What Is Expedited Review?

1. Must meet the regulatory definition of minimal risk research, or a minor change to existing research. Anything greater than minimal risk, or that is more than a minor change to existing research, requires review by a convened board.
   1. WCG considers the following to be a minor change to existing research:
      1. All added procedures fall into categories 1 – 7 below. 
      2. When there is no substantial alteration of the research design (Allterations considered substantial may include a significant increase in enrollment, certain financial disclosures, increased volume of blood draw, or inclusion of a new subject population)
      3. The addition of a new investigator, research site, or change of investigator to previously approved research.
      4. Approval of a Previously approved change in research for another research site
      5. Approval of Translated documents
2. Must fit into one of the nine categories described below  as per 45 CFR 46.110 and published as a Notice in the Federal Register.

Categories of research that may be reviewed through an Expedited Review Procedure:

1. Clinical studies of drugs and medical devices only when:
   1. An investigational new drug application is not required.
      1. Exception: any research involving legally 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 and will require review by a convened board
   2. An investigational device exemption application is not required
   3. The medical device is cleared/approved for marketing and the device is being used in accordance with the cleared/approved indications.
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from:
   1. Healthy, nonpregnant adults who weigh at least 110 pounds. The amounts drawn from these participants cannot be more than 550 ml in an eight-week period, with no more than two blood collections allowed per week.
   2. Other adults and children. The amounts drawn from these participants must be less than 50 ml or 3 ml per kg (whichever level is lesser applies) per eight-week period, with not more than two blood collections allowed per week.
3. Prospective collection of biological specimens intended for research purposes if:
   1. The collection is noninvasive (e.g. urine specimens, saliva samples, fingernail or hair clippings).
4. Collection of data if:
   1. The procedure collecting the data is noninvasive (and cannot require sedation or anesthesia).
   2. The procedure is routinely employed in clinical practice (cannot involve X-rays, microwaves, or require contrast).
   3. If a medical device is being used, it is cleared/approved for marketing.
5. Research involving materials that have been collected retrospectively or prospectively solely for non-research purposes.
6. Collection of data from voice recordings, video recordings, or digital or image recordings made for research purposes.
7. Research on individual or group characteristics or behavior, or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
8. Continuing review of research previously approved by the convened IRB if:
   1. The research is permanently closed to enrollment, or no participants have been enrolled and no additional risks have been identified.
   2. All participants have completed all the research-related interventions.
   3. The research remains active only for long term follow up or the remaining research activities are limited to data analysis.
9. Continuing review of research not conducted under an IND or IDE where:
   1. None of the above categories apply.
   2. The IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks are identified.