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
:
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.
– 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 Dean’s 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)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:
- FHS013
- Protocol
- Synopsis
- Consent and assent documents
- Original protocol if a sub-study
- Any other relevant appendices
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 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:
- 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 DETAILS of the Faculty Human and Animal Research Ethics Committees are found here:
www.health.uct.ac.za/fhs/research/humanethics/about
www.health.uct.ac.za/fhs/research/animalethics/members
FAQs
What is research protocol and proposal? ›
Protocol writing allows the researcher to review and critically evaluate the published literature on the interested topic, plan and review the project steps and serves as a guide throughout the investigation. The proposal is an inevitable document that enables the researcher to monitor the progress of the project [5].
How do you write a research project proposal? ›- TITLE. Your title should give a clear indication of your proposed research approach or key question.
- BACKGROUND AND RATIONALE. You should include: ...
- RESEARCH QUESTION(S) ...
- RESEARCH METHODOLOGY. ...
- PLAN OF WORK & TIME SCHEDULE. ...
- BIBLIOGRAPHY.
A research proposal is a concise and coherent summary of your proposed research. It sets out the central issues or questions that you intend to address. It outlines the general area of study within which your research falls, referring to the current state of knowledge and any recent debates on the topic.
What is study protocol in research? ›A research protocol is a document that outlines the planning of your study. The plan must be designed to answer the research question and it must also provide a detailed description of the objectives, design, methodology and statistics used. The protocol in effect is the cookbook for conducting your study.
What is the purpose of a study protocol? ›A protocol gives written evidence for the necessity and feasibility of a research study. It provides a full and detailed description of the objectives, design, methodology, statistical considerations and organisation of the study, including specific details on how the research will be conducted and evaluated.
What are the 7 parts of research proposal? ›- Title. Are we stating the obvious by saying you need a working title? ...
- Introduction. ...
- Literature Review. ...
- Aims and Objectives. ...
- Methodology. ...
- Scope of Research. ...
- Outline and Timetable.
- Step 1: The Title. Naming your research is an important part of the research proposal. ...
- Step 2: The Abstract. ...
- Step 3: Aims and Objectives. ...
- Step 4: Background. ...
- Step 5: Methodology and Method. ...
- Step 6: Schedule and Timeline. ...
- Step 7: Ethical Approval. ...
- Step 8: Resources.
The purpose of the research proposal: The research proposal is your chance to explain the significance of your project to organizations who might wish to fund or otherwise support it. Ideally, it will demonstrate the quality and importance of your project as well as your ability to conduct the proposed research.
What is the most important part of a research proposal? ›The Executive Summary of a proposal is the most important section. It should provide the reader with an overview of the information which follows.
What are the main components of a research proposal? ›Some main components to a research proposal include title, abstract, table of contents, introduction, literature review, method, discussion, and budget.
What are the main features of research proposal? ›
- Title. The title of your proposal should clearly summarise what the research is about – it must be descriptive. ...
- Introduction. ...
- Definitions. ...
- Literature review. ...
- Research questions / hypothesis. ...
- Research approach. ...
- Research ethics. ...
- Anticipated problems/limitations.
Protocol summary: Give a concise overview of the project. Describe the purpose of the study, including problem to be investigated and hypothesis(es) to be tested, the population, and the methods that will be used. Avoid the use of acronyms. Include the expected benefit of the study.
How do you make a study protocol? ›- Protocol title, protocol identifying number (if any), and date.
- Name and address of the sponsor/funder.
- Name and title of the investigator(s) who is (are) responsible for conducting the research, and the address and telephone number(s) of the research site(s), including responsibilities of each.
Protocols exist for several different applications. Examples include wired networking (e.g., Ethernet), wireless networking (e.g., 802.11ac), and Internet communication (e.g., IP). The Internet protocol suite, which is used for transmitting data over the Internet, contains dozens of protocols.
What is research proposal with example? ›A research proposal is a simply a structured, formal document that explains what you plan to research (i.e. your research topic), why it's worth researching (i.e. your justification), and how you plan to investigate it (i.e. your practical approach).
Who writes the study protocol? ›The actual writing of a protocol is a team effort with contributions from a medical expert, a statistician, a pharmacokinetics expert, the clinical research coordinator, and the project manager, who all provide input to the medical writer to produce the final document.
How do you write a research protocol example? ›- I. BACKGROUND AND SIGNIFICANCE.
- II. STUDY OBJECTIVE(S); INCLUDING SPECIFIC AIMS AND/OR HYPOTHESES.
- III. METHODS.
- A. Study Design.
- IV. DATA COLLECTION.
- V. DATA ANALYSIS.
- A. Sample Size Considerations.
- VI. DATA AND SAFETY MONITORING PLAN (if applicable)
The elements of a good research proposal are the title, the introduction, literature review, aims and objectives, methodology, scope of the research, outline and timetable, and bibliography. It's important to include these elements in your research proposal exactly in the order in which they appear in the list above.
