Lecture 12 Ethics

Question 1

What is the stance of the Helsinki declaration on the use of placebo while standard treatment exists.

Answer 1

The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best proven intervention(s), except in the following circumstances:

• when no proven intervention exists.
• when there is a compelling and scientifically sound methodological reason to use placebo in order to determine the efficacy or safety of an intervention.
• the patients who will receive the placebo will not be subject to additional risks of serious/irreversible harm

Question 2

What is the METc? What do they review? And what are responsibilities of their members?

Answer 2

They test medical-science research concerning human participants. They weigh the scientific interest of the research against the demand and risk on the patient/participant.

They review: medical-scientific research in competent subjects, therapeutic research in minors and incompetent subjects, observational research in minors and incompetent subjects

The responsibilities are: protector, assessor, facilitator, advisor, educator.

Question 3

What is the WMO and what is its scope?

Answer 3

WMO: Wet medisch-wetenschappelijk onderzoek met mensen.
the law on medical scientific research in human subjects.
Scope: medical-scientific research in which subjects are subjected to actions or in which a certain mode of conduct is imposed.

Question 4

What is a central consideration for REC’s and CCMO

Answer 4

Protection of the subject against risks of medical research without unnecessarily hampering the progress of medical science.

Question 5

What is the CCMO?

Answer 5

Stands for: de centrale commisie mensgebonden onderzoek.
The CCMO carries out the WMO.
They supervise the METC.
* the composition, requirements for members, number of protocols annually, efficiency and effectivity.
They review certain protocols.

Question 6

Of what groupmembers is the METC legally required to consist of?

Answer 6

One or more physicians
lawyer
Ethicist
‘lay member’
Pharmacologist
Methodologist/statistician

Question 7

What are the ethical and legal pillars?

Answer 7

1. Acceptability –> to be acceptable, research needs: Social or scientific value, Scientific validity, Fair subject selection, Favorable risk-benefit ratio, Independent review (via Emmanuel)
   But also: proportionality, value, subsidiarity, methodological rigour, clinical equipoise.
2. Informed consent –> WMO needs to meet the informed consent demand: written consent after being given information, if the person is not able to do so, a legal representative needs to consent.

Question 8

What are problems of an informed consent? And how can these be tackled?

Answer 8

• Subjects do not read the patient information form
• They do not understand information
• Patients understand but do not oversee the consequences
• They overestimate the benefits and underestimate the risks, i.e. the therapeutic misconception.

Can be tackled by:

• Phases in provision of information, also after having signed the consent form
• A 2nd moment at which the patient is allowed to ask questions and at which the physician can check whether the information is understood
• Information on the proceedings of the research and on the results
• Use of different media
• Extensive brochures need a summary

Question 9

When may a clinical trial be conducted on minors?

Answer 9

There are scientific grounds for expecting that participation in the clinical trial will produce:

• a direct benefit for the minor concerned outweighing the risks and burdens involved;
• some benefit for the population represented by the minor concerned and the clinical trial will have minimal risk and burden compared to the standard treatment.

Question 10

Explain the protection model.

Answer 10

Incompetent subjects need to be protected against any form of damage that may be the result of participation in scientific research. Negligible risks and minimal burden.
This model leads to little or no progress in treatment of conditions of incompetent patients. Experience based medicine.

Question 11

Explain the admission model

Answer 11

Also incompetent patients have a right to the best proven treatment. Reliable studies with generalizable results are necessary.
This implies that the minimal risk standard should be abandoned and that incompetent subjects may be subjected to more than minimal risks and burdens.

Question 12

What are challenges in the future for the ethics field.

Answer 12

• Informed consent as continuing process
• Developing insight into the life world of subjects participating in medical research
• Involve subjects in the review process of protocols (to be discussed)
• Clarity in the proceedings of the research, also after approval
• Harmonization of non-WMO review
• Openness, also about research that has not led to progress.