Human Subjects Research
Texas Christian University Guidance for Human Subjects-Related Research during the COVID-19 Outbreak
Effective August 19, 2020
IRB review process during the COVID-19 Outbreak
The Protection of Human Subjects is based on U.S. federal law and key principles defined in the Belmont Report. The TCU Institutional Review Board (“IRB”) oversees human subjects research at TCU and plays a key role in promoting adherence to ethical principles, professional standards, and applicable law related to human subjects research. The IRB reports to Research Compliance with open lines of communication to the Associate Provost of Research and Institutional Official.
The IRB develops standards and reviews proposed projects to ensure compliance with TCU policy related to provisions for health, welfare, privacy, dignity and human concerns in research involving human subjects. Areas of concern include health, welfare, privacy, dignity and human concerns when research involves human subjects. See the IRB Policies, Procedures and Forms for information about protocol review and approval.
If you are a principal investigator (“PI”) contemplating TCU human subjects research, you must submit a protocol to the TCU IRB for review and approval. As the PI, you are responsible for the ethical conduct of the study. These responsibilities include proper documentation and reporting to the IRB, ensuring all researchers involved in the research are adequately and properly trained. The PI is ultimately responsible for the oversight of the consent process to ensure all participants are informed properly for adequate consent to participate. The PI assumes all responsibility for compliance of federal, state, local and institutional policies. The PI may not initiate any research involving human participants prior to the IRB approval.