Waiver of informed consent

1. Waiver of Informed Consent
Ghiath Alahmad

2. Some elements
Degrees of waiving of informed consent

3. Declaration
of Helsinki
Nuremberg
Code
Must
Requirement of informed
consent from
EACH subject
Can be
Research with vulnerable subjects
(mentally impaired and children)
can/may de done with less than full
consent through surrogate consent
Research Without Consent in the Guidelines

4. Mentally impaired
Children
Record Review
Epidemiologic studies
Emergency setting
Justification
Performance of important research
could not be performed with a
requirement for informed consent

5. Advancement of Science
Protection of Subject Welfare/Rights
Balancing Two Goals

6. Limited Contact Research (minimal risk)
Medical Records research
Observational Research on large
groups
Research on tissue/blood samples
Research in the Emergency Setting
Potential subjects are not competent
to give consent at the time of the
intervention
No opportunity to obtain surrogate
consent
Types of Research

7. The probability and magnitude
of harm or discomfort
anticipated in the research are
not greater in and of
themselves than those
ordinarily encountered in daily
life or during routine
performance of physical or
psychological examination or
tests
Minimal Risk
The research presents no
greater than minimal risks.
Obtaining informed
consent is not practicable.
The waiver of informed
consent is consistent with
individuals’ rights.
Subjects will be informed
as appropriate.

8. The human subjects are in a life-threatening situation
Research in the Emergency Setting
The research presents no
greater than minimal risks.
Obtaining informed
consent is not practicable.
The waiver of informed
consent is consistent with
individuals’ rights.
Obtaining informed consent is not feasible because
Participation in the research holds out the prospect of
direct benefit to the subjects because subjects are facing a
life-threatening situation that necessitates intervention
Research must yield important generalizable knowledge
not otherwise available
Additional protections of the rights and welfare of the
subjects will be provided
consultation with
representatives of the
communities from which the
subjects will be drawn
public disclosure to the
communities in which the
research will be conducted.
public disclosure of
sufficient information
following completion.

9. Thank you for Listening