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Regenerative Medicine Ethics pp 173–185Cite as

Protecting Human Participants in the Procurement of Materials in Regenerative Medicine Research

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Abstract

Human participants provide a variety of materials that are essential for research in regenerative medicine, including adult stem cells, embryos, sperm, ova, blood, and urine. Because regenerative medicine depends so heavily on the cooperation of human participants, researchers must take appropriate measures to protect their rights and welfare and secure their trust. This chapter focuses on some emerging issues in the procurement of materials in regenerative medicine research that merit special attention, including informed consent and confidentiality. Though these issues also arise in other types of biomedical research, regenerative medicine investigators face some unique challenges, due to the nature of their subject matter. Since the ethical questions and problems related to procurement of human biological materials are likely to change in response to advances in science and technology, it is important for regenerative medicine researchers to stay abreast of current policies and ethical guidance and to think critically about the dilemmas they face.

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Notes

  1. 1.

    The return of individualized tests results, such as genetic or genomic information or clinical laboratory findings, is a controversial topic in bioethics that will not be explored in depth in this chapter. For further discussion, see Wolf et al. (2008), and Resnik (2011).

References

  • Aalto-Setälä, K., Conklin, B. R., & Lo, B. (2009). Obtaining consent for future research with induced pluripotent cells: Opportunities and challenges. PLoS Biology, 7(2), e42.

    Article  PubMed  Google Scholar 

  • Beskow, L. M., Dame, L., & Costello, E. J. (2008). Research ethics. Certificates of confidentiality and compelled disclosure of data. Science, 322, 1054–1055.

    Article  PubMed  CAS  Google Scholar 

  • Brock, D. (2008). Philosophical justifications of informed consent in research. In E. Emanuel, C. Grady, R. Crouch, et al. (Eds.), The Oxford textbook of clinical research ethics. New York: Oxford University Press.

    Google Scholar 

  • Capron, A. M. (2008). Legal and regulatory standards of informed consent in research. In E. Emanuel, C. Grady, R. Crouch, et al. (Eds.), The Oxford textbook of clinical research ethics. New York: Oxford University Press.

    Google Scholar 

  • Cohen, C. B. (2007). Renewing the stuff of life: Stem cells, ethics, and public policy. New York: Oxford University Press.

    Google Scholar 

  • Cohen, C. B. (2009). Ethical and policy issues surrounding the donation of cryopreserved and fresh embryos for human embryonic stem cell research. Stem Cell Reviews and Reports, 5, 116–122.

    Article  PubMed  Google Scholar 

  • Department of Health and Human Services. (2009). Protection of human subjects, 45 CFR 46. Retrieved June 14, 2012, form http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.

  • Dickenson, D. (2009). Good science and good ethics: Why we should discourage payment for eggs for stem cell research. Nature Reviews Genetics, 10, 743.

    Article  PubMed  CAS  Google Scholar 

  • El Emam, K., Arbuckle, L., Koru, G., et al. (2011). The re-identification risk of Canadians from longitudinal demographics. BMC Medical Information and Decision Making, 11, 46.

    Article  Google Scholar 

  • Grady, C. (2005). Payment of clinical research subjects. Journal of Clinical Investigation, 115, 1681–1687.

    Article  PubMed  CAS  Google Scholar 

  • Grady, C., Dickert, N., Jawetz, T., et al. (2005). An analysis of U.S. practices of paying research participants. Contemporary Clinical Trials, 26, 365–375.

    Article  PubMed  Google Scholar 

  • Hodge, J., & Gostin, L. (2008). Confidentiality. In E. Emanuel, C. Grady, R. Crouch, et al. (Eds.), The Oxford textbook of clinical research ethics. New York: Oxford University Press.

    Google Scholar 

  • Homer, N., Szelinger, S., Redman, M., et al. (2008). Resolving individuals contributing trace amounts of DNA to highly complex mixtures using high-density SNP genotyping microarrays. PLoS Genetics, 4(8), e1000167.

    Article  PubMed  Google Scholar 

  • International Society for Stem Cell Research. (2006). Guidelines of the conduct of human embryonic stem cell research. Retrieved June 14, 2012, from http://www.isscr.org/AM/Template.cfm?Section=GuidelinesforhESCResearch&Template=/CM/ContentDisplay.cfm&ContentID=2916.

