Submission Requirements
How to Make a Submission
Interactive Approval Pathway
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Each box in the diagram represents a stage or institution in the approval pathway for health research in Zimbabwe. Click any of them for a plain-language explanation of its role.
Before You Begin
Researchers are encouraged to familiarize themselves with all submission requirements before preparing their application package.
Clinical Trials
If your study is a clinical trial, you are required to submit your application to both the Medical Research Council of Zimbabwe (MRCZ) and the Medicines Control Authority of Zimbabwe (MCAZ) simultaneously. A clinical trial is defined in the Medicines and Allied Substances Control Act [Chapter 15:03] as:
“A systematic study in human beings or animals in order to establish the efficacy of, or to discover or verify the effects or adverse reactions of medicines, and includes a study of the absorption, distribution, metabolism and excretion of medicines”
The National Biotechnology Authority (NBA) must approve any research involving genetically modified organisms or regulated biotechnology materials. This step only applies when Genetically Modified Organisms (GMOs) are part of the study.
Information for Foreign Researchers
- The Research Council of Zimbabwe (RCZ) is mandated to register foreign researchers.
- A foreign researcher is defined in Section 27 of the Research Act as: any person who wishes to conduct research in Zimbabwe on behalf of a foreign institution, foreign organization, or other foreign person, whether as an employee or otherwise; or any person, other than a citizen of or a person ordinarily resident in Zimbabwe, who wishes to conduct research in Zimbabwe.
- All foreign researchers should follow the registration guidelines outlined on the Council’s website.
- Full regulatory approval and commencement of participant recruitment is contingent upon issuance of a foreign researcher permit and unconditional approval by the RCZ and MRCZ, respectively.
Material Transfer
- Investigators wishing to ship biospecimens outside Zimbabwe for research purposes will be required to seek clearance from the RCZ in line with Council guidelines and applicable data protection. Applicable fees are available on the RCZ website.
Making a Submission
Download the Application Form
Download the MRCZ New Study Application Form (MRCZ Form 101) from the MRCZ website. The first page of the application form contains a comprehensive checklist of all documents required for submission.
Prepare Your Application Package
Before submission, ensure that the following documents are included:
Application Form
- Completed MRCZ Form 101.
- Signed and dated by the Principal and any Co-investigators.
Research Proposal
- Proposal summary (maximum 4 pages) — use the guidelines provided in MRCZ Form 101.
- Full research proposal.
- All documents should be clearly labelled, paginated, and version-controlled.
Informed Consent Documents
- Informed Consent Forms (ICFs) for recruitment of participants in Zimbabwe must be aligned with the MRCZ informed consent form template.
- ICFs should be on your institutional letterhead.
- Where applicable, consent forms must be translated into the appropriate local language by a qualified professional.
- Consent forms must be appropriately titled, paginated, and version-controlled.
Assent Forms
- Studies involving participants under 18 years of age must include assent forms.
- Assent forms should be developed in simple language appropriate for the age of participants.
- Refer to the assent form template provided by MRCZ.
Data Collection Tools
- Questionnaires, interview guides, case report forms, and other study tools.
- Local language versions should be provided where applicable.
Permission Letters
- Letters from institutions, facilities, communities, schools, hospitals, or organizations where data will be collected.
- These letters should demonstrate authorization and authenticity.
Investigator Documentation
- Curriculum Vitae (CVs) of all Principal Investigators.
- Valid Good Clinical Practice (GCP) certificates for all Principal Investigators.
- ICH GCP training can be facilitated by MRCZ upon request.
- Acceptable free GCP training and certification: NIDA Clinical Trials Network, TRREE, WHO Training Platforms.
Funding Documentation
- Proof of funding on the funder’s official letterhead.
Ethics Approval
- Submit approval or clearance from your Institutional Review Board (IRB), where one is available to you.
- For international researchers, where applicable, a support letter from a local institution of affiliation is required.
- Local IRB approval is required, where necessary.
