The NHRTI Research Ethics Committee provides independent ethical review and oversight of health research conducted in Zambia. It protects the rights, safety, dignity and wellbeing of research participants.
People at the centre
Research begins with respect.
Ethical review considers what taking part means for people: the information they receive, the choices they can make, potential risks and how their privacy and wellbeing will be protected.
The NHRTI Research Ethics Committee (NHRTI-REC) brings together multidisciplinary experts and community representatives to review biomedical, clinical, social, behavioural, and epidemiological research involving human participants.
Choice and understanding
Participant selection, recruitment, informed consent and assent.
Safety and wellbeing
Potential risks and benefits, protection of vulnerable participants and reporting of safety concerns.
Privacy and trust
Confidentiality, management of research data and samples, and engagement with communities.
Prepare your submission, one step at a time
Research involving human participants must not begin without written ethical approval.
-
01
Speak with the Secretariat
Clarify whether ethical review is needed and obtain current submission guidelines. Consultations: Mon 14:30–16:30, Wed & Fri 10:30–12:30.
-
02
Prepare a complete protocol
Detail objectives, methodology, participant recruitment, informed consent/assent in local languages, questionnaires, and data safeguards.
-
03
Complete academic and institutional review
Students and institutional researchers should obtain prior departmental or supervisor endorsement letters.
-
04
Pay review fees and submit dossier
Deposit fees into the official Stanbic Bank account and submit electronic and printed dossiers to the Secretariat for review.
Documents that may be required
Your protocol and research tools
- Research protocol with version and date
- Study summary
- Questionnaires, interview guides and other research tools
- Investigator CVs and NHRA registration
Information for participants
- Participant information sheet and consent/assent forms in English and local languages (e.g. Bemba)
- Recruitment materials and advertisements
Approvals, budget and proof of payment
- Institutional or departmental approval letter
- Detailed study budget and funding documentation
- Stanbic Bank deposit slip confirming review fee payment
- ZAMRA / regulatory approvals or clinical trial insurance where applicable
Ethical review continues beyond a decision.
The Secretariat first checks an application for completeness. The Committee may approve it, grant conditional approval, request major revisions, defer a decision or not approve the application. Applicants receive the decision and any required changes.
After approval, researchers must follow the approved protocol, provide required progress reports, report serious or unexpected events promptly through the appropriate channels and in accordance with the approved protocol, REC procedures and applicable regulatory requirements, and seek written approval before implementing protocol amendments.
Harmonized Regulatory Templates & Downloadable Tools
Pursuant to National Health Research Authority (NHRA) national directives, all principal investigators and researchers submitting protocols to NHRTI-REC are mandated to adopt and use the following harmonized templates and reporting tools with immediate effect:
Mandatory Adoption Memo
Official notice on the mandatory adoption of harmonized REC templates, reporting tools, and guidelines.
Download Memo (PDF)Approved Fee Schedule (REC/GUD/003)
National Guidelines on Fees for Health Research Ethics Committee Review across academic and clinical categories.
Download Fee Schedule (PDF)Protocol Violation & Deviation Form
Mandatory NHRA reporting form for non-compliance, protocol deviations, violations, and unexpected events.
Download Violation Form (PDF)Research Progress Report Form
Harmonized periodic progress and continuing review submission tool for active studies.
Download Progress Form (PDF)Serious Adverse Event (SAE) Form
Standardized reporting template for Serious Adverse Events, reactions, and study safety incidents.
Download SAE Form (DOCX)Study Close-Out Report Form
Final study closure, subject disposition, data archiving, and completion reporting tool.
