Lecture 22 Ethics Flashcards
Why ethics?
Norms how we should live
Research in the life sciences raises particular ethical concerns which scientists need to understand (sensitive)
What is the value of health research?
Improve health
Knowledge
Beneficence
Duty to do good
Produce something good
Benefit people
Non maleficence
Duty not to harm people without justification
Basic ethical considerations
What can we do make research ethically ok?
- Researchers take account both benefits and the harms
- Aware of vulnerabilities of participants
- Avoid conflicts of interest
- Obtain informed consent
- Consider how the benefits and burdens of the research would be distributed
- Introduce regulations and process to ensure these all happen
NEAC Guidelines: Underlying
ethical considerations
1.Respect for persons • Respect for autonomy • Protection of vulnerable people 2.Justice 3.Beneficence and non-maleficence 4.Integrity 5.Diversity 6.Addressing conflict of interest
what does NEAC stand for?
National ethics advisory committee
Nuremberg code
international agreement on how health research should be conducted
german WW2 research on concentration campls
Declaration of helsinki 1964
ethical requirements for research involving human subjects, including research on identifiable human material and data.
Japan WW2. not prosecuted secret agreement USA
Clinical equipoise
Generally uncertain
Applies to intervention studies
If going to intervene into someones situation, shouldnt be making a situation worse of than they would be if they werent in the study
NEAC guidelines
Make sure its not just your opinion actually need to produce evidence to show that you have equipoise
what are some examples (experiments) of protecting vulnerable
Tuskegee syphilis - (african, lied about treatment)
The Milgram Experiment: (shocking, obey authority)
For example, doctors are often not permitted to directly recruit their own patients to studies. why?
Patients might not be able to say no
Milgram experiment
There are special expectations on how we involve vulnerable people in experiments
- Ethics have to be made to mitigate any sense of coercion
- Ensure decisions voluntary
Conflict of interest
Any situation where you might have competing interests
Right 6
Everyone has the right to information
Right 7
Everyone has the right to make an inform choice and give informed consent
Disclosure of the purpose, risks, and processes of the study
- Disclosure of information
- Study - what is study going to involve, cost, what will happen, whats the purpose
Reasonable efforts from the researcher to explain this information
Can person understand information
That the person is competent to give consent
Person with disability, kindy, cognitive impairments
The absence of any coercive factors (including financial inducements)
Voluntary decision
Lack of consent example
experiment on women with carcinoma in situ of the cervix (CIS)
The study lacked scientific integrity. The investigator interpreted results
in accordance with what he wanted to find
Invested in his theory
society equitable
- People have been bought to an equal level
- If there are differences try to address those in some way
Applied to research
Inclusion exclusion criteria considered ensure that were not over researching certain population
Clinical equipoise
What standard treatment would be in rich country
Or what standard treatment would be used in experiment
3 main committees
NEAC
ACART
ECART
Advisory Committee on Assisted Reproductive Technologies (ACART)
Recently developed area of medicine
- surrogacy, chinese Dr (GM embryos twin girls)
What needs ethical review in NZ?
- Anything involving human participants
- Patients will
- Any deviation from currently accepted practice by HCP
Audit
Not require ethics approval
Includes patient satisfaction surveys
Health care institutions required to
Audit practices and outcomes
Looking what happened in general
General policies for balancing benefits and harms
Typically, research ethics committees require applicants to show:
- An awareness of the various costs or harms to participants, including time, resources, coercive factors, and any opportunity costs (including other treatments).
- Strategies to address these harms or costs
- An awareness of potential cultural sensitivities or interests, including (in NZ) the implications for Maori
- Evidence of the scientific validity of the research
whats clinical equipoise?
researchers only provide an
experimental treatment if the evidence for the experimental treatment is equal to that available for the standard treatment.
participant should not suffer any disadvantage from being in the study.
what is a vulnerable person?
person who is more at risk of exploitation, because of social or physical disadvantages.
what are some examples of a vulnerable person?
- Poorer people
- Those subject to racial or religious discrimination
- People who are less educated
- Those suffering cognitive impairments
- Older people
- Prisoners
- Children
- People who are ill (patients)
Research involving vulnerable people needs to include
measures to protect those people from exploitation.
Ethics committees will normally not permit researchers to do anything that may take advantage of the participants vulnerability.
what is conflict of interest?
situation where a person holds two or more potentially incompatible interests.
where the researcher(s) have interests that might compromise the values discussed.
Conflicts of interest can arise in research in various ways such as
- Professionally
- Academically
- Financially
- Politically
How can Conflict of interests be managed?
peer review, blinding, open access to data, auditing, and using independent people to recruit participants.
what appears to be an increasing threat to the integrity of research?
conflict of interest
Informed consent is ordinarily required when
participants are enrolled in research studies.
The Code of Rights, Right 6(1)(d) states:
Every consumer has the right to information that a reasonable consumer, in that consumer’s circumstances, would expect to receive, including … notification of any proposed participation in teaching or research, including whether the research requires and has received ethical approval.
Adequately informed consent requires:
- Disclosure of purpose, risks, and processes of the study
- Efforts from researcher to explain information
- person competent to give consent
- The absence of any coercive factors (including financial inducements)
informed consent example
1966 to circa 1984 womens Dr Herbert Green,
CIS
ethical problems with Dr Green’s Study
• Lack of consideration of the harms to ‘participants’. Doctors acted on own views as to what was best
• information was withheld from participants. Participants
weren’t asked if they wanted to participate
• poorer patients with less social support
• lacked scientific integrity. The investigator interpreted results in accordance with what he wanted to find
• The institution failed to hold it’s members accountable to the expected ethical standards. This showed the need for external oversight
Justice requires:
- Transparency
- That all people are considered of equal worth
- That efforts are made to make society equitable
justice applied to research means
• Within population, should be fair distribution of benefits
and burdens of participation in a study. Investigators must avoid imposing on particular groups an unfair burden of participation.
• inclusion and exclusion
conditions for participants are fair. People should not be excluded on the basis of sex, ethnicity, national origin, religion, education or socioeconomic status, except where such exclusion or inclusion is essential to the purposes of the study.
• Funders and researchers should support and design research that could help reduce inequity.
