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

2. 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. 3 Proposals Submitted – Total5,230 (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) Proposal Statistics – FY2005

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

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

9. 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. 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. 11 Required Information 1.General Project Info 2.Sponsor Information 3.Performance Sites 4.Study Abstract 5.Research Design 6.Benefits & Risk to Subjects 7.Special Considerations 8.Subject Description 9.Survey/Subject Populations 10.Informed Consent 11.Security 12.Exemption Special Consideration Details 13.Subject Payments and Other Incentives 14.Health Care Treatments and Procedures 15.Drugs, Biologics, etc. 16.Devices 17.Placebo 18.Biological Specimens 19.Stem Cells 20.Genetic Analysis 21.Ionizing Radiation 22.Organ/Tissue/Cell Transfer 23.Gene Transfer 24.Secondary Data Analysis 25.Protected Health Information (HIPAA) 26.Epidemiology 27.Deception Research 28.Internet/Email 29.Survey Research 30.International 31.Watching/Listening to Audiovisual Materials 32.Data Safety Monitoring Plan New Application Sections Vulnerable Subjects Details 33.Children 34.Neonates 35.Pregnant Women and/or Fetuses 36.Lactating Women 37.Women of Child Bearing Potential 38.Prisoners 39.Cognitively Impaired Adults 40.College Students 41.Subjects Vulnerable to Coercion GCRC and PRC 42.GCRC Resources 43.MADRC Information

12. 12 Application Review Process

13. 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. 14 eResearch Phase II Coming Soon… eResearch Phase II Proposal Management

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

16. 16 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 Business Drivers for Automating Proposal Management at UM

17. 17 Phased Implementation Approach 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 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.