Download Close-Out Form (PDF)Standard Fee Structure for RECs (REC/GUD/003)
Approved national schedule of fees for Health Research Ethics Committee review under Document No. REC/GUD/003:
| Review Category | Approved Fee |
|---|---|
| Undergraduate Research | |
| Local undergraduate research | K1,000 |
| International undergraduate research | K1,500 |
| Postgraduate Research (Masters) | |
| Local postgraduate research (Masters) | K2,000 |
| International postgraduate research (Masters) | K3,000 |
| Postgraduate Research (PhD) | |
| Local postgraduate research (PhD) | K4,000 |
| International postgraduate research (PhD) | K5,000 |
| Non-Academic & Externally Funded Research | |
| Non-academic research | K5,000 |
| Internationally initiated and/or funded studies | 6% of total study budget |
| Clinical Trials & Specialized Studies | |
| Clinical trials of investigational products | K10,000 |
| Clinical trial of investigational inspection fee | K10,000 |
| Clinical trials of non-investigational products | K8,000 |
| Clinical trial of non-investigational inspection fee | K5,000 |
| Gene therapy, forensic, biologics, device trials, or other highly technical studies | K20,000 |
| Inspection fee (Gene therapy, forensic, biologics, device trials, or technical studies) | K20,000 |
| Fast-Track Review Protocols | |
| Fast-track protocols (local postgraduates Masters) | K7,000 |
| Fast-track protocols (local postgraduates PhD) | K9,000 |
| Fast-track protocols (international postgraduates Masters) | K10,000 |
| Fast-track protocols (international postgraduates PhD) | K12,000 |
| Administrative & Regulatory Charges | |
| Other charges — Minor (observational study amendments, annual renewals) | K2,500 |
| Other charges — Major (delayed reporting of Severe Adverse Events, non-reporting of deviations, major amendments to clinical trials, continuing review of clinical trials) | K10,000 |
Download the complete official REC Fee Schedule Guideline (PDF)
Institutional Oversight & Academic Partnerships
NHRTI-REC actively engages with higher learning institutions, regulatory authorities, and clinical trial sites across Zambia to foster ethical compliance, review ongoing protocols, and build sustainable research ethics capacity.
Northrise University Supervisory Visit
Some members of the research ethics committee after a supervisory visit at Northrise University.
NHRA Regulatory & Ethics Training
NHRA conducting a two-day Regulatory and Ethics Capacity Building Training for the NHRTI Research Ethics Committee.
Mukuba University Collaboration
NHRTI Research Ethics Committee leadership and delegation during an institutional review, compliance monitoring, and ethics engagement visit at Mukuba University Central Administration.
Rusangu University Oversight
Institutional engagement and ethical oversight mission with academic leadership and research investigators at Rusangu University.
Secretariat Office Hours & Review Timelines
Office consultation hours
Monday: 14:30–16:30; Wednesday and Friday: 10:30–12:30. The Committee does not work on weekends or public holidays.
Expedited review & renewal/amendment
The stated turnaround time is 2 weeks for expedited review and 2 weeks for renewal/amendment.
Ordinary initial review
Non-academic and PhD research: 4–6 weeks. Student research: 4 weeks.
Official Bank Payment Details
Applicants should make payment into the designated TDRC Ethics Bank Account at Stanbic Bank, Ndola Branch. Proof of payment must be submitted with the ethics application.
- Kwacha Account (ZMW): 9130000745654
- Dollar Account (USD): 9130001315734
- Account Name: TDRC Fieldmal
- Bank: Stanbic Bank
- Branch: Ndola Branch
- Branch Code: 1003
- Sort Code: 040103
- SWIFT Code: SBIC ZMLX
Use the Kwacha account for payments in Zambian Kwacha and the Dollar account for payments in United States Dollars. Proof of payment is a required submission document for non-academic and PhD research protocols.
Research Ethics Committee FAQs
Find answers to common questions about ethics clearance, student applications, clinical trial approvals, amendments, and reporting.
What is the NHRTI Research Ethics Committee?
The NHRTI Research Ethics Committee (NHRTI REC) is an independent committee responsible for reviewing research involving human participants, their data or biological specimens. Its purpose is to protect the rights, safety, dignity, welfare and confidentiality of research participants and to ensure that research meets applicable ethical standards.
Why is ethical approval required?
Ethical approval helps ensure that research risks are minimised, potential benefits are reasonable, informed consent is appropriately obtained, participant privacy and confidentiality are protected, and vulnerable participants receive appropriate safeguards.
Who should submit a research proposal to the NHRTI REC?
Researchers whose studies fall within the REC’s scope of review should submit their proposals before starting research activities requiring ethical review. This includes researchers, students, academic institutions, government institutions, NGOs, research organisations and collaborative or multicentre research teams.
Can I start data collection before receiving ethical approval?
No. Researchers should obtain the required ethical approval before commencing research activities involving human participants, identifiable human data or biological specimens, unless the REC has formally determined that the activity does not require ethical review.
What documents are required for an REC submission?
Depending on the study, submissions may include the REC application form, research protocol, protocol summary, participant information sheet, informed consent and assent forms where applicable, data collection tools, recruitment materials, investigator CVs, NHRA registration, proposed budget, proof of payment and other supporting documents requested by the REC.
What additional documents are required for clinical trials and multicentre studies?
For clinical trials, applicants should submit the Investigator’s Brochure, insurance documents and study advertisements where applicable.
For multicentre studies, applicants should submit the decisions of the other ethics committees in the countries where the study is being conducted.
What are the submission requirements for student research?
