Informed Consent Policy
The National Journal of Physiology, Pharmacy and Pharmacology (NJPPP) is committed to protecting the rights, dignity, privacy, and welfare of human research participants. Informed consent is an essential ethical requirement for research involving human participants and, where applicable, for the publication of identifiable information, images, or clinical details.
Authors are responsible for ensuring that informed consent has been obtained appropriately and in accordance with applicable ethical, legal, and institutional requirements. The journal may request evidence of consent or clarification from authors when necessary to assess ethical compliance.
1. Ethical Foundation
1.1. Respect for Participants
NJPPP requires research involving human participants to respect individual autonomy, dignity, privacy, and welfare. Participants should receive sufficient information to make a voluntary and informed decision about whether to participate in research.
1.2. Applicable Ethical Standards
Authors should conduct human research in accordance with applicable national and institutional requirements and internationally recognized ethical principles, including the Declaration of Helsinki and, where applicable, relevant Good Clinical Practice (GCP) standards.
The specific ethical requirements applicable to a study may vary according to its design, population, jurisdiction, and institutional requirements.
2. Requirements for Informed Consent
2.1. Information Provided to Participants
Where informed consent is required, participants should receive information appropriate to the nature of the research, including, as applicable:
the purpose and objectives of the study;
research procedures and interventions;
reasonably foreseeable risks and potential benefits;
available alternatives where relevant;
confidentiality and privacy arrangements;
how personal or health information will be collected, used, stored, and shared;
voluntary participation;
the right to decline participation; and
the right to withdraw from the research where applicable.
Information should be presented in a form and language that participants can reasonably understand.
2.2. Voluntary Participation
Consent must be given freely and without coercion or inappropriate influence. Participants should understand that refusal to participate or withdrawal from research should not result in inappropriate disadvantage or loss of entitled care or benefits.
2.3. Comprehension and Accessibility
Consent information should be communicated in language and a format appropriate to the participant's age, education, language, and capacity to understand the information.
Where necessary, appropriately approved translations, interpreters, or other communication methods should be used.
3. Documentation of Consent
3.1. Written Consent
Where written informed consent is required, authors should obtain and document consent using procedures approved by the relevant ethics committee or Institutional Review Board (IRB).
The journal does not normally require authors to submit participants' signed consent forms with the manuscript. However, NJPPP may request confirmation that appropriate consent was obtained or request relevant documentation where ethical concerns arise.
3.2. Alternative Methods of Consent
Where applicable regulations or an ethics committee permit oral, electronic, or other forms of consent, such methods may be acceptable provided that they are appropriately documented and ethically justified.
4. Research Involving Vulnerable Participants
Research involving individuals or groups who may have limited autonomy or increased vulnerability requires additional ethical safeguards.
This may include, where applicable:
children and minors;
individuals with impaired decision-making capacity;
individuals who are otherwise dependent on or vulnerable to researchers or institutions; and
other populations identified as requiring additional protection under applicable ethical standards.
Where participants cannot legally or ethically provide consent themselves, consent should be obtained from an authorized representative as required, together with the participant's assent where appropriate and feasible.
5. Research Involving Minors
For research involving children or minors, authors should comply with applicable legal and ethical requirements concerning parental or guardian permission and child assent.
The manuscript should clearly identify the ethical approval obtained and the consent/assent procedures used when relevant.
6. Participants Who Lack Decision-Making Capacity
When a participant lacks the capacity to provide informed consent, authors should follow the requirements established by the relevant ethics committee and applicable law.
Where legally authorized representatives provide consent, the manuscript should describe the relevant ethical approval and consent procedures where appropriate.
7. Consent in Clinical and Interventional Research
For clinical trials and other interventional research, authors must ensure that informed consent procedures comply with applicable ethical and regulatory requirements.
Where applicable, manuscripts should provide information concerning ethics committee approval, trial registration, and other relevant regulatory requirements.
8. Waiver or Modification of Informed Consent
Informed consent may not be required in every type of human research.
For example, an ethics committee may approve a waiver or modification of consent for certain retrospective studies, secondary analyses of existing data, research involving adequately de-identified information, or other studies where obtaining consent is impracticable and the applicable ethical requirements permit a waiver.
Where consent has been waived or modified, authors should provide:
the name of the approving ethics committee or IRB;
the approval or reference number, where available;
the date of approval, where applicable; and
a brief explanation of the basis for the waiver or modification.
NJPPP does not require informed consent where a valid and appropriately documented ethics committee waiver or exemption applies.
9. Publication of Identifiable Information
Informed consent for participation in research is distinct from consent for publication.
Authors must obtain appropriate consent for publication when a manuscript contains information that could reasonably identify an individual, including, where applicable:
identifiable clinical or medical information;
photographs or other recognizable images;
detailed case descriptions;
genetic or other potentially identifying information; or
other personal information that could permit identification.
Authors should ensure that identifying information is removed or minimized wherever possible.
A statement confirming that consent for publication was obtained should be included in the manuscript when applicable.
10. Case Reports and Clinical Images
For case reports, clinical images, videos, or other material containing potentially identifiable patient information, authors should obtain appropriate consent for publication unless an applicable and documented ethical or legal exception exists.
The journal may request confirmation of consent for publication when necessary.
Patient names, initials, hospital identification numbers, addresses, or other unnecessary identifying information should not be included in the manuscript.
11. Privacy and Confidentiality
Authors must protect the confidentiality of research participants and comply with applicable data-protection and privacy requirements.
Personal information should be collected, stored, accessed, and disclosed only as necessary for legitimate research purposes and in accordance with the approved research protocol and applicable requirements.
Consent documentation should be securely maintained by the responsible researchers or institution and should not be submitted to the journal unless specifically requested.
12. Withdrawal of Consent
Participants should be informed of their right to withdraw from research where such withdrawal is applicable and of any limitations that may arise once data have been irreversibly anonymized, incorporated into analyses, or otherwise used in accordance with the approved research protocol.
Withdrawal from participation does not necessarily require removal of information that has already been lawfully and irreversibly anonymized or incorporated into the research record where removal is not technically or ethically feasible.
13. Ethical Review and Author Responsibility
Authors are responsible for obtaining the appropriate ethical approval and informed consent before conducting research where such approval or consent is required.
The manuscript should include an appropriate Ethics Approval and Informed Consent statement, as applicable.
The statement should identify the approving institution or ethics committee and relevant approval/reference information when available.
NJPPP may request additional information or documentation when there is uncertainty concerning ethical approval, consent, participant protection, or compliance with applicable requirements.
14. Editorial Assessment of Consent
During editorial assessment and peer review, NJPPP may evaluate whether the manuscript provides adequate information regarding:
ethical approval;
informed consent;
consent waivers or exemptions;
consent for publication;
protection of participant privacy; and
other relevant ethical safeguards.
Where appropriate, the journal may request clarification or additional documentation from the authors.
Failure to provide satisfactory evidence of ethical compliance may result in rejection, withdrawal from consideration, publication delay, correction, expression of concern, or other appropriate editorial action depending on the circumstances.
15. Post-Publication Concerns
If credible concerns subsequently arise regarding informed consent, ethical approval, participant protection, or consent for publication, NJPPP may investigate the matter in accordance with its Publication Ethics and Correction and Retraction Policy.
Depending on the findings, the journal may issue a correction, Expression of Concern, retraction, or other appropriate notice.
16. Commitment to Participant Protection
NJPPP is committed to maintaining high standards of ethical research and responsible publication. The journal expects authors, editors, and reviewers to respect the rights, dignity, privacy, and welfare of research participants and to address ethical concerns transparently and appropriately.
