© imperial college londonpage 1 informed consent paula nicholson research facilitator...

© Imperial College London

Informed Consent

Paula NicholsonResearch Facilitator

[email protected]

Patricia HenleyResearch Facilitator

[email protected]


Outline

• What is informed consent?

• Essential information

• Vulnerable groups

• Patient’s perspective

• Top tips


Background

• 1905: Mort v Williams• 1949: Nuremberg trials• 1957: Salgo v Leland Stanford

– 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


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


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– COREC, DoH, WHO etc


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


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


Points to Consider

• Language– Must suit level of understanding

• Comprehension– Must ensure understanding

• Documentation– Signed consent form

• Intimidation/Undue Influence– Invalidates consent


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


Process of Informed Consent

• Informed consent is a process, not a single event– Continuous – Maintain communication– Update if new information becomes available


Vulnerable Groups


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!


The age of consent

• Age 16 -17:– If not competent, parent or guardian can take

decision for them• Child should still be involved as much as possible

• Under 16s:– Not automatically competent– Case Law: can consent to treatment if deemed

competent• Fraser Competence (nee Gillick)

• Age appropriate Information Sheets (eg <5yrs, 6-12yrs, 13-15yrs and >16yrs


Assent of Minors

• Only research that can only be carried out on children or that directly relates to the child’s clinical condition should be conducted

• Parent’s signature sufficient in law– Best practice: assent of child (if deemed competent)– Assent is not legally binding, however, favoured by

ethics committees

• Parental consent should reflect wishes of the child, these may overrule parents’ wishes


Adults without Capacity

• Mental Illness/Mental Disability/Brain Damage• Mental Capacity Act 2005

– New powers for a legally designated person to give consent for another adult

– Hierarchy:

1. Personal legal representative• Suitable by virtue of relationship• Willing

2. Professional legal representative• Not connected with study• Primarily responsible for person’s medical care OR• Nominated by relevant health care provider


Unconscious Patients

• Ethical dilemma concerning consent• Research should only be carried out if comparable

research cannot be carried out on those able to consent• Research should relate directly to life-threatening condition

of participant• Legal representative and/or independent clinician to give

assent• Emergency research should be re-consented after 24

hours– Follow-up


From the patient’s perspective….


Common Barriers to Informed Consent

• Technical language– Randomisation– Scientific language

Ok, what part of antiaromatase neoadjuvant therapy for adenocarcinoma of the sigmoid colon demonstrating the EGFR receptor mutation don’t you understand?


Who benefits?

‘I’d like you to take part in an experiment that may be to your benefit but possibly won’t. I’ve no idea how this is going to turn out, neither has anyone else. I have no intention of telling you what we find out as a result of your participation and once the experiment is over you probably won’t see me again’

Thank you to Christine Gratus for the patient’s perspective!


Example PIL and Consent Form

• Is there anything wrong with the Participant Information Leaflet and Consent Form given?


Top tips for your PIL (1)

• Write in short sentences• You can start sentences with and, but or so

to split a long sentence into two shorter ones• Leave lots of ‘white space’ – use short

paragraphs• Use bullet points for lists• Add pictures or diagrams where possible• If lengthy, consider summary sheet• Headed paper



• Use second person rather than third– ‘you’ rather than ‘they’ or ‘the patient’

• Use active voice rather than passive voice where possible– ‘you will have chemotherapy, rather than, ‘the

chemotherapy will be given to you’



• Include medical terms, but after the plain English– ‘You will have an operation to remove your

prostate (a radical prostatectomy)– ‘cancer that has spread (metastasised)’

• Include abbreviations after the full term– Chronic lymphocytic leukaemia (CLL)



• Use simpler words:

Participate in --- Take partPrior to --- BeforeDiscontinue --- Stop In the event of --- If Duration --- TimeInform --- TellScheduled to undergo --- Due to haveEfficacy --- How well it works


Plain English

An office notice read:

“If there are any points on which you require explanation or further particulars we shall be glad to furnish such additional details as may be required by telephone.”

When what they actually wanted to say was:

“If you have any questions, please ring.”

Thank you to Claire Connolly for the Plain English tips! www.cancerhelp.org.uk


Top Tips for Consent Form

• Additional clauses on the consent form should be included if using:– Additional invasive tests or samples required for

study purposes only– Audio or video taping– Photographs– Transfer of data/samples to countries outside the

EU– Agreement to receive feedback from tests– Genetic analysis of samples


Useful Guidance

• COREC– http://www.corec.org.uk/applicants/help/guidance.htm#consent

• Imperial College SOPs– http://www3.imperial.ac.uk/clinicalresearchoffice/

standardoperatingprocedures • DoH Consent for Research

– http://www.dh.gov.uk/PolicyAndGuidance/HealthAndSocialCareTopics/Consent/fs/en

• Declaration of Helsinki– http://www.wma.net/e/policy/b3.htm

• European Convention of Human Rights and Biomedicine– http://conventions.coe.int/Treaty/EN/Treaties/Html/164.htm

• World Health Organisation– http://ori.dhhs.gov/documents/WHOHandbookonGCP04-06.pdf


In Summary

• Written Consent is gold standard • Full information in Patient Information Leaflet and

Consent Form• More explicit your consent, the more robust it is!

If in doubt – check with Clinical Research Office

[email protected]

[email protected]

www.imperial.ac.uk/clinicalresearchoffice

mailto:[email protected]

mailto:[email protected]

http://www.imperial.ac.uk/clinicalresearchoffice

© imperial college londonpage 1 informed consent paula nicholson research facilitator...

Documents

consent slide

imperial college londonpage

valid consent consent

use of informed consent

available slide

information time

age of consent age

new information