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The Nepal Health Research Council (NHRC) is the statutory body that grants ethical approval for health research in Nepal. Its Ethical Review Board (ERB) is the mandatory gateway: if your study involves human participants, human biological material, or health data collected in Nepal, it does not lawfully begin until NHRC or a delegated institutional committee has approved the protocol.
This page covers the parts researchers actually get stuck on — which committee reviews your proposal, the online portal NHRC migrated to, what the submission checklist demands, what NHRC publishes about processing fees, and how long the ERB realistically takes.
A note on the acronym. “NHRC” also denotes India’s National Human Rights Commission, and several other countries use it for national human-rights councils. This page is exclusively about Nepal’s health research council at nhrc.gov.np. If you arrived looking for a human-rights body, this is not it.
What NHRC approval covers, and who needs it
NHRC is Nepal’s apex body for health research, operating under the Ministry of Health and Population. Ethical review is one of its core functions, alongside research coordination, capacity building and publication.
The requirement is broad. Health research conducted in Nepal — by Nepali institutions, by students, or by foreign investigators and sponsors — requires ethical clearance before data collection starts. NHRC applies this to itself as well: its own FAQ confirms that “Every research project conducted by NHRC has to go through strict review process and needs to be approved by ethical review board of NHRC.” There is no internal exemption for the regulator’s own studies.
NHRC’s ERB has been recognised by the Forum for Ethical Review Committees in the Asian and Western Pacific Region (FERCAP) since 2019, per NHRC’s own site navigation, which labels the board “Ethical Review Board (FERCAP Recognized, Since 2019)”. That recognition matters for investigators who need to demonstrate to a sponsor or journal that review was conducted by an externally assessed committee.
The governing framework is the National Ethical Guidelines for Health Research in Nepal, published by NHRC in 2022. Read these before drafting a protocol rather than after a query letter arrives — most avoidable revisions come from proposals written against generic international templates instead of Nepal’s stated expectations.
NHRC ERB or your institution’s IRC — which one reviews your proposal?
This is the first decision, and getting it wrong costs weeks. Nepal operates a two-tier system: NHRC’s central ERB, and Institutional Review Committees (IRCs) registered with NHRC at individual institutions.
NHRC’s rule is jurisdictional, not risk-based. Per its FAQ: “IRC is authorized to provide ethical approval to students and teachers within the institution only. If you are not of that institution, you will have to submit a proposal to the NHRC.”
The practical decision rule:
- You are a student or faculty member at an institution with a registered IRC, studying within that institution’s remit → your IRC can approve it.
- You are external to the institution — an independent researcher, a foreign investigator, an NGO, a multi-site study spanning institutions, or affiliated with a body that has no registered IRC → the proposal goes to NHRC’s ERB.
Note what this rule keys on: membership, not study risk. A low-risk survey by an outside researcher still routes to NHRC; a higher-risk study by an institution’s own faculty may sit within IRC competence. Confirm your target institution’s IRC is currently registered with NHRC before relying on it — registration status is what makes an IRC’s approval valid.
Submitting through IRERP, NHRC’s current online portal
This is the detail most third-party guidance still gets wrong. NHRC has migrated new proposal submissions to the Integrated Research Ethics Review Platform (IRERP). NHRC’s notice states that IRERP “is now the official system for the submission of new research proposals requiring ethical review” and that “All new proposals must be submitted through IRERP. New submissions will no longer be accepted through the old ERB system.”
What this means in practice:
- New proposals go to the IRERP portal at irerp.nhrc.gov.np.
- You must register a fresh IRERP account even if you already hold an account on the old ERB system. Credentials do not carry over.
- After logging in, the “Submit New Proposal” control sits at the bottom-left of the dashboard.
- Proposals filed before the migration — including those under review or in revision — continue to be processed in the old system at erb.nhrc.gov.np, which researchers should now use only for tracking and managing those pre-existing submissions.
If you are resuming a project after a gap, or following a supervisor’s instructions written before the migration, check which system your proposal lives in before assuming a lapsed login means a lost application.
Hard copies are not an option. NHRC states plainly: “No, we only accept online submission. Hard copies will not be reviewed.” A physical dossier delivered to the NHRC office does not enter the review queue.
What the submission checklist requires
NHRC publishes a checklist for proposal submission and processing fee. Beyond the protocol itself, it calls for a set of supporting documents that investigators routinely underestimate:
- CVs of the Principal Investigator, Co-Principal Investigator and other team members, in PDF or Word format.
- Photographs of the PI, Co-PI and team members, in JPG format.
- Scanned signatures of the PI, Co-PI and team members, in JPG format.
- Data collection tools — observation checklists, questionnaires and similar instruments.
- Consent forms in Nepali, and in the local language where necessary. An English-only consent form is not sufficient for a study recruiting Nepali-speaking participants.
- A letter of acceptance from each hospital, organisation or institution where the study will be conducted.
- Conceptual framework, where applicable, and a list of abbreviations and acronyms.
- An agreement letter with the donor, if the study is funded.
