Admin Table of Contents
What procedures must be described in an assurance of compliance?
What procedures must be described in an agreement called an “assurance of compliance” with OHRP? 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 is something an IRB should do with respect to review of GSD research?
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 can “gender expression” tell you about a particular subject?
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.
What are the criteria for the regulatory definition of research?
The Common Rule defines research as: “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”
What is assurance of compliance?
An assurance of compliance is a written document submitted by an institution (not an Institutional Review Board) that is engaged in non-exempt human subjects research conducted or supported by HHS. The Federalwide Assurance is the only type of assurance of compliance accepted and approved by OHRP.
Who needs a FWA?
A Federal Wide Assurance (FWA) provides assurance that the institution receiving HHS support will follow HHS regulations for human subjects found in 45CFR46. Institutions engaged in DMID human subjects research must obtain a FWA.
Social behavioral research applies the behavioral and social sciences to the study of people’s or animals’ responses to certain internal and external stimuli. This kind of research is conducted by the following academic disciplines: economics, political science, sociology, psychology, anthropology, and history.
Which of the following are the three principles discussed in the Belmont Report?
Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice.
What is IRB approval 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 types of research require 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 determines the procedures to be followed to determine type of IRB review that is required?
The review path is determined by: Level of risk to subjects associated with the project. The type of research being conducted (e.g., an educational intervention, a survey, an ethnographic observation, etc.) The sensitivity of the research questions or complexity of the research design.
What initiates the process of research?
The first step in the process is to identify a problem or develop a research question. The research problem may be something the agency identifies as a problem, some knowledge or information that is needed by the agency, or the desire to identify a recreation trend nationally.