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.