Federal regulations require a review on the scientific merit of the proposal by the Institutional Review Board. The risks to the subjects are compared to the direct benefit. The involvement of protected groups is assessed. The consent form is assessed in detail to be sure that the purpose is conveyed accurately, the study is described in sufficient detail for the subject to decide what is involved, and the risks and benefits are accurately portrayed. The consent form must be determined to be written in a language appropriate to the study population.
Regulatory agencies recommend a reading level of no higher than eighth grade for all consent forms.
Within one week of the Board meeting, letters outlining the Board s decision concerning the study are prepared. At times the Board will make suggestions which are not accurate, because of not fully understanding what the protocol said or not knowing the precise details of the science. The principal investigator must therefore review the letter to be sure that the changes recommended will not misrepresent the study to the subject. If adequate changes have been made and all questions answered, immediate Board approval will be granted. If the study was deferred, resubmission to the entire Board is required.