Procedure Internal Review Research Proposals and Study tocol

ผู้เขียน: เวลา:2022-11-24 แหล่งที่มา:ต้นฉบับ
สรุป:Institute Of Infectious Disease and Molecular Medicine For information on South Africas response to COVID-19 please visit the COVID-19 Corona Virus South African Resource Portal HomeResources for Member Groups Research Proposal Submission O

Institute Of Infectious Disease and Molecular Medicine

For information on South Africas response to COVID-19 please visit the

COVID-19 Corona Virus South African Resource Portal

HomeResources for Member Groups Research Proposal Submission

Operations & Laboratory Meeting Dates

Procedure: Internal Review, Research Proposals and Study Protocols

INSTITUTIONAL RESEARCH COMMITTEE, IDM: INTERNAL PROTOCOL FOR

The Pre-awards section of the electronic Research Administration (eRA) system was created to streamline and standardise UCTs 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.

Allnew protocolsapplying for external funding must follow theproposal approval processvia 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 thecontract 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 thepre-awards FAQ page.

Pre-awards internal approval process

VisitUCTs Research Portaland 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 (

) 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

Internal review and approvals are then completed by relevant Faculty Finance and Deanery (

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

If UCT is required to authorise submission of your application to a funder, it is advised that the PI contactsResearch Contracts and Innovation (RC&I)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.

The Universitys 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 theFinancial Informationtab 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

Step 1: Applicants who submit applications by the internal closing deadline are guaranteed an internal review.

Step 2: Internal review is undertaken by the Research Office. In rare but necessary cases Thuthuka, CPRR, and CSUR scientific reviews are also undertaken by discipline experts.

Step 3: Feedback is provided to applicants and, if necessary, applications reopened for amendment.

Step 4: Applicants resubmit applications before the NRF final deadline.

Cancer Association of South Africa (CANSA) & Poliomyelitis Research Foundation (PRF) for Health Sciences researchers: To apply, researchers email their completed application form to the funder and copy an administrator in the Faculty of Health Sciences Deans Office. The administrator will obtain institutional approval from the Deputy Dean for Research and forward this to the funder.

South African Medical Research Council (SAMRC): For the SAMRC Self-Initiated Research (SIR) grant scheme, researchers complete an online application form and press submit. The application then gets sent to an internal administrator in the Faculty of Health Sciences who takes the application to the Deputy Dean for Research for institutional approval. Once the signed application is received, the administrator uploads this and completes the online submission to the funder.

B)Forall study protocolsthat 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 Facultys 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 (toAndruween 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 requiringhuman scientific reviews, the following materials are to be submitted:

If your protocol is a sub-study of an existing study, please include a brief description of the parent study, the current status of the parent study, and how the sub-study will fit with the parent study.

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 applicants 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 listedhere.

Andruween Kadalieservices the Subcommittees.

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 havealreadyundergone 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:

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.

Protocol involving minimal complexity, for example: establishment of biobanks or databases; some laboratory studies using previously stored samples.

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.

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.

FURTHER DETAILSof the Faculty Human and Animal Research Ethics Committees are found here:

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