Procedure: Internal Review, Research Proposals and Study Protocols (2022)

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) How To Write A Strong Research Proposal | Thesis or Dissertation

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) How to Review a Research Paper

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) Research Protocol / Proposal Preparation made Easy!!

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) Full Research Proposal Example - Part 1

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) Mohammed Saheb Hussain-Guidelines to Research Proposal-Part-I-Online Class-21-07-2022

FAQs

What are the protocols in research process? ›

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 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 the research protocol required by the IRB? ›

Therefore, the protocol must include the scientific rationale to justify the conduct of the study, the information necessary to conduct the study, the plan for managing and analyzing the data, and a discussion of the research ethical issues relevant to the 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.

What is the importance of research protocols? ›

Primarily, publishing a research protocol is a means to allow the academic community to evaluate whether subsequent analysis and results are in line with the investigators' initial objectives. Additionally, it informs the academic community on ongoing research and may avoid duplication of work.

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.

How do you write a research protocol example? ›

Sample Research Protocol Template
  1. I. BACKGROUND AND SIGNIFICANCE.
  2. II. STUDY OBJECTIVE(S); INCLUDING SPECIFIC AIMS AND/OR HYPOTHESES.
  3. III. METHODS.
  4. A. Study Design.
  5. IV. DATA COLLECTION.
  6. V. DATA ANALYSIS.
  7. A. Sample Size Considerations.
  8. VI. DATA AND SAFETY MONITORING PLAN (if applicable)
Sep 13, 2016

What makes a good protocol? ›

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

How do you write a protocol summary? ›

  1. Understand the Requirements before Writing. ...
  2. Develop the Synopsis and Schedule of Events Early in the Process. ...
  3. Provide Clear Objectives and Associated Endpoints. ...
  4. Be Detailed in Describing Assessments, with Operational Feasibility in Mind. ...
  5. Arrange the Protocol to Promote Ease of Reference. ...
  6. Practice Judicious Redundancy.
Sep 9, 2019

What are the elements of research protocol? ›

Protocol Elements
  • 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.

How do I submit a research proposal to IRB? ›

Apply for IRB Review
  1. Step 1: Determine if your project requires IRB approval. ...
  2. Step 2: Complete the Mandatory Online Certification for Researchers. ...
  3. Step 3: Complete the IRB Research Project Application. ...
  4. Step 4: Prepare the Informed Consent Document(s) ...
  5. Step 5: Submit Proposal Form.
Nov 14, 2018

What is an approved protocol? ›

Protocols are standard procedures which may be used in a variety of experiments. In order to be approved, a protocol will normally be well established in the relevant subject community.

What is a study protocol article? ›

Abstract. A study protocol is an important document that specifies the research plan for a clinical study. Many funders such as the NHS Health Research Authority encourage researchers to publish their study protocols to create a record of the methodology and reduce duplication of research effort.

What is protocol in simple words? ›

The most common meaning of protocol is “a system of rules that explain the correct conduct and procedures to be followed in formal situations,” as in these example sentences: The soldier's actions constituted a breach of military protocol.

What is a protocol document? ›

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 is the difference between proposal and 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].

Why is having a research protocol important in qualitative research? ›

In addition, the written research protocol serves as a manual to guide the entire research effort, and it can also be used as a monitoring and evaluation tool to monitor progress throughout the research and to evaluate success at the completion of the research.

Why is having a research protocol and a research script important in qualitative research? ›

The information the script provides to the participant helps them understand their rights as a person being studied and it ensures that you conduct your research in an ethical manner. 2. Collect consent.

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 is the difference between procedure and protocol? ›

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 the different types of protocols? ›

Types of Protocols
  • Transmission Control Protocol (TCP)
  • Internet Protocol (IP)
  • User Datagram Protocol (UDP)
  • Post office Protocol (POP)
  • Simple mail transport Protocol (SMTP)
  • File Transfer Protocol (FTP)
  • Hyper Text Transfer Protocol (HTTP)
  • Hyper Text Transfer Protocol Secure (HTTPS)

How do you write a research protocol for a systematic review? ›

The protocol should include:
  1. Search question or objective.
  2. Inclusion/exclusion criteria (scope including types of studies, participants, interventions)
  3. Databases to be searched.
  4. Proposed search strategy.
  5. Methodology for data extraction and analysis.
  6. Declaration of interests.
  7. Time-frame.
Jul 6, 2022

What is a 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.

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 protocol in clinical research? ›

A research protocol is a document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organization of a clinical research project.

How does a protocol work? ›

protocol, in computer science, a set of rules or procedures for transmitting data between electronic devices, such as computers. In order for computers to exchange information, there must be a preexisting agreement as to how the information will be structured and how each side will send and receive it.

Which section of the research protocol should contain the procedures for recording and reporting adverse events? ›

Safety considerations

Safety aspects of the research should always be kept in mind and information provided in the protocol on how the safety of research participants will be ensured. This can include procedures for recording and reporting adverse events and their follow-up, for example.

Which section of the research protocol should contain a description of the problem the study is addressing as well as its public health significance? ›

Expert-verified answer

The rationale and background information section of the research protocol contains a description of the problem the study is addressing, as well as its public health significance.

