Ethics Approval - What is this?

  • Institutional Review Board Statement

    • Applicable guidelines: MDAR, CONSORT

    • A statement (usually a single sentence) addressing IRB approval for biomedical research involving human subjects (or why IRB approval was not required).

    • More information from authority: (please see instuctional materials about IRBs and human subject protections from NIH)

    • If we find an IRB statement, then SciScore expects to find the following items ((ie_criteria or attrition), sex, (age or weight), randomization, blinding, power);

    • Example: The trial was approved by the NRES Committee London—South East.

  • Consent Statement

    • Applicable guidelines: MDAR, CONSORT

    • A statement (usually a single sentence) addressing subject/patient consent in human research (or why consent was not required).

    • If we find a consent statement, then SciScore expects to find the following items ((ie_criteria or attrition), sex, (age or weight), randomization, blinding, power);

    • Example: All infants were enrolled with informed parental permission under a protocol that was reviewed and approved by the Institutional Review Boards of the respective study sites.

  • Institutional Animal Care and Use Committee Statement

    • Applicable guidelines: MDAR, ARRIVE

    • A statement (usually a single sentence) addressing IACUC ethical approval for research involving vertebrate organisms.

    • More information from the NIH Office of Laboratory Animal Welfare

    • More information from ARRIVE guideline on Ethics

    • If we find an IACUC statement, then SciScore expects to find the following items ((ie_criteria or attrition), sex, (age or weight), randomization, blinding, power);

    • Example: All animal experiments were performed in accordance with relevant guidelines and regulations and were approved by the University of Pennsylvania Institutional Animal Care and Use Committee (IACUC).

  • Field Sample Permit

    • Applicable guidelines: MDAR

    • A statement (usually a single sentence) addressing field sampling approval for research (or why field approval was not required).

    • If we find a permit, then SciScore expects to find the following items (randomization, blinding, power);

    • Example: Permission to conduct field surveys on each location was given by the individual landowners concerned, and by the regulatory authority (Natural England) in those situations where the field site was afforded protected status (i.e. Site of Special Scientific Interest).

  • Euthanasia

    • Applicable guidelines: MDAR

    • A statement addressing the method and/or agent used regarding the euthanasia of organisms.

    • Authoritative source for information: Sivula & Suckow 2018 doi: 10.1201/9781315152189-35

    • If we find a euthanasia agent, then SciScore expects to find the following items ((iacuc), (ie_criteria or attrition), sex, (age or weight), randomization, blinding, power);

    • Example: Mice were deeply anesthetized by intraperitoneal injection of sodium thiopental before decapitation, followed by brain extraction.