Post by David Feder on Oct 19, 2009 5:06:00 GMT -5
--------------------------------------------------------------------------------
www.treat-nmdconference2009.eu/
www.treat-nmdconference2009.eu/Portals/15/International%20Conference%20Programme%20-%20Oct%202009.pdf
Chairperson: Simon Woods (Newcastle University, UK)
It is absolutely necessary to conduct clinical trials involving adults and children with rare diseases. It is also mandatory that participation in clinical trials is based upon voluntary and adequately informed consent. However there is a growing body of
evidence that those with parental decision making responsibility may be unable to distinguish between research and treatment, the so-called “therapeutic misconception”.
In this session we will explore the possible implications of this evidence for the design and conduct of clinical trials for neuromuscular diseases through a formal debate and interactive panel discussion. It is perhaps uncontroversial that those
responsible for regulating research and for providing ethical approval have the responsibility to ensure the safety and well-being of vulnerable children. During this session we will explore the extent of this responsibility and its implications for
parents, researchers, and regulators. It will be proposed that where parents have unrealistic expectations of benefit it is unlikely that they meet the conditions for a legal and ethical consent. With this in mind, the panel will debate the following
motion:
‘Parents who express hope in the possibility of therapeutic benefit from clinical trial participation should not be allowed to consent for their children to enter trials’
The audience will be invited to vote on the motion before and after the debate.This session involves people with NMDs, patient advocates, a clinician, an ethicist, a parent and a lawyer. During the debate the panel will:
· deconstruct the concept of the “therapeutic misconception”
· invite audience participation and questions
· provide expert commentary
· conclude with constructive advice using examples of good practice with a view to their dissemination throughout the wider community.
www.treat-nmdconference2009.eu/
www.treat-nmdconference2009.eu/Portals/15/International%20Conference%20Programme%20-%20Oct%202009.pdf
Chairperson: Simon Woods (Newcastle University, UK)
It is absolutely necessary to conduct clinical trials involving adults and children with rare diseases. It is also mandatory that participation in clinical trials is based upon voluntary and adequately informed consent. However there is a growing body of
evidence that those with parental decision making responsibility may be unable to distinguish between research and treatment, the so-called “therapeutic misconception”.
In this session we will explore the possible implications of this evidence for the design and conduct of clinical trials for neuromuscular diseases through a formal debate and interactive panel discussion. It is perhaps uncontroversial that those
responsible for regulating research and for providing ethical approval have the responsibility to ensure the safety and well-being of vulnerable children. During this session we will explore the extent of this responsibility and its implications for
parents, researchers, and regulators. It will be proposed that where parents have unrealistic expectations of benefit it is unlikely that they meet the conditions for a legal and ethical consent. With this in mind, the panel will debate the following
motion:
‘Parents who express hope in the possibility of therapeutic benefit from clinical trial participation should not be allowed to consent for their children to enter trials’
The audience will be invited to vote on the motion before and after the debate.This session involves people with NMDs, patient advocates, a clinician, an ethicist, a parent and a lawyer. During the debate the panel will:
· deconstruct the concept of the “therapeutic misconception”
· invite audience participation and questions
· provide expert commentary
· conclude with constructive advice using examples of good practice with a view to their dissemination throughout the wider community.
