[In this post contributing author Katherine Drabiak shares her assessment of some of the strengths and weaknesses of Indiana House Bill 1020. The legislation was referred the Committee on Public Health on January 14th, 2008. - J.O.]
Drafters of Indiana’s House Bill 1020 proposing to establish a nonprofit operation of umbilical cord blood bank seem to have learned from the ownership battles over donations recently impeding biobank research efforts. Unlike other existing state laws relating to the property rights associated with cord blood donations, HB 1020 explicitly promulgates a waiver of ownership rights. HB 1020 proposes to illuminate the “ownership” transfer (Chapter 1 Section 7) that would ostensibly be drafted into the informed consent form templates. The current draft of HB 1020 and the proposed amendments as of January 18, 2008 unequivocally specify that any property rights related to the cord blood, including intellectual property rights developed, would vest in the Bank.
While this provision on its face provides additional legal certainty, its efficacy assumes several propositions: the informed consent form is legally sufficient and the pregnant patient truly understands the nature of the donation, the Bank’s IRB will ensure precautions to overcome potential conflicts of interest that could undermine the legitimacy of informed consent, and that property waivers will not be found to conflict with federal law.
As HB 1020 is currently drafted, Chapter 1 Section 4 relating to informed consent broadly tasks the Bank with drafting and providing informed consent forms without specific directives. Prior to donating and signing such a waiver, the pregnant patient must be adequately informed of the options to either donate the umbilical cord blood to the Bank or the possibility of using a private banking facility. Yet currently proposed amendments to HB 1020, if passed, would change the amount of information provided and only inform the pregnant patient of the value of donating to the Bank, eliminating the requirement to discuss the possibility of private banking options. This marks a significant departure from other state law practices, which typically present the pregnant patient with the options of public banking, private banking, or forgoing any donation. This departure could potentially undermine consent by insufficiently informing the pregnant patients. Efforts to promote a public bank may topple, if supported by a weakened informed consent process. Is the fact that few pregnant patients would choose (or be able to afford) a private banking facility a legitimate and prudent reason to eliminate this option in the informed consent process?
The legislation also assumes the sufficiency of potentially blanket consent (Chapter 2 Section 2) and the Bank’s adherence of allocating donations to “ethical” research protocols. The amendments to the legislation propose that the Board of Directors for the Bank would form an independent Institutional Review Board to establish and oversee the informed consent process and privacy protections which would occur separately from the allocation decisions. Per Chapter 1 Section 3, an advisory board comprised of at least 51% research scientists would be tasked with reviewing applications of parties interested in receiving nontransplantable donations. The Board and the IRB are guided by the proposition that research use of the donations shall be used “to promote medical advances, life sciences research, or biotechnology research.” (Chapter 1 Section 5) Logistically, the IRB’s representations of potential research uses of the donations to the pregnant patients should align with the allocation criteria used by the research scientists. If for some reason the majority of the Board decides (assuming research scientists would urge maximum distribution to cutting edge research) to allocate donations to a technologically forward yet ethically questionable project, this may not conform to the IRB’s representations to the pregnant patients during the donation process. The question arises whether the Bank will develop an internal mechanism to ensure the function of the IRB is preserved throughout the allocation process.
Even if the informed consent procedure and forms are found to be sufficient, the property waiver itself could be interpreted as potentially conflicting with federal law. The FDA has objected to the terms donation and abandonment of property rights, asserting that 21 CFR 50.20 prohibits requiring subjects to waive or appear to waive any rights as a condition for participation. Yet recent case law suggests that the drafters of HB 1020 may be on to the recent legal trend that disfavors the FDA’s interpretation and instead posits that the pregnant patient is not actually waiving any legal right by signing the "waiver" because she has no legal right to direct the use of the donation after signing the informed consent form, nor is she entitled to any potential intellectual property rights should they arise. Rather, the property waiver serves as a legal clarification to pre-empt potential disputes from spinning into costly or lengthy judicial interference.
If we assume these potential conflicts relating to the informed consent process and allocation procedure are resolved in an ethical manner, the drafters of the Bill may be initiating a trend to adopt property waivers for all banked donations. If this property waiver is adopted, it would most certainly eliminate many of the potential conflicts previously associated with donating banked specimens and, therefore, would allow the Bank to concentrate fully on maximizing its research efforts. – Katherine Drabiak