Human Research Ethics:
What it is and getting
approval at LSHTM
John Porter
Outline
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Research ethics principles
Ethics review
Consent
Confidentiality
Ethics in the field
Making an ethics application to LSHTM
[Key reference: Rhodes & Bernays Principles of Research Ethics in
Practice in Durand & Chantler (2014) Principles of Social
Research]
2
Values
All research is rooted in social values
o Research is not neutral and value-free
o We must consider the scientific methods and merits of our research as
well as its social and policy implications
o Scientists may have a primary obligation to ‘doing good science’ and to
advancing ‘knowledge’, but not at the expense of risking or doing harm
o We must consider ‘what we can contribute’, whilst ‘doing the right
thing’
[Homan, 1991; Green and Thorogood, 2009]
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The ethics of health
research
• Autonomy
o Respecting the rights of the individual
• Beneficence
o Doing good
• Non-maleficence
o Not doing harm
• Justice
o Creating distributive justice and equity [Beauchamp and Childress, 1983]
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Situational ethical
practices
• Just as science is not ‘value-free’, there may not be ‘universal’
ethical principles applicable to all situations
• Ethical codes can not legislate effectively for all eventualities
• Therefore, what is needed is a professional commitment to
ethical practice based on an understanding of the dilemmas
involved
• Ethical review is one step in an ongoing process
[Homan, 1991; Green and Thorogood, 2009]
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Two men meet, each believing the other to be
in a higher position (RESPECT, BALANCE and
INTEGRITY)
(Paul Klee 1903)
Ethical review
• Nuremberg Trials (1947)
o Established Nuremberg Code for medical research
 Voluntary participation
 Informed consent
 Justification of risk
• Ethical crisis in research practices
o Tuskegee Syphilis Study, 1932-1972
o Willowbrook Hepatitis Experiment, 1956-1970
o Humphrey’s covert observations of male sex workers, 1972-1974
• Declaration of Helsinki (1964/2000)
o Outlined research ethics principles for World Medical Association
 Well-being of humans above the interests of science and society
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The lessons of Tuskegee
[Made available publicly, United States Federal Government], Section
105, U.S. Code]
Is this research ethical?
Deception and covert observation
o Rosenhan (1973): studied psychiatric hospitals by having
research assistants gain admission as patients pretending to
have symptoms
o Miligram (1974): studied influence of authority figures on
decision-making by deceiving participants that they were
actually administering (life-threatening) electric shocks to others
o Pollini (2008): studied pharmacists’ attitudes to drug injectors by
having fieldworkers purchase needles and syringes as if they
were drug injectors
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Informed consent
Participants should not be coerced, persuaded or induced into
research ‘against their will’, but participation is voluntary and fully
informed
• Declaration of Helsinki (2000)
o “Subjects must be volunteers and informed participants”
o “Subjects must be told the duration, methods, possible risks, and the
purpose or aim” of research”
• Challenges in practice
o
o
o
o
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Medical research more clear cut than social and qualitative research
How much should participants be informed?
Should evidence of informed consent be written?
How do we prevent gate-keepers from exercising influence?
Example consent and
information sheets
See:
http://www.lshtm.ac.uk/edu/taughtcourses/stude
ntforms/careforms.html
1
Confidentiality
Participants’ privacy and the confidentiality of information related to
them should be protected
• Declaration of Helsinki (2000)
o “Every precaution should be taken to respect the privacy of the subject
[and] the confidentiality of the patient’s information”
o Unwanted exposure/disclosure single most likely source of harm
• Challenges in practice
o Non-disclosure: Can be difficult distinguishing ‘confidential’ from
‘everyday’ information to be shared, eg, in participatory research
o Non-disclosure through dissemination: Difficult in single case and small
studies; discuss with participants; protects researchers or participants?
o Exceptions: Children or adults at risk of harm
1
Making your application
• Discuss with your supervisor
o
o
o
o
o
Your supervisor is your first port of call regarding ethical questions
Your supervisor has to sign-off your CARE form before it is submitted
Your supervisor will have discussed and checked with you research ethics issues
Only contact the Ethics Committee after your supervisor has reviewed your proposal
Also keep your supervisor updated, for example, regarding local ethics approvals / changes
• Consult: edu/taughtcourses/careforms
o And also Project handbook (Ch 6) for guidance on submission and examples
• Submit your application on time!
