ILM JAHM complies with the recommendations of the International Committee of Medical Journal Editors (ICMJE) regarding Protection of Research Participants:

“All investigators should ensure that the planning, conduct, and reporting of human research are in accordance with the Helsinki Declaration as revised in 2013. All authors should seek approval to conduct research from an independent local, regional, or national review body (e.g., ethics committee, institutional review board). 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 local, regional, or national review body explicitly approved the doubtful aspects of the study. Approval by a responsible review body does not preclude editors from forming their own judgment whether the conduct of the research was appropriate.

Patients have a right to privacy that should not be violated without informed consent. Identifying information, including names, initials, or hospital numbers, should not be published in written descriptions, photographs, or pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) gives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 an identifiable patient be shown the manuscript to be published. Authors should disclose to these patients whether any potential identifiable material might be available via the Internet as well as in print after publication. Patient consent should be written and archived with the journal, the authors, or both, as dictated by local regulations or laws. Applicable laws vary from locale to locale, and journals should establish their own policies with legal guidance. Since a journal that archives the consent will be aware of patient identity, some journals may decide that patient confidentiality is better guarded by having the author archive the consent and instead providing the journal with a written statement that attests that they have received and archived written patient consent.

Nonessential identifying details should be omitted. Informed consent should be obtained if there is any doubt that anonymity can be maintained. For example, masking the eye region in photographs of patients is inadequate protection of anonymity. If identifying characteristics are deidentified, authors should provide assurance, and editors should so note, that such changes do not distort scientific meaning. The requirement for informed consent should be included in the journal’s instructions for authors. When informed consent has been obtained, it should be indicated in the published article. When reporting experiments on animals, authors should indicate whether institutional and national standards for the care and use of laboratory animals were followed.should provide assurance, and editors should so note, that such changes do not distort scientific meaning.

The requirement for informed consent should be included in the journal’s instructions for authors. When informed consent has been obtained, it should be indicated in the published article.

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

Human Subject Research

ILM JAHM uses the following definitions for human subject research:

Clinical Trial Research

ILM JAHM uses the ICMJE definition:

“The ICMJE defines a clinical trial as any research project that prospectively assigns people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the relationship between a health-related intervention and a health outcome.

Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes.

Health outcomes are any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events.”

Observational/Retrospective Chart Review Research in Human Subjects

Issues in Law and Medicine recognizes the ICMJE understanding that research which is purely observational in which the exposure or intervention is not dictated by the researchers, is not a clinical trial.

Clinical Case Reports

The Editors of Issues in Law and Medicine may consider publication of case reports which adhere to CARE Case Report Guidelines. Authors should follow instructions for creating the case report as outlined in CARE Writing a Case Report.

ILM JAHM Requirements for Submission of a Manuscript Regarding Human Subject Research

1. Acknowledgement of compliance with Federal requirements for the Protection of Human Subjects. ILM JAHM requires authors to acknowledge compliance with Federal requirements for the Protection of Human Subjects in order to begin the process of peer review for a manuscript.
2. Documentation of IRB Approval or Waiver of IRB Review. In addition, research involving human subjects must be submitted to an Institutional Review Board. ILM JAHM will require you to upload documentation of the decision of an IRB when you are uploading your manuscript to Scholar One. Failure to include documentation of IRB review or waiver will result in an inability to proceed with peer review of your manuscript. Surveys must also have documentation of IRB review with documentation of exemption or approval.
3. Statement of Compliance with Requirement for Informed Consent from Research Subjects.ILM JAHM will require authors to make the following acknowledgement in order to enable the peer review process to commence: By submitting my manuscript, I acknowledge that my human subject research has been conducted in accordance with Title 45 Subtitle A Subchapter A Part 46 Protection of Human Subjects.  Further I acknowledge that an informed consent discussion was completed and signed informed consent documentation was obtained from each research participant prior to the start of the intervention.”

4. Epidemiological Studies from Databases. Data obtained from databases must be deidentified and must comply with HIPAA requirements.