PM-138 Informed Consent and the HTA PDF

PM-138 Skills for Medical Scientists Informed consent and the HTA Dr Siân-Eleri Owens Learning outcomes By the end of this session you should: To develop an understanding of the consent process (including vulnerable participants) To demonstrate an awareness of the laws and regulations surro...

PM-138 Skills for Medical Scientists Informed consent and the HTA Dr Siân-Eleri Owens Learning outcomes By the end of this session you should: To develop an understanding of the consent process (including vulnerable participants) To demonstrate an awareness of the laws and regulations surrounding research and consent Briefly describe the Human Tissue Act Give examples of materials and activities covered by the HTA Be aware of when the HTA is relevant, and its exceptions Discuss the consent process for obtaining material under the HTA  INFORMED CONSENT There is a subtle distinction between consent for clinical care and research: Clinical - inform patients; protect clinicians; often implied Research - inform participants; protect participants; arguably more rigorous. INFORMED CONSENT For consent to clinical research we must ensure that the participant understands: What is being done Why it is being done That participation is voluntary The risks The alternatives  INFORMED CONSENT “A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial after having been informed of all aspects of the trial that are relevant to the subjects decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form” ICH E6 Good Clinical Practice 1996 APPLIES TO ALL HEALTH AND SOCIAL CARE RESEARCH Research Governance Overseen by a number of regulatory bodies and advisory groups Declaration of Helsinki (1964) Expands the 10 principles of the Nuremberg Code with particular reference to: Identifies minimum information to be given to competent subjects Caution if dependent relationship exists Caution if possibility of duress Special attention paid to individual information needs and methods of delivery Declaration of Helsinki (updated 2013) This version is very empowering, aims to strengthen standards internationally-but especially relating to developing countries with limited resources Inclusion of under-represented groups Compensation and treatment must be in place for those harmed Access to new interventions where no proven one exists, following advice and informed consent Use of innovative consent methods i.e. recordings, videos etc. Giving feedback to participants after the research-demystifying and respectful  The Process of Consent 1. 2. 3. 4. 5. Invitatio Time to Discussio Formal Willingne n to consider n Agreeme ss to Participa nt continue te Scenario 1 A potential study participant is waiting in the emergency department to be seen by the doctor. There is currently a 20 minute wait time The study involves the administration Is this of a quality of life questionnaire, acceptable? which takes about 20 minutes to Why? complete The research nurse ask the potential participant to complete the questionnaire whilst they are waiting for the doctor to receive consent Scenario 2 A number of patients are failing screening due to a blood result which must be within certain parameters for the patient to be eligible The screening visit takes about one Is this hour to complete and the consent acceptable? form is seven pages long Why? To save both time and effort, the doctor decides to take the extra blood sample along with routine bloods to check eligibility, before approaching the patient The Human Tissue Act Alder Hey - The Royal Liverpool Children’s Inquiry Human Tissue Act 1961 – based on a lack of objection to tissue removal from deceased for research or education The Alder Hey organs scandal involved the unauthorised, non-consensual removal, retention, and disposal of human tissue during the period 1988 to 1996 by Dick van Velzen Some tissues from live children sold to pharmaceutical companies without consent By 2000: 2128 retained hearts 1564 stillborn babys Foetal and child eye collection – 188 eyes What is the Human Tissue Act? Human Tissue Act established the Human Tissue Authority – to regulate removal, storage, use and disposal of human tissue Human Tissue Act 2004 – effective 1st September 2006  Consent and licensing are underlying principles of the Act; HT Act (Scotland) 2006 – no licences Stipulates that consent is legally required to store and use “relevant material” for “scheduled purpose” of research (some exemptions) Consent requirements differ for tissue from the living and the deceased DNA theft – new offence Criminal penalties for breach of the Act – fine, 3 years imprisonment or both HTA Regulated Sectors Anatomy Bone marrow donation from children / lack of capacity Human application – cells / tissues (e.g. Skin, stem cells, bone marrow, bone) Living organ donation assessment Post mortem Public display Research Organ donation and transplantation Key terms Scheduled Purpose: Covers all activities or purposes under the Human Tissue Act for which consent is required Relevant Material: material that is made of, or includes, human cells other than gametes (eggs and sperm) What activities are covered by the act?  HT Act uses the term “scheduled purposes” to cover all activities that fall under the Act. Research is a scheduled purpose – “removal, storage and use of relevant material for research into disorders, or the functioning of, the human body” All scheduled purposes legally require consent Scheduled Purposes General Anatomical examination Determining cause of death Efficacy of drug or treatment after death Obtaining information about a person which may be relevant to others Public display Research in connection with disorders, or functioning of the human body Transplantation When is consent not needed? Consent is not needed for the following purposes if tissue or samples are obtained from the living. It MUST however be obtained if they relate to a deceased individual Clinical audit Education/training (including research techniques) Performance assessment Public health monitoring Quality assurance What tissues are covered? Relevant material under the Human Tissue Act 2004 The definition of relevant material in the Act is: Section 53: Relevant material: 1. In this Act, "relevant material" means material, other than gametes, which consists of or includes human cells. 2. In this Act, references to relevant material from a human body do not include embryos outside the human body, or hair and nail from the body of a living person. Human Tissue: ‘Relevant material’ Includes Any bodily product likely to contain a single cell: Blood Plastinated tissues Tissues Slides / stained slides Organs Tissue blocks Waste products Breast milk Stem cells Placenta Bone marrow Bodily fluids – tears, urine, saliva, wound fluid Primary cell cultures Body of a deceased Teeth / bones individual Human Tissue: ‘Relevant material’ Excludes Acellular material e.g. serum, plasma (depending on preparation) Gametes Embryos created outside the body Cell lines Extracted cellular components including DNA Hair and nails from the living Offences under the Act Removing, storing or using relevant material for Scheduled Purposes without appropriate consent Storing or using relevant material donated for a Scheduled Purpose for another purpose Holding bodily material with the intention of its DNA being analysed for research without consent Carrying out licensable activities without holding a licence from the HTA Trafficking in human tissue for transplantation purposes Licensable activities The HTA licenses and inspects organisations which: Carry out anatomical examination Carry out post-mortem examination Remove ‘relevant material’ from a deceased person Store ‘relevant material’ for a ‘scheduled purpose’ Store anatomical specimens Publicly displays a body or relevant material from a deceased person Relevant material, including commercially sourced tissues and samples from healthy individuals, can only be stored for research under the governance of: HTA licence or NHS REC approval (university approval not sufficient) On expiry of NHS REC approval for a study involving relevant material, a HTA licence is required to legally continue storage of any residual material. Exceptions to HTA Licensing REC approved (or pending) projects Material pending transfer (