Pay the Relevant Application Fee
Review categories, fees, and turn-around times are listed in the fee structure table under the Banking Details and Fee Structure tab. Other applicable fees include:
Payment details can be obtained from the MRCZ Finance Department.
Submit Your Application
Submit the complete application package electronically to mrcz@mrcz.org.zw.
Incomplete applications will not be accepted.
Review Process
Application Acknowledgement
- MRCZ will acknowledge receipt of your application.
- A unique study reference number will be assigned.
- All future correspondence should quote this reference number.
Ethical Review
- Your application will undergo ethical review by the relevant MRCZ review committee.
- Researchers are advised to submit applications well in advance of their intended study start date.
- Submission deadlines and committee meeting dates are available on the MRCZ calendar.
Receive Reviewer Feedback
Following review, MRCZ will send comments, recommendations, and feedback via email. Researchers should carefully address all reviewer comments.
- Applicants may be invited to an ad hoc meeting with members of the National Health Research and Development Committee, where necessary, to assist with the review process. This primarily helps with reducing the query loops and ultimately shortens lead times, thus improving efficiency.
Submit Responses to Comments
- Respond to reviewer comments within two weeks.
- Submit revised documents with tracked changes.
- Complete and submit the MRCZ Responses to Comments Form.
Final Review and Decision
Responses to reviewers’ comments should be sent back to the MRCZ secretariat at mrcz@mrcz.org.zw. Once responses have been received, the application will undergo further review, and the committee’s decision will be communicated to the applicant.
- Local researchers: full regulatory approval is issued when all queries have been adequately addressed.
- Foreign researchers: a Conditional Approval Letter is issued. Before final approval can be granted, researchers must (1) register the study with the Research Council of Zimbabwe (RCZ), and (2) present the required documents to MRCZ for official stamping and signature before RCZ submission.
Foreign Researcher Registration
- Pursuant to the requirements of the Research Act, foreign researchers are required to obtain clearance from RCZ before full ethical approval documentation can be issued.
- Once RCZ clearance has been received, researchers should collect the research permits from MRCZ.
Post-Approval Compliance
Research Levy Payment
Before an unconditional letter of approval can be issued, applicants must settle the MRCZ research levy: 1% of the total approved study budget. An invoice can be obtained from the MRCZ Finance Office.
Collection of Approval Documents
Once the research levy has been paid, the MRCZ Approval Letter will be issued. Researchers should bring clean final copies of the approved research proposal, Informed Consent Forms, Assent Forms (where applicable), and data collection tools. These documents will be stamped and endorsed by MRCZ. Researchers may then collect their approval letter and documents, and commence the study in accordance with all approval conditions.
Research Execution
Research Implementation and Continued Monitoring
Approved studies must be conducted with the highest level of ethical and regulatory compliance and integrity. In keeping with MRCZ policy, ongoing approved research must be continuously monitored to ensure that the safety, rights, and welfare of study participants are upheld.
Annual Renewal
- Ethical clearance issued by MRCZ is valid for one year and must be renewed without exception.
- The Principal Investigator is responsible for timely submission of an annual renewal application, at least 3 months before the expiry of the approval date. Failure to do so will result in the accrual of punitive late renewal fees, study suspension, and possible termination.
- Check that your submission package is aligned with the checklist in the MRCZ Annual Renewal Form.
- Valid MRCZ approval must be held during study round-up and data analysis as well.
- An up-to-date SAE Report Log must be submitted as part of the annual renewal documentation, where applicable.
Protocol Amendment
- No deviations from or changes to the approved protocol should be initiated without prior documented MRCZ approval of an appropriate protocol amendment, except when necessary to eliminate immediate hazards to study participants.
- Before submitting, check that your package is aligned with MRCZ requirements and that the standard MRCZ Amendment application form is completed.
Protocol Deviation
- Any unplanned departure from the study’s approved protocol should be documented and reported to MRCZ for review within 7 calendar days, using the MRCZ Deviation form.
