GET NOTES

1. Informed Consent
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2.  Introduction
 Informed consent is a Document or a Process
1. Consent is a continuous process, not a one-time event.
2. Document
 Useful information for subjects
 Names and contact information
 Reminder about study procedures
“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.”
Goal
 “The goal of the informed consent process is to provide people with sufficient information so they
can make informed choices about whether to begin or continue participation in clinical research.”
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3.  Need of IC
 Understand nature of research.
 Be informed of purpose, risks, and benefits, and alternative therapies.
 Make a Voluntary Decision about Participation.
Facts
Enrol
do harm
best
alternative
Potential
alternatives
Therapeutic
misconception
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4. 1. Enroll: Researchers need the person to enroll.
2. Do harm: Research can do harm.
3. Best alternative: Protocols may require specific procedures that may not be the best alternative.
4. Potential alternatives: Researchers may be blinded to potential alternatives.
5. Therapeutic misconception: of research subjects.
PROCEES OF IC
Discussion Review
SignaturesTime
Concerns
Signature
obtained
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5.  The process not only includes reviewing and signing the consent document, but may also include the following:
 Recruitment materials
1. Oral instructions or explanations
2. A question and answer period
3. Assessing subject understanding
4. Providing adequate time for the subject to review the form and consider their participation
5. Providing new findings or study updates as appropriate throughout the study
6. Periodic re-affirmation or re-consent as appropriate throughout the study
 In developing the consent process in the protocol, the following should be considered:
1. Setting
2. Timing
3. Minimizing Undue Influence
4. Use additional aids
5. Ask open-ended questions
6. Discuss
Information
provided
Comprehension
monitored and
maintained
Decision madeInformation
understood
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6. 1. Setting: Generally speaking consent discussions should occur in a private setting where your conversation
won’t be overhead by others.
2. Timing: It may take several meetings/discussions before the potential subject not only understands the study
but, for those recently diagnosed with a new disease or disorder it may also require additional time to
understand the new information and what alternative treatment options may be available.
3. Minimizing Undue Influence: Vulnerable populations such as minors and students are particularly
susceptible to influence from authority. Healthcare providers have tremendous influence over patients within
their clinical practice.
4. Use additional aids: (videos, brochures, etc.) to explain study procedures and supplement the information
provided in the consent document.
5. Ask open-ended questions: to potential subjects to assess their understanding of the study (e.g., “In your
own words, tell me…what the study is about; what will happen to you if you decide to be in the study; what
risks might you experience; what other options do you have.”).
6. Discuss: the study in the presence of “personal advisors” (friends/family members) who may aid in the
subject’s decision making process, with the permission of the potential subject.
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7.  Guidelines for Informed Consent
1. The Nuremberg Code, 1947
2. The Declaration of Helsinki, 1964 (2000)
3. The Belmont Report, 1979
4. ICH GCP, 1997
5. ICMR Guidelines, 2000
 The Nuremberg Code What is it?
 Published in 1947
 The voluntary consent of the human subject is absolutely essential
 Person must have legal capacity to consent
 Should have “sufficient knowledge
 Inform the subject of
 The nature, duration and purpose
 The method and means
 All inconveniences and hazards
 Possible effects on health
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8.  The Declaration of Helsinki
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
 Subjects must be
 Volunteers
 Informed participants
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9.  The Belmont Report
 Ethical principles and guidelines for protecting humans in clinical research
 Published in 1979
 Identifies three elements of the process
 Information
 Comprehension
 Voluntariness
 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
 Understand risks and benefits.
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10.  ICMR Guidelines
 Ethical guidelines for research involving humans “Ethical Guidelines for Biomedical Research on Human Subjects”
 Published by the Indian Council of Medical Research in 2000
 Revised version – 2006
1. Nature and purpose: of study stating it as research
2. Duration: of participation with number of participants
3. Procedures: to be followed
4. Investigations, if any, to be performed
5. risks and discomforts adequately described and whether project involves more than minimal risk
6. Compensations in trial related injury
a. Adverse effects of Investigational product(s).
b. Departure from approved protocol, scientific misconduct or negligence by the Investigator.
c. Failure of an Investigational Product to provide attended therapeutic effect.
d. Administration of placebo providing no therapeutic benefits.
e. Compensation for injury to a child in utero because of the participation of parent in Clinical. 5/21/201910 DR. GK SHARMA PHARMD

11. 7. No loss of benefits on withdrawal
8. Benefit sharing in the event of commercialization
9. Contact details of PI or local PI/Co-PI in multicentric studies for asking more information
10. Contact details of Chairman of the IEC for appeal against violation of rights
11. Voluntary participation
12. If test for genetics and HIV is to be done, counseling for consent for testing must be given as per national
guidelines
13. Storage period of biological sample and related data with choice offered to participant regarding future use
of sample, refusal for storage and receipt of its result
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12.  Elements of informed consent
Elements of informed consent
Essential Additional
Alternativ
es
Confidentialit
y
Benefi
ts
Risks
Purpo
se
Voluntary
participatio
n
Compensat
ion
Contact
informatio
n
Essential
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13. 1. Protocol number or name of study
2. Purpose of the study.
3. Duration of study and subject involvement
4. A statement that the protocol, and the informed consent were reviewed with the
5. participant, including the risks and benefits of the study.
6. Alternative treatment options discussed.
7. Confidentiality record
8. No of subjects
9. Compensation for injury
10. Time for questions to be asked and answered.
11. Description of the participant’s decision
12. Contact details
13. Travel reabusment
14. Subject responsibilities
15. Subject satisfaction
16. Use understandable language
17. Copy of consent was given to the participant
18. Sign copy of ICF
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14.  Additional
 Additional elements required by federal regulations:
1. Unforeseeable risks: to the subject (or to the embryo or fetus, if the subject is or may become pregnant)
2. Side effects: of a study drug are too severe, the sponsor terminates the study.
3. Additional costs: to the subject to participate (e.g., hospitalization, cost of testing)
4. Consequences of subject withdrawal from the study and procedures for withdrawal: that may be
necessary – include whether any adverse health or welfare effects may be anticipated (e.g., the need to taper
a drug treatment),
5. New toxicities develop: if findings of a data & safety monitoring board raise safety concerns.
 Additional elements required for FDA regulated research:
1. A statement that the test article is “investigational” or “not FDA-approved”
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15.  Revisions to Informed Consent
1. Informed consent documents must be revised every time new safety information becomes available or there is
a change in trial procedures, participant compensation or personnel noted on the consent form.
2. Revisions to the informed consent document must be approved by an IRB/IEC prior to its use, and the
informed consent process with the new information and documentation needs to be repeated with every
clinical trial participant.
3. The participant is then required to sign the revised form.
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