o Submit at: http://leo.lshtm.ac.uk
o Review takes up to 4 weeks
• Respond to Committee questions
o Again, seeking advice of your supervisor where appropriate
1
Ethics Principles
• Autonomy - the participant has the right to refuse or choose their
treatment
• Beneficence – acting in the best interest of the participant
• Non-maleficence - "first, do no harm”
• Justice - concerns the distribution of scarce health resources, (fairness and
equality).
• Dignity - the participant has the right to be treated with dignity.
• Truthfulness and honesty - the concept of informed consent
Ethics reading
• The ethics of medical research on humans. Manual for Research Ethics
Committees, Kings College London, Cambridge University Press 2009
• The ethics of research related to healthcare in developing countries.
Nuffield Council on Bioethics http://www.nuffieldbioethics.org/researchdeveloping-countries-follow
• Council for International Organizations of Medical Sciences (CIOMS)publishes guidance:
http://www.cioms.ch/publications/frame_available_publications.htm
Good Clinical Practice (GCP)
• An IRB/IEC should safeguard the rights, safety, and wellbeing of all trial subjects. Special attention should be
paid to trials that may include vulnerable subjects.
Research Ethics Committee
• Our Research Ethics Committees review and oversee the ethical
aspects of our research projects and focus on reviewing applications
for new projects and changes to existing studies.
• Any research involving human participants must be referred to, and
approved by, the relevant LSHTM Research Ethics Committee. This
includes all research involving LSHTM staff or students regardless of
whether the Chief Investigator is based at LSHTM or the research is
being conducted away from LSHTM premises.
• The only exception are studies using data fully in the public domain.
No study should commence until ethical approval has been notified
in writing to the Investigator/student.
The Purpose of an
Ethics Committee
• ‘The purpose of an Ethics Committee in reviewing
biomedical research is to contribute to safeguarding the
dignity, rights, safety and well-being of all actual or
potential research participants. A cardinal principle of
research involving human participants is respect for the
dignity of persons’.
• The goals of research, while important, should never be
permitted to override the health, well- being and care of
research participants.
(The Role of an Ethics Committee page 506 Manual for Research Ethics Committees. Editor Sue Eckstein. Cambridge University Press 2003)
The Purpose of an
Ethics Committee
• Ethics Committees should also take into consideration
the principles of justice. Justice requires that the
benefits and burdens of research be distributed fairly
among all groups and classes in society, taking into
account age, gender, economic status, culture and
ethnic considerations’.
• Protecting the individual within the population….
(The Role of an Ethics Committee page 506 Manual for Research Ethics Committees. Editor Sue Eckstein. Cambridge University Press
2003)
Ethical review
To balance the interests of research participants and other
stakeholders, and to ensure proposed studies are ethically sound
• LSHTM Ethics Committee
o Chair: Professor John Porter, 7 members for Intervention and 7
members of Observation (including 2 lay members)
• LSHTM MSc Sub Committee
o Chair: Dr Cicely Marston, 9 cross-Faculty members
• Local research ethics committees
o NHS, local field and university sites
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Online Applications
LSHTM Ethics Online
• Online ethics application system
• Used for staff and students at LSHTM
Website link: https://leo.lshtm.ac.uk
Logging in for the first time
Does NOT use
your standard
LSHTM log-in, but
can use LSHTM
email with same
password
Register - Click new
user
Registration
Navigation screen
Share allows collaboration on
form with two users working on
it at the same time.
Queries and Help
• Contact: MScethics@lshtm.ac.uk
• Telephone: 020 7927 2221
•
LSHTM ethics webpage
•
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Good Research Practice
•
•
http://www.lshtm.ac.uk/ethics
http://www.lshtm.ac.uk/research/about/guidelines_on_good_research_practice.pdf
Declaration of Helsinki
•
http://www.wma.net/en/30publications/10policies/b3/index.html
Community
• Community
• Who am I?
• Who am I with?
• What is my role/place