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This compilation of laws, regulations, and guidelines is helpful to CITI Program organizations that are involved in international research. They included laws, regulation, and guidelines have been classified into nine categories:
- Drugs and Devices
- Clinical Trial Registries
- Research Injury
- social-behavioral Research
- Privacy/Data Protection
- Human Biological Materials
- Embryos, Stem Cells, and Cloning
A researcher proposes a study and wants to recruit subjects from health care clinics in Jamaica. The survey will be conducted by U.S. researchers at the clinic. The nurses at the clinic will inform prospective subjects about the availably of the research, but will not consent the subjects nor perform any research procedures (even screening procedures). Are the nurses engaged in the research according to federal regulations?
No, they are not engaged because they are only informing the subjects and not consenting or performing any research procedures, or receiving or sharing any private, identifiable information.
A professor at Big State University proposes to study attitudes about obesity in Chile by giving subjects in Chile surveys to complete. Which is a question that the Big State University IRB should ask the researcher in order to determine if this study should be reviewed by a local Chilean IRB or ethics committee as well as the Big State University IRB?
Will the researcher have collaborators at the research site abroad?
Which of the following is the LEAST important activity when protecting human subjects in international research?
Assessing transportation conditions
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.
What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects?
In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought
Which of the following activities constitutes engagement in research?
Obtaining informed consent and conducting research interviews.
The age of majority in international research is determined by the
Laws, customs, and norms in the area in which the research will be conducted.
The University of Scranton IRB or its designated reviewers must review all research involving
Both simple anonymous surveys and class assignments outside of class
A Departmental Review Board (DRB) can review
Form A and B
Which type of research cannot be submitted on Form A
No risk experiment
Which type of research must be submitted on Form B – no risk beyond everyday life and
Both recording participant identity and experimental procedures
Which type of research must be submitted on Form C
Both research involving children and risk beyond everyday life
To speed up the approval process, an IRB administer can be the sole reviewer of __ proposals.
Which of the following is the general guideline that IACUCs use to evaluate the potential pain of a procedure conducted with animals?
Any procedure that causes pain or distress in human beings may cause pain or distress in other animals.
Prior to implementing any significant change in the use of animals, what is the most important thing that the research team must do?
Obtain IACUC approval for the change.
Which of the following most accurately describes the process that must occur when working with research animals covered by U.S. federal regulations?
The research team must obtain IACUC approval for the proposed research procedures prior to starting the work.
Which entity is responsible for monitoring institutional compliance with PHS Policy?
The Office of Laboratory Animal Welfare (OLAW)
Which of the following is true regarding the use of animals in research?
The attending veterinarian must be allowed to have access to all research animals at all times.
Which of the following is empowered by the U.S. federal government to review and approve research activities involving vertebrate animals?
The Institutional Animal Care and Use Committee (IACUC)
Which of the following is the main reason why proper training in euthanasia techniques is important?
Improper techniques can cause unnecessary pain and distress in animals.
What is the primary purpose of the “3Rs” concept from Russell and Burch?
To decrease the use of animals in research and to minimize pain and distress caused by animal experiments.
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