Control of DNA Samples and Information

Elements of informed consent for pharmacogenetic research; perspective of the pharmacogenetics working group

“…Some regional guidelines/laws in fact protect against such disclosures of genetic results, 16 whereas others encourage/require the sharing of genetic results in situations where such information will (or may) favorably impact the quality of life or allow preventative or therapeutic health care. 2,17 The circumstances requiring disclosure of unintended genetic results including respect for a subject's 'right not to know' must be carefully considered by weighing possible health benefits to the study subject and/or family members against possible informational risks (see the next subsection) implicit in such disclosures.…”

“…17 The provisions of these regulations, policy statements, and guidelines differ, but IRBs/IECs are generally now charged with determining whether researchers and research sponsors have taken adequate steps to safeguard genetic information and with evaluating plans for data security. These methods include various coding mechanisms and other procedures designed to insure that genetic information from pharmacogenetic trials is appropriately protected, disclosed and utilized.…”

“…These methods include various coding mechanisms and other procedures designed to insure that genetic information from pharmacogenetic trials is appropriately protected, disclosed and utilized. 17 Those selected for each study should be described (in understandable language) during the IC process.…”

“…17 Research sponsors/researchers must be able to demonstrate to IRBs/IECs that they possess sufficient expertise and have procedures in place adequately to protect data. Recently defined categories of genetic sample collection afford various levels of security in pharmacogenetic studies based on a spectrum of coding procedures.…”

“…Guidance policies of many international, regional or national ethical-legal bodies prohibit payment for human genetic samples (reviewed by Knoppers et al co-workers 17,24 ). Selected policy positions maintain that the human genome is 'common heritage of humanity' and not 'personal property' and that human genetic materials are part of the 'person' (vs 'property'), which may only be shared as a 'gift' for research purposes.…”