Biospecimen "Ownership": Counterpoint

Center for Genetic Research Ethics and Law Department of Bioethics, Case Western Reserve University, 10900 Euclid Avenue, Cleveland, OH 44106-4976, USA.
Cancer Epidemiology Biomarkers & Prevention (Impact Factor: 4.13). 03/2007; 16(2):190-1. DOI: 10.1158/1055-9965.EPI-06-1004
Source: PubMed
3 Reads
  • [Show abstract] [Hide abstract]
    ABSTRACT: Obtaining informed consent for the collection, storage, and future research use of biospecimens is challenging, as potentially complex and controversial information must be communicated clearly. We gathered input on a consent template developed for the Duke Biorepository from individuals representative of those who might one day consider contributing specimens. Forty subjects were recruited from the Durham, NC area and screened to achieve diversity by race/ethnicity, education, age, and sex. Cognitive interviews assessed participants' (a) understanding of information in the template, and (b) opinions about that information. Participants also completed a survey assessing trust in medical researchers. Interviewees seemed to understand the template. Although responses were diverse, majority views emerged: more than half were comfortable with indefinite biospecimen storage, periodic contact to update information and to inform participants of additional research opportunities, the prospect that commercial products could be developed, and the fact that profits would not be shared. More than half were willing to provide medical record access, although this was a primary concern for others. More than two thirds were comfortable with not receiving individual research results as a matter of routine, but many thought they should be informed of findings with serious health implications. Lack of trust in researchers was associated with declining certain consent options. Protecting and promoting trust in research is essential to fostering widespread participation in biorepositories. Biorepositories should also devise ways to communicate clearly about the research being conducted and what is being learned.
    Cancer Epidemiology Biomarkers & Prevention 07/2008; 17(6):1440-51. DOI:10.1158/1055-9965.EPI-08-0086 · 4.13 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: An ethical quandary is emerging over custodianship of and access to DNA specimens and attached data, clinical and genetic, held in large disease cohort collections. The balance of patients' rights and science/society's quest for broad open access must be resolved in order to realize the promise of gene association studies of complex human disease. A way forward may be to convene a colloquium of international medical and science organizations charged with developing global consensus guidance and ethical principles for access to and use of genomic biobanks.
    Annual review of genomics and human genetics 07/2009; 10(1):193-209. DOI:10.1146/annurev-genom-082908-150133 · 8.96 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Human biological specimens (biospecimens) are increasingly important for research that aims to advance human health. Yet, despite significant proliferation in specimen-based research and discoveries during the past decade, research remains challenged by the inequitable access to high-quality biospecimens that are collected under rigorous ethical standards. This is primarily caused by the complex level of control and ownership exerted by the myriad of stakeholders involved in the biospecimen research process. This article discusses the ethical model of custodianship as a framework for biospecimen-based research to promote fair research access and resolve issues of control and potential conflicts between biobanks, investigators, human research participants (human subjects), and sponsors. Custodianship is the caretaking obligation for biospecimens from initial collection to final dissemination of research findings. It endorses key practices and operating principles for responsible oversight of biospecimens collected for research. Embracing the custodial model would ensure transparency in research, fairness to human research participants, and shared accountability among all stakeholders involved in biospecimen-based research.
    Cancer Epidemiology Biomarkers & Prevention 04/2010; 19(4):1012-5. DOI:10.1158/1055-9965.EPI-10-0029 · 4.13 Impact Factor
Show more