Week 11- Research Ethics Flashcards
What is the focus of medical ethics?
-Disease knowledge
-Patterns of disease
-Treatment/ vaccine/ drug development
-Bio-psycho-social aspects (lived patients)
-Legal and ethical aspects (doctor-patient interactions)
-Health systems (structural factors)
What is the aim of medical research?
-Increase length and quality of life
-Alleviate suffering
-Address patient perspective
-Improve experiences of care
THE NUREMBERG CODE (READ THROUGH)
- The voluntary consent of the human subject is absolutely
essential - The experiment should be such as to yield fruitful results
for the good of society. - The anticipated results will justify the performance of the
experiment. - The experiment should be so conducted as to avoid all
unnecessary physical and mental suffering and injury. - No experiment should be conducted where there is a
priori reason to believe that death/disabling injury will occur. - The degree of risk to be taken should never exceed that
determined by the humanitarian importance of the problem
to be solved. - Proper preparations should be made and adequate
facilities provided to protect the experimental subject. - The experiment should be conducted only by scientifically
qualified persons. - During the course of the experiment the human subject
should be at liberty to bring the experiment to an end. - The scientist in charge must be prepared to terminate
the experiment at any stage.
Give examples of medical experimentation in history.
- Nazi medicine
- Mendelian genetics and eugenetics
- Tukegee Syphillis Study (USA)
What is the Belmont Report and what is its main points?
-Ethical Principles and Guidelines for the Protection of Human Subjects of Research
-Principles include:
1. respect of persons
2. beneficence
3. justice
Application to the conduct of research:
1. informed consent [information,
comprehension, voluntariness]
2. risk/benefit assessment [research
justified on a favorable risk/benefit
assessment]
3. selection of subjects of research
[fair procedures and outcomes]
What areas does the WMA Declaration of Helsinki (1964) cover?
- Ethics review of medical research study
- Scientific grounding
- Social value and contribution
- Assessment of Risks and Benefits
- Informed Consent
- Confidentiality
What arguments are there against medical research on humans?
- Human involvement; lack of respect for human dignity and/or autonomy
- Subjects’ exposure to risk for no good reason
- Expenditure of resources
- Misleading results
- Doubtful social value
What are the factors determining valid consent?
- Capacity
- Information
- Voluntary
- Continuous
What is the process of obtaining consent?
- Signed consent form & oral explanation of the project and what
participation will involve (in a way the patient can understand) - including that they are free to withdraw their consent to participate at
any time, without any consequence or compromise of their healthcare
What are the 3 key ethical issues for medical research?
- Confidentiality
- Vulnerable Groups
- Assessment of Risks vs Benefits
Explain confidentiality as a key ethical issue in medical research.
- Research subjects are entitled to confidentiality
- right to privacy with regard to their personal health
information - right to choose who they want to have access to their
confidential information
*Using data from patient records in research - Some data may be medically important but absolutely
identifying eg facial photos - Clinical case histories are unique, even if demographics are
removed - Communicating research results
- Anonymised data
- Consent for research uses/conference/publication etc
should be sought in advance and should be explicit consent
Explain Vulnerable Groups as a key ethical principles in medical research.
Vulnerable groups = patients with terminal illness/ disadvantaged
* Misconceiving research for therapy
* Research as the only gateway to some type of medical care
* Sense of duty or expression of gratefulness to the doctor
* Fear of withdrawal of care
Explain Assessment of Risks vs Benefits as a key ethical principles in medical research.
*the benefit must outweigh the risk of harm to research participants
* Risk: likelihood of the occurrence & severity of the harm
* Benefit: direct/indirect, benefit to others
* But how much risk is acceptable is debatable
*the degree of acceptable risk partly depends on whether the
research study is therapeutic or non-therapeutic.
–> a likely risk of a serious harm would be unacceptable unless the
study provides the only hope of treatment for terminally ill patients
* Consequences for society
What are issues in publication ethics?
- Authorship
(Ghost; Contributing/not acknowledged
Gift; weak contribution) - Conflict of Interest
- Fabrication & falsification of data/results
- Plagiarism
Why is publication ethics important?
For: 1. Scientific advancement
2. Contribution to society
REVISION QUESTIONS
- Outline key international documents/declarations related to
medical research and experimentation ethics - What are important ethical issues related to the
design/implementation of medical research? - Outline what applies with respect to consent when human
subjects participate in medical research studies - Outline what applies with respect to confidentiality of research
subjects’ personal data - Address ethical issues in publication of a research study
