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Ethical, Legal and Social Implications of Biobanking in Cancer Research

The ethical, legal, and social implications (ELSI) of cancer research are increasingly complex and require careful attention from researchers, especially when biological samples and associated data are collected for potential genetic or genomic studies. Protecting the rights and welfare of biospecimen donors involves ethical considerations as well as regulatory compliance. Researchers should be aware of best practices in the following areas:

  • Biobank governance and custodianship obligations
  • Engagement of research participants as partners, and respectful engagement of research communities
  • Models of consent for secondary and future research uses of collected biological samples and genetic data
  • Data privacy, donor confidentiality, and researcher access to potentially identifiable information
  • Promoting data sharing and data security
  • Return of research results and incidental findings

BBRB has worked to develop and harmonize ethical guidelines for access to biospecimen and associated data, and has collaborated nationally and internationally to keep pace with evolving ideas around biospecimen resource governance. A culmination of these efforts can be found in NCI's Best Practices for Biospecimen Resources.

Explore the following resources for more information on ELSI related to cancer research and biobanking.

Ethics Studies and Strategies in CDP Activities

BBRB has incorporated several ethics studies and strategies in initiatives such as the Genotype Tissue Expression project and the Biospecimen Preanalytical Variables program.

Genotype Tissue Expression

The Genotype Tissue Expression (GTEx) project, supported by the National Institutes of Health (NIH) Common Fund, has collected and analyzed normal human biospecimens from deceased donors. It forms a resource database and tissue bank to help researchers better understand the relationship between human genetic variation and inherited susceptibility to disease. As part of the project, BBRB facilitated several studies looking at different aspects of the ethical, legal and social implications of GTEx. The ELSI studies included interviews with family decision makers who had been approached to donate their loved one's tissues. The interviews assess the effectiveness of the consent process in informing donor families of the potential impacts of participating in the study. Community Advisory Boards were also created to get community input into various issues including the development of improved consenting processes.

  • Siminoff LA, Wilson-Genderson M, Gardiner HM, Mosavel M, Barker KL. Consent to a Postmortem Tissue Procurement Study: Distinguishing Family Decision Makers' Knowledge of the Genotype-Tissue Expression Project. Biopreserv Biobank. 2018;16(3):200-206. doi:10.1089/bio.2017.0115
  • Siminoff LA, Traino HM, Mosavel M, Barker L, Gudger G, Undale A. Family decision maker perspectives on the return of genetic results in biobanking research. Genet Med. 2016;18(1):82-88. doi:10.1038/gim.2015.38
  • Siminoff LA, Wilson-Genderson M, Mosavel M, Barker L, Trgina J, Traino HM. Confidentiality in Biobanking Research: A Comparison of Donor and Nondonor Families' Understanding of Risks. Genet Test Mol Biomarkers. 2017;21(3):171-177. doi:10.1089/gtmb.2016.0407
  • Lockhart NC, Smith AM, Carithers LJ, Weil CJ. Genomic Research with Organs and Tissues Originating from Transplant Donors: Ethical Considerations for the GTEx Project. IRB. 2016;38(2):1-7. [PubMed ID: 27188030]

Biospecimen Preanalytical Variables

The Biospecimen Pre-analytical Variables Program (BPV) was created to improve the quality of collected biospecimens by investigating what effects pre-analytical factors like preservation methods, storage conditions, and time to processing may have on the molecular characteristics of biospecimens. Results of these studies have been used to develop evidence-based best practices protocols for biospecimen collection and processing.

People with cancer consented to the collection of their biospecimens for the BPV program. A broad consent model was utilized to enable the use of the BPV biospecimens for future research. A BPV sub-study was conducted to explore the ethical, legal and social implications related to consent for broad future research use of the donated biospecimens. Patients who had been asked to donate biospecimens to the BPV study were later asked to participate in the BPV ELSI study. The study addressed comprehension, attitudes, and potential concerns regarding broad consent and return of results across the diverse BPV research participant population. Read the resulting publication here:

  • Warner TD, Weil CJ, Andry C, et al. Broad Consent for Research on Biospecimens: The Views of Actual Donors at Four U.S. Medical Centers. J Empir Res Hum Res Ethics. 2018;13(2):115-124. doi:10.1177/1556264617751204

Resources for Researchers

Federal requirements to protect human subjects apply to most federally funded or sponsored research that uses human specimens, residual diagnostic specimens, and medical information. The following resources can help you understand what these regulations mean for researchers.

  • Office of Human Research Protections (OHRP): OHRP provides leadership and guidance in the protection of the rights, welfare, and wellbeing of human subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).
  • Office of Human Subjects Research Protections (NIH Office of Intramural Research): The Office of Human Subjects Research Protections (OHSRP) carries out day-to-day operations and regulatory oversight of human research activities within the Human Research Protections Program (HRPP). The OHSRP promotes the protection of rights, safety and welfare of human subjects.
  • NIH Bioethics Interest Group: The Bioethics Interest Group provides a discussion forum, considers different views, and presents research on complex ethical issues. Topics address issues involving research with individual humans and with communities, as well as research with animals. The group also discusses research integrity and scientific conduct.
  • Federal Regulations and the Ethical Collection of Research Specimens and Data: Start here for an overview and brief history of the regulations and associated policy guidance.

Resources for Patients and Advocates

Federal requirements to protect human subjects apply to most research that uses human specimens, residual diagnostic specimens, and medical information. The following resources can help you understand what happens when a person decides to participate in a cancer clinical trial and donate their biological samples and data.

  • Updated:

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