February 8, 2007

eResearch: eResearch: University of MichiganUniversity of Michigan

Business & Finance Forum

Marvin G. ParnesAssociate Vice President for Research &

Executive Director of Research Administration

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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

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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)

Proposal Statistics – FY2005

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= Focus of eResearch Phase I – Compliance

= Focus of eResearch Phase II – Proposal Management

Overview of Research Administration

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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

eResearch Studies

Amendments Continuing Reviews

AE/ORIOs Total Submissions

Pre-Submission 1433 228 72 51 1025Under Review 527 177 178 147 703Approved 4065 1580 2212 544 5016Term/Expired/Withdrawn 1092 192 77 74 948Held for SCR n/a n/a n/a 87 58Acknowledged at SCR n/a n/a n/a 456 147Total 7117 2177 2539 1359 7897

All eResearch Submissions

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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

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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)

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UM Institutional Review Boards

UM has 9 IRBs:

5 Biomedical

Behavioral Science

Health Science

Flint

Dearborn

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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

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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

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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

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Application Review Process

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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)

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eResearch Phase II

Coming Soon…

eResearch Phase II

Proposal Management

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= Focus of eResearch Phase I – Compliance

= Focus of eResearch Phase II – Proposal Management

eResearch Phase II

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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

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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.