The Christ Hospital IRB Number: 3.12
Submitted By: Becky Riddell, CIP Effective Date: 08/24/07
Reviewed By: Jennings/Roberts Revised/Reviewed Date: 06/15
Approved By: Steve Roberts, MD______
(I.1.E, III.2.A)
STANDARD OPERATING PROCEDURE
Education of IRB Staff/Board Members/Investigators/Research Staff
POLICY:
It is the policy of TCH IRB to assure education is provided to its staff, board members, investigators and research staff(those having direct patient contact, analyzing data, etc.), if you have any questions, please contact the IRB. To that end, the IRB provides the following:
· Continuing education through a web-based training course, the Collaborative IRB Training Initiative (CITI) Course in the Protection of Human Research Subjects. IRB board members, staff and investigators must provide documentation that this course has been completed by submitting a certificate of completion to the IRB Office. A composite score of 80% or above is required by TCH IRB to assure adequate comprehension. This course must be completed every 3 years.
If an investigator submits a protocol for approval or continuing review and has not taken the CITI course, the investigator must be removed from the study.
· Monthly research newsletters and periodicals are distributed with the monthly meeting packets to the IRB members to keep members abreast of new and developing issues in the realm of human research protection.
· Opportunity to attend local IRB continuing education conference every fall.
· IRB Chair and/or Board Member and an IRB staff member attend PRIMR/ARENA conference at least every 2 years, and the AAHRPP conference annually.
PROCEDURE:
I. CITI Course:
To Log On to CITI Course in The Protection of Human Subjects
NEW USERS:
1. Log on to www.citiprogram.org, Click on “New Users Register Here” button.
2. Step One- Select your institution or organization:
Go to “Participating Institutions” drop down menu.
Click on “down” arrow to the right of the window and scroll down to “Greater Cincinnati Academic and Regional Health Centers”.
3. Step Two- Select your username and password:
(Create username and password you’ll remember)
USERNAME: Create a username (at least 4 characters, not case sensitive)
PASSWORD: Create a password (at least 8 characters, not case sensitive)
VERIFY PASSWORD: Re-type your password.
4. Step Three- Enter your first and last name.
5. Step Four- Enter your e-mail address.
Then Click the SUBMIT button at the bottom of the page.
6. Registration Information
Fill in all the fields with an asterisk “*” in the left-hand column.
Click SUBMIT button
7. Select Curriculum – *Select Christ Hospital* and submit
8. At this point you will be asked if you want to affiliate with another institution. If you choose YES, you may be asked to complete additional courses for that institution.
9. Main Menu – My Courses
GCARHC-AAFP-Advanced
Under STATUS, click on enter (in red). This will take you to the list of modules to complete. Enter each module by clicking the text that is underlined and highlighted. You will read about each subject, and then click on to take the quiz. When completing a quiz, you may “Go to the Next Module”, or “Go to the Grade Book for this Curriculum”. You may take modules as time allows and come back later; they do not all have to be completed at the same time. If you log out and come back to take more modules, click on the Grade Book to get you to the list of modules that still need to be completed.
TO RE-TAKE A COURSE:
· Click on “Review Completed and Optional Modules”
· Click on title of module to re-take.
· Go to end, click on “Take the Quiz for …”
· Click on “Click here to generate the quiz.”
· Re-take exam and hit “Submit Exam” button.
EXISTING USERS:
· Enter username and password
· Click in the link located in the learner's menu: affiliate with another institution, choose Greater Cincinnati Academic and Regional Health Care (GCARHC) and follow the prompts.
IRB STAFF:
1. The IRB staff must assure that all Board members, investigators and research staff have completed the CITI course. A copy of the verification of the completion of the course must be on file in the IRB office before a study may be activated or approved for annual review.
2. When an email is received documenting completion of the course by an investigator, research staff or IRB member, the completion date is entered into the CITI Course Log database.
3. New investigators, research staff and/or board members must be sent the above instructions for completing the course.
II. Newsletters/Publications:
IRB STAFF:
1. Assures that subscriptions are budgeted for and ordered annually.
2. Distributes publications to IRB members monthly with the IRB packets.
IRB MEMBERS:
1. Utilizes publications received with IRB packet to keep abreast of new developments in the realm of human research protection.
III. Continuing Education Programs:
IRB STAFF:
1. Provides information to IRB members each fall on local continuing education conference and strongly encourages attendance; The Christ Hospital pays the cost of attending these programs.
2. Registers IRB members wishing to attend conference.
3. Keeps records of those who have attended conferences.
IRB MEMBERS:
1. Informs IRB staff that he/she desires to attend local conference.
2. Provides information for conference registration and submits records of attendance to IRB staff upon completion, if applicable.
Page 1 of 3