- Where the research involves a study product such as an investigational pharmaceutical or device: a summary of the available safety, pharmacological, pharmaceutical and toxicological data, together with a summary of clinical experience to date — for example a current investigator’s brochure, published data, or a product summary.
The Nepali co-investigator requirement
One checklist item is easy to miss and structurally significant for foreign-led research: “If the Principal Investigator is a non Nepali citizen, one principal Investigator should be a Nepali citizen who is related to that research.”
A foreign investigator cannot submit as sole PI. A Nepali citizen with a genuine connection to the research must be named at principal-investigator level. This is a substantive collaboration requirement, not a formality to be satisfied by adding a nominal local name — plan the partnership at design stage, because retrofitting it after a query letter means rewriting authorship and responsibility structures mid-review.
Processing fees — what NHRC publishes, and what you must confirm
NHRC does not state a single flat fee. Its FAQ says the fee “depends on the type of researcher and the budget of the study” and links to the checklist document above for the schedule itself.
From that published schedule, the fee structure is tiered by researcher category and scaled by study budget, and combines a flat component with a percentage-of-total-budget component charged in addition. Figures appearing in NHRC’s document include a Rs. 1,000 band, a Rs. 10,000 (US$100) band, and a percentage of total budget applied as an additional charge.
CASRAI is not reproducing a full fee table here, deliberately. The published checklist file carries a September 2019 document date, and the mapping of each amount to each researcher category could not be extracted from it with the confidence a researcher budgeting a grant needs. Quoting a precise figure against the wrong category would be worse than quoting none. Confirm the current fee for your specific researcher category and budget directly with NHRC before you budget for it — via the checklist on NHRC’s ethics FAQ or by contacting the council. Third-party sites reproducing a “US$100 or a flat percentage” rule of thumb are quoting an undated secondary summary, not NHRC’s current schedule.
How and where to pay
NHRC states that the processing fee may be paid in either Nepali rupees or US dollars, and deposited either at the NHRC office or at Standard Chartered Bank or Global IME Bank, with account details published alongside the FAQ. Budget-holders working in a third currency should note that the choice of payment currency is available at the payer’s discretion.
How long ERB review takes
NHRC gives a direct answer: “It usually takes four to eight weeks to get ethical approval depending upon the nature of the proposal. Proposals with serious ethical concerns might take more than eight weeks.”
Two qualifications NHRC attaches to that window are worth planning around:
- Additional-information requests extend it. NHRC advises that extra time should be allowed where the ERB needs further information — so four to eight weeks describes the review, not necessarily the elapsed time from submission to approval letter.
- Completeness is the main lever you control. NHRC’s own advice on urgent cases is to submit with all sections completed and all documents supplied “so that there are no delays”.
On expedited review, NHRC will consider urgent requests case by case, but asks explicitly that researchers not request urgency without genuine need, “as it will cause delays for those who do.” Treat expedited handling as a scarce shared resource, not a scheduling tool.
The planning implication: for a study with a fixed field season, funder start date or academic deadline, count back at least eight weeks from your intended start — and further if the protocol involves an investigational product, vulnerable participants, or export of biological samples.
Consent, biological samples and clinical trials
Three areas carry specific NHRC requirements beyond general protocol quality.
Consent and assent, by participant age
NHRC sets age-banded documentation requirements:
- Below 7 years — a consent form from a parent or guardian.
- 7 to 18 years — an assent form from the participant in addition to parent or guardian consent.
- Above 18 — participant consent form only.
Combined with the Nepali-language consent requirement above, a study spanning child and adult participants needs several distinct, correctly translated documents. Build them before submission; they are not something the ERB will let you supply later. For the underlying principles, see CASRAI’s guide to informed consent in research.
Export of human biological material
NHRC’s position here is restrictive and stated in absolute terms: “Transfer of any raw/crude human biological materials outside the country is strictly prohibited. Only extracted and amplified samples may be transported abroad for further study.”
NHRC further encourages laboratory analysis to be performed inside Nepal wherever possible. Where offshore analysis is genuinely necessary, the submission must include:
- The curriculum vitae of the sample handlers; and
- A commitment letter from the receiving laboratory, which must clearly state that samples will be used strictly for the purpose of the study and that any samples will be promptly destroyed on completion of the analysis.
Study designs that assume whole-blood or tissue shipment to an overseas partner lab need rethinking at protocol stage, not at query stage. The permitted route is extraction and amplification in Nepal, with derived material travelling.
Clinical trials of new drugs
Ethical approval is not the only authorisation a trial needs. NHRC points to article 31 of Nepal’s National Drug Act (1978): any person intending to conduct a clinical trial of a new drug must obtain a licence from the Department of Drug Administration (DDA).
The proposal must explicitly set out the pharmaceutical, pharmacological and toxicological information for the drug, including dosage, duration, possible adverse effects and their management. NHRC additionally requires insurance for all participants and an agreement letter from the donors.
This dual-authorisation structure — an ethics body plus a separate regulatory authority for the product — mirrors the pattern CASRAI documents elsewhere, for instance in ANVISA’s Brazilian trial approval pathway and EFDA authorisation in Ethiopia.
