Informed consent for whole blood donation

Abstract

Background and objectives It is recognized that blood transfusion services have an ethical duty to obtain informed consent from their voluntary, non-remunerated donors. This right was most recently affirmed by the 2017 revision of the International Society of Blood Transfusion (ISBT) Code of Ethics. However, the constituent elements necessary to adequately inform such consent have not been definitively established. Materials and methodsThis review evaluates the historical background to informed consent in medicine and as it has been applied to blood donation. The question of what information should be disclosed is then considered with regard to existing statutory requirements in both the United States and EU as well guidance from relevant international organizations. The emerging ethical issues around repurposing of donated blood for sale as recovered plasma and use in research are included in this analysis.Results A reasonable basis is found in the literature to advocate that valid informed consent of blood donors should encompass: the donation process itself and potential adverse effects, the need for pre-donation transfusion-transmissible infection (TTI) screening, potential non-transfusion uses of derived products, requirements to obtain and store personal information, the consequences that non-disclosure of such information may have for both the donor and the recipient and reassurance as to the confidentiality of this information.Conclusion Informed consent is a key component of the duty of care between a blood service and its donor. We identify essential elements that should be present for such consent to be considered valid.

A Review of Amelioration of Awareness About Blood Donation Through Various Effective and Practical Strategies

“…In several nations, LGBTQ individuals may be eligible to donate blood provided they have not engaged in sexual activity with a new partner in the preceding three months [45]. Healthcare professionals should obtain the appropriate consent from the donor and recipient before blood donation [46].…”

Health data protection and confidentiality in EU BTC legislation: ethical and safety standards

“…Therefore, an accurate approach to the EUTCD ethical issues addresses the “mandatory consent” before the authorization for the procurement of human T&C or other authorization procedures established in the MS [Article 13(1) EUTCD]. In this context, contemporary researches cover new bioethical perspectives of consent and related legal approaches [ 25 , 26 ] in the EU legislation.…”

Liquid biopsies in blood donors: Issues in implementing cell‐free DNA cancer screening tests in the blood donor population

“…Standards for informed consent in the context of blood donation vary somewhat, but are generally thought to include specific consent to non-transfusion-related uses of the donated blood. 4 However, informed consent for cfDNA testing may not be possible in the donation context, given uncertainty regarding test characteristics, the unique implications for donor (rather than recipient) health, and the risk for the donor to be overwhelmed by the sheer volume of information, which can obviate the consent process. 5 It may be, then, that cfDNA testing would require a separate, research-type consent in this population, to avoid situations such as the donor unwillingly discovering the existence of a particular genetic abnormality.…”