This Guideline reviews the ethical and legal basis of the consent doctrine and suggests elements of the consent process that should be included in both the donor and recipient settings. It also reviews the roles of the physician directing a phlebotomy, the blood bank and transfusion service medical directors, and the treating clinician. The goal of this guidance document is to help readers achieve high-quality consent processes at their institutions.

Individuals who donate their blood provide a unique and precious gift in an act of human solidarity. In order to donate blood, prospective donors should be in good health and free from any infections that can be transmitted through transfusion. Most blood donors perceive themselves to be healthy, but some are unsuitable to donate blood due to the potential risk of compromising or worsening their own health or the risk of transmission of infections to patients. Blood transfusion services (BTS) have a duty of care towards blood donors as well as to the recipients of transfusion. This duty of care extends to prospective donors who are deferred from donation--whether on a temporary or permanent basis--as well as those who donate blood and are subsequently found to have unusual or abnormal test results. BTS have a responsibility to confirm test results and provide information, counseling and support to enable these individuals to understand and respond to unexpected information about their health or risk status. Counseling is part of the spectrum of care that a BTS should be able to provide to blood donors--including referral to medical practitioners or specialist clinical services. Pre-donation counseling was recognized as one element of the strategy to reduce and, if possible, prevent the donation of blood by individuals who might be at risk for HIV and other TTI including hepatitis B and C viruses as well as to inform the donor of the donation process and testing of blood for HIV. Post-donation counseling was acknowledged to be a necessary element of donor management as an adjunct to informing donors of unusual or abnormal test results. Blood donor counseling by trained specialist staff is now considered to be a key component of the blood system in most countries with a well-developed blood transfusion service. It may be required at a number of stages in the blood donation process or following blood screening and should be available at any point at which the BTS has an interface with donors. In many countries, however, blood donor counseling is not yet available in a structured way. Blood Donor Counselling: Implementation Guidelines has therefore been developed to provide guidance to blood transfusion services that have not yet established donor counseling programs.