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exemptions for th<strong>in</strong>gs that require prior review. There<br />

would be very serious work <strong>in</strong>volved, I believe, <strong>in</strong><br />

design<strong>in</strong>g appropriate exemptions. If you th<strong>in</strong>k about the<br />

def<strong>in</strong>ition broadly applied to all activities the current<br />

def<strong>in</strong>ition of research you could arguably -- you would<br />

encompass many activities of poll<strong>in</strong>g organizations, market<br />

research, arguably some forms of journalism, as well as the<br />

th<strong>in</strong>gs that are obviously considered research. The k<strong>in</strong>ds<br />

of th<strong>in</strong>gs that are of the most concern. For example, some<br />

of the <strong>in</strong> vitro fertilization cl<strong>in</strong>ics and diet cl<strong>in</strong>ics.<br />

Some of the th<strong>in</strong>gs that you immediately th<strong>in</strong>k of when you<br />

th<strong>in</strong>k of as unregulated research, health services research,<br />

<strong>in</strong>ternal evaluation research, corporations that are look<strong>in</strong>g<br />

at how do their employees like one th<strong>in</strong>g or another about<br />

the company. There are a whole variety of th<strong>in</strong>gs that<br />

could be encompassed under the current def<strong>in</strong>ition.<br />

So exam<strong>in</strong><strong>in</strong>g carefully the prospect of serious<br />

harm, how small is it, is it small, versus the cost of<br />

regulation is I th<strong>in</strong>k the most press<strong>in</strong>g important issue. I<br />

th<strong>in</strong>k that one could design appropriate exemptions with<br />

appropriate work but that raises a second category of<br />

practical problems which I have to tell you is really<br />

hang<strong>in</strong>g me up.<br />

Who determ<strong>in</strong>es the applicability of the

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