StemCell Therapy

such de-identified material to be exempted from its coverage (Clayton et al., 1995; Clayton, 1995; Bradburn, 2001; OHRP, 2004; Clayton, 2004).

While the de-identification may clear the institution of any obligations under HIPAA or the need for an IRB-approved informed consent procedure, Clayton (2004) explains that public opinion is different, and that most patients still believe they should be informed of all potential research uses of their biological materials and retain some autonomy over their use. Thus, she concludes that research institutions would be best served by working with patients collectively and individually to ensure appropriate oversight.

REFERENCES

Black N. 2003. Secondary use of personal data for health and health services research: Why identifiable data are essential. Journal of Health Services Research Policy. 8(S1):3640.

Bradburn NM. 2001. Medical privacy and research. Journal of Legal Studies 30(2):687701.

Burgess MM, Laberge CM, Knoppers BM. 1998. Bioethics for clinicians. 14. Ethics and genetics in medicine. Canadian Medical Association Journal 158(10):13091313.

Clayton EW. 1995. Why the use of anonymous samples for research matters. Journal of Law, Medicine and Ethics 23(4):375377.

Clayton EW. 2004. So what are we going to do about research using clinical information and samples? IRB 26(6):1415.

Clayton EW, Steinberg KK, Khoury MJ, Thomson E, Andrews L, Kahn MJ, Kopelman LM, Weiss JO. 1995. Informed consent for genetic research on stored tissue samples. Journal of the American Medical Association 274(22):17861792.

FDA (Food and Drug Administration). 2004. Eligibility determination for donors of human cells, tissues, and cellular and tissue-based products. Final rule. Federal Register 69(101): 2978529834.

Fernandez CV, Gordon K, Van den Hof M, Taweel S, Baylis F. 2003. Knowledge and attitudes of pregnant women with regard to collection, testing and banking of cord blood stem cells. Canadian Medical Association Journal 168(6):695698.

Fernandez MN. 1998. Eurocord position on ethical and legal issues involved in cord blood transplantation. Bone Marrow Transplantation 22(Suppl. 1):S84S85.

Gluckman E. 2000. Ethical and legal aspects of placental/cord blood banking and transplant. Hematology Journal 1(1):6769.

Haley NR. 1999. Linking donors to stored cord blood units: Duties to donors and recipients. Cancer Research Therapy and Control 8(4):345346.

HHS (U.S. Department of Health and Human Services Office for Civil Rights). December 3, 2002, revised April 3, 2003. General Overview of Standards for Privacy of Individually Identifiable Health Information. [Online] Available: http://www.hipaadvisory.com/regs/finalprivacymod/goverview.htm [accessed March 2005].

HHS. 2003. Privacy and Your Health Information. [Online] Available: http://www.hhs.gov/ocr/hipaa/consumer_summary.pdf [accessed March 2005].

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