Collaborative Institutional Training Initiative (CITI) Education

Introduction to CITI Training

Rowan University is part of the CITI program along with nearly 1,200 other organizations around the world. CITI training content is extensively reviewed and critiqued by many experts and academic institutions and found to be one of the most appropriate training sites for human research subject protections. CITI training is an effective method in administering training amongst the Institutional Review Boards at Rowan University. It brings consistency, reviews and edits by experts in the field, allows for continued training, and accommodates researchers who already have completed CITI training or are affiliated with other institutions. In some instances, Rowan University may require additional CITI training pertaining to affiliated researchers and collaborators who are identified in an IRB application and who will conduct human subjects research at Rowan University.

Training Requirements

Investigators and key personnel at Rowan University who participate in the design, conduct, and/or reporting of research conducted on humans (including exempt categories of research) and all IRB members and IRB staff must be appropriately trained in the protections of human subjects. Continuing education and training is required every three (3) years for those who are continuously engaged in conducting research using human subjects. After three years, investigators planning for long-term engagement with human subject research may receive a reminder from the CITI training program to complete an abbreviated refresher course.

All key research personnel at Rowan University or its affiliated sites, for which the Rowan University IRB's have provided approval to conduct human subject research or anyone not affiliated with Rowan, but conducting human subject research in collaboration with Rowan employees, must provide a current human subjects protections training certificate or complete the online CITI training as well as any other necessary courses. IRB approval of any individual application is contingent upon fulfillment of this requirement. IRBs have the authority to suspend a study until human subjects protections training requirements are met. IRB members, Rowan's Human Subjects Protection administration officials, and staff are also required to complete this training. Non-Rowan employees who have completed training at another institution must affiliate themselves with Rowan University. Instructions for non-Rowan investigators to affiliate with Rowan CITI training is provided on the CITI IRB website. Individuals not engaged in human subject research as defined in our policies and procedures are not required to take CITI training.

CITI Training by Learner Groups

During CITI registration you will be prompted to select one of the three Learner Groups listed below. Select the Learner Group that most closely associated with the main emphasis of your IRB work. Learner Groups are divided as follows:

Learner Group 1:

IRB Chairs, Members and IRB Administrators are to complete training in Learner Group 1. Any IRB Chair is required to complete both the Chair and Member and Administrator training. Investigators and researchers cannot take Learner Group 1 training, and it will not be accepted as adequate training related to an IRB application submitted for review. CITI Learner Group 1 training titles are:

  • Group 1: IRB Chair, Members, and Administrators - IRB Chair
  • Group 1: IRB Chair, Members, and Administrators - IRB Member and Administrator Training

Learner Group 2:

This group is applicable to researchers conducting Biomedical Research at Rowan University, regardless of which IRB reviews the human subjects research. If an investigator or researcher is working with protected health information, they must complete HIPAA training. If an investigator or researcher is NOT working with protected health information, then they are NOT required to complete HIPAA training. If the investigator or researcher is conducting clinical trials or they are members of a clinical trial study team, they are required to complete the Good Clinical Practice (GCP) Courses. CITI Learner Group 2 training titles are:

  • Group 2: Biomedical and Basic Research - Biomedical and Basic
  • Group 2: Biomedical and Basic Research - Biomedical Data and Specimens Only Research

Additional courses that may apply:

  • Good Clinical Practice Course (US FDA Focus Required for those conducting clinical trials)
  • GCP Course for Clinical Trials Involving Investigational Medical Devices ( Optional International focus)
  • GCP Course for Clinical Trials Involving Investigational Drugs (Optional ICH focus)

HIPAA and Medical Research Training

Rowan University has prepared a training module entitled “HIPAA and Medical Research” for investigators, research staff and research coordinators to understand how HIPAA regulations affect research. This training module is in addition to the basic HIPAA training provided by Rowan University (via the HCCS website) for physicians and other healthcare staff to remain in compliance with HIPAA Privacy Rule. Please go to this webpage to review HIPAA and Medical Research Information and Training - HIPAA and Medical Research

Learner Group 3:

This group is applicable to researchers conducting Social and Behavioral human subjects research at Rowan University, regardless of which IRB reviews the human subjects research. If an investigator or researcher is working with protected health information originating from any part of RowanSOM (SOM Clinics and Kennedy Memorial Hospital), they must complete HIPAA training. If an investigator or researcher is NOT working with protected health information, then they are NOT required to complete HIPAA training. CITI Learner Group 3 training titles are:

  • Group 3: Social, Behavioral and Education Research

 

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, which is your Rowan University email account. You should always use in eIRB and CITI, your Rowan University email account as the primary email account. CITI allows you to add a secondary email.

