CISN - Questions for Your Doctor About Donating

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Understanding Tissue Issues
(Biospecimen) Donation

Questions for Your Doctor About Donating

“The informed consent says that the researcher will perform genetic research. What does this mean?”

Many individuals are unclear about the meaning of the term, “genetic research.” Ask whether the research involves genes involved in inherited disease and if there are potential consequences for your privacy. In many cases, the research may focus on acquired genetic alterations, genes that may predict response to a specific treatment, common genetic variations called SNPs (single nucleotide polymorphisms), the silencing of genes that may confer risk or protection (epigenetic alteration), or other aspects.

“Should I donate tissue?”

When deciding whether to participate in research or donate tissue, it is important to do so knowledgeably and comfortably. The overwhelming majority of research participants have done so without adverse consequences.

       
 

Ask your doctor about the nature of the research to be performed and any potential risks. Protect yourself by noting any possible conflicts of interest.

  

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“Does the investigator or the institution have a financial interest in the research?”

Institutions allow researchers to receive small amounts of money from pharmaceutical and biotechnology companies to conduct the research. Any amount in excess of this constitutes a “conflict of interest.” More frequently, institutions prohibit researchers with a financial stake in the research from taking part in the study.
 
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“If I donate tissue, how do I know if my identity will be linked to the
tissue or de-identified?”

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.

  1. The samples must be in existence at the time the research begins (no procurement for the sake of the research study).
  2. 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.

“Will the information about my tissue be made available to me?”

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.

“What are my rights?”

The law stipulates that you can withdraw from a study at any time. You can also withdraw your tissue donation.

“Content Developed September 1, 2012”
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