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.

(Video) Research Protocol / Proposal Preparation made Easy!!

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

National Research Foundation (NRF)

:
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 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.

(Video) Full Research Proposal Example - Part 1

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

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.

(Video) How IRBs Protect Human Research Participants

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.

(Video) How to Review a Research Paper

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.

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

(Video) How to write a research Proposal ?

FAQs

What is research proposal and protocol? ›

A proposal is meant to persuade your instructor, peers, or a grant-making committee, while a research protocol is meant to detail a study's methodology to meet specified ethical norms for animal and human subjects.

What is a 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.

Is a research proposal the same as a protocol? ›

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 prepare a research proposal? ›

Your proposal should include the following:
  1. TITLE. Your title should give a clear indication of your proposed research approach or key question.
  2. BACKGROUND AND RATIONALE. You should include: the background and issues of your proposed research. identify your discipline. a short literature review. ...
  3. RESEARCH QUESTION(S)

What is the purpose of a study protocol? ›

The protocol is a document that describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and organization of a clinical trial,) and ensures the safety of the trial subjects and integrity of the data collected.

What should be included in a study protocol? ›

It should include detailed information on the interventions to be made, procedures to be used, measurements to be taken, observations to be made, laboratory investigations to be done etc. If multiple sites are engaged in a specified protocol, methodology should be standardized and clearly defined.

How do you write a procedure and protocol? ›

Here are some good rules to follow:
  1. Write actions out in the order in which they happen. ...
  2. Avoid too many words. ...
  3. Use the active voice. ...
  4. Use lists and bullets.
  5. Don't be too brief, or you may give up clarity.
  6. Explain your assumptions, and make sure your assumptions are valid.
  7. Use jargon and slang carefully.

What are the examples of protocol? ›

Among the most important sets of Internet protocols are TCP/IP (Transmission Control Protocol/Internet Protocol), HTTPS (Secure HyperText Transmission Protocol), SMTP (Simple Mail Transfer Protocol), and DNS (Domain Name System).

Where can I find study protocols? ›

Study protocols
  • PROSPERO.
  • PROSPERO is an international database containing protocols of systematic reviews with a health-related outcome. ...
  • Find more information about PROSPERO here.
  • ClinicalTrials.gov.
  • ClinicalTrials.gov is a database of clinical studies conducted around the world.

What is the importance of making a research proposal? ›

A research proposal helps the authors create a roadmap and explain the key concepts to the audience in extreme detail. Its purpose is to convince the publishers and reviewers that a book is worth publishing. You should focus on your target audience, objectives, and core content while writing a book proposal.

What is a protocol title for IRB? ›

Protocol Title. << The ITHS basic protocol is meant to be a document to explain key features of study purpose, study design, study population, procedures, timeline, and participant safety in order to ensure that your study is conducted in a safe and reproducible manner on the UW Clinical Research Center.

What makes a good protocol? ›

For a network protocol to be well designed, it must have five attributes: Focus, Unity, Simplicity, Clarity, and Generality.

What are the 7 parts of research proposal? ›

Your proposal should include each of the components of the research proposal (title, abstract, table of contents, introduction, literature review, method, discussion, budget).

What is research proposal format? ›

The format of a research proposal varies between fields, but most proposals should contain at least these elements: Cover page. Introduction. Literature review. Research design.

What are the types of research proposal? ›

Types of Research Proposals
  • Solicited. ...
  • Unsolicited. ...
  • Title. ...
  • Abstract. ...
  • Introduction. ...
  • Background. ...
  • Preliminary Studies. ...
  • Research Methodology.

What is the importance of data gathering protocol? ›

The data collection provides the basis for reliability estimations. Thus, a good data collection procedure is crucial to ensure that the reliability estimate is trustworthy. A prediction is never better than the data on which it is based. Thus, it is important to ensure the quality of the data collection.

How long does it take to develop a study protocol? ›

It is often thought that the clinical trial study design is not really the concern of statisticians and that it takes only about one week in total to develop the complete protocol document.

