Protocol Compliance on Sponsored ProjectsDecoupling IRB and IACUC end date from the budget period while mitigating risk

ContentsExecutive Summary.....................................................................................................................................2

Definitions...................................................................................................................................................3

Acronym key................................................................................................................................................3

Project Set-up..............................................................................................................................................4

Guidance for DSR entry into NOA database............................................................................................4

Notification of potential and actual project shut down...............................................................................5

Transactions during lapse and retro’s posted after lapse............................................................................7

Anticipated benefits....................................................................................................................................7

Appendices..................................................................................................................................................8

Appendix 1: Warning of potential shutdown email................................................................................8

Appendix 2: Shut Down Notification Email.............................................................................................9

Appendix 3: Reopen spending email....................................................................................................10

Flow Diagram – Business Process..........................................................................................................11

Flow Diagram - Appropriate allocation of “status”...............................................................................12

Flow Diagram - Action to record after spending shut down.................................................................13

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Executive SummaryHuman Subjects and Vertebrate Animal use are two research compliance areas that by their nature require the most attentive management. The approval process to consider and ultimately allow researchers to utilize human participants or animals on their research is scrutinized to ensure that the utmost protections for the subjects’ welfare are in place. In parallel, sponsored projects administration must adhere to processes that ensure that appropriate approvals are in prior to spending place on each sponsored project. To ensure sponsored projects are managed to mitigate risk that human or animal subjects will not be involved without proper approval, the following documents the procedures at the University of Florida.

Once the initial congruence between the protocol and the sponsored project has been determined by the appropriate compliance committee, this information is provided to the Division of Sponsored Research (DSR) and entered into the DSR database by Awards Administration. Through a Notice of Award, DSR directs Contracts & Grants Accounting (C&G) to establish a project in the PeopleSoft accounting system and the research can begin.

Historically at the University of Florida, the budget end date was entered as the protocol expiration date. Effective August 2012, the budget end date will be the date provided by the Sponsor. Should the protocol identified for use on the project be renewed on time, automated processes will update the protocol information in the DSR and PeopleSoft systems. Reports will facilitate monitoring and notification to DSR of discrepancies in the data entry.

In the event that the protocol comes within two weeks of expiring, the PI will be provided an email warning to remind them that the protocol must stay active in order for spending on the project to continue. Should the protocol expire, DSR, C&G and the PI will be sent an email from the DSR database and C&G will inactive the project. No spending will be allowed until the protocol is renewed. C&G will work with departments to stop all spending including removal of existing salary distributions. Without redistributing, salary distributions will continue to post against the project In exceptional circumstances, reprieve can be granted by the Director of the Division of Sponsored Research to continue work that does not require protocol coverage.

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Definitions Project period – The total time for which support of a project has been programmatically

approved. A sponsor may fund in increments (budget periods) or fully funds the entire project period up front.

Budget period– The intervals of time (usually 12 months each) into which a project period is divided for budgetary and funding purposes. Some sponsors obligate funds for individual budget periods (National Institutes of Health or NIH) referencing intention to fund future budget periods comprising the overall project period. Other sponsors obligate funds the full project period even if greater than 12 months.

Protocol expiration – When the investigator intends to continue activities requiring approval but has allowed the approval to lapse.

Protocol closure – When activities related to human or animal activities have completed and the investigator has certified to the compliance committee (IRB or IACUC) that no future contact with human or animal subjects requiring review will occur.

Appropriate charges – Applying NIH guidance regarding animal activities to all sponsors and both human and/or animal activity, sponsors do “not permit charges to grant awards for the conduct of [live vertebrate animal] activities during periods of time” where there is an absence of a valid committee approval.

