Health and Human Services (HHS) has regulation regarding research engagement (research versus service) under clinical research. This is important because a service is a transaction that can be purchased as a vendor (billed as a service) as opposed to research where Offices of Sponsored Programs are involved. I’ve included the link to the HHS regulation – https://<https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-engagement-of-institutions/index.html>www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-engagement-of-institutions/index.html<https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-engagement-of-institutions/index.html.

Amy

Amy Sikalis

Director Research and Science

Radiology and Imaging Sciences

University of Utah

Phone: 801-581-6088

Cell: 801-209-0223

Email: xxxxxx@hsc.utah.edu

u_health_email

From: Research Administration List [mailto:xxxxxx@LISTS.HEALTHRESEARCH.ORG] On Behalf Of Blanchard, Alesia M
Sent: Tuesday, July 17, 2018 12:10 PM
To: xxxxxx@LISTS.HEALTHRESEARCH.ORG
Subject: Re: [RESADM-L] Clinical Experience Question

Hey Dave,

I’m not sure this is something that would run through your sponsored office. It sounds more like clinical experience paid via clinical revenue. You might want to reach out to your internship/graduate office to see if they have a contract for an internship you can utilize. This type of work doesn’t sound like a contract were you could gather IDC.

Hope this helps!

Alesia Blanchard, BS

Grants and Contracts Coordinator

Colorado Center for Personalized Medicine

Division of Biomedical Informatics and Personalized Medicine

University of Colorado Denver | Anschutz Medical Campus | 13001 East 17^th Place, E5C02 Building 500 | Mail Stop F563 | Aurora, Colorado 80045-2570

xxxxxx@ucdenver.edu | (303) 724-0567 (office)

CCPM Logo Red-Gray.jpg

From: Research Administration List <xxxxxx@LISTS.HEALTHRESEARCH.ORG> On Behalf Of Dave Harris
Sent: Tuesday, July 17, 2018 9:26 AM
To: xxxxxx@LISTS.HEALTHRESEARCH.ORG
Subject: [RESADM-L] Clinical Experience Question

Good morning fellow list-servers - "long time listener/first time caller"

We have a scenario we hope to get some feedback on:

A professor, the director of clinical studies in our Psychology Department, places graduate students in external clinical and hospital sites for supervised clinical counseling experience. The clinical sites pay our university, and we in turn pay the students, cover the fringes, and the other associated costs such as malpractice insurance, etc.

Question 1) Would these types of agreements run through your Office of Sponsored Programs or equivalent?

Question 2) If they do run through your OSP, would they recover full (or partial) IDC?

Question 3) If they don’t run through your OSP, do they run through the university at all or do you simply defer to the clinical site hiring the student directly?

We are running into resistance from our faculty member with the recovery of any IDC's on this and similar projects. His take is that no other university is collecting IDC and that many are not running them through their OSP offices.

Thanks in advance for any and all responses!

--
Dave B. Harris
Assistant Vice President for Research
Sponsored Programs & Support
Office for Research
Idaho State University

1651 Alvin Ricken Drive, Suite 116

STOP 8046
Pocatello, Idaho 83209-8046
(208)282-2592 fax(208)282-4723
https://www.isu.edu/research

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