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1. Risk and Harm
in Research
Chesapeake IRB
Copyright 2015 Chesapeake IRB

2. Assessment of Risks and Benefits
• An opportunity and a responsibility
For the researcher: a means to examine whether
research is properly designed
For the IRB: a method for determining whether risks to
subjects are justified
For the prospective subjects: assistance in determining
whether or not to participate
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3. Important Concepts
• Risk: refers to the probability that some type of
harm will occur
• Harm: refers to some outcome or event that has
a level of magnitude (e.g., mere inconvenience,
serious illness)
• Benefit: refers to something of positive value
related to health or welfare
Copyright 2015 Chesapeake IRB

4. Risk <≠> Benefits
Proper Contrasts :
Harms ó Benefits
Risk of harms ó Probability of benefits
Magnitude of harms ó Magnitude of benefits
Copyright 2015 Chesapeake IRB

5. Types of Benefits
• Gain to society or science through contribution
to the knowledge base
• Gain to the individual
– Through improved well-being, or
– Through empowerment of the individual by giving
him/her a voice
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6. Types of Harm
• Mere inconvenience
• Emotional harm: distress, embarrassment, trauma
• Physical harm: from a research procedure or from
from those who would harm the subject for
participating
• Social harm: disclosure leads to stigma, rejection of
subject, persecution, loss of social status
• Economic Harm: Economic costs due to efforts to
avoid or recover from other harms, loss of
employment
Copyright 2015 Chesapeake IRB

7. Sources of Harm
• Participation in research: reaction to materials
or procedures; mere contact
• Breach of Confidentiality: Disclosure of
information from subjects’ participation in
research
• Socioeconomic: The impact of the research
project after its completion
Copyright 2015 Chesapeake IRB

8. “Minimal Risk”
• The probability and magnitude of harm or
discomfort anticipated in the research are not
greater in and of themselves than those
ordinarily encountered in daily life or during the
performance of routine physical or psychological
examinations or tests
Copyright 2015 Chesapeake IRB

9. The “Daily Life” Standard
• Routine physical or psychological tests
– Some discomfort or stress
– Low magnitude
– Transient, short duration
• Daily life encounters
– Hassles, arguments, minor accidents that happen to
most people over a couple of years
Copyright 2015 Chesapeake IRB

10. Interpreting “Risk”
• “Low-risk” refers to research where the worst
harm possible is low-magnitude and transient,
whether or not it is likely to occur
• “Minimal risk” refers to research where the
worst harm likely is not very serious, and if it is,
the probability of a subject experiencing it is
extremely low
• “Greater than minimal risk” is all other research
Copyright 2015 Chesapeake IRB

11. Minimizing Risk
• Alternatives
– Substitute other procedures that are less risky
• Precautions
– Incorporate procedures to decrease the likelihood that
harms will occur
• Safeguards
– Incorporate procedures to deal with harms if they do
occur
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12. Chesapeake IRB
Human Connection >>>Technology Driven
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Copyright 2015 Chesapeake IRB