UT Southwestern Medical Center

Request for Determination That a Proposed Activity is Not Human Research

(Not Human Research Activity)

1. Date:

2. Title:

3. Name and Address of Project Director/Principal Investigator (PD/PI): (This is the primary local contact information used by the HRPP. Indicate where mail can most reliably reach the PD/PI.)
PD/PI Name:
Employer(s):
Department:
PD/PI’s Telephone #
PD/PI’s e-mail address:
PD/PI’s Position Title:
Point of contact name:
Point of contact email
Point of contact telephone #:

4. Project Sites - List all sites where your project will occur
Check all that apply	Name of Institution / Site (list all participating sites below)
UT Southwestern (Insert Department or Clinic):
Parkland HHS (PHHS) (Insert Department or Clinic):
Children’s Health (Insert Department or Clinic):
Texas Scottish Rite (Insert Department or Clinic):
Retina Foundation of the Southwest (Insert Department or Clinic):
Texas Health Resources (THR) Hospital (Insert Department or Clinic)
Other (Insert Department or Clinic):

Item 5: Other individuals working on this project	In addition to the PD/PI, will other individuals be working on this project?	Yes	No
If yes, list names of the individual research team members below: To add rows use copy & paste

The Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) regulations have different definitions of the term Human Research. Use the following series of questions in order to determine whether the activity you propose is Human Research for either agency.

Item 6: Is this research which doesn’t require IRB approval? If you answer NO to all questions below, then IRB review and approval IS NOT required. Upon review, the Human Research Protection Program Office (HRPPO) will issue you with a determination letter that your research does not require IRB review and approval. If you have questions, call the HRPPO for further guidance at 214-648-3060.
Yes	No
Will the UTSW or an affiliated institution receive a direct federal (DHHS) award to conduct human subjects’ research, even where all activities involving human subjects are carried out by a non-UTSW entity (e.g., subcontractor or collaborator)? Research Funding from the Department of Health and Human Services (DHHS) (e.g., Agency for Healthcare Research and Quality (AHRQ); Centers for Disease Control and Prevention (CDC); National Institutes of Health (NIH); etc.)
Does the project involve a drug or device used outside of usual medical practice, including non-FDA-approved agents, or off-label uses of FDA-approved drugs or devices being administered to one or more humans?
Will the safety and/ or effectiveness of a drug (FDA approved or non-FDA approved) or regulated device being administered to one or more humans be evaluated or be compared to that of another?
Will data from the activity of an active group or a control group be submitted to, or held for inspection by the FDA in support of a marketing or research application for an FDA-regulated product (drug or device)?
Will data obtained from use of a device on human tissue specimens be submitted to, or held for inspection by, the FDA in support of a marketing application or research application for an FDA regulated product?
Will the investigator obtain data through intervention or interaction with living individuals
The information obtained by the investigator is both private and identifiable.
Obtaining newborn screening blood spots for research purposes (regardless of funding or identifiability)

Item 7: Do the Research Activities Involve Collecting Data about Living Individuals? ☐ NO – all individuals in this research are deceased (SKIP to item 8 below) ☐ YES – Select the appropriate option below:
Using anonymous pre-existing data or specimens. This refers to uses of anonymous pre-existing data or specimens (anonymous materials are either those with no personally identifiable information contained in the original data or attached to the original specimen).
Using coded pre-existing or coded prospective data or specimens and the investigator(s) never obtains identifiable data/specimens because:. If this choice is selected, choose the applicable statements below:
The holder of the key to decipher the code destroys the key before the data is provided to the investigator.
The investigators and the holder of the key enter into an agreement prohibiting the release of the key to the investigators under any circumstances, or until the individuals are deceased; (Attach a De-identification agreement signed by the owner of data/specimens and the investigator receiving it de-identified.)
There are laws or IRB-approved written policies for a repository/data management center that prohibit the release of the key to the investigators under any circumstances, or until the individuals are deceased.

Item 8: Summary of the Research: Provide a summary of the proposed research activity. Provide sufficient detail for the reviewer to verify whether or not the activity requires IRB approval as you have indicated above. If a separate research description/written plan is available, attach it to this document.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.

Interaction includes communication or interpersonal contact between investigator and subject.

The information is private because it includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).

The information is individually identifiable because the identity of the participant is or may be ascertained by the investigator or associated with the information