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EMU Research

UHSRC Expedited Review Procedures

 

Introduction

Not all human subject research subject to Federal Regulation 45 CFR 46 requires review at a UHSRC meeting. Research deemed not greater than minimal risk* and that falls into at least one of nine categories can undergo Expedited review. Expedited review does not necessarily mean “quick,” but rather the UHSRC burden is alleviated in that the entire committee is not required to review the study. Expedited reviews are conducted by one or two UHSRC members in lieu of the entire committee. Expedited reviews also are conducted on an ongoing basis and not at monthly meetings. As such, there is no submission deadline for Expedited review. Turn-around time for Expedited research, from initial submission to approval letter generally takes 3 to 4 weeks.

 

*minimal risk means that “the probability or 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(i))

 

 

Categories for Expedited Review

In order to qualify for Expedited review, your research must not pose greater than minimal risk to subjects, and all research activities must fit into one or more of the nine categories below:

 

  1. Clinical studies of drugs and medical devices only when the drug research does not require an Investigational New Drug (IND) application and the medical device research does not require an Investigational Device Exemption (IDE) application or the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling

 

  1. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture. Collection may not occur more frequently than 2 times per week and must proceed as follows:
    1. Up to 550 ml (roughly 1 pint) in an 8 week period for healthy, non-pregnant adults; or
    2. No more than 50 ml or 3ml per kg body weight in an 8 week period for other adults and children.

 

  1. Prospective collection of biological samples for research purposes by noninvasive means (e.g., hair and nail clippings, sweat, urine, saliva samples, cheek cells collected via swab, etc.)

 

  1. Collection of data through noninvasive clinical procedures, excluding procedures involving ionizing radiation (e.g., x-rays and microwaves). Medical devices used must be cleared/approved for marketing. Examples include motion sensors, ECG, EEG, MRI, galvanic skin response, strength testing, body composition assessment, and flexibility assessment.

 

  1. Research involving materials (data, documents, records, or specimens) that have or will be collected solely for non-research purposes (e.g., medical records, educational records, etc.)

 

  1. Collection of data from voice, video, digital, or image recordings made for research purposes

 

  1. 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

 

  1. Continuing review of research previously approved by the Full Board if :
    1. The research is permanently closed to enrollment, all subjects have completed research-related interventions, and the research remains active only for long-term follow-up of subjects; or
    2. No subjects have been enrolled and no additional risks have been identified; or
    3. The remaining research activities are limited to data analysis

 

  1. Continuing review of research not conducted under an IND or IDE where categories 2 through 8 above do not apply, but the Full Board has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

 

 

Expedited Submission Processing

  • Submission is received and reviewed for completeness and risk.
  • If the application is incomplete or any supplemental documents are missing, the Office of Research Compliance will return the application to the principal investigator with comments for revision and resubmission.
  • Once the application package is complete, it will be sent to one or two UHSRC members for review. The UHSRC members have 2 weeks to complete their reviews. The UHSRC Chair or Vice-Chair reviews the review and makes a decision.
      • Deferral:  Your study cannot be approved as-is and requires some major revisions or clarifications. You must revise and resubmit accordingly.
      • Minor revisions required: The submission is returned to the principal investigator with comments embedded in the application. All comments must be addressed and the submission returned to the UHSRC for processing.
      • Approval: The submission is approved. You will receive an approval letter and can begin your research.

 

Expedited Review Process

All research reviewed under Expedited procedures must be compliant with Federal Regulations outlined in 45 CFR 46. The UHSRC reviews the application in accordance with 45 CFR 46 and EMU policy to ensure protection of human subjects in research. Principal Investigators may be asked to revise or make changes to their application or supporting documents accordingly prior to approval.

 

Post-Approval

Once you receive your approval letter, you may begin your research. Along with your approval letter, you will receive stamped copies of your consent and recruitment documents attached to your Cayuse IRB submission. You must use the stamped versions of these documents and actual stamped copies whenever possible (e.g., in-person consent, posting recruitment fliers, etc.).

 

Continuing Review: Your UHSRC approval will last for 365 days unless otherwise indicated. Your study expiration date will be printed on the letter. If you plan to continue your research beyond 365 days, you must submit for renewal in Cayuse IRB 2 to 4 weeks before your expiration date to allow for timely processing. If your study approval expires without renewal, you must cease and desist all human subject research activities. It is against Federal Regulation 45 CFR 46 to conduct human subject research without valid UHSRC approval. Expedited Continuing Reviews are typically approved within one week from the submission date.

 

Changes to Approved Research: If you plan to make any changes to your study during the course of your approval period, you must submit a Modification Request and obtain UHSRC approval prior to implementation. Any changes made to already-approved documents must be highlighted or tracked using Track Changes mode in Word. Expedited Modification Requests are typically approved within one week from the submission date.

 

 

If you have any questions about Expedited review, contact the Office of Research Compliance at research.compliance@emich.edu or 734-487-3090.

 

 

 

 

 

Elevating Communities, Inspiring Generations

EMU Research, 200 Boone Phone: 734.487.3090 mail orda_dept@emich.edu