Ethical Approvals, Patient Rights, and Informed Consent Policy

1. Overview
The International Journal of Pharmacy and Life Sciences (IJPLS) is committed to ensuring that all research published in the journal adheres to the highest ethical standards, particularly with respect to the treatment of human participants and the integrity of the research process. This policy outlines the requirements for ethical approval, patient rights, and informed consent for studies involving human participants.
We require that all research involving humans (whether clinical trials, observational studies, surveys, or other types of research) complies with the relevant ethical guidelines and legal requirements of the country or institution where the research was conducted.

2. Ethical Approval

  • Requirement for Ethical Approval:
    Manuscripts reporting research involving human participants must include a statement confirming that the research has been reviewed and approved by an appropriate Institutional Review Board (IRB) or Ethics Committee before the research was conducted. The name of the reviewing body and the approval number (or reference) must be provided in the manuscript.
  • Compliance with Ethical Guidelines:
    Research involving human subjects must comply with internationally recognized ethical standards, including:
    • The Declaration of Helsinki (World Medical Association).
    • The International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines.
    • Local regulations and guidelines relevant to the research setting (e.g., national research ethics guidelines).
  • Informed Consent (IC) and Patient Rights:
    For all research involving human participants, authors must ensure that informed consent was obtained from participants, and that their participation was voluntary. This is a key ethical requirement for the journal’s acceptance of such research.

3. Patient Rights

  • Respect for Participants' Autonomy:
    Researchers are required to respect the autonomy of participants by ensuring that they are fully informed about the nature, purpose, and risks of the research before agreeing to participate.
  • Right to Privacy and Confidentiality:
    Participants have the right to privacy and confidentiality. Any personal information gathered during the research must be protected, and data must be anonymized or pseudonymized wherever possible. Personal identifiers should not be disclosed in the publication unless explicit consent has been obtained.
  • Right to Withdraw:
    Participants must be informed that they have the right to withdraw from the study at any time, without any penalty or loss of benefits. This right should be clearly stated in the informed consent document.
  • Protection from Harm:
    Researchers must ensure that no harm comes to participants, whether physical, psychological, or social. The risks and benefits of the research must be assessed and balanced in advance, and research protocols should minimize any potential harm.
  • Vulnerable Populations:
    Extra care must be taken when conducting research involving vulnerable populations, such as minors, pregnant women, prisoners, or individuals with cognitive impairments. In such cases, additional ethical safeguards should be implemented, and informed consent must be obtained from a legally authorized representative if the participant is unable to consent independently.

4. Informed Consent (IC)

  • Informed Consent Requirements:
    Authors must provide clear documentation of informed consent for research involving human participants. This includes a statement indicating that informed consent was obtained from all participants or their legally authorized representatives prior to the initiation of the research.
  • Content of Informed Consent:
    The informed consent document should include, but not be limited to, the following key elements:
    • Purpose of the Study: A clear description of the study's objectives and the nature of the research.
    • Procedures: A detailed explanation of the procedures involved in the study, including any interventions or tests participants will undergo.
    • Potential Risks and Discomforts: A description of any potential risks, discomforts, or side effects that participants may experience as a result of their participation.
    • Benefits of Participation: Information about any potential benefits, both direct (e.g., therapeutic benefits) and indirect (e.g., contribution to scientific knowledge).
    • Confidentiality: An assurance that all data collected will be kept confidential and the conditions under which confidentiality may be breached (e.g., legal requirements).
    • Voluntary Participation: A statement that participation is voluntary, and that participants can withdraw at any time without penalty.
    • Contact Information: Details of whom participants can contact for questions about the study, their rights, or if they feel they have been harmed during the study.
    • Right to Access Results: A statement informing participants whether they will be informed of the results of the study and how they will be shared.
  • Consent in Writing:
    The informed consent document must be signed and dated by the participant (or their legal representative), and a copy should be provided to the participant. For online surveys or studies, an electronic version of consent may be obtained, where appropriate.
  • Language and Readability:
    The informed consent document should be written in clear, simple language that is easily understandable to participants. If needed, the document should be translated into the participant’s native language or a language they understand well.

5. Special Considerations for Clinical Trials

  • Clinical Trial Registration:
    Authors reporting clinical trials must ensure that the trial is registered in a publicly accessible database before enrollment of the first participant. Registration should be in accordance with international standards such as the World Health Organization (WHO) Trial Registration Platform or the International Clinical Trials Registry Platform (ICTRP).
  • Trial Protocol:
    Authors should include the trial protocol, detailing the design, methodology, and ethical considerations of the clinical trial, as part of the manuscript submission. The trial protocol should undergo independent ethical review and should follow established international standards (e.g., CONSORT guidelines).

6. Ethical Approval for Animal Studies
For studies involving animals, authors must state that the research complies with relevant animal welfare guidelines and that the study was approved by an institutional animal care and use committee (IACUC) or an equivalent body. Ethical approval and adherence to The ARRIVE Guidelines (Animal Research: Reporting of In Vivo Experiments) should be clearly stated.

7. Ethical Violations and Consequences

  • Non-compliance with Ethical Standards:
    If a manuscript is found to have violated ethical standards—such as lack of ethical approval, failure to obtain informed consent, or inadequate protection of patient privacy—the manuscript may be rejected or retracted. In cases where the misconduct is serious, the authors may be banned from submitting to the journal for a specified period.
  • Whistleblower Protection:
    The journal supports the ethical reporting of misconduct. Authors, reviewers, or other individuals who report ethical violations in a study will be protected from retaliation and the journal will handle all reports confidentially.

8. Contact Information for Ethical Concerns
For any questions regarding ethical standards or to report concerns about ethical violations, please contact the editorial office:
Email: [editor@ijpls.com]