What are the 5 components of a research? ›research components, introduction, literature review, method, results, discussion, conclusion.
What are the types of research proposal? ›- Solicited. ...
- Unsolicited. ...
- Title. ...
- Abstract. ...
- Introduction. ...
- Background. ...
- Preliminary Studies. ...
- Research Methodology.
What are the 7 steps of the research process? ›
- Step 1: Identify and Develop Your Topic. ...
- Step 2: Find Background Information. ...
- Step 3: Use Catalogs to Find Books and Media. ...
- Step 4: Use Databases to Find Journal Articles. ...
- Step 5: Find Internet Resources. ...
- Step 6: Evaluate What You Find. ...
- Step 7: Cite What You Find Using a Standard Format.
A project proposal outlines the purpose and scope of a project. This is helpful before a project takes place since it ensures both parties agree about what the project itself will include.
What are the three types of proposals? ›- Formally solicited.
- Informally solicited.
- Unsolicited.
Research proposal refers to a brief and cogent synopsis of the proposed research in a written form. Research Report refers to a document that systematically, coherently and methodically presents the research work in a written form.
What are the 3 chapters of a research proposal? ›8. The research proposal should include three Appendices: (a) draft research instruments; (b detailed work plan for the research project; and (c) budget (if relevant). 9. The research proposal should have a sound structure and a clear writing style.
What are the four qualities of a good research proposal? ›- Cover the Basics.
- Describe the Relevance.
- Emphasize the Significance.
- Explain the Approach.
- Highlight the Expertise.
To conclude, a good research proposal is specific and well thought through, and the results should contribute with important, applicable information.
What is the difference between proposal and research? ›...
Comparison Chart.
Basis for Comparison | Research Proposal | Research Report |
---|---|---|
Length | Short | Comparatively long |
Deals with | Problem or topic to be investigated. | Results of the completed research work. |
A research proposal is a simply a structured, formal document that explains what you plan to research (i.e. your research topic), why it's worth researching (i.e. your justification), and how you plan to investigate it (i.e. your practical approach).
How do you write a research protocol example? ›- I. BACKGROUND AND SIGNIFICANCE.
- II. STUDY OBJECTIVE(S); INCLUDING SPECIFIC AIMS AND/OR HYPOTHESES.
- III. METHODS.
- A. Study Design.
- IV. DATA COLLECTION.
- V. DATA ANALYSIS.
- A. Sample Size Considerations.
- VI. DATA AND SAFETY MONITORING PLAN (if applicable)
Which is same as research proposal? ›
Academic research proposals are generally written as part of the initial requirements of writing a thesis, research paper, or dissertation. They generally follow the same format as a research paper, with an introduction, a literature review, a discussion of research methodology and goals, and a conclusion.
What are the components of a research proposal? ›- The title. ...
- The background. ...
- Objectives of the research. ...
- Literature review. ...
- Limitations and delimitations of the study. ...
- Work plan. ...
- Bibliography. ...
- Introduction to the research.
After completing the research proposal, you will have to submit the work to your committee members. Take their advice and suggestions on your research, particularly the ones that limits the scope of your research further. Once the committee signs and approves your proposal, you can resume your research.
What are the types of research proposal? ›- Solicited. ...
- Unsolicited. ...
- Title. ...
- Abstract. ...
- Introduction. ...
- Background. ...
- Preliminary Studies. ...
- Research Methodology.
- Title. Are we stating the obvious by saying you need a working title? ...
- Introduction. ...
- Literature Review. ...
- Aims and Objectives. ...
- Methodology. ...
- Scope of Research. ...
- Outline and Timetable.
The Executive Summary of a proposal is the most important section. It should provide the reader with an overview of the information which follows.
What is purpose of research proposal? ›The purpose of the research proposal: The research proposal is your chance to explain the significance of your project to organizations who might wish to fund or otherwise support it. Ideally, it will demonstrate the quality and importance of your project as well as your ability to conduct the proposed research.
How do you write a procedure protocol? ›Protocol summary: Give a concise overview of the project. Describe the purpose of the study, including problem to be investigated and hypothesis(es) to be tested, the population, and the methods that will be used. Avoid the use of acronyms. Include the expected benefit of the study.
How do you make a study protocol? ›- Protocol title, protocol identifying number (if any), and date.
- Name and address of the sponsor/funder.
- Name and title of the investigator(s) who is (are) responsible for conducting the research, and the address and telephone number(s) of the research site(s), including responsibilities of each.
- Table of Contents.
- Introduction/Abstract.
- Hypothesis.
- Objectives and Rationale.
- Methods and Procedures.
- Subject Population Selection and Inclusion/Exclusion Criteria.
- Risks and Benefits.
- Provisions for Treatment of Adverse Events.