Mandatory Training


Purpose

The purpose is to outline the policies and procedures for mandatory educational training in human and animal research.

Definitions

CITI is the Collaborative Institutional Training Initiative (www.citiprogram.org). Established by the University of Miami and developed with the aid of many other research institutions, it is the provider of high quality, peer-reviewed, web-based educational courses in research, ethics, regulatory oversight, responsible conduct of research, research administration, and other topics pertinent to the interests of member organizations and individual learners.

Engaged in research activities with humans means that an individual during research:

  1. obtains the informed consent of human subjects;
  2. performs an intervention or interaction with human subjects for the purposes of the research; or
  3. works with identifiable, private information about the subjects of the research.


Policies

Educational training in the protection of human subjects (or participants) or animals is required for all investigators and sponsors/advisors involved in research with humans or vertebrate or non-vertebrate animals. Investigators include members of the research team, such as co-investigators and research assistants, but also may extend to others who work directly with subjects, such as live interpreters (human research).

All persons engaged in research activities involving human subjects must complete two, basic online training courses and submit to the Institutional Review Board or Exempt Review Committee their completion reports (indicating all modules completed), as follows:

  1. Human Research Curriculum (HRC) - Social/Behavioral or Biomedical learner group based on learner's primary discipline or role
  2. Responsible Conduct of Research (RCR) - Basic learner group (Individual selections by discipline were discontinued July 30, 2015, but are still valid.)

Additional learner groups or individual modules may be required in certain circumstances, such as, but not limited to the following:

  • Investigators utilizing FDA-covered drugs (requiring an Investigational New Drug application to the FDA), biologics or devices must complete the Clinical Trial Researcher learner group.
  • Investigators working with a population in a foreign country need to complete the Human Research Course's International module (listed as optional, but needed for International research).
  • The School of Social Work requires those completing field placements to complete the brief Information Privacy Security learner group. The completion report does not need to be submitted to the IRB/ERC.

Interpreters working directly with participants need only complete the Human Research Curriculum course.

Transcriptionists, document translators, translators of de-identified audio recordings, or other hired professionals performing a specific skill (e.g., X-ray technician) are usually not considered to be engaged in research activities so long as they are not interpreting or analyzing results, and therefore may not be required to complete online training. Decisions about training for these individuals will be made on a case-by-case basis.

Completion of the training courses is a one-time requirement and currently does not expire.

Each course consists of several modules followed by brief quizzes. According to CITI, each course takes approximately 2-4 hours to complete. 

The Human Research Curriculum (HRC) course covers topics such as:

  • History and Ethical Principles
  • Privacy & Confidentiality
  • Assessing Risk
  • HIPAA
  • Informed Consent
  • The Regulations

The Responsible Conduct of Research (RCR) course covers topics such as:

  • Authorship
  • Peer Review
  • Collaborative Research
  • Research Misconduct
  • Conflict of Interest
  • Responsible Mentoring
  • Data Management
 

Chart of Available Courses Required by IRB, ERC, IACUC or School of Social Work

Responsible Conduct of
Research (RCR)
Human Research Curriculum
(HRC)
Institutional Animal
Care & Use Committee (IACUC)





Basic Track

Learner groups based on individual disciplines were
discontinued on
July 30, 2015, but are still valid if previously completed.

*Social & Behavioral Vertebrate Animal
*Biomedical Vertebrate Animal (Student)
Clinical Trial (Additional Track)

This is only for investigators involving FDA-covered drugs (involving an Investigational New Drug application to FDA),
biologics or devices. Such researchers
must complete this in addition to the Biomedical track.



Non-Vertebrate Animal

Information Privacy Security (Additional Track)

This brief, four-module track is a requirement of the School of Social Work for field placements. Training evidence must be submitted directly to the SSW and does not need to be submitted to the IRB/ERC.

IACUC Members & Staff

For individuals who serve on the IACUC
or office staff ONLY

IRB Staff & Members (Not for investigators)

This is only for RSP employees or IRB/ERC board members.
The course includes both Biomedical and Social/Behavioral learner groups.

 
* One of these two courses is required for all investigators and sponsors/advisors involving humans in research. Some investigators may have to take additional learner groups or specific modules as stated in the policies above.

Procedures

CITI Registration:

  1. Visit the Collaborative Institutional Training Initiative (CITI) at www.citiprogram.org.
  2. If new to the website, click Register in the upper right corner of the page. If already registered, click Login.
  3. CITI's Step 1:
    1. Under Select Your Organization Affiliation, type Marywood University into the search box.
    2. Click the check box agreeing to the Terms of Service. 
    3. Click Continue to Step 2.
  4. CITI's Steps 2, 3 and 4: Supply your name, email address, user name, password and country of residence.
  5. CITI's Step 5: Click yes or no to indicate if continuing education credits will be purchased. They are not required for Marywood University's boards and are optional.
  6. CITI's Step 6: Indicate language preference and other institutional specific questions.
  7. CITI's Step 7: Enroll in required courses by checking the appropriate boxes under each section.
    1. Question 1 (Human Research Course): Those working with human subjects will check a box for one learner group within this course (e.g., social/behavioral, biomedical, etc.). The IRB Members and Staff group is only for those serving on the IRB or working in the IRB office.
    2. Question 2 (Responsible Conduct of Research Course): Check the box next to this basic course.
    3. Any additional requirements are described above in the policies.
  8. Click Finalize Registration. You will now be able to access the Main Menu of your account. Learners may complete course content on their own schedule and sign in any time to view their progress.
  9. To begin a course, click on the course name. 
  10. If you need to change your course registration, click on Add a Course or Update Learner Group.
  11. After each course is completed, the CITI system will make available a completion report for downloading.

Accessing Completion Reports and Submitting via IRBNet:

  1. Visit the Collaborative Institutional Training Initiative (CITI) at www.citiprogram.org and log in on the home page.
  2. If it does not automatically open, click on Marywood University Courses on the blue menu to expand it.
  3. To the right of the appropriate course, and under the column labeled Completion Record, click View-Print-Share.
  4. Under the section called Completion Report, click the blue link. Do not select the link under Completion Certificate. The board requires the full report version, which will show all completed modules and course grades.
  5. Save the .pdf document to a computer or flash drive.
  6. Upload and submit the training reports in one of the following ways (see IRBNet Instructions for Researchers document). Note that IRBNet's "External Account" transfer feature is not active because Marywood University does not subscribe to it.
    1. Directly into your IRBNet user profile
      Submitting the reports in this manner will take place one time and carry across multiple IRBNet projects, provided that the Principal Investigator (if other than the learner) shares an IRBNet project with you.
    2. In a package with other application materials
      Submitting the reports in this manner will require the action to be repeated with each new project.
NOTE: The Information Privacy Security course, required by the School of Social Work for field placements, must be submitted directly to that department.

Questions about online training requirements or the CITI web site should be directed to Ms. Courene M. Loftus, MPA, CIP,  at (570) 961-4782 or cloftus@marywood.edu.

 


Related Policies

 


History

08/30/2013 - Updated
07/07/2014 - Updated with the word biologics; chart adjusted
04/10/2015 - Updated with additional information on Information Privacy and Security
07/31/2015 - Updated procedures and contact information for questions
12/14/2016 - Updated to include new contact information and Animal policy link (related policies)
02/28/2017 - Updated instructions about full completion report with modules instead of general certificate
06/09/2017 - Updated CITI definition and added link
09/14/2017 - Updated procedures to match revised CITI site.