Collaborative Institutional Training Initiative (CITI) Education

SECTION ONE:  REQUIREMENTS

All Rutgers faculty, students, and other individuals involved in human subjects research* are required to complete the Collaborative IRB Training Initiative (CITI) Basic Course and complete the CITI Refresher Course every three (3) years thereafter. This requirement extends to all IRB members and Human Subjects Protection program staff.

Campus IRBs will not issue final approval of any IRB submissions until it is verified that listed study personnel have completed the current requirements for human subjects research education.

Detailed Requirements:

You must take Rutgers’ CITI educational program prior to engaging in human subjects research if:

  • a human subjects research project is going to be performed in whole or in part on Rutgers premises. Those study personnel engaged in the research to be conducted on Rutgers premises must take the CITI program.  It doesn't matter whether these individuals are affiliated with Rutgers or with another institution and it doesn't matter which IRB or IRBs have reviewed and approved the study.
  • a Rutgers IRB is the sole IRB reviewing and approving a human subjects research project. All study personnel engaged in research for that project must take the CITI program.  It doesn't matter where the research is being performed and it doesn't matter whether the individuals engaged in the research are Rutgers-affiliated or affiliated with another institution.
  • a Rutgers-affiliated individual is going to engage in human subjects research (faculty, non-faculty staff, house staff officer, student, volunteer or other agent, acting in connection with his or her Rutgers responsibilities or educational program). An individual must take the CITI program, regardless of where the research is being performed, or which IRB or IRBs will review and approve the research.
  • a research project will make use of Rutgers private, identifiable information about human subjects or potential subjects. Study personnel using this information must take the CITI program, regardless of where the research is being performed, which IRB or IRBs will review the research, or whether the study personnel are affiliated with Rutgers.

Individuals not "engaged in research," as defined by federal Guidance on this topic, need not take the CITI program under any circumstances.  Consultation with Rutgers IRB staff should be sought prior to determining whether certain activities for a human subjects research project constitute "engagement in research." If you have any questions regarding the requirements detailed above, you may contact Rutgers’ CITI Administrator @ (973) 972-9595 or your Campus IRB office for assistance.

SECTION TWO:  INSTRUCTIONS

IMPORTANT:The CITI education course is not the same as any other Human Subjects Protection training you may have already completed. In order to conduct Human Subjects Research at Rutgers you must complete the “CITI Human Subject Protections Basic Course” for the learner group appropriate to your involvement in research activities at Rutgers.

SAVE THE DATE

The office of Human Subjects Protection and Institutional Review Boards presents: "Understanding the Various Types of IRB Review: Non-Human Subject, Exempt, Expedited, Facilitated, Full Board, and Quality Assurance"

Speakers:

  • Paula Bistak, DMH, RN, MS, CIP, CHRC
  • Donna Hoagland, LPN, BS, CIP, CCRC
  • Carlotta Rodriguez, BS, CIP

Date 1: October 7, 2011 - (10AM -12PM): Newark Location 1: Medical Science building, 185 South Orange Ave, Rosemary Gellene Room, Level B, Room 515

Date 2 : October 20, 2011 - (10AM -12PM): Stratford Location 2 : University Education Center (UEC), 40 East Laurel Road, Room 1081, Speakers: Paula Bistak, DMH, RN, MS, CIP, CHRC and Carlotta Rodriguez, BS, CIP

Date 3 : November 1, 2011 - (10AM -12PM): New Brunswick Location 3 : 125 Paterson Street, CAB Conference Center, Room 1302 , Speakers: Paula Bistak, DMH, RN, MS, CIP, CHRC and Donna Hoagland, LPN, BS, CIP, CCRC

RSVP: Shelia Evans: evanssg@umdnj.edu

eIRB Note: eIRB will synchronize your completion records with CITI. The criteria for synchronization is a matching email address. The email provided to CITI must match the email listed in eIRB.

Instructions

Initial Registration for New Learners - Print View (PDF format)

  1. Go to http://www.citiprogram.org and select 'New Users: Register Here'.
  2. Select Rutgers - The State University of New Jersey (All Campuses) from the drop down menu of participating institutions.
  3. Enter a user name & password, name and other demographics as prompted.   For Rutgers faculty and staff, your user name must be your Rutgers email address.  For affiliates, you may use your professional/personal email account.
  4. To complete the CITI registration process, you must choose an answer to the enrollment questions as follows:

Question 1:   With very few exceptions, new learners must select the first option:
                       “CITI Human Subject Protections Basic Course”.
Question 2:   Please choose from one of five options appropriate to your research activities.

Question 3:   If you have not previously completed a CITI Basic Course, you must select “I have not previously completed a Rutgers-approved CITI Basic Course”. Any other answer here will take you to a “Refresher Course” for that curriculum.  Please note that Rutgers learners must complete the Basic Course first.
Questions 4 thru 6 – SKIP   However, you can select those optional modules if you choose to complete them.  If not, you can return to the website and add those modules at your convenience.  (See instructions below to “Add a Course or Update Your Learner Groups”)

Completing the course - Print View (PDF format)

  1. Enter the course from “Main Menu” under “My Courses”.  You will see the “Status” column, click “Enter”. This will permit access to the required modules and associated quizzes.  

