INFORMED CONSENT FORM

Submitted to: Dr. Sanjula Presented by :Yasmeen

Baboota M.Pharm( Pharmaceutics)
School of Pharmaceutical School of Pharmaceutical

Education and Research Education and Research
Jamia Hamdard Jamia Hamdard

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CONTENTS

 ICF(Informed Consent Form)
 Introduction
 Informed consent cases /studies
 Ethical Principles
 Informed Consent process

 IRB( Institutional Review Board)
 Responsibilities of IRB
 IRB composition

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INTRODUCTION
Informed Consent is a process by which a subject voluntarily
confirms his or her willingness to participate in a particular trial,
after having been informed of all aspects of the trial that are
relevant to the subject’s decision to participate

Informed consent is documented by means of a written ,signed
and dated Informed Consent Form(ICF)

Informed consent is a vital part of the research process, and as
such entails more than obtaining a signature on a form

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Informed Consent Cases/ Studies
 Tuskegee Syphilis Study(1932-1972)

 Patients left with untreated syphilis for decades
 Nazi Medical War Crimes( 1935-1945)

 Physician –conducted experiments especially harmful to
subjects

 Cold War Human Radiation Experiments(1944-1974)
 Radiation Experiments on U.S citizens

 The Wichita Jury Study (1955)
 Audiotaped Jury Deliberation

 Milgram Studies of Obedience to Authority (1960s)
 People do cruel and umethical things when authority tells

them to
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Contd…….
 Thalidomide Experience (1962)

 Birth defects in pregnant women

 Jewish Chronic Disease Hospital Study (1963)
 Live cancer cells injected into chronically ill patients

 Willbrook Hepatitis Study (1963-1966)
 Infected mentally ill children with hepatitis without

telling parents or children

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WHY IT IS IMPORTANT

 These studies are intended to test the safety and
effectiveness of new treatments and therapies on
people because of this, participants must understand
that they are acting as subjects in a research study
and not as patient .

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Ethical Principles – Why
• Nuremburg Code: “The voluntary consent of the human

subject is absolutely essential”. This means that the person
involved should have legal capacity to give consent, without
any intervention of deceit or coercion; and should have
sufficient knowledge and comprehension of the subject matter.
(Nuremburg Code, 1949)

• Declaration of Helsinki: “…the well-being of the individual
research subject must take precedence over all other
interests.” (Declaration of Helsinki, 1964)

• Belmont Report: “…respect for persons demands that subjects
enter into the research voluntarily and with adequate
information.” (The Belmont Report, February 1976)

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The Informed Consent Process – Who

Who Must be Consented?
• Potential subjects who are thought to fulfill the

inclusion/exclusion criteria for the study.

Who May Obtain Consent?
• Qualified research team members trained in Human

Subject Protection & with sufficient knowledge about the
specific study. This may include the Principal Investigator
(PI), sub-investigators, research coordinators or other
research team member approved by the IRB.

• Though the PI may delegate obtaining consent to other
team members, proper oversight and execution is always
the PI’s responsibility.

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The Informed Consent Process – What
8 Required Elements of Informed Consent:

1. Research – statement that study involves research, its purpose,
duration, procedures, & identification of experimental procedures.

2. Risks – or discomforts, that are reasonably foreseeable.
3. Benefits – to subject or others, that are reasonably expected.
4. Alternative – procedures or treatments available, if any.
5. Confidentiality – of records identifying subject, though may be

inspected by authorized entities (i.e., FDA, IRB, UCD/UCH, Sponsor).
6. Research-Related Injury – available treatment & compensation (if

study is greater than minimal risk).
7. Contact – person for questions regarding the study, subject’s rights, or

research-related injury.
8. Voluntary – no penalty or loss of benefits for choosing not to

participate & may discontinue at any time.(FDA 21 CFR 50.25 & 45 CFR 46.116)

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The Informed Consent Process – What
Additional Elements of Informed Consent:

1. Unforeseeable Risks – may be involved.
2. Participation Termination – circumstances under which PI

may terminate subjects participation without their consent.
3. Additional Costs – to subject due to participation.
4. Withdrawal – consequences of subject’s decision to

withdraw & withdrawal procedures.
5. Significant New Findings – subjects will be notified of new

findings which develop during the course of research that
may relate to their willingness to continue participation.

6. Subject Numbers – approximate number involved in study.

The 8 basic elements are required in all consents. Additional
elements are used when appropriate and as required by IRBs. They
are typically incorporated in the IRB templates with instruction for

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use.

The Informed Consent Process – When

Informed consent must be obtained:

• Prior to conducting any study related tests, procedures,
treatments, or questionnaires.

• Using the current IRB approved consent form (HRRC approval
is also required prior to consenting any subjects if using UCH
facilities).

• Re-consent is required if there is new information that would
effect the subjects willingness to continue participation or as
directed by the IRB.

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The Informed Consent Process – How
• Identify potential study participants based on study criteria.
• Describe the study verbally, as outlined in the approved consent,

using non-technical language. An interpreter should be involved if
necessary.

• Invite questions and ensure all are answered satisfactorily.
• Allow time to review the consent alone or with physician, family or

friends if desired.
• Assess understanding of the major elements of the consent.
• If there is voluntarily agreement to participate, obtain signature,

initials where indicated, and date from the subject.
• Consenter must also sign and date, as must the PI if there is a PI

signature line on the consent form.
• Provide a copy to the subject and maintain the original in the

subject’s study file.
• Complete the Consent Process Documentation form & file.

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Institutional Review Board (IRB)
 The purpose of an IRB is to review research and to ensure the rights and

welfare of human subjects involved in research are adequately protected.
 Responsibilities of IRB
 safeguard the rights, safety, and well-being of all trial subjects. Special

attention should be paid to trials that may include vulnerable subjects
 Should obtain the documents

 trial protocol(s)/amendment(s)
 written informed consent form(s) and consent form updates that the

investigator proposes for use in the trial
 subject recruitment procedures (e.g. advertisements)
 written information to be provided to subjects
 Investigator’s Brochure (IB)
 available safety information
 information about payments and compensation available to subjects

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IRB cont….
 should consider the qualifications of the investigator for the

proposed trial, as documented by a current curriculum vitae and/or
by any other relevant documentation the IRB/IEC requests

 should conduct continuing review of each ongoing trial at intervals
appropriate to the degree of risk to human subjects, but at least once
per year

 may request additional information would add meaningfully to the
protection of the rights, safety and/or well-being of the subjects

 should review both the amount and method of payment to subjects
to assure that neither presents problems of coercion or undue
influence on the trial subjects

 should determine that the proposed protocol and/or other
document(s) adequately addresses relevant ethical concerns and
meets applicable regulatory requirements for such trials

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IRB composition

 The IRB/IEC should consist of a reasonable number of
members, who collectively have the qualifications and
experience to review and evaluate the science, medical aspects,
and ethics of the proposed trial.

 It is recommended that the IRB should include:
 Chair Person
 1-2 basic medical scientist
 1-2 clinician from various institutes
 1 legal expert
 1 social scientist/ representative of NGO
 One lay person
 Member secretary

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Summary
• Consent is an ethical obligation governed by federal regulation,

which requires the use of current IRB approved consent forms.

• Consent must be informed and voluntary.

• Consent must be completed prior to any study-related activity.

• Documentation of the consent process (by signing the consent
form) is required for most studies.

• Obtaining consent may be delegated to trained research team
members, but is always the PI’s responsibility.

Consent is a Process – Not just a Form!
• 3/28/2013

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THANK YOU