After approval: duration, amendments and reviewers’ comments
Approval duration. NHRC grants approval for the duration of the study as stated in the research proposal, and the expiry date is written into the approval letter itself. Read that date and diarise it — an over-running study is not covered by an expired approval.
Amendments. Changes made after ethical clearance require a request for amendment submitted to NHRC, clearly indicating the changes and the reasons for them. NHRC attaches a firm limit: “The request for amendment will not be considered if your study period has expired.” An expired approval cannot be amended back into life, which makes the expiry date a genuine operational deadline rather than an administrative note.
Reviewers’ comments. Once review is complete, NHRC provides a link in the notification email giving access to the reviewers’ comments on the proposal. Retain these — they are the record of what the ERB required and why.
Where NHRC sits among Nepal’s research bodies
NHRC is one of several national bodies a researcher in Nepal may deal with, and they are not interchangeable:
- NHRC — ethical approval and coordination for health research. The subject of this page.
- UGC Nepal (University Grants Commission) — higher-education funding, quality assurance and accreditation, PhD and faculty research grants.
- NAST (Nepal Academy of Science and Technology) — the apex science and technology body, running research grants and fellowships.
A funded doctoral health study might involve all three: NAST or UGC for the funding, an institutional IRC or NHRC’s ERB for the ethics. Ethical approval is not substitutable by a funding award, and a grant does not imply clearance.
For comparison with equivalent national gateways elsewhere, see CASRAI’s guides to Kenya’s NACOSTI research permit, Zambia’s NHRA health research authorisation, MCAZ in Zimbabwe and Thailand’s NRCT code of ethics. The recurring pattern across these jurisdictions — a national ethics gateway, a separate product regulator, and a local-investigator requirement — is worth internalising if you work across multiple countries. See also CASRAI’s reference material on the institutional review board (IRB) and the definition of human subjects research, and the wider research integrity and compliance hub.
Frequently asked questions
Is NHRC the same as India’s National Human Rights Commission?
No. They share an acronym and nothing else. Nepal’s NHRC is the Nepal Health Research Council, the health-research ethics and coordination body at nhrc.gov.np. India’s NHRC is a human-rights institution. Nepal also has a separate National Human Rights Commission, which is likewise a different organisation from the health research council described here.
How do I submit a proposal to NHRC?
Online only, through the IRERP portal at irerp.nhrc.gov.np. You must create a new IRERP account even if you previously had one on the older ERB system. Hard-copy submissions are not reviewed.
How long does NHRC ethical approval take?
NHRC states four to eight weeks, depending on the nature of the proposal, with proposals raising serious ethical concerns taking longer. Allow additional time if the ERB requests further information.
How much does NHRC ethical approval cost?
NHRC does not publish a single flat fee — the amount depends on the researcher category and the study budget, and combines a flat charge with an additional percentage of total budget. Because NHRC’s published schedule carries a 2019 document date, confirm the current figure for your category directly with NHRC rather than relying on any third-party summary.
Can I pay the fee in US dollars?
Yes. NHRC accepts the processing fee in either Nepali rupees or US dollars, payable at the NHRC office or at Standard Chartered Bank or Global IME Bank.
Should I submit to my institution’s IRC or to NHRC?
An IRC may approve research by students and teachers of that institution only. If you are not a member of the institution, submit to NHRC’s ERB.
Can a foreign researcher be the sole principal investigator?
No. Where the PI is not a Nepali citizen, NHRC requires that one principal investigator be a Nepali citizen connected to the research.
Can I ship blood or tissue samples abroad for analysis?
Not in raw form. Transfer of raw or crude human biological materials out of Nepal is strictly prohibited; only extracted and amplified samples may be sent abroad, and only with the sample handlers’ CVs and a commitment letter from the receiving laboratory undertaking to use samples solely for the study and destroy them on completion.
What happens if my study runs past the approval expiry date?
Approval lasts for the study duration stated in the proposal, with the expiry date given in the approval letter. NHRC will not consider an amendment request once the study period has expired, so extensions must be sought before that date.
Do clinical trials need anything besides NHRC ethical approval?
Yes. Under article 31 of the National Drug Act (1978), a clinical trial of a new drug requires a licence from the Department of Drug Administration. NHRC also requires participant insurance and a donor agreement letter.
Sources and verification: this page is drawn from the Nepal Health Research Council’s own published material at nhrc.gov.np — its ethics FAQ, its ethical review process pages and IRERP migration notice, and its published checklist for proposal submission and processing fee — together with the National Ethical Guidelines for Health Research in Nepal (2022). Fee amounts are the single item CASRAI has deliberately not tabulated in full: NHRC’s published fee document carries a September 2019 date and its category-to-amount mapping could not be read off with sufficient confidence, so current fees must be confirmed with NHRC directly. Portal URLs and requirements were verified against NHRC’s live site in August 2026; administrative details of this kind change without notice, and NHRC’s own pages are always the authority.
