eResearch: University of Michigan

1. eResearch: University of Michigan Business & Finance Forum Marvin G. ParnesAssociate Vice President for Research & Executive Director of Research Administration February 8, 2007

2. The Big Picture – Research at U-M • At any given time, more than 5,000 externally sponsored research projects are underway at UM • UM has about 7,000 active research studies involving human subjects, all of which must receive annual scrutiny from a number of campus boards and committees • UM uses over 400,000 animals in research each year. Studies involving animals are also subject to review to ensure compliance

3. Proposal Statistics – FY2005 • Proposals Submitted • Total 5,230 (2,502 Federal) • Dollar Value $3,282,880,553 ($2,686,777,794 Federal) • Awards Received • Total 2,375 (904 Federal) • Dollar Value $780,795,422 ($605,410,738 Federal)

4. Overview of Research Administration = Focus of eResearch Phase I – Compliance = Focus of eResearch Phase II – Proposal Management

5. Submissions in system as of February 2, 2007: • Usage Statistics – January 2007 • Number of unique users for month = 2266 • Number of total page hits for month = 604,157

6. A Brief History of Human Subjects Research in the US 1974: National Research Act and IRB System • Congressional hearings directed by Senator Edward Kennedy in 1973,culminating in National Research Act of 1974 • Established modern Institutional Review Board (IRB) system • Established the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research • In 1978, the Commission issued the Belmont Report The Belmont Report • Eight-page document explaining the three principles IRB members use to evaluate the ethics of specific research proposals: • Respect for persons • Beneficence • Justice Code of Federal Regulations (CFR) • Specific legal requirements originating from Belmont Report are covered in: • CFR Title 21: Food and Drugs • CFR Title 45: Public Welfare

7. UM Institutional Review Boards The IRB System • IRB = Institutional Review Board • Board for the review and approval of all research involving human subjects conducted at the institution (i.e., UM) Who is on the IRB? • Physician scientists • Non-physician scientists • Social/Behavioral scientists • Non-scientists (e.g., community members) • Special advocates for children, the disabled, prisoners, etc. • IRB committee meetings are also regularly attended by special consultants who are non-members (e.g., legal counsel)

8. UM Institutional Review Boards UM has 9 IRBs: • 5 Biomedical • Behavioral Science • Health Science • Flint • Dearborn

9. eResearch – Why is it Important? • The purpose of eResearch is to help ensure that researchers and the IRBs are in compliance with the Belmont Report and the CFR. • If the government finds (or suspects) that an institution is non-compliant it can (and will) halt all research activity at the institution: • Duke University • Johns Hopkins University

10. eResearch – What is it? • Web-based system for the preparation, submission, and management of human subjects approvals • eResearch uses “extranet” technology developed by Click Commerce (formerly Webridge) • Processes are automated using a series of online workspaces, web forms, and predefined workflows. • Security controls which studies, activities, etc. a user can access • The system provides researchers a single, comprehensive application that is automatically routed to all review committees • The online research application form uses “Smart Form” technology to automatically tailor questions based on information entered • Email notifications are sent at transition points to alert next party that action is required

11. New Application Sections

12. Application Review Process

13. Post-Approval Activities • Once a research application is approved, the Study Team uses other “smart forms” in eResearch to create: • Scheduled Continuing Reviews • Renewals • Terminations • Amendments • Modifications to approved studies • Adverse Events (AEs)/Other Reportable Information and Occurrences (ORIOs)

14. eResearch Phase II Coming Soon… eResearch Phase II Proposal Management

15. eResearch Phase II = Focus of eResearch Phase I – Compliance = Focus of eResearch Phase II – Proposal Management

16. Business Drivers for Automating Proposal Management at UM • Requirement to submit all proposals for federal funding electronically via Grants.gov • Without an electronic system-to-system interface, the University risks missing key submission deadlines and losing federal research funds. • Reduce administrative burden on research faculty and staff by automating routing, approval and submission of funding proposals • Request for more comprehensive research reporting • Elimination of duplicate data entry • Improve usability of data across University Systems • Leverage M-Pathways data, including financial, space, projected effort, salaries, and departmental information

17. Phased Implementation Approach The new system will be implemented in phases to allow for base functionality implementation in a shorter time frame and for a more controlled implementation. • Phase 1 – Routing, approval, and submission of proposals to external sponsors, including Grants.gov • Electronic Proposal Approval Form (ePAF) • Proposal Preparation • Routing and Approval • Proposal Submission • Grants.gov • Non-Grants.gov External Sponsors • Award Notification • Data Warehouse • Phase 2 – Internal system integration • Enhance functionality by integrating with existing systems, such as M-Pathways, eResearch Compliance, PEERRS, and eSirius. • Phase 3 – Routing, approval, and submission of proposals to internal funding sources • The third phase of the project would focus on the routing and approval of internally funded projects. • Phase 4 – Budget development online tools