NCBS

Mandate: Upholding research integrity through timely, high-quality ethical reviews

About Rec

1. Purpose

These Guidelines establish a national framework for setting, charging, waiving, and reviewing fees for ethics review by Health Research Ethics Committees (HRECs). The aim is to ensure that HRECs are adequately resourced while preserving their independence, fairness, transparency, and accessibility. The fees are structured in accordance with the level of accreditation of the HRECs (i.e., level 1, level 2 & level 3).

2. Scope

These Guidelines apply to:

• All registered or accredited HRECs in the country;
• All investigators, institutions, sponsors, and applicants submitting research for ethics review;
• All fee-bearing ethics review activities, including initial review, amendments, continuing review, and specialized review categories where applicable.

3. Guiding Principles

3.1 Fairness and transparency

All HREC fees shall be set out in a published fee schedule and applied consistently to comparable applications.

3.2 Cost-based approach

Fees shall be reasonably related to the real administrative and review costs of operating the HREC, including secretariat support, meeting logistics, document management, archiving, training, and quality assurance.

3.3 No pay-to-approve model

No fee shall be linked to the approval outcome of a protocol. Payment of a fee grants the applicant access to review, but does not confer a right to approval. In light of this, fast-track or expedited review does not guarantee approval.

3.4 Protection of independence

Fee collection, invoicing, and accounting shall be handled through institutional or secretariat financial systems and not by individual HREC members. This supports independence and reduces the risk of conflicts of interest.

3.5 Access and proportionality

The fee structure should not unduly block important public-interest, student, unfunded, or lowrisk research. Reduced fees, exemptions, or waiver of fees may be used for eligible categories.

3.6 Predictability

The HRECs shall, prior to submission, provide applicants with all information concerning applicable fees, payment due dates, the consequences of withdrawal of a submission, and whether resubmissions or amendments incur additional charges

4. Chargeable Activities

HRECs shall charge fees for the following activities:

• Initial review of a new protocol
• Review of protocol amendments
• Continuing review
• Annual renewal
• Non reporting of protocol deviations
• Delayed submission of Serious Adverse Events
• Re-review of a previously withdrawn or administratively closed application

5. Categories for Fee Setting

The national fee schedule should distinguish applications by risk, complexity, and funding
source. Suggested categories are:

A. Exempt / no-fee category

• student projects with no external funding and minimal risk;
• internally funded academic audits or service evaluations that require ethics review
  under national rules;
• public-health emergency studies specifically exempted by the national authority.

B. Reduced-fee category

• Local undergraduate research
• Local postgraduate research

C. Standard-fee category

• External undergraduate
• Postgraduate research
• Non-academic research

D. Premium / complex-review category

• Clinical trials of investigational products;
• Clinical trials of non-investigational products;
• Gene therapy, forensic, biologics, device trials, or other highly technical studies;
• Internationally initiated and/or funded studies
• Fast-track protocols (only applicable to postgraduate studies)

6. National Fee Schedule Model

All HRECs shall adopt the national a fixed-fee schedule

Serial No.	Review Category	Fees (ZMW)
1	Local undergraduate research	1,000.00
2	Local postgraduate research (Masters)	2,000.00
3	Local postgraduate research (PhD)	4,000.00
4	International undergraduate research	1,500.00
5	International postgraduate research (Masters)	3,000.00
6	International postgraduate research (PhD)	5,000.00
7	Non-academic research	5,000.00
8	Clinical trials of investigational products	10,000.00
9	Clinical trial of investigational inspection fee	10,000.00
10	Clinical trials of non-investigational products	8,000.00
11	Clinical trial of non-investigational inspection fee	5,000.00
12	Gene therapy, forensic, biologics, device trials, or other highly technical studies	20,000.00
13	Inspection fee (Gene therapy, forensic, biologics, device trials, or other highly technical studies)	20,000.00
14	Internationally initiated and/or funded studies	6% of the total study budget
15	Fast-track protocols (only applicable to local postgraduates (Masters))	7,000.00
16	Fast-track protocols (only applicable to local postgraduates (PhD)	9,000.00
17	Fast-track protocols (only applicable to international postgraduates (Masters)	10,000.00
18	Fast-track protocols (only applicable to international postgraduates (PhD)	12,000.00
19	Other charges – Minor (observational studies amendments, annual renewal)	2.500.00
20	Other charges – Major (delayed reporting of Severe Adverse Events, non-reporting of deviations, major amendments to clinical trials, continuing review clinical trials)	10,000.00

Option B: Percentage-and-cap model

For commercially sponsored research, the Authority shall allow a fee based on a small percentage of the local study budget, subject to a minimum (6%) and maximum (10%) cap.

