I want to thank you for taking the time to review our program. I reviewed the summary
of your findings and recommendation for improving our human subject protections program. We
definitely seem to have some deficiencies. Well, no program is perfect and I was encouraged
that your IRB chairperson and members are very committed to their mission. In addition,
hiring Mr. Cash as the Director of the IRB Office was a good move. I think between that
hire and responding to my feedback, you will be in a good position to have a very strong
human subject protections program. Yes, we are very fortunate in being able to recruit
him at this crucial juncture. If it’s ok, I’d like to limit our meeting today to discussing
a few key findings. First, those needing your immediate attention and then I’ll bring
you up to date on where we are with some of the other findings and recommendations. Certainly,
we can do that. I’d like to start by discussing your needs related to space and support for
the IRB duties. The regulations require that institutions provide meeting space and sufficient
staff to support the IRB's review and recordkeeping duties. As you know I found that the IRB does
not appear to have adequate meeting space. I didn’t recognize this was a problem. They
should feel free to use the administrative conference room on this floor. All they need
to do is reserve it in advance. I’d suggest they block out a recurring time frame on the
calendar and I will ensure it’s available for all future IRB meetings. Excellent – that
was an easy fix. Where are we with the staffing? As you know, the IRB has had only one part
time position, Ms. Knowles, but she is only here 1 day a week. Mr. Cash and I discussed
this and we would like Ms. Knowles to continue to help with copying and other support services
as needed; we would like to increase her hours. And of course we now have Mr. Cash. We can
certainly allow up to 3 days a week if that’s sufficient. I think that should be adequate
for now. What about space allocation for records– what is your assessment of our needs? As we
both observed when we stopped by Ms. Knowles’ cubicle last week, the IRB records have outgrown
the space and I have concerns about whether the records are being maintained appropriately.
The HHS regulations require that the institution prepare and maintain adequate documentation
of IRB activities. When I requested certain records to review for my audit, Ms. Knowles
was not able to find all the records that the regulations require institutions to retain.
We also found that some IRB members have the official records in their offices. Oh, that’s
not good. I recommend maintaining all IRB records in one location and in a manner that
allows them to be available for review by IRB members and for inspection by others,
when needed - they should be kept in an area that can be secured in order to limit access.
I recognized last week that we have a problem with this – so do you have a particular
space in mind? I have had my eye on a room on this floor, at the end of the hall, Room
301. Apparently it is not being used except to store some old records. It would be ideal,
especially since it is next door to the conference room you are making available for the IRB
meetings. Another step you might consider is whether it would be worthwhile to use an
electronic record system, which might solve some of your storage and access issues. I
have no problem making that room available. I’ll have it vacated and cleaned– that
should only take a day or so. And if you can make some suggestions about electronic records
system I’d be glad to hear them. So what is next on your agenda? The other overarching
concern I have related to the IRB records is that, in some cases, the institution did
not appear to maintain adequate documentation of IRB activities. For example, the IRB
did not prepare and maintain adequate documentation of minutes of IRB meetings. In some instances,
it could not be determined what the IRB actually approved at convened meetings. Does the
IRB need additional training to know how to review research? That’s not clear.
From my discussions with IRB members it appears that the IRB came to appropriate decisions.
However, in some cases, the documentation was not adequate under the requirements of
the regulations at section 46.115. Among other considerations, we need to ensure adequate
documentation of what is happening at IRB meetings, as stipulated by the regulations.
As you know, Mr. Cash will be attending all IRB meetings and will be able to observe whether
the IRB is making the findings required for taking specific actions. If not, additional
training would be indicated. He will be responsible for drafting the minutes of the
meetings and will ensure that they are in sufficient detail to reflect the documentation
that is required by the regulations. We are meeting tomorrow to go over in detail
the deficiencies I observed and requirements related to the IRB meeting minutes and other
IRB records. I will leave it up to you to work with Mr. Cash on those details. Thank
you for stopping by. I’ll see you next week for an update on our progress. Thank you.