Required Education in Protecting Human Research Participants

Background

Agencies that fund research, including federal agencies, require investigators to demonstrate that they understand the principles and regulations related to protecting human subjects. For example, since 2000, the National Institutes of Health have required education in the protection of human research participants for all investigators and key personnel submitting applications for grants or proposals for contracts, or receiving new or non-competing awards.

At many colleges and universities, such requirements are often extended to all research involving human participants at colleges and universities, whether funded or not, by institutional policies governing such research.

In order to be eligible to submit applications for IRB review at St. Norbert College, all faculty and staff researchers, those who supervise student researchers, and student researchers themselves, must demonstrate their understanding of the fundamental principles underlying and current regulations guiding the ethical conduct of research involving human participants.

And these requirements also apply to members of the St. Norbert College IRB and to those whose administrative responsibilities include oversight of the IRB and research on human participants.

Rationale

Required training in the principles and regulations guiding research on human participants is beneficial to:

• Researchers, who will be better able to plan and conduct research that upholds the values of respect, beneficence and justice and to prepare IRB applications that meet the criteria for approval 
• IRB members, who will be better prepared to review and evaluate proposed research projects, and who will be more confident in approving research applications prepared by researchers with a basic understanding of fundamental principles and current regulations
• Research administrators, who will be better prepared to train and to monitor the activity of Institutional Review Board members

Required Courses and Modules

At St. Norbert College, the required human participants research ethics courses and modules are provided by the Collaborative Institutional Training Initiative (CITI).

Specific requirements vary depending on one’s status (researcher or IRB member/administrator; faculty/staff or student) and one’s research focus (biomedical; social/behavioral/educational; public health; research grant recipient). For example, most student researchers will be assigned  five modules to complete a given course, whereas faculty/staff researchers or IRB members may be required to complete twice as many modules. The length of individual modules varies, and hence the time required to complete a module may range from 10 to approximately 30 minutes.

And in addition to the modules required of researchers as a result of their status or research focus, during the review of a given application the IRB may decide to require additional modules from a researcher depending on the particular ethical issues arising in the proposed project. 

With that said, all courses and modules are accompanied by quizzes, by a quiz scores of at least 80% correct for successful completion, and by a three-year approval before renewal of training is required.

Click the appropriate link below to access the CITI courses and modules:

• First time CITI users: how to register a new account, affiliated with SNC
• Returning CITI users at SNC: how to login in to resume or start a course/module

Frequently Asked Questions (FAQ) about CITI

• How do I transfer completed courses from my previous institution/CITI account?
• Can I complete a CITI course or modules over time, in multiple sessions? 
• In what formats are the courses and modules offered?
• How are quiz scores calculated? 
• How do I know whether I have passed a course or not?
• How can I view/print/share my record of completed courses/modules? 
• How do I know when my completed course expires? 
• I think I’m in the wrong course. How do I change and/or add a course?
• How do I troubleshoot a CITI problem?