Informed consent policy

Frontiers in Preventive Medicine is committed to the ethical principles of research involving human participants as outlined in the Declaration of Helsinki. This policy mandates that all manuscripts reporting such research must contain a statement confirming that informed consent was obtained from all participants or their legally authorized representatives.

Research involving human participants must be conducted in accordance with all applicable international, national, and institutional guidelines. The welfare and rights of the participants are paramount. A fundamental component of this ethical obligation is the procurement of voluntary, informed consent.

2.1. Process of Obtaining Consent:

• Consent must be obtained prior to the participant's involvement in the research.

• The consent process must be informed, meaning that the participant must be provided with clear and comprehensible information about the study. This information must include, but is not limited to:

  • The nature and purpose of the research.

  • The procedures involved, including the time commitment.

  • Any potential risks, discomforts, or benefits.

  • The right to withdraw from the study at any time without penalty.

  • Measures taken to ensure confidentiality of data.

  • Whom to contact for answers to pertinent questions about the research.

• Consent must be voluntary and free from any form of coercion or undue influence.

• For research involving children or participants who are unable to give consent, consent must be obtained from a parent, guardian, or legally authorized representative.

2.2. Documentation of Consent:

• Authors must be prepared to provide documentation of ethical approval and consent procedures upon request by the editors.

• Consent must be documented in writing. A signed consent form is the standard and expected method of documentation.

In certain specific circumstances, the requirement for written consent may be waived by an Ethics Board or Institutional Review Board (IRB). This is typically considered for:

• Minimal risk research where a signed consent form would be the only record linking the participant to the study, thereby posing a primary risk to confidentiality (e.g., sensitive surveys).

• Research where consent is implied by the action of participation (e.g., completion of an anonymous online questionnaire), provided this is explicitly approved by the relevant ethics committee.

In such cases, the manuscript must include a statement detailing the reason for the waiver and confirming that the waiver was granted by the overseeing ethics committee.

All manuscripts reporting research involving human participants must include a statement within the "Methods" or "Ethics" section that confirms:

1. That informed consent was obtained from all participants.

2. That the study was approved by an appropriate Ethics Committee or Institutional Review Board (IRB), including the name of the board and the reference number of the approval.

3. The methods used to obtain consent (e.g., "written informed consent was obtained from all participants").

Example Statement for Manuscripts:

"This study was conducted in accordance with the Declaration of Helsinki and was approved by the Institutional Review Board of [Institution Name] (Approval No. [IRB Number]). Written informed consent was obtained from all individual participants involved in the study."

• Authors must protect the anonymity and privacy of research participants.

• Identifying details (e.g., names, initials, addresses, specific dates, hospital numbers) should not be published in written descriptions, photographs, or genetic profiles unless the information is essential for scientific purposes and the participant (or legal representative) has provided written informed consent for publication.

• If identifying information is necessary, authors must declare in the manuscript that they have obtained specific consent for its publication.

Manuscripts that fail to include the required ethical statements or that, upon investigation, are found to have violated ethical standards of informed consent will be rejected or, if already published, will be subject to retraction.