Quiz: The scope of the Dutch law

The best way to test your knowledge regarding the scope of the law is to complete the quizzes of this theme. Each quiz has a brief introduction text, followed by a multiple-choice question, and then an explanation. In most cases, you will need to select which reviewing committee (e.g., an accredited MREC or the CCMO) is authorized to review the study described in the introduction text. This has already been covered rather extensively in the first theme of this course, “The Dutch Review System”. You are also encouraged to use the Committee Finder (CoF) tool. By clicking on this link the CoF will open in a separate tab of your browser.

1. Intensive Care

Researchers want to perform a study to investigate the safety and tolerability of a new pulmonary surfactant (a substance designed to reduce surface tension in the alveolae) in twelve adult patients with advanced lung failure. These patients are in intensive care, are sedated, and can breathe only with the assistance of a ventilator. In this study, two different dosages of the test compound will be administered over the course of four days.

Which of the following applies to this study?

2. Contrast Gel for Echoscopy

In a double-blinded, randomized monocenter trial, the tolerability of two types of gel used in contrast echoscopy will be compared. Although both gels are approved for use in patients, different hospitals use different gels. The study is designed to test the hypothesis that patients experience less pain with one gel than with the other. Pain will be measured using a VAS (visual analog scale in which patients rate the pain they experience on a scale ranging from 0 (no pain) to 10 (intolerable pain). The study will be performed in adult female patients who are scheduled to undergo contrast echoscopy.

Which of the following applies to this study?

3. Measuring Intraocular Pressure

Is it possible to measure intraocular pressure in individuals while they are wearing contact lenses? Researchers have designed a study to investigate this in competent adult research subjects.

Opticians routinely perform optometric examinations on their patients. Although intraocular pressure provides an important measurement for detecting glaucoma, this is generally not measured during a routine contact lens consultation, as the patient will be wearing his/her contact lenses during the consultation. The aim of this study is therefore to investigate whether intraocular pressure can be measured accurately in patients wearing their contact lenses using a standard, non-invasive method.

Which of the following applies to this study?

4. Medical Devices

How safe is a non-CE marked custom made medical device designed for use in patients 18 to 55 years of age with damaged cartilage in the knee? Researchers would like to investigate this in a randomized intervention study. The aim of their study is to evaluate the safety of the medical device when used to repair the damaged cartilage. During the study, each patient will undergo a single MRI scan and will report their outcome using a VAS (visual analog scale).

Which of the following applies to this study?