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   New Research Forms

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

  Examples:

• Quality Improvement

• Health Surveillance

• Program Evaluation

  Examples:

• Only using leftover, de-identified specimens

• Only using commercial cell lines

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

  Examples:

• retrospective chart review & not recording identifying information

• survey of adults

• comparing two educational methods

  Examples:

• prospective clinical data and specimens

• non-invasive measurements

• Survey of children

  Examples:

• 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

 

Humanitarian
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)

 Planned
Emergency
Research

Requirements:

- Condition treated/diagnosed affects fewer than 4,000 in US per year

- Requires an approved HDE from FDA

- Requires prior IRB approval, but is not considered research

Requirements:

- 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

Requirements:

- Life-threatening or serious disease

- No acceptable alternative

- Requires prior IRB approval, but is not considered research

- Requires an IND/IDE from FDA

Examples:

- 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

Examples:

 - 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

where UTHSA IRB
is the Reviewing IRB
External IRB
Review

where other external IRB is the Reviewing IRB

(link will redirect you to the OCR website)

     
Examples: Examples:      

- SMART IRB

- 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