RISKS

& Research Ethics

Ghiath Alahmad

Overview

1. What is human research?

2. Why research ethics matters?

3. History of the governance of human research ethics – Response to international scandals

What is Human Research?

Examples of human research

• Interviews

• Surveys

• Focus Groups

• Observations

• Chat rooms

• Testing

• Identified personal information not onthe public record.

Human research isconducted with or aboutpeople, or their data ortheir tissue.

Examples of human research

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

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)

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

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

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

• 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

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 commonmistake is to focusonly on the risks tothe participants.

Risks in human research

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

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…

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 torecognise that theNational Statementhas its limitations