Human Subjects Training
All investigators (faculty, staff and students) are required to complete the CITI Program training in human subjects protection prior to conducting research using human subjects. Human-subjects researchers are required to take either the “social-behavioral-educational” or the “biomedical” version of the “Human Subjects Researcher” course, depending on your discipline. While other courses, such as “Responsible Conduct of Research,” are beneficial for your ethical understanding of various aspects of the research process, TCU requires the “Human Subjects Researcher” course because it provides sufficient, in-depth understanding of the particular ethical and logistical concerns associated with researching human subjects.
Please see below for additional required modules based on your research.
The following modules are required based on the type of research you will be conducting HSR Social-Behavioral-Educational:
|FERPA: An Introduction (ID:17407); and |
FERPA for Researchers (ID:17410)
|If you will be working with/accessing “education records” such as records, files, documents, and other materials that are maintained by an educational agency or institution.|
|Research with Prisoners- SBE (ID:506)||If you will be working with any individual involuntarily confined or detained in a penal institution. For additional examples please visit HHS.gov|
|Research with Children- SBE (ID:507); and|
Research in Public Elementary and Secondary School- SBE (ID:508)
|If you will be working with any individuals who have not attained the legal age for consent to treatment or procedures involved in the research.|
|International Research- SBE (ID:509)||If you will be conducting your research in a country outside of the United States.|
The following modules are required based on the type of research you will be conducting HSR-Biomedical
|Genetic Research in Human Populations (ID: 6)||If you will be conducting any of the following as a part of your research; genetic testing; gene therapy; reproductive genomics; genetic databanks and pharmacogenomics.|
|FDA-Regulated Research (ID: 12)||If your research involved the use of FDA approved drugs or devices or any investigational drugs or devices.|
|Research and HIPAA Privacy Protections (ID: 14)||If you will be collecting Protected Health Information, obtaining HIPAA Authorization, or requesting waivers, and how to meet HIPAA requirements.|
|Vulnerable Subjects - Research Involving Workers/Employees (ID: 483)||workers/employees may be a vulnerable population when they participate in research, and the potential risks and benefits associated with research involving workers/employees.|
|Research Involving Children (ID: 9)||Reviews the assent and informed consent requirements, and the current efforts by the FDA to ensure the inclusion of children in studies on the safety and efficacy of new drugs.|
This training requirement applies regardless of whether such research receives external funding, and it applies to all academic levels. This training expires every four (4) years and you must take the refresher course to remain compliant. The expiration date for CITI training must also not fall within a protocol’s would-be Approval Period (one calendar year).
While the IRB has accepted NIH training in the past and encouraged PIs to take CITI as their NIH training expired, TCU will no longer accept NIH training for new protocols, requests for continuing review, and requests for modifications/amendments starting Monday, Oct. 1, 2018.