  • Isasi, R., Knoppers, B. M., & Lomax, G. (2011). Sustained interaction: The new normal for stem cell repositories? Regenerative Medicine, 6, 783–792.

    Article  PubMed  Google Scholar 

  • McGuire, A., & Gibbs, R. (2006). No longer de-identified. Science, 312, 370–371.

    Article  PubMed  CAS  Google Scholar 

  • National Academy of Sciences. (2005). Guidelines for human embryonic stem cell research. Washington, DC: National Academies Press.

    Google Scholar 

  • National Institutes of Health. (2009). Guidelines for human stem cell research. Retrieved May, 29, 2012, from http://stemcells.nih.gov/policy/2009guidelines.htm.

  • National Institutes of Health. (2010). Policy for sharing of data obtained in NIH supported or conducted genome-wide association studies (GWAS). Retrieved June 14, 2012, from http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html.

  • Petrini, C. (2010). “Broad” consent, exceptions to consent and the question of using biological samples for research purposes different from the initial collection purpose. Social Science and Medicine, 70, 217–220.

    Article  PubMed  Google Scholar 

  • Resnik, D. B. (2001). Regulating the market for human eggs. Bioethics, 15, 1–25.

    Article  PubMed  CAS  Google Scholar 

  • Resnik, D. B. (2004). Owning the genome: A moral analysis of DNA patents. Albany, NY: State University of New York Press.

    Google Scholar 

  • Resnik, D. B. (2009). Re-consenting human subjects: Ethical, legal and practical issues. Journal of Medical Ethics, 35, 656–657.

    Article  PubMed  CAS  Google Scholar 

  • Resnik, D. B. (2010). Genomic research data: Open vs. restricted access. IRB, 32(1), 1–6.

    PubMed  Google Scholar 

  • Resnik, D. B. (2011). Disclosure of individualized research results: A precautionary approach. Accountability in Research, 18, 382–397.

    Article  PubMed  Google Scholar 

  • Salvaterra, E., Lecchi, L., Giovanelli, S., et al. (2008). Banking together: A unified model of informed consent for biobanking. EMBO Reports, 9, 307–313.

    Article  PubMed  CAS  Google Scholar 

  • Shamoo, A. S., & Resnik, D. B. (2009). Responsible conduct of research (2nd ed.). New York: Oxford University Press.

    Book  Google Scholar 

  • Skloot, R. (2010). The immortal life of Henrietta Lacks. New York: Crown.

    Google Scholar 

  • Steinbock, B. (2004). Payment for egg donation and surrogacy. Mount Sinai Journal of Medicine, 71, 255–265.

    PubMed  Google Scholar 

  • Streiffer, R. (2008). Informed consent and federal funding for stem cell research. Hastings Center Report, 38(3), 40–47.

    Article  PubMed  Google Scholar 

  • Weir, R., & Olick, R. (2004). The stored tissue issue. New York: Oxford University Press.

    Google Scholar 

  • Wendler, D. (2006). One-time general consent for research on biological samples. British Medical Journal, 332, 544–547.

    Article  PubMed  Google Scholar 

  • Wertheimer, A. (2010). Rethinking the ethics of clinical research: Widening the lens. New York: Oxford University Press.

    Book  Google Scholar 

  • Wolf, S. M., Lawrenz, F. P., Nelson, C. A., et al. (2008). Managing incidental findings in human subjects research: Analysis and recommendations. Journal of Law, Medicine & Ethics, 36, 219–248.

    Article  Google Scholar 

  • World Medical Association. (2008). Declaration of Helsinki. Retrieved June 14, 2012, from http://www.wma.net/en/30publications/10policies/b3/index.html

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Acknowledgements

This article is the work product of an employee or group of employees of the National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH); however, the statements, opinions, or conclusions contained therein do not necessarily represent the statements, opinions, or conclusions of NIEHS, NIH, or the United States government.

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Authors and Affiliations

  1. National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle Park, CA, USA

    David B. Resnik J.D., Ph.D.

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  1. David B. Resnik J.D., Ph.D.
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Correspondence to David B. Resnik J.D., Ph.D. .

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Editors and Affiliations

  1. University of Wisconsin, Madison, Wisconsin, USA

    Linda F. Hogle

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Resnik, D.B. (2014). Protecting Human Participants in the Procurement of Materials in Regenerative Medicine Research. In: Hogle, L. (eds) Regenerative Medicine Ethics. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-9062-3_7

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