- An up-to-date Protocol Deviations Log must be submitted as part of the annual renewal documentation, where applicable, including corrective and preventive actions taken.
Adverse Events
- An adverse event is any unfavourable occurrence in a research participant, not necessarily causally related to the study.
- A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability or incapacity, or leads to a congenital anomaly/birth defect.
- SAEs must be reported within 3 calendar days of site awareness using the MRCZ SAE form; AEs within 7 calendar days.
Study Extension
- Should a study be projected to go beyond the initially proposed timeline, a study duration extension application must be submitted to MRCZ for review and approval.
- Check that you have also completed the MRCZ Study Extension Form.
Study Termination
- Study termination is the formal closure of the study after completion of research activities.
- The Principal Investigator is required to inform the RCZ and MRCZ of study closure by submitting the standard study termination form and aligning with the requirements outlined in the form checklists.
Study Reopening
- Study re-opening is the process of seeking MRCZ approval to resume a research study that was previously terminated.
- Submit the standard study re-opening application form together with all supporting documentation as outlined in the form checklist.
- No research activities may resume until formal written approval has been granted. Upon approval, the Principal Investigator must notify all study personnel that research activities may recommence under MRCZ oversight.
Additional MRCZ Provisions
Recusals
- A recusal is the formal withdrawal of an MRCZ reviewer or committee member from the review of a study due to a real, potential, or perceived conflict of interest. All recusals must be formally declared and documented in accordance with MRCZ conflict of interest policies.
Destruction of Research Materials
- Destruction is the approved disposal of research-related materials (data, records, or biological samples) in accordance with the approved protocol. Researchers must submit a formal request to MRCZ detailing the materials, justification, location, method, and timelines. No destruction may take place without prior MRCZ approval.
Biospecimens
- Biospecimens are human biological materials collected for research (blood, tissue, saliva, urine, and other samples). All collection, storage, use, transfer, or export requires prior MRCZ ethical approval, with procedures clearly outlined in the protocol and informed consent documents.
MRCZ Submission Process Overview
Researchers intending to submit protocols for ethical review must follow the outlined procedure to ensure timely and efficient processing of their applications.
General Submission Requirements
Payment
All applicants must pay the required review fees at the bank and attach proof of payment to their submission documents.
NOSTRO ACCOUNT
NMB Account Details:
Account Name: Medical Research Council of Zimbabwe
Branch: Excellence
Swift Code: NMBLZWHX
Branch Sort Code: 11112
Account No: 0000350046119
MRCZ ZWG BANK DETAILS
CBZ Account Details:
Account Name: Medical Research Council of Zimbabwe
Branch: Kwame Nkrumah
Swift Code: COBZZWHA
Branch Sort Code: 6101
Account No: 01120068040016
Fee Structure
| No. | Submission Type | Standard Fee | Expedited Fee |
|---|---|---|---|
| 1 | Individual Researcher | $500 | $1 000 |
| Students PhD MSc Undergraduate/Diploma Students registered with local universities can pay using the local currency equivalent at the intermarket rate. | $200 $50 $10 | ||
| Exemption from full ethics review (Researchers are not supposed to exempt themselves from ethics review) | $200 | ||
| 2 | Study Extension | $100 | $200 |
| 3 | Amendment | $100 | $200 |
| 4 | Annual Renewal | $100 | $200 |
| 5 | Study Reopening/Reactivation | $400 | |
| 6 | Training | $40/day/person | |
| 7 | Search fee | $20 | |
| 8 | Late Submission Penalties | $200/30 days $1 200/year | |
| 9 | Non-Research Specimen Shipment Request | $20 | |
| 10 | Late SAE Submission | $20/day | |
| 11 | Research Levy (Diplomas, Undergraduate, Masters and Exemptions are waived to pay) | 1% of Total Budget Flat fee of $100 for studies with budgets <10 000 | |