Informed Consent

Dr Bushra Shirazi

Sketch

Definition
Process
The elements
Variations
Case
Summary

Informed Consent

Agreement or acceptance
Clinician/Researcher

Inquiry into a topic to discover or revise facts

or add to knowledge about the topic.
New avenues/ ideas

Informed consent involves an education and

information exchange that takes place between
the researcher and the potential subject

www.rgs.uci.edu/ora/rp/hrpp/informedconsentprocess.htm

Myths and Reality

Myths

Consent is designed
to protect legal
interest of the
research team

Once enrolled
cannot leave the
research

Reality

Protection of you
and the participants,
by providing access
to information that
helps in informed
choice. Aware to
rights as a
participant
Patient may leave
research project at
any time

Myth

My doctor knows
best; he or she
can tell me
whether or not I
should consent to
participate

Reality

You're doctor is likely

to be a valuable
source of advice and
information, but only
you can make this
decision. No one , not
even an expert can
predict whether.

www.cancer.gov/clinicaltrials/aguidetound
erstandinginformedconsent/pg2

The Process

Who should take consent ?

Consultant/Investigator
Designated person

http://www.fhi.org/en/RH/Training/trainmat/ethicscurr/RETCCREn/ss/Contents/SectionV/b5sl47.htm

How to deliver information?

Verbally/written
Language
Time lapse

http://www.fhi.org/en/RH/Training/trainmat/ethicscurr/RETCCREn/ss/Contents/SectionV/b5sl49.htm

Verbal consent
Written consent

Clinician/Investigator
Subject
Witness

What need to told?

http://www.fhi.org/en/RH/Training/trainmat/ethicscurr/RETCCREn/ss/Contents/SectionV/b5sl58.htm

http://www.fhi.org/en/RH/Training/trainmat/ethicscurr/RETCCREn/ss/Contents/SectionV/b5sl54.htm

The Elements

Disclosure
Comprehension
Voluntary

Disclosure

The study objectives/purpose

The procedure/requirements
Possible risks
Possible benefits
Alternatives
Medical care for adverse effects
Compensation
Whom to contact for information

Comprehension

Open ended questions

What do you understand of what I

said?
Any questions?

Voluntarily

Financial incentives
Coercion

Emotional
Physical

Loyalty to primary physician

No choices

Variations

Community

Vulnerable group

Gatekeeper
Children
Mentally challenged
Prisoners
Orphans

Women

Any issues in the given case

Artificial induction of hepatitis was carried

out in an institution for mentally defective
children in which a mild form is endemic

David J Rothmans Strangers at the bedside

Summarize

Informed consent
The process

Who should ask

How to deliver
Written consent

The elements

Disclosure
Comprehension
Voluntary

QUESTIONS

http://www.emedicinehealth.com/inf
ormed_consent/article_em.htm
http://www.med-ed.virginia.edu/cour
ses/rad/consent/
http://depts.washington.edu/bioethx/
topics/consent.html
http://jpma.org.pk/ViewArticle/ViewA
rticle.aspx?ArticleID=196