No Written Language: For studies involving populations that have no written language an English consent form shall be used as a template for translation into the oral language. A statement translated into the foreign language must be included to explain the process of informed consent. The consent form should be signed by the interpreter, the Principal Investigator or approved designee, and the by the subject, who should be requested to make a mark or thumb print, as appropriate.
Group Consent: For studies involving populations that utilize group consent, the IRB may approve this procedure with appropriate description and written justification by the Principal Investigator for the use of group consent. The Principal Investigator should also provide a method to obtain private or individual subject assent (if possible) and a method for protecting those who choose not to participate in the study.
“Non-Therapeutic” Research: (i.e. research without the intent to produce a diagnostic, preventive, or therapeutic benefit to the current subjects, although it may benefit those with a similar condition in the future) -- Whenever possible, provisions should be made for the study population to benefit from the research study.
“Therapeutic” Research: The Principal Investigator must explain to the IRB why the study should or should not provide continued access to the experimental intervention (should it prove efficacious) or other research benefits after the completion of the study
Studies Involving Minors (Participants under the age of 18 years): The University of Miami requirement for assent for minors in research studies are applicable for minors at foreign institutions or sites. It is usual that written, parental permission is also required. If local customs and regulations are such that active parental permission would be culturally inappropriate, a waiver of such permission may be granted at the discretion of the UM IRB providing the IRB determines that the research does not place the participant(s) at untoward risk.
Investigators seeking a waiver of parental permission must supply the IRB with proof that such permission is not culturally appropriate. Examples of such proof would be specific regulations indicating that such permission is not required, an official letter from a ranking official in the foreign country indicating that such permission is not culturally appropriate, or the appearance at a UM IRB meeting by someone of official standing in the research or academic community who can attest to the cultural inappropriateness of the requirement for active parental permission.
If a waiver of active parental permission is granted, and if a letter informing the parents of the research is deemed appropriate, it must be written at a literacy level that would be understood by the parents and translated (if appropriate) pursuant to UM policies that govern translations of informed consent and other documents. The letter should be sent to parents by the most expeditious method possible.
HIPAA and the Collection of Protected Health Information: HIPAA policies do not apply to those international sites not covered by HIPAA although individually identifiable health information may be collected. However, HIPAA requirements do become effective if (or when) data is transferred to a HIPAA covered entity such as a covered component of the University of Miami. No matter whether HIPAA policies are applicable or not, standard methods of protecting confidentiality and privacy for research in human subjects should apply and investigators should have these in place.
The use and disclosure of data from the University of Miami requires investigators to adhere to the Authorization requirements of HIPAA. In Studies where identifiable data will be transferred from a site not covered by HIPAA to a HIPAA covered entity, investigators should obtain HIPAA Authorizations to reduce the need to account for subsequent disclosure(s) of the PHI. Alternatively, investigators may bring data to UM either stripped of all of the 18 HIPAA identifiers with or without a code maintained at the collection site, or as a Limited Data Set with an accompanying Data Use Agreement.