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Perry Cohen, Ph.D. presents Sham Neurosurgical Procedures in Clinical Trials:  Patient Activists’ Perspectives at the NIH conference
Sham Neurosurgical Procedures in Clinical Trials for Neurodegenerative Diseases: Scientific and Ethical Considerations
held on June 30 and July 1, 2010

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Ethical Issues

I only want to make a few quick points about ethical issues.

We see the ethical context as an important component to building collaborative relationships in an atmosphere of trust and mutual respect which are necessary to gain greater incorporation of patient interests and observations into research and care as well as to recruit PWP to volunteer as research subjects.

The ethics of sham brain surgery are questionable, for example

Any procedure based on deception starts on shaky ground ethically

We believe that total transparency and full disclosure of information about risks are necessary for informed consent. Patients will take risks if we trust that sponsors will to cover the cost of fixing adverse events and live up to other obligations.

Therapeutic misconception may be a misconception itself about motivations of PWP who want to contribute to science and at the same time receive benefits from treatments: greater promise of the treatment means greater patient expectations. Attempts to lower expectations only dilute the effectiveness of the treatment

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