What procedures must be described in an agreement called an "assurance of compliance" with OHRP? - correct answer Procedures in place that ensure that
... [Show More] 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.
-To each person according to individual effort.
-To each person according to societal contribution.
-And to each person according to merit.
IRB Review - correct answer to protect the rights and welfare of human subjects by ensuring equitable subject selection, assuring adequate informed consent, assessing and minimizing risks, and maintaining privacy and confidentiality.
Exempt Review - correct answer research with human subjects that generally involves no more than minimal risk. Does not require ongoing review, unless amended st it no longer fulfills the exempt criteria
Expedited Review - correct answer research presents no more than minimal risk. Does not have to be full convened committee.
Full Board (convened) Review - correct answer research that involve more than minimal risk require full board review at a convened meeting at which a quorum of IRB members is present.
Must receive approval by majority of members.
Research - correct answer a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
To test a hypothesis with conclusions to be drawn
Human subject - correct answer a living individual ABOUT whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
Which of the following studies need IRB approval? - correct answer Studies collecting data about living individuals.
Which type of IRB review does not require an IRB approval but does require a determination by the IRB or an IRB designee? - correct answer Exempt
Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent? - correct answer A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond.
Researchers endeavoring to conduct an on-line study should consider that there are some potential risks of harm to subjects unique to Internet-based research. One of these risks is: - correct answer Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers.
Which of the following methods could be considered a "best practice" in terms of informing respondents how their answers to an on-line survey about personal information will be protected? - correct answer The investigator uses the informed consent process to explain how respondent data will be transmitted from the website to his encrypted database without ever recording respondents' IP addresses, but explains that on the Internet confidentiality cannot be absolutely guaranteed.
breach of obligation - correct answer describes an actual violation of a moral or legal duty.
Conflict of Interest - correct answer objective fact situation in which there is increased potential for harm or wrongdoing as a result of compromised independence.
The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold: - correct answer Any equity interest in a publicly held company that exceeds $50,000
Current NIH rules require investigators to disclose details regarding financial conflicts of interest to: - correct answer Designated institutional officials
To ensure that researchers are conducting a study according to IRB requirements, IRBs could: - correct answer Observe the consent process or research procedures
Federal regulations require that additional safeguards have been included in a study to protect the rights and welfare of these subjects: - correct answer Children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons
Research with older adults should include: - correct answer Provisions for assessing capacity to consent
An aging population has resulted in the need to: - correct answer Include more older adults in research to ensure generalizability of research results
Older adults have been excluded from research participation because: - correct answer Their conditions are conside [Show Less]