 

Instructions

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

Step 1 - Go to http://www.citiprogram.org

Step 2 - Click on "register" in the Create new account box on the CITI webpage

Step 3 - In the box titled "Select Your Organization Affiliation" type in Rowan. Rowan University will appear in a box under the type. Click on Rowan University and then click on "Continue to Step 2"

Step 4 - Type in your First and Last Name. In the email box, input your Rowan University email address. Your secondary email address can be a personal email address, such as gmail or other email provider. Click on "Continue to Step 3" when completed.

Step 5 - Type in your Rowan University username (network username) or other username. Complete the sections for the password and security question. Click on "Continue to Step 4" when completed.

Step 6 - Complete the information for Country of Residence, Gender, Ethnicity and Race. Click on "Continue to Step 5" when completed.

Step 7 - Complete the information for Continuing Education Credits and Survey. Click on "Continue to Step 6" when completed.

Step 8 - Complete the information for Information Requested by Rowan University. Select the role that is most applicable to your purpose of creating a CITI account. Click on "Continue to Step 7" when completed.

Step 9 - Select the training to be completed. Users can select multiple training programs. For example, if you need to complete Responsible Conduct of Research (RCR) and Human Subjects Research Protections then you would select both. Click on "Continue" when completed.

 
 

Completing the course

1. Go to http://www.citiprogram.org and logon with your username and password.

2. Return to the Main Menu and click on the title of the CITI training located in the column labeled ‘Course’. The column labeled ‘Status’ will appear as ‘not started’ or ' incomplete - Re-enter'. Click on this link to gain access to the required modules and associated quizzes.

a. 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.

b. The minimum passing aggregate score is 80%. A running tally is automatically compiled for you by the CITI system.

c. The average time to complete the human subjects protections training is roughly 3 to 4 hours. However, those times may vary depending on additional modules required to be completed and/or an investigataor/researcher prior knowledge of human subject research protections.

Note: The Course status options are listed below:

  • Not started - Enter
  • Incomplete - Re-enter (at least one required module is complete) or
  • Passed - completion date (All required modules are complete) Follow the link to "Print" a Completion Report.

CITI Completed at other institution

If you have taken the CITI education at another institution within the last three (3) years, you may not need to repeat the Basic Course at this time; however, Rowan University needs to verify that the CITI modules you have completed meet the Rowan University human subjects protection education requirement.

To do this, you must updeate your affiliation in CITI to include Rowan University.

1. Go to http://www.citiprogram.org and logon with your username and password.

2. Return to the main learner menu and select 'Affiliate with another institution'. You then should complete a Rowan University information screen (see Step 8 in the webpage section titled: Initial Registration for New Learners). Upon being able to or directed to identify the training required, please go to the appropriate curriculum and select the training that is most approrpriate to your research purposes, and if you have a previous CITI certificate, select that training that you have already completed at another institution and which is documented in the CITI program.

For example, after affiliating with Rowan University, you are required to select the appropriate modules/courses. Since I have a current certificate in the Social and Behavioral Basic training with another institution in the CITI program, I will select Social and Behavioral Basic training in my Rowan University Affiliated CITI account. That will bring in our required training modules, and of those modules that are the same pertaining to your past certificate, you will be given credit. If some modules that Rowan University requires, but was not required at your other affiliated institution, then you need to complete those modules ONLY. You will receive a certificate in CITI upon completion. However, there are some instances in which an affiliated member may not be required to take additional courses / modules.

 

You must return to the ‘Learner’s Menu’ to determine whether you have completed the Basic Course modules required by Rowan University. The column labeled ‘Status’ will appear as either ‘ Incomplete - Re-enter’ or ‘Passed - completion date’. Click on the re-enter link to gain access to any outstanding modules needed to complete Rowan University’s specific education requirement.

If your ‘status’ appears as Passed - completion date, this means there are no additional modules you need to take at this time; simply print a completion report.

Rowan University requires that once you have completed a Rowan University-approved Basic Course, you must complete the Rowan Univeristy CITI Refresher Course every three (3) years.

You will receive an automatic reminder from CITI approximately 90 days prior to your anniversary date.

You may return to the CITI site once you have completed the Basic Course.

In order to begin the refresher course, go to http://www.citiprogram.org and logon with your username and password.