Acronym key C&G – Contracts & Grants Accounting Services. Unit responsible for creation of projects and

fiscal accounting on University of Florida sponsored funding. DSR – Division of Sponsored Research. Unit responsible for ensuring compliance with sponsor

policies for University of Florida sponsored funding. IACUC – Institutional Animal Care & Use Committee. Unit responsible for ensuring University of

Florida compliance with animal use laws, regulations and policies. IRB – Institutional Review Board. Unit responsible for ensuring University of Florida compliance

with human subjects laws, regulations and policies. KK – PeopleSoft Commitment Control. Dates in the accounting system against which

transactions are compared to determine allowability. NOA – Notice of Award. Document submitted from DSR to C&G and University of Florida to

communicate administrative actions on sponsored projects. PI – Principal Investigator. Individual directing the scope of work and ultimately responsible for

technical and fiscal compliance. UPN – University Project Number. DSR number to identify an action on a sponsored project. WIRB – Western Institutional Review Board. Third party organization contracted to review

protocols for industry sponsored clinical trials.

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Project Set-upWhen projects are set up or existing projects are modified, DSR will enter the budget period and project period per the sponsor’s award. The approved protocol ID number and end date will be entered in the DSR NOA database appropriated fields. The fields will be used to confirm initial data entry. Protocol ID, Expiration Date and Status mismatches will be provided to DSR daily on error reports. C&G will continue to enter the budget period end date as the KK end date – only now this date will not reflect the protocol expiration but the sponsor’s award.

1. Clinical Trials and other Sponsored Awards with no defined end date in the award will be set up with a budget and project end date 3 years from the start date. When the protocol end date reaches beyond the current end date, 3 year increments will be added to the budget and project end dates.

2. Internally funded (UFF, DSR, etc), Miscellaneous Donor and Multiple Sponsor projects with no defined end date will be set up with a budget and project end date 5 years from the start date. When the protocol end date reaches beyond the current end date, 5 year increments will be added to the budget and project end dates.

3. Standard entry formats must be used. Reports are available for DSR to review and correct errors in the initial entry (where protocols do not match this format, do not match the end date as provided by the committee or the do not match the status as provided by the committee).

Guidance for DSR entry into NOA database Source of Approval

Approval number Length

Format of Approval number

Sample Notes

IRB Legacy

7-chars YYAnnnn 11H0123 Where YY is year, A is the IRB letter (H,J,U) and nnnn is a padded sequence number.

WIRB 7-chars nnnnnn 1141123 WIRB Study Number (not Protocol number).

IRB Click 9-chars YYYYnnnnn 201101234 Click format is IRBYYYYnnnn. Due to PeopleSoft limitations, remove the IRB prefix and just enter the YYYYnnnn.

IRB Deferred

8-chars Deferred Deferred Where the IRB has approved deference to non-UF IRB for the approval, enter ‘Deferred’ as the approval number and the institution’s protocol end date.

IACUC Click

5-chars nnnnn 01234 Where the Click IACUC includes the YYYY as the original year of the 3 year approval, only the 5 digit sequence number nnnnn following the year is entered. If the protocol number is a “collided triennial” (includes-xx at end), exclude the dash and suffix.

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Guidance for DSR entry for unusual approvals or those with non-date end dates

Type of approval

Indicator Approval number

End date

Notes

IRB Exempt

H per guidance above

EXEMPT

Indefinite use

H per guidance above

INDEFI Review should be done at EACH NOA transaction to confirm that is still an appropriate status. A report will be provided to DSR for review weekly.

WALSH X WALSH Leave End Date blank. Review should be done at EACH NOA transaction to confirm that is still an appropriate status. A report will be provided to DSR for review weekly.

Non-Human

N Non-Human use indicated by the IRB is not required to be tracked. HS use = NO according to IRB Executive Director Mahoney.

Notification of potential and actual project shut downWhen an IRB or IACUC used on a project in the DSR database expires within 8 days, an email will be generated to the PI with copy to the PeopleSoft Project department contact, Brad Staats, Assistant Vice President of Contracts & Grants Accounting; Tiffany Schmidt, Associate Director of Contracts & Grants Accounting; Brian Sevier, Associate Director of Contracts & Grants Accounting; Peter Pevonka, Associate Vice President for Research; Tom Walsh, Director of Research and Compliance, Division of Sponsored Research; and Brian Prindle, Associate Director of Research, Division of Sponsored Research. This email will notify the PI that if the protocol is not extended or an exception granted by DSR then the spending on the project will be stopped (See Appendix 1).

