8. Continuing review of research previously approved by the convened IRB follows:

1. Where
   1. the research is permanently closed to the enrollment of new subjects;
   2. all subjects have completed all research-related interventions; and
   3. the research remains active only for long-term follow-up of subjects (Note: “Long-term follow-up” includes research interactions that involve no more than minimal risk to subjects (e.g., quality of life surveys); and collection of follow-up data from procedures or interventions that would have been done as part of routine clinical practice to monitor a subject for disease progression or recurrence, regardless of whether the procedures or interventions are described in the research study, but not interventions that would not have been performed for clinical purposes, even if the research interventions involve no more than minimal risk.); or
2. Where no subjects have ever been enrolled at and no additional risks have been identified (Note: “no additional risks have been identified” means that neither the investigator nor the IRB has identified any additional risks from any institution engaged in the research project or from any other relevant source since the IRB’s most recent prior review.); or
3. Where the remaining research activities are limited to data analysis. (Note: Simply maintaining individually identifiable private information without using, studying, or analyzing such information is not human subject research and thus does not require continuing review.)

9. Continuing review of research previously approved by the IRB at a convened meeting that meets the following conditions:

• The research is not conducted under an investigational new drug application (IND) or an investigational device exemption (IDE);
• Expedited review categories (2) through (8) do not apply to the research;
• The IRB has determined and documented at a convened meeting that the research, or the remaining research activity involving human subjects, involves no greater than minimal risk to the subjects; and
• No additional risks of the research have been identified. (Note: “no additional risks have been identified” means that neither the investigator nor the IRB has identified any additional risks from any institution engaged in the research project or from any other relevant source since the IRB’s most recent prior review.)

The CSS IRB Best practice is to leave the approval period up to the expedited reviewer with the default being a one-year approval period but allowing the reviewer to assign longer or shorter approval periods based on their assessment of the study.

OR

In order to collect information needed by the CSS IRB to be able to identify active research projects, the CSS IRB PI’s of projects that are eligible for no annual continuing review will be required to complete a brief Annual PI Assurances process request issued by IRBNet submission system. The process will be applicable to research approved the first time by Expedited Review procedures.

4.Procedure

1. Expedited Review Procedures for Initial Protocol Applications
   1. The CSS IRB Chair conducts administrative review on the Application and documents any concerns within IRB Committee notes within the data management system. Once complete, the request is routed to a designated IRB reviewer depending on the research proposed in the protocol application.
   2. The IRB may review through the expedited review procedure research activities that present no more than minimal risk to human subjects and involves only procedures listed in one or more of the expedited research categories (see, above). The categories in this list apply regardless of the age of subjects, except as noted.
   3. For studies where identifying the subjects or their responses would place them at reasonable risk of criminal or civil liability or damage the subjects’ financial or personal interests, the IRB may use the expedited review procedure only if the researchers implement reasonable and appropriate protections to reduce risks from invasion of privacy and breach of confidentiality, so they are minimal.
   4. The expedited review procedure may not be used for classified research involving human subjects.
   5. The standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or convened--used by the IRB.
   6. When reviewing proposed research activities using expedited procedures, IRB reviewers may take one of the following actions:
      • Approve
      • Require modifications to secure approval
      • Recommend the item to a convened full committee meeting.
   7. Proposed human subject research which does not fall into either the exempt or expedited review categories must be submitted for full committee review.
   8. If the reviewer or reviewers find that the protocol should be disapproved, the protocol must go to the full board for a vote.
   9. For an expedited review, the primary reviewer submits a summary of human subject concerns and recommendations for stipulations and suggestions to the IRB Chair.
   10. The designated IRB Reviewer can be the IRB Chair or another IRB Member who has been designated to conduct expedited review. The designated IRB Reviewer can choose to consult with the IRB Chair or another IRB Member or an outside consultant with appropriate expertise and with the approval of the Chair.
   11. The reviewer discloses conflicting interest with any submission sent for review. If there is a conflict of interest the submission will be reassigned to another member.
   12. The IRB Reviewer will conduct a review of the research which includes, but is not limited to, the criteria for IRB approval of research outlined in 45 CFR 46.111 and/or 21 CFR 56.111 and found in CSS IRB SOP #12 Criteria For IRB Approval Of Research and IRB Review Checklist.
   13. If it is determined that the submitted documents are not adequate, the Investigators may be required to submit additional information, answer questions, or explain the details of the study and/or revise the application. Incomplete or inadequate submissions will not be approved.
   14. A PI’s responses to a request for additional information and/or application revisions are reviewed by the IRB Chair and/or the IRB Reviewer. If the application is in order, the IRB Reviewer may approve the protocol by signing the Protocol Review Form on IRBNet.
   15. Designated IRB Reviewers conducting expedited review may exercise all the authority of the IRB in reviewing the research except they may not disapprove the research. Research that cannot be approved via expedited procedures must be reviewed by the convened IRB.
   16. Expedited approvals will be reported in the agenda for the next convened meeting in IRBNet. Expedited approvals will be documented in the CSS IRB minutes. (See, CSS IRB SOP #04 IRB Meeting Management, Function and Operations See also, CSS IRB SOP # 17 Minutes.)
   17. Letters to the PI from the IRB will include the following information:
       1. same as exempt language about not needed continuing review
       2. other language that is currently in the letters having to do with need for review if protocol is changed or if there are adverse events; send closure letter.
   18. The IRB Chair / Administrator will archive the approved consent document(s) and generate the approval letter.

