IRB News Archive, 2011

Fri Aug 26 12:53:53 CDT 2011

This message is distributed via the IRB Listserv at the request of Susan Partridge, BSN, MBA, Vice President, Clinical Research Parkland Health and Hospital System.

Dear Investigators and Research Personnel:

Effective immediately, all research consent forms obtained at Parkland must include the date and the time the consent was signed. Following each signature and date on the consent form, insert the time right next to the date.

This process meets the requirements for CMS (Centers for Medicare and Medicaid Services) for proper consent form execution (procedure A-0238).

Thank you for your prompt attention to this important requirement.

If you have questions or concerns, please contact:

Anna Barden, RN, MHR, MBA, CPHRM, CHRC

Compliance Manager, Clinical Research

Parkland Health & Hospital System

Telephone: 214-590-6723

Mon Feb 21 09:32:10 CST 2011

Dear Investigators and Research Personnel:

As many of you know we have been experiencing some slow response times in eIRB. In our ongoing efforts to improve the performance and functionality of the eIRB system we will be implementing a change in how the eIRB system processes modifications. This process change is the first in a series designed to alleviate known performance issues.

Once implemented our users will see new screen messages after completing the first page of the Modification SmartForm.

First, you will receive a message screen indicating the system is processing the modification. You will be directed to click "Finish" and the system will redirect you to the Processing Modification page.

During processing, the eIRB system is making a copy of your currently approved study and all related documents for tracking and auditing purposes. Depending on the size of your study and the number of attachments this processing time may take up to 15 minutes. During the processing time you will not be able to edit the Modification SmartForm; however, you can navigate to other sections of eIRB and perform other eIRB tasks.

Once processing is completed, the information listed under "Current State" (the orange box) in the upper left hand corner in the Modification workspace will change from "Processing" to "Draft." At this time you will be able to edit/save and finish the Modification SmartForm. You may check to see if the processing is complete by pressing the F5 key to refresh your screen.

The primary purpose of this change is to improve overall performance.

If you have any questions, please do not hesitate to contact the IRB office at 214-648-3060.

Thu Jan 27 13:11:52 CST 2011

Dear Investigators and Research Personnel:

I am writing to clarify the University policy on the sharing of passwords to electronic systems including the UTSW eIRB. It has come to our attention that some Principal Investigators are sharing their UTSW User ID and password with their staff for the purpose of performing functions in eIRB that are designated as actions to be performed only by the PI.

This is a violation of University Information Security policy (#200-2), University Acceptable Use policy (#200-22), and the University Password User Management policy (#200-7), which collectively state, "Users are responsible for keeping their User IDs and passwords confidential and are prohibited from sharing their User IDs and passwords with anyone."

Additionally, a recently approved directive, the Electronic Signature Policy (#200-29) considers electronic signatures produced by communications and transactions initiated by a UT Southwestern-issued user account, to the extent authorized for that account, to be legally binding as the equivalent of a handwritten signature.

This activity also violates the Information Systems User Responsibilities Policy (#200-13), which implicitly states:

* Users shall not log onto a workstation using another person's User ID nor shall the User permit another person to log on with his or her User ID.

* Users shall not enter data under another User's unique User ID and password.

The Information Security Group maintains these policies on MyUTSW.

Going forward, any instance in which it is determined that a workforce member has used another person's ID and password to login will be considered an information security incident. This will result in disciplinary actions (up to and including termination) for both the person using another's ID, as well as the person who gave his or her ID and password to another to use.

If you have any questions regarding this communication, please contact me directly.

Thank you for your cooperation.