Informed Consent Manorama

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INFORMED CONSENTDr. I. Manorama ThomasB.Sc. (Hons.), MBBS; M.S; F.A.M.S.

Emeritus Professor, St. Johns Medical College, Chairperson Independent Ethics Committee, Bangalore

Why Informed Consent ?

Research Done The Wrong Way I

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 II

Nazi Prisoner Research During World War IIObjectives 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 Research The OriginsBefore the 20th century, guidelines required physicians need to adhere to acceptable medical standards Issue of patients agreement to the research never discussed Most requirements arose after the Nuremberg trials

Informed Consent in Human Research The 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?Informed consent is a PROCESS Involves

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 HumansGuidelines for Informed ConsentThe Nuremberg Code, 1947 The Declaration of Helsinki, 1964 (2000) The Belmont Report, 1979 ICH GCP, 1997 ICMR Guidelines, 2000

The Nuremberg Code 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 Informed 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 Informed 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 HelsinkiWhat is it? A statement of ethical principles on research involving humans Published by the World Medical Association Developed from the Nuremberg Code Made by physicians First adopted at Helsinki in 1964

The Declaration of Helsinki and Informed Consent

Subjects must be Volunteers Informed participants

Consent be obtained, preferably in writing If subject in a dependent relationship with the physician, consent be obtained by an independent physician

The Declaration of Helsinki and Informed 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 and Informed 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 ReportWhat 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 Informed Consent

Identifies three elements of the process Information Comprehension Voluntariness

The Belmont Report and Informed Consent

Information All information be provided Conditions under which information provided also important (rapid/ disorganized manner?)

Comprehension Adapt presentation of information to subjects capacities Investigators must ascertain comprehension Special provisions immaturity, mental disability

Voluntariness There must be no coercion or undue influence

ICMR GuidelinesWhat 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 Informed 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)


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

Informed ConsentVarious 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

WHAT IS INFORMED 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

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 consent

Provided in writing The informed consent form

Discussed with the subject Consent must be in a language the subject understands

CounselingWho does the counseling.? Clinical InvestigatorPreferably a senior who has experience or at least trained in counseling .


Nature of research project Explicitly state that it is research How subjects will be recruited Purpose / aim of research Investigators names & affiliations

What must a subject know?Treatments

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

Study procedures What is subjects involvement Duration of study Explain about sample collections (not just names of tests) Procedures which are research / experimental If treatment, how different from conventional Randomization / blinding No. of subjects in study

Potential risks : Benefits Medical, social, psychological, economic Probability, magnitude Participation Voluntary Can withdraw No penalty, no loss of benefits No coercion No statement / information that causes subject / subjects legally acceptable representative to waive any legal rights or release investigator / sponsor /institution from liability for negligence Circumstances for termination of subjects participation by investigator

Any questions, further informationwhom to ask rights of research subject, AEs

Language Clear, simple, non technical Sufficient time to make decision Give written information Translations written / verbal Thumb impressions allowed All signatures should be dated

ljy, LiV

Confidentiality, privacy adverse consequences of information eg. psychiatric illness, sexual preferences, substance abuse, to employers, insurance, legal authorities, HIV stigma Monitor / auditor/IRB/IEC/ regulatory authority

have direct access to records without violating confidentiality to extent permitted & subject authorizes such access by signing consent Publication, identity will remain confidential


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 :___________ Date of births / age ________ Subjects Name :____________ Please initial box 1. 2. (Subject) I confirm that I have read and understood the information sheet date [ for the above study and have had the opportunity to ask questions I understand that my participation in the study is voluntary and tha