As discussed briefly by Deputy General Counsel Jack Thompson during the NAVREF Annual Conference, in November Acting Under Secretary for Health Michael Kussman, MD, and Acting General Counsel Paul Hutter jointly charged a team comprised of senior VA personnel to review the current situation in regard to CRADAs, and to propose solutions for overcoming any obstacles to timely processing of CRADAs that they may identify.

The team members are Associate General Counsel Renée Szybala and Margaret Hammond, MD, chief consultant for the Spinal Cord Injury and Disorders Service within the Office of Patient Care Services at the Puget Sound VA Health Care System and professor at the University of Washington. Also participating is Jonathan Gurland, a staff attorney in OGC Professional Staff Group III.

Since beginning work in mid-November, the team has devoted considerable effort to researching events to date, relevant statutes, regulations and policies as well interviewing a broad spectrum of knowledgeable individuals both within and outside of VA, including NPC and NAVREF personnel. On December 15, the team presented preliminary results of its work to VHA and OGC personnel. It is NAVREF’s expectation that it will take the recipients several weeks – particularly in view of the upcoming holidays - to fully review and consider the team’s recommendations. NAVREF appreciates the diligence of the team in fulfilling their charge in such a timely fashion.

The NAVREF office is receiving questions about gift giving among VA and NPC employees and NPC reimbursement for gifts. A NAVREF discussion of this topic, as well as end of year bonuses for NPC or VA personnel, is provided at http://www.navref.org/newsletter/2004/update_112404.htm. Please take a moment to review this guidance if you are not already familiar with it.

Over 10 years ago NAVREF disseminated private legal opinions that concluded that VA and NPCs are so closely related that overtime pay may be required for individuals employed by both institutions when the combined hours worked exceed 40 hours per week. Unfortunately, these opinions subsequently were erroneously applied generally rather than only in the fact-specific situations they address. Whether a VA/NPC employee is exempt or non-exempt from the Fair Labor Standards Act (FLSA) regulations regarding overtime pay for purposes of their VA or NPC position is a key factor in whether pay at the time and a half rate is required.

NAVREF guidance on joint VA/NPC employment situations is posted at http://www.navref.org/bestpractices/hr_compliance_joint.htm. This includes a matrix designed to help NPCs analyze a joint VA/NPC employee’s circumstances and to reach a determination on whether pay at time and a half is required under the federal joint employment regulations.

VA employees who are also NPC executive directors are likely to be exempt from the FLSA overtime rules for purposes of both their VA and NPC positions so the time and a half requirement for some joint VA/NPC employees probably will not apply to executive directors. Instead, NPC boards should be following the IRS regulations pertaining to executive compensation when establishing the executive director’s pay. Specific compensation guidance for NPC executive directors is posted at http://www.navref.org/bestpractices/hr_phiringterm_hiring_contract.htm.

NAVREF continues to recommend against NPCs hiring VA employees due to concerns about the risk of running afoul of anti-supplementation of pay/dual compensation statutes and regulations (see http://www.navref.org/library/VA_Physician_Pay_18USC209.htm) and the associated penalties to both the payer and the payee. NAVREF guidance is provided at http://www.navref.org/bestpractices/hr_compliance_joint.htm and http://www.navref.org/library/VA_Physician_Pay_main_page.htm

The Association for the Accreditation of Human Protection Programs (AAHRPP) requires research organizations to specify in sponsored research agreements how the parties will respond in the event of an adverse event. Clause 3.6 of the Model CT CRADA meets the AAHRPP requirements. However, NPCs should also incorporate the necessary clause in clinical research agreements (CRAs) during this interim time when NPCs are obtaining TTP waivers to use CRAs in lieu of CRADAs. The sample clause has been inserted in Clause 7 of the NAVREF model CRA found at http://www.navref.org/archive2006/Legal_Resources_default_030806.htm

As discussed in detail during the NAVREF Annual Conference, all NPCs should have an MOU with their affiliated VAMC to address NPC reimbursement to the medical center for clinical services provided purely for research purposes. Although the conference session focused on routine reimbursements, another reason to have such an MOU and additionally, to have one with the affiliated university, is to address the possibility of reimbursing VA for necessary treatment in the case of an adverse event.

Clinical research agreements and NIH policy provide for reimbursement for adverse event care, but it is incumbent on an NPC to establish an understanding on the applicable rates. Please go to http://www.navref.org/newsletter/word/Adverse_Event_Reimbursement.doc for details of a situation experienced by one NPC and a summary of an applicable VA regulation as well as NIH policy.

Theresa Azevedo, executive director of the East Bay Institute for Research and Education (EBIRE) for many years, has resigned effective in early 2007 to accept a new position with a private sector organization. Theresa has generously shared her extensive NPC and QuickBooks expertise with numerous other NPCs and has mentored newly appointed executive directors at NAVREF’s request. NAVREF wishes Theresa all the best in her new position.

Theresa’s departure leaves NAVREF without a resource to whom we may refer NPCs that have questions about using QuickBooks to manage their funds. Please send an email to amurakami@navref.org if you have experience with QuickBooks and are interested in helping out your NAVREF colleagues in this capacity.

NAVREF Chair Donna McCartney, the rest of the board of directors and the NAVREF staff wish everyone associated with the NPCs a joyful holiday season and a happy New Year.