Policies & Procedures
- An Overview
- Application Process and Deadlines
- Approval of Research
- Closure or Withdrawal
- Continuing Review
- Deception or Incomplete Disclosure
- Departmental Review Boards
- Dietary Supplements
- Exempt Review
- Expedited Review
- Full Review
- Incentives in Research
- Informed Consent, Parental Permission and Child Assent
- International Research
- IRB Administration
- IRB Review Process
- Mandatory Reporting
- Mandatory Training
- Non-English Speaking Participants
- Oral History
- Prisoner Research
- Records Retention
- Recruitment of Participants
- Reproductive Risk in Clinical Research
- Responsibilities of Investigators and Sponsors
- Revisions to Approved Research
- Separation of Principal Investigators
- Student Research
- Suspension or Termination
- University Policy on Human Research
- Whistleblower Policy
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 (CITI Program). Established by the University of Miami, 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:
- 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.
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:
- 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 (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 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 (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.
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
IRB Staff & Members (Not for investigators)
This is only for ORSP employees or IRB/ERC board members.
- The learner visits the Collaborative Institutional Training Initiative (CITI) at www.citiprogram.org.
- The learner registers following the CITI New Learner Account Registration instructions, and selects affiliation with Marywood University.
- The learner selects the appropriate courses and learner groups within these courses (as applicable).
- As each course is completed, the CITI system will make available a completion report for the course. On the main menu under the Completion Record heading in the table, the learner clicks view/print (do not click share).
- The completion report must be the version which shows all modules completed, not the general certificate.
- The learner saves each completion certificate electronically as a .pdf file to his/her computer.
- The learner uploads each completion report electronically to his/her IRBNet user profile or submits it with an application package (see IRBNet Instructions for Researchers document). The Information Privacy Security course, required by the School of Social Work, may 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 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