Stating ethics approval and compliance in a report or manuscript
A manuscript and a clinical study report each carry a statement about the ethics of the study they describe. In a manuscript, the Methods section states that a committee approved the research or exempted it from review, and describes the consent, registration and protection of patients' rights the study used, in the form the ICMJE and each journal ask for. The approval still leaves the editor free to judge the conduct of the research. In a clinical study report, the statement may attest compliance with good clinical practice and the Declaration of Helsinki, which the report of a study that could not fully comply can qualify rather than affirm.
The ethics statement in a manuscript
What the statement contains
The ICMJE recommendations ask that the Methods section include a statement that the research was approved, or exempted from the need for review, by the responsible institutional or national review committee. Where no formal ethics committee is available, a statement that the research was conducted according to the principles of the Declaration of Helsinki should be included instead. The December 2014 revision of the recommendations added this as new guidance on the Methods section.
Approval by a responsible review committee does not preclude editors from forming their own judgment of whether the conduct of the research was appropriate, which the December 2014 revision added to the recommendations' section on protecting research participants.
The Methods section should answer what the study's ethical considerations were: whether a randomized controlled trial was conducted in a manner compatible with good clinical practice and ethical tenets originating in the Declaration of Helsinki, whether participants gave informed consent (or verbal assent for minors), and whether an ethics committee or institutional review board approved the informed-consent document and the protocol. If the study was registered, the Methods give its identifier, such as a ClinicalTrials.gov NCT number.
The methods used to protect patients' rights should be disclosed in the Methods section of the manuscript and also in the cover correspondence accompanying its submission.
An example of a statement of the protections given to patients, compatible with the ethical disclosures on subject rights in a randomized controlled trial report, reads: "This study was conducted in accordance with Good Clinical Practices, ethical tenets originating in the Declaration of Helsinki, and national laws (whichever conferred the greatest protection to the individual). All potential study participants and/or legal guardians provided written informed consent (or verbal assent) to participate after being informed of the potential study risks and benefits and before any study assessment or treatment. Translators and other surrogates were provided for non-native speakers and illiterate persons. Both the informed-consent document and study protocol were reviewed and approved by local institutional review boards. As per §801 of the Food and Drug Administration Amendments Act (FDAAA) of 2007, the study was registered at https://www.clinicaltrials.gov (NCT # [number])."
The report of another type of study, such as an observational study, may state that all data were anonymised (de-identified) and that the study was conducted in a manner compatible with guidance from the International Society for Pharmacoepidemiology (ISPE) and with the patient protections of the Health Insurance Portability and Accountability Act (HIPAA) of 1996, the Ethical, Legal and Social Implications (ELSI) Research Program, or the Genetic Information Nondiscrimination Act (GINA) of 2008.
What journals ask for
Journals' instructions for authors set out the ethics statement that a manuscript based on an observational study should include:
- BMJ: every submitted research article should state that the study obtained ethics approval, or that it was not required, with the name of the ethics committee or institutional review board and the number or identifier of the approval.
- JAMA: any manuscript reporting data from studies involving human participants or animals requires formal review and approval, or formal review and waiver, by an appropriate institutional review board or ethics committee, which the Methods section should describe; investigators who have no formal ethics review committee should follow the principles of the Declaration of Helsinki.
- PLOS ONE: the Methods section of any observational or field study must include an ethics statement specifying the permits and approvals obtained, including the full name of the authority that approved the study; if none were required, the authors should explain why.
- The Lancet: studies on patients or volunteers need ethics committee approval and informed consent from participants, and both should be documented in the paper.
- Springer: an ethical approval statement should be included before the References section, stating that all procedures involving human participants accorded with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards; for retrospective studies, it should state that formal consent is not required.
Failing to obtain or disclose approval and consent
A failure by investigators or authors to seek, obtain and disclose ethics committee or institutional review board approval of the study protocol or informed-consent documents is a form of misconduct, as is a failure to secure written informed consent or verbal assent from study candidates or their legal guardians before the first assessment or other procedure.
The compliance statement in a clinical study report
A clinical study report may have to attest that the study was conducted in compliance with good clinical practice and the Declaration of Helsinki. For a study that includes people without access to a gold-standard health care system, for whom the best possible protections are not feasible, a writer being absolutely honest probably could not affirm that. The report can instead carry an explanatory note that the study was conducted as far as possible in compliance with good clinical practice and the Declaration, given the circumstances of the study and the environment in which it had to be conducted.
Full compliance is the aim but is not always possible. A regulator would likely understand that, because regulators hold that, technically, a study cannot be conducted that does not afford people outside the European Union and the other countries that subscribe to GDPR, for example, the same protections that people inside them have, while in practice those protections cannot always be applied.