NAVREF UP TO DATE - August 27, 2003

TO:  NAVREF Members
FROM:  Barbara West, Executive Director

1. Adverse Events Notification Clause in CRAs
2. NAVREF 2003 Fall Workshop
3. NIH Add On
4. NPCs and HIPAA
5. Governance Training
6. ORD Town Hall Today

As detailed in the February 24, 2003, NAVREF Update, NPCs should include in all clinical research agreements (CRAs) for industry sponsored studies a clause requiring prompt reciprocal notification between the sponsor and the NPC (generally the “Institution” in the agreement) of any study findings that could affect patient safety.

Among other requirements, FDA regulation 21 CFR 312.32 specifies that the study sponsor must notify the FDA and all PIs of any adverse experience associated with a new drug that is both serious and unexpected. However, there is no FDA requirement to notify the institution administering the study. To ensure full disclosure of such adverse events, NPCs are strongly encouraged to include in CRAs a clause requiring prompt reciprocal notification among all parties.

A sample clause was provided in the February 24 update and on the NAVREF web site. This has been fine-tuned with the assistance of the VA NPC Program Office, George Tady, counsel for the Seattle NPC, and Rich Ciamacca, senior contracts manager at Vicuron Pharmaceuticals, Inc.

Please make note of the new sample clause which has also been added to the NAVREF web site at http://www.navref.org/legal/main.htm#Sample Clinical Research Agreements:

Experience to date indicates that pharmaceutical companies readily accept including this requirement for mutual notification in CRAs.

Registration materials for the workshop on Best Practices in Clinical Research Agreements were mailed to NAVREF members on August 11. Please complete and return the yellow form by Wednesday, October 8, 2003, to qualify for the regular registration rate. The same information and a downloadable registration form are also posted at http://www.navref.org/development/main_fallseminar.htm. Plan to join your colleagues in San Antonio, Texas, on November 3 and 4 for in-depth discussion of clinical research agreement negotiations and NPC administration of projects!

Discussions between VA and NIH regarding reimbursement to VA of costs associated with NIH-sponsored research conducted in VA facilities appear to have reached a standoff. Dr. Wray and NIH Director Elias Zerhouni, MD, met in early July to discuss VA’s request for such reimbursement. However, rather than a positive resolution, the meeting appears to have resulted only in restatement of NIH’s position in opposition to reimbursement for VA facilities and administration (F&A) costs.

In a July 25 follow up letter to Dr. Wray, Dr. Zerhouni affirms that NIH will continue to allow VA investigators to receive NIH support for their university salaries in proportion to their NIH- funded university projects. Also, NIH will continue to reimburse universities at their off-campus rates for projects involving VA sites. However, Dr. Zerhouni states that NIH considers the DHHS policy prohibiting agencies from reimbursing facilities and administration costs on grants to federal institutions to be “prudent and sound.” He maintains that “to reimburse the VA for F&A for its infrastructure would amount to double paying at the taxpayers’ expense, since VA receives funds appropriated by Congress.” The letter is available at http://navref.org/newsletter/pdf/Zerltr.pdf and a similar restatement of NIH policy has been issued on the NIH web site at http://grants1.nih.gov/grants/policy/va_fa_costs.htm

Despite this setback, the House and Senate Committees on Veterans Affairs are anticipated to press NIH and VA to reach an agreement on equitable cost sharing between VA and NIH. Congress appears to view the issue narrowly, perceiving that VA funds spent in support of NIH funded research conducted in VA facilities – estimated between $50 to $100 million – detracts from funds available for veterans’ care. As the FY 2004 outlook for VA medical care funding looks increasingly grim and veterans spend many months on waiting lists for their first VA appointments, legislators are seizing on every item that could maximize the funds available for veterans’ care. NAVREF is exploring ways to present this issue more positively and will provide updates when there are new developments.

After careful review of HIPAA regulations, NPC operations and their relationships with VA, in consultation with NAVREF, ORD Privacy Advisor Patricia Watts has concluded that generally NPCs themselves are not likely to be "covered entities" for purposes of HIPAA in regard to their research activities. Nor do the NPCs fall under VA's single covered entity approach to HIPAA.

However, to minimize NPC exposure to the Privacy Rule requirements and risk of noncompliance:

• All NPC employees should have VA WOC appointments.
• Other than for the purposes specifically permitted by the patient, use of protected health information (PHI) by NPC employees should be in connection with their responsibilities regarding VA approved research.
• NPC use of PHI should be only for purposes specifically permitted by the individual patient, such as to facilitate subject payments and/or billing for tests or services performed by non-VA entities.

Study human consent forms and HIPAA authorization forms signed by patients should specifically name the NPC as an entity to which PHI may be disclosed for specific purposes, such as for subject payment and/or non-VA billing.  If the NPC is named as a recipient of PHI in these forms, there is no need to establish a Business Associate Agreement (BAA) between an NPC and its affiliated VAMC for purposes of sharing PHI.

NPCs receiving PHI must take steps to ensure that it is maintained in accordance with Privacy Rule and VA requirements.  NPC personnel must undergo VA Privacy Rule training so as to become familiar with appropriate administration of PHI. 

NPCs are encouraged to examine their individual operations and consult with local VA compliance personnel to determine whether they may have HIPAA responsibilities that have not been anticipated by NAVREF. To the extent possible, NPCs should take steps to eliminate instances when they may inadvertently find themselves responsible for PHI.

As employers, NPCs may incur responsibilities under HIPAA that are separate from research. NPCs that sponsor a health insurance plan, employee assistance plan, flexible spending accounts, dental or vision plans may have new responsibilities under HIPAA. NPCs are encouraged to work with their insurance companies and plan providers to determine their responsibilities, establish policies to minimize their exposure to PHI and train their employees as appropriate. Employers with “small health plans” – annual gross receipts of less than $5 million – have until April 14, 2004, to comply with the privacy regulations. Failure to comply with HIPAA carries civil and criminal penalties, including fines ranging from $100 to $500,000 and 10 years in jail.

Seventy-three medical center directors, associate directors and chiefs of staff attended NAVREF’s July 29 two hour training session on NPC governance. Many thanks to all who encouraged senior VAMC personnel to attend. As NAVREF board members Jacqueline Parthemore, MD, COS at San Diego, and Bill Montague, MCD at Cleveland, discussed the ten basic responsibilities of board members, attendees asked questions and shared their own experiences as NPC board members. A handout listing a few governance “best practices” elicited particular interest. The checklist is posted in the NAVREF Best Practices Program section on Governance at http://www.navref.org/bestpractices/main_Governance.htm

Participants expressed an interest in receiving more information about NPC governance and administration. As a result, from time to time NAVREF may send a copy of particularly relevant information directly to MCDs, but will continue to rely primarily on the designated NAVREF NPC contact to distribute emails and hard copy mailings to board members as appropriate. It was clear from the Chicago session that board members want more information, not less, so executive directors are encouraged to disseminate NAVREF notices more broadly than they may have in the past.

Chief Research and Development Officer Nelda Wray, MD, has established an objective of making governance training available to NPC boards during 2004. NAVREF has been invited to collaborate on this effort and will be working closely with the VA NPC Program Office to develop the content and a convenient means of delivery.

Dr. Wray will conduct a national videoconference town hall meeting today, August 27, from 2:00 p.m. to 3:30 p.m. Eastern time. NPC personnel may wish to coordinate with the facility research office to tune in to VAKN Channel 2. Open phones will be available from 3:00 –3:30 . To ask a question, dial 202-273-9112.