Research Ethics John Porter London School of Hygiene and Tropical Medicine.
-
Upload
horatio-oliver -
Category
Documents
-
view
220 -
download
0
Transcript of Research Ethics John Porter London School of Hygiene and Tropical Medicine.
Research Ethics
John PorterLondon School of Hygiene and
Tropical Medicine
This Presentation
1) What is ethics?2) Ethics and research ethics in
history; creation of ‘the principles’3) How to make ‘ethical decisions’4) Ethics committees
What is ethics?
Rights and wrongs ‘Values’ Codes of conduct ‘How we ought to live’ (Socrates) ‘Learning to live together’
(Bonhoeffer)
Alternative approaches to Ethics
Subjectivist approaches - to make a moral statement is to express an opinion or a taste which is neither right nor wrong.
Realist approaches - there are facts about the matter when it comes to morality, some things are right and others are wrong.
What is ethics?
Ethics is contained within the ‘delicious tension between uncertainty – or the state of decision making in a probabilistic environment – and the periodic duty to act’
From: Ethics and Evidence Based Medicine: fallibility and responsibility in clinical science. Kenneth Goodman, Cambridge University Press 2003.
Ethics – going in the right direction?
When what we think And what we say And what we feel And what we do Are all going in the same direction….
Individual, Professional and Societal ethics
STAGES OF BIOETHICS (Wikler, 1994)
Stage 1: Codes of professional conduct Stage 2: 1960s, doctors entered into
dialogue with society on issues like euthanasia, confidentiality...
Stage 3: 1980s, health care reform and health policy
Stage 4: 1990s, ‘bioethics of population health’
Character of guidelines for research on human subjects
All guidelines relate back to Nuremberg code, the Declaration of Helsinki and the Universal Declaration of Human Rights. The CIOMS guidelines are most specific in their reference to developing countries
Main sources of regulation The Declaration of Helsinki (2000,
2008) International Ethical Guidelines for
Biomedical Research involving human subjects (1993) (CIOMS)
The Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products (WHO) (1995)
The Guidance on Good Clinical Practice (ICH) (1996)
Issues covered in the Declaration of Helsinki
Basic principles divided into five subsections
Fundamental requirements for conduct of biomedical research involving human subjects
Scientific and ethical review of research protocols
Helsinki continued
Informed consent and selection of research subjects
Responsibilities of physicians and other research investigators
Data Management and publication of results
CIOMS Guidelines or Research on Human Subjects (1992) - Developing
Country Perspective
a) Issues of informed consent
b) Issues of equity, priority, consent and review
c) Issues of externally sponsored research
EthicsThe Four Principles
(Beauchamp and Childress)
Respect for autonomy Beneficence Non-maleficence Justice
What makes an action morally acceptable?
‘Ethical analysis needs to be firmly based on rationality and logic. In a morally pluralist society, where competing moral claims are supported by competing ethical theories, there is a need to systematically understand and balance rival positions to come to reasonable conclusions’. (Kessel A, Ethics and Research in Psychiatry 1998)
ETHICS: What makes an action morally acceptable?
Goal based approach - action is good if goal/outcome is good
Duty based approach - asks if an action accords with certain principles
Rights based approach - stresses those individual freedoms and claims protected in a given society by ‘rights’
Goal based approach
An action is good if goal or outcome is good. Utilitarian. ‘End justifies the means’.
Scientific validity Is the research necessary and
important? Will the study answer the question
being asked?
Duty based approach
Does an action accord with certain principles like cheating or lying? If so it is wrong. Kantianism
Welfare of research subject What will participating in the
research involve? Are the risks necessary and
justifiable?
Rights based approach
Stress individual claims protected in society by ‘rights’. Individual rights v community benefits
Humanity/Dignity of research subject
Will consent be sought? Will confidentiality be respected?
CONSENT
INFORMED? intentionality comprehensibilit
y coercion
COMPETENCE
chance to think/ask
method of recruitment
way invitation to participate is put
payment?
TYPE OF RESEARCH
ASSESSMENT TEMPLATE
1) VALIDITY OF THE RESEARCH
2) WELFARE OF SUBJECTS
3) DIGNITY OF RESEARCH SUBJECTS
SUMMARY
Consider the moral problems the proposed research poses
Use the assessment template to help Describe how the moral issues will be
addressed Think about moral relativism,
especially with trans-cultural research
Framework for Ethical Decision Making
(From www.scu.edu/scu/centers/ethics)
1) Recognising a Moral Issue Is there something wrong personally,
inter-personally, socially, that could be damaging to people? Is there conflict that could be damaging to people?
Does the issue go deeper than legal or institutional concerns?
Ethical Decision Making
2) Get the facts3) Evaluate the alternative actions
from various moral perspectivesWhich options produce the most good
and do least harm?Which option respects the rights and
dignity of all stakeholders?Which option promotes the ‘common
good’?
Ethical Decision Making
4) Make a decision Considering these perspectives,
which of the options is the right one to do?
If you told someone you respect why you chose this option, what would that person say?
5) Act, then reflect on the decision later
Research Ethics Committees‘Roles’
Facilitate ethically acceptable attempts to identify new and better treatments from which we may all potentially benefit
Protect research subjects and patients from exposure to unethical risks or invasion of privacy
The Ethics Committee
Function: to review study proposals and to ensure research investigations conform to certain standards
Constituents: at least one medical member, at least one nurse, with at least two lay members (Royal College of Physicians, 1990)
Research and Ethics
Research is a means to solving health problems, not an end in itself. The goal must be to create interventions that will benefit the people of the countries in which the research is conducted. They will benefit only if the knowledge gained produces interventions that are affordable and accessible (Glantz et al 1998 - Hastings Centre Journal)
Externally Sponsored Research
Review: through ethics committees in both countries
Review: according to the standards of the country of sponsoring agency
Role of Ethics Committees
‘Like the juggler we must do our best to keep as many balls in the air, by improving our juggling skills’ (Calebresi and Bobitt, 1978)
‘Muddling through elegantly’ (Hunter, 1993)