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They would certa<strong>in</strong>ly want fair and consistent<br />

enforcement of the regulatory compliance authorities. I<br />

have added here, but you probably cannot read it, <strong>in</strong>clud<strong>in</strong>g<br />

feedback to the regulated entities on the pitfalls to be<br />

avoided. If entities are <strong>in</strong> noncompliance we owe them and<br />

other entities an explanation of why that is the case and<br />

try to put <strong>in</strong> some corrective measures.<br />

And then I th<strong>in</strong>k another goal would be to have<br />

actions aga<strong>in</strong> consistent with promot<strong>in</strong>g protection of human<br />

participants <strong>in</strong> an as a political a manner as possible.<br />

Try to keep it shielded from politics and other goals that<br />

divert us from really protect<strong>in</strong>g people who are <strong>in</strong>volved <strong>in</strong><br />

research.<br />

Lastly, I th<strong>in</strong>k the regulated entities would<br />

have some expectation of m<strong>in</strong>imization of paperwork and<br />

other adm<strong>in</strong>istrative burdens consistent with the<br />

accomplishment of protection goals. I also th<strong>in</strong>k an<br />

important goal to preserve is decentralization and hav<strong>in</strong>g<br />

decisions made at the local level and the benefit of<br />

understand<strong>in</strong>g the local milieu so that there was not a big<br />

centralized group that would dictate but that would have an<br />

open system that would ebb and flow and collect <strong>in</strong>formation<br />

and develop policies and procedures that could be<br />

applicable but would help from the local perspective.

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