Risks and research ethics

1. RISKS
& Research Ethics
Ghiath Alahmad

2. Overview
1. What is human research?
2. Why research ethics matters?
3. History of the governance of human research
ethics – Response to international scandals

3. What is Human Research?
Examples of human research
• Interviews
• Surveys
• Focus Groups
• Observations
• Chat rooms
• Testing
• Identified personal information not on
the public record.
Human research is
conducted with or about
people, or their data or
their tissue.
Examples of human research

4. Why research ethics matters?
Responsibility to participants
Reputation of the Research Center &University
Requirements of research funding bodies, state, federal and international
Requirements of the University’s insurer of researchers
Future access to populations and sites
Use of public funds carries with it obligations to the community
Professional obligations
Requirements of many journals

5. Scandals – Deception / Consent
Watch Queen
• Observation of homosexual acts in
public toilets.
• Recorded car licence plates.
• Learned of names and addresses from
friendly policemen while pretending to
be a market researcher.
• As a public health surveyor
interviewed men he had observed.
• Most men married and secretive about
homosexual activity.
Laud Humphreys –
The Watch Queen in
the Tea Room (1967)

6. Principles of ethical conduct
Merit and integrity
o Genuine search for knowledge
o Based on literature, prior research and / or established problem
o Sufficient expertise and resources
o Any conflicts of interest addressed
Respect for persons
o Intrinsic value of humans, rather than resources
o Welfare, beliefs, perceptions, customs and cultural heritage
o Privacy, confidentiality and cultural sensitivities
o Honour assurances provided
o Respect the capacity for self determination

7. Beneficence
o Responsibility to minimise harms
o Not non-maleficence
o Not overstating the benefits
o Benefits must justify the risks
o Fair flow of benefits versus burdens
o Genuinely informed consent
Justice
o Fair selection and inclusion
o Distributive justice
o No unfair burden
o Fair flow of / access to benefits
o No exploitation
o Impact on prejudice and discrimination
Principles of ethical conduct

8. Risks in human research
A common mistake researchers make is to describe a project as involving no risks
When what they actually mean is that there are strategies in place to negate
or minimise the risks

9. • What are some of the risks of Human
Research.
» Physical (Injury, illness, harm)
» Psychological (significant distress)
» Social (impact on social networks, access
to services and support)
» Economic (loss of income, earnings and
cost to participants)
» Legal (exposure to civil or criminal
proceedings)
» Humiliation (reduction of value)
» Environment
• Recognition of burden on participants.
Another common
mistake is to assume
that risks only refers to
physical or perhaps
also significant
psychological harms.
Risks in human research

10. Assessing Risks
• To whom do the risks apply?
» Participants, potential participants, third
parties, environment, and / or researchers.
• Addressing risks
» Are there alternatives?
» Can risks be negated or minimised?
» Can risks be managed?
• Can the risks be justified?
• Disclosure to potential participants
Yet another common
mistake is to focus
only on the risks to
the participants.
Risks in human research

11. Justifying the risks in Human Research
Assessing Benefits
• What are the benefits?
• To whom do the benefits flow?
» Directly to participants and/or participant community (people like the
participants)
» Other stakeholders / wider society
» Sponsors / University
» Researchers
• Recognising uncertainty in research
• Justifying research with minimal benefit
• Describing benefits to potential participants

12. Have you “Done” ethics yet?
• Research ethics is first and foremost a
personal responsibility
• It is a design, conduct and quality issue
• Researchers should engage with the
ethical principles and review process
• See the process as a continuing
professional responsibility until the
research is completed
• Not form filling – someone else ’ s
problem
• Objective is to help you improve design
and quality of the research
This is not an
expression we like
to hear because…

13. Limitations
Clinical Research
• Examples and scandals relate primarily to
medical research.
• More easily proven risks
Quantitative Assumptions
• Sample size
• Consent (verbal)
Human Respect Expectations
• Consent
• Attitudes towards personal burdens vs
collective benefits
• Standard of care
It is important to
recognise that the
National Statement
has its limitations