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November 7, 2011

NOTES of DEC/EC Meeting
Monday, November 7, 2011

Items for Discussion/Presentation

1. Questions from last DEC/EC meeting?

2. SGEs and Committee Management

  • Justification for Waivers
    1. Confirm that information used to justify the waiver (usually from appointment document) is still accurate
    2. Read the entire waiver, especially if another waiver was used as a model
  • Changes in financial interests
    1. If a stock was sold, employment has changed or the term as an officer position has been completed, revise the recusal list (consider whether a covered relationship is now created (if yes, insert one-year cooling off period expiration date)), and make a note in the file. 
    2. No need to amend the waiver when a financial interest changes. 
  • SAO Sector Funds and De Minimis Value
    1. Note:  underlying assets of healthcare sector funds are nearly all pharmaceutical and biotechnology companies.  Ownership above the de minimis likely creates an insurmountable conflict.
    2. Confirm value of all SAO funds owned or imputed to the filer.
    3. If aggregate value is above de minimis ($50,000), SGE will likely have to sell some of the fund(s) to get value of asset(s) below the de minimis.  Recusal will likely not work because the conflicting assets are so numerous (all SAO stocks).  Resulting disqualification would be from so many matters that it would preclude the SGE from having any meaningful participation on the Committee.


3. Revised NEAC Jurisdiction Policy and Employee’s DEC

  • This policy does not change who is the responsible DEC.
  • Revised NEAC Jurisdiction Policy allows Presumed Approved activities that, but for this policy, would go to NEAC (because senior employee’s activity or salary threshold met), to be approved by employee’s DEC without NEAC review.  So
    1. Activity within NEAC’s jurisdiction is reviewed by NEAC and approved by NIH DEC in the first year.
    2. Years two and three approved by employee’s DEC (IC DEC for non-senior employees and NIH DEC for senior employees) without NEAC review.
    3. Year four back to NEAC for review and NIH DEC’s approval

4. Awards Criteria

  • Selection criteria need to be more than “did you look at the number of manuscripts published by the awardee”
  • Please stop suggesting this kind of criteria to organizations
  • Need to ask how organization distinguished among candidates, e.g, was the successful candidate selected as award winner because, for example, his research was the most groundbreaking, had the largest impact on the field, or was the most novel.  A copy of ranking form or score sheet is very helpful, if such a form or sheet is used.

5. IC SOP re:  Gifts of Grants

  • Traci Melvin, NIDDK DEC, asked if ICs have a standard procedure for receipt of gifts of grant money. 
  • Please send comments to Traci.

6. Case Studies

  • Gifts:  Qs & As in OGE handout: Pamphlet entitled Gifts Between Employees (June 1998) (pdf, 8.5" x 14" landscape format)
  • PI submitting an official duty manuscript to a journal which is edited by the PI submitting the manuscript
    1. While an Editor in Chief creates a section 208 relationship (he’s viewed an employee of the journal), the particular matter (the manuscript) would not have a direct and predictable effect on the journal’s financial interest.  No one manuscript would. 
    2. The relationship should be viewed as a section 2635.502.  Need DEC determination whether the PI/Editor needs to be disqualified from the specific party matter (submitting a manuscript to the journal) because a person (the journal) is a party to the matter.  Here, the DEC determined no recusal necessary.  DEC felt that PI should be involved in determining to which journal the manuscript is submitted. 

Posted 2/3/12