Facing Up The Challenge Sep 27 2007

Facing Up to the Challenge Informed Consent in Vulnerable Populations

Vulnerable populations ,[object Object]

Delimiting the problem ,[object Object],[object Object]

Good of many or respect of the few? ,[object Object],[object Object]

Quest for justice? ,[object Object],[object Object],[object Object],[object Object]

Timeline concept of protection ,[object Object]

Current challenge ,[object Object]

Protective concept of justice ,[object Object]

Protective concept of justice (continued) ,[object Object]

A new concept of justice ,[object Object]

Possible pitfalls of the new concept ,[object Object],[object Object],[object Object]

Proposed course of action ,[object Object]

Essential elements to consider ,[object Object],[object Object],[object Object],[object Object]

Informed consent ,[object Object]

Informed consent (continued) ,[object Object]

Kant’s Imperative ,[object Object]

Basis of research ,[object Object]

Free and informed consent ? ,[object Object]

Barriers to informed consent ,[object Object],[object Object],[object Object],[object Object]

Patient-centered barriers ,[object Object],[object Object],[object Object],[object Object],[object Object]

Process-centered barriers ,[object Object],[object Object],[object Object],[object Object]

Overall message ,[object Object]

How to proceed? ,[object Object],[object Object],[object Object]

First case study ,[object Object]

Setting the case ,[object Object],[object Object],[object Object]

Any foreseen difficulties? ,[object Object],[object Object],[object Object],[object Object]

Proposed alternatives ,[object Object],[object Object],[object Object]

FDA ‘Final Rule’ Guidelines (1996) ,[object Object],[object Object],[object Object]

Final Rule Guidelines (continued) ,[object Object],[object Object],[object Object],[object Object]

Weak provisions? ,[object Object],[object Object],[object Object]

Questions remain ,[object Object],[object Object],[object Object]

Questions remain (continued) ,[object Object],[object Object]

Current situation ,[object Object],[object Object],[object Object]

Publications: Waiver of Informed Consent ,[object Object],[object Object],[object Object],[object Object]

Publications: Waiver of Informed Consent (continued) ,[object Object],[object Object],[object Object],[object Object]

Other solutions ,[object Object],[object Object]

Tri-Council Policy Statement ,[object Object]

Canadian overview ,[object Object],[object Object],[object Object],[object Object],[object Object]

Back to the beginning ? ,[object Object],[object Object]

Second case study ,[object Object]

Setting the case ,[object Object]

Competency to consent to research ,[object Object],[object Object],[object Object],[object Object],[object Object]

Competency, subject to change? ,[object Object],[object Object],[object Object]

Any foreseen difficulties? ,[object Object],[object Object]

Any foreseen difficulties? (continued) ,[object Object],[object Object]

Proposed alternatives ,[object Object],[object Object]

Complexity/Nature of the Informed Consent Content ,[object Object],[object Object],[object Object]

Effectiveness of Various Delivery Systems ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Effectiveness of Various Delivery Systems (continued) ,[object Object],[object Object]

Effectiveness of Various Delivery Systems (continued) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Question remains ,[object Object]

Back to the beginning? ,[object Object],[object Object]

Conclusions (continued) ,[object Object],[object Object],[object Object]

Contact information ,[object Object],[object Object],[object Object],[object Object]

Facing Up The Challenge Sep 27 2007

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