National Cancer Institute Home at the National Institutes of Health | www.cancer.gov

Documents


The following documents were developed by the members of the Group Banking Committee and already are in use in some Cooperative Group trials. Although we are now finalizing print-quality brochure materials and harmonizing with NCI's concise consent project, we wish to make these documents available to the community as a resource.

Informed Consent Template (MS Word)

This informed consent template for biospecimen use was developed in an effort to update the standard text used by the Cooperative Groups. It is responsive to issues in modern translational science. Given the rapidly changing landscape, the document will be revised and updated frequently as both the science and regulations evolve.

IRB Information Sheet (MS Word)

This brochure was developed as a companion to the informed consent for tissue use. It is intended to be offered to patients considering participating in clinical trials which involve biospecimen collection and use. The document contains some detail about issues and ideas which are present in the consent document, but abbreviated due to length considerations.

Patient Brochure (MS Word)

This brochure is intended as a companion to the informed consent for tissue use. It may be offered as a reference to IRBs considering a clinical trial which incorporates the informed consent template, especially where the new template is employed for the first time. The brochure includes some background on common Cooperative Group biospecimen research principles as well as wording of the informed consent template. In addition, detailed clarifications of a number of points are presented in a Frequently Asked Questions format, arranged by topic.