CITI -Social&Behavioral Research Exam Questions with Correct Answers

What procedures must be described in an agreement called an "assurance of compliance" with OHRP? Correct 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? Correct 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? Correct Answer In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought? Nuremberg Code Correct Answer Judged human experimentation conducted by Nazis. Voluntary consent by human subject is absolutely essential Declaration of Helsinki Correct Answer basis of good clinical practices. Addresses research protocols, informed consent, risks/benefits, et plus Belmont Report Correct Answer basic ethical principles for research involving human subjects. -Respect for person's autonomy -Beneficence -Justice Respect for Person Correct Answer individuals treated as autonomous agents, and those with diminished autonomy are entitled protection Beneficence Correct Answer Make effort to secure well-being. -Do not harm -Maximize possible benefits and minimize possible harm/risk Justice Correct Answer Equals be treated equally. -To each person an equal share. -To each person according to individual need.