Click a link below to read messages sent to the University community

Communication to the general University Community (March 3, 2005)
Communication to University Deans, Directors, and Department Heads (May 12, 2005)
Message to System Administrators (May 5, 2005)

Note: You may have received additional messages from the IRB offices. For more information about any communications from those offices, contact your IRB.

Global Communication

From: Marvin Parnes, Associate Vice President for Research & Laura Patterson, Associate Vice President for Administrative Information Services
Sent: Thu 3/3/2005 7:23 AM
To: "The University Community"
Subject: Introducing the New eResearch System

As a component of its ongoing commitment to enhance human subject protection, the University of Michigan will release eResearch in late Spring. A web-based system designed to standardize the application and approval process to conduct human subject research, the unified application will encompass biomedical, behavioral, and social science research.

eResearch will provide some advantages over the current systems. Researchers will complete one application that will be reviewed by several regulatory committees, including the Institutional Review Boards (IRBs). In addition, eResearch offers all researchers and study staff the ability to electronically review and manage their projects currently under approval and to follow the application approval process for projects under review. The system also provides continuous access to the currently approved informed consent document.

eResearch replaces the current manual and electronic applications and procedures used to review and approve the human subject research, including the web-based system currently employed by the Health and Behavioral Sciences IRBs. eResearch applies consistent, web-based technology to further enhance reviews and to eliminate redundant processes for investigators and review boards.

Institutional Review Boards, research faculty, and other affiliated research review committees participated in the design and testing of the unified eResearch application. eResearch is currently successfully testing its production capacity with a limited number of selected research applications. It will be fully available to researchers submitting applications to IRBMED in May and to IRB Behavioral Science and IRB Health Science in June. Implementation dates for the Flint and Dearborn campuses are still under discussion.

Making the transition to eResearch will likely require an investment in time and effort by some investigators and their teams as they learn to use and enter applications into eResearch. However, the long-term gains of a more streamlined process make this investment an important one.

We invite you to learn more by visiting the eResearch Infosite at http://www.umich.edu/~eresinfo. Further details and information about training and support will be provided by the eResearch team and the IRBs in the coming weeks. If you have questions or need more information, please contact either of us directly.

Sincerely,

Marvin Parnes, Associate Vice President for Research
Laura Patterson, Associate Vice President for Administrative Information Services

 

Communication to U-M Deans, Directors, and Department Heads

From: Marvin Parnes, Associate Vice President for Research and Laura Patterson, Associate Vice President for Administrative Information Services
Sent: Thursday, May 12, 2005 9:21 AM
To: "U-M Deans, Directors & Department Heads"
Subject: eResearch System Use Begins in June and July

Greetings,

We need your assistance in launching a new approach to supporting research involving human volunteers.

This summer, members of the University research community conducting human subject research will begin to use the new web-based system--eResearch--for the submission, review and approval of studies.
This message provides information about the benefits, timeline and training for using the new system. Please share this information with the research personnel in your school, college or unit.

The eResearch system (http://eresearch.umich.edu) is designed to standardize the application and approval process to conduct human subject research by providing a unified application encompassing biomedical, behavioral, and social science research. Principal investigators will submit a single application for review by the Institutional Review Boards (IRBs) and when applicable, by additional regulatory committees. The new application is longer than current applications and requests more detailed information to enhance compliance with federal requirements and guidelines for research involving human participants.

BENEFITS
The new system provides some functional advantages over the current systems.
1. A unified application replaces multiple applications required of many biomedical research studies.
2. The application is an online "smart form" so researchers are presented with only the questions related to their study.
3. eResearch offers the ability to electronically review and manage projects currently under approval and to follow the application approval process for projects under review.
4. The system provides continuous access to the currently approved informed consent document.

TIMELINE
On June 1, 2005, applications for new studies can be entered into eResearch for IRB-Health and IRB-Behavioral Science. Between June 1 and June 20, information about studies in the current system will be loaded into eResearch. On June 20, IRB-Health and IRB-Behavioral Science will retire the current IRBWebapp system and begin to use eResearch for all new studies, renewals, amendments, and adverse event reporting.

On June 13, IRBMED will begin to use eResearch for new study applications. The current application will be accepted by IRBMED until July 17. After that date, all new study applications must be submitted using eResearch. Existing studies will be converted to eResearch over a period between October 1 and December 1. Amendments, adverse events and renewals for existing studies will continue to be submitted in paper form until the study is converted to eResearch.

On July 1, IRB-FLINT and IRB-DEARBORN will begin to use eResearch for new studies.

