FULL BOARD REVIEW

All research studies that involve more than minimal risk to the subjects requires a full-board review by the IRB.  Some examples of these types of studies are prospective drug trials, comparisons of surgical techniques and surveys which involve invasive questions.  The GRMERC Research Department assists residents and faculty with every step of the process for submitting a study for full-board review.  The processes for full-board review

for Spectrum Health and Saint Mary’s Health Care IRBs are described below.

Spectrum Health:  The Spectrum Health IRB meets on the first Tuesday of every month at 6:00 pm in the Meijer Heart Center.

The deadline for submitting a protocol is at 5:00 pm on the first Wednesday following the previous month’s IRB meeting – click here for a list of meeting and submission dates.

Saint Mary’s Health Care:  The Saint Mary’s Health Care IRB meets on the 4th Monday of every month at 12:15 pm in the Wege Center.

The deadline for submitting a protocol is four weeks prior to the IRB meeting.

Steps for full-board submission for both institutions are similiar to this:

           1.  Pre-review process - once your study is submitted it

                will undergo a pre-review of study materials (e.g., scientific

                merit, statistical design, informed consent).

           2.  The comments from these reviewers will be forwarded to you.

                Each comment will need to be addressed before your study will be

                put on the agenda.  This may seem overwhelming, but GRMERC

                Research Department has experience in responding to reviewer

                comments and is available to assist investigators through this

                process.  Just forward the emails to research@grmerc.net for

                guidance.

           3.  Pending any unforeseeable issues, you will receive an email

                invitation from the IRB to attend the meeting and present your

                project.  This is a 2-3 minute overview of your study delivered

                verbally (no ppts or handouts).  Note: Residents must be

                accompanied by one of the faculty authors on the project.

           4.  After your presentation IRB members are given an opportunity to

                ask study related questions.  This usually lasts about 5-10

                minutes.  You will then be asked to leave the room and the IRB will

                vote on your study in closed session.  An email notification of your

                approval will be sent.

We know that this type of submission may seem intimidating, but we want to emphasize that we are available to assist investigators throughout every step of the process for full-board review.