Waiver of Informed Consent

Ghiath Alahmad

Some elements

Degrees of waiving of informed consent

Declaration of Helsinki

Nuremberg Code

Must

Requirement of informed consent fromEACH 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

Mentally impaired

Children

Record Review

Epidemiologic studies

Emergency setting

Justification

Performance of important researchcould not be performed with arequirement for informed consent

Advancement of Science

Protection of Subject Welfare/Rights

Balancing Two Goals

Limited Contact Research (minimal risk)

Medical Records researchObservational Research on largegroupsResearch on tissue/blood samples

Research in the Emergency Setting

Potential subjects are not competentto give consent at the time of theinterventionNo opportunity to obtain surrogateconsent

Types of Research

The probability and magnitudeof harm or discomfortanticipated in the research arenot greater in and ofthemselves than thoseordinarily encountered in dailylife or during routineperformance of physical orpsychological examination ortests

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.

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 theresearch will be conducted.

public disclosure of sufficient information following completion.

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