What is ‘Informed Consent’
‘Informed Consent’ is the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. The patient must be competent to make a voluntary decision about whether to undergo the procedure or intervention.
The requirements of informed consent for a medical or surgical procedure, or for research, are that the patient or subject (i) must be competent to understand and decide, (ii) receive a full disclosure, (iii) comprehend the disclosure, (iv) act voluntarily, and (v) consent to the proposed action.
Patients must give their permission before they receive any type of medical treatment, test or examination.
How Does Informed Consent Apply to Pathology Services?
- Consent to Treatment
Consent to treatment and examination is covered by UK Common Law and the Mental Capacity Act of 2005.
For the majority of routine laboratory procedures, consent is inferred when the patient willingly provides specimens during the sample collection procedure. Laboratory personnel receipting requests and associated specimens for laboratory testing or sample storage, do so on the basis that the request form provides implied consent.
However, special procedures, including more invasive procedures, or those associated with an increased risk of complications, may require a more detailed explanation to be provided by the person conducting the collection procedure and, in some cases, written (recorded) consent must be obtained.
If obtaining consent is not possible in emergency situations, the laboratory may decide to perform procedures such as sample storage of laboratory testing, providing that they are in the best interests of the patient.
The LTHT Trust Labelling Policy is used to determine whether specimens sent to the laboratory for analysis or storage can be accepted in relation to clearly defined criteria which act to protect the patient against incorrect results being issued. With regard to informed consent, the labelling policy stipulates that it is the responsibility of the person requesting laboratory investigations/sample storage to ensure that the necessary informed consent has been obtained.
The Trust Safer Transfusion Policy which acts to ensure the safe collection of blood samples, blood components and administration of blood transfusions, references the procedure followed to ensure that informed consent is obtained, which involves a verbal discussion backed up with written information.
2. Further Activities
The Human Tissue Act 2004 sets out a legal framework for the storage and use of tissue from the living, and the removal, storage, and use of tissue from the deceased. Consent is a fundamental principle and the document ‘HTA Code A: Guiding principles and the fundamental principle of consent’ is the overarching code of practice under the HTA governance framework.
2.1 Research Activities
In addition to performing routine testing to support patient care, some Pathology services store samples and perform analysis relating to clinical research activities.
A lot of tissue stored for research is automatically exempted from licensing and consent requirements, because it comes from living people and there is project-specific approval from a recognised Research Ethics Committee (REC). The project-specific ethical approval is checked by the Central Research and Innovation team, during the LTHT research application process. Samples can only be stored for the duration of the study and all samples transferred outside LTHT must be de-identified. On notification of study closure/expired ethical approval, all samples must be either transferred to a Research Tissue Bank (RTB) with appropriate consent or destroyed.
Once human tissue is no longer being stored for a project approved by a recognised REC (e.g., the study is declared to have been concluded or REC approval is pending), it must be stored on HTA-licensed premises if it is intended for a scheduled purpose. Where it is to be used for further research that does not have recognised REC approval, the research must be in accordance with the initial consent obtained or, if appropriate, further consent should be obtained.
In the case of deceased patients, human tissues must be used in accordance with their wishes expressed when consent was obtained (e.g., in relation to disposal of tissues), or in accordance with the wishes of nominated representatives who must be given the information that they require to be able to make a decision that ensures the dignity of the deceased.
2.2 Post-mortem Examinations
Consent that is both appropriate (provided by the deceased before their death/the deceased’s appointed representative/a person in a qualifying relationship such as a spouse or partner) and valid (consent has been given voluntarily by an appropriately informed person who has capacity), must be provided for a hospital post-mortem examination to take place and also for tissue from the deceased to be removed, stored and used for a scheduled purpose.
Further detailed information can be found within the Trust Policy (you must be connected the Trust VPN) – ‘Procedure for Obtaining Valid and Appropriate Consent for a Hospital Post Mortem Examination’