Campus Map/Tour Request Information Employment A-Z Index Directories
EDU Site
A Bold Heart Centennial Campaign

IRB: Mandatory Training

Mandatory Training


Purpose

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

Definitions

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:

  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) 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:

  1. Human Research Curriculum (HRC) - Biomedical or Social/Behavioral track based on discipline
  2. Responsible Conduct of Research (RCR) - Biomedical, Humanities, Physical Sciences or Social/Behavioral track based on discipline

Additional training courses or individual modules may be required in certain circumstances, such as, but not limited to:

  • Investigators utilizing FDA-covered drugs 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.

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:

  • 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
 

 

CITI TRAINING
CHART OF AVAILABLE COURSES

Human Research Curriculum

(HRC)

Responsible Conduct of Research (RCR)

Institutional Animal Care & Use Committee (IACUC)

Biomedical

Biomedical

Vertebrate Animal

 

Clinical Trial

For investigators involving FDA-covered drugs or devices only; such researchers must complete this in addition to the Biomedical track.

Humanities
Art Therapy, Music Therapy, Fine Arts, etc.

Vertebrate Animal (Student)

Non-Vertebrate Animal

 

Social & Behavioral

 

Physical Sciences

Use of Animals for Teaching Demonstrations

 

IRB Staff & Members

For individuals who serve on the IRB or office staff ONLY; course covers both Biomedical and Social/Behavioral research.

 

Social & Behavioral

IACUC Members & Staff

For individuals who serve on the IACUC or office staff ONLY


Procedures

  1. The learner visits the Collaborative Institutional Training Initiative (CITI) at www.citiprogram.org.
  2. The learner registers following the CITI New Learner Account Registration instructions.
  3. Courses consist of several modules followed by brief quizzes. According to CITI, each course can be completed in approximately 2-4 hours. 
  4. Once a course is completed, the CITI system will make available a completion certificate for the course.
  5. The learner saves each completion certificate electronically to his/her computer.
  6. 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 lacamlet@marywood.edu.



Related Policies

 


History

08/30/2013 - Updated

 


    For IRB or IRBNet questions, please contact irbhelp@marywood.edu.
    For web content editor questions, please contact cloftus@marywood.edu.
    Keith J. O'Neill Center for Healthy Families, Room 208 | 570-348-6211, x.2233