Spring 2008, Issue 8

Updated Human Subject Education Requirements

What are the updated HSC IRB education requirements?
They consist of basic training and annual continuing education.

Basic training consists of two parts:

  • Part 1. Four (4) required, online education modules provided through the Collaborative Institutional Training Initiative (CITI).

  • Part 2. One (1) elective CITI module or an HSC IRB-approved lecture.

Annual continuing education requirements for 2008 consist of the CITI module “Workers as Research Subjects - A Vulnerable Population,” plus one elective CITI module or an HSC IRB-approved lecture. The 2008 continuing education must be completed before December 31, 2008.

Who is required to complete the HSC IRB education requirements?
All key personnel involved in human subjects research are required to complete the HSC IRB requirements.

Exception: If you completed Tufts HSC IRB education requirements prior to 2007 you do not need to complete basic training but you do need to complete annual continuing education.

When do the education requirements have to be completed?
Basic training has to be completed prior to participation in any human subjects research activity. Annual continuing education is required as long as involvement in human subjects research continues.

Note: You may wish to complete the CITI HSC Course before developing a protocol because the course features tips and information on the process.

How do I get started on the CITI HSC Course?

  1. Review the Tufts HSC IRB education requirements.
  2. Review the Tufts HSC IRB Instructions on Accessing CITI.
  3. Review the Tufts institutional instructions for the CITI HSC Course. These are especially important because they tell you which Learner Group you should choose and which modules you need to complete.
  4. Register at the CITI Program website. Your affiliation is with Tufts University/Tufts Medical Center.

How do I complete a CITI HSC Course module?
Click on the first required module, read the information, click on the quiz link at the bottom of the page, take the quiz, and click “Submit Exam” to receive a score and save it. If you exit the quiz without submitting it, you will have to take it again.

Tips:

  • You can log in and out of the CITI Program at your convenience, completing modules at your own rate. Remember to submit the exam before exiting each module.
  • You can go back to review a completed module at any time.
  • You can copy the content of the page to a Microsoft Word file for future reference.

What do I do when I’ve completed all modules required by the HSC IRB?

You have two choices:

  1. You can download and print your CITI Completion Report from the Learner Main Menu, or
  2. You can complete an elective CITI module to fulfill Part 2 of the HSC IRB education requirements and then download and print your CITI Completion Report.

What do I do with my CITI Completion Report?
Retain your original CITI Completion Report and provide a copy to the principal investigator (PI) of your research project. PIs are required to retain copies of CITI Completion Reports for all research team members. Please note that these documents are subject to audit.

What do I do if I choose to fulfill Part 2 of the requirements by attending an HSC IRB-approved lecture?

  • Lectures related to IRB/human subjects protection topics will be announced through the HSC IRB office. Off-site lectures may also be approved.
  • Before attending a lecture, please contact the HSC IRB training coordinator at IRBoffice@tuftsmedicalcenter.org (or call the main HSC IRB office at (617) 636-7512) to confirm that the lecture will count toward the HSC IRB education requirements.
  • At the lecture, obtain a certificate of attendance. The HSC IRB office recommends that you bring a prepared paper with the title, speaker, date, and location of the lecture that the presenter can sign in case certificates are not available.
  • After attending a lecture, inform the HSC IRB training coordinator that you would like it to count toward your basic or continuing education requirements.
  • Retain the original certificate of attendance and provide the PI of the research with a copy.

For more information, please go to http://tnemcirb.tufts.edu/.

 

 

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