    Each module of the required Basic Course takes approximately 15 – 20 minutes to complete. You may log in as many times as necessary; however, you may only print a ‘Completion Report’ after all required modules / quizzes are completed.

    The minimum passing aggregate score is 80%. A running tally is automatically compiled for you by the CITI system.
  2. To return to CITI at any time, log in as Already Registered”.  Click on the “Re-enter” link on the “Main Menu” under ‘Status’ to access remaining modules and quizzes.

 

CITI Completed at other institution - Print View (PDF format)

Changing Affiliation to Rutgers - The State University of New Jersey (All Campuses): 

If you have taken the CITI education at another institution within the last three (3) years, you maynot need to repeat the Basic Course at this time.  However, Rutgers needs to verify that the CITI modules you have completed meet the Rutgers human subjects protection education requirement. To do this, you must change your affiliation to “Rutgers - The State University of New Jersey (All Campuses)”.

  • Return to the main learner menu and select 'Affiliate with another institution'.  Work through this screen. You will be prompted to answer six enrollment question
  • Question 1:    Select “CITI Human Subject Protections Basic Course”.
  • Question 2:   To select a learner group, choose from one of five options only.
  • Question 3:  You must select “I have not previously completed a Rutgers-approved CITI Basic Course”. This allows the computer system to compare CITI modules already taken with those required by Rutgers.
  • Questions 4 thru 6 - SKIP, However, you can select those optional modules if you choose to complete them.  If not, you can return to the website and add those modules at your convenience. 
  • At “Main Menu” under “My Courses”.  You will see the “Status” column which will appear as either “Complete” or “Incomplete”. Click on the “Re-enter” link to gain access to any outstanding modules needed to complete Rutgers’ specific education requirement. If your status appears as complete, this means there are no additional modules you need to take at this time; simply click “Print” for the completion report.

Printing a completion report:
Print a “Completion Report” as evidence that you have met Rutgers educational requirement.  You can also return to the CITI site at any time to obtain a copy as needed.  

Add a Course or Update Your Learner Groups
To add a course or update your learner groups for Rutgers - The State University of New Jersey (All Campuses)

    1. Go to http://www.citiprogram.org and select “Already Registered”.
    2. Select “Add a course or update your learner groups for Rutgers - The State University of New Jersey (All Campuses)”.   You will be taken to the “Select Curriculum” page
    3. Question 1, select “CITI Human Subject Protections Basic Course”.
    4. Question 2, select the additional course you want to access.
    5. Question 3, select the course you previously completed. 
    6. Skip Question 4, unless you are also adding Laboratory Animal Welfare research course.
    7. Questions 5 and 6 – Select all courses which are of interest to you and click “Continue”.
    8. Enter the course from “Main Menu” under “My Courses”.  You will see the “Status” column, click “Enter”. This will permit access to the required modules and associated quizzes.  

Refresher requirements:

Rutgers requires that once you have completed a Basic Course in human subjects protection, you must also complete the Rutgers CITI Refresher Course every three (3) years. Your CITI profile will be electronically notified when you are required to take the Refresher Course ninety (90) days prior to expiration.

The CITI website is frequently adding new modules that may be viewed at any time. All required and optional CITI modules are available for ongoing use and reference; however, you will receive no continuing education credits toward the Basic or Refresher Courses required by Rutgers. You may, however, request credits directly from the University of Miami Leonard M. Miller School of Medicine at umcme@med.miami.edu

Optional modules:

a. General interest and suggested reading only

You do not receive "extra credit" for completing them. They do not show up on any completion reports. They will be credited in a grade book if you subsequently enroll in a course that includes them.

1. Return to CITI at any time, log in as "Already Registered". In "Main Menu", select the topic of your choice by clicking "Optional Modules"

b. Good Clinical Practice Course / Responsible Conduct of Research

  1. Go to http://www.citiprogram.org and select "Already Registered".
  2. Select "Add a course or update your learner groups for Rutgers - The State University of New Jersey (All Campuses)". You will be taken to the "Select Curriculum" page
  3. Question 1, select "CITI Human Subject Protections Basic Course".
  4. Question 2, If you wish to upload the optional module "Reference Resource" make that selection. If not, select the course you previously completed.
  5. Question 3: Select the course you previously completed.
  6. Skip Question 4, unless you are also adding the Laboratory Animal Welfare research course
  7. Questions 5 and 6 – Select all courses which are of interest to you and click "Continue".
  8. Enter the course from "Main Menu" under "My Courses". You will see the "Status" column, click "Enter". This will permit access to the required modules and associated quizzes.

A record of all modules you completed is maintained in the database. You can locate your previously completed modules at "Main Menu" "Click here to see your previously completed coursework for Rutgers - The State University of New Jersey (All Campuses)"

Questions:

You may contact the Rutgers CITI Administrator @ (973) 972-9595 or your Campus IRB office for assistance.