Informed Consent Documents Dr. Prerana.pptx

INFORMED CONSENT
DOCUMENTS
Dr. Prerana Kadam (JR-1)
Guide: Dr. Smita Tiwari
Dr. Prerana Manik Kadam 1

History
Introduction
 Purpose
 Process
 What is informed consent form?
 Elements of informed consent
 Special cases
 Electronic consent
 Challenges with informed consent
CONTENTS

HISTORY
The term “Informed consent” emerged only in the 1950s
Informed consent is a technical term first used by
attorney, Paul G. Gebhard, in a medical malpractice United
States court case in 1957.
Notable historical cases of research abuse have influenced
the development and regulation of informed consent
processes.
The discovery of unethical research and the resulting
public outcry over the years contributed to the institution of
informed consent policies in research. Walter Reed authored these informed
consent documents in 1900 for his
research on yellow fever [6]
Spanish
English

1947: Nuremberg Medical Tribunal :
-Found 16 individuals guilty of abuses
-Medical research involving Nazi human experimentation.
-Resulted in the 1947 establishment of the Nuremberg Code.
-Stresses the necessity of informed consent to research.
1932 until 1972 Syphilis Study conducted in
Tuskegee, Alabama:
-Participants were left untreated for syphilis infections
-Despite the availability of penicillin, for observation of
natural progression of disease
-Informed consent was not obtained
-Participants voluntarily elected
-But were not informed of the availability of treatment
-Were not made aware of the risks of lack of treatment

•1946 to 1948: Public Health Service study
in Guatemala, because of this Patient
Autonomy was imbibed in informed consent
form.
•1964: World medical association Declaration
of Helsinki -emphasizes the centrality of
informed consent in research process.

1974 : National Research Act
-Establishes National Commission for the
Protection of Human Subjects of Biomedical and
Behavioral Research
-Provided guidance for ethical human subjects
research.
1979: Belmont Report
-Written by the National Commission for the
Protection of Human Subjects of Biomedical and
Behavioral Research.
-The rights are protected through the use of 3
ethical principles:

1982: Council for International Organizations of Medical Sciences
-Published International Ethical Guidelines for Biomedical Research
Involving Human Subjects (revised in 1993 and 2002)
-It stressed on the importance of informed consent process and its subsequent
addition in research.

 Informed Consent is a process
Health care provider discloses appropriate information to a patient
So that the patient may make a voluntary choice to accept or refuse treatment.
INTRODUCTION
 Informed Consent is important for protection of autonomy, confidentiality,
rights and decision making process of the patients.
INFORMED
CONSENT
Informed consent is defined by the ICH for GCP
“ 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.
Written Informed consent - Obtained from each study subject
- Freely given
- Complete verbal consent as well as using a patient information sheet
- In a nontechnical and understandable language
 Audio-video recording of the informed consent process - Vulnerable subjects
- Trials of New Chemical Entity or New Molecular Entity
- Providing information to the subject and his understanding
- Shall be maintained by the investigator for record:
Waiver: - only audio recording of the informed consent process
- consent shall be maintained by the investigator for record.
- clinical trial of anti-HIV and anti-leprosy drugs
THIRD SCHEDULE (rules 8, 10, 11, 25, 35, 42 and 49)
Point 2 (a, b & g)

INFORMED CONSENT

“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”
PURPOSE
 The main purpose of the informed consent process is to
protect the patient.
-A consent form is a legal document that ensures an ongoing
communication process between you and your health care
provider.
 It implies:
-Health care provider has given information about the
condition and treatment options.
-The subject has used this information to choose the
right option.

1
• A consent form is provided by the sponsor with the study protocol or created by the site
investigator.
2
• The consent form is personalized by each site, adding local contact names and
numbers.
3
• The consent from is approved for use by the institutional review board(IRB)
4
•Investigator informs the patient about the study ,purpose, risks, and potential benefits.
5
• The patient is allowed time to read the consent form, ask questions and consider
participation.
6
• Patient or legal representative signs and dates the consent form.
7
• The sponsor and/or IRB may require additional signatures
8
• The patient is given a copy of the consent form and study treatment and procedures
can be started

PROCESS

An informed consent document is typically used to provide subjects
with the information they need to make a decision to volunteer for
a research study.
It provides the framework for information (i.e., the "elements") that must
be included as part of the consent process.
The consent document begins with a "concise and focused" presentation of
key information that will help potential participants understand why they
might or might not want to be a part of a research study.
WHAT IS INFORMED CONSENT FORM?

