Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Sep 6;29(9):e1169-e1179.
doi: 10.1093/oncolo/oyae074.

From ownership to custodianship of tumor biopsy tissue in genomic testing: a mixed methods study of patient views

Megan C Best  1 , Phyllis Butow  2 , Jacqueline Savard  3 , Ainsley J Newson  4 , Rachel Campbell  5 , Sabina Vatter  2 , Christine E Napier  6 , Nicci Bartley  2 , Katherine Tucker  7 , Mandy L Ballinger  8 , David M Thomas  8 ; PiGeOn Project
Collaborators, Affiliations

From ownership to custodianship of tumor biopsy tissue in genomic testing: a mixed methods study of patient views

Megan C Best et al. Oncologist. .

Abstract

Tumor mutation profiling (MP) is often conducted on tissue from biopsies conducted for clinical purposes (diagnostic tissue). We aimed to explore the views of patients with cancer on who should own tumor biopsy tissue, pay for its storage, and decide on its future use; and determine their attitudes to and predictors of undergoing additional biopsies if required for research purposes. In this mixed methods, cross-sectional study, patients with advanced solid cancers enrolled in the Molecular Screening and Therapeutics Program (n = 397) completed a questionnaire prior to undergoing MP (n = 356/397). A subset (n = 23) also completed a qualitative interview. Fifty percent of participants believed they and/or relatives should own and control access to diagnostic tissue. Most (65.5%) believed the government should pay for tissue preparation. Qualitative themes included (1) custodianship of diagnostic tissue, (2) changing value of tissue across time and between cultures, (3) equity regarding payment, and (4) cost-benefit considerations in deciding on additional biopsies. Policy and regulation should consider patient perspectives. Extension of publicly funded health care to include tissue retrieval for clinical trials should be considered.

Keywords: genomics; medical ethics; patient perspectives; tumor biopsy.

PubMed Disclaimer

Conflict of interest statement

David M. Thomas is the paid part-time CEO of a nonprofit company providing precision oncology infrastructure (Omico). Omico has multiple industry partnerships supporting clinical trials and genomic profiling. Dr. Thomas has held this position since 2018. He is also a paid advisor to an investment fund (Australian Unity). The other authors indicated no financial relationships.

References

    1. Cheung CC, Martin BR, Asa SL.. Defining diagnostic tissue in the era of personalized medicine. CMAJ. 2013;185(2):135-139. 10.1503/cmaj.120565 - DOI - PMC - PubMed
    1. Dry S. Who owns diagnostic tissue blocks? Lab Med. 2009;40(2):69-73. 10.1309/lm3xp8hbkdsgicjh - DOI
    1. Skene L. Ownership of human tissue and the law. Nat Rev Genet. 2002;3(2):145-148. 10.1038/nrg725 - DOI - PubMed
    1. Andrews L. Who owns your body? A patient’s perspective on Washington University v. Catalona. J Law Med Ethics. 2006;34(2):398-407. 10.1111/j.1748-720X.2006.00046.x - DOI - PubMed
    1. Lebacqz K. Who “owns” tissues and cells. Health Care Anal. 2001;9(3):353-367. - PubMed