Human Subjects Education Training Requirement
Why?
91精简版 is committed to the continuing education of persons engaged in human subjects research to ensure that high-quality research is conducted with integrity. A human subjects education training requirement was first mandated by the National Institutes of Health in 2000 for individuals considered 鈥漦ey personnel" on research studies involving human subjects. In its written, legally binding agreement with the federal government (Federalwide Assurance 00007297), 91精简版 has indicated that it has elected to apply the same high-quality standards and education training requirements to all human subjects research, regardless of the source of support.
The reasons for the training requirement are numerous. Failure to meet the education component of our Federalwide Assurance (FWA) is considered noncompliance and has the potential to negatively affect funding opportunities for 91精简版 faculty, staff and students. In addition to federal funding, research funded by the state government and many foundations requires IRB approval. These requirements apply even for indirect support such as grants for student scholarships, developing facilities, and other purposes. In order to ensure the college is not at risk of losing these funds or prevented from obtaining funding from these sources in the future, we must apply the same rigorous standards to all research.
Additionally, rigorous IRB review of all human subjects research is part of 91精简版's mission to educate responsible citizens with a concern for research ethics during our students鈥� undergraduate careers and after graduation. We expect faculty to model this important aspect of scholarly citizenship and teach core ethical principles about human subjects research to their students.
As a result, beginning January 1, 2018, the individuals listed below are required to complete a human subjects education training course or show proof of a valid training certificate prior to IRB protocol approval for new applications, continuing review applications, and amendment requests.
Who?
Because of our legally binding agreement with the federal government and our commitment to high-quality, ethical research, the education requirement is extended to the following individuals:
- All key personnel, including students, conducting research involving human subjects and/or identifiable private information or identifiable biospecimens.
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- 鈥淜ey personnel鈥� are those individuals directly involved in conducting research with human subjects through an interaction or intervention, including participating in the consenting process, or who have access to identifiable private information or identifiable biospecimens, including protected health information.
- Faculty members who are listed as the faculty advisor on a student investigator鈥檚 IRB application (even if they are not interacting with participants and/or identifiable, private participant data).
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- The faculty advisor is an active mentor to the student researcher and shares the responsibility for the ethical conduct of the research with the student. The advisor is expected to be familiar and discuss with the student researcher the ethical and regulatory requirements of human subjects research prior to the initiation of any project involving human subjects, help students determine whether their project requires Institutional Review Board (IRB) review, and guide students through the IRB application process. The advisor must support the student in the conduct of the research project after IRB approval is attained, giving special attention to maintaining participant protections (including privacy, confidentiality, and informed consent), minimizing risk and ensuring voluntary participation and withdrawal.
What?
Two options are available to fulfill the human subjects education training requirement:
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(Recommended): The web-based Human Subjects Research (HSR) Series through the Collaborative Institutional Training Initiative (CITI). The IRB recommends this option as its primary one because IRB personnel are able to access individual transcripts and verify training, making this the most convenient option for the PI.
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The IRB will also accept NIH Human Subject Research training certificates.
How?
CITI Training
Basic step-by-step instructions for registering with CITI and completing initial certification can be found here: Instructions for Accessing CITI Training Modules
In order to meet the needs of the diverse researchers at 91精简版, there are two user groups in CITI for researchers involved in human subjects research:
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Social-Behavioral-Educational Researchers: Human Subjects Research
- Biomedical Researchers: Human Subjects Research
Researchers should register for one of these two groups according to the type of research they conduct. Do not register for the Responsible Conduct of Research module in order to meet the human subjects education training requirement.
All researchers who have not previously completed the training will complete the CITI "Basic Course" for their user group. All of the required modules within that group must be completed with a score of 80% or above in order to attain certification.
Once researchers have completed all the modules in their course, they will have access to a completion certificate, and their education will be valid for three years, at which time researchers must complete the CITI "Refresher Course" for their user group, also valid for three years. The expiration date of an individual's certification is based on the day the last required module was completed.
NIH Training
Visit NIH's to register. You will be required to re-take the training three years after the certificate's expiration.