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Instructions for Registering and Completing Initial Human Subjects Training Certification

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Instructions for Registering and Completing Initial Human Subjects Training Certification 1. Go to the Collaborative Institutional Training Initiative (CITI) webpage at www.citiprogram.org and click on

“Register” in the upper right-hand corner. (Note that if you already have a CITI username and password from work at a previous institution, follow the instructions provided on page 4 for Affiliating with Another Institution.) 2. Registration Step 1: Enter the University of Rochester in the textbox to identify your affiliated institution and click

“Continue to Step 2”.

3. Complete Registration Steps 2-6 as prompted. These sections collect personal, demographic and contact information and will prompt you to create a username and password. Note that Step 5 also provides users the option of receiving Continuing Education Units (CEUs) for course completion. Should you wish to receive CEUs, you must answer “Yes” and provide the requested information regarding credits. Users are responsible for the fees associated with these CEUs (the University of Rochester does not cover this fee); as such appropriate billing

information will need to be provided when prompted. Additional information about obtaining CEUs can be found by clicking on the “CE Credits” link on the horizontal toolbar at the top of the screen or by contacting CITI directly at (305) 243-7970.

4. Registration Step 7: Select the checkbox for “Human Subject Protection” and click “Next”.

5. On the following page, select 1 of the 4 “Initial Certification Program” courses based on the type of research you will conduct (see descriptions below) and click “Next".

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6. After selecting the initial certification program course, click “Finalize Registration”. Your learner account registration will then be complete.

7. To begin the initial certification course, click on “University of Rochester Courses” and then the name of the course.

• Greater Than Minimal Risk Biomedical - Select this course if you will conduct research that involves drugs, devices, biologics, or medical procedures that involve greater than minimal risk (e.g., biopsies, x-rays, etc.).

• Greater Than Minimal Risk Behavioral - Select this course if you will conduct social/behavioral research that involves sensitive or illegal behaviors (e.g., sexual behaviors, domestic violence, drug abuse, etc.).

• Minimal Risk - Select this course if you will conduct research using minimal risk procedures only (e.g., collection of small amounts of blood or other biological materials, surveys, record reviews, etc.). Please note that if you obtain certification for minimal risk research, but then become involved in a greater than minimal risk study, you will be required to complete one of the greater than minimal risk research training modules.

• IRB – Select this course only if you are OHSP staff or are currently a voting member of 1 of the 5 RSRB boards.

• If you are not sure which course to complete, please contact the OHSP office at (585) 275-5244. Alternately, completing one of the greater than minimal risk courses will generally ensure that you have the proper training for all levels of research. If you are unsure which course to complete and elect to complete one of the greater than minimal risk courses, faculty/staff/students working in a healthcare setting should complete the Greater than Minimal Risk Biomedical course, while all other faculty/staff/students should complete the Greater than Minimal Risk Behavioral course.

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8. You will be prompted to complete the “Integrity Assurance Statement” prior to initiating the training. Once this has been completed, click on the name of the first training module to begin the course.

9. Complete all required training modules and each respective quiz: After reviewing the information in each module select “Take the quiz…” at the bottom of the computer screen. Once the quiz has been completed, click “Take the next required module…” to continue your training. Note that:

• You may start the course, leave it and come back to it at any time. To access the course at a later time, log into CITI and, from the Main Menu, click on “University of Rochester Courses” and then the name of the training course. From there, you will be able to select the next module in the course to complete.

• You may review modules and take quizzes, if you wish, by selecting “View this module again and re-take the quiz” at the bottom of the computer screen. You may re-review modules and re-re-take quizzes as many times as you wish until your Completion Report has been issued (keep in mind, you need to score at least 85% to successfully obtain certification for human subjects research).

10. Once you have completed the final module, you will receive a “Course Complete” notification at the bottom of the bottom of the screen. Click “Go to the Main Menu”.

11. From the Main Menu, it is recommended that print a Completion Report for your records (you may also elect to complete a survey regarding the course, if you wish). Information about obtaining Continuing Education Units (CEUs) can be found by clicking on the “CE Credit Status” link on the horizontal toolbar at the top of the screen or by contacting CITI directly at (305) 243-7970. Users who wish to receive credit for completing the training are

responsible for the fees associated with these CEUs (the University of Rochester does not cover this fee); as such appropriate billing information will need to be provided when prompted.

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12. The Office for Human Subject Protection (OHSP) will be notified automatically that you completed the course. Therefore, you do not need to provide a copy of your completion report to OHSP. Within 1-2 business days, OHSP will email users who have successfully completed the training course a letter confirming certification. This letter will include a certification expiration date and information about registering for an account with the RSRB Online

Submission System (ROSS).

If you have any questions about registering for CITI or completing this training, please contact Kelly Unsworth at (585) 275-5244 or by email at [email protected].

Instructions for Affiliating with Another Institution

NOTE: The instructions provided below are intended only for study team members who already have a CITI username and password from work at a previous institution (e.g., a new faculty member who previously conducted research at an

outside institution that also required CITI training). 1. From the Main Menu, select “Click here to affiliate with another institution”.

2. Enter the University of Rochester in the textbox to identify your affiliated institution and click “Next”.

3. Follow the remaining registration and course selection information from Step 3 above as prompted. Once your affiliated institution and the training course has been selected, CITI’s software will sum the requirements of both the University of Rochester and your previous institution to evaluate whether any previously completed modules may

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be eligible for transfer credit. Transfer credits are based on both the type of training required by each institution and each institution’s training expiration procedures.

References

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