аЯрЁБс>ўџ 24ўџџџ1џџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџџьЅС‘@ №ПjbjbШ&Ш& "ЂDЂD џџџџџџl’’’’’’’ТТТТТ ЮТГЊююююю]]]prrrrrr,] }!Lž’]@]]]žЙ’’юю/юЙЙЙ] ’ю’юpЙІД’’’’]pЙhЙ!Ž(h’’dт ‚†ФТТgRd ГГ ФЩ!ЙЩ!dЙУхIRC Page number 3.2.1 Copyright IRC Page topic Select the Right Review Process Page date 5/9/07, 12/98, 7/1/08 DETERMINATION OF HUMAN SUBJECT RESEARCH (HSR) Occasionally a sponsor or vendor wants verification from an impartial source that activities do not require IRB Review or approval. This occurs infrequently. To make a determination, we need sufficient information to know if the activities are considered research, research involving human subjects and research involving human subjects that is regulated. This is a one-time determination and does not need re-review. If activities have changed, a new determination request is needed. GENERAL APPROVAL A federal grant application must have IRB review before it is funded. Grants make terrible protocols. The intent of a grant application is to justify funding a line of inquiry. The audience is expert reviewers. The intent of a protocol is to explain and justify use of humans as subjects and the audience is diverse. Grants often describe sequential studies some of which must be fairly amorphous until the initial studies are complete. Other grants describe large programs with multiple projects at multiple sites with multiple coordinating centers. Nevertheless, funding agencies require IRB approval of grant applications. The IRB – using the expedited process – will consider acceptance of the grant with the caveat that no activity is allowed until a protocol is approved. EXEMPTION FROM IRB REVIEW Some human subject research is either so common or such a low perceived risk that they do not require review by an IRB. Exemption requests can be reviewed by IRC or an institutional authority. To qualify all of the procedures in the study under consideration must fit comfortably within the categories allowed under the regulations. Although often assumed, fitting in an exemption category does not equate to minimal risk. The exemption is from IRB review but is not from ethical conduct or, where needed, appropriate consent. Continuing review is not required but IRC establishes a one year “check in” to assure that the activity is on-going and continues to merit the exemption. IRB REVIEW - EXPEDITED PROCESS A few more activities do not necessarily need the attention of the full board. They are either repetitive or low perceived risk. Expedited review is performed by one or two experienced members who may approved, ask questions or refer to full board. It is not necessarily faster when the full board meets often ALL of the activities in the application must be found to create less than a minimal risk of harm and all of the procedures must fit in one or more of the expedited review categories. Continuing review of a study that was originally full board if it meets categories 8 or 9. a minor modification to an already approved study. Minor is undefined and the trend among IRBs is toward more conservative evaluations of what constitutes a minor change. Any change that does not alter or that reduces risk is likely to be a minor change as would new advertising copy, or pre-arranged changes or reviews of new investigators. IRB REVIEW - FULL BOARD PROCESS All other applications must be reviewed by the full board at a convened meeting with enough circulation time to allow members to fully consider the proposal.  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