MESA Steering Committee Meeting

1. MESA Steering Committee Meeting Project Office Report September 14, 2005

2. Exam 3 • Exam 1 (7/2000 – 9/2002) N=6,814 • Exam 2 (9/2002 – 1/2004) N=6,237 (92%) • Exam 3 (9/2003 – 7/2005) N=5941 (88%)* 8/27 *as of 8/27/05

3. Exam 4 • Set target for retention • Get off to a good start • Determine ways to optimize cohort retention

4. MESA Publications Number of Manuscripts * *6 published and 2 in press.

5. Budget • Discovery of impending major budget shortfall 5-2005 • Email note to all centers 7-1 • Communications with all centers 8-1 to 9-1 • Final budget evaluation 9-2 • Feedback to all centers 9-9

6. MESA Budget StatusProposal (cuts) 7-1-05 1. Cut Exam 4 cardiac MRI scanning 2. Cut Exam 4 cardiac CT scanning 3. Cut plans for cell immortalization 4. Shorten the post-exam contract period by 2-4 months 5. Shorten Exam 4 by 2 months 6. Redistribution of funds from centers with a balance 7. Cut the Exam 4 ECG (already effected)

7. MESA Budget StatusProposal (cuts) 9-9-05 1. Cut Exam 4 cardiac MRI scanning 2. Cut Exam 4 cardiac CT scanning by half (~800) 3. Cut plans for cell immortalization 4. Shorten the post-exam contract period by 3 months 5. Shorten Exam 4 by 2 months 6. Redistribution of funds from centers with a balance 7. Cut the Exam 4 ECG

8. MESA Budget StatusProposal (additions) 9-9-05 1. Additional staffing at the Field Centers 2. Re-reading endothelial function studies 3. Exam 4 training 4. Offset shortfalls

10. For working with us in a prompt, helpful, courteous manner

11. Also, thank you, Cheryl Jennings!

12. MESA II • Design Committee has proposed components: • Development of LV dysfunction • Cognition, physical fn, QOL and subclinical CVD • Predictive value of CAC • Abdominal aortic calcium • Metabolomics, proteomics • Further exploration of carotid atheroma

13. MESA II • Need analyses to support new work • Need to integrate with MESA Air • Tight fiscal times

14. MESA II • Rough timeline for acquisition (1): • Winter 2005/2006 Ad hoc advisory group • April 2006 NHLBI BEA • June 2006 NHLBAC • December 2006 Release of RFPs • March 2007 Receive initial proposals • March 2008 Receive final proposals • May 2008 Awards

15. MESA II • Rough timeline for acquisition (2): • May 2006 Ad hoc advisory group • September 2006 NHLBI BEA • October 2006 NHLBAC • April 2007 Release of RFPs • July 2007 Receive initial proposals • May 2008 Receive final proposals • July 2008 Awards

16. Timeline

17. Limited Access Data Sets- New Policy (as of 10-1-05)- Main Changes, continued • Timing of Release of Data • Clinical Trials – No later than 3years after final visit of participants to clinical trial sites or 2 years after main paper has been published, whichever comes first. • Observational Epidemiology Studies – No later than 3 years after completion of each examination or follow-up cycle or 2 years after the baseline, follow-up, genetic, ancillary study, or other data set is finalized, whichever comes first. • Ancillary Studies – In cases where the timeline for an ancillary study differs from that of its parent study, the release date will relate to the timeline of the ancillary study.

18. Limited Access Data Sets- New Policy (as of 10-1-05)- QUESTIONS? • Does MESA fall under new policy? • Must all data be included? • How much main data needs to be included with ancillary study data?

19. Current Challenges • Endothelial function studies • Pilot re-reads being performed at Wake Forest by David Herrington • Changes in CT scanners • Analyzing data to address MESA objectives and support renewal

20. MESA NHLBI Project Office • Teri Manolio is leaving NHLBI! • Director of the Epidemiology and Biometry Program • Former CHS Project Officer • Major impetus behind MESA • MESA Publications Committee • Taking a sabbatical for create a Division of Population Genetics at NGHRI

21. NIH Issue:Reimbursement for Reviewers • Reviewers need Data Universal Numbers System (DUNS) numbers and need to register with CSR in order to receive reimbursement. • Published in NIH Guide August 19, 2005. • http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-05-065.html

22. NIH Issue:HIPAA • Trans-NIH Bioethics Committee is looking into the impact of HIPAA • Thank you for your responses

23. Reminders • IF YOU NOTIFY YOUR IRB, notify the Project Officer • MESA is a contract; grants are separately administered, but MESA grants are managed in coordination with contracts, SO COMMUNICATE WITH BOTH ENTITIES

24. Consider Recommending NHLBI • Frequent new hires (http://www.jobs.nih.gov) • At the heart of new initiatives and multiple ongoing studies • Influence policy • You need good people at NIH! • Talk to one of us

26. The End

27. Limited Access Data Sets- New Policy (as of 10-1-05)- Main Changes • Clarifies that policy applies to: • Clinical trials and epidemiology studies supported by the U01 (cooperative agreement) mechanism AND have 500 or more participants • Trials or studies requesting $500,000 direct costs or more in any one year • Ancillary studies based on clinical trials or epidemiology studies that are required by this policy to provide limited access data sets http://www.nhlbi.nih.gov/resources/deca/policy_new.htm

28. MESA NHLBI Project Office • Diane Bild, Project Officer Executive, Steering, CT, US, Lab, P&P • Jean Olson, Deputy Project OfficerM&M, MRI, Ops, • Hanyu Ni, Deputy Project OfficerAS, Air liaison • Colin Wu, BiostatisticianQC • Cashell Jaquish, Statistical GeneticistGenetics • Andrew Arai, CardiologistMRI consultant • Cheryl Jennings, Contracts Officer Budget issues

29. Division of Epidemiology and Clinical Applications Training and Special Programs: Jared Jobe, CAPP, Lorraine Silsbee, EBP SBIR/STTR Program: Paula Einhorn, CAPP