BME 314 Lecture 23 2012

Thecurrentirbhas1studentmemberand2membersfromthe

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Unformatted text preview: therapy from any other sources. In exchange for their participation, the men received free meals, free medical examinations, and burial insurance. The IRB The IRB (Institutional Review Board) A review committee set up by each institute (university, hospitals, companies whoever ones to use human subjects) consisting of experts in various fields (related or unrelated to a particular application) along with “lay” people and members from the community Composition of the UT Austin IRB Composition of the UT Austin IRB Faculty/staff committee appointed annually by the VP for Research, Must be sufficiently qualified through the maturity, experience, and expertise of their members and diversity of membership to insure respect for their advice and counsel specific to safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific activities, the committee must be able to ascertain the acceptability of proposals in terms of organizational commitments, regulations, applicable law, standards of professional conduct and practice, and community attitudes. The Current IRB has 1 student member and 2 members from the community (including one prisoner representative) http://www.utexas.edu/research/rsc/humanresearch/aboutIRB/index.php Key IRB Rules: Key IRB Rules: UG students as Study Subjects Subject pool: Undergraduate students enrolled in particular departmental courses requiring participation in one or more research projects. All student participation in subject pool research must be completely voluntary. Departments provide students with incentives (usually extra credit) to participate in the subject pool. Reimbursement for participation must not jeopardize subject confidentiality or anonymity. Any subject pools offering extra credit to participating students must provide alternative opportunities to earn extra credit to students declining to participate in research. It is up to the student to decide whether to participate in any study; instructors cannot mandate or require student participation . In accordance with our recruitment policy, instructors are strongly discouraged from recruiting subjects they directly supervise or selecting subjects on such basis. http://www.utexas.edu/research/rsc/humanresearch/aboutIRB/index.php What do you need in an informed consent? What do you need in an informed consent? A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental A description of any reasonably foreseeable risks or discomforts to the subject; A description of any benefits to the subject or to others which may reasonably be expected from the research; A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information ma...
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This note was uploaded on 03/17/2014 for the course BME 314 taught by Professor Frey during the Spring '08 term at University of Texas.

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