(for authors) Institutional Research Board / Research Ethics Board and Informed Consent

Please note this important information about the ethics of human subjects research.

• Authors/Investigators are responsible to ensure their research adheres to relevant regulations.
• Authors are advised to inform themselves of local, institutional/organizational, and regional/national regulations and policies regarding human subjects research.
  • Authors must transparently and completely attest to adhering to such regulations when submitting scientific manuscripts for peer review. For instructions on information to include in the Ethics Approval / Ethical Considerations section of a manuscript submitted to a JMIR Publications journal, see: How should headings be formatted?

On this website, authors can find more detail about what to include in their Ethics Approval / Ethical Considerations section of a JMIR Publications manuscript.

1. Ethics Approval (Ethical Considerations)
2. Informed Consent
3. Privacy and Confidentiality

Journal Ethics Policy

As stated on each JMIR Publications journal website:

All JMIR Publications journals require that all studies on human subjects have approval from the Institutional Review Board (IRB) or equivalent body. IRB approval/exemption along with gender and age of all subjects should be clearly stated in all papers involving studies on humans and/or uploaded as supplementary material. The editors reserve the right to request such documentation. See section below on Ethics Approval (Ethical Considerations).

Similarly, authors must acknowledge that informed consent was obtained for studies on humans after the nature and possible consequences of the studies are explained. All JMIR Publications journals require authors to provide a statement that informed consent was obtained from participants in any research involving human subjects. In all JMIR Publications journals, authors of manuscripts describing studies of internet and digital tools and technologies are required to verify that they complied with informed consent guidelines when necessary and have adhered to local, national, regional, and international law and regulations regarding protection of personal information, privacy, and human rights. See section below on Informed Consent.

Also, regarding each JMIR Publications journal's editorial policy on ethics: 

The Journal of Medical Internet Research is a member of COPE (Committee on Publication Ethics) and JMIR Publications is in the process of converting its journal-level COPE membership into a publisher-level membership for JMIR Publications journals. The entire publication process from submission, review, to publication in all JMIR Publications manuscripts, adheres to COPE guidelines, and suspected cases of misconduct (e.g., including plagiarism) will be investigated using COPE Flowcharts. Authors are expected to review COPE guidelines to ensure their studies and publications adhere to guidance therein. In addition, all JMIR Publications journals adhere to the guidelines stated in the WMA Declaration of Helsinki. Authors may also refer to this discussion regarding ethical issues in qualitative research on the Internet. 

JMIR Publications also provides guidance on authorship, retractions, corrections, and publishing malpractices (such as misconduct). For more information on JMIR Publications' ethics policies, please visit our Knowledge Base (KB), here.

Ethics Approval (Ethical Considerations)

When reporting experiments or research involving human subjects as participants, authors must:

• Clearly state the outcome of a research ethics evaluation. Such evaluations are typically completed by an Institutional Review Board (IRB), which is also known as a Research Ethics Board (REB) or Research Ethics Committee (REC). Example outcomes can include ethics approval, exemption, or other possible outcomes, depending on the board's/committee's procedures. Authors may also state whether the procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the WMA Declaration of Helsinki, although authors declaring this alone may not alone be sufficient for compliance with local, institutional/organizational, and regional/national regulations on human subjects research.
• Include a case or application number or the research ethics evaluation, if one is available. This is not mandatory, however, it is strongly recommended.
• State the process of informed consent. See below section on Informed Consent.
• Attest to maintaining privacy and confidentiality of research subjects' data and/or identity. See below section on Privacy and Confidentiality.
• Disclose compensation to participants, if applicable. 

If doubt exists whether the research was conducted in accordance with the Helsinki Declaration, the authors must explain the rationale for their approach and demonstrate that the institutional review body explicitly approved the doubtful aspects of the study.

Vulnerable populations

Researchers will need to consider additional ethics concerns or issues arising from working with potentially vulnerable people. Researchers will need to assess potential vulnerability within the context of the research, in terms of potential consequences from their participation (immediate and long-term) or lack of positive impact where this is immediately needed or expected. Researchers should make the participants aware of the limits to confidentiality when eliciting consent, and decide whether verbal or written consent will be more appropriate and protective of the participants’ interests.

