Lecture 11: Ethics of medical research Flashcards
Why is ethics important in medical research?
Clinical research has the potential for exploitations of human subjects by placing them at risk for the good of others
What are the 7 requirements for ethical research?
(devided into the first and second pillar)
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
Explain social and scientific value
Evaluation of a treatment/ intervention/ theory that will improve health and well-being or increase knowledge
Explain scientific validity
Use of accepted scientific principles and methods (including statistical techniques) to produce reliable and valid data
Explain fair subject selection
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
Explain favorable risk-benefit ratio
- Minimization of risks
- Enhancement of potential benefits
- Risks to the subject are proportionate to the benefits to the subjects and society
Explain independent review
Review of the design and research trail, it’s proposed subject population, and risk-benefit ratio by individuals unaffiliated with the research
Informed consent
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
Respect for potential and enrolled subjects
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
Responsibility of METC’s? REC’s (pyramid)
Ethical review:
- ccmo (1)
- METC’s (15)
Practical issues/ non-WMO:
- Diverse committees (various)
Define the WMO and it’s scope
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
Responisbilities of METC members
Facilitator
Advisor
Assessor
Protector
Educator
The METC reviews…
- Medical-scientific research in competent subjects
- Therapeutic research in minors and incompetent subjects
- Observational research in minors and incompetent subjects
Legally required membership of the METC
- One or more physicians
- Lawyer
- ‘Lay member’
- Ethicist
- Pharmacologist
- Methodologist
What is the central consideration of RECs and CCMO
“Protection of the subject against risk of medical research without unnecessarily hampering the progress of medical science”
The CCMO reviews..
… 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
A methodologically unsound protocol is by definition…
Unethical
WMO research should meet the informed consent demand, which includes…
- 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
Emanuel on informed consent
To provide informed consent individuals must be…
- 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
Problems with informed consent (4)
- Subjects do not reed the patient information form
- Subjects do not understand the information
- Subjects understand but do not oversee the consequences
- Subjects overestimate the benefits and underestimate the risks (e.g., therapeutic consideration)
Takling the problems with informed consent (4)
- Phases in provision of information (also after having signed the consent form)
- Second moment to allow patients to ask questions and at which the physician checks whether the information is understood
- Use of different media
- Extensive brochures need a summary
The prtection model versus the admission model
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
Challenges for the future:
- 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
