Effort on Trials based on UMN or UMN+UMP

[Andrea Johnson]

I know that departments often pay effort on industry-sponsored clinical trials based on their PI's total salary (UMN plus UMP pay).  When the UMP portion of their salary is a small percentage of their total, this doesn't have a significant effect on the percentage effort that shows up in ECRT.  Sometimes, however, the UMP portion is much larger than the UMN.

What would you do in the following situation:

UMN pay: $50K

UMP pay: $150K

Total: $200K

This PI has a large clinical trial, on which they have a steady 10% effort paid (it is part of their distribution).

10% of UMN is only $5K/year.  10% of total is $20K.  However, if we pay $20K on the trial, it's going to show up as 40% in ECRT.  The PI's only sponsored effort is on industry-sponsored trials, everything else on the UMN record is non-sponsored.

Should we:

1) Just let the PI certify in ECRT (there is no effort on federal grants), and add a note that it is really 10% effort, but based on total pay?  

2) Do a manual effort statement?

3) Something else...?

Thanks for your input!

[hage...@umn.edu]

Hi Andrea,

The problem is with your first statement -- that effort paid on industry-funded clinical trials is based on their combined U of M and UMP salary.

Per University policy, only institutional base salary can be charged to sponsored projects, and Institutional Base Salary is defined in policy as:

"The base annual compensation set by the University for an employee. It includes salary increments, augmentations and paid overtime. It does not include non-service payroll items such as awards and overload payments, nor does it include compensation for patient care activities provided through the University of Minnesota Physician (UMP) practice plan that are paid through the University's common paymaster."

Including the UMP clinical portion of their salary in a request for funding, but only certifying effort based on University salary, is exactly what got Northwestern University into big trouble a few years ago (resulting in a multi-million dollar payback and fine).

The UMP clinical practice is not part of the University and the salary that is paid by UMP cannot be included in the base salary being charged to a sponsor. If a department is doing this they are violating policy and putting the University at significant risk.

David

[Andrea Johnson]

David and I discussed this a bit offline.

I asked whether, if the PI could honestly say that they spent 40% of their UMN/non-clinical time on the trial, could we go ahead and pay them the $20K worth of salary, and they would certify 40% effort in ECRT.

Here is the response David emailed to me, copied here with his permission:

I would point the PI to the policy, which has always been pretty clear about UMP time and salary not being included in a sponsored proposal.   It can be confusing, especially if they came from another institution that had a practice plan that was part of the University (like our Vet Med clinic, for which clinical salaries are paid directly by the University and are therefore included in the University base salary).  UMP is a legally separate entity from the University and we cannot enter into contracts based on UMP salaries.  

It would be somewhat helpful in this example if the PI can truthfully certify that he spent 40% of his University appointment on the clinical trial, and if the sponsor only paid for 40% of the University base salary, but there would still be an inconsistency if, in the proposal, we said he would be providing ten percent of his time and would be charging 10% of a $200,000 salary.  This is something that should be corrected with the sponsor if the proposal indicated something other than his University base salary.

The issue would also be with whether or not he can truthfully certify that he spent 40% of his University time on the trial.  In this case it might be possible if he doesn't have a lot of other University responsibilities, such as a teaching load, but if he happened to have two more industry funded clinical trials just like this one he would need to certify 120% of his UMN time to equate to what he thinks of as just 30% of his total combined time, and then the math just falls apart.

Also, here is a link to the Effort Certification policy: http://www.policy.umn.edu/Policies/Research/EFFORTCERTIFICATION.html 

[s-w...@umn.edu]

I absolutely agree with David's assessment. We in REO spent a considerable amount of time a couple of years ago with a unit who did not understand the need to separate UMP and UMN salaries and it had a significant impact on their effort certification. In addition, there is a requirement that the balance between UMN and UMP salaries can be revised only twice per year and should be done if a significant change in investigator's obligations to one entity or the other will be changing - for example she/he will be awarded a project, taking on teaching or advising responsibilities.

[gros...@umn.edu]

I agree with the statement that we need to separate UMP and UMN salaries

Here is a better example of how to handle grant applications for faculty that spend most of their time working in clinic.
If a faculty is paid $200,000 of this $100,000 is paid for by the University and $100,000 is paid for by UMP. This means 20 hours per week are paid for by the University and 20 hours by UMP. If this faculty member is asked to work 4 hours per week on a grant their University side effort would be 20% since we can't include UMP salary or time when considering effort on a grant.

[s-w...@umn.edu]

No, this isn't the correct interpretation of the issue.

Under the scenario above, the researcher would have only a 50% time appointment with the University. If this were the case the effort would be 20%. The majority of appointments in these situations is 100% to the University and an institutional base salary which computes the pay received from the U and the amount of effort on a given project. Certifying 20% effort in this situation is inflating the actual effort to align with an outside appointment. Appointments outside the University, for such things as clinical practice (UMP) cannot be calculated as part of the UMN appointment for either institutional base salary or effort certification. They must be clearly separated throughout the application, award, and conduct of a project.

The two key factors are % time appointment WITH the University and institutional base salary (IBS) paid BY the University.

[David Hagen]

I agree with Sarah.  In most cases, individuals with appointments at both UMP and UMN have a full time appointments with each entity.  Regents policy makes this exception for individuals with appointments at UMP.  In the proposed scenario, the individual is likely being paid $100,000 for a 100% appointment with the University, and an additional $100,000 for a 100% appointment with UMP.  Despite the fact the the faculty physicians received a single paycheck through the shared Common Paymaster system, the two organizations are separate entities and the UMP activities are irrelevant for effort reporting purposes. 

You cannot think of professional effort of a Faculty member in terms of hours since they are not hourly employees. A 100% FTE in one department may put in 30 hour per week while fulfilling her professional obligations, while someone else on a 100% appointment in another department puts in 80 hours per week.  They can both be considered 100% FTEs if they are in a P&A or Faculty classification.  Effort reporting is based on the percent of time spent on a University activity (such as a research project) relative to the time spent on all of their other University-compensated activities.

David