Also, not all of the federal agencies that have codified the Common Rule
have uniformly adopted the subparts only subpart A.

If you are receiving funding other than from PHS or NIH ("45 CFR 46"), you
need to review the Common Rule for that agency.

For instance, the FDA regulates human subjects research for any drug,
biologic or devices that will seek approval from the FDA, 21 CFR 50 & 56
which does not mirror exactly 45 CFR 46.

If human subjects research comes under the purview of more than one Federal
Agency you must comply with both sets of rules including the subparts.

Deborah Everds, JD
Northwestern University

312 503 4334

>Date:    Mon, 12 Jun 2006 21:57:17 +0000
>From:    Robert Bienkowski <xxxxxx@ATT.NET>
>Subject: Re: Common Rule
>
>Each of the 20 or so federal agencies that have adopted the common rule
>has issued its own set of regulations articulating the CR. So, while many
>of us are funded by HHS and cite 45CFR46, it is would be politic to cite
>those regs that are specific to your own funding agency.
>Also, be careful about research with subjects who are not covered by
>45CFR46 Subpart A. Thus, if your research involves children or prisoners,
>which are covered in other subparts of 45CFR46, you have to look to your
>funding agency for specific guidance.
>
>--
>Robert S Bienkowski, PhD
>xxxxxx@att.net
>

======================================================================
 Instructions on how to use the RESADM-L Mailing List, including
 subscription information and a web-searchable archive, are available
 via our web site at http://www.hrinet.org (click on "Listserv Lists")
======================================================================