International Ethical Guidelines for Health-related Research Involving Humans

GUIDELINE 9:
INDIVIDUALS CAPABLE OF GIVING
INFORMED CONSENT
Researchers have a duty to provide potential research participants with the information
and the opportunity to give their free and informed consent to participate in research, or to
decline to do so, unless a research ethics committee has approved a waiver or modification
of informed consent (see Guideline 10 – Modifications and waivers of informed consent).
Informed consent should be understood as a process, and participants have a right to
withdraw at any point in the study without retribution.
Researchers have a duty to:
ff
seek and obtain consent, but only after providing relevant information about the
research and ascertaining that the potential participant has adequate understanding
of the material facts;
ff
refrain from unjustified deception or withholding of relevant information, undue influence,
or coercion (see Guideline 10 – Modifications and waivers of informed consent);
ff
ensure that the potential participant has been given sufficient opportunity and time to
consider whether to participate; and
ff
as a general rule, obtain from each potential participant a signed form as evidence
of informed consent. Researchers must justify any exceptions to this general rule and
seek the approval of the research ethics committee.
Guideline 9: Individuals capable of giving informed consent
With the approval of the research ethics committee, researchers must renew the informed
consent of each participant if there is a substantive change in the conditions or procedures
of the research, or if new information becomes available that could affect the willingness of
participants to continue. In long-term studies, researchers should ensure at pre-determined
intervals that each participant is willing to stay in the study, even if there are no changes
in the design or objectives of the research.
It is the principal investigator’s responsibility to ensure that all personnel obtaining informed
consent for a study comply with this Guideline.
Commentary on Guideline 9
General considerations. Informed consent is a process. The start of this process requires providing
relevant information to a potential participant, ensuring that the person has adequately understood
the material facts and has decided or refused to participate without having been subjected to
coercion, undue influence, or deception.
INTERNATIONAL ETHICAL GUIDELINES FOR HEALTH-RELATED RESEARCH INVOLVING HUMANS
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