Guidance for Addressing Tissue
Sharing in Informed Consent
National Heart, Lung, and Blood
Institute National Institutes of Health
Revised: October 2000
The purpose of this guidance is to bring to the
attention of investigators, NHLBI staff, and any other relevant parties the
need to include in all informed consent documents appropriate language
regarding the potential use of tissue by investigators outside the collecting
study. Many studies collect and store blood or other tissue samples for future
research, including, but not limited to, genetic research. Informed consents
typically address only the collection and use of samples by the investigators
involved in the collecting study, while ignoring the potential for distribution
of samples to investigators from outside that study. Because this is becoming a
more common practice, it is essential that language addressing this practice be
included in all informed consents. Such language should indicate that study
participants may, but need not, allow their tissue to be used by investigators
other than those involved in the collecting study, and if so, whether such use
would be limited to non-commercial purposes or certain kinds of research. The
informed consent should make clear that all such tissue samples are potential
sources of genetic information about individuals. In addition, it should state
clearly that names and other personal identifiers of subjects will not be sent
to any recipients of the blood or tissue samples. The specific language
addressing these points in the consent form is left to the discretion of the
investigators on each individual study and their local IRBs.
October 2000 |