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)