CITI -Social&Behavioral Research question and answer TOP rated (latest update 2024)

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.