Name of study,
Purpose of the study
Study number,
Subject Identifier
ESSENTIAL
ELEMENTS
Patient details
Nominee /
Legal heir details
Description of:
procedures to be followed,
foreseeable risks,
any benefits (Y/N),
appropriate alternative
medical & physiotherapies.
Confidentiality record

Confidentiality details
Statement that
participation is voluntary
Contact details
Sign copy of ICF

(i) Title , nature and purpose of the research.
(ii) Expected duration
(iii) Description of the procedures to be followed including all invasive procedures, research methods used such as
randomization & placebo controls
(iv) Description of any reasonably foreseeable risks or discomforts.
(v) Description of any benefit or no benefit
(vi) Appropriate alternative procedures or therapies
(vii) Confidentiality of records , who will have access to Subjects medical records.
(viii) Trial treatment schedule ,probability for random assignment
(ix) Financial compensation and the medical management as under:
(a) Injury during the clinical trial, free medical management shall be
given as long as required or till such time it is established that the injury is not related to the clinical trial, whichever is
earlier.
(b)Trial related injury or death, provide financial compensation for the injury or death.
ELEMENTS OF INFORMED CONSENT FORM

(x)Contact detail in case of queries
(xi) The anticipated prorated payment, if any
(xii) Responsibilities of subject
(xiii) Statement that participation is voluntary, that the subject can withdraw from the study at any time and that refusal to
participate will not involve any penalty or loss of benefits to which the subject is otherwise entitled.
(xiv) Statement that there is a possibility of failure of investigational product to provide intended therapeutic effect.
(xv) Statement that in the case of placebo controlled trial, the placebo administered to the subjects shall not have any
therapeutic effect.
(xvi) Any other pertinent information.
(xvii)Approximate number of Subjects enrolled in the study
ELEMENTS OF INFORMED CONSENT FORM

Informed consent documents for clinical studies should disclose all
reasonably foreseeable risks and benefits.
Risks and benefits should be clearly communicated to the subject
well in advance.

Ref: INDIAN COUNCIL
OF MEDICAL RESEARCH 2017
Definition of risk by Merriam -Webster
Dictionary
1: possibility of loss or injury
2: someone or something that creates or
suggests a hazard
CATEGORIES OF RISK IN CLINICAL TRIAL

COMPENSATION
1. In case of clinical trial related death:
Compensation = (B x F x R) / 99.37 Where,
B = Base amount (i.e. 8 lakhs)
F = Factor depending on the age of the trial subject as per Annexure 1 (based on Workmen Compensation Act)
R = Risk Factor depending on the seriousness and severity of the disease, presence of co-morbidity and duration
of disease of the trial subject at the time of enrolment in the clinical trial between a scale of 0.5 to 4
However, in case of patients whose expected mortality is 90% or more within 30 days, a fixed amount of Rs. 2 lakhs should
be given
(a) In case of an injury occurring to the subject during the clinical trial, free medical management shall be
given as long as required or till such time it is established that the injury is not related to the clinical trial,
whichever is earlier.
(b) In the event of a trial related injury or death, the sponsor or his representative or the investigator or
centre, as the case may be, in accordance with the rule 39, as the case may be, shall provide financial
compensation for the injury or death
Chapter VI
SEVENTH SCHEDULE
( rules 39, 40, and 42)

2. In case of clinical trial related injury (other than death):
Quantum of compensation for SAE should not exceed quantum of
compensation for death.
(i) A permanent disability
(ii) Congenital anomaly or birth defect

In case of A permanent disability:
In case of SAE causing permanent disability to the trial subject, the quantum of compensation in
case of 100% disability shall be 90% of the compensation which would have been due for payment to the
nominee (s) in case of death of the trial subject.
The quantum for less than 100% disability will be proportional to the actual percentage disability the
trial subject has suffered.
Accordingly, following formula shall be applicable for determination of compensation:
Compensation = (C x D x 90) / (100 x 100)
Where :
• D = Percentage disability the trial subject has suffered.
• C = Quantum of Compensation which would have been due for payment to the trial subject's nominees) in case of
death of the trial subject.

(ii) In case of Congenital anomaly or birth defect:
The congenital anomaly or birth defect in a baby may occur due to participation of anyone or both the
parent in clinical trial. Following situations may arise due to congenital anomaly or birth defect.
(a) Still birth;
(b) Early death due to anomaly;
(c) No death but deformity which can be fully corrected through appropriate intervention;
(d) Permanent disability (mental or physical).
The compensation
-a lump sum amount
-fixed deposit or alike, it shall bring a monthly interest amount
-approximately equivalent to half of minimum wage of the unskilled worker.
-The quantum of compensation in such cases of SAE shall be half of the base amount as per formula for
determining the compensation for SAE resulting into death.
In case of birth defect leading to sub-clause (c) and (d) of this clause to any child, the
medical management as long as required shall be provided by the Sponsor or his representative which
will be over and above the financial compensation.

