eResearch:
University of Michigan
Business & Finance Forum
Marvin G. Parnes
Associate Vice President for Research &
Executive Director of Research Administration
February 8, 2007
The Big Picture – Research at U-M


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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
2
Proposal Statistics – FY2005

Proposals Submitted
–
–

Total
Dollar Value
5,230 (2,502 Federal)
$3,282,880,553 ($2,686,777,794 Federal)
Awards Received
–
–
Total
Dollar Value
2,375 (904 Federal)
$780,795,422 ($605,410,738 Federal)
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Overview of Research Administration
= Focus of eResearch Phase I – Compliance
= Focus of eResearch Phase II – Proposal Management
4
Submissions in system as of February 2, 2007:
eResearch
Studies
Pre-Submission
Under Review
Approved
Term/Expired/Withdrawn
Held for SCR
Acknowledged at SCR
Total
1433
527
4065
1092
n/a
n/a
7117
All eResearch Submissions
Amendments
Continuing
AE/ORIOs
Reviews
228
177
1580
192
n/a
n/a
2177
72
178
2212
77
n/a
n/a
2539
51
147
544
74
87
456
1359
Total
Submissions
1025
703
5016
948
58
147
7897
Usage Statistics – January 2007
• Number of unique users for month = 2266
• Number of total page hits for month = 604,157
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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
6
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?
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
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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)
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–
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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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New Application Sections
Required Information
Special Consideration Details
Vulnerable Subjects Details
1.
General Project Info
13.
Subject Payments and Other Incentives
33.
Children
14.
Health Care Treatments and Procedures
34.
Neonates
2.
Sponsor Information
35.
Pregnant Women and/or Fetuses
15.
Drugs, Biologics, etc.
36.
Lactating Women
16.
Devices
37.
Women of Child Bearing Potential
17.
Placebo
38.
Prisoners
18.
Biological Specimens
39.
Cognitively Impaired Adults
19.
Stem Cells
40.
College Students
20.
Genetic Analysis
41.
Subjects Vulnerable to Coercion
21.
Ionizing Radiation
22.
Organ/Tissue/Cell Transfer
GCRC and PRC
23.
Gene Transfer
42.
GCRC Resources
24.
Secondary Data Analysis
43.
MADRC Information
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
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
11
Application Review Process
12
Post-Approval Activities

Once a research application is approved, the Study
Team uses other “smart forms” in eResearch to
create:
–
Scheduled Continuing Reviews
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–
Amendments

–
Renewals
Terminations
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
14
eResearch Phase II
= Focus of eResearch Phase I – Compliance
= Focus of eResearch Phase II – Proposal Management
15
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
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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
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–
–
–
–
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Phase 2 – Internal system integration
–
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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
–

Electronic Proposal Approval Form (ePAF)
Proposal Preparation
Routing and Approval
Proposal Submission
 Grants.gov
 Non-Grants.gov External Sponsors
Award Notification
Data Warehouse
The third phase of the project would focus on the routing and approval of internally funded
projects.
Phase 4 – Budget development online tools
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