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Thought Leadership – Generic Participant Information Sheet and Consent Form

Friday, September 13th, 2013

Bellberry is committed to improving clinical research and having been in business for almost 10 years, decided to ask more searching questions than just what our human research ethics committees might do to support health research.

To establish the questions we held a series of meetings with senior people involved in clinical research in Australia. These engagements were extremely enlightening and positive in so many ways.

We now, have a number of things, that stemmed from these meetings, in the pipeline, the first of which is the development of a generic Participant Information Sheet and Consent form (PISC).

The current problems associated with the PISC were raised at every meeting. Bellberry intends to collaborate nationally and consult widely with all stakeholders to develop a generic document, that provides information relevant to all trials, and broker it to an acceptable national standard and in many formats.

This document would be given to all clinical trial participants. A shorter document containing information specific to the trial would also be required.

I intend to keep you informed of this and other initiatives we take in the future.

Imelda Lynch, CEO, Bellberry Limited.

Posted in Bellberry Community, Company News, From Our CEO, HREC News

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