Texas Tech University
    Human Research Protection Program

Research is a systematic investigation that may include research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. 45 CFR 46.102

Human Subjects in research must be living individuals. The study must involve an intervention or interaction with an individual and/or identifiable private information is collected. 45 CFR 46.102

Generalizable Knowledge  might include information presented to a broader audience or published with the intent of drawing scientific conclusions or increasing the body of scientific knowledge.

Does Your Project Need IRB Review?

Program evaluation - Is the work you are planning:

  • intended to learn how well a particular program is working
  • AND is not intended to add to generalizeable knowledge?

Class projects - Is the work you are planning:

  • a classroom assignment
  • AND is not intended to add to generalizeable knowledge?

Quality Assurance/Quality Improvement - Is the work you are planning:

  • intended to learn how to make a particular program better
  • AND is not intended to add to generalizeable knowledge?

Case Study - Is the work you are planning an intensive study of the records or experiences of one or a very few people in depth?

Oral History - Is the work you are planning an intensive study of one or a very few people, often through interviews concerning their experiences or recollections?

Does the work you are planning include secondary analysis of existing data or specimens, deidentified or coded?

Identifiers in Existing Data.

Do the data you will receive have any of the following identifiers?

  • Names
  • Telephone numbers
  • Any elements of dates (other than year) for dates directly related to an individual, birth date, admission date, discharge date, date of death. For ages over 89 all elements of dates (including year) indicative of such age, expect that ages and elements may be aggregated into a single category of age 90 and older
  • Any geographic subdivisions smaller than a state, including street address, city, county, precinct, zip code and their equivalent geocodes except for the initial three digits of a zip code
  • Fax numbers
  • Electronic mail addresses
  • Social security numbers
  • Medical record numbers
  • Health plan beneficiary numbers
  • Account numbers
  • Certificate/license numbers
  • Vehicle identifiers and serial numbers (VIN0, including license plate numbers
  • Device identifiers and serial numbers (e.g., implanted medical device)
  • Web universal resource locators (RULs)
  • Internet protocol (IP) address numbers
  • Biometric identifiers, including finger and voice prints
  • Full face photographic images and any comparable images
  • Any other unique identifying number, code, or characteristic, other than dummy identifiers that are not derived from actual identifiers and for which the re-identification key is maintained by the health care provider and not disclosed to the researcher

 

 

Contact

Human Research Protection Program
Administration Building, Room 357
Box 41075 | MS 1075
Lubbock, TX 79409-1075
(806) 742-2064 ofc | (806) 742-3947 fax
HRPP Contact Information
hrpp@ttu.edu