on behalf of Sarah M. Smith [firstname.lastname@example.org]
Sent: Thursday, September 13, 2012
Cc: Crystally Wright;
'email@example.com'; 'firstname.lastname@example.org'; 'Gibbs, Patricia'; 'email@example.com'; 'firstname.lastname@example.org';
'email@example.com'; 'firstname.lastname@example.org'; 'email@example.com';
Subject: [Uncga_compliance] Compliance
Breakout Session Discussion Points
You are getting this email because you either signed up for
in-person attendance or teleconference for the Compliance Breakout Session at
the SPARC meeting on Monday and/or you’re on the UNC Compliance List
Serve. The call in number for the Compliance Breakout Session is
919-962-2733. For those attending in person, the session will be in
conference room C.
Please see the following set of questions/topics from the
session leaders, John Chinn and Julie Taubman. Please come prepared to
discuss these within your campus implementation setting:
Questions for Compliance Breakout Session - September 17th
- Subcontracts -
- How are you handling those institutions that
do not have a COI policy that conforms with PHS regulations?
- How do you grant access to your training and
disclosure system by external organizations?
- A subcontract does not fund personnel but
funds supplies, travel, equipment, etc, do you require training and
disclosure for the subcontractor?
- Does the subcontractor's PI meet the definition of an
investigator/person responsible for the design, conduct or publication of
the research when the subcontractor only provides supplies, travel,
- Scholarships -
- For PHS agencies that fund scholarships to
the university, does the PHS COI regulations apply to recipients of
- Scholarships are typically for tuition, books, and
other expenses related to the educational expenses of the scholar.
An example are HRSA scholarships. NIH training grants (K, T, and F
series) have a expectation of research. But if the expenses are
used only for educational purposes (tuition, benefits, and travel to
meetings), is the HRSA or NIH scholar subject to PHS COI regulations?
- Personnel -
- If your policy only applies to PHS funded personnel,
how do you account of for those employees who were on August 24th not
funded by PHS but are later placed on a PHS grant?
- What mechanism do you have in place to capture
personnel who are transferred in and out of PHS accounts?
- Public disclosures -
- As public universities, how are you processing
the disclosures through your legal office so that it complies with
state personnel records regulations and public disclosures?
- Are disclosures and COI management plans shared with
Sponsored Programs, IRB, and other university offices?
- Workload -
- What percentage of those PHS funded employees
who made a disclosure reported a COI?
- How will that impact on the
- Who will develop the COI management plan?
- How will you assist the PI in reporting the
COI in their annual report to sponsor?
- Travel disclosures -
- How are you handling the travel
- What criteria will be used to determine if the
travel is problematic and require action by the university?
- Resources -
- What resources have been provided to you to comply
with the additional PHS requirements?
- If no additional resources were provided, what got put
- Who is handling COI on your campus?
- Is research COI handled differently than
- Your experience so far -
- What war stories do you have about complying with the
PHS COI regulation?
- Non COI discussion topics – Data security, HIPAA
compliance, and HiTech regulation
- Has your IRB or university developed guidance for data
- What encryption program do you use?
- Do you require personal laptops to be encrypted or
have encryption capabilities?
- What do you do to secure PHI and SSN and comply with
HIPPA and HiTech regulations?
The intent of these questions is to trigger discussion and perhaps
lead to other related questions so that we can all learn from each
other. Please bring other questions that you may have about the PHS
COI regulations and compliance issues that was not covered in this advance
list. If you have advance questions that you want to have discussed at
the compliance break out session, send them to John Chinn (firstname.lastname@example.org) or Julie Taubman (email@example.com).
Thanks. John Chinn and Julie Taubman.
Director of Sponsored Programs
UNC General Administration
910 Raleigh Road
Chapel Hill, NC 27514
(919) 962-4557 - phone
(919) 843-4942 - fax
(919) 698-8434 - cell