Planning a study in Nepal

1. Classify the study before choosing the route

Write a short classification statement describing the research question, design, intervention, product status, phase, risk and funding. Identify each participating institution and investigator. Use that statement to ask the relevant bodies which reviews and permissions apply.

2. Establish the Nepal investigator and institutional arrangements

NHRC 2022 section 3.9.3 calls for a Nepalese PI in international collaborative research. Annex II also requires an additional relevant Nepali PI when the PI is a non-Nepali citizen. Confirm the investigator's responsibilities and the documents required from collaborating institutions. Obtain institutional support and agree participant care, safety and record arrangements. Home-country approvals do not replace Nepal review.

3. Build an authority-specific document checklist

Use NHRC’s current checklist and IRERP instructions for new ethics proposals; the legacy ERB route remains for earlier submissions. Trial submissions need additional protocol-specific documentation. Resources links to the authority systems.

• Scientific protocol, analysis plan and data-collection tools
• Investigator CVs, institutional letters, funding and conflict-of-interest information
• Versioned consent and assent materials in relevant languages
• Product information, prior evidence and safety-reporting arrangements
• Monitoring, DSMB and insurance documentation as applicable
• Trial registration and product-related authority documents

4. Plan participant protection explicitly

Describe how participants will receive understandable information, have time to decide and withdraw without inappropriate pressure. Address vulnerable groups, reimbursement, care for research-related harm and confidentiality. Consent waivers or alternative consent processes need an ethics decision rather than an investigator assumption.

5. Confirm the authority sequence

National ethics review, DDA trial permission, import authorization and site permissions are related but separate steps. NHRC guidance describes DDA documents in the submission checklist and an investigational-product import licence after NHRC approval. Confirm the current sequence for the particular trial before promising a start date.

6. Keep the submission under control

Record the exact protocol and participant-material versions submitted, queries received, responses and final conditions. Assign owners for continuing reports, renewals, safety reporting and amendments. A changed protocol, added product or new institution may require further review.

7. Check the safety-reporting instructions

NHRC 2022 section 4.5 describes ERB notification within 48 hours of an event and a detailed report within two weeks; section 3.5 also calls for immediate sponsor and ERB reporting with protocol-defined exceptions. Read these provisions together with DDA requirements and the study's approval conditions. Never use the outer reporting window to delay urgent notification or care.

8. Plan national and international trial registration

Include Nepal Clinical Trials Registry in the registration plan. Check WHO’s Primary and Other registry lists and the intended journal’s requirements. Assign responsibility for accurate records, identifiers and updates; registration and ethics approval serve different purposes.

9. Confirm readiness before recruitment

Use a documented activation review covering permissions, registration, consent versions, trained staff, product supply, emergency arrangements and essential records. No website checklist can itself authorize research. Confirm the remaining protocol-specific requirements with the responsible bodies.