Personnel changes must be submitted for all human subjectHuman Subjecta living individual about whom an investigator conducting research: 1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; OR 2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. researchResearcha systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. protocols (including exempt studies) whether utilizing the UTHSA IRB or an external IRBExternal IRBAn IRB operated by an organization other than UTHealthSA . Only personnel listed on the currently approved personnel form (e.g. Form B-2, Inst M) are allowed to engage in human subject research.
Changes in study personnel are submitted using the process outlined below to the OCR.
A change to PI/Co-PI or new/updated conflict of interestConflict of Interestrefers to situations where the individual has the opportunity to influence the Health Science Center's business, administrative, academic, research, clinical, or other decisions in ways that could lead to personal financial gain or advantage or could appear to cause bias in the design, conduct, or reporting of research or educational activities. disclosure are be submitted through the UTHSA IRB amendment process or Institutional Modification process (for external IRB studies).
Adding new duties or removing critical duties to those currently approved by the IRB may require an IRB amendment.
New Personnel Submission Checklist
Personnel must finalize the following prior to submission:
Note: OCR will not accept / withdraw submissions if Research Scope of Practice and required training are not complete.
To change (add/remove) one person on up to 5 protocols
- For all other personnel changes
- Update appropriate, currently approved document containing personnel (e.g. Inst M, B-2, etc.).
- Email the modified form to OCRmail@uthscsa.edu. Copy the PI(s) on the email.