International Research: Study Start-Up Considerations
Yes No N/A / The investigator(s) have a clear understanding of cultural and societal norms in the region (e.g., for consent, standard of care, and risk assessments).Yes No N/A / Any differences in the role of women and children in this community (when compared to men) have been considered when planning the study recruitment and consent process.
Yes No N/A / The local language(s) have been identified.
Yes No N/A / Study materials, including informed consent form(s) will be translated into the local language. (Note: A Translation Attestation form must be submitted to the IRB)
Yes No N/A / The investigators have a clear understanding of the literacy level and have procedures in place to ensure adequate recruitment and consent process.
Yes No N/A / When applicable, alternative methods of consent will be considered (verbal, thumb mark, comprehension checklist) and an appropriate waiver (waiver of documentation of consent or waiver of consent or alteration of elements of consent) will be requested from the IRB.
Yes No N/A / The local age of majority has been determined.
Yes No N/A / Study remuneration has been evaluated in respect to local economic standards.
Yes No N/A / There is a monitoring plan in place to ensure data security and confidentiality.
Yes No N/A / Local ethical review boards/community advisory boards (with adequate composition) have been identified and/or permissions have been obtained from collaborating institutions to conduct the research.
Yes No N/A / A determination has been made regarding relying/reviewing IRB or whether concurrent review will occur. (Note: The Harvard LMA IRB does not routinely serve as the IRB of record for international sites, therefore concurrent review by a local IRB is most appropriate for international studies. An Individual Investigator Agreement (IIA) to cover the work done by individual investigators may be used, if applicable. Contact your department assigned IRB Review Specialist to confirm appropriateness.
Informed Consent Checklist and Consent Observation Assessment Tool
Version: July 29, 2014