TO:  MCWIRB Members
 RESADM Members

During a lively meeting yesterday, our IRB asked me to seek input from
MCWIRB and RESADM members on several policy issues.  Please take a few
moments to answer the following questions.  You may send your reply
directly to me and I will post a summary of responses on both lists.

1.  Has your IRB officially adopted Subparts B, C, and D of 45 CFR 46
(special protections for pregnant women and fetuses, prisoners, and
children, respectively) for **ALL** human subject research, not just
subjects involved in Federally funded research?
_____ Yes
_____ No
COMMENTS:

2a. If an investigator proposes recruitment of subjects through another
organization (daycare center, public school, another college, etc.), do
you require letters of permission/cooperation signed by a responsible
person (director, principal, etc.) at that organization?
_____ Yes
_____ No
COMMENTS:

2b. If yes, does your IRB require the investigator to submit copies of
these letters before approving the protocol?
_____ Yes
_____ No
COMMENTS:

2c. If yes, if the investigator plans to recruit subjects from two
different external organizations (for example, two public schools) and
has secured a letter of permission/cooperation from only one, does the
IRB allow the investigator to begin recruiting from that one
organization while waiting for the letter of permission from the second
organization?
_____ Yes
_____ No
COMMENTS:

3a.  My office has the ability to scan IRB applications and distribute
them to IRB members electronically for review prior to the IRB
meeting--which saves us a bunch of photocopying and mailing effort. Are
we breaching confidentiality (the investigator's) by putting this on the
email system?
_____ Yes
_____ No
_____ Uncertain
COMMENTS:

3b.  If you think confidentiality is a problem in emailing IRB
applications to members for review, does encryption of the message solve
the problem?  (It is my understanding that the latest version of
Netscape allows encryption of an email message so that only the specific
addressees of the message can decrypt it--although this is done
automatically for them by Netscape at their end.)
_____ Yes
_____ No
_____ Uncertain
COMMENTS:

3c. If you think confidentiality is a problem in sending protocols by
email to IRB members for review, is there any problem with
confidentiality in developing a system by which investigators can
electronically submit their IRB applications to the sponsored programs
office?
_____ Yes
_____ No
_____ Uncertain
COMMENTS:

Thanks for your help!

Barbara

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Barbara H. Gray                      Telephone:  803-953-5673
Director of Sponsored Programs       Fax: 803-953-6577
College of Charleston                email:  xxxxxx@cofc.edu
Charleston, SC  29424                http://www.cofc.edu/~osp
(Location:  407G Bell Building)
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