Informed Consent Considerations

PIs should be prepared to describe any local exceptions to the required consent process and how these will be addressed (e.g., a request from outsiders to sign documents would be treated with suspicion based on customs, previous history, etc.). PIs should also be prepared to provide local contact information for participants who have questions or issues with the project.

If the research includes enrollment of children in other countries, the PI is responsible for providing the IRB with sufficient information to verify the age at which participants in such jurisdictions have the ability to consent to participation in research, including any medical treatments or procedures if applicable. The IRB may, if it appears advisable, require the submission of an opinion rendered by an appropriate authority from the applicable jurisdiction on the age at which an individual can consent to participation in research.

If local customs and regulations are such that active parental permission would be culturally inappropriate, the researcher must supply the IRB with proof of this. Examples of such proof would be specific regulations (in English and certified to be accurate) indicating that such permission is not required, an official letter from a ranking official in the country of interest indicating such, or an expert opinion from another ISU employee (preferably a faculty member) who can attest to the cultural inappropriateness of the requirement for active parental permission. In these cases, a waiver of such permission may be granted at the discretion of the IRB, as long as the research does not place the participants at untoward risk. Regardless, the participants in the research retain the right to discontinue participation, without penalty, at any time during the gathering of data.

If a waiver of active parental permission is granted, a letter informing the parents of the research, written at a literacy level that would be understood by the parents, may be required and should be prepared and sent to the parents by the most expeditious method possible.