2. Expedited Review Procedures for Revision and Continuing Review Requests
   1. Submission requirements for continuing review in order to ascertain the current status of the study when mandated by the CSS IRB:
      • Completed Continuing Review form;
      • A copy of the current informed consent document(s) or any newly proposed consent document(s) if enrollment is ongoing;
      • A copy of current recruitment material(s) or any newly proposed recruitment material(s) if enrollment is ongoing;
      • A summary of adverse events and any unanticipated problems involving risks to subjects or others and any withdrawal of subjects from the research or complaints about the research since the last IRB review;
      • A summary of any relevant information about risks associated with the research; and
      • Any relevant multi-center trial reports.
   2. The continuing review submission and the protocol are reviewed by the IRB Chair and/or the expedited reviewer. The criteria for approval of research with continuing review are the same as for initial review (see SOP #12 Criteria for Approval of IRB Research ). The IRB reviewer considers any significant new findings that may relate to participant’s safety or willingness to continue participation.
   3. Once the continuing review request is approved, the IRB Chair will enter the approval in the data management system (IRBNet) and assign the protocol/revision to the agenda for the next meeting of the IRB as an expedited reported item. Expedited approvals will be reported in the agenda for the next convened meeting via the agenda in the IRB electronic management system. Expedited approvals will be documented in the CSS IRB minutes.
   4. The IRB Chair/Administrator will generate the approval letter. Copies of the approval letter and approved consent document(s) will be sent via electronic data management system (IRBNet) to the Investigator.
3. Expedited Review Procedures for Modifications to Research Initially Approved by a Convened IRB

Modifications to applications previously approved by a convened IRB may be reviewed by the expedited review process if they meet the following criteria:

1. Modifications do not pose an increased risk to subjects; AND
2. Any additional procedures fall within categories 1-7 of research that may be reviewed using the expedited procedure; AND
3. Modifications constitute a minor change to previously approved research. (Minor Modifications: Any modification that does not materially affect the assessment of risks and benefits.)
4. Expedited approvals will be reported in the agenda for the next convened meeting via IRBNet. Expedited approvals will be documented in the CSS IRB minutes

4. Expedited Review Procedures for Modifications to Research Initially Approved by Expedited Review

45 CFR 46.109 IRB Review of Research – In effect as of July 19, 2018

(f)(1) Unless an IRB determines otherwise, continuing review of research is not required in the following circumstances:

1. Research eligible for expedited review in accordance with §46.110; (no more than minimal risk, any changes must be minor.)
2. Research reviewed by the IRB in accordance with the limited IRB review (See below (E);
3. Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study:
   1. Data analysis, including analysis of identifiable private information or identifiable biospecimens, or
   2. Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.

5. Limited IRB Review

The IRB will use the expedited review process for research for which limited IRB review is a condition of exemption under § 46.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7) and (8) that clarifies the information obtained is recorded by the investigator in such a manner that the identity of the human subjects can be readily ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by 45 CFR 46.111(a)(7) which states that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. Expedited approvals will be reported in the agenda for the next convened meeting via IRBNet. Expedited approvals will be documented in the CSS IRB minutes.

Exclusion criteria: (If any are true, the research cannot be reviewed using the expedited procedure)

• The research is <Classified Research>
• The research is DOD-regulated and involves <Prisoners> as subjects

Risk level

• The research in its current state presents no more than Minimal Risk¹ to subjects, including Minimal Risk of criminal or civil liability, or damage financial standing, employability, insurability, reputation, or be stigmatization related to invasion of privacy and breach of confidentiality
• One of the following is true:
  • The research does not involve <Prisoners> as subjects
  • A prisoner representative has reviewed the research and concurs with the minimal risk determination
• The activity falls into one of these categories below

Expedited Categories (63 FR 60364-60367, Nov 9, 1998)

Initial or continuing review of research that only involves one or more of the following:

• (1)(a) Clinical studies of drugs for which an IND is not required
• (1)(b) Clinical studies on medical devices for which an IDE is not required
• (2)(a) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from healthy, nonpregnant adults who weigh at least 110 pounds, where 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
  Each access of an indwelling line is one venipuncture.
• (2)(b) Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from other adults and <Children>, where the amount drawn may not exceed the lesser  of 50 ml or 3 ml/kg in an 8 week period and collection may not occur more frequently than 2 times per week.
  Consider 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.
• (3) Prospective collection of biological specimens for research purposes by noninvasive means
  Examples:
  1. hair and nail clippings in a non-disfiguring manner;
  2. deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
  3. permanent teeth if routine patient care indicates a need for extraction;
  4. excreta and external secretions (including sweat);
  5. uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gum-base or wax or by applying a dilute citric solution to the tongue;
  6. placenta removed at delivery;
  7. amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
  8. 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;
  9. mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
  10. 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
  Examples:
  1. 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 subject or an invasion of the subject's privacy;
  2. weighing or testing sensory acuity;
  3. magnetic resonance imaging;
  4. electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, Doppler blood flow, and echocardiography;
  5. 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 that have been collected for any purpose, or will be collected solely for non-research purposes
• (6) Collection of data from voice, video, digital, or image recordings made for research purposes.
• (7)(a) 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.
• (7)(b) Research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies