Clinical Trial Registration Policy

Advances in Nursing and Health (ANH) requires prospective registration of clinical trials in publicly accessible registries recognized by the World Health Organization (WHO) or the International Committee of Medical Journal Editors (ICMJE). Registration must occur before enrollment of the first participant, and the registration identifier must be reported in the submitted manuscript. This requirement aims to promote transparency, reduce selective reporting of results, and strengthen research integrity in health sciences.

1. Purpose

This policy establishes the requirements for registering, identifying, and reporting clinical trials submitted to ANH, in accordance with ICMJE recommendations and WHO transparency principles.

2. Definition of a Clinical Trial

For the purposes of this policy, a clinical trial is any research study that prospectively assigns human participants, individually or in groups, to one or more health-related interventions to evaluate their effects on health outcomes.

Interventions may include medications, procedures, devices, care strategies, educational, behavioral, preventive, rehabilitation, or other health-related practices.

Trial classification must be based on study design and methodological characteristics, regardless of the terminology used by the authors.

3. Prospective Registration Requirement

Clinical trials submitted to ANH must be registered in a recognized public registry before enrollment of the first participant.

The registration record must include essential information about the study, including objectives, interventions, population, eligibility criteria, outcomes, and information about the investigators.

Registration completed after participant enrollment has begun does not meet the prospective registration requirement. In such cases, authors must explicitly disclose the registration date and circumstances. The editorial team will assess whether the manuscript is eligible for consideration, without guaranteeing further review.

4. Accepted Registries

ANH accepts registration in WHO primary registries or registries recognized by the ICMJE, in accordance with current eligibility criteria.

Examples include:

  • Brazilian Clinical Trials Registry (ReBEC);

  • ClinicalTrials.gov;

  • International Standard Randomised Controlled Trial Number (ISRCTN).

Other registries may be accepted provided they meet the applicable recognition criteria.

5. Required Information in the Manuscript

Authors must provide, preferably at the end of the abstract and in the methods section:

  • Registry name;

  • Clinical trial registration number;

  • Registration date;

  • Public URL of the registration record.

The information reported in the manuscript must be consistent with the public registry record.

Example Statement

Clinical trial registration: Brazilian Clinical Trials Registry (ReBEC), identifier [registration number], registered on [day/month/year]. Available at: [public registry URL].

6. Protocol and Registry Amendments

Relevant changes made after initial registration, particularly those involving outcomes, interventions, or study design, must be updated in the registry and explained in the manuscript when appropriate.

Authors must ensure consistency between the registered protocol, study conduct, and reported results.

7. Ethical Approval and Consent

Clinical trial registration does not replace ethical review.

Research involving human participants must comply with applicable laws and ethical requirements, including approval by the appropriate research ethics committee and obtaining informed consent when required.

Ethical approval information must be reported in the manuscript in accordance with ANH's Author Guidelines.

8. Authors' Responsibilities

Authors are responsible for the accuracy, completeness, and updating of registry information.

The editorial team may request clarification, additional documentation, or corrections when discrepancies between the registry record and the submitted manuscript are identified.

Missing required registration, inconsistent information, or significant omissions may result in discontinuation of editorial assessment or manuscript rejection.

9. Final Provisions

ANH recommends that authors consult the latest ICMJE and WHO guidance before initiating their research to ensure timely registration in an eligible registry.

Institutional references: