Imperial College LondonPage 1 Informed Consent Christine BuickeBecky WardResearch Governance Manager Imperial College LondonPage 2 Outline Background What is informed consent? Essential information Vulnerable groups Patients perspective Top tips Imperial College LondonPage 3 Background 1905: Mohr v Williams 1947: Nuremberg trials 1957: Salgo v Stanford University First use of informed consent in treatment 1963: Jewish Chronic Disease Hospital Case 1972: End of Tuskegee Syphilis Study 1990: Moore v. Regents of the University of California Imperial College LondonPage 4 Informed Consent that taken by a person after receiving the necessary information; and after doing so, arrived at a decision without being subject to coercion, undue influence, or inducement, or intimidation Council for International Organizations of Medical Sciences (CIOMS), 2002 Imperial College LondonPage 5 Informed Consent Laws UK case law need for consent No consent = battery Medicines for Human Use (Clinical Trial) Regulations 2004 Human Tissue Act 2004 Deceased vs living Mental Capacity Act 2005 Legal representative Extensive guidance available NRES, DoH, WHO etc Imperial College LondonPage 6 Requirements for valid consent Consent to treatment can be expressed or implied for research written strongly recommended Must have adequate information Decision must be voluntary Must be obtained before research participation begins Imperial College LondonPage 7 Essential Information Invitation to participate Purpose of research Why chosen Free to refuse/ withdraw Study details Study duration What is being tested Alternatives Foreseeable risks, pain or discomfort Potential benefits Compensation arrangements Confidentiality arrangements Results Organising and funding the research Payments / reimbursements 24 hour contact details Imperial College LondonPage 8 Points to Consider Language Must suit level of understanding Comprehension Must ensure understanding Documentation Signed consent form Intimidation/Undue Influence Invalidates consent Imperial College LondonPage 9 Requirements Must ensure: Sufficient opportunity to read and consider information Time to reflect on implications of participation Time to ask questions Time to discuss with family Time given >24 hrs Voluntary, no coercion Who should obtain consent? Principal Investigator or suitably qualified individual Dependent relationships Imperial College LondonPage 10 Process of Informed Consent Informed consent is a process, not a single event Continuous Maintain communication Update if new information becomes available Imperial College LondonPage 11 Vulnerable Groups Imperial College LondonPage 12 Competence How do you assess competence? Must be able to: Understand the issues, and Retain the information long enough to Believe that the information could be true, and Consider the information appropriately, and Make a decision based on the information received. Being open and honest ensures consent is robust! Imperial College LondonPage 13 The age of consent UK Clinical Trial Regulations