IRB Changes
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Section Identified Issue

07 Special Considerations Sec 7.7: Is there potential this protocol
could bring financial benefit to the investigators and/or University?
Rupa will contact Technology Transfer office

08-3 Subject Recruitment Sec 8-3.4.1 - As this is deemed "cold
contact" meaning the study team does not have a relationship with
potential subjects, it is suggested that the use of postal mail as
another means of initial recruitment in addtion to the e-mail contact
and also give potential participants an opt-out option. Jenna, Sec
8-3.6 (online survey): Add the study#, add "research" before "survey"
in the first sentence, add IRBMED phone #, inform partcipants that
they may skip questions they do not wish to answer, give participants
an opt-out within this document: if you do not wish to participate
please send and e-mail to * to avoid future contact for this study..
Jenna, Sec 8-3.6 (structure interview): Add the study#, add "research"
before "survey" in the first sentence, add IRBMED phone #, particpants
need to be told about the video taping of interview, Jenna Sec 8-3.6:
Add a phone script that will be used as a possible recruitment tool.
Rupa will do phone script

10-1 Informed Consent Documents Oral consent form: Add "research"
before "survey", add "there are no known risk" Jenna, , Written
consent form: format to the 9/07 template: for example section 4 needs
to be broken into 3 different sections. As interviews will be video
taped, separate line to consent to the taping needs to be added.
Please refer to: http://www.med.umich.edu/irbmed/ict/Standard_ICT.doc
to make the appropriate formatting changes. Rupa can you do this? I
built it based on their template... maybe an old one?

13 Subject Payments Or Other Incentives FYI: U-M is a Qulified
Organization and can follow streamlined procedures for conducting a
raffle without a license: 1-No presale of tickets, 2- One drawing per
day and the vallue of the prize or prizes is $100 or less, 3-No second
chance drawings allowed.

31 Audio visual material for Casepedia repository application
protoypes developed for the design and development of a case report
tool. is required

31 Watching/Listening to Audiovisual Materials Needed Jenna.