1. If the IRB or IACUC protocol is approved before the expiration of the project, the protocol end date in the NOA database and PeopleSoft databases will automatically be updated using loading and interface tools that are in the process of being built.

2. If the PI has mitigating circumstances and wishes to continue spending after the expiration of the protocol, the PI must contact the Director of DSR to discuss the situation. a. If the Director of DSR approves of an extension, DSR will update the DSR database in accordance

with the entry guidance for Director approved protocols. C&G will be courtesy notified but no update in PeopleSoft is required. When the actual protocol is approved by the compliance committee, DSR will update the DSR database with the extension information. If the protocol approval number differs from the prior, an NOA will be processed. If the NOA is the same and only the protocol end date changes, C&G will receive courtesy notification but no update of any information in PeopleSoft is required.

b. If the Director does not approve, the spending will be stopped per item c below.3. If the protocol expires, an email will be sent to Brad Staats, Assistant Vice President of Contracts &

Grants Accounting; Tiffany Schmidt, Associate Director of Contracts & Grants Accounting; Brian Sevier, Associate Director of Contracts & Grants Accounting with copy to the PI, the PeopleSoft Project contact, Peter Pevonka, Associate Vice President for Research; Tom Walsh, Director of Research and Compliance, Division of Sponsored Research; and Brian Prindle, Associate Director of

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Research, Division of Sponsored Research to notify C&G to insert a new Project Status row effective dated the protocol expiration with Status Closed (See Appendix 2). This effectively inactivates the project which will stop future transactions from posting to the project. Standard text in the comments beginning with “PROTOCOL EXPIRED” will be used to be able to identify this cause as opposed to any other closure on file.

This status is visible to C&G and campus on the PeopleSoft Project Summary page Grants>Grants Summary Pages>Project Summary and searching for the project. The Project Status is in the upper right hand corner.

4. When the protocol is reapproved, an email will be sent to Brad Staats, Tiffany Schmidt, and Brian Sevier with copy to the PI, the PeopleSoft Project contact, Peter Pevonka, Tom Walsh & Brian Prindle to notify C&G to update the Project Status to Open. The PI and the IRB/IACUC are responsible for ensuring that no human and/or animal experimental contact occurred during the lapse. Assuming such is audited by the IRB or IACUC, charges should be allowed to post as they could only be for non-human or non-animal activity.

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Transactions during lapse and retro’s posted after lapseAs soon as the project is inactivated at protocol expiration, all non-salary transactions will be rejected. However, it is the policy of the University of Florida that salaries, once distributed, are allowed to post. Therefore, salaries distributed past the protocol expiration date may post when the lapse occurs. C&G will make best efforts to communicate with departments at the time the project is inactivated to move these to discretionary fund sources. Should this not be possible prior to inactivation, C&G will be responsible for working with the departments to review the salary charges and either remove or gain certification from the PI that the salaries were incurred for work not related to the protocol.

Any charges that are attempted to be retro’d or cost transferred onto a project for dates during the lapse period will be subject to increased C&G scrutiny. Animal holding charges would not be allowed unless prior approval from the sponsor is granted. Investigators will be responsible for all charges for holding protocols and such charges should be posted to discretionary (not sponsored) funds. All other charges would be reviewed in detail to ensure that the transactions do not reflect work on the protocol. The efforts are to help reinforce the regulations that no human or animal work (no matter where charges are posted) is allowed during a period when the protocol has lapsed.

Reports will be available for review by C&G, the Office of Research, or any of the compliance committees to review charges that were posted or retro’d on during the lapse period.

