As the Compliance

World Turns

Sherrie Settle

Assistant Director, Research Compliance

October 7, 2009

Three Topics in 20 Minutes

Ready, set, go!

Something Old: Conflict of Interest

• > 22,000 records created since

January 2, 2008

• >85% “spontaneous compliance”

• < 4% require committee review

• > 40 management plans

• Most involve corporate sponsorship

• 13 FCOI reported to NIH in FY2009

Certification Pitfalls

• Investigators listed on the IPF are not working on the project or have left the University

• Investigators identified in the proposal are not listed as investigators on the IPF

• IPF Personnel changed after initial submission (e.g. faculty sponsors)

• Incorrect University directory information

• Right name, wrong person

A Note About COI and

External Activity Reporting

Conflict of Interest:

• Event-based for sponsored research, IRB protocols and technology transfer

• Annual disclosure for administrative responsibilities

External Professional Activities for Pay:

• UNC General Administration Policy

• Filed prior to activity

• Approved by Department Chair

• Expire June 30

What Activities are Exempt from

External Professional Activities for Pay

Reporting?

• Activities unrelated to area of scholarly expertise

• Activities for which no compensation is received, even if travel is reimbursed

• Service to professional associations and learned societies

• Professional review or advisory panels

• Guest lectures, paper presentations, concerts, exhibits

• Reviewing or editing scholarly publications

• Accreditation bodies

Something New: Export Control

IPF Questions

• IPF section review

• Lots of email noise, little signal

• Proposal usually is not a trigger for Export

Control issues

• Contract language, project initiation, hiring,

procurement, shipping, etc.

• Only ask for what will be used

• New questions arriving in November

So what are the questions?

And what happens to the

answers?

1) Have you signed or been asked

to sign a DD Form 2345 “Militarily

Critical Technical Data Agreement”

related to this project?

Notifies University Counsel

2) Do you anticipate that the project

work may involve sending/transporting/

transmitting/carrying any material or

equipment related to this project outside

the US (examples include: GPS,

biologicals, diagnostic kits, reagents)?

What items do you plan to ship or

transport out of the US? To what

countries?

Notifies Environment, Health and Safety at time of award.

3) Do you anticipate that the

project work may involve travel

outside the U.S?

Automatic email of international

travel considerations to PI and

business manager at time of award.

4) Transmitting funds (through

payments, for example) or goods or

technology to any of the following

countries on the OFAC list: Balkans,

Burma, Cuba, Iran, Iraq, Ivory Coast,

Liberia, Libya, North Korea, Rep. of

Congo, Sudan, Syria or Zimbabwe?

Email OFAC sanctions to PI and

Business Manager + notice to University

Counsel

5) Do you anticipate that the project

work may involve:

Non-commercial encryption or

information security software?

Any equipment, technology, materials or

software specifically designed, modified,

or adapted (even slightly) for a military

purpose or that may involve national

security?

Any classified materials, equipment,

technology or data?

Email foreign national participation

guidance + notice to University Counsel

Something Borrowed: NSF Training

Requirements

• America COMPETES Act

• Required training in Responsible Conduct

of Research (RCR) for trainees supported

on National Science Foundation awards

• Menu of training programs to meet

requirement, based on existing programs

• Training database to record completion,

modeled on human subjects training

database

NSF Training Requirements

• Applies to proposals submitted on or after

January 4, 2010

• Part of institutional official certification

• No language required for grant proposal

• No reporting (not part of progress report)

• Essential that payroll reflects work

assignment

Something Carolina Blue

Research administration and compliance:

A perfect partnership!

Questions?