Are you enrolling subjects at the other institutions?

If not, the answer would be no.

If so, the answer would be yes

Per the NIH research instructions:

3.2 Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site?

Select "Yes" or "No" to indicate whether this is a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site.

Judi

From: xxxxxx@lists.healthresearch.org <xxxxxx@lists.healthresearch.org>
Sent: Thursday, June 2, 2022 12:58 PM
To: xxxxxx@lists.healthresearch.org; Jeanie Neal <xxxxxx@uindy.edu>
Subject: [External] Re: [RESADM-L] HELP! NIH R01 Project/Performance Site

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Hi Jeanie,

That's a good question that I've been wondering, as well. I would think that the answer is yes, but I would like to hear others' thoughts. The reasoning is that for federal grants, especially for a clinical trial, part of the selection process both for funding by the Scientific Review Committees (SRCs) and the choice of a particular site impact the proposal package and its strength. You would only add those Co-Is and sites if you felt that they added strength/merit/capabilities to the project or trial. The site is almost as important as the investigator in some cases, I would think, if the trial is targeting a specific patient population that is most prevalent in certain regions.

Chas Dunn, MBA

Manager of Research Operations

xxxxxx@yahoo.com

Sent from Yahoo Mail on Android

On Thu, Jun 2, 2022 at 11:31 AM, Jeanie Neal

<xxxxxx@uindy.edu> wrote:

Hello. We're finalizing a proposal to PAS-20-160 (R01 Clinical Trial Required).

Our intention is this would be a single site proposal. We are the primary with Co-Is at 2 other institutions as subs.

My question is this: Does adding each of the other institutions (the subs), as "Project/Performance Sites" mean that ours is a multi-site project?

---

Jeanie M. Neal, MS | Certified Research Administrator (CRA)

Director, Office of Grants & Sponsored Programs

University of Indianapolis, 1400 E. Hanna Ave., Indianapolis, IN 46227

email: xxxxxx@uindy.edu | phone: 317.781.5766 | pronouns: she/her

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