informed consent

ICF Process

1. Informed Consent

2. Respect for persons
Autonomy
Do Good to people
Beneficence
Non-malfeasance
Be Fair to All
Justice
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3. Autonomy
Each person has a right to decide his/her own
fate
This choice should be exercised after getting
full information
The person exercising personal rights must be
legally capable of taking decisions
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4. 2/11/2020 4
Adult
Alert
Independent
Literate
Intelligent

5. Individuals who due to their maturity, mental
capacity, dependence, illiteracy, lack of
freedom or alertness are susceptible to
coercion.
Individuals who are downtrodden, subjugated
or lack the freedom to decide what shall be
done to them.
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6. All people are vulnerable at some stage or
condition in their life.
During childhood, acute sickness, imprisonment,
unconsciousness, serious illness.
Some people remain vulnerable throughout
their lives
Mental or physical retardation, psychiatric illnesses
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7. Vulnerability is a dynamic phenomenon, it
increases and decreases over time and change
of conditions.
Vulnerability differs with family conditions,
social set up, financial or political status.
Vulnerability differs from country to country,
over time and various other factors.
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8. Wars
Poverty
Anarchy
Illiteracy
Regimentation
Fanaticism
Dictatorships
Peace
Prosperity
Stability
Literacy
Freedom
Liberalism
Democracy
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9. 2/11/2020 9
Autonomy
Informed
Consent

10. Informed Consent was brought in use by
Walter Reed in 1900
The concept was introduced in the Berlin Code
in December 1900
Both ideas probably developed independently,
there is no evidence that either of the parties
were aware of the work of the other.
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13. Informed consent has evolved considerably over
the last 113 years.
Earliest requirements were defined by the
Guidelines of 1931, these were issued by the
Weimar Government. However, the government
fell a mere four months after issuing the
guidelines, and Nazi Party came in power. They
ignored the Guidelines.
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14. 5. Innovative therapy may be carried out only
after the subject or his legal representative has
unambiguously consentedto the procedure in
the light of relevant information provided in
advance. Where consent is refused, innovative
therapy may be initiated only if it constitutes
an urgent procedure to preserve life or prevent
serious damage to health and prior consent
could not be obtained under the circumstances.

15. 6. The question of whether to use innovative
therapy must be examined with particular care
where the subject is a child or a person under
18 years of age.
7. Exploitation of social hardshipin order to
undertake innovative therapy is incompatible
with the principles of medical ethics.

