Ask the physician or researcher whether the hospital/research center will be able to link the information derived from the material to you or whether the tissue specimens will be de-identified and have all links to you as the patient/research participant removed.
Linking is often an option on the informed consent document, but be sure to check with your doctor to clarify this point. Although de-identified samples may be more protective of your privacy, they do not provide researchers with the ability to access your medical records to see how your cancer responded to treatment. This lack of ability to match the research done using your tissue with your outcome slows down the advance of personalized medicine.
De-identified specimens must meet two criteria to be exempt from the federal requirements for the protection of human subjects.
- The samples must be in existence at the time the research begins (no procurement for the sake of the research study).
- Identifiers must be irretrievably removed from the information or samples that will be studied.
(Taken from 45 Code of Federal Regulations §46.101(b)(4) 1994)
US federal regulations allow for de-identified specimen collection without formal informed consent from the patients whose samples are included. Some studies have indicated that patients prefer to support biobanks that give them the opportunity to opt out.
This will depend on the type of research study. In many cases, research takes a long time to complete and researchers may prefer not to commit to this extra step.
The law stipulates that you can withdraw from a study at any time. You can also withdraw your tissue donation.
