Lecture fourteen: Ethics in research Flashcards
Why is ethics important in research?
“Ethical and legal issues in research are concerned with the protection and maintenance of important moral values such as respect for the principles of human dignity, autonomy, privacy and bodily and personal integrity”
Important to protect human dignity, autonomy, privacy and bodily and personal integrity
What is the Nuremberg trials?
The Nuremberg trials into war crimes in WWII Germany
- A group of German Doctors and military were charged with crimes against humanity (research on prisoners of war)
- As a result, the Nuremberg code was developed
- The code contained ethical principles that apply to research involving human participants
The Nuremberg code is the foundation for guidelines of legitimate and ethical research
Briefly what are the 10 nuremberg codes?
- Voluntary consent
- Yield fruitful results. Good for society
- Anticipated results will justify performance
- Avoid all physical and mental suffering.
- Research shouldn’t happen if it is expected to cause death or injury
- The degree of risk should never be exceeded
- Protect the subject
- Experiment done by scientifically qualified people
- Right to withdrawal
- Science in charge must be prepared to terminate the experiment at anytime
What is the Declaration of Helsinki (1964)?
- Agreed ethical conduct to safeguard the rights and wellbeing of patients in research
Aspects include –
* Benefit versus risk
* Protection of vulnerable groups
* Clear research protocols
* Ethics approval by independent ctte
* Privacy and confidentiality
* Informed consent
* Use of placebo
* Declare conflicts of interest
* Disseminate of results (including negative!)
What was the “The unfortunate experiment”
Gynaecologist, Dr. Herb Green conducted his own research in 1966 that aimed to prove that untreated CIS would not become invasive carcinoma.
817 women had the standard surgery and 131 were monitored. At least 29 of the women developed cancer and had a premature death.
DEONTOLOGY –
‘the end does not justify the means’
Women treated as subjects with no
value, for the needs of the
researchers
UTILITARIANISM –
‘happiness for the greatest number’
Sacrificing the rights of a few women
to improve the lives of many
What was the result of the unfortunate experiment
Judge Cartwright recommended –
* establishing national ethical standards
* review of all research proposals by ethics committees
The Health Research Council (HRC) was established to monitor public research and provide ethical guidelines
The Office of the Health And Disability
Commissioner (HDC) was established
AND
the Code of Health Consumers’ Rights written
What are national and international law, regulations and codes that apply to NZ research?
INTERNATIONAL
* Nuremberg code (1949)
* Declaration of Helsinki (1964)
* UNESCO Universal Declaration on Bioethics and Human Rights (2005)
NATIONAL ethics approval
* Health and disability ethics committees (HDECs)
LOCAL ethics approval
* OPREC – OP research ethics ctte
* School of Nursing ethics committee
What is UNESCO
(UNITED NATIONS EDUCATIONAL, SCIENTIFIC AND CULTURAL ORGANISATION)
Universal Declaration on Bioethics and Human Rights (2005)
– Respect for autonomy and individual responsibility (informed consent)
– Respect for privacy, anonymity and confidentiality
– Respect for justice, beneficence
– Respect for human vulnerability and personal integrity
– Respect for cultural diversity
What is Privacy in research?
how personal information is concealed and protected (legal + ethical requirement)
What is Anonymity in research?
No person can identify individual participants
e.g. anonymous questionnaire
What is Confidentiality in research?
The participant cannot be linked to the
information provided e.g. using an ID number not a name on a transcript
What is the ethical principles of
research involving humans
- Merit and integrity of research design
- Researcher integrity and honesty
- Justice
- Beneficence
- Respect for persons
- Autonomy
What is Autonomy in ethical research?
Participants have the right to hold views and make decisions about what happens to them based on personal beliefs
- They should know who is conducting the research, what it hopes to measure, what participation involves, possible risks and benefits
- Participation is voluntary and they can withdraw from a study at any time
What is Informed consent in research
Informed consent in research involves a person freely agreeing to participate in a study after receiving information about the nature of the study and what it will involve for them personally
- The researcher must ensure that:
– The information sheet and consent are free from jargon
– The participant has sufficient information and can ask questions and discuss with family and friends
– The participant is competent to consent
– Privacy, anonymity and confidentiality are afforded
– Conflicts of interest are declared
What are situations where consent
may not be required in research?
- RCT with placebo (not told if they receive placebo or study drug)
- In a study where the ‘Hawthorne effect’ could significantly alter the validity of the study (acting differently when being studied)
- Where research involves minimal risk and it is not possible to consent each participant e.g. observation of cycle helmet use
- When non-identifiable data is used e.g. retrospective audit of statistical data
