FAQ: Study Advertisements and Handouts

Answer
Written information, which is entirely trial specific and MUST be supplied to the subject for them to be on the trial (not just for their treatment) must be approved by the FHREB. Information that is supplied to patients, whether they are on the trial or not or for standard treatments given during trials do not require FHREB review. For example, in an immunization trial all subjects may receive standard chemotherapy prior to the experimental immunization. The standard chemotherapy regimen is used for both trial subjects and patients not on a trial. There is no need for FHREB review of the standard chemotherapy handouts that are given to the subject. Or, for example, a general pamphlet describing vaccine treatment prepared by the company for any individual interested in the topic whether they are a patient or not or whether they will be a subject on the trial or not, does not need approval. However, if a subject could not be on the trial without receiving a document, for example, a required questionnaire, that document must be approved.

Answer
Yes, all advertisements and other recruitment material are considered to be part of the consent process, and therefore, must be submitted to the FHREB for review and approval, prior to use.

Answer

Occasionally non-FH researchers conducting studies involving humans ask permission to advertise their research project within FH facilities and the question arises whether such research requires FHREB approval.

Research being carried out elsewhere by non-FH staff is not under FH jurisdiction. If research is being done elsewhere and a researcher would like to advertise the study in FH facilities for the purpose of recruiting volunteers, FH has no legal jurisdiction and therefore this is not a FHREB issue. However, any such advertisements do need to meet FH advertising standards and approval. The non-FH researcher must contact the FH Administrative Offices in their program area of interest in order to obtain permission for posting recruitment notices.