Research Ethics John Porter London 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 Rights and wrongs ‘Values’ ‘Values’ Codes of conduct Codes of conduct ‘How we ought to live’ (Socrates) ‘How we ought to live’ (Socrates) ‘Learning to live together’ (Bonhoeffer) ‘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. 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. 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’ 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 When what we think And what we say And what we say And what we feel And what we feel And what we do And what we do Are all going in the same direction…. Are all going in the same direction….

Individual, Professional and Societal ethics

STAGES OF BIOETHICS ( Wikler, 1994 ) Stage 1: Codes of professional conduct Stage 1: Codes of professional conduct Stage 2: 1960s, doctors entered into dialogue with society on issues like euthanasia, confidentiality... Stage 2: 1960s, doctors entered into dialogue with society on issues like euthanasia, confidentiality... Stage 3: 1980s, health care reform and health policy Stage 3: 1980s, health care reform and health policy Stage 4: 1990s, ‘bioethics of population health’ 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) The Declaration of Helsinki (2000, 2008) International Ethical Guidelines for Biomedical Research involving human subjects (1993) (CIOMS) 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 Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products (WHO) (1995) The Guidance on Good Clinical Practice (ICH) (1996) 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 Fundamental requirements for conduct of biomedical research involving human subjects Scientific and ethical review of research protocols Scientific and ethical review of research protocols

Helsinki continued Informed consent and selection of research subjects Informed consent and selection of research subjects Responsibilities of physicians and other research investigators Responsibilities of physicians and other research investigators Data Management and publication of results 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

Ethics The Four Principles (Beauchamp and Childress) Respect for autonomy Respect for autonomy Beneficence Beneficence Non-maleficence Non-maleficence Justice 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 Goal based approach - action is good if goal/outcome is good Duty based approach - asks if an action accords with certain principles 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’ 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’. An action is good if goal or outcome is good. Utilitarian. ‘End justifies the means’. Scientific validity Is the research necessary and important? Is the research necessary and important? Will the study answer the question being asked? 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 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? What will participating in the research involve? Are the risks necessary and justifiable? Are the risks necessary and justifiable?

Rights based approach Stress individual claims protected in society by ‘rights’. Individual rights v community benefits Stress individual claims protected in society by ‘rights’. Individual rights v community benefits Humanity/Dignity of research subject Will consent be sought? Will consent be sought? Will confidentiality be respected? Will confidentiality be respected?

CONSENT INFORMED? INFORMED? intentionality intentionality comprehensibility comprehensibility coercion coercion COMPETENCE COMPETENCE chance to think/ask chance to think/ask method of recruitment method of recruitment way invitation to participate is put way invitation to participate is put payment? payment? TYPE OF RESEARCH 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 Consider the moral problems the proposed research poses Use the assessment template to help Use the assessment template to help Describe how the moral issues will be addressed Describe how the moral issues will be addressed Think about moral relativism, especially with trans-cultural research Think about moral relativism, especially with trans-cultural research

Framework for Ethical Decision Making (From 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? 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? Does the issue go deeper than legal or institutional concerns?

Ethical Decision Making 2) Get the facts 3) Evaluate the alternative actions from various moral perspectives Which 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? 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? 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 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 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 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) 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 Hastings Centre Journal) 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 Hastings Centre Journal)

Externally Sponsored Research Review: through ethics committees in both countries Review: through ethics committees in both countries Review: according to the standards of the country of sponsoring agency 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) ‘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) ‘Muddling through elegantly’ (Hunter, 1993)