INFORMED CONSENT INFORMED CONSENT Dr. I. Manorama Thomas Dr. I. Manorama Thomas B.Sc. (Hons.), MBBS; M.S; F.A.M.S. Emeritus Professor, St. Johns Medical College, Emeritus Professor, St. Johns Medical College, Chairperson Independent Ethics Committee, Bangalore Chairperson Independent Ethics Committee, Bangalore
40
Embed
INFORMED CONSENT Dr. I. Manorama Thomas B.Sc. (Hons.), MBBS; M.S; F.A.M.S. Emeritus Professor, St. Johns Medical College, Chairperson Independent Ethics.
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
INFORMED CONSENTINFORMED CONSENT
Dr. I. Manorama ThomasDr. I. Manorama ThomasB.Sc. (Hons.), MBBS; M.S; F.A.M.S.
Emeritus Professor, St. Johns Medical College, Emeritus Professor, St. Johns Medical College,
Research Done The Wrong Way – IResearch Done The Wrong Way – IThe Tuskeegee Syphilis Study *The Tuskeegee Syphilis Study *
Longest non-therapeutic experiment on human beings in medical history: The progress of untreated syphilis (1932-72).
399 poor African-American sharecroppers in rural Macon County, Alabama, USA.
The men were told they were being treated for “bad blood”. Even after penicillin was discovered and found to be a miracle cure, the
men were not treated or even told what they had. US government officials went to extreme lengths to insure that they
received no therapy from any source. Presidential apology, May 1997* Tuskegee Syphilis Study Legacy Committee Final Report of May 20, 1996
Research Done The Wrong Way – IIResearch Done The Wrong Way – IINazi Prisoner Research During World War IINazi Prisoner Research During World War II
Objectives of various trials:– Effect of cold, heat, chemicals on men, women and children– “Time to death” testing in response to stressors in healthy
“volunteers”– Organ transplant experiments on healthy “volunteers”
Any information given (some?) is irrelevant because prisoners were forced to participate
Outcome: – 23 German scientists taken to court, 7 acquitted, 9 imprisoned, 7
given death sentence– Nuremberg Code of 1947
Informed Consent in Human ResearchInformed Consent in Human ResearchThe OriginsThe Origins
Before the 20th century, guidelines required physician’s need to adhere to acceptable medical standards
Issue of patient’s agreement to the research never discussed
Most requirements arose after the Nuremberg trials
Informed Consent in Human ResearchInformed Consent in Human ResearchThe OriginsThe Origins
Emerges from the ethical principle of Respect for Persons– Individuals be treated as capable of taking decisions
for themselves (“autonomy”)– Those with diminished autonomy be protected
What is informed consent?What is informed consent?
Informed consent is a PROCESSInvolves
– Providing all relevant information to the volunteer/ patient
– The patient/ volunteer understanding the information provided
– Voluntarily agreeing to participate A basic right
Biomedical Research in HumansBiomedical Research in HumansGuidelines for Informed ConsentGuidelines for Informed Consent
The Nuremberg Code, 1947The Declaration of Helsinki, 1964 (2000)The Belmont Report, 1979ICH GCP, 1997ICMR Guidelines, 2000
The Nuremberg CodeThe Nuremberg CodeWhat is it?What is it?
A set of 10 principles on research involving humans
Developed after the horrors of Nazi experiments on humans became public
Published in 1947
The Nuremberg Code and The Nuremberg Code and Informed ConsentInformed Consent
The voluntary consent of the human subject is absolutely essential– Person must have legal capacity to consent– Should have “sufficient knowledge and
comprehension” to make an “understanding and enlightened decision”
– Must be able to exercise “free power of choice”
The Nuremberg Code and The Nuremberg Code and Informed ConsentInformed Consent
Inform the subject of– The nature, duration and purpose – The method and means– All inconveniences and hazards– Possible effects on health
There should be no force, fraud, deceit, duress, coercion
The Declaration of Helsinki The Declaration of Helsinki What is it?What is it?
A statement of ethical principles on research involving humans
Published by the World Medical AssociationDeveloped from the Nuremberg CodeMade by physiciansFirst adopted at Helsinki in 1964
The Declaration of Helsinki andThe Declaration of Helsinki andInformed ConsentInformed Consent
Subjects must be – Volunteers– Informed participants
Consent be obtained, preferably in writingIf subject in a dependent relationship with the
physician, consent be obtained by an independent physician
The Declaration of Helsinki andThe Declaration of Helsinki andInformed ConsentInformed Consent
Consent from legally acceptable representative required if subject:– Minor– Incapable of giving consent
• Physical or mental disability
If subject is a minor, assent be taken, where possible
The Declaration of Helsinki andThe Declaration of Helsinki andInformed ConsentInformed Consent
When consent not possible prior to participation in research– Approved by the “review committee”– Consent must be obtained as soon as possible from
the subject or a legally acceptable representative
The Belmont ReportThe Belmont ReportWhat is it?What is it?
Ethical principles and guidelines for protecting humans in clinical research
Developed by a commission set up in the US in the aftermath of the Tuskeegee Study becoming public
Published in 1979
The Belmont Report and The Belmont Report and Informed ConsentInformed Consent
Identifies three elements of the process– Information– Comprehension– Voluntariness
The Belmont Report and The Belmont Report and Informed ConsentInformed Consent Information
– All information be provided– Conditions under which information provided also important
(rapid/ disorganized manner?) Comprehension
– Adapt presentation of information to subject’s capacities– Investigators must ascertain comprehension– Special provisions – immaturity, mental disability
Voluntariness– There must be no coercion or undue influence
ICMR GuidelinesICMR GuidelinesWhat are they?What are they?
