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The Institutional Review Board: A Road Map and Why You Want to Go There Presented by: Sara H. Kiskaddon, J.D. The IRB exists as a federally mandated board in all institutions engaged in human research. Its purpose is to assure in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of all participants in involved in research. (Research is defined as any systematic analysis designed to obtain generalizable knowledge with data linked to a person.) The IRB is composed of at least 5 members of diverse backgrounds with at least: 1 scientist, 1 non-scientist, and 1 person non-affiliated with the institution. CCMC has 12 members (see link). Applications - 15 copies must be signed the PI (principle investigator) and delivered 3 weeks before the meeting date (each 2nd Monday of the month). Each is assigned a primary and secondary reviewer. Reviews are stratified as: Exempt - when there is completely anonymous data with no link to a person Expedited - when determined to be of "minimal risk" (not greater than that ordinarily encountered in everyday life) Full Board - all others The IRB keeps minutes (CCMC staff can access the minutes through the g drive: ccmcdocs/res/IRBadmin/minutes) and has the authority to approve, approve with contingencies, and table / disapprove protocols. A response is provided to the PI one week after a meeting. The Informed Consent: Is written in lay language and in the "second person" Is a voluntary agreement, with options outlined, and offer opportunity for questions Acknowledges to provide to participants new information as it arises Should incorporate "8 Essential Elements" to explain the study: purpose, procedures, risks/discomforts, benefits, confidentiality, questions, voluntary participation, right to withdraw. The IRB process seeks to ensure the principles of Beneficence, Justice, and Autonomy for research participants as outlined by a National Commission. Beneficence; the subject's well-being takes precedence, risks are minimized and justified by anticipated benefit. Justice; fair sharing of burden and benefit among study subjects, research is only justified when there is a reasonable likelihood of benefit to that population, children should be included if there exists potential benefit for them. Autonomy; must be adequate provisions for child assent/parental permission, the informed consent incorporates "8 essential elements". Many controversies currently exist in the arena of clinical research. New regulations concerning outcomes research will impact upon all phases of the process. The HIPAA regulations are soon to be fully implemented (Health Insurance Portability and Accountability Act of 1996). Summarized by F. DiMario