Paul Janssen Futurelab

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Question 1 of 3

1. Question
1 Discussion in the Dutch parliament

During discussions in the nineties in Dutch parliament regarding the Medical Research Involving Human Subjects Bill, an important issue was whether non-therapeutic clinical research involving minors and incapacitated subjects is acceptable practice. Some politicians advocated a complete ban on this type of research.

What was their main reason for advocating such a ban?
- Non-therapeutic clinical research with minors and incapacitated subjects is not essential, as this research can also be conducted with adult subjects who can provide informed consent.
- Non-therapeutic clinical research with minors and incapacitated subjects cannot provide new insights into disease, as these groups are too heterogeneous.
- Non-therapeutic clinical research with minors and incapacitated subjects cannot provide new insights into disease, as the number of subjects who can participate in clinical research is too low to yield statistically valid conclusions.
- Minors and incapacitated subjects are unable to make an informed decision with respect to the risks, burden, and lack of direct benefit resulting from their participation in a non-therapeutic study.
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Question 2 of 3

2. Question
2. Changing the role of the MREC

The Medical Research Involving Human Subjects Act, which was introduced in the Netherlands in 1999, introduced an important change in the role of the MREC upon accreditation by the CCMO.

Which of the following statement is correct?
- Upon accreditation, the MREC becomes the official advisory committee to the board of directors at the institute where the committee operates.
- Upon accreditation, the MREC is authorized to review all types of clinical research.
- Upon accreditation, the MREC becomes an independent administrative body, issuing legal decisions regarding research proposals that it reviews.
- Upon accreditation, the MREC can decide to forward the research files to the CCMO for review if they feel they lack the expertise for the type of research proposed in the file.
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Question 3 of 3

3. Question
3. The review by an accredited MREC

Which of the following statements regarding accredited MRECs is correct?
- The review of research files by an accredited MREC is limited to the ethical aspects of the clinical trial protocol and the informed consent form.
- An accredited MREC performs a thorough review of the scientific, medical, and ethical aspects of all documents in the research file.
- At minimum, an accredited MREC that reviews clinical research involving medicinal products must contain the following five members: one physician, one clinical statistician, one ethicist, one legal expert, and one lay member.
- An accredited MREC must review at least ten research files each year.
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