Human Research Guidelines

Trial Registration

If applicable, JAH publishes papers that include a link to pre-registration of the study and/or analysis plan. Study registration involves registering the study design, variables, and treatment conditions. Registering the analysis plan involves specifying the sequence of analyses and/or the statistical model. Example registries based on study type are listed below:

• Clinical Trials: http://clinicaltrials.gov/, https://www-isrctn-com.laneproxy.stanford.edu/
• Animal Studies: http://AnimalStudyRegistry.org
• General: https://osf-io.laneproxy.stanford.edu/registries

If authors have pre-registered the study, a link to the registry and a unique identifier for the pre-registration must be included at the beginning of the Methods section upon submission of the paper.

If authors have pre-registered an analysis plan, the authors must:

• Confirm in the text that the study was registered prior to conducting the research, with links to the time-stamped pre-registration at the institutional registry
• Confirm that the pre-registration adhere to the disclosure requirements of the institutional registry or those required for the preregistered badge with analysis plans maintained by the Center for Open Science.
• Report all pre-registered analyses in the text. If there were changes in the analysis plan following pre-registration, those changes must be disclosed with explanation for the changes.
• Clearly distinguish in the text which analyses were pre-registered and which were not, such as having separate sections in the results for confirmatory and exploratory analyses.

 

Informed Consent

For research involving human participants, authors should adhere to ICMJE recommendations for Protection of Research Participants.

Authors must include in the methods section a statement indicating the study was approved by an institutional review board (IRB) along with the name of the IRB, and that the participants gave written informed consent (or justification for why informed consent was not necessary). Documentary evidence of institutional review and participant consent must be supplied if requested.

When publishing identifiable images from human research participants, authors must include a statement affirming that they have obtained informed consent for publication of the images. Images should be cropped to remove nonessential identifying details and protect patient anonymity, but should not be otherwise altered.