INFORMED CONSENTPrinciples, Practice, and

legal challenges DR.T.V.RAO MD

Chairman

Azeezia Ethics Committee

Azeezia Medical College

Kollam , Kerala

AZEEZIA ETHICKS COMMITTEEAzeezia Medical College

Kollam

We all started practicing after

Why Doctors need ethics

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 cannot be tampered

Components of an Acceptable Informed Consent

Decision-Making Capacity

Complete Disclosure

Understanding

Authorization

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Biomedical Research in HumansGuidelines for Informed Consent

• The Nuremberg Code, 1947

• The Declaration of Helsinki, 1964 (2000)

• The Belmont Report, 1979

• ICH GCP, 1997

• ICMR Guidelines, 2000

Understanding Informed Consent

• Millions of volunteers participate in government- and industry-sponsored clinical trials each year. Prior to agreeing to participate, every volunteer has the right to know and understand what will happen during a clinical trial. This is called informed consent and it is a process that can help you decide whether or not participating in a trial is right for you

Research Done The Wrong Way – II

Nazi Prisoner Research During World War

• 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 Research

The 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

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)

The participant should know well

• When any one gives written consent to participate in a clinical trial, they are acknowledging that they understand and accept all aspects of the research study—including any risks or benefits involved.

Physician has a Ethical obligation

• The physician has an ethical obligation to help the patient make choices from among the therapeutic alternatives consistent with good medical practice. Informed consent is a basic policy in both ethics and law that physicians must honor, unless the patient is unconscious or otherwise incapable of consenting and harm from failure to treat is imminent

A Step wise approach in communication of Information

• Physicians need not communicate all information at one time, but should assess the amount of information that patients are capable of receiving at a given time and present the remainder when appropriate

The Role of the Physician is important

• Physicians themselves, rather than a representative, nurse, or other related health care professional, are the best choice to speak to the patient about informed consent. In discussing the matter with the patient, the physician should cover:

• The patient's diagnosis, if it is known.

• The nature and purpose of the proposed treatment or procedure.

Pros and Cons in Communication

• The benefits and the risks of that proposed treatment or procedure.

• The alternatives to the proposed treatment or procedure.

• Alternatives should be discussed regardless of their cost and regardless of whether they will likely be covered by the patient's health insurance.

• .• .• -

Consent form should include

• The form will have information specifically about the procedure. Generally speaking, a to Your surname, given names, date of birth, sex and other details

• Whether or not an interpreter is required• An explanation of your condition, in plain

language• An explanation of the procedure, in plain

language• General risks of anaesthesia, which may be

included in a separate form

Obtaining Consent from Incompetent Individuals and Minors

• In most cases, a mentally disabled person has an appointed guardian authorized to make medical decisions, informed consent, for that individual. Medical providers need to make sure that when they obtain informed consent for incompetent individuals, they have obtained it from the correct person or persons.

• In most situations, parents can give informed consent for treatment for their minor children.

• -

What Signature means ?

• However, informed consent is not strictly about signing a document. It is a process that involves ongoing conversations between the research staff and you before, and even after, you decide to become a study volunteer.

A open discussion avoids legal litigations

• To begin, the research staff is obligated to discuss all the pertinent information about the trial—its purpose, the procedures involved, the potential risks and benefits—with you. It is your responsibility to ask questions if there is something you do not understand.

ALL RESEARCHERS MUST EXPALIN BEFORE THE RESEARCH

COMITTE

About the clinical trialmust explain before the Ethical Committee

• That is the main purpose of the study?

• Why is this study important to me?

• What are the chances that this drug will work?

• What kinds of risks are involved?

• How much of my time will this take?

• Does the study involve a placebo or a treatment already on the market?

• What is subject’s 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

Study procedures

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 /

subject’s legally acceptable representative to waive

any legal rights or release investigator / sponsor

/institution from liability for negligenceCircumstances for termination of subject’s

participation by investigator

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 my

medical 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 will

not 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 relation

to it, even if I withdraw from the trial. I agree to this access. However, I

understand that my identity will not be revealed in any information

released to third parties or published.

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Was this initial interaction with the patient approached

appropriately?

Would you have done anything differently?

EMERGING CHALLENGES TO RESEARCHERS

• Who will review information collected about me during the trial?

• What happens if I decide to quit the study?

• Can the investigator take me out of the study even if I want to continue?

Summary• 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

Reference and Adopted from

Dr. I. Manorama Thomas

Emeritus Professor, St. Johns Medical College,

Chairperson Independent Ethics Committee,

Bangalore

From Google page.

Ethics for long term success