This model should only be used if it remains predictable, transparent, and not outcomedependent.

7. Recommended National Fee Rules

7.1 Initial review fee

The full initial review fee shall be paid before the application is scheduled for ethics review.

7.2 Amendment fees

• Minor administrative amendments may be charged a lower fee or no fee.
• Major amendments affecting risk, consent, population, design, or site arrangements
  may attract a separate review fee.

7.3 Continuing review fee

Continuing review may attract a reduced annual fee for active studies that remain under
HREC oversight

7.4 Safety-related submissions

Routine SAE notifications should generally not attract a separate fee. However, a substantial safety-related resubmission or revised protocol package may attract a review fee if it requires committee reconsideration

7.5 Multi-site studies

Where one HREC serves as the reviewing HREC for multiple local sites, the national policy
may allow:

• one lead review fee; and
• a smaller per-site administrative fee.

7.6 Withdrawn submissions

If an application is withdrawn:

• before administrative screening, up to 80% may be refunded;
• after screening but before committee review, up to 50% may be refunded;
• after full review has started, no refund shall normally be made.

8. Fee Waivers and Exemptions

HRECs may grant full or partial waivers for:

• students;
• early-career researchers;
• unfunded local investigators;
• urgent public-health studies requested by government;
• research in underserved settings;
• nationally prioritized health research.
  Any waiver policy shall be written, objective, and publicly available

9. Payment Administration

1. Fees shall be paid into an official institutional or national account.
2. Payment receipts shall be issued for every transaction.
3. HREC members shall not personally receive protocol-review fees from applicants.
4. The Secretariat shall confirm payment status before scheduling review.
5. Non-payment shall result in administrative hold, not informal negotiation.

10. Use of Fee Revenue

Fee income should be used only for legitimate ethics-review functions, including:

• secretariat staffing;
• meeting facilitation;
• secure document management;
• records retention and archiving;
• member orientation and training;
• external expert support where needed;
• digital review systems;
• quality assurance and audit readiness.

11. Conflict-of-Interest Safeguards

To avoid financial influence on ethics decisions:

• fees shall be fixed by policy and not negotiated case by case;
• no fee shall depend on whether a protocol is approved, deferred, or rejected;
• members with conflicts shall recuse themselves from the affected review;
• fee administration shall be separated from protocol decision-making.

12. Public Disclosure

Each HREC shall publish or make available:

• its current fee schedule;
• waiver and refund rules;
• payment instructions;
• categories of review;
• turnaround targets linked to submission completeness, not payment amount.

13. Appeals and Complaints on Fees

Applicants may appeal or complain where they believe:

• the wrong fee category was applied;
• a waiver request was wrongly denied;
• a refund was wrongly withheld;
• a fee was charged contrary to the national schedule.

Fee complaints shall be handled administratively and separately from the scientific or ethical
merits of the protocol.

14. Periodic Review of Fees

The National Health Research Authority shall review HREC fees:

• every 2 to 3 years; or
• earlier if inflation, workload, technology, or legal changes materially affect review
  costs.

Any revision shall be formally approved and publicly announced before taking effect.

15. Optional – aligned note

NHRA shall align this NHREB fee guideline and regularly publish reviewed and revised versions after stakeholder consultations.

16. Short policy clause

HREC fees shall be fair, transparent, published in advance, reasonably related to the actual cost of review, and shall never depend on the approval outcome of the protocol. Fee administration shall be separated from ethics decision-making, and waiver mechanisms shall be available for eligible low-resource, student, public-interest, or nationally prioritized research.