16. Required as per Schedule Y in the Drugs and
Cosmetics Rules 1945 (Second amendment of
2005).
Required as per ICMR Guidelines for
Biomedical Research 2000, and 2006.
Presently controlled by Rule 122 DAB of Drugs
and Cosmetics Rules 1945.
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17. (i)Inalltrials,afreelygiven,informed,writtenconsentis
requiredtobeobtainedfromeachstudysubject.The
Investigatormustprovideinformationaboutthestudy
verballyaswellasusingapatientinformationsheet,ina
languagethatisnon-technicalandunderstandablebythe
studysubject.TheSubject’sconsentmustbeobtainedin
writingusingan‘InformedConsentForm’.Boththepatient
informationsheetaswellastheInformedConsentForm
shouldhavebeenapprovedbytheethicscommitteeand
furnishedtotheLicensingAuthority.Anychangesinthe
informedconsentdocumentsshouldbeapprovedbythe
ethicscommitteeandsubmittedtotheLicensingAuthority
beforesuchchangesareimplemented.
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18. (ii)Whereasubjectisnotabletogiveinformedconsent
(e.g.anunconsciouspersonoraminororthose
sufferingfromseverementalillnessordisability),the
samemaybeobtainedfromalegallyacceptable
representative(alegallyacceptablerepresentativeisa
personwhoisabletogiveconsentfororauthorizean
interventioninthepatientasprovidedbythelaw(s)of
India).IftheSubjectorhis/herlegallyacceptable
representativeisunabletoread/write–animpartial
witnessshouldbepresentduringtheentireinformed
consentprocesswhomustappendhis/hersignatures
totheconsentform.
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19. (iii) A checklist of essential elements to be
included in the study subject’s informed
consent document as well as a format for the
Informed Consent Form for study Subjects is
given in Appendix V.
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20. Before any trial related activity!
Any activity, which is specific for the trial, and
would not be conducted, but for the trial, must be
preceded by informed consent.
Does taking blood pressure of a patient require
informed consent?
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21. Any member of the investigative team, but the
responsibility is that of the investigator.
There is no specification in Indian rules as to who
can administer the Informed Consent. In the US it
is the responsibility of the PI.
Can a study nurse administer Informed Consent.
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22. Informed consent should be sought only after a
detailed explanation of the trial, the risks and
benefits if any. The patient should be given
adequate time to understand the document and
ask as many questions as possible. Should also be
allowed to take the ICF home, to discuss with
family members and friends.
What is the patient does not turn up again?
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23. The ICF should be prepared in language in which
the subject is comfortable. The writing should be
simple for the understanding of a non technical
person. The document may not be grammatically
correct or pure, it should be understandable.
What is no member of the investigative staff
speaks the subject’s language?
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24. Translation should be done by a registered
organization and should be certified as a correct
translation.
Back translation is a requirement.
ICF must be read by as many members of the
investigative team staff and IRB members as
possible.
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25. If the subject is unable to take a decision, either
due to maturity (age) or incapacity, a near relative
(who is a legally authorized representative) may
take a decision after attending the IC process.
PI should probe the interest of LAR, and the
possibility of coercion before accepting LAR.
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26. If the subject can take a decision, but cannot record
the same (due to blindness or illiteracy) then a
witness may be used to testify that the IC process
was done in the presence of the witness.
Witness may be used when subject is a psychiatric
patient.
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27. ICF must be signed and dated by the subject
and Investigator.
One copy of the ICF must be given to the
subject.
ICF must be stored with the PI, not to be given
to the sponsor.
ICF is an essential document that must be
archived as long as legally required.
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28. Appendix V of the Schedule Y to the Drugs and
Cosmetic Rules 1945 provides the basic
elements for the informed consent document.
Additions made vide Rule 122 DAB dated
31.1.2013.
All essential items must be present for a
consent document to be approved by IRB.
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29. 1. Statement that the study involves research and
explanation of the purpose of the research
2. Expected duration of the Subject's participation
3. Description of the procedures to be followed,
including all invasive procedures
4. Description of any reasonably foreseeable risks
or discomforts to the Subject
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30. 5. Description of any benefits to the Subject or
others reasonably expected from research. If no
benefit is expected Subject should be made aware
of this.
6. Disclosure of specific appropriate alternative
procedures or therapies available to the Subject.
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31. 7. Statement describing the extent to which
confidentiality of records identifying the Subject
will be maintained and who will have access to
Subject’s medical records
8. Trial treatment schedule(s) and the probability
for random assignment to each treatment (for
randomized trials)
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32. 9. Statement describing the financial
compensation and medical management as
under:
(a) In the event of an injury occurring to the
clinical trial subject, such subject shall be
provided free medical management as long as
required.
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33. (b) In the event of a trial related injury or death,
the sponsor whosoever had obtained permission
from the Licensing Authority for conduct of the
clinical trial, shall provide financial compensation
for injury or death.
10. An explanation about whom to contact for trial
related queries, rights of Subjects and in the event
of any injury
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34. 11. The anticipated prorated payment, if any, to the
Subject for participating in the trial
12. Subject's responsibilities on participation in the
trial
13. 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
14. Any other pertinent information


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35. 1.2 Additional elements, which may be required
a.Statement of foreseeable circumstances
under which the Subject's participation may
beterminated by the Investigator without
the Subject's consent.
b.Additional costs to the Subject that may
result from participation in thestudy.
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36. c. The consequences of a Subject’s decision to
withdraw from the research and procedures
fororderly termination of participation by Subject.
d. Statement that the Subject or Subject's
representative will be notified in a timely manner
ifsignificant new findings develop during the course
of the research which may affect the Subject's
willingness to continue participation will be provided.


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37. e. A statement that the particular treatment or
procedure may involve risks to the Subject (or to
the embryo or fetus, if the Subject is or may
become pregnant), which are
currentlyunforeseeable
f.Approximate number of Subjects enrolled in the
study
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