If you seek to publish a study involving human subjects, clinical samples, or patient data, missing information about ethical approval and informed consent can delay peer review and even result in rejection of your manuscript. Journals generally require information about ethics committee approval and informed consent for all manuscripts that involve human subjects. Due to the broad definition of “human subjects research”, you may have questions about whether your study falls into this category and what information will be required by journals when you are ready to publish. Here, we answer some of the most common questions that researchers ask about reporting human subjects research.
What is the definition of “human subjects research”?
The NIH defines a human subject as "a living individual about whom an investigator (whether professional or student) conducting research:
- obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens."
Therefore, a study may require ethical approval and informed consent even if the researcher never meets the human subject. For example, performing experiments on a tumor removed from a patient is considered human subjects research. Analyzing an individual’s genome sequence also falls into this category.
Who approves human subjects research?
At an institutional level, an ethics committee reviews and approves a study protocol before human subjects research can begin. The protocol outlines the purpose of the study, how subjects will be recruited, inclusion and exclusion criteria, the procedure for obtaining participant consent, the procedures that will be performed, and how the data will be used. Journals generally require that authors provide the name of the ethics committee when submitting their manuscript (for example, “the Institutional Review Board at Duke University”).
What is “informed consent”?
Informed consent is a process in which the researcher informs the subjects about their rights, the purpose of the study, the procedures that will be performed, and the potential risks and benefits of participation. The subjects must understand all these aspects of the study to provide their consent; the materials must be provided at an appropriate reading level, presented verbally for illiterate subjects, and translated if necessary. For participants that cannot understand this information (e.g., a child), consent from a guardian must be obtained. Subjects must willingly give their permission for the study without feeling coerced; for example, participation in the study must not influence other aspects of the subject’s medical care.
Does consent always have to be written?
Generally, subjects sign a form to indicate that they have received all of the required information and give their permission to participate in the study. However, there are some situations in which verbal consent is more appropriate (e.g., the record of the subject names could compromise their safety). In these cases, the need for verbal consent is usually explained in the protocol and approved by the ethics committee.
Is there any human subjects research where informed consent is not required?
The institutional ethics committee may waive the requirement for informed consent for studies in which the risk to the subjects is low. For example, the ethics committee may not require informed consent for retrospective analyses of de-identified data or for a survey-based study. However, these studies still require ethics committee review and approval.
What if blood or tissue was obtained from a third party, such as a blood or tissue bank?
Blood and tissue banks generally have their own ethics committees and approved consent protocols, so authors generally provide the name of the blood or tissue bank and a statement about their ethics protocols. The authors may still need ethics committee approval from their own institutions, but they do not need a statement about consent.
Is ethics committee approval or informed consent needed for a meta-analysis or systematic review?
As these studies are re-analyses of published papers and no additional human subjects are involved, no ethics committee approval or consent if required.
Can a study be retroactively approved by an ethics committee?
Retroactive ethics committee approval of human studies is generally not accepted by journals. However, in some unique circumstances, retroactive approval may be permitted: for example, a study that analyses samples collected during an epidemic and ethics committee review prior to sample collection was not possible.
What other types of consent may be requested by a journal?
If a manuscript includes photographs or other identifying information about human subjects, journals will often require a publication release form from the subjects or a statement that the subjects provided permission to publish the information or photographs. In some cases, photographs can be anonymized (blurring or obscuring identifying features), but journal policies in these circumstances vary.