|
IRB Rates effective September 24, 2012
McLaren Health Care IRB (MHC IRB) charges for the review of research studies supported by
pharmaceutical companies and other for-profit entities.
Investigators submitting industry-sponsored research protocols are required to include in the
study budget, the cost of initial protocol review, continuing review, and sponsor initiated fullboard amendments requiring MHC IRB review.
These non-refundable fees are based on the assessment of costs associated with the protocol
review by the MHC IRB and are charged for services rendered. Because the MHC IRB office
commits its full resources to each review, the fees are due in full even if the MHC IRB does not
approve the study, participants are never enrolled, a research contract is never executed, or the
study is terminated prior to objectives being reached.
|
REVIEW TYPE
|
FEE
|
|
Initial Submission
|
$1,500
|
|
Sub-Study*
|
$500 (in addition to Initial Application Fee)
|
|
*This fee applies when one or more sub-studies accompany a new submission or when a sub-study is added to an existing
study. It is a one-time flat fee--not a per sub-study fee.
|
|
Multi-Site Review Fee***
|
$750
|
|
***This fee applies when investigators are requesting an addition of their site to a multi-center protocol already
approved by the MHC IRB. Investigators are considered a separate site by both the IRB and the FDA.
|
|
Continuing Review Submission
|
$750
|
|
Multi-Site Continuing Review Fee***
|
$375
|
|
Amendments Requiring Full Board Review
|
$500
|
|
Multi-Site Amendments Requiring Full Board Review***
|
$250
|
|
Final Reports
|
$0
|
|
Protocol Deviations / Violations
|
$0
|
|
Unanticipated Problems Involving Risk to Subjects and Others
|
$0
|
|
|