Consent is legally and ethically required for blood and blood component donation. The relationship between a donor and blood service is different to the patient setting, however, the approach to consent is the same.
In the UK, consent is governed under common law. In addition, blood services must comply with the Blood Safety and Quality Regulations 2005. A recent case law (known as Montgomery) was an important update to the law regarding consent. Montgomery states that there is a duty to ‘take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments’ [Montgomery, 2015]. A material risk is ‘one that a reasonable person in the patient’s position is likely to attach significance to, or if the doctor is or should reasonably be aware that their patient would be likely to attach significance to it’. That is, when seeking consent for blood and component donation, the question of whether the information given to a donor is adequate is judged from the perspective of a reasonable person in the donor's position, rather than a health professional.
The principles of consent are included in the General Medical Council (GMC) professional standards and the Nursing and Midwifery Council (NMC) code. To be valid, consent must be voluntary and fully informed, and the individual giving consent must have the capacity to do so as per the Mental Capacity Act 2005.
Blood services should have a consent policy including roles and responsibilities (these may differ between whole blood donation and donation via apheresis). Consent may need to be adapted for specific donation types, e.g. pre-operative autologous donation. The policy should set out monitoring and quality assurance requirements to ensure standards in training, and practice of consent, are maintained.
Consent must be obtained by a trained person familiar with the Montgomery principles. In practice, this means donors should be asked what they would like to know, and if they have any questions. Donors must be aware that there is an alternative to proceeding with donation, i.e. they can withdraw consent or stop the donation at any point before its completion.
Consent is an ongoing process between a donor and blood service staff; it is not simply obtaining a signature. The process of consent starts when a donor registers to give blood and continues throughout the donor journey. Information provided prior to the donor’s attendance, for example via the organisation’s website, contributes to the consent process. Leaflets or equivalent materials should be comprehensive and comprehensible; that is, they should be presented in everyday language.
Informed consent must be obtained before every donation, including for experienced or frequent donors. Privacy and confidentiality must be ensured, and donors should have the time they need to consider consent. Donors should be informed of any recent updates to processes, including testing, or risks involved. The individual seeking consent must satisfy themselves that the donor has reviewed, understood, and had the opportunity to ask questions relating to the information provided.
The following information should be provided to blood and component donors:
Further information which must be provided to and obtained from whole blood and component donors is detailed in the following chapters:
Donors should be counselled regarding recognised risks of harm. Risks of serious harm should be disclosed regardless of how rarely these occur (see GMC guidance on Decision making and consent and International Society of Blood Transfusion (ISBT) Code of Ethics Relating to Transfusion Medicine). Furthermore, donors should have the opportunity to ask about any risks of significance to them as individuals [Montgomery, 2015].
Side effects include iron deficiency, which can be symptomatic even in the absence of anaemia. Complications (adverse events) are classified according to the Standards for Surveillance of Complications Related to Blood Donation (2014), as described in Chapter 5.10. Reported adverse event rates are variable; any data provided should be applicable to the specific service. Individual donor circumstances should be considered when assessing the likelihood and impact of risk. Risk reduction strategies, and advice regarding recognition and management of complications and side effects, should be provided.
For the donor’s consent to be valid the donor must have capacity to consent. Capacity is defined in the Mental Capacity Act 2005.
The five principles of this act state that:
We must therefore presume that every donor that we deal with has capacity to make decisions. To have capacity the person must, with the appropriate help and support, be able to understand, retain, use and/or weigh up the information they are given to make the decision or to communicate their wishes. Just because a person is of a certain age, or has a disability, communication difficulty or medical condition we cannot assume that they lack capacity. Thus, staff who consent donors must understand and apply these principles. All donors, be they 17 or 70, should have capacity when they sign their consent and it is the duty of the attending carers and healthcare professionals at the session to ensure that they do have that. Since the Family and Law Reform Act 1969 children have capacity to give consent in medical matters from the age of 16 (applies to England and Wales. Equivalent legislation applies in Scotland and Northern Ireland).
There is concern that the use of third parties during any exchange of confidential information between the donor and the qualified health professional may compromise the confidentiality of the donor and the safety of the blood supply. It is permissible for any third party to act as an enabler by helping to reassure the donor and to assist in establishing effective communication between the donor and the qualified health professional.
The third party must not participate in the health screening interview, including any exchange of confidential information, unless they are not personally known to the donor, and they are an accredited trained interpreter or a member of blood service staff with appropriate language skills. Confidential parts of the process include the evaluation of the health and medical history questionnaire, the medical interview and the obtaining of valid consent.
Professional interpretation services may be delivered remotely (e.g. telephone, video) instead of face to face. If blood services wish to use an interpretation service for verbal communication or translation service for written information, these must meet relevant healthcare standards. Services should ensure that: