The purpose is to outline the policies and procedures for mandatory educational training in human and animal research.
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, and 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:
- obtains the informed consent of human subjects;
- performs an intervention or interaction with human subjects for the purposes of the research; or
- works with identifiable, private information about the subjects of the research.
A Clinical Trial (for National Institute of Health purposes) is a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes
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 (transcripts indicating all modules completed, not certificates), as follows:
- Human Research Curriculum (HRC) - Social/Behavioral or Biomedical learner group based on learner's primary discipline or role
- Responsible Conduct of Research (RCR) - Basic learner group (specific disciplines were discontinued July 30, 2015)
ADDITIONAL LEARNER GROUPS OR INDIVIDUAL MODULES MAY BE REQUIRED IN CERTAIN CIRCUMSTANCES, such as, but not limited to:
- Investigators conducting research with FDA-covered drugs (requiring an Investigational New Drug application to the FDA), biologics or devices must complete the Clinical Trial Researcher learner group (includes Good Clinical Practice).
- Investigators conducting NIH-funded clinical trials must complete the Clinical Trial Researcher learner group (includes Good Clinical Practice), and NIH requires it to be renewed every three years.
- Investigators conducting research on foreign soil must complete the Human Research course's international module (listed as optional, but needed for International research).
- Students in the School of Social Work completing field placements must complete the brief Information Privacy Security learner group, but should not submit reports to the IRB or ERC. They are required by that school, which uses our training system.
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 (exception - those involved in an NIH-funded clinical trial).
Each course consists of several modules followed by brief quizzes. According to CITI, each course takes approximately 2-4 hours to complete.
The Responsible Conduct of Research (RCR) course covers topics such as:
Chart of Available Courses Required by IRB, ERC, IACUC or School of Social Work
|Responsible Conduct of
|Human Research Curriculum
Care & Use Committee (IACUC)
Learner groups based on individual disciplines were
July 30, 2015, but are still valid if previously completed.
|*Social & Behavioral||Vertebrate Animal|
|*Biomedical||Vertebrate Animal (Student)|
|Clinical Trial/Good Clinical Practice (Additional Track)
This is only for investigators involving FDA-covered drugs (involving an Investigational New Drug application to FDA), biologics or devices, or those conducting clinical trials funded by NIH. Such researchers
must complete this in addition to the Biomedical track.
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 should not be submitted to the IRB/ERC.
|IACUC Members & Staff
For individuals who serve on the IACUC
IRB Staff & Members (Not for investigators)
This is only for IRB office employees or IRB/ERC board members.
- Visit the Collaborative Institutional Training Initiative (CITI) at www.citiprogram.org.
- If new to the website, click Register in the upper right corner of the page. If already registered, click Login.
- CITI's Step 1:
- Under Select Your Organization Affiliation, type Marywood University into the search box.
- Click the check box agreeing to the Terms of Service.
- Click Continue to Step 2.
- CITI's Steps 2, 3 and 4: Supply your name, email address, user name, password and country of residence.
- 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.
- CITI's Step 6: Indicate language preference and other institutional specific questions.
- CITI's Step 7: Enroll in required courses by checking the appropriate boxes under each section.
- 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.
- Question 2 (Responsible Conduct of Research Course): Check the box next to this basic course.
- Any additional requirements are described above in the policies.
- 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.
- To begin a course, click on the course name.
- If you need to change your course registration, click on Add a Course or Update Learner Group.
- After each course is completed, the CITI system will make available a completion report for downloading.
Accessing Completion Reports and Submitting via IRBNet:
- Visit the Collaborative Institutional Training Initiative (CITI) at www.citiprogram.org and log in on the home page.
- If it does not automatically open, click on Marywood University Courses on the blue menu to expand it.
- To the right of the appropriate course, under the Completion Record column, click View-Print-Share.
- Under the section called Completion Report, click the blue link (first link). Do not select the link under Completion Certificate. The board requires the full report (transcript) version, which will show all completed modules and course grades.
- Save the .pdf document to a computer or flash drive.
- Upload and submit the training reports in one of the following ways (see IRBNet Instructions for Researchers document). Do not use IRBNet's "External Account" transfer feature. Marywood University does not subscribe to it, so it will not work.
- Upload the report into the project package with other application materials. Submitting the reports in this manner will require the action to be repeated with each new project.
- Upload the report directly into your IRBNet user profile (must be own profile, not another's). Submitting the reports in this manner will take place one time (exception: NIH clinical trial requiremen) and carry across multiple IRBNet projects. You do not need to link training reports to a particular study, as staff will see them so long as they've been uploaded into your IRBNet user profile.
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 email@example.com.
- Educational Training in Human Participants Protection for Investigators (Research Team)
- Educational Training in Human Participants Protection for IRB Members and IRB Administrative Personnel
- Educational Training in Responsible Conduct of Research
- Educational Training in Animal Research
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
03/15/2018 - Updated NIH-related definition and training requirements; updated procedures section