eIRB RELEASE COMPLETED

The full release of Insight 2.0 / eIRB to all departments/units at BWH and MGH is complete. The eIRB application within the Insight Research Portal allows users to electronically prepare, submit, sign and track their submissions to the Partners IRBs. An important reminders document has been created to help users with this new process.

The Partners Human Research Office (HRO) will no longer accept submissions prepared using the Word template application forms previously posted on the IRB web site. Offline signatures will also not be accepted. Two exceptions to this rule are the External Adverse Event/Safety Report form and the Investigator Disclosure form. Both must be completed offline and faxed to your department's protocol administrator.


ELECTRONIC SIGNATURE REQUIRED FOR ALL SUBMISSIONS

The requirements for signatures on IRB submissions will be the same, only now individuals will sign off on the submission electronically using their Partners user name and password. They are prompted by an email from the Partners IRB with the subject line ‘eIRB Action Required’. The email is only an alert and is not necessarily needed to complete the activity.

All investigators and study staff are required to review and sign submissions electronically in eIRB.  Investigators can not delegate sign off permanently. Temporary delegation may be allowed but is considered on a case-by-case basis. Contact your protocol administrator if a submission must be processed when an investigator is not available.

Department/Unit Chiefs/Chairs may delegate departmental sign off authority temporarily/permanently to another faculty member with a responsibility for research in the department. Delegation can be set up through the Insight Help Desk.

In order to sign electronically, an active Partners user name and password must be maintained.  Because an individual’s Partners user name and password are unique identifiers, they constitute the “electronic signature,” which is equivalent to the individual’s handwritten signature.  As such, passwords must be kept private and should not be shared with other Partners employees.  Passwords must be changed every 180 days and can be managed through the Partners self-service Internet web site: https://myprofile.partners.org/


TRAINING

Training opportunities are still available in addition to a user manual, reference guides, and PHS Insight Help Desk Support.

Drop-in/Office Hour sessions will be conducted for one-on-one help at both MGH and BWH by Daniel Connor, IRB Systems Analyst from the Partners Human Research Office. No appointment is needed. Other members from Research Management are also available to answer questions about grants and contracts and effort reporting. See the Partners Research Management calendar for more information (PHS internal link). Dates/times for eIRB help is listed below. 

DROP-IN SESSIONS
DATE
TIME
LOCATION
January 26, 2010 3:00pm-4:00pm MGH 50 Staniford Street, 10th fl, room 1043
February 19, 2010 9:30am-10:30am BWH Thorn Building, 11th floor, room 1117
February 23, 2010 3:00pm-4:00pm MGH 50 Staniford Street, 10th fl, room 1043

Department in-services: For groups of approximately 5 or more, someone can come to your office and provide specialized training to address department-specific IRB research submissions. To set up an in-service, contact Daniel Connor.

Computer-based training: Online training is available that will allow users to learn eIRB while being able to stop and start at their own pace (PHS internal link).