Informed Consent

Question 1

“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”

Answer 1

What is informed consent?

Question 2

Elements of Informed Consent

Answer 2

Competence
Consent
Comprehension
Disclosure
Voluntariness

Question 3

Obtain
consent
from

Answer 3

Subject

LAR

Question 4

If LAR is
used

Answer 4

Subject
assessed

Subject
Assent

Question 5

Signature &
Date

Answer 5

Subject/
LAR

Investigator

Question 6

• Project details
• Research information
• Terms of participation
• Risks & Benefits
• Privacy, Confidentiality, Future
  Use
• Financial Issues
• Researcher Information and COI

Answer 6

Standard content

Question 7

Competent adult,
typically literate,
not vulnerable &
comfortable to sign

Answer 7

Population

Question 8

written, text

Answer 8

Medium of
consent

Question 9

• Essential to obtain vital
  information
• No substantial risks
• Participant informed
  deception is part of the
  approved design of study
• Participants consented
  despite the deception
• Full disclosure will harm
  participants
• There is provision for
  debriefing

Answer 9

WITHHOLDING INFORMATION
(second order consent)

Question 10

▪ Clinical Research
▪ Herbal Research
▪ Complementary/
Alternative Medicine
▪ Assisted Reproductive
Health
▪ Research on Cosmetics
▪ Environmental Health
Research
▪ Epidemiologic Research
▪ Research Using Online &
Digital Tools

▪ Health-related Social
Research
▪ Mental Health Research
▪ Emerging Technologies
▪ Genetic & Genomic
Research
▪ Stem Cell Research
▪ Research Using Human
Samples and Data from
Biobanks, Registries and
Databases

Answer 10

NEGHHR 2017: ICF Guidelines
for Specific Methods

Question 11

If impracticable & low
risk, waiver of consent
for review of medical
records can be
approved if anonymity
can be maintained and
if information sought

is considered non-
sensitive

Answer 11

TOTAL WAIVER

Question 12

If the information is
obtained by means of
a questionnaire, and
adequate information
has been given to the
research participant

Answer 12

WAIVER OF
SIGNATURE ONLY

Question 13

Special Populations

Answer 13

Indigenous People
* Children/Minors
* Older Persons
* Military Personnel
* People with Physical
Disabilities
* People Living with
HIV/AIDS
* Research in Disaster
Situations

Question 14

<7 yrs old:

Answer 14

no assent
needed

Question 15

7 to < 12 yrs old:

Answer 15

verbal assent
acceptable

Question 16

12 to <15 yrs old:

Answer 16

can
sign simplified assent
form;

Question 17

15 to <18:

Answer 17

can co-sign
parent ICF

Question 18

Both parents can sign
if

Answer 18

merited

Question 19

▪ Dissent at any age
should be

Answer 19

respected

Question 20

Research
involving children and adolescents

Answer 20

Justification for involvement of children

Order of involvement

Assent and reConsent

Managing deliberate objection of children
LAR and waiver of parental consent

Entitlements of the LAR