Clinical research in Nepal: plan the pathway.

Clinical research and clinical trials follow different pathways

Clinical research includes observational studies, health-data research and interventional trials. A clinical trial prospectively assigns an intervention to assess health outcomes. Identify the design and product first; a records review is not automatically exempt, and a marketed medicine is not automatically outside trial oversight.

• Observational research: determine the ethics route, consent or waiver, and authorized access to records.
• Interventional research: establish ethics review, participant protections and study-specific authorizations.
• Drug, vaccine and device studies: assess product regulation as well as research ethics.

NHRC and institutional ethics review

The Nepal Health Research Council (NHRC) provides national ethical oversight through its Ethical Review Board (ERB) and recognizes Institutional Review Committees (IRCs). IRC review is limited by the committee's recognized remit. Clinical trials and studies outside an IRC's authority require national ERB consideration. Confirm routing for multicentre or externally sponsored research; do not assume approval from one institution covers the entire study.

Use the current NHRC ethics submission portal

NHRC’s migration notice directs new proposals to the Integrated Research Ethics Review Platform (IRERP), with a new account even for existing ERB users. Earlier ERB submissions continue in that system. Ethics submission and trial registration are separate processes. Find both portal links in Resources.

DDA authorization and investigational-product imports

The Department of Drug Administration (DDA) has a separate role in clinical-trial permits and product regulation. For drug or vaccine trials, establish the DDA requirements alongside NHRC review. Ethical approval, trial permission and authorization to import an investigational product are distinct. Confirm the required sequence, product documents, quantities, importer, storage conditions and permit validity before shipping or starting trial procedures.

Build a submission package around the protocol

Use the current authority checklist rather than a generic dossier. Keep each document dated and versioned, with an owner and a record of review responses.

• Protocol, scientific rationale, study methods and data-collection tools
• Investigator qualifications, site support and funding arrangements
• Participant information, consent and assent in Nepali and relevant local languages
• Trial-specific product, safety, monitoring, insurance and registration documentation
• Additional approvals and agreements for international collaboration or specimen transfer

Early-phase and device studies need particular care

NHRC's 2022 guidance places specific conditions on early-phase trials, including institutional infrastructure and supporting safety evidence. Its device section addresses risk and the implications of implanted devices for consent and follow-up. Obtain a study-specific determination for the proposed phase and product; overseas approval or a device's commercial availability is not a substitute for Nepal requirements.

Register trials and keep oversight active

Nepal Clinical Trials Registry (NCTR) is described on NHRC’s project page, which links to npctr.nhrc.gov.np. WHO lists Nepal under “Other registries”, separately from Primary Registries. For ICMJE requirements, WHO says records in these other registries also need inclusion in a Primary Registry or an ICMJE-approved registry. Confirm the appropriate national and international registration route before recruitment; registration does not authorize research. NHRC 2022 section 3.5 describes annual progress reports, or more frequent reporting when requested, and extension applications at least one month before the approved study period ends. Track these alongside amendments, safety and final reports.

Assess feasibility with site evidence

Country selection should follow documented evidence from candidate institutions. Review eligible patient pathways, competing studies, investigator time, consent languages, laboratory capability, emergency care, storage, transport and reliable records. Population size and disease burden alone do not demonstrate recruitment capacity or site readiness.

Confirm the live requirements before submission

Check current forms, fees, portal instructions, review scheduling and permit conditions directly with NHRC, DDA and the participating institutions. No fixed approval timeline, fee or recruitment outcome is promised here. The sponsor and Nepal investigator should document the pathway and resolve contradictory or outdated instructions before implementation.