Patient information and

informed consent process

Dr. Pratibha Nadig

ICRI,Bangalore.
Validity of Informed
consent
 A.Provide appropriate and
Complete information to the
subject
 B.Understanding by the patient
 C.Voluntariness
 D.Formal consent
 E.IRB written approval
Patient information: basic
elements 4.8.8 ICH-GCP
1.A statement that
the study involves research,
 purpose of the research

 expected duration of the subject's

participation,
 No.of patients to be enrolled

 procedures to be followed,

 identification of any procedures

which are experimental.

Patient information: basic
elements
2. reasonably foreseeable risks or
discomforts to the subject.

3. any benefits to the subject or to

others which may reasonably be
expected from the research.
Patient information: basic
elements
4.appropriate alternative
procedures or courses of
treatment, if any, that might be
advantageous to the subject

5.the extent, to which

confidentiality of records
identifying the subject will be
maintained
Patient information: basic
elements
 6.If involving more than minimal
risk, compensation ?
any medical treatments?
what they consist of
or where further information may
be obtained.
Patient information: basic
elements
7. whom to contact for
 answers to pertinent questions

about the research and research

subjects' rights,OR

 In the event of a research-related

injury to the subject.
Patient information: basic
elements
8.A statement that
 participation is voluntary,
 that refusal to participate will
involve no penalty or loss of
benefits to which the subject is
otherwise entitled,
 and that the subject may
discontinue participation at any
time without penalty or loss of
benefits to which the subject is
otherwise entitled.
Patient information:
format
 Explanation not too technical

 Culturally appropriate and

understandable manner

 Language local vernacular

language and
Patient information :
format
 Language that causes the
subject/LAR to wave off any legal
rights or that releases the
investigator of any responsibilities
The consent process
 More than reading and signature

 Information exchange

 subject recruitment materials, verbal

instructions, question/answer sessions
and measures of subject
understanding.
The consent process
 Step-I VERBAL EXPLANATION

 Investigator/IRB approved
designee explains the
study,purpose,procedure, risks and
benefits,alternatives.

 Allows to ask questions

The consent process
 Step-2 INFORMED CONSENT FORM
submission

 Sufficient time is provided-- subject

time

 Maximum time 6 days

The consent process
 Step-3 OBTAINING CONSENT ON THE
ICF

 Investigator meets the subject

and answers queries
 Signature of the participant,

Investigator
Witness
with date
UNDERSTANDING
 Patients comprehension depends
on the intelligence
 APPROACHES TO ENSURE
UNDERSTANDING

 Individualised approach

 Audiovisual aids
UNDERSTANDING
 Giving appropriate time

 Asking open ended questions

 Questionnaires
VOLUNTARINESS
 Not coerced or unduly influenced

 Freedom to withdraw at any stage

Interferences?
Social
Economical influences
FORMAL CONSENT: THE
SIGNATURE

 1.Evidence of explicit consent to

participate
 FIRST PERSON CONSENT-
SUBJECTS CONSENT
FORMAL CONSENT: THE
SIGNATURE
 2.LEGALLY ACCEPTABLE
REPRESENTATIVE –LAR
 Alternative when the person is
unable to give consent

 vulnerable groups Mentally

impaired,geriatric,unconcious,illiter
ate
FORMAL CONSENT: THE
SIGNATURE
 WITNESS important especially in
the vulnerable groups

 INVESTIGATOR ,date
FORMAL CONSENT: THE
SIGNATURE
 UNCONCIOUS PATIENTS

 Trial to be conducted only when it

cannot be done on concious
individuals

 Signed by two doctors

Consent in children
 Vulnerable groups
 ASSENT
 CONSENT by PARENTS provided
there is minimal risk

 Age for consent 18