What procedures must be described in an agreement called an “assurance of compliance” with a U.S. federal agency?
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.
Which of the following activities constitutes engagement in research Citi?
Which of the following activities constitutes engagement in research?
Obtaining informed consent and conducting research interviews
. Laws, customs, and norms in the area in which the research will be conducted.
Which of the following is something an IRB should do?
To evaluate research adequately, the IRB must be able to (1)
identify the risks involved in the study
, (2) identify how the risks are minimized, and (3) assess whether the risks are reasonable in relation to the anticipated benefits.
Which of the following strategies would help ensure that participation in a survey about a sensitive personal topic remains voluntary throughout a study?
Which of the following strategies would help ensure that participation in a survey about a sensitive personal topic remains voluntary throughout a study?
Designing the survey so that subjects are not forced to answer one question before going to the next.
Which of the following is something an IRB should do with respect to review of GSD research quizlet?
Which of the following is something an IRB should do with respect to review of GSD research?
Seek consultants with expertise in specific segments of GSD communities to provide information on research in those communities
.
What activities constitutes engagement in research?
In general, an institution is considered engaged in a particular non-exempt human subjects research project when its employees or agents for the purposes of the research project obtain: (1)
data about the subjects of the research through intervention or interaction with them
; (2) identifiable private information about …
What action can he expect by the IRB?
The researcher submits the research proposal to the institution’s IRB. What action can he expect by the IRB?
The IRB will not review this study because
it is not research as defined by the federal regulations. You just studied 35 terms!
What are the three types of IRB review?
IRB must review all projects that meet the definition of research and that involve human subjects prior to any data collection to determine the appropriate level of review, and, as appropriate, approve them. There are three major types of review:
Exempt, Expedited, and Full
.
What is the IRB process?
Under FDA regulations, an IRB is an appropriately constituted group that has been formally
designated to review and monitor biomedical research involving human subjects
. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.
What needs IRB approval?
FDA regulations generally require IRB review and approval of
research involving FDA-regulated products
(e.g., investigational drugs, biological products, medical devices and dietary supplements) (21 CFR Part 56).
What is the term for management controls that are built in to a research study for example independent data analysis )? Quizlet?
Terms in this set (88) What is the term for management controls that are built in to a research study (for example, independent data analysis)? Inherent controls.
What statement about risks in social and behavioral sciences research is most accurate:
Risks are specific to time, situation, and culture
. The primary purpose of a Certificate of Confidentiality is to: Protect identifiable research information from compelled disclosure.
What is the main risk of using the Internet for research purposes?
In most internet-based research, the primary risk of harm is
a breach of confidentiality
.
Which of the following is a reason that prisoners need special protection?
Which of the following is a reason that prisoners need special protection?
Prisoners have limited free choice because their autonomy is restricted
.
Which type of IRB does not require approval?
“Exempt” human subjects research
is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the Common Rule.
Which of the following elements must be included in an informed consent?
- Description of Clinical Investigation. …
- Risks and Discomforts. …
- Benefits. …
- Alternative Procedures or Treatments. …
- Confidentiality. …
- Compensation and Medical Treatment in Event of Injury. …
- Contacts. …
- Voluntary Participation.
