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Research: Office of the Vice Provost
 

FAQs for Training in the Protection of Human Subjects

 

1. What is CITI?

2. Who is required to take the CITI Human Subjects Protection Training?

3. Is there a fee?

4. Where do I find the on-line CITI training modules?

5. Which CITI training modules should I take?

6. How long will it take me to take the CITI training modules?

7. Do I have to finish the training in one session?

8. What is the passing score on the quizzes?

9. How will the IRB know my training is complete?

10. Will UMASS accept certificates of training from other institutions?

11. Will the IRB review a protocol if all key personnel are not trained?

12. When do I have to renew my training?

13. What if I have questions?


1. What is CITI?

The Collaborative IRB Training Initiative (CITI) is an educational program for the protection of human subjects in research.  CITI was developed by experts in the IRB community and is focused on different aspects of bioethics and human subject research.  There is a core course in biomedical research and one in social/behavioral research.  Each module includes educational materials that can either be read on the screen or printed out.  A brief quiz follows each module.

 

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2. Who is required to take the CITI Human Subjects Protection Training?

The training will be required of all investigators, including faculty, staff and students, who are engaged in the planning, conduct or analysis of research that is sponsored by a funding agency and that includes the use of human subjects.  Additional training requirements may be required by local review boards

 

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3. Is there a fee?

The University pays an annual fee for all UMASS Amherst users, individual users are not assessed a fee for the CITI training.

 

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4. Where do I find the on-line CITI training modules?

The training site can be found at http://www.citiprogram.org/.  Please read through the materials provided in the section entitled, Institutional Information.

 

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5. Which CITI training modules should I take?

Researchers should select the track that corresponds to the type of research typically conducted.  Generally, the Biomedical Research Module would be required for medical, physiological or pharmacological studies. This includes, but is not limited to, research with drugs, devices or other interventions. The Social and Behavioral Research Module related to studies on sociological, psychological, anthropological or educational phenomena including observational and survey research and work with population and/or epidemiological studies.

 

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6. How long will it take me to take the CITI training modules?

The time required to complete each of the basic modules varies between 10 to 30 minutes.  The total time is estimated to be 2-3 hours.  The course does not have to be completed in one sitting and you can enter the course at any time.  Units are designed to be taken sequentially.

 

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7. Do I have to finish the training in one session?

You do not need to complete the course in just one session.  You are encouraged to use several "log-on" sessions, but you should take the quizzes immediately after completing each module.

If you log off the site and return at a later time, you will re-enter at the "Learner's Menu" page. Choose the Basic Course and you will be taken to the Grade Book to begin at the next required module.  The course software will keep track of your progress.  When you finish the quiz for a module, the software will give you a link to your next module or the opportunity to view the Grade Book.

 

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8. What is the passing score on the quizzes?

A passing score of 75% is required.  If you are not satisfied with your score, you can retake the quiz to improve.

 

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9. How will the IRB know my training is complete?

When you have completed all requirements, you will be able to download a Course Completion Report. This "Report" is like a transcript and will provide a detailed record of you accomplishments and must be submitted with your human subject protocol materials when seeking IRB review of your research.

 

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10. Will UMASS accept certificates of training from other institutions?

Certificates provided by researchers that have completed training on the previously required modules located on the Veteran's Administration web site, from the NIH modules or from another institution holding a Federal-wide Assurance will be accepted.

 

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11. Will the IRB review a protocol if all key personnel are not trained?

Yes, the IRB will begin the review of the initial application, however, the project will not be approved until all key personnel are trained and certified.  Researchers must inform the IRB when additional personnel are added to a project.  Training certificates for any new key personnel must also be submitted prior to the submission of the IRB Annual Protocol Report Form.

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12. When do I have to renew my training?

UMASS Amherst does not currently require renewal of this training program.

 

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13. What if I have questions?

Please contact:

Human Research Protection Office (HRPO)
108 Research Administration Building
70 Butterfield Terrace
University Of Massachusetts
Amherst, MA 01003-9242

Phone: (413) 545-3428
FAX: (413) 577-1728
Email: humansubjects@ora.umass.edu

 

 

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