Why is it important for a researcher to do a literature review before planning a study? ›

The purpose of a literature review is to:

Provide foundation of knowledge on topic. Identify areas of prior scholarship to prevent duplication and give credit to other researchers. Identify inconstancies: gaps in research, conflicts in previous studies, open questions left from other research.

What are the main sections of a protocol? ›

Brief Outline
  • Title Page (essential for all protocols).
  • Contents or Index (optional).
  • Protocol Synopsis (optional).
  • Schema (essential for complex safety and efficacy and comparitive treatment efficacy protocols).
  • Objectives of the Study (essential for all protocols).

How do you conduct a research study? ›

How to conduct a research study
  1. Step 1: Identifying the Subject. ...
  2. Step 2: Find the literature. ...
  3. Step 3: Clarify the Subject. ...
  4. Step 4: Definition of Terms and Concepts.
  5. Step 5: What is your audience? ...
  6. Step 6: Instrumentation Plan.
  7. Step 7: Collecting the Data. ...
  8. Step 8: Analyzing the Data.
12 Oct 2018

Why are study protocols published? ›

Publication of study protocols can reduce publication bias and improve reproducibility. Submissions of study protocols will be treated on a case by case basis and preference will be given to submissions describing long term studies and those likely to generate a considerable amount of outcome data.

What is the difference between a protocol and a procedure? ›

A Protocol defines a set of Procedures or steps to be followed for the accomplishment of a given task. Procedures are task oriented. Procedures provide step-by-step instructions on how to do a task.

What are policies procedures and protocols? ›

Policy procedure protocol consists of information which specifies an organization's standards of practice that may include professional, legislative, regulatory and other business requirements.

What is Process protocol? ›

Process Protocols are special sets of master rules that make processes to work in suitable manners: effectively, safely, economically, etc. By following process protocols you can reach specific goals, such as prevent process fails, errors and upsets.

What are the 7 protocols? ›

Common Management Information Protocol (CMIP) On TCP/IP stack:
  • Hypertext Transfer Protocol (HTTP)
  • File Transfer Protocol (FTP)
  • Simple Mail Transfer Protocol (SMTP)
  • Simple Network Management Protocol (SNMP)

What do you understand by protocol explain all its types? ›

What is Protocol? Different types of networking operating systems uses different digital languages to control the communication process between the computers. These languages is called Network protocols. Definition : A protocol is a set of rules to govern the data transfer between the devices.

What are two features of protocols used? ›

TCP and UDP destination port numbers are dynamically generated by the sending device in order to track the responses to requests. TCP mechanisms retransmit data when an acknowledgment is not received from the destination system within a set period of time.

How do you write a study protocol paper? ›

The protocol should outline the rationale for the study, its objective, the methodology used and how the data will be managed and analysed. It should highlight how ethical issues have been considered, and, where appropriate, how gender issues are being addressed.

What is trial protocol? ›

An agreed plan issued by the sponsor of a clinical trial giving details of the objectives, design and organisation of the study.

When should a study protocol be published? ›

Ideally, a protocol/proposal should be published before data collection starts, however, there is no policy against publishing protocols/proposals when data collection is already underway or completed, or even after the primary paper has already been published, as long as this is made explicit in the manuscript.

What are the characteristics of a good research proposal? ›

Features of a 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.

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 is the purpose of proposal? ›

A proposal is a document that is prepared for a prospective customer to persuade the prospect to adopt the solution to a problem or the fulfillment of a need proffered in the proposal. Proposals are written for both private and public sector organizations.

What is a protocol template? ›

This protocol template is a tool to facilitate the development of a research study protocol specifically designed for the investigator initiated studies. It contains sample text to assist investigators in answering the questions reviewer may have. Protocol template instructions and samples are in italics.

What does IRB stand for? ›

What is the IRB? IRB stands for “Institutional Review Board”. The IRB is a committee established to review and approve applications for research projects involving human subjects. The primary purpose of the IRB is to protect the rights and welfare of the human subjects.

