http://www.regulatorysolutionsgroup.com/risk-management/2008/01/17/ethics-and-drug-trial-recruitment-by-health-professionals/ Manage the risks that REALLY matter Wed, 7 Jan 2009 05:20:16 +0000 http://wordpress.org/?v=2.5.1 http://www.regulatorysolutionsgroup.com/risk-management/2008/01/17/ethics-and-drug-trial-recruitment-by-health-professionals/#comment-21 Richard Page Thu, 01 May 2008 18:54:42 +0000 http://www.regulatorysolutionsgroup.com/risk-management/2008/01/17/ethics-and-drug-trial-recruitment-by-health-professionals/#comment-21 Thanks for reading and leaving your comments. Our view of regulation is that it's the method by which society manages its most serious risks. I think it's important to acknowledge that regulators have more of a supervisory role; and that regulatees are fundamentally responsible for their own actions--for operating within terms of their license, or, however compliance is measured. So the regulator is really looking for the exceptions--activities that are outside the boundaries that have been established by statute, regulation, standards, principles, ethics and, more generally, by expectations. These "expectations" are the expectations of performance: the expectations about performance held by reasonable stakeholders. Establish the expectations, make it clear to regulatees what the expectations are, and then measure the failures (and the successes) in relation to expectations. Various methods, consistent with your objectives, can be used to measure risk -- the variance from expectations. In the end, what you want is a clear/transparent, objective, consistent, efficient and effective way of evaluating the matters that come to your attention. This is a risk-based, decision-support approach to regulation. Good luck. Thanks for reading and leaving your comments. Our view of regulation is that it’s the method by which society manages its most serious risks. I think it’s important to acknowledge that regulators have more of a supervisory role; and that regulatees are fundamentally responsible for their own actions–for operating within terms of their license, or, however compliance is measured. So the regulator is really looking for the exceptions–activities that are outside the boundaries that have been established by statute, regulation, standards, principles, ethics and, more generally, by expectations.
These “expectations” are the expectations of performance: the expectations about performance held by reasonable stakeholders. Establish the expectations, make it clear to regulatees what the expectations are, and then measure the failures (and the successes) in relation to expectations. Various methods, consistent with your objectives, can be used to measure risk — the variance from expectations.
In the end, what you want is a clear/transparent, objective, consistent, efficient and effective way of evaluating the matters that come to your attention. This is a risk-based, decision-support approach to regulation.
Good luck.

]]> http://www.regulatorysolutionsgroup.com/risk-management/2008/01/17/ethics-and-drug-trial-recruitment-by-health-professionals/#comment-20 Veronica Livingstone Thu, 01 May 2008 17:25:29 +0000 http://www.regulatorysolutionsgroup.com/risk-management/2008/01/17/ethics-and-drug-trial-recruitment-by-health-professionals/#comment-20 I enjoyed your articles on risk management. However, I am interested in risk management as it relates to a self regulatory body, particularly as it relates to investigations into complaints against physicians. Can you direct or advise me on same. I enjoyed your articles on risk management. However, I am interested in risk management as it relates to a self regulatory body, particularly as it relates to investigations into complaints against physicians. Can you direct or advise me on same.

]]>