Ethics Flashcards
Nuremberg Code
developed to prosecute the Nazi doctors
Point 1 -voluntary consent of the human subject is absolutely essential
2- detailed description of it
3- animal research should yield fruitful results for the good of all humanity
4-should be conducted in a way that minimizes physical and mental suffering
5 & 7- avoiding death injury
6 the degree of risk should never exceed that determined by the humanitarian importance of the problem to be solved
8 conducted only by a qualified person
9the subject has the right of withdrawal
10 the scientist must be prepared to terminate at any time
Helsinki declaration
added some principles
world medical association 1964, updated periodically (last 2014)
- independent investigator to review research projects (ethics boards)
- medically qualified supervisor to assume responsibility of health and welfare of subjects
- preserving the accuracy of results
- details on informed consent
- special rules for children and mentally incompetent persons
- only using experimental treatments on patients
- determining which situations and conditions are actually appropriate for research
belmont report
1979
boundaries between medical practice and actual research
beneficence
civil rights movement
2nd catalyst after nuremburg trials in creating guidelines
public policy after supreme court ruling on individual rights
a time of increased understanding and legislation on equal rights
not just expecting experts to act in the best interests of participants, but actually legislating on it
technology
3rd catalyst
increased capacity to do things (transplants, genetic engineering, enhancement of intelligence through drugs, pharma treatments of mental disorders that were previously intractable (hard to deal with)
and increased perception of people as individual consumers (freedoms, privacy, individual well being)
Australian specific ethical guide
and CSU specific
The National Statement on Ethical Conduct in Human Research 2007
“All human interaction, including the interaction involved in human research, has ethical dimensions. However, ‘ethical conduct’ is more than simply doing the right thing. It involves acting in the right spirit, out of an abiding respect and concern for one’s fellow creatures. This National Statement on ‘ethical conduct in human research’ is therefore oriented to something more fundamental than ethical ‘do’s’ and ‘don’ts’ – namely, an ethos that should permeate the way those engaged in human research approach all that they do in their research” (National Health and Medical Research Council, 2007, p.3).
https://www.nhmrc.gov.au/research-policy/ethics/national-statement-ethical-conduct-human-research
CSU “Human Research Ethics Committee” (HREC)
https://research.csu.edu.au/integrity-ethics-compliance/human
they meet 11 times a year and discuss 20 applications each time, they are the gatekeepers of all research at CSU
the team is minimum 8, equal number men and women, 2 laypeople unaffiliated with research, 2 people currently engaged in research, a pastoral care worker (religious/indigenous), a professional care person (allied health/nurse), a lawyer
Limitations of the code
Corey et al 2015
“They inform us but do not replace our effort in critically thinking through ethical issues. In short, ethics codes are necessary, but not sufficient, for exercising ethical responsibility” (p.6)
- these codes are the best we have, not a bible though, the beginning not the end of the road
- ethics codes are reactive not proactive
- they are interpreted, and not all interpreters will agree
- a researcher or participants personal values may actually be in conflict with the code, e.g. not wanting total privacy, wanting to be named. Cultural values may vary, and an organisation being studied may vary.
-it may conflict with a methodology e.g. exploratory qual research
Conflict of interest or bias in committee members
•Lack of training and experience of members to function adequately in a quasi-judicial capacity
•Excessive time taken to adjudicate cases, resulting in possible harm to the public in the interim
•Insufficient resources to do the job properly
•Failure to follow due process
•Timid procedures from fear of lawsuits
•Reactive rather than proactive procedures
•The tendency to protect institution and staff over complainants
•(inversely) Tendency to take complainants side over researcher.
Define ethics in research
Continuous throughout research, involving external governing, formal processes as well as basic values at the core
“…Being ethical involves putting oneself in the position of another, taking a universal point of view and deriving reason from basic ethical principles” (Singer, 1993, p.10-12).
“Ethics are about motivations that reach beyond personal interest.”
