International Ethical Guidelines for Health-related Research Involving Humans

GUIDELINE 4:
POTENTIAL INDIVIDUAL BENEFITS
AND RISKS OF RESEARCH
To justify imposing any research risks on participants in health research, the research
must have social and scientific value. Before inviting potential participants to join a
study, the researcher, sponsor and the research ethics committee must ensure that risks
to participants are minimized and appropriately balanced in relation to the prospect of
potential individual benefit and the social and scientific value of the research.
The potential individual benefits and risks of research must be evaluated in a two-step
process. First, the potential individual benefits and risks of each individual research
intervention or procedure in the study must be evaluated.
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For research interventions or procedures that have the potential to benefit participants,
risks are acceptable if they are minimized and outweighed by the prospect of potential
individual benefit and the available evidence suggests that the intervention will be at
least as advantageous, in the light of foreseeable risks and benefits, as any established
effective alternative. Therefore, as a general rule, participants in the control group of
a trial must receive an established effective intervention. The conditions under which a
placebo may be used are spelled out in Guideline 5 – Choice of control in clinical trials.
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For research interventions or procedures that offer no potential individual benefits to
participants, the risks must be minimized and appropriate in relation to the social and
scientific value of the knowledge to be gained (expected benefits to society from the
generalizable knowledge).
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In general, when it is not possible or feasible to obtain the informed consent of
participants, research interventions or procedures that offer no potential individual
benefits must pose no more than minimal risks. However, a research ethics committee
may permit a minor increase above minimal risk when it is not possible to gather the
necessary data in another population or in a less risky or burdensome manner, and the
social and scientific value of the research is compelling (see Guideline 16 – Research
involving adults incapable of giving informed consent, and Guideline 17 – Research
involving children and adolescents).
Guideline 4: Potential individual benefits and risks of research
In a second step, the aggregate risks and potential individual benefits of the entire study
must be assessed and must be considered appropriate.
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The aggregate risks of all research interventions or procedures in a study must be
considered appropriate in light of the potential individual benefits to participants and
the scientific social value of the research.
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The researcher, sponsor and research ethics committee must also consider risks to
groups and populations, including strategies to minimize these risks.
INTERNATIONAL ETHICAL GUIDELINES FOR HEALTH-RELATED RESEARCH INVOLVING HUMANS
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