Students should submit a Supervisor’s confirmation letter, approval from the relevant Dissertation, Technical or Scientific Committee, one spiral-bound copy of the complete protocol, a soft copy, data collection tools, informed consent and participant information sheets, and the proposed budget.
Do students need NHRA registration?
For Bachelor’s students, the Supervisor’s NHRA Registration Certificate is required. All postgraduate students are required to register with NHRA.
Do I need to submit both hard and soft copies?
Yes. The required hard copies and soft copies should be submitted according to the applicable submission category. Soft copies should be emailed to the REC email address provided in the submission guidelines.
Does research using secondary data require ethical review?
It may. The need for ethical review depends on factors such as whether the data are identifiable, the sensitivity of the information, the original consent, the proposed secondary use and applicable data-protection requirements. Researchers should seek a formal REC determination where appropriate.
Can I request a waiver of ethical review or informed consent?
Researchers may request a waiver where they believe the study meets the applicable criteria. The request should provide a clear justification. The REC determines whether a waiver is ethically and legally appropriate; researchers should not assume that a waiver applies automatically.
How can I pay the REC review fee?
Applicants should make payment into the designated TDRC Ethics Bank Account at Stanbic Bank, Ndola Branch. Proof of payment must be submitted with the ethics application.
- Kwacha Account (ZMW): 9130000745654
- Dollar Account (USD): 9130001315734
- Account Name: TDRC Fieldmal
- Bank: Stanbic Bank
- Branch: Ndola Branch
- Branch Code: 1003
- Sort Code: 040103
- SWIFT Code: SBIC ZMLX
Use the Kwacha account for payments in Zambian Kwacha and the Dollar account for payments in United States Dollars. Proof of payment is a required submission document for non-academic and PhD research protocols.
For the applicable review fee, consult the published harmonised REC/GUD/003 fee schedule and confirm the review category with the REC Secretariat before payment.
What happens after I submit my application?
The REC Secretariat checks the submission for completeness and determines the appropriate review pathway. The application is then assigned for review, after which the REC communicates its decision and any required conditions or revisions to the investigator.
What types of REC decisions may be issued?
The REC may issue a decision such as approval, approval with conditions, request for modifications or clarification, deferral pending further information, or non-approval. The decision communicated by the REC should be followed before the study proceeds.
What is the difference between expedited and full committee review?
Expedited review is available for submissions that meet the REC’s criteria for expedited consideration, such as certain minimal-risk studies, continuing reviews or minor amendments. Studies requiring more comprehensive ethical consideration may undergo full committee review. The REC determines the appropriate review pathway.
How long does the ethics review process take?
The stated turnaround times are:
Non-academic and PhD ordinary initial review: 4–6 weeks
Student ordinary initial review: 4 weeks
Expedited review: 2 weeks
Renewal/Amendment: 2 weeks
Can I change an approved research protocol?
Proposed changes to an approved protocol or study documents should be submitted to the REC for review and approval where required before implementation. Changes may include modifications to objectives, methodology, sample, participants, recruitment, consent procedures, study sites, investigators or data collection tools.
What is continuing review or renewal?
Continuing review or renewal is the process for maintaining ethical oversight of an ongoing study after the current approval period. Researchers should submit the required renewal documentation before the existing approval expires and should not continue activities requiring active approval after expiry.
What should I do if an adverse event or serious incident occurs?
Researchers should follow the reporting requirements in the approved protocol, REC procedures and applicable regulatory requirements. Serious or unexpected events that may affect participant safety should be reported promptly through the appropriate channels.
When can I contact the NHRTI REC and where can I obtain clarification?
The REC working hours are:
Monday: 14:30–16:30
Wednesday: 10:30–12:30
Friday: 10:30–12:30
The Committee does not work on weekends or public holidays.
For clarification or further information:
NHRTI Research Ethics Committee
P.O. Box 71769
Ndola, Zambia
Tel/Fax: +260 212 615 444 / 612837
Mobile: +260 977 852443 / +260 977 807411 / 0962 755894
About the Committee
The NHRTI-REC grew out of the former TDRC Research Ethics Committee. Its institutional information identifies IRB registration IRB00002911 and Federalwide Assurance FWA00003729 with the US HHS OHRP, and accreditation by NHRA.
Our commitment
Good research depends on sound science and on treating participants with respect throughout a study. NHRTI-REC supports responsible research relevant to the communities it serves. Researchers and students are encouraged to speak with the Secretariat early and seek guidance when requirements are unclear.
National research authority
Ethics review and national research authority requirements are separate parts of the research process. Consult the National Health Research Authority for its requirements and online services.
Visit NHRA NHRA online services