Informed consent and capacity

1. Informed consent and capacity Caroline Humphreys Head Clinical Research Nurse 12th April 2017

2. Consent to research and it’s history 1963: Jewish Chronic Disease Hospital 1966: First research ethics committee (REC) in the UK 1972: End of Tuskigee Syphilis study 1979: Belmont Report – Legal requirement in USA 2004: Legal requirement in UK

3. Informed Consent in research “A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial after having being 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

4. Informed Consent Process • Fundamental role within research and a basic human right • Consent within research is a process, it is not a single event • Consent is given by the participant • We receive consent, we do not ‘take it’ • Responsibility of the PI however….. • Everyone involved in the consent process is trained and competent to perform their specific role • The role is delegated to you by the PI

5. Informed Consent • For consent to clinical research we need to ensure • The patient is informed • what is being done • why it is being done • the risks and inconveniences • the alternatives • Patient is competent to make a decision • Voluntary process • Time • Evidence of confirming consent at each visit • If in doubt excellent reference in ICH GCP 4.8.10

6. Informed Consent Process • Everyone involved in the consent process will be • Familiar with the study - training log • Knowledgeable of the optional treatments • Aware of the need for informed consent • Having the time to discuss the study with the participants • Understanding of the participants particular circumstances

7. Informed consent • Lastly and most importantly you must document the process • Name of the study –not the ‘POPPY’ study – full name is required • IRAS number • Version and date of PIS given to patient • Any information and questions that you might have answered • Will anyone to contacting the patients? • Sign and date Fill out the worksheet!

8. Capacity or the lack of it… • Those who lack capacity should not be deprived of evidence(research) based care. • There is are legal frameworks for the conduct of research with patients who lack capacity: • Mental Capacity Act (2005) • The Medicines for Human Use (Clinical Trials) Regulations (SI 2004/1031) and it’s subsequent amendments

9. Research Consent and Incapacity: key points Research Involving Incapacitated Adults • Specific reason for inclusion – not able to undertake study in patients with capacity • Higher threshold for including adults with incapacity • Direct benefit outweighs foreseeable risk • Research about pts condition or treatment • Research of equal effectiveness cannot be carried out if confined to participants with capacity • Possible benefits not disproportionate to burden 1. Personal Legal Representative Suitable by virtue of relationship to adult and able & willing to act as PerLR 2. Professional Legal Representative Person NOT connected to trial who is: Doctor primarily responsible for adult’s medical tx OR Nominated by NHS Trust 1. Personal consultee e.g. carer (unpaid), family member or nominated third party (e.g. Lasting power of attorney, court appointed deputies) 2. Nominated consultee i.e. a person independent of the research appointed in accordance with DH guidance (e.g. paid carer independent of research; IMCA) • Informed Consent • Legally represents presumed will of patient • LR gives consent • Remains legally valid when patient regains capacity • Advice / Agreement • Reflects presumed will of patient • If person shows signs of resistance or indicates in any way they do not wish to take part – must be withdrawn • Valid until patient regains capacity – patient consent must be sought as soon as possible

10. Emergency research consent • CT regulation initially made no provision for recruitment without prior written consent • Amendments in 2006 (adults), 2008(minors) introduced waivers • Waivers apply where: • Treatment needs to be given urgently to a person lacking capacity • Urgent action for the purpose of the trial is required • Not reasonably practicable to obtain informed consent from a parent/legal representative prior to entering the participant in the trial

11. Emergency Consent Waivers • Cover the duration of the emergency only • Retrospective consent from the patient/PER/PLR must be sought as soon as possible • Documentation is key in this whole process

12. Designing your study • The process is key to a successful study • Think about the when, where & how • Use the HRA templates for consent forms and PIS • Get the language right in your participant information sheet • Involve PPI • How do you document it?

13. Consent • Consent will in the majority of the trials/studies occur. • How and the when may differ but the what generally stays the same • Know your studies and what you have ethical approval for with regards to consent

14. Thank you & any questions?