Anticipated benefitsThe major benefit to compliance will be the systematic comparison of protocols in the DSR database to the IRB and IACUC databases. Reports document and make available information to ensure that all ongoing sponsored activities have protocols in a status appropriate for continued work. Notification will be sent to DSR each time the protocol information falls out of sync. It is expected that these projects will be reviewed immediately. Reports are available to review protocols and their related projects at: http://my.research.ufl.edu/Applications/Compliance/ProtocolReports.aspx

Some protocols and some statuses of protocols do not have University of Florida IRB or IACUC expiration dates and therefore cannot be managed using the above processes. In order to facilitate tracking of these, reports are available for protocols in the following situations:

If the UF IRB defers approval to another IRB, DEFERRED is entered as the protocol number with appropriate hard copy documentation on file.

If the UF DSR Director approves proceeding with activities that do not require IRB or IACUC approval while a protocol is not yet in place, DSR enters WALSH as the protocol ID.

When a project indicates use of human subjects but not in the initial stages of the work, the Principal Investigator can get an INDEFINITE determination from the IRB. The approval indicates that the IRB is aware of the ongoing activities with the intent to use human subjects in the future but the current activities do not require IRB review. Since there is IRB review with a protocol number, the appropriate number is entered with INDIFINTE as the expiration date.

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Appendices

Appendix 1: Warning of potential shutdown emailFROM: Compliance@research.ufl.edu on behalf of Dr. Tom Walsh, Director, Division of Sponsored Research

TO: [PI]

CC: [PeopleSoft Project Dept Contact], Brad Staats, Tiffany Schmidt, Brian Sevier, Peter Pevonka, Tom Walsh & Brian Prindle, *Roslyn Heath.

SUBJECT: Sponsored Project to be Shut Down – [Source] Protocol Expiring within the week

BODY: [Source] Protocol [Protocol_ID] is associated with Project [Project_ID]. Per the [Source], this protocol is set to expire within the week. Spending on all projects that use this protocol will be stopped the day the protocol expires unless approval is extended by the committee.

If you have additional information about the status of the human or animal activity on this project (a new protocol now covers the work, the human or animal work has ended or other such appropriate updates), please provide this information to the Division of Sponsored Research by reply to this email immediately.

If you wish to apply for an exception allowing continued work on the project that does not involve human or animal use, please respond to this email describing the circumstances and requesting spending be allowed to continue until such time as the protocol can be renewed.

(*) Include when project involves Engineering.

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Appendix 2: Shut Down Notification EmailFROM: Compliance@research.ufl.edu on behalf of Dr. Tom Walsh, Director, Division of Sponsored Research

TO: Brad Staats, Tiffany Schmidt & Brian Sevier

CC: [PI], [PeopleSoft Project Dept Contact], Peter Pevonka, Tom Walsh & Brian Prindle, *Roslyn Heath.

SUBJECT: Shut Down Spending on Sponsored Project – [Source] Protocol Expiring

BODY: [Source] Protocol [Protocol_ID] associated with Project [Project_ID] has now expired. This email is to direct Contracts & Grants Accounting Services to close project [Project_ID] immediately. Please insert a new Project Status row effective dated the protocol expiration with Status Closed and insert comments “PROTOCOL EXPIRED” identify this cause.

(*) Include when project involves Engineering.

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Appendix 3: Reopen spending emailFROM: Compliance@research.ufl.edu on behalf of Dr. Tom Walsh, Director, Division of Sponsored Research

TO: Brad Staats, Tiffany Schmidt & Brian Sevier

CC: [PI], [PeopleSoft Project Dept Contact], Peter Pevonka, Tom Walsh & Brian Prindle, *Roslyn Heath.

SUBJECT: Re-open Sponsored Project – [Source] Protocol Renewed

BODY: [Source] Protocol [Protocol_ID] associated with Project [Project_ID] has been appropriately renewed or closed. This email is to direct Contracts & Grants Accounting Services to re-open project [Project_ID] immediately. Please insert a new Project Status row effective dated the protocol expiration with Status Open and insert comments “PROTOCOL APPROVED” identify this cause.

(*) Include when project involves Engineering.

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Flow Diagram – Business Process

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Flow Diagram - Appropriate allocation of “status”

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Flow Diagram - Action to record after spending shut down

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