Review Types
Exempt & Limited Review
Research in the Exempt category includes research that involves minimal risk and fits certain precisely defined categories (45 CFR 46.104). The data is typically collected or received in a manner that is anonymous or de-identified. Exempt research still requires an IRB to be submitted through Cayuse IRB. A limited review is only required if the research involves identifiable information. Limited IRB review requires the IRB to determine that there are adequate provisions for protecting privacy and confidentiality.
Exempt Categories
- Category 1: Established or Commonly Accepted Educational Settings
- Category 2: Educational Tests, Survey Procedures, Interview Procedures or Observation
of Public Behavior
- Limited review is required if identifiers are collected.
- Focus groups are allowed with a limited review.
- Category 3: Benign Behavioral Interventions in Conjunction with the Collection of
Information From Adult Subjects
- Limited review is required if identifiers are collected.
- Limited review is required if deception is a part of data collection. The participants must prospectively agree that they will be unaware of or misled regarding the nature or purpose of the research.
- Category 4: Secondary Research for Which Consent is Not Required
- Category 5: Research and Demonstration Projects that Are Conducted or Supported by a Federal Department or Agency
- Category 6: Taste and Food Quality Evaluation and Consumer Acceptance Studies
- Category 7: Storage or Maintenance for Secondary Use for Which Broad Consent is Required
- Limited review is ALWAYS required.
- Consultation with the HRPP Director or the IRB Chair is required before completing IRB application for Exempt Category 7.
- Category 8: Secondary Research for Which Broad Consent is Required
- Limited review is ALWAYS required.
- Consultation with the HRPP Director or the IRB Chair is required before completing IRB application for Exempt Category 8.
Expedited
Project involves no more than minimal risk. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Most studies that involve children, non-invasive/invasive, or sensitive data with personal identifiers will need Expedited review. Projects with children or other vulnerable populations must be approved by two reviewers.
Expedited Categories
- Category 1a: Drugs for which an Investigational New Drug Application (21 CFR Part 312) is NOT Required
- Category 1b: Medical Devices
- Category 2a: Collection of Blood Samples for Nonpregnant Adults who Weigh At Least 110 pounds
- Category 2b: Collection of Blood Samples from Other Adults and Children
- Category 3: Prospective Collection of Biological Specimens for Research Purposes by Noninvasive Means
- Category 4: Collection of Data Through Noninvasive Procedures Routinely Employed in Clinical Practice
- Category 5: Materials Collected, or Will Be Collected Solely for Nonresearch Purposes
- Category 6: Collection of Data from Voice, Video, Digital, or Image Recordings Made for Research Purposes
- Category 7: Individual or Group Characteristics or Behavior
Full Board
Full Board research projects are greater than minimal risk to human participants. Research that involves an interaction/intervention with prisoners will require a full board review.
Human Research Protection Program
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Address
Texas Tech University, 2500 Broadway, Box 41075 Lubbock, TX 79409 -
Phone
806.742.2064 -
Email
hrpp@ttu.edu