“..being concerned with human flourishing and well-being, prescribing what we should do rather than what we actually do, being universalisable in its relevance to all individuals regardless of their religion, culture or other background, and following a systematic approach to recognising and defining what ought or ought not be done” (Kerridge, Lowe & Stewart, 2009, p.1)
values v morals v ethics
- Values – a set of beliefs of how life should be lived – general ways to be, broad preferences
- Morals – a set of ideas about how people should act – ideas about right and wrong actions/decisions/intentions
- Ethics – a system of moral principles, based on shared moralities of a culture and on cultural value systems
going from the more personal to the more general/public
mandatory v aspirational ethics
rules laws minimum standards, verses the highest possible standards to aim towards and an understanding of the spirit of the code and principles
the 4 points from HREC at CSU (Respect, Research merit and integrity, Justice, Beneficence)
in detail;
Research merit and integrity
the design of the research as well as the actual interactions with partipants should be ethical, valuable (good)
- fruitful
- methods actually useful and ethical
on the national ethics application form (NEAF) you have to describe the theoretical, empirical and/or conceptual basis, and background evidence, for the research proposal, and state the aims of the research and the research question and/or hypotheses, where appropriate
Speaking of ethics committees in Sweden, which have
drawn heavily on the Helsinki Agreement in their operation Lynoe et al 1999 argue that, “A poorly designed
study is by definition unethical”
in detail;
Beneficence
project should make a valuable contribution to knowledge (beneficence) and the design itself should be sound, have merit and be ethical.
on the NEAF it asks;
–What expected benefits (if any) will this research have for the wider community? AND for participants?
in detail;
Respect
ensure no harm, prove non-maleficence
(what constitutes a harm is contested e.g. keith and mentioning suicide)
the place where preventing litigation is a worry and its becoming stricter. Its not aways perfectly possible to guarentee confidentiality, non-maleficence, anonymity, ALL RESEARCH CARRIES RISK - it should be attending to the biggest problems in society, and so inherantly carries risk!
on the NEAF it asks; participants; •How participants are accessed •Informed Consent •Anonymity •Confidentiality •Right to Withdraw
what are the risks to the participants?
Explain how the likely benefit of the research justifies the risks of harm or discomfort to participants
in detail;
Justice
Participant rights also implicated here; (and also in beneficence)
NEAF asks •How participants are accessed •Informed Consent •Anonymity •Confidentiality •Right to Withdraw
NEAF also asks about how the data will be analyzed and disseminated as this applies to many of the 4 principles
Issues particular to Qual research
The “Ethics as process” model Ramcharan, P., & Cutcliffe, J. (2001)
(The literature addresses such issues as: avoiding the “delusion of alliance” (Stacey 1988), in which informants reveal more than they intend; “member checks”, i.e. discussion of findings with participants to make sure they are being faithfully represented (Acker et al 1983, Rodgers 1999); how to establish that consent is informed on an “on-going” basis or that there has been no coercion or pressure exerted for participants to continue (Lipson 1994, Knox et al. 2000); how to avoid pressurising participants, manage suggestibility and compliance in interviews with vulnerable subjects (Brown & Thompson 1997); developing a practical response to participants autonomy (Dworkin 1988); how to manage the general “terms and conditions” of the research relationship and recognise when relationships become intrusive (Stalker 1998); how to handle relationships that develop with vulnerable and otherwise lonely people (Booth 1999); and when individualised consent, as opposed to “collective consent”, of groups or communities is required (Lloyd et al. 1996, Clear & Horsfall 1997).
participants should check how they are represented in whatever is written in field notes at the very least (if not publications) and be actively encouraged to change what has been written; and an “audit trail” should be created by the researcher as a record of their work.
1) research methodology is often novel and often at odds with the biomedical guidelines
2) consent is different
3) the relationship between researcher and participant is different
4) vulnerable groups often worked with
5) beneficence goes beyond non-maleficence
