Read the summary and the most important questions on Master Nutrition in Health and Disease

• 1 Week 1

• 1.1 Lecture 2: Rules and regulation

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• What is the MREC? (of METC? In dutch)

  Medical research ethical committee. If you do scientific research with humans, you have to report your research proposal here. (or with the CCMO)

• To which two organizations do you have to report your research proposal for ethical consideration?

  The CCMO and the MREC (METC)
  Central committee on research involving human subjects
  Medical research ethical committee

• What is the danger of not doing sample size calculation and having a too small sample size?

  If the sample size is too smalle, you might get a false negative outcome (type 2 error, ß)

• What is a type two error?

  A false negative, there is a true effect, but you do not find it in your study.

• What is a type one error?

  False positive. You find an effect, but in truth, there is not effect.

• What are the two consequences if your sample size is too large?

  - If the intervention is effective: too many subjects missed out on the intervention
  - If the intervention is ineffective: too many have been exposed to this ineffective intervention.

• What is the desired power of the study?

  This is how certain you want to be to prevent a type 2 error. It is 1-ß, normally, ß is 20%. So 1-20% = 80%. You want to be 80 percent certain you prevent a type 2 error.

• Why is it not always ethical to have a control group?

  Sometimes it is very clear from literature that a certain intervention is effective. Its not ethical to have the control group not get the intervention.

• Why do you always need to arrange insurance?

  You always need liability insurance if one of the patients develops negative outcomes that might be related to your intervention.

• Your research falls under WMO when which two criteria are met?

  1. It concerns medical scientific research and
  2. Participants are subject to procedures or are required to follow rules of behavior:
  - infringement on the patients physical or mental integrity
  - subject theirself must be physically involved in the research