Training
Human Subjects Research Training at No Cost to Investigators
Successful completion of approved training is expected for all principal investigators (PI) and faculty mentors involved in human subjects research (HSR). Principal investigators applying for IRB review and approval of research proposals must demonstrate successful completion of human subjects research training that reflects the revised Common Rule (effective 2018).
In addition, PI's (and Faculty Sponsors in the case of student research) are expected to ensure that all investigators involved in their study are adequately trained on current human subjects research standards/regulations, and must agree to meet this expectation in their application for an exemption or their request for expedited or full review.
CITI Program offers online HSR basic research training that is intended for anyone involved in research studies with human subjects, or who have responsibilities for setting policies and procedures with respect to such research. This training requires registration but is now provided by Keuka College at no cost to the individual.
Researchers seeking an introduction to the protection of human subjects and to satisfy Keuka College’s IRB proposal requirements have two options (listed below), and should complete the course(s) that best corresponds with their research and/or administrative activity.
The CITI Program divides HSR basic content into disciplinary categories:
Biomedical (Biomed) and
Social-Behavioral-Educational (SBE).
A description of these courses can be found at https://about.citiprogram.org/en/series/human-subjects-research-hsr/
Additional modules of interest within HSR are also available and allow for exploration of several important topics and may be selected to meet the researcher’s needs. All HSR modules (except legacy versions) reflect the revised Common Rule (2018 Requirements).
To set up your account through the college’s CITI Program subscription and register for courses:
Go to CITI Program’s Learner Registration page at https://www.citiprogram.org/index.cfm?pageID=154&icat=0&ac=0®ion=1&message=0
Under the first option, Select Your Organization Affiliation, type and select “Keuka College”
Follow the steps for setting up your account and choosing courses to complete. You will find the HSR basic content courses (referenced above) listed in the first set of course offerings. At this point, you will be allowed to choose 1 of the two HSR basic courses, and select other courses of interest. Once registered and enrolled, you will be able to enroll in additional courses available through the institution’s subscription.
Other Online Tutorials
OHRP Tutorials (videos) on the revised Common Rule
OHRP has produced a set of videos to help IRB personnel, researchers, and others in the research community learn about and understand the revised Common Rule. These videos are free and for educational purposes.
OHRP Online Tutorials & Videos
OHRP offers online educational materials at no cost to help IRB members and administrators, investigators, institutional officials, and others better understand the HHS regulations for the protection of human subjects in research and their responsibilities in protecting human subjects. https://www.hhs.gov/ohrp/education-and-outreach/online-education/index.html
The OHRP offers a series of lectures by esteemed individuals with thought-provoking insights on human subjects research protections. Recordings of these lectures are available at https://www.hhs.gov/ohrp/education-and-outreach/luminaries-lecture-series/index.html
National Institute of Health Financial Conflict of Interest (FCOI) Training
Looking for a training to satisfy the requirement for investigators to complete training in financial conflict of interest (FCOI) regulations when conducting NIH or PHS sponsored research? NIH has developed a new training that institutions can use to help satisfy this need. This interactive training module allows for printing of a certificate at the end. Remember, as per the NIH Grants Policy Statement, institutions will require investigators to complete the training prior to engaging in NIH-supported research and at least every four years, and immediately under the designated circumstances:
Institutional FCOI policies change in a manner that affects Investigator requirements
An Investigator is new to an Institution
An Institution finds an Investigator noncompliant with the Institution’s FCOI policy or management plan.
https://grants.nih.gov/grants/policy/coi/tutorial2018/story_html5.html