(iii) Chronic life-threatening disease; and
(iv) Reversible SAE in case it is resolved.
• Accordingly, following formula shall be applicable for determination of
compensation:
• Compensation = 2 X W X N.
Where,
W = Minimum wage per day of the unskilled worker
N = Number of days of hospitalization

SPECIAL CASES
Case 1 : Children
Case 2 : Illiterate person
Case 3 : Unable to give informed consent
Case 4 : Vulnerable population
Case 5 : Pregnant women
Case 6 : Non english speaking person
Case 7 : Covid-19 Pandemic

CASE 1 : CHILDREN
No decision-making capacity
Parents or other surrogate decision-makers give informed consent for diagnosis, treatment
and participation in clinical trials.
Assent
A child’s affirmative agreement to be a participant in
research.
 Term used to express willingness to participate in research
 By person who are too young to give informed consent
 Old enough to understand in general, the research, its expected
risks and possible benefits, and the activities expected of them as
subjects.
[45 CFR 46(sub part D)]

CASE 1 : CHILDREN
0-7 Years
Parent, guardian,
7-12 Years
Parent, guardian &
verbal assent
13-17 Years
written assent
required

0-7 Years
Parent, guardian
7-12 Years
Parent, guardian &
verbal assent
13-17 Years
Parent guardian consent
written assent required
Parent Yes
Child Yes
Parent Yes
Child No
Parent, guardian
Parent, guardian
Parent, guardian &
verbal assent
Court-ordered appointment
of a guardian
Parent guardian consent
written assent required
Court-ordered appointment
of a guardian

The potential subject must be able to place a sign/thumb
impression on the consent form after understanding the
clinical trial.
After that the subject must also be able to:
1.Comprehend the concepts of the study and understand the
risks and benefits of the study as it is explained verbally, and
2. Be able to indicate approval or disapproval for study
enrolment.
Who will confirm the above facts?
NDCTR Third schedule 2(d) If the trial subject his or her
legally acceptable representative is unable to read or write an
impartial witness should be present during the entire
informed consent process who must append his or her
signature to the consent form.
CASE 2 : ILLITERATE PERSON
[45 CFR 46.117]

CASE 3 : UNABLE TO GIVE INFORMED CONSENT
Unconscious person
Suffering from severe mental illness / disability
 Written informed consent obtained from a legally acceptable
representative (LAR)
NDCTR Third schedule 2(c)
LAR is a person who is able to give consent for or authorize and
intervention in the patient as provided by the law of India)

Persons who are relatively or absolutely incapable of protecting their own
interests are termed as Vulnerable Research Population. (ICH,GCP 4.8.10)
Group/individuals that cannot give informed consent because of limited
autonomy (e.g, children, mentally ill and prisoners)
Also refers to subjects who may be unduly influenced to participate (e.g,
students, subordinates and patients.
 Persons with – incurable diseases, – in custody, – unemployed or needy, – in
emergency rooms, – homeless persons, – wanderers, any ethnic or racial
minority groups should be considered as dangerous population whose mode
of consent should be carefully considered and approved by the Ethics
Committee.
 For such populations, full committee meeting is a must. Ethics Committee,
IRB are responsible for protecting the rights of such population in any
clinical trial.
CASE 4 : VULNERABLE POPULATION

Researchers should obtain informed consent from both the pregnant woman and the
father, provision of two signatures to be made in the consent form.
Consent of the father is not necessary if…
1. The purpose of the study is to meet the health needs of the mother.
2. The identity or where about of the father can not be reasonably ascertained.
CASE 5 : PREGNANT WOMEN
[45 CFR 46 (sub part B)]

CASE 6 : NON ENGLISH SPEAKING PERSON
[45 CFR 46.116]
1. Ideal is to use consent translated to participant’s native language
a)If it a major Indian language
-Certified of professional translator used to translate the consent form
-Copy of consent form to be attached to the protocol pre approved by ethics committee.
b) In case of foreign language
-Impartial witness required in this case
2. A copy of the consent document must be given to each subject.
3.While a translator may be helpful in facilitating conversation with a non-English
speaking subject, verbal translation of the consent.

