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This is a guideline created by the World Health Organization (WHO), is to assist researchers in
dealing with the ethical issues of obtaining clinical research samples. It is intended for live
collection of samples, but can apply to human biological materials stored in repositories. Included
are guidelines for designing different types of consent, such as consent for the use of identified,
unidentified, and coded samples. Institutional Review Boards may also find these guidelines
useful.
This resource, from the National Human Genome Research Institute (NHGRI), is a guide to the
development of a consent form for a genomics research project. This is a useful resource for both
IRBs and investigators. It contains each of the sections of a consent form required by federal
human subjects protections regulations and provides sample language for both ‘initial consent’
and ‘re-consent’.
Informed Consent is explained in an ‘easy to read’ question and answer format. Topics such as
coercion during the informed consent process and monetary and non-monetary incentives for
participation are also discussed. This resource is provided by the Office of Human Research
Protections (OHRP).
