From: Crescenzi, Terrie
Sent: Monday, November 06, 2006 10:10 AM
To: Tinch, Latroy D
Subject: FW: 71 Fed Red 51143-511-46

 Hi Latroy,

Here is a comment that was sent directly to me and should be posted to the docket.

I looked for the transcripts in the docket but did not see them yet.  Are they posted in the docket or on some other site?

Thanks,
Terrie

-----Original Message-----
From: Jennifer Phillips [mailto:revjphillips@earthlink.net] 
Sent: Wednesday, November 01, 2006 4:12 PM
To: Crescenzi, Terrie
Subject: re:71 Fed Red 51143-511-46

I am an IRB chair at the University of RI. I have over 20 years' 
experience on IRBs in 5 different institutions in 3 states, and I 
happen to be nonscientist (clergy).
I want to comment about the issue of Community Consultation. I suspect 
that if our university Research Office were to attempt to quickly 
convene a meeting of community people to make a determination about 
emergency clinical research without prior informed consent, community 
reps would be found by personal connection with URI staff, and by 
choosing a few community leaders. My expectation would be that these 
people might have a substantially different reaction to such a study 
than "average" community members, especially non-college educated ones, 
and members of minority groups who are under-represented among leaders 
and URI staff and faculty.
It is not easy to summon "the public" to a meeting, and most people 
would assume such a study would have nothing to do with them or their 
families -- until they found they had become subjects during emergency 
care. I suspect then that the anxiety and anger at being uninformed 
might add to the suspicion and mistrust many people already direct 
toward scientists, doctors, and even toward university people.

The maximum public exposure might be achieved via very large display 
ads in local newspapers - though again, only the more literate read 
these. There are many people in this country who don't read newspapers 
or read at all. TV ads might be more effective, if far more expensive.

  I have major misgivings about emergency clinical studies that involve 
any substantial risk - if researchers lose the goodwill of the public 
they may never get it back! I have read about plans to test blood 
alternatives in ambulance care in Britain, and I know that even as a 
well-educated person with some knowledge about such things, I would be 
outraged if I or a member of my family was given without knowledge or 
consent  a blood substitute that had not been thoroughly tested and 
found to have no greater risk than blood - and they suffered a reaction 
or injury.

Trust is a most precious commodity in the community that, once lost, is 
very hard to rebuild. It should not be risked if there is any other way 
to provide good care to patients who become research subjects in their 
most vulnerable hour. It may be that once in a great while there is 
simply no other means of providing care  but via an investigational 
drug, procedure, or device in an emergent situation. The blood 
substitute studies I have read about do not fit that criterion, but 
seem a fast track way to do research to bring a product to market that 
should first be tested in non-emergent, or at least consent-capable 
situations.
Yours sincerely,
The Rev. Dr. Jennifer M. Phillips