Investigator Responsibilities in Research Involving Human Subjects (Biomed/Cancer)
A. Investigators must comply with all applicable federal regulations, as well as UT policies regarding research with human subjects.
B. Investigators must provide a copy of the UT IRB-approved informed consent document to each subject, unless the IRB has specifically waived this requirement.
C. All documents and study records are to be retained for at least 3 years after the study has been terminated/closed/expired in a manner approved by the UT IRB. Investigators must also follow all additional records retention guidance (HIPAA, State laws, Sponsor requirements, etc.) as applicable to their research.
D. Investigators will promptly report to the IRB any injuries or other unanticipated problems involving risks to subjects or others.
E. Investigators must submit proposed changes/amendments to IRB approved human subject research studies for IRB review. The proposed changes must be approved by the IRB before the changes can be initiated, except where necessary to eliminate apparent immediate hazards to the subjects.
F. Investigators are responsible for complying with the continuing review/annual report requirements as prescribed by the IRB. The continuation of research after expiration of IRB approval is a violation of federal regulations. If IRB approval has expired, all research activities (recruitment, enrollment, data collection, data analysis) must stop.
G. Investigators are responsible for submitting a Final Report Form within 30 days of study expiration or within 30 days of cessation of all study activity, whichever date occurs first. This includes IRB approved studies for student research projects.
H. HIPAA regulations require that researchers keep a signed copy of participants’ authorization for six years after the study has been terminated/closed/expired. Identifiers must always be destroyed at the earliest opportunity consistent with conduct of the research. If a waiver (or partial) waiver of authorization has been granted by the IRB, retain the documentation IRB approval of the waiver for six years after the study has been terminated/closed/expired.
I. When applicable, Investigators must comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA). If consent or authorization is revoked by a subject, it is the responsibility of the P.I. to obtain the required signed document(s) and submit these to UT's Health Information Management Department as required by institutional policy in compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule Privacy Rule (45 CFR 164).
J. No investigator will seek to obtain research credit for, or use data from, patient interventions that constitute the provision of emergency medical care without prior UT IRB approval. A physician may provide emergency medical care to a patient without prior IRB review and approval to the extent permitted by law. However, such activities will not be counted as research nor the data used in support of research.
K. Investigators will advise the UT IRB, Research & Sponsored Programs Administration and the appropriate officials of other institutions of the intent to admit human subjects into another institution (e.g., into another hospital) who are involved in research protocols. When such admissions are a planned part of DHHS-supported research, those institutions must possess an applicable Human Research Assurance prior to involvement of such persons as human subjects in those research protocols at those institutions.