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IRB: Expedited Review of Research

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Expedited Review of Research

Expedited review is a method of review permitted by the federal regulations at 45 CFR 46.110 for certain types of non-exempt research involving no more than minimal risk, or for minor changes in approved research. While the language used by the federal regulations might appear to involve a swift review, the federal definition of expedited is a process of review which is performed outside of a convened meeting of the Institutional Review Board (IRB).

Certain types of research may qualify for expedited review, so long as all activities fit into one or more of the categories described in the section below. If an investigator wishes to apply for expedited review, s/he must submit an application to the IRB for review and approval prior to initiation of any research activities.

Federal regulations state that expedited review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. Marywood University’s IRB chairperson delegates review to all members of the IRB at the beginning of each academic year. Review of such applications is assigned to one IRB member, who is chosen by the Director of Human Participants Protection either on a rotating basis or after consideration of the reviewer’s particular expertise. In addition to the assigned reviewer, the Director of Human Participants Protection and the Assistant Vice-President for Research assist with review to ensure regulatory and institutional compliance. The chairperson may serve as one of the assigned reviewers. In examining the research, the reviewer(s) may exercise all of the authorities of the IRB except that the reviewer(s) may not disapprove the research. A research activity may be disapproved only after review at a convened meeting of the IRB. 

An expedited review procedure may be used for research which involves no greater than minimal risk but does not qualify for exemption (i.e., it does not fit into one or more of the exemption categories or involves a population prohibited from exemption). An administrator from the Office of Research and Sponsored Programs makes the final determination regarding eligibility for expedited review.

Expedited consent forms require signature lines for the participant or legally authorized representative, and for the principal investigator. In some cases, the requirement for documentation of consent (signature) or elements of consent may be waived. In addition, research involving children has specific requirements for parental consent and child assent. Please see the informed consent section of these policies for further information.

Expedited applications must include a narrative description following the outline shown under the full review section of these policies. This narrative outline is also provided on the IRB application.


Expedited Review Categories – A Regulatory List

45 CFR 46.110 (a)

(1) Clinical studies of drugs and medical devices only when condition (a) or (b) is met.

(a) 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.)

(b) 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.

(2) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

(a) from healthy, non pregnant adults who weigh at least 110 pounds. For these participants, 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

(b) from other adults and children, considering the age, weight, and health of the participants, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these participants, 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.

(3) Prospective collection of biological specimens for research purposes by noninvasive means.

Examples: (a) hair and nail clippings in a non-disfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.

(4) Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)

Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the participant or an invasion of the participant's privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

(5) Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human participants 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)

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

(7) Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human participants. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)

(8) Continuing review of research previously approved by the convened IRB as follows:

(a) where (i) the research is permanently closed to the enrollment of new participants; (ii) all participants have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of participants; or

(b) where no participants have been enrolled and no additional risks have been identified; or

(c) where the remaining research activities are limited to data analysis.

(9) Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB 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 Review of Minor Changes to Approved Research

Federal regulations at 45 CFR 46.110 (b)(2) allow for expedited review of minor changes in previously approved research during the period for which approval is authorized (one year or less). This applies to research which was previously reviewed and approved under a full or expedited procedure.

A change is considered to be minor only if it does not represent a material change in the research.

A change is only considered minor if:

  • It does not adversely alter the risk/benefit ratio;
  • It does not alter the willingness of participants to continue participation or of potential participants to enroll in the study;
  • It does not alter the aims of the study;
  • It does not diminish the scientific validity of the study;
  • It does not significantly alter the participant population;
  • It does not alter the qualifications of the research team;
  • It does not alter the facilities available to support the safe conduct of the research;
  • It does not include any other factor that would warrant review by the convened IRB;
  • Any added procedure falls into one or more of the categories 1-7 of research that may be reviewed using an expedited procedure.


Examples of Minor Changes

  • Addition or removal of research personnel (e.g., research assistant, sponsor/advisor, etc.), so long as it does not alter the competence of the research team to conduct the research;
  • Minor alteration of the protocol or consent document in order to clarify or correct earlier information, provided that there is no change in the evaluated risks or potential benefits;
  • Correction of typographical errors;
  • Addition of non-sensitive questions to interviews or surveys;
  • Addition of a new recruitment site;
  • Alteration of the funding source


Minor changes must be submitted to the IRB using a Revisions to Approved Research Request form. The changes must be approved by the IRB prior to implementation.

An administrator in the Office of Research and Sponsored Programs makes the final determination regarding eligibility for expedited review under these circumstances. The Assistant Vice-President for Research and the Director of Human Participants Protection review changes which are considered minor.


Related Policies

  • Revisions to Approved Research


History

12/14/2012 - Revised to include minor change information and examples.

 


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