Human Subject Research (IRB): Mandatory Education Requirements
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Since June 2000 the NIH has mandated educational training in the protection of study volunteers for all clinical investigators.
Lifespan IRBs require all clinical investigators and their key personnel certify they have completed this mandatory training in human subjects protection.
To meet this mandatory training certification in Human Subjects Protection the Office of Research Administration offers an online training program through CITI, Collaborative IRB Training Initiative. This online program offers both the initial certification and a three year re-certification program required by Lifespan.
Instructions for logging on to the CITI site are provided below. The Office of Research Administration will be notified upon Completion of either the Basic CITI Protection of Human Research Subjects course (Initial certification), or the Refresher course (3 year Re-certification course). HIPAA certification is included in both programs so whichever program you take you will have certified in HIPAA for research training as well. If you require HIPAA training only the program allows for selecting HIPAA alone. HIPAA requires an annual re-certification.
CITI now offers Good Clinical Practice (GCP) training. The instructions below will provide you with information in selecting this training program as well.
You may complete the course and exams at one time or over several different times. Remember the password and logon you use to register so you may log on and complete the course if you decide not to complete the course in one sitting. We do not receive notification of the password or logon you used to complete this course.
The ORA maintains a list of individuals who have completed the training. You will receive notification when your three-year recertification is due.
For additional information concerning initial certification, re-certification, HIPAA for Researchers or GCP training please contact Jacqui Poore, firstname.lastname@example.org, or Janice Muratori, email@example.com.
Thank you for taking these mandatory Human Subjects Protection and HIPAA courses. Your efforts are helping Lifespan maintain our high standard of research and ensure protection for all research participants.