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Second in our series on eIRB+ application types is the eIRB+ application for minimal risk research titled “Research Protocol Study (minimal risk) - Expedited/Exempt.”
Have you seen the new eIRB+ application for research projects involving minimal risk activities?
Choosing the “Research Protocol Study (minimal risk) - Expedited/Exempt” application routes the study through the exempt or expedited review process in eIRB+. This means that a designated reviewer (or reviewers) will review the application without the need for discussion at a convened, full board meeting of the IRB. The “Research Protocol Study (minimal risk) - Expedited/Exempt” application type should only be used for minimal risk research.
Note: The IRB reserves the right to request that the research team change the application type depending on the IRB’s analysis of the application.
What does minimal risk mean?
Minimal Risk means “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” (45 CFR 46.102(j); 21 CFR 56.102(i)).
When should this application be used?
This application should only be used when your research creates/analyzes new information gathered through interaction or intervention with living individuals and the research is considered minimal risk.
This application should also be used when your research is analyzing biospecimens created by other research or originally created for non-research purposes and the research is considered minimal risk.
Can you give me some examples of minimal risk research?
The following are examples of types of research that may be submitted to the IRB under this application type if 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:
- Survey research
- Interview or Focus Group research
- Research involving benign behavioral interventions (e.g. having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else)
- Observation of human subject activities
- Research on regular and special education instructional strategies
- Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods
- Research involving analysis of biospecimens collected under a prior research activity by other research or originally created for non-research purposes (left over specimens from a routine medical procedure)
- Biospecimens collected in non-invasive ways (e.g. urine sample, hair and nail clippings)
- Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves
- Taste and food quality evaluation and consumer acceptance studies
May I use this application for clinical research involving drugs or medical devices?
It depends. This application should only be used if your clinical study of drugs and / or medical devices meets one of the following two conditions:
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Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review). or
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Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
May I use this application for research that involves collection of blood from human subjects?
It depends. This application should only be used if your research involves the collection of blood samples by finger stick, heel stick, ear stick, or venipuncture and the following criteria are met:
- Collection from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
- Collection 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. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
Learn more about the Research Protocol Study (minimal risk) - Expedited/Exempt eIRB+ application.
eIRB+ PDF Quick Guides for each of the eIRB+ initial submission types are available.
These step-by-step Quick Guides provide overviews, screenshots, and tips for the eIRB+ application.
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