Research Ethics Education and Training
Researchers have a responsibility for protecting the rights and well-being of their research participants and for conducting research in an ethical manner that is in compliance with university and federal regulations. Ongoing education and training in research ethics by those conducting research with human subjects is an essential part of ensuring that the rights and safety of the research participants are protected. The Fairfield University IRB expects Principal Investigators and their research team members to understand and comply with the federal regulations, state and local laws, and Fairfield University policies governing research with human subjects.
“Research Team members” refers to persons who have direct contact with subjects, contribute to the research in a substantive way, have contact with subjects' identifiable data or biological samples (e.g., tissue, blood, urine, plasma, saliva), or use subjects' personal information.
Effective September 1, 2019, Principal Investigators who submit new IRB protocols will be required to offer evidence of appropriate education and training in research ethics for themselves and members of their research team. This applies only to protocols that are reviewed using expedited review or full board review, though education and training are encouraged for all types of research, including those categorized as exempt or quality improvement research.
The Principal Investigator (PI) who submits the protocol is responsible for ensuring that members of his or her research team are appropriately trained in research ethics and protecting human subjects. When a new protocol is submitted, the PI will be prompted to indicate what form of training he or she has had (typically by completing the CITI certificate program [described below] or some equivalent course such as the NIH Research Ethics course) and how he or she ensured appropriate training and education for the members of the research team (e.g., by having them complete CITI training, by engaging on project-specific training with them, or some suitable alternative).
How do I demonstrate ongoing research ethics training?
The Collaborative Institutional Training Initiative (CITI) is a web-based training program in human research subject protection. Fairfield University subscribes to this program so that all faculty, staff, and students are eligible to take the various courses at no cost to themselves. CITI contains modules on topics like informed consent, vulnerable populations, ethical principles and IRB regulations. Each module has a short quiz at the end to assess understanding.
Which CITI modules are required?
The modules are grouped by categories of research. You only need to complete one group of modules, and should choose the group that best fits the type of research you normally conduct. If in doubt, ask your IRB Chair. For many researchers at Fairfield University the “Social-Behavioral-Educational (SBE) Basic Course” will be the most useful. Others will find the “Biomedical (Biomed) Basic Course” more relevant if they conduct research in clinical or hospital settings. These and other courses are available to all faculty, students, and staff through the University’s subscription to the CITI Program, so please use it and encourage your students to do the same if it is relevant to their course of study.
- Group 1: Biomedical Research: Medical, physiological or pharmacological studies that typically involve direct contact with subjects. Includes, but is not limited to, research with drugs, devices or other interventions.
- Group 2: Social and Behavioral Research: Studies on sociological, psychological, anthropological or educational phenomena that typically involve direct contact with subjects. Does not include drug or device studies.
- Group 3: Data and Specimens ONLY: No direct contact with human subjects. Research limited to use of records, data (including secondary data sets), or biological samples.
In addition to the required modules, you should complete any “OPTIONAL” modules that apply to your research projects. For instance, the CITI “Good Clinical Practice (GCP)” course is relevant for researchers involved in the design, conduct, or reporting of clinical trials involving human subjects.
What if I completed CITI training at another institution?
If you completed CITI training at another institution within the past 3 years, (1) log-on to CITI using your existing CITI username and password, (2) click “affiliate with another institution,” (3) select Fairfield University as your Participating Institution. If it was longer than 3 years ago, you should take the CITI refresher course.
What if I completed some other ethics training certificate program?
If you completed an equivalent alternative program such as the NIH Research Ethics Course within the past 3 years, you can provide that certificate as evidence of ethics education and training. If it was longer than 3 years ago, you should take the CITI refresher course. If in doubt, ask the IRB Chair.
How much time will it take to do the CITI course?
This will depend on your experience with human research issues. Most modules will take about 10-20 minutes to complete, and there are several modules for each course. Researchers familiar with these topics may require 3 hours or less to complete all of the required modules for a given course. You do not have to complete all the modules at once. The CITI course is designed for you to work at your own pace, and allows you to exit and return at a later date to where you left off.
What is the passing score on the quizzes?
You must receive a total passing score of 75% after completing all the required modules. You can track your progress on-line by clicking on the GRADE BOOK. If you do not obtain a total passing score of at least 75%, you can return to the modules and retake the quizzes.
Is there a fee?
The University pays an annual fee for all Fairfield faculty, staff, and students so that individuals are not assessed a fee for the CITI training.
When do I have to renew my training? Does it expire?
Continuing education is not required at this time. Note: Disregard any statements about training expiration being valid only for 3 years on your CITI certificate. For this new required training by the Fairfield IRB, certification does not expire. When in the future an annual refresher course is required, ample notice will be provided on the Fairfield University IRB website.
How do I access the CITI courses?
- Go to http://www.citiprogram.org
- As a “new” user, you will need to select “Register".
- Select “Fairfield University” from the Participating Institutions.
- Complete the required registration fields and contact information and click submit.
- You will need to select “Human Subjects Research” from the CITI Enrollment web page and click next.
- Select the “Biomedical Human Research Investigators Course” or the “Social & Behavioral Human Research Investigators Course” and click submit.
A table will be displayed listing the course(s) you are enrolled in. You can begin the course by clicking on the course name.
You will have the opportunity to print a Training Certificate Completion Report upon completion of the training course and exam. Please save a copy of this report for your records and to upload to the Fairfield IRB submission portal when you submit a new protocol.