How do you write a thesis protocol? ›

The thesis protocol should be arranged as:
  1. Introduction.
  2. Review of literature.
  3. Aims and Objectives.
  4. Material & Methods.
  5. Statistical Analysis.
  6. Ethical Consideration.
  7. Consent.
  8. Information to patients.
11 Jan 2020

What is research protocol PDF? ›

The Research Protocol

A research protocol outlines the plan for how a study is run. The study plan is developed to answer research questions. It provides evidence for feasibility of a study, detailed objectives, design, methodology, statistical considerations and how the study will be conducted and evaluated.

What is your experimental protocol? ›

Experimental protocols are fundamental information structures that support the description of the processes by means of which results are generated in experimental research (Giraldo et al., 2017; Freedman, Venugopalan & Wisman, 2017).

What are the 8 steps of writing a research proposal? ›

Research Proposal Steps
  • 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.

What are the 6 elements of a research proposal? ›

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 contents of a research proposal? ›

The research proposal should include three Appendices: (a) draft research instruments; (b detailed work plan for the research project; and (c) budget (if relevant).

What is introduction in research proposal? ›

Introduction is an initial pitch of an idea; it sets the scene and puts the research in context. [6] The introduction should be designed to create interest in the reader about the topic and proposal. It should convey to the reader, what you want to do, what necessitates the study and your passion for the topic.

What are the 3 main types of proposals? ›

There are three distinct categories of business proposals: Formally solicited. Informally solicited. Unsolicited.

What are the 4 parts of a proposal? ›

Basic components of a proposal
  • Abstract/Summary. The abstract is the most important component of the proposal. ...
  • Statement of Need. What is the issue that you are addressing and why does it matter? ...
  • Project Activity, Methodology and Outcomes. ...
  • Evaluation. ...
  • Dissemination. ...
  • Budget and Continuation Funding.

What is internal proposal? ›

An internal proposal is a type of proposal used to pitch a project within your organization. Many times when people think of proposals, they think of external proposals submitted to another organization to secure work.

How do you write a protocol? ›

The protocol should outline the rationale for the study, its objective, the methodology used and how the data will be managed and analysed. It should highlight how ethical issues have been considered, and, where appropriate, how gender issues are being addressed.

What is the importance of making a research proposal? ›

A research proposal helps the authors create a roadmap and explain the key concepts to the audience in extreme detail. Its purpose is to convince the publishers and reviewers that a book is worth publishing. You should focus on your target audience, objectives, and core content while writing a book proposal.

What is the difference between research proposal and project proposal? ›

The main difference is in the scope of work. The research paper proposal relates to a more serious academic field, whereas projects are mainly assigned in schools and don't have the scientific significance the research paper could have.

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 is the difference between protocols and procedures? ›

A Protocol defines a set of Procedures or steps to be followed for the accomplishment of a given task. Procedures are task oriented. Procedures provide step-by-step instructions on how to do a task.

What is an example of a protocol? ›

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 makes a good protocol? ›

For a network protocol to be well designed, it must have five attributes: Focus, Unity, Simplicity, Clarity, and Generality.

What are the characteristics of a good research proposal? ›

Features of a 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.

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 is the purpose of proposal? ›

A proposal is a document that is prepared for a prospective customer to persuade the prospect to adopt the solution to a problem or the fulfillment of a need proffered in the proposal. Proposals are written for both private and public sector organizations.

What are the components of 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 types of research proposal? ›

Types of Research Proposals
  • Solicited. ...
  • Unsolicited. ...
  • Title. ...
  • Abstract. ...
  • Introduction. ...
  • Background. ...
  • Preliminary Studies. ...
  • Research Methodology.

What are the parts of research proposal? ›

Thus, the components of a research proposal include, but are not limited to those mentioned in this guide.
  • The title. ...
  • The background. ...
  • Objectives of the research. ...
  • Literature review. ...
  • Limitations and delimitations of the study. ...
  • Work plan. ...
  • Bibliography. ...
  • Introduction to the research.
11 Aug 2022

What comes after a research proposal? ›

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 is difference between research paper and research proposal? ›

While an essay or a research paper requires an overall argument and provides evidence to support it, a research proposal is organized around questions to which the author does not yet have answers.

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