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What procedures must be described in an agreement called an "assurance of compliance" with OHRP? - ANSWER Procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB. A researcher proposes to conduct a study at a foreign site that has been determined to be exempt from the federal regulations by institutional policy. According to federal regulations, is review required at the foreign site? - ANSWER If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted. What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects? - ANSWER In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought? Nuremberg Code - ANSWER Judged human experimentation conducted by Nazis. Voluntary consent by human subject is absolutely essential Declaration of Helsinki - ANSWER basis of good clinical practices. Addresses research protocols, informed consent, risks/benefits, et plus Belmont Report - ANSWER basic ethical principles for research involving human subjects. -Respect for person's autonomy -Beneficence -Justice Respect for Person - ANSWER individuals treated as autonomous agents, and those with diminished autonomy are entitled protection Beneficence - ANSWER Make effort to secure well-being. -Do not harm -Maximize possible benefits and minimize possible harm/risk Justice - ANSWER Equals be treated equally.