Regulation medical research - National
9 important questions on Regulation medical research - National
Research that is subjected to the WMO is that interventional or observational?
As long as a participant is subjected to procedures; or has to follow rules of behaviour => physical ACTIVE INVOLVEMENT.
Can active involvement also mean, filling in questionnaires?
Observation of participants without asking anything from them, is this part of WMO?
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When comes the MREC in the picture?
So in the protocol must be written what the burden + benefit is for the subject. What is important in this? What is important to look at when reviewing this?
Therapeutic vs non-therapeutic.
=> what is the aim of the study?
When are you subjected to the CCMO?
- Complex research ( gene therapy, embryos, human gametes)
- I you want to administer against the negative decision of the MREC
What are the WMO guidelines for informed consent? (3)
- It should be written, and written consent
- Understandable for target group
- Reflection time
What are the privacy regulations by the WMO and which other regulations are important? (3)
- Participants must be anonymously => coded
- You have to be able to trace back to the patient
- Online security
What says the WMO about vulnerable groups? Who are they (3) and what are the regulations? (5)
- Children under 16
- Incapacitated adults
- Subjects that are not in a free position
- They can be included in therapeutic and non therapeutic research
- Only if the research can not be conducted without them
- When resistance; don't include them
- Informed consent should be taken by legal representatives.
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