From:                                         uncga_compliance-bounces@lists.northcarolina.edu on behalf of Sarah M. Smith [smsmith@northcarolina.edu]

Sent:                                           Thursday, September 13, 2012 11:10 AM

To:                                               uncga_compliance@lists.northcarolina.edu

Cc:                                               Crystally Wright; 'twiner@mail.ecsu.edu'; 'browne@mail.ecsu.edu'; 'Gibbs,   Patricia'; 'fatraore@mail.ecsu.edu'; 'mjrice@mail.ecsu.edu'; 'jtraynor@mail.ecsu.edu'; 'rayv@mail.ecsu.edu'; 'faubert@email.unc.edu'; 'sroberts@mail.ecsu.edu'

Subject:                                     [Uncga_compliance] Compliance Breakout Session Discussion Points

Attachments:                          ATT00001.c

 

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 SPARC meeting.

  1. Subcontracts - 
    1. How are you handling those institutions that do not have a COI policy that conforms with PHS regulations?  
    2. How do you grant access to your training and disclosure system by external organizations?
    3. A subcontract does not fund personnel but funds supplies, travel, equipment, etc, do you require training and disclosure for the subcontractor?
    4. 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, equipment, etc?  
  2. Scholarships -
    1. For PHS agencies that fund scholarships to the university, does the PHS COI regulations apply to recipients of these scholarships?
    2. 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? 
  3. Personnel -
    1. 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?
    2. What mechanism do you have in place to capture personnel who are transferred in and out of PHS accounts?
  4. Public disclosures - 
    1.  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?
    2. Are disclosures and COI management plans shared with Sponsored Programs, IRB, and other university offices?
  5. Workload - 
    1.  What percentage of those PHS funded employees who made a disclosure reported a COI?   
    2. How will that impact on the workload?   
    3. Who will develop the COI management plan?   
    4. How will you assist the PI in reporting the COI in their annual report to sponsor?
  6. Travel disclosures - 
    1. How are you handling the travel disclosures?  
    2. What criteria will be used to determine if the travel is problematic and require action by the university?
  7. Resources - 
    1. What resources have been provided to you to comply with the additional PHS requirements?  
    2. If no additional resources were provided, what got put aside?
    3. Who is handling COI on your campus? 
    4. Is research COI handled differently than non-research COI?
  8. Your experience so far - 
    1. What war stories do you have about complying with the PHS COI regulation?
  9. Non COI discussion topics – Data security, HIPAA compliance, and HiTech regulation 
    1. Has your IRB or university developed guidance for data security?  
    2. What encryption program do you use?
    3. Do you require personal laptops to be encrypted or have encryption capabilities?
    4. 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 (chinnj@ecu.edu) or Julie Taubman (taubmanjl@appstate.edu).   Thanks.   John Chinn and Julie Taubman.

 

 

Sarah Smith

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

smsmith@northcarolina.edu