incorrect approximately 30% of the time Proposed project must be evaluated for fit with institutional mission Proof that all interested parties are aware and approve of submission and

its consequences/commitments Clinical trial performance sites must be aware and approve of studies Export control issues may arise

Why?

• Because the NIH says so:

– “NIH grant applicants are responsible for verifying the accuracy and validity of all administrative, fiscal, and programmatic information at the time of submission [including] information submitted through the Just-in-Time process. [Applicants] are responsible for establishing and maintaining the necessary processes to monitor their compliance with this policy and informing NIH of any problems or concerns. “

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How?Hand delivery is generally wiser than relying on campus mail

Directions to 433 Bolivar Street:

Room 206

Resource Center Building (same building as library)

Down the hall from Campus Federal Credit Union

“In” box affixed to Nicole Hammill’s door

Also, “ORS After-Hours Drop-Off” located just outside of room 205.

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Thank you!

Questions?