TRAINING
1. eResearch provides a practice environment--a sandbox--where investigators and their teams can practice completing an application and using the system.
2. Lecture/demo presentations, hands-on training, and online training and documentation are available to introduce basic information about how to submit projects for review using the online application. The training includes helpful tips for filling out the application efficiently.
3. Open lab sessions are scheduled where researchers, study coordinators, or other team members can drop in and practice or use the system with the support of a trainer.

WHAT YOU CAN DO TO HELP
To make the transition to eResearch, investigators and research teams will likely need to invest time and effort to learn to use and enter applications into the eResearch system. However, this investment will eventually result in a more streamlined process. We encourage you to support the faculty and staff in your unit by providing time for training and encouraging research staff to take advantage of the resources available to support them.

Information about eResearch, access to the sandbox, recommendations for computer configurations, training schedules and registration, and other related information are available at http://eresearch.umich.edu. If you have questions about eResearch, or need more information, please contact one of us directly.

Sincerely,

Marvin Parnes, Associate Vice President for Research
Laura Patterson, Associate Vice President for Administrative Information Services

Message to System Administrators

From: eRes.Inform [mailto:eres.inform@umich.edu]
Sent: Thursday, May 05, 2005 11:10 AM
To: "Unit System Administrators"
Subject: Information to Support Implementation of eResearch System

This message has been sent to system administrators who may support faculty, staff and students who do research at U-M. It is intended to provide information to help you support faculty and their research teams and administrators when they begin using the new eResearch system this summer. Please share this information with the help desk and other desktop support staff in your unit as appropriate.

eResearch (<http://eresearch.umich.edu>) is the University's new Web-based system for the review and approval of research applications involving human subjects. Beginning in June and July, researchers working with IRBMED, IRB-Health, IRB-Behavioral Science, IRB Flint and IRB Dearborn will begin using the new system. eResearch will replace the IRBWebapp currently in use by IRB-Health, and IRB-Behavioral Science. To help prepare researchers for a positive experience using the new system, the eResearch team has prepared the following information for you. In addition, you will find support information in the Getting Started section of the eResearch Web site (<http://eresearch.umich.edu>).

DESKTOP GUIDELINES
To use the eResearch Web-based system, the following guidelines should be followed for researchers' desktop configurations.
-- Set browser to allow cookies, Javascript, and Java applets
-- Set browser to permit pop-ups from the secure eResearch Web site <https://eresearch.umich.edu>
-- Set system display to at least 1024x768 resolution
-- Encourage high-speed internet connection (128K or higher). Dial-up internet connections are not recommended.
-- Macromedia Flash Player is required to view some training materials.
You can download the free plug-in from <http://www.macromedia.com/go/getflashplayer>.
A license is not required.

BROWSER SUPPORT
eResearch has been tested on the following desktop operating systems/browser combinations.
-- Windows 2000/XP with Internet Explorer 6.0
-- Apple Macintosh OS X with Safari
The MAIS Help Desk will support only these combinations, and use of non-recommended browsers can result in unexpected Web behavior and data input issues. The MAIS Support Model for Web-delivered Vendor Systems can be viewed at <http://www.mais.umich.edu/systeminfo/support_model.html>.

AUTHENTICATION
Everyone using the eResearch system will need to know their uniqname and UMICH (Kerberos) password. In particular, new researchers, Friends accounts, researchers on the Flint and Dearborn campuses, and individuals working with IRBMED may need assistance. (MCIT-supported computers login screens reference the UMICH password as the Level 1 password.) Please refer individuals with questions to the ITCS Web site at <http://www.itd.umich.edu/help/faq/uniqnames/index.html>

FRIENDS ACCOUNTS
Researchers from outside the U-M community must obtain a Friends account before they are granted access to eResearch. Information and instructions are on the Getting Started section of the eResearch web site at <http://eresearch.umich.edu>.

SUPPORT INFORMATION
Research content and regulatory questions:
-- Contact your IRB office. Information about the University's IRB
offices is at http://www.irb.research.umich.edu/
-- For IRBMED, call (734) 763-4768 or e-mail irbmed@umich.edu.
-- For IRB BehavSci or IRB Health, call (734) 936-0933 or e-mail
irbhsbs@umich.edu.
-- For IRB Flint, call (810) 762-3383
-- For IRB Dearborn, call (313) 593-5468

Technical, desktop, browser, and system navigation questions:
-- Contact the MAIS Help Desk at (734) 936-7000 and select option 6, or send e-mail to maishelpdesk@umich.edu.
-- Help Desk hours are Monday - Friday 8:00 a.m. to 5:00 p.m.

Thank you for your support. If you have questions or concerns about the coming eResearch system implementation, please contact the MAIS Help Desk at 734-936-7000 and select option 6, or send e-mail to maishelpdesk@umich.edu.