Procedure: Internal Review, Research Proposals and Study Protocols (2023)

INSTITUTIONAL RESEARCH COMMITTEE, IDM: INTERNAL PROTOCOL FOR

• FINANCIAL REVIEW OF IDM RESEARCH PROPOSALS AND
• STUDY PROTOCOLS REQUIRING ETHICS APPROVAL

eRA pre-awards approval process

The Pre-awards section of the electronic Research Administration (eRA) system was created to streamline and standardise UCT’s current grant application and submission processes. This process helps to manage risk (in terms of resource use, research ethics, health and safety, and finances) to both the PI and the university and serves to support internal application review to ensure all information required by the funder is complete upon submission.

All new protocols applying for external funding must follow the proposal approval process via the eRA Pre-awards module. If there was no specific funding call and the process was initiated by contract negotiation with the funder/sponsor or if a proposal approval form was submitted at the time of application, but the funder requests changes to the project or budget at award/contract stage then PIs must follow the contract approval process.

Applications for NRF, URC, and SAMRC self-initiated research grants are not required to follow the eRA Pre-awards approval process but still require liaising with the Central Finance and Research offices directly.

If in doubt as to when an approval form should be submitted, ask yourself: will what I am submitting pose any potential risk to UCT, whether in terms of resource use, research ethics, health & safety, and finances? If the answer is yes, then complete a pre-awards approval form. For further information visit the pre-awards FAQ page.

Pre-awards internal approval process

• Visit UCT’s Research Portal and log in to the eRA system using the Login option at the top right-hand corner of the screen.
• Under the ”Add New Content” button in the top right corner of your Dashboard select “Project Application/Approval Request” ?
• Under the “Other Funding Schemes” menu, choose “Application stage approvals” or “Contract stage approvals” and select relevant form type (Preliminary Proposal Approval / Proposal Approval / Contract Approval)
• The PI uploads the requested project documents and captures key project information and details relating to resourcing, ethics, and biosafety online.
• The form is sent online to Departmental Research Finance Staff (Budget Reviewer) to complete project-related finance information that was discussed with the PI prior to submission of the form.
• When the Budget Reviewer has completed the Financial Information, the form will be returned to the PI for review of the financial details.
• The PI confirms their agreement with this financial information and sends the form to the Finance Approver step.
• Internal review and approvals are then completed by relevant Faculty Finance and Deanery (Final Faculty Approver) staff.
• Completion of internal approval through the eRA system will deem your application ready for submission by the institution (or PI) to the funder or for sign off of the research contract. Importantly for proposals, please note, your application is not submitted to the funder via the eRA system.

If UCT is required to authorise submission of your application to a funder, it is advised that the PI contacts once internal Faculty approval is complete to confirm expectations of when their review would be complete, and which documents require a signature to proceed to submission to the funder.

A) FINANCIAL REVIEW

The University's Pre-Awards process must strictly be adhered to. Submission of the eRA pre-awards approval form via the eRA portal needs to be assigned to the Assistant Research Management Accountant, Joy Joachims (extension 1582) who will reassign to one of the pre-award team members based on workload and / capacity.

The Budget Reviewer will complete the “Financial Information” tab within the eRA approval form for all external grants and drug trial funding following review of the budget. The Budget Reviewer should return the supported financial information within 3 working days of receipt of the approval form, but only if IDM Finance assistance was sought and engaged prior to logging the application onto the eRA portal.

The advantages of contacting the Budget Reviewer timeously are:

• Budgets will be in line with UCT Finance Policies and Procedures.
• Budgets are fully or appropriately costed [if the grant is awarded, no further re-negotiation with funders is required as is often the case at present].
• VAT implications are correctly incorporated, as the VAT Apportionment ruling has changed how much Input VAT can be claimed on purchases.
• IP protocols are followed with regard to financial implications.
• There is no delay in the final contract process.
• UCT will sign a grant contract sooner compared to if finances were still to be signed off after the grant is awarded.

Current exceptions for eRA pre-awards approval process

B)For all study protocols that require Faculty Human or Animal Research Ethics Committee clearance

Two standing subcommittees of the IRC will be responsible for thescientificreview of protocols requiring human or animal ethics clearance. The two standing subcommittees of the IRC namely the Human Research Scientific Review and the Animal Research Scientific Review subcommittees will be responsible for establishing an explicit and formal scientific review process that evaluates the scientific merit and potential risks of each protocol before the protocol is submitted to Faculty's Human or Animal Research Ethics Committees. Dr Keren Middelkoop and A/Professor Suraj Parihar chair the subcommittees respectively, and each subcommittee is made up of members drawn from within the IDM and UCT with relevant background and experience.

Send an electronic copy of the application (to Andruween Kadalie (ext 6098) including names of two potential and suitably qualified researchers/reviewers affiliated to or within the IDM and UCT but who are not collaborators. Andruween in turn will log the application with a tracking number. Hardcopies will be requested only once the relevant IRC subcommittee has approved the application.

For protocols requiring human scientific reviews, the following materials are to be submitted:

1. FHS013
2. Protocol
3. Synopsis
4. Consent and assent documents
5. Original protocol if a sub-study
6. Any other relevant appendices

Andruween will forward the proposal electronically to the subcommittee Chair who in turn assigns the proposal to a member of the subcommittee as primary reviewer. The secondary reviewer will be assigned by the subcommittee member and will be drawn from the names of potential reviewers as per applicant's recommendation

Protocols to be reviewed within one week. Comments of primary and secondary reviewers will be sent to all members of the relevant subcommittee. Each subcommittee will meet and consider all reviews. Hardcopies of approved proposals will be requested and signed on the same day. A report will be sent to the applicant within 24 hours to give the applicant the opportunity to respond and/or revise their application if the proposal requires revision. The applicant will thus have approximately three days to re-submit to the subcommittee Chair, prior to the HREC and AREC deadlines. Approval of resubmissions is however at the discretion of the subcommittee Chairs and outstanding or major issues may be held over to the next subcommittee meeting.

Due Dates for submission of applications for 2022 Scientific and Ethics reviews are listed here.

Andruween Kadalie services the Subcommittees.

PLEASE ALSO NOTE:

The IRC Committees will not normally review Grant applications unless a complete protocol is submitted for review.

Protocols that are the result of successful grant awards following the C1 process, and that have alreadyundergone scientific review, will only be re-reviewed by the IRC if substantive changes to the study design have taken place.

Mechanismsarein place to deal withurgent applications. Please notify either Keren Middelkoop or Jo-Ann Passmore,andAssistant Research Management Accountant Joy Joachim well in advance of a looming deadline should this be anticipated, so that the necessary arrangements can be made to expedite the approval process.

Resubmission of amended proposals to AERC require the Animal Research Scientific Committee Chair and IDM Director signatures. An additional column has been added to accommodate due dates for required signatures.

Eligibility Criteria for IRC Expedited Review:

1. Protocol submitted outside the published submission-review cycle for which there is reasonable confidence that UCTHREC will also offer expedited review. 'Reasonable confidence' would in almost all instances need the investigator to approach the UCTHREC Chair for confirmation.
2. Protocol involving minimal complexity, for example: establishment of biobanks or databases; some laboratory studies using previously stored samples.
3. IDM/UCT involvement is a minor component of an external study, for example: laboratory analysis of non-endpoint assays for samples collected at non-UCT sites.
4. Protocol is a sub-study of a previously IRC and UCTHREC reviewed and approved protocol that is carried out in the same study population with expansion of the same aims and interventions.

www.health.uct.ac.za/fhs/research/humanethics/about

www.health.uct.ac.za/fhs/research/animalethics/members