Ethical guidelines for research involving humans– “Ethical Guidelines for Biomedical Research on
Human Subjects”Published by the Indian Council of Medical
Research in 2000
ICMR Guidelines and ICMR Guidelines and Informed ConsentInformed Consent Participation must be voluntary Participants must be “fully apprised of the research” The investigator must obtain informed consent
– Responsibilities and information that must be provided
Assent be obtained, where possible, for minors Requirement for consent can be waived by an ethics
committee if risk is minimal (e.g. collecting data from subjects’ records)
SummarySummary
Guidelines require – All relevant information be provided to subjects– Ascertaining they understand what their participation
means for them– Voluntary consent– Protecting vulnerable subjects with additional
safeguards
Various termsVarious terms
Patient Information Sheet– Provides only the information
Informed Consent Form– Used to document consent
Both integrated in to one document called the informed consent form
Informed ConsentInformed Consent
Informed consent is … “consent given by a competent individual who
• has received the necessary information
• has adequately understood the information
• after considering the information, has arrived at a decision without having been subjected to coercion, undue influence or inducement, or intimidation”. CIOMS International Ethical Guidelines
WHAT IS INFORMED CONSENT ?
INFORMED CONSENT AS A PROCESS
Informed consent is a communication process :
• between the researcher and the participant
• starts before the research is initiated
• continues throughout the duration of the study
FHI, Research Ethics Training Curriculum
Information in informed consentInformation in informed consent
Provided in writing – The informed consent form
Discussed with the subject Consent must be in a language the
subject understands
CounselingCounseling
Who does the counseling.?Clinical Investigator—Preferably a
senior who has experience or at least trained in counseling .
PROCESS OF INFORMED CONSENT
Nature of research project
Timing Before screening
• Explicitly state that it is research• How subjects will be recruited• Purpose / aim of research• Investigators’ names & affiliations
What must a subject know?What must a subject know?TreatmentsTreatments
Trial treatment(s)– Treatments
• Investigational product and placebo• Investigational product and active comparator• Investigational product in different doses
– Probability for random assignment of treatments
• “flipping a coin”/ “drawing a card”• What chance that the subject would be
assigned to a particular treatment– “equal chance”
• What is subject’s involvement
• Duration of study
• Explain about sample collections (not just names of tests)
• Voluntary• Can withdraw• No penalty, no loss of benefits
No coercion
No statement / information that causes subject / subject’s legally acceptable representative to waiveany legal rights or release investigator / sponsor /institution from liability for negligence
Circumstances for termination of subject’s participation by investigator
• Clear, simple, non technical• Sufficient time to make decision• Give written information
• Translations written / verbal• Thumb impressions allowed• All signatures should be dated
Any questions, further informationwhom to ask rights of research subject, AEs
Language
ljy, Li”V
Monitor / auditor/IRB/IEC/ regulatory authority have direct access to records without violating confidentiality to extent permitted & subjectauthorizes such access by signing consent
Publication, identity will remain confidential
Confidentiality, privacyadverse consequences of information eg. psychiatric illness, sexual preferences, substance abuse, to employers, insurance, legal authorities, HIV stigma
WAIVER OF INFORMED CONSENT
• Minimal risk
• Rights and welfare of participants protected
• Research not possible without a waiver
• Appropriate information provided
FHI, Research Ethics Training Curriculum
SUMMARY-INFORMED CONSENT
• Moral, not just legal requirement
• Comprehensibility essential
• Cultural influences
• Support information helpful
• Pre-testing
• Free of coercion
Format of informed consent form for subjects participating in clinical trialStudy Title:Study Number :Subject Initials :___________ Subject’s Name :____________Date of births / age ________
Please initial
box (Subject)
1. I confirm that I have read and understood the information sheet date [ ]for the above study and have had the opportunity to ask questions
2. I understand that my participation in the study is voluntary and that I [ ]am free to withdraw at any time, without giving any reason, without mymedical care or legal rights being affected.
3. I understand that the Sponsor of the clinical trial, others working on the [ ]Sponsor’s behalf, the Ethics Committee and the regulatory authorities willnot need my permission to look at my health records both in respects of the current study and any further research that may be conducted in relationto it, even if I withdraw from the trial. I agree to this access. However, Iunderstand that my identity will not be revealed in any information released to third parties or published.
4. I agree not to restrict the use of any data or results that arise from this study [ ] provided such a use is only for scientific purpose(s)5. I agree to take part in the above study [ ]Signature (or Thumb impression) of the Subject/Legally acceptableRepresentative :_______________Date : Signatory’s NameSignature of the Investigator : DateStudy Investigator’s NameSignature of the witness
Date
1. Ethical guidelines for Biomedical Research on Human Subjects, Indian Council of Medical Research (ICMR) New Delhi 2000
2. The Gazette of India Extraordinary Part II Section 3(I)
3. Research Ethics Training Curriculum R.Rivera, D. Borasky, R. Rice, Family Health International, 2001. http://www.fhi.org
4. Designing Clinical Research An Epidemiologic Approach Ed Stephen, B Hulley, Steven R. Cummings Williams & Wilkins, Batlimore
Resource Material
What IEC/IRBs should look for:Inspect facility in C.R.Os/