In cases where research involves potentially vulnerable groups (for example children, minors, older persons or adults with learning disabilities, persons in humanitarian crises or health emergencies) every effort should be made to secure freely given informed consent that participants have actively provided. Every effort should be made to ensure that they have the time and opportunity to access support in their decision-making, for example by discussing their choice with a trusted adult or relative.

Additional reading on research involving vulnerable people:

WMA Declaration of Helsinki

The Belmont Report

UKRI Economic and Social Research Council: Research with potentially vulnerable people

COPE: The protection of vulnerable groups and individuals

Animal studies

When reporting experiments on animals, authors are expected to adhere to the ARRIVE guidelines on reporting animal studies (currently only peer-reviewed in JMIRx Bio). Specifically, authors are responsible for complying with regulations and guidelines relating to the use of animals for scientific purposes. This includes ensuring that they have the relevant approval for their study from an appropriate ethics committee and/or regulatory body before the work starts.

When reporting experiments on animals, authors should indicate whether institutional and national standards for the care and use of laboratory animals were followed. 

Informed Consent

Informed consent (or waiver thereof) and the ability of participants to opt out should be provided. For secondary analyses utilizing existing data with primary consent, specify that the original consent or IRB approval covers secondary analysis without additional consent. When informed consent has been obtained, it should be indicated in the published article.

However, for certain types of research, informed consent cannot be obtained (e.g. analyses of social media posts, A/B testing of websites etc.). In these cases, the investigator should comment on the criteria proposed by Eysenbach & Till (BMJ 2001) and obtain IRB approval which is often particularly important for research with mental health e-communities.

See also: Vulnerable populations

Privacy and Confidentiality

Patients have a right to privacy that should not be infringed without informed consent.

Identifying details should be omitted if they are not essential. If in doubt, informed consent should be obtained if there is any doubt. Identifying information, including patients' names, initials, or hospital numbers, should not be published in written descriptions, photographs, and pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) gives written informed consent for publication. Informed consent for this purpose requires that a patient who is identifiable be shown the manuscript to be published.

Please make sure that identifiable features of research participants or users in any images of the manuscript or supplementary material are not visible; if including such images is unavoidable, please include a statement that consent has been granted from identifiable individuals, and also upload the relevant consent forms or written communications as a supplementary file ("Other files — not for publication"). For example, masking the eye region in photographs of patients is inadequate protection of anonymity. If identifying characteristics are altered to protect anonymity, such as in genetic pedigrees, authors should provide assurance that alterations do not distort scientific meaning and editors should so note.

Secondary data analyses

Some examples of specific study designs are noted here, however, this is not an exhaustive list. Authors are advised to refer to appropriate reporting guidelines for their study design and consult with their organizations ethics review board as appropriate.

For secondary analyses of pre-existing datasets, although authors may not necessarily have performed the data collection themselves (e.g., it may have been done by another research group, institution, or agency), authors nevertheless should:

• State the ethics approval status of the original data collection. Frequently, citing the original study that describes the data collection and reports the original ethics approval is necessary to appropriately credit the original investigators and source of data. 
• If no ethics evaluation of the present analysis was done, authors must provide an appropriate rationale for this. In rare instances, regional/national regulations may specifically state that certain types of research do not require ethics approval; citation of relevant policies should be included in the manuscript, including name of the exact policy and, preferably, include also a URL as a numbered reference, where the policy can be viewed. 
• State that authors had permission or a license to use the data. For example, some pre-existing datasets have specific licensing or citation requirements that authors must agree to, so that such data are used solely for the (research) purposes intended when investigators originally collected the data.

See also: Do I need ethics approval for social media research?

Related

• See "Ethical Considerations" section in: How should headings be formatted? 
• JMIR Publications Author Instructions (check each journal's Author Instructions as applicable)
• JMIR Publications Ethical Issues and Considerations
• JMIR Blog: Ethical Considerations in eHealth & Informatics Research: The Reviewer's Role
• WMA Declaration of Helsinki
• The Belmont Report
• UKRI Economic and Social Research Council: Research with potentially vulnerable people
• COPE: The protection of vulnerable groups and individuals