Hospitality Expenses on Clinical Trials

[ca...@umn.edu]

Can a sponosred clinical trial be charged for costs related to a blind-reveal event? According to some of the subcontracting hospitals on this particular study, in the past, they have had great success with hosting a blind reveal event, an event that discusses outcomes of a clinical trial and also informs subjects whether they received the placebo or drug. My PI is interested in hosting one at the close of one of her trials.

Hosting such an event would depend on HIPAA compliance, but in the case that it is, could food, location, and supplies be charged to the grant (a fixed price, no rebudgeting restrictions)? This is a federal pass through.

[krz...@umn.edu]

No, this would not be an allowable cost.

[ca...@umn.edu]

Can you expand a little on why this is an unallowable cost? Our intent is that these discussion boards can be used as educational opportunities as well, so some additional background/policy reference might be useful to the anonymous poster.

Thanks so much for your feedback.

[march016]

Hi all,

Judy was having trouble replying to the thread so she sent me her response to post.  I'm posting her response below but I also wanted to thank the original poster for sending us the question.  It was a good one.  Judy's response:

This cost was not specific to the aims of the study and in addition Federal guidelines (NIH):

Entertainment Costs

Unallowable. This includes the cost of amusements, social activities, and related incidental costs.

Meals

Allowable for subjects and patients under study, or where specifically

approved as part of the project activity, provided that such charges are not duplicated in

participants’ per diem or subsistence allowances, if any.

When certain meals are an integral and necessary part of a meeting or conference

(i.e., a working meal where business is transacted), grant funds may be used for such meals

only when consistent with terms of award.

The cost of meals served at a meeting or conference, for which the primary purpose is

the dissemination of technical information, is no longer allowable on NIH grants where

the primary purpose of the grant is to support a conference or meeting (see also

Support of Scientific Meetings (Conference Grants) Section 14.10.1). However, when

such a meeting/conference is an ancillary effort under a grant where the primary

purpose is other than to support such a meeting/conference, then the cost of meals

would be allowable. When allowable as a direct charge, the cost of any meal must

meet a test of reasonableness. However, recurring business meetings, such as staff

meetings, should not be broadly considered as meetings for the primary purpose of

disseminating technical information in order to justify charging meals or refreshment costs to grants.

[Jerian Lind]

David,

Can REO weigh in on the HIPAA compliance of an event like this?  I gathered more information and subjects would be invited (not required to attend).  They would learn whether they were on the drug or placebo by receiving individual sealed envelopes.  I think the biggest factor is that you would have a number of subjects in the same room all knowing they are there because they participated in a particular study.

Thoughts on this?

[march016]

I'm looking into this a little more.  I've got a call out to some folks in HRPP.  I'll post our position when I get a couple questions answered.

[march016]

Ok, I looked into this one with HRPP and this would require IRB review and approval.  So if this was not included in the original protocol that was reviewed and approved by the IRB it would be viewed as a change to that proposed protocol and would require another review.  I also agree with Judy above on the allowability of the cost.