IRB Policies and Procedures

Mandatory Training

Purpose

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

Definitions

CITI is the Collaborative Institutional Training Initiative (www.citiprogram.org). Established in 2000 by the University of Miami and developed with the aid of other research institutions, it is the provider of high quality, peer-reviewed, and web-based educational courses in research ethics, regulatory oversight, research administration, and other topics pertinent to the interests of member organizations and individual learners.

A clinical trial 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 biomedical or behavioral health-related outcomes.

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.

A Human Subject (Participant) is a living individual about whom an investigator (whether professional or student) conducting research:

  • Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
  • Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Policies

Educational training in the protection of human subjects is required of all investigators who are engaged in such research. 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. Research advisors (sponsors) and IRB staff and members must also complete training.

Educational training is conducted online through the CITI Program (www.citiprogram.org). Consisting of several modules followed by brief quizzes, each basic CITI course takes approximately two to four hours to complete. Completion of the human training courses is a one-time requirement with no current expiration. The Responsible Conduct of Research course will need to be repeated based on the specific federal award (e.g. four years for NIH clinical trial or three years for other types of awards).

Upon application to the Institutional Review Board or Exempt Review Committee for review, investigators must include their completion reports containing all transcripts. No CITI refresher courses will be accepted.

REQUIRED - Human Research Course (HRC)This course is required of all investigators engaged in human research and covers topics such as history and ethical principles, regulations, informed consent, assessing risk, privacy and confidentiality, vulnerable populations, etc. Learners must earn a minimum passing score of ninety (90) percent in this course. Learners must select one of the following tracks according to their primary discipline or role. The Staff & Members learner group is only for IRB office staff or members.
  • Social/Behavioral learner group
  • Biomedical learner group
  • Staff & Members learner group
Responsible Conduct of Research Course (RCR) – Only If Applicable

Only required if certain Federal funding is involved (e.g., NSF, NIH, USDA, etc.), this course covers topics such as authorship, collaborative research, conflict of interest, peer review, research misconduct and responsible mentoring. Investigators must earn a minimum passing score of eighty (80) percent for this course. The course will need to be repeated at intervals set by the funding agency.

Additional Courses or Individual Modules – Only If Applicable

One or more of the following may be required with the conduct of certain activities. The Information Privacy and Security course required by the School of Social Work does not need to be submitted to the IRB/ERC.

  • Clinical Trials Funded by NIH: Clinical Trial Researcher course (includes Good Clinical Practice); NIH requires renewal every three years.
  • FDA Oversight (e.g., drugs, some supplements, devices or biologics): Clinical Trial Researcher course (includes Good Clinical Practice)
  • International Research: International module.

Professional Services – Interpretation, Transcription, etc.

Because they interact with subjects and often participate in the informed consent process, live interpreters working directly with human subjects must complete the Human Research 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.

Unaffiliated Investigators

Training evidence provided by investigators who are not affiliated with Marywood University will be evaluated on a case-by-case basis. However, evidence of an outside training course must clearly indicate all topics covered. If outside investigators have completed training via their home institution’s CITI account, they must provide their full, basic course transcripts, not their refresher course transcripts.

Chart of Available Courses - IRB, ERC and SSW

Note: The Staff & Member learner group is only for board members or IRB office employees. Do not complete it unless requested to do so.

Main Courses

Learner Groups (Tracks) within Courses

Human Research Curriculum (HRC)


Required of All

Social/Behavioral
OR Biomedical


As Needed

Clinical Trial Researcher/GCP
Only for FDA or NIH Clinical Trails

As Needed
Information Privacy Security
Only for SSW - Do not submit to the IRB/ERC.

Responsible Conduct of Research (RCR)

As Needed
Basic Course -
Only for Federal Funding

Procedures

CITI Registration Instructions:

  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 checkbox 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, username, password and country of residence. If you have a secondary email account, add it. If not, leave it blank.
  5. CITI's Step 5: Click yes or no to indicate if you will purchase continuing education credits. This is optional and is not required by Marywood University.
  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 select one learner group (social/behavioral, biomedical, clinical trial or IRB Staff and Members). The social/behavioral course applies in most cases. Those working on a federally-funded clinical trial (e.g. drugs, biologics, devices) should take both the biomedical and clinical trial courses. Only those serving on the IRB or working in the IRB office may select the IRB Members and Staff course. It contains both social/behavioral and biomedical modules).
    2. Question 2 - Responsible Conduct of Research Course: Those working on a federally-funded project requiring this basic, RCR course will choose this selection in addition to the human research course or courses.
    3. Question 3 - Information Privacy and Security Course: Those in the School of Social Work (SSW) involved in field placements may be asked by the SSW to select this course. IT IS NOT REQUIRED BY THE IRB/ERC. Do not submit this report to the IRB or ERC.T he SSW requested that we add this course to meet its own needs.  Submit your report directly to the SSW only.
    4. Question 4 - Animal Research Course: Those working with animals will select the appropriate course.
  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.

CITI Completion Report Access Instructions:

  1. Visit the Collaborative Institutional Training Initiative (CITI) at www.citiprogram.org and log in on the homepage.
  2. Under Completed Courses, locate the course you wish to access. Then, click the yellow View-Print-Share Record button.
  3. On the left and under Completion Report, click the View / Print button. The board requires the full report (transcript) version, which will show all completed modules and course grades. Do not click Completion Certificate.
  4. Save the .pdf document to a computer or flash drive.
  5. Log in to IRBNet at www.irbnet.ort, and upload and submit the training reports in one of the following ways (see also 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 function.
    1. Upload the report to the project package with other application materials. Submitting the reports in this manner will require the action to be repeated with each new project if you have more than one.
    2. Upload the report directly to your IRBNet user profile (must be your own profile, not another's). Submitting the reports in this manner will take place one time (exception: NIH clinical trial requirement) 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.

Information Privacy Security (IPS) Course

Complete this only if required by the School of Social Work (SSW). Submit your report directly to the SSW only, not the IRB or ERC.

Questions

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

Related Policies

  • Educational Training in Human Participants Protection for Investigators
  • 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

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
03/15/2018 - Updated NIH-related definition and training requirements; updated procedures section
05/14/2018 - Updated RCR content, per a change approved by Marywood University's Policy Committee
05/23/2018 - Added that IPS course report should be submitted to the SSW
09/06/2018 - Updated how to submit reports
09/20/2018 - Updated additional courses for clarity
12/12/2018 - Updated procedures to reflect updates to CITI's website
07/05/2019 - Updated as a result of the Revised Common Rule
08/25/2020 - Updated the CITI instructions for learner group selection
10/19/2020 - Clarified the RCR training renewal requirement