Lecture 11: Ethics of medical research

Question 1

Why is ethics important in medical research?

Answer 1

Clinical research has the potential for exploitations of human subjects by placing them at risk for the good of others

Question 2

What are the 7 requirements for ethical research?

(devided into the first and second pillar)

Answer 2

First pillar: Acceptability
1. Social of scientific value
2. Scientific validity
3. Fair subject selection
4. Favourable risk-benefit ratio
5. Independent review

Second pillar: informed consent
6. Informed consent

Other..
7. Respect for potential and enrolled subjects

Question 3

Explain social and scientific value

Answer 3

Evaluation of a treatment/ intervention/ theory that will improve health and well-being or increase knowledge

Question 4

Explain scientific validity

Answer 4

Use of accepted scientific principles and methods (including statistical techniques) to produce reliable and valid data

Question 5

Explain fair subject selection

Answer 5

Selection of subjects so that stigmatized and vulnerable individuals are not targeted for risky research and the rich and socially powerfull are not favoured for potentially beneficial research

Question 6

Explain favorable risk-benefit ratio

Answer 6

• Minimization of risks
• Enhancement of potential benefits
• Risks to the subject are proportionate to the benefits to the subjects and society

Question 7

Explain independent review

Answer 7

Review of the design and research trail, it’s proposed subject population, and risk-benefit ratio by individuals unaffiliated with the research

Question 8

Informed consent

Answer 8

Provision of information to the subject about the purpose, procedures, potential risks, benefits and alternatives, so that the individual can make a voluntary desicion whether to enroll and continue to participate

Question 9

Respect for potential and enrolled subjects

Answer 9

Respect for sibjects by:
1. Permitting withdrawal
2. Protecting privacy (confidentiality)
3. Informing subjects of newly discovered risks/ benefits
4. Informing subjects of results of clinical research
5. Maintaining welfare of subjects

Question 10

Responsibility of METC’s? REC’s (pyramid)

Answer 10

Ethical review:
- ccmo (1)
- METC’s (15)

Practical issues/ non-WMO:
- Diverse committees (various)

Question 11

Define the WMO and it’s scope

Answer 11

The WMO is the law on medical scientific research in human subjects

Medical-scientific research in which subjects are subjected to actions or in which a certain mode of conduct is imposed

Question 12

Responisbilities of METC members

Answer 12

Facilitator
Advisor
Assessor
Protector
Educator

Question 13

The METC reviews…

Answer 13

• Medical-scientific research in competent subjects
• Therapeutic research in minors and incompetent subjects
• Observational research in minors and incompetent subjects

Question 14

Legally required membership of the METC

Answer 14

1. One or more physicians
2. Lawyer
3. ‘Lay member’
4. Ethicist
5. Pharmacologist
6. Methodologist

Question 15

What is the central consideration of RECs and CCMO

Answer 15

“Protection of the subject against risk of medical research without unnecessarily hampering the progress of medical science”

Question 16

The CCMO reviews..

Answer 16

… certain protocols:
- Appeal cases
- Non-therpapeutic intervention-research in minors and incompetent subjects
- Scientific research with embryos
- Sorts of scientific research such as gene therapy, xenotransplantation, research with administration of addictive drugs, research with egg cells and semen, vaccines

Question 17

A methodologically unsound protocol is by definition…

Answer 17

Unethical

Question 18

WMO research should meet the informed consent demand, which includes…

Answer 18

• Written consent of the subjects, after written, comprehensive, sufficient information
• If the subject is incapable of reasonable assessment of the interest at stake, the legal representative needs to consent in writing

Question 19

Emanuel on informed consent

To provide informed consent individuals must be…

Answer 19

• Adequately informed of the purpose, methods, risks, benefits and alternatives to the research
• Understand the the information and it’s bearing on their own clinical situation
• Make a voluntary decision whether to participate

Question 20

Problems with informed consent (4)

Answer 20

1. Subjects do not reed the patient information form
2. Subjects do not understand the information
3. Subjects understand but do not oversee the consequences
4. Subjects overestimate the benefits and underestimate the risks (e.g., therapeutic consideration)

Question 21

Takling the problems with informed consent (4)

Answer 21

1. Phases in provision of information (also after having signed the consent form)
2. Second moment to allow patients to ask questions and at which the physician checks whether the information is understood
3. Use of different media
4. Extensive brochures need a summary

Question 22

The prtection model versus the admission model

Answer 22

Protection model:
- Protection of incompetent subjects from damage that may be the result of scientific research
- leads to little or no progress in treatment of conditions in incompetent patients

Admission model:
- Incompetent subjects have the right to the best proven treatment. Reliable studies with generalizable results are necessary.
- Implies that minimal risk standard should be abondoned and that incompetent subjects may be subjected to more than the minimal risk

Question 23

Challenges for the future:

Answer 23

• Informed consent as continuing process
• Developing insight into the perception of subjects participating in medical research
• Involve subjects into 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