Any thoughts on the still (to me) unclear definition of “investigator”?

 

“…regardless of title or position, who is responsible for the design, conduct, or reporting of research… which may include, for example, collaborators or consultants”

 

How deep or broad does responsibility go? 

 

KEY persons are those who “contribute to the scientific development or execution of a project in a substantive, measurable way” and we all know that some PIs consider some postdocs (and senior technicians?) as key…and some do not!

 

Charlie

 

From: Research Administration List [mailto:xxxxxx@lists.healthresearch.org] On Behalf Of Stroud, Suzanne
Sent: Tuesday, April 17, 2012 3:26 PM
To: xxxxxx@lists.healthresearch.org
Subject: Re: [RESADM-L] NIH FCOI implementation of new reg (8/24/12)

 

Please see something very helpful that NIH published last Thursday.   This is NIH’s updated checklist for the FCOI policy implementation.  There is no mention of JIT or limiting it only to JIT stage.

 

http://grants.nih.gov/grants/policy/coi/checklist_policy_dev_20120412.pdf

 

According to the regs via 42 CFR 50.603 it will be required that only the investigator must disclose SFI that may impact the investigator’s institutional activities one of three options:

·         In preaward at the time of the proposal submission or

·         in postaward annually during the period of the award

·         Or within 30 days whenever a new SFI is realized.

 

Don’t forget this applies to all (y)our subawardees also, so will impact pre- and post-award in how you handle contract certification.  Some suggestions have been to have a certification statement in the Letter of Intent from our subs that carries through to the post-award contract stage. Consultants can provide a certification at the proposal stage if the individual has been identified.

 

 

So whatever is decided at your institution to implement a process to adhere to the reg, it is written in the CFR that you must have a system organized enough to deliver responses to HHS immediately:

 

Agrees to make FCOI and SFI information (including related Institutional reviews and determinations) available to HHS, promptly, upon request …”

 

 

 

Suzy

 

Suzanne Stroud, CRA, CPRA

Sr. Research Administrator, Post-award
Office of Contracts and Grants

Division of Research

University of Houston

xxxxxx@uh.edu

713-743-9626

                        

Description: Description: Description: Description: cid:image007.png@01CC29E9.D452B290

 

 

 

 

 

 

From: Research Administration List [mailto:xxxxxx@lists.healthresearch.org] On Behalf Of Cindy Fuqua
Sent: Tuesday, April 17, 2012 1:52 PM
To: xxxxxx@lists.healthresearch.org
Subject: [RESADM-L] NIH FCOI implementation of new reg (8/24/12)

 

Dear Resadmins,

 

Can you please share how the FCOI-regulation required certification will be coordinated by your pre-award offices for new and competing awards? Will such certifications be triggered at Just-in-Time typically, for example?

 

Many thanks!

 

Cindy Fuqua

Manager, Administrative Post-Award

Sponsored Research and Program Development

The Rockefeller University

1230 York Avenue, Box 82

New York, NY 10065-6399

t: 212-327-8055

f: 212-327-8400

e: xxxxxx@rockefeller.edu

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====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.healthresearch.org (click on the "LISTSERV" link in the upper right corner)

A link directly to helpful tips: http://tinyurl.com/resadm-l-help ======================================================================

====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.healthresearch.org (click on the "LISTSERV" link in the upper right corner)

A link directly to helpful tips: http://tinyurl.com/resadm-l-help ======================================================================