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Update November 19, 2010
As part of quarterly scheduled updates, the following changes have been made in eIRB:
- New Application – 12 (Participant Information), question 7.0 – an upload field has been added for the DSS application if enrolling foster children in Maryland.
- New Application – 13 (Recruitment Information), question 3.0 – “Telephone Screening Script” has been added as an optional recruitment document.
- New Application – 14 (Consent and Waivers – Adults) and 15 (Written Consent – Adults) – the term “Adults" has been removed from the title, as some consent forms may include an assent statement.
- New Application – 14 (Consent and Waivers) – by indicating that written consent will be obtained by non-English speakers, a question appears to clarify if a short form consent will be used, and if so, which type. If “other” is selected, you will be required to not only upload any short form consents, but also a certificate of translation.
- New Application – 28 (Radiation Calculator – "THE BUTTON" has been changed to "CALCULATE".
- New Application – 29 (Incidental Findings), question 2.0 – “Will images be read at Hopkins?” If answered “No”, a text box will now appear prompting you to describe the plan for the external reading center. Questions 2.0 and 3.0 will swap places.
- Insurance and Research Participant Financial Responsibility Information Sheet – this document is now located under "Written Consent" under the “Stamped Documents” tab. The name of the document has been changed to "Financial Information Sheet (Use with Consent Form)".
- Continuing Review Application –3 (Unanticipated Problems, Events, Deviations) – Question 5.0 has been modified to prompt the PI to submit any unanticipated problem/events not previously reported to the JHM IRB in addition to sponsor required protocol events that do not meet the JHM IRB requirements for reporting.
- Continuing Review Application – 4 (Study Population) – you will be prompted to indicate the number of participants approved to be consent, or enrolled with a waiver of consent, at Hopkins from the current application as opposed to the original application.
- New Application Approval Letters – an explanation regarding stamped consent forms has been added to the approval letter.
- New language has been added to New Application and Change in Research Letters where the eIRB application indicates the Department of Defense (DoD) as a funding source.
- Exempt and Not Human Subjects Research Acknowledgement Letters have been revised to indicate that the New Application qualifies as “exempt research” as opposed to an “exemption”.
- Exempt and Not Human Subjects Research Acknowledgement Letters have been revised to include language regarding the new policy for assigning expiration dates to new and existing Exempt and Not Human Subjects Research studies.
- Termination Acknowledgment Email Notifications will be sent to all study team members listed as opposed to only those designated to receive email notifications.
- The Agree to Participate Activity will include an option for the study team member to confirm their inclusion on all study related notifications from eIRB.