NEXT ORSSP WORKSHOP (OPTIONAL)

Title: How to Comply with the IRB
Instructor: Leanne Prete
Date: Upon Request
Time:
Place:
Who May Attend: Administrators, Faculty, Staff, Students
Description: IRB requirements will be reviewed, common compliance problems will be highlighted, and strategies for avoiding non-compliance will be discussed.

ONLINE TRAINING FOR RESEARCHERS (REQUIRED)

Who needs to complete IRB training?

Any person involved in the design and/or conduct of a human subject research project must complete the approved online human subject protections training program offered by the University of Miami's Collaborative Institutional Training Initiative (CITI).  The IRB will not review a protocol until training documentation is on file at ORSSP.  This requirement includes any faculty, staff, students, or collaborators from other institutions.

Submission of IRB Training Completion Certificates: PLEASE NOTE: The new CITI program automatically emails ORSSP when training is completed. You are no longer required to submit hard copies of training certificates to ORSSP if you complete training through CITI and identify the University of North Carolina Wilmington as the participating institution. If you completed CITI training through a different participating institution, or if you completed training through the National Cancer Institute site, please see the second FAQ below for more information.

PLEASE READ THE INSTRUCTIONS BELOW TO REGISTER FOR THE CORRECT HUMAN SUBJECTS COURSE.  

Go to:    IRB Training for Human Subject Researchers

Instructions:

New Learners: If you never registered before on the CITI site, register as a New User.

Registration Steps:
1. Select your institution or organization - In the Participating Institutions box, please scroll down to University of North Carolina Wilmington. Skip the other boxes.
2. Select your Username and Password - follow instructions to select an acceptable username and password. Make note of them so that you can complete the course in multiple sessions if needed.
3-4. Enter your name and email address and select the Submit button

Course Registration:
1. Which course do you plan to take? - Select Basic Human subjects protection. Do not select either of the Refresher Courses unless you can provide documentation to the IRB that you previously completed the full basic course.
2. Role in human subjects & Animal Welfare research - Select the most appropriate role. Appropriate roles for students might be research assistant (if you are helping a faculty member on a research project), or student researcher (if a faculty member will mentor you on your own graduate or undergraduate research project).

Citi Course Enrollment Procedure:
Scroll down to the CITI Course Enrollment Questions.

Question 1. If this is the first time taking a CITI course at UNCW, choose your learner group.

Choose one answer - -
- Biomedical Research Investigators - this is appropriate for anyone conducting human subject research involving clinical activities.
- Social & Behavioral Research Investigators - this is appropriate for most research conducted at UNCW other than research involving clinical activities. This learner group is appropriate for survey research, focus groups, oral history projects, etc.
- Research with data or laboratory specimens - ONLY - this is only appropriate if a researcher will only work with data and will have no direct contact with human subjects.
- IRB Members - DO NOT select this learner group unless you have been directed to as a member of the Institutional Review Board.

If you are unsure what your learner group should be, please ask the principal investigator of the research or call the regulatory compliance officer at xt. 2-7774.

Question 2. Select the statement that is most appropriate - If you are taking the basic course for the first time select the last answer, "N/A". If you can provide documentation that you previously completed the full basic course, you may select one of the other choices.

Question 3. You can ignore this question unless you are also conducting research on live, vertebrate animals.

Question 4. You can skip this question unless your instructor has assigned this as a course requirement. The Responsible Conduct of Research Course is optional at this time and strongly encouraged. Link to more information about Responsible Conduct of Research at UNCW.

Select the Submit button.

A screen will appear to confirm that you selected the correct institution. University of North Carolina Wilmington should appear. Select the "No" button unless you wish to register with another institution.

The Main Menu screen will appear. This will show you the courses for which you are enrolled. Select "Enter" under the Status column to begin the course. You must score at least 80% overall on the course before you are permitted to view your completion certificate. This screen is your main tool for reviewing modules completed, updating user information, changing your username and password and adding new courses.

Returning Learners: If you are returning to the site to continue working on your modules or if you are returning to change to a different learner group, login with the username and password you already have. The Learner's menu allows you to choose a new learner group or go to the grade book to see which modules you have already completed.

Training FAQs

How often do I need to renew my training?

At this time there is no expiration to your completion certificate.  However, since the new training course has refresher courses available, this may change in the future. Some institutions require refresher training after 3 years, so if you conduct research at another institution they may consider your training to be expired.

Who do I send my completion certificate to?

If you are a research assistant on a project, the principal investigator may ask you to provide him or her with a hard copy of the completion certificate. You are strongly encouraged to keep a hard copy for your own records as well.

You are no longer required to submit a hard copy of your completion certificate to ORSSP if you complete the CITI training and identify the University of North Carolina Wilmington as the participating institution. When you complete the course for which you registered, the regulatory compliance officer will receive an email notification directly from CITI. This notification is considered "official" documentation of your training.

However, if you completed the CITI training through a participating institution other than the University of North Carolina Wilmington, ORSSP will not be able to access those records. There are several options available for this situation and you should contact the regulatory compliance officer, Leanne Prete, to see what is best for you (962-7774 or pretel@uncw.edu).

Also, if you completed training through the National Cancer Institute site you must still provide a hard copy of your completion certificate if it is not already on file with ORSSP, since there is no other way for ORSSP to obtain this documentation. Please send completion certificates to Leanne Prete, Regulatory Compliance Officer, ORSSP, Campus Box 5973.

Are Institutional Review Board members required to complete additional training?

The IRB Member learner group has more modules than any other group. IRB members must complete all of the required modules. If a new IRB member previously completed the Social & Behavioral Research Investigator learner group, the IRB member only needs to complete the additional modules required for IRB members.

See All FAQs

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