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.
Jan 11, 2020

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.
Oct 12, 2018

What are the minimum elements that are typically required for an IRB protocol? ›

Common Protocol Elements

At a minimum, IRB protocols should contain the Objectives, Methods, Quality Control and Assurance, Ethics/Protection of Human Subjects, and Data Handling and Record Keeping.

What are the three types of IRB review? ›

IRB must review all projects that meet the definition of research and that involve human participants prior to any data collection to determine the appropriate level of review, and, as appropriate, approve them. There are three major levels of human subjects' research review: Exempt, Expedited, and Full.

What documents need IRB approval? ›

IRB Submission Checklist
  • Application.
  • Consent Document(s)
  • Recruitment Materials.
  • Study Instrument(s)
  • Permission Letters (if applicable)
  • Certificate of Education (if not already on file)
  • Grant proposal narrative (if applicable)
  • The application materials have been made into one PDF.

Why do research proposals need to be reviewed by an IRB? ›

The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research.

Who approves a protocol? ›

The protocol has been approved by the Institutional Review Board (IRB) with responsibility for review and approval of the protocol in accordance with the requirements of 21CFR56.

What are the 4 phases of clinical trials? ›

Each stage of a clinical trial has its own purpose in ensuring that a treatment is safe and effective for use by the public.
...
Phases of Clinical Trials
  • Phase 1 Clinical Trial. ...
  • Phase 2 Clinical Trial. ...
  • Phase 3 Clinical Trial. ...
  • Monitoring Post-FDA Approval.
Sep 2, 2021

What is an important protocol deviations in clinical research? ›

Important protocol deviations are a subset of protocol deviations that might significantly affect the completeness, accuracy, and/or reliability of the study data or that might significantly affect a subject's rights, safety, or well-being.

How do you create a protocol for a clinical trial? ›

  1. GUIDELINES FOR DESIGNING A CLINICAL STUDY PROTOCOL. ...
  2. Study Summary: ...
  3. List of Abbreviations: ...
  4. Background Information/Significance: ...
  5. Objectives/Rationale/Research Question: ...
  6. Clinical Study Design: ...
  7. Inclusion and Exclusion criteria of the Subjects: ...
  8. Informed consent form process:

What is the purpose of protocols in data communications? ›

Protocols provide rules that define how a message is transmitted across a network. Implementation requirements such as electronic and bandwidth details for data communication are specified by standards. Operating systems are not specified by protocols, but will implement protocols.

What is project protocol? ›

Project Protocol means the document which describes the Project objectives, design, methodology, statistical considerations and organization of a Project.

What are the elements of research protocol? ›

Protocol Elements
  • 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.

How do you write a research protocol example? ›

Sample Research Protocol Template
  1. I. BACKGROUND AND SIGNIFICANCE.
  2. II. STUDY OBJECTIVE(S); INCLUDING SPECIFIC AIMS AND/OR HYPOTHESES.
  3. III. METHODS.
  4. A. Study Design.
  5. IV. DATA COLLECTION.
  6. V. DATA ANALYSIS.
  7. A. Sample Size Considerations.
  8. VI. DATA AND SAFETY MONITORING PLAN (if applicable)
Sep 13, 2016

What is protocol in simple words? ›

The most common meaning of protocol is “a system of rules that explain the correct conduct and procedures to be followed in formal situations,” as in these example sentences: The soldier's actions constituted a breach of military protocol.

What makes a good protocol? ›

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

Why is having a research protocol important in qualitative research? ›

In addition, the written research protocol serves as a manual to guide the entire research effort, and it can also be used as a monitoring and evaluation tool to monitor progress throughout the research and to evaluate success at the completion of the research.

What is a 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.

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.
Jan 11, 2020

How do you write a protocol summary? ›

  1. Understand the Requirements before Writing. ...
  2. Develop the Synopsis and Schedule of Events Early in the Process. ...
  3. Provide Clear Objectives and Associated Endpoints. ...
  4. Be Detailed in Describing Assessments, with Operational Feasibility in Mind. ...
  5. Arrange the Protocol to Promote Ease of Reference. ...
  6. Practice Judicious Redundancy.
Sep 9, 2019

How do you write a research protocol for a systematic review? ›

The protocol should include:
  1. Search question or objective.
  2. Inclusion/exclusion criteria (scope including types of studies, participants, interventions)
  3. Databases to be searched.
  4. Proposed search strategy.
  5. Methodology for data extraction and analysis.
  6. Declaration of interests.
  7. Time-frame.
Jul 6, 2022

What is a study protocol article? ›

Abstract. A study protocol is an important document that specifies the research plan for a clinical study. Many funders such as the NHS Health Research Authority encourage researchers to publish their study protocols to create a record of the methodology and reduce duplication of research effort.

What is the difference between a protocol and 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.

How do protocols work? ›

A network protocol is an established set of rules that determine how data is transmitted between different devices in the same network. Essentially, it allows connected devices to communicate with each other, regardless of any differences in their internal processes, structure or design.

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 a protocol document? ›

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.

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