ML20045B327
| ML20045B327 | |
| Person / Time | |
|---|---|
| Issue date: | 04/09/1993 |
| From: | Remick NRC COMMISSION (OCM) |
| To: | Chilk S NRC OFFICE OF THE SECRETARY (SECY) |
| References | |
| NUDOCS 9306170195 | |
| Download: ML20045B327 (2) | |
Text
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REi. EASED TO THE PDR H0TATI0N V0TE*
6g//'93 4*
w we RESPONSE SHEET T0:
SAMUEL J. CHILK, SECRETARY OF THE COMISSION FR014:
C0l44ISSIONER REl4ICK
SUBJECT:
SECY-93-050 - PROPOSED AMENDMENTS ON PREPARATION, TRANSFER, AND USE OF BYPRODUCT MATERIAL FOR 14EDICAL USE
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J APPROVED X DISAPPROVED ABSTAIN NOT PARTICIPATING REQUEST DISCUSSION C0!44ENTS:
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ea RELEASE VOTE
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7 de/ 93 DATE WITHHOLD VOTE
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ENTERED ON "AS" YES NO i
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Commissioner Remick's Comments on SECY-93-050:
5 I agree with Commissioner Rogers'. comment that the term " patient" should be used only in the conventional way, and that research subjects should be referred to as such in the proposed rule.
I would not make the modifications which Commissioner de Planque suggests be made to the proposed i 35.6, on research involving human subjects. I am not persuaded that all such research must be conducted, funded, supported, or regulated by a federal agency which has implemented the Federal Policy for the Protection of Human Subjects.
Although I would wager they are rare, it is possible that certain research providers who are NRC licensees may not be covered by the Federal Policy. However, the staff's version of f 35.6 allows such licensees to request license amendments which would incorporate the salient parts of the Federal Policy.
The Supplementary Information in the Federal Register Notice should tell readers how they can acquire a copy of the Federal Policy, so that they can more easily conunent on whether the proposed text of f 35.6 is sufficient protection for human subjects.
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