Policies & Procedures
- Approval of Research
- Closure or Withdrawal of Research
- Continuing Review
- Deception in Research
- Departmental Review Boards
- Dietary Supplements
- Exempt Review of Research
- Expedited Review of Research
- Full Review of Research
- General Application Procedures
- 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
- Submission of Applications
- 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 research.
CITI is the Collaborative Institutional Training Initiative (CITI Program). Established by the University of Miami, it is the provider of web-based, educational content covering research.
Engaged in research activities 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) is required for all investigators and faculty sponsors involved in research with humans. 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.
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 certificates, as follows:
- Human Research Curriculum (HRC) - Biomedical or Social/Behavioral track based on learner's primary discipline
- Responsible Conduct of Research (RCR) - Basic track (Individual selections by discipline were discontinued November 25, 2014, but are still valid.)
Additional training courses 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 additional HRC Clinical Trial Researcher track.
- Investigators working with a population in a foreign country need to complete the HRC's International module.
- The School of Social Work requires completion of the brief Information Privacy Security track.
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 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.
The Human Research Curriculum (HRC) course covers topics such as:
The Responsible Conduct of Research (RCR) course covers topics such as:
CHART OF AVAILABLE COURSES
|Responsible Conduct of
|Human Research Curriculum
Care & Use Committee (IACUC)
Selections offered according to individual disciplines were
November 25, 2014, but are still valid.
|*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 and must be completed in addition to a full track in human research (either one of * above).
|IACUC Members & Staff
For individuals who serve on the IACUC
IRB Staff & Members (Not for investigators)
This is for individuals who are IRB office staff or board members only. The course includes both
- The learner visits the Collaborative Institutional Training Initiative (CITI) at www.citiprogram.org.
- The learner registers following the CITI New Learner Account Registration instructions.
- Courses consist of several modules followed by brief quizzes. According to CITI, each course can be completed in approximately 2-4 hours.
- Once a course is completed, the CITI system will make available a completion certificate for the course.
- The learner saves each completion certificate electronically to his/her computer.
- The learner uploads each completion certificate electronically to his/her IRBNet user profile or submits it with an application package (see IRBNet Instructions for Researchers document).
Questions about online training requirements or the CITI web site should be directed to Dr. Laura Ann Camlet Houser, Director of Research Compliance, at (570) 340-6031 or firstname.lastname@example.org.
- 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
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