CASE 7 : COVID-19 PANDEMIC
- If obtaining Informed consents becomes difficult, plan alternative mechanisms
(4.2 – Electronic IC +pt digital signal allowed)
-Additional safeguard to protect participants to be considered (4.1.4 –Broad IC +opt
out/clin samples)
-Roles of researchers, caregivers and volunteer workers must always be clarified, address
COI (5.3 – HCW-Spon responsible for their safety)
-Ensure that there is no inducement, special protection of orphaned. (vulnerable++)
-Consider waivers for consent.(ano/surv/emer)

•These are electronic processes that use various, and possibly multiple, electronic formats such as text,
graphics, audio, video, podcasts or interactive websites to explain information related to a study and to
document informed assent/consent from a participant or LAR.
•The process, electronic materials, method of documentation (including electronic/ digital signatures),
methods used to maintain privacy of participants, confidentiality, and security of the information as
well as data use policies at the research site must be reviewed and approved by the EC
•In addition to electronic consent, if required a paper/soft copy of the document is needed for archiving
and a paper/soft copy is also given to the participant.
•Interactive formats, if used, should be simple to navigate.
•Electronic methods should not be used if participants, for any reason, indicate a lack of comfort with
electronic media.
ELECTRONIC CONSENT

The researcher can apply to the EC for a waiver of consent if the research involves less than minimal risk to participants and the
waiver will not adversely affect the rights and welfare of the participants
The EC may grant consent waiver in the following situations: [45 CFR 46.116 c,d]
• Research cannot practically be carried out without the waiver and the waiver is scientifically justified;
• Retrospective studies, where the participants are de-identified or cannot be contacted;
• Research on anonymized biological samples/data;
• Certain types of public health studies/surveillance programmes/programme evaluation studies;
• Research on data available in the public domain; or
• Research during humanitarian emergencies and disasters, when the participant may not be in a position to give consent.
Attempt should be made to obtain the participant’s consent at the earliest
In most cases, investigators are expected to obtain a signature from the participant on a written informed consent document (i.e.,
to document the consent to participate) unless the IRB has waived the consent requirement or documentation (signature)
requirement
WAIVER OF CONSENT

Challenges
with Informed Consent
Problems Physicians may face
a. Use of technical
language
b. Uncertainties intrinsic
to all medical
information
c. Worried about harming
or alarming the patient
d. Hurried and pressed
by multiple duties
Problems Patients may face
a. Limited knowledge
b. May be inattentive
or distracted
c. Overcome by fear
and anxiety
d. Selective hearing
because of denial,
fear, or
preoccupation with
illness

15*
CONCLUSION
39
1. Informed consent is not just a document but a continous process.
2. It must be approved prior to the commencement of the study by IRB
/Ethics committee.
3. It protects the patient autonomy and ensures safeguarding of
patient’s and investigator’s beneficence and rights.
4. It should be personalized according to the special consideration related
to the trial subjects like children , pregnant women etc.
Dr. Prerana Manik Kadam

REFERENCES
1. Singh, N., Madkaikar, N. J., Gokhale, P. M., & Parmar, D. V. (2020). New drugs and clinical trials rules
2019: Changes in responsibilities of the ethics committee. Perspectives in clinical research, 11(1), 37–43.
https://doi.org/10.4103/picr.PICR_208_19
2. Mathur, R., & Swaminathan, S. (2018). National ethical guidelines for biomedical & health research
involving human participants, 2017: A commentary. The Indian journal of medical research, 148(3), 279.
3. Junod, Valérie (2005). Clinical drug trials Studying the safety and efficacy of new pharmaceuticals.
Genève: Schulthess. p. 545.
4. Faden, Ruth R.; Beauchamp, Tom L.; King, Nancy M.P. (1986). A history and theory of informed
consent (Online ed.). New York: Oxford University Press. ISBN978-0-19-5036862.
5. Masic, Izet & Hodzic, Ajla & Mulic, Smaila. (2014). Ethics in Medical Research and Cambridge
Quarterly of Healthcare Ethics , Volume 20 , Issue 4 , October 2011 , pp. 515 – 523
DOI: https://doi.org/10.1017/S0963180111000259
6. Laura Cutter, MA, MLIS, (2016 )Walter Reed, Yellow Fever, and Informed Consent, Military Medicine,
Volume 181, Issue 1, January, Pages 90–91, https://doi.org/10.7205/MILMED-D-15-00430
7. "UN Treaty Collection - International Covenant on Civil and Political Rights". Status of ratification
8. Publication. International Journal of Preventive Medicine. 5. 1073-1082.
9. Nijhawan LP, Janodia MD, Muddukrishna BS, et al. (2013); Informed consent: Issues and challenges. J
Adv Pharm Technol Res. 4(3):134-140. doi:10.4103/2231-4040.116779

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