Office of the Institutional Review Board

   New Research Forms

new clinical trial submission process
Clinical trials must be reviewed and cleared by the Clinical Trials Office (CTO) before the research application can be submitted to the IRB.


Non-Regulated Research

Research Not Involving Humans

Human Research
Determined Exempt (Submit to OIRB for Determination)

Human Research
Not Exempt
but eligible for Expedited IRB Review

Human Research
Not Exempt
That must be reviewed by convened IRB

irb irb irb irb irb


• Quality Improvement

• Health Surveillance

• Program Evaluation


• Only using leftover, de-identified specimens

• Only using commercial cell lines

• Data / specimens from a repository (de-identified to recipient)


• chart reviews

• survey of adults

• comparing two educational methods


• blood collection through venipuncture

• non-invasive measurements

• Survey of children


• All greater than minimal risk research

• Clinical trials

• Any research use of  radiation

• Any research use of anesthesia

• Any research use of invasive procedures

Non-regulated Research Forms Non-human Research Forms Exempt Research Forms Human Expedited Review Forms Human Full Board Forms



 Other Types of Submissions Forms


Device Forms


Emergency Use
of an Unapproved Drug or Device Forms

(single patient)

Treatment Use
/ Expanded Access of Drug or Device Forms

(single patient/small group)

Repository or Databank Forms

(for use in future, undefined research)



- Condition treated/diagnosed affects no more than 8,000 in U.S. per year

- Requires an approved HDE from FDA

- Requires prior IRB approval, but is not considered research


- Patient’s condition is life-threatening

- No standard treatment available

- There is not sufficient time to obtain IRB approval

- Requires post-use IRB reporting/ concurrence but is not considered research


- Life-threatening or serious disease

- No acceptable alternative

- Requires prior IRB approval, but is not considered research

- Requires an IND/IDE from FDA


- Creation of local biorepository

- Creation of Data repository or Registry

- Collection of data and/or specimens to be sent and stored at another (non-UTHSCSA) repository


 - life-threatening, emergency situations

 - Requirements: - human subjects research designed to test medical interventions, drugs, or devices in urgent, life-threatening situations


IRB Review for Multi-Site Research / External IRB Review

Single IRB Review
for Multi-Site Research

is the Reviewing IRB

External IRB

where other external IRB is the Reviewing IRB

(link will redirect you to the OCR website)

Examples: Examples:      


- Multiple institutions within the state of Texas under an IRB Reciprocity Agreement

- Collaborative UT system research relying on single non-UTHSCSA IRB

- Sponsored Phase III studies relying on commercial IRB

- NCI cooperative research relying on NCI CIRB

- Other federally funded collaborative research initiatives