Researchers must obtain ethical clearance before initiating any study involving human participants.

Step 1: Prepare documentation

Applicants must submit complete copies of their research proposals. Proposal applications should include:

• A signed and dated application letter, addressed to the NUL-IRB chairperson
• Main narrative for the protocol for the proposed research project, together with supporting documents and annexes (Protocols must follow the appropriate NUL IRB proposal template)
• CVs of all researchers who will be involved in the study
• All data collection forms to be used in the research project as an annex to the protocol (translate to Sesotho if necessary). This includes, but is not limited to, case report forms, data collection tables, questionnaires, interview schedules, guides, etc., clearly identified and dated. All forms, documents, and advertisements used in recruiting potential participants must also be included.
• Participant information sheet and consent form in languages understood and at a reading level appropriate for the potential research participants, as annex (translate to Sesotho if necessary)

Step 2: Submission

Email your completed application to lm.monare@nul.ls by the published deadlines. FOHS undergraduate students must submit hard copies to the SAR office (SCH0205).

Step 3: Review and decision

The NUL IRB makes decisions regarding research proposals by consistently applying fundamental ethical principles drawn from global human rights instruments, internationally recognized ethics guidelines, and Lesotho’s national policies. The specific ethical codes guiding our work are clearly communicated and are available to both researchers and the wider public. To ensure fairness and transparency, the IRB utilizes structured checklists for protocol review. This ensures that all proposals are assessed against the same benchmarks and helps maintain consistent decision-making.

Key factors that guide the IRB’s ethical review include:

Scientific merit: Research is only permissible if it is scientifically valid. The IRB evaluates the methodological soundness, investigator qualifications, data oversight plans, and research resources.

Risk-benefit assessment: The IRB ensures that potential risks to participants are minimized and justified by the potential benefits. Various types of risk, including physical, social, financial, and psychological, are carefully considered at both the individual and group level.

Fair Participant selection: No population group should be unfairly burdened or excluded from potential benefits. Recruitment approaches must be equitable, and the target population should be likely to benefit from the research findings.

Privacy and confidentiality: Strong protections are required to safeguard participant privacy and ensure the secure handling of all personal data, preventing harm, stigma, or loss of opportunities.

Informed consent: The IRB ensures that participants (or authorized surrogates) are fully informed and freely agree to participate, with special considerations for children or those lacking mental capacity.

Community engagement: The IRB reviews studies for their broader impact on communities, aiming to prevent harm (including stigma or depletion of local resources) and, where possible, foster capacity-building. Engagement with communities in shaping research design and consent processes is encouraged, and IRB members are sensitive to cultural and traditional contexts.

IRB review schedule and timelines

• The IRB reviews research submissions every Tuesday.
• Once submitted, proposals typically require 2 to 4 weeks to be fully assessed, deliberated, and to receive a formal decision letter from the Board.
• Researchers should submit complete applications in accordance with eligibility requirements and plan their project timelines to accommodate the IRB’s schedule.
• Timely compliance helps meet both university standards and Ministry of Health requirements.

Step 4: Approval letter

After review, researchers receive an official written communication from the IRB outlining the outcome of their submission. The approval letter will specify the decision category and clearly detail the suggested revisions.

Category 1: Approved with minor technical/language revisions

• The proposal is generally acceptable and meets IRB standards for ethical and scientific integrity.
• Minor corrections are needed, typically related to grammar, clarity, or formatting.
• Applicants must address any required technical or linguistic changes and submit the revised sections for administrative confirmation; however, further substantive review is not required.
• Once revisions are confirmed, an official IRB approval letter will be issued.

Category 2: Approved with minor methodological revisions

• The proposal’s methodology requires clarification or minor modification, such as refining sampling procedures or strengthening data protection strategies.
• Researchers must prepare a rebuttal outlining the specific changes made in response to reviewer comments.
• The rebuttal and revised proposal sections must be submitted directly to the assigned reviewer for review and confirmation.
• Final approval is issued once the assigned reviewer is satisfied with the response.

Category 3: Conditional approval with major changes

• Significant modifications are required. These may involve changes to study design, recruitment procedures, ethical safeguards, or data management protocols.
• Researchers must prepare a thorough rebuttal and a revised proposal addressing all IRB concerns.
• The updated documents must be submitted to the full IRB panel for consideration, discussion, and final noting/approval at a subsequent IRB meeting.
• Approval is contingent upon satisfactory revision and explicit IRB endorsement.

Uncategorized/No category: Deferred or resubmission required

• The proposal does not fit standard approval categories, presents unresolved ethical concerns or methodological flaws, or lacks necessary documentation.
• The IRB defers the application and requests a complete resubmission with substantial improvements.
• A new, full proposal must be prepared, supported, and vetted by all IRB members.
• Prior to resubmission, the IRB Chairperson must personally review and approve the revised proposal to ensure it is suitable for reconsideration.

Counter approval process:

Only proposals that have received final ethics clearance from the NUL IRB are subsequently forwarded to the Ministry of Health (MOH) research ethics committee for counter approval. Proposals without IRB approval are not eligible for further consideration by the MOH.

*Note:

All correspondence and required revisions must be submitted within the time frames outlined in the IRB communication, and researchers are encouraged to consult the Secretary or IRB administrative support for guidance during the revision process