Research methods utilizing interventions to obtain study information may consist of physical procedures to gather data (e.g., venipuncture) and manipulations of the participant or the participant's environment that are performed for research purposes.
- The submission is first confirmed as covered research with living human subjects or their identifiable, private information.
- Then, eligibility for exemption is determined.
- If review takes place under expedited procedures or by the full board, these Criteria for Approval will need to be met in addition to any applicable state or local laws and University/HRRC policies.
A concern for intervention-based methods are harms that may occur from study procedures unique to the research (as opposed to procedures already being done for treatment or diagnosis purposes).
Researchers are advised to address the following criteria for approval in their materials
- Potential risks for any study procedure along with plans for minimizing the chance of harms occurring - particularly in context of vulnerable populations included
- Indicate procedures that are unique to the research (vs. those already being performed for non-research purposes)
- Any potential benefits anticipated
- Whether there is a plan to monitor data collected for patient safety
Reviewers will also be interested in assessing
- PI qualifications to conduct the methods described; key personnel training and responsibilities within the research
- Use of any equipment or devices and plans for monitoring proper functioning and handling
- Proof of permissions to use facilities or resources
Level of Review Distinctions
Most intervention-based research is reviewed under expedited procedures or by the full board; however, some may be eligible for exemption. Protocols that include mixed methods may fall within multiple review categories; when this happens the most protective standard will be applied.
More on Levels of Review
Exemption Criteria for Intervention-based Research
Education research (exempt cat. 1) may include an assessment of changes in curriculum or classroom materials
- Must be conducted in an educational setting
- Must involve normal educational practices (determined by local context)
- May NOT be used for educational tests of the individual student's ability or functioning
Factors that may preclude exemption: greater than minimal risk (would not constitute normal practice); radically new instructional strategies or randomization of subjects (these methods deviate from normal educational practices).
DHHS funded or approved projects (exempt cat. 5) that study, evaluate or otherwise examine
- Public benefit or service programs
- Procedures for obtaining benefits or services under those programs
- Possible changes in or alternatives to those programs or procedures; or
- Possible changes in methods or levels of payment for benefits or services under those programs
Taste and food quality evaluations and consumer acceptance studies (exempt cat. 6)
- IF wholesome foods without additives are consumed
- For studies involving food ingredients (including agricultural chemical or environmental contaminants): must be at or below safety level as determined by the FDA, EPA or USDA
NOTE: Research involving prisoners may not be exempt. Research to which FDA regulations or policies apply are not eligible for exemption categories 1-5.
Expedited Criteria for Intervention-based Research
Collection of blood samples (expedited cat. 2) by finger stick, heel stick, ear stick, or venipuncture
- From healthy, nonpregnant adults who weigh at least 110 pounds:
- <550 ml in 8 weeks
- no more than 2 times per week
- From other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected.
- <50 ml or 3 ml per kg, whichever is less, in 8 weeks
- no more than 2 times per week
Individual or group characteristics or behavior (expedited cat. 7)
- Measured responses to prompts (e.g. psychological testing), interventions (e.g. physical activities/exercises), or manipulations of environment
- Must be minimal risk
Interventions that do not fit into an exempt or expedited category must be reviewed and approved during a convened full board meeting.