III.05

Expedited Review

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PURPOSE

1. 1. This policy and procedure describes the review of human subjects research proposals that qualify for expedited review.

SCOPE

2. 2. This policy and procedure is applicable to all investigators, CPHS Members and ORSC Staff.

DEFINITION

3. Minimal risk - Minimal risk means that 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.

POLICY

4. Research is reviewed by CPHS at convened meetings unless it is minimal risk and qualifies for expedited review. An expedited review procedure consists of a review of research involving human subjects by the IRB Chairperson or by one or more experienced reviewers designated by the Chairperson from among the members of the IRB.

4.1. An experienced CPHS member is one who has served on the CPHS for at least one year, has received training relative to the expedited review categories, and has the expertise required to review the proposed research.

5. Initial Review - To qualify for review by expedited process, a research proposal must meet the following criteria:

1. The research proposal presents no more than minimal risk to human subjects,
2. Identification of subjects and / or their responses does not reasonably place them at risk of criminal or civil liability or be damaging to their financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal,
3. The research is not classified, and
4. The research activity is listed in the Categories of Research in Item 6 below.

6. Categories of Review

6.1. Category 1: Clinical studies of drugs and medical devices only when condition (i) or (ii) is met.

1. Research on drugs for which an investigational new drug application is not required. (Note: Research on marketed drugs that significantly increase the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
2. Research on medical devices for which;
   1. An investigational device exemption application is not required; or
   2. The medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

6.2. Category 2: Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

1. From healthy, non-pregnant adults who weigh at least 50 kg. 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
2. 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.

6.3. Category 3: Prospective collection of biological specimens for research purposes by noninvasive means. Examples include:

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 gumbase 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 sub-gingival 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;

6.4. Category 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).

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 participant or an invasion of the participant’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.

6.5. Category 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).

6.6. Category 6: Collection of data from voice, video, digital, or image recordings made for research purposes.

6.7. Category 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 groups, program evaluation, or quality assurance methodologies.

7. Continuing Review - Continuing review of research may undergo expedited review if it meets the following criteria:

1. The research is not classified and
2. Category 1-7 as defined above still apply; or

7.2. Category 8a:

1. The research is permanently closed to the enrollment of new participants.
2. All participants have completed all research-related interventions; and
3. the research remains active only for long-term follow-up of participants; or

7.3. Category 8b:

1. No participants have been enrolled (at this site)
2. No additional risks have been identified (neither the investigator nor the CPHS at this site has identified any additional risks from any site or other relevant source)
3. The remaining research activities are limited to data analysis; or

7.4. Category 9:

1. The research is not conducted under an investigational new drug application or investigational device exemption.

7.5. If Categories 2 through Category 8.8 do not apply, but the CPHS has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

8. Submission for Expedited Review

8.1. The Principal Investigator may make a preliminary determination that the protocol may qualify for expedited review and choose the appropriate category.

8.2. The ORSC Staff assigns an IRB tracking number to the submission and reviews the submission to ensure that the information provided is complete. If the submission if not complete, the ORSC staff returns the submission to the Principal Investigator for additional information.

8.3. For those research proposals where the PI requests expedited review, the ORSC Staff will assess the research proposal and if it does not qualify for expedited review, the ORSC staff will assign it for full board review. When it is difficult to determine whether a protocol qualifies for review using the expedited procedure, the ORSC staff will consult with the ORSC Director and/or IRB Chair. When in doubt, the proposal is assigned for full board review.

8.4. Documents to be submitted for expedited review are the same as those for review by a Full Board as outlined in CPHS Policy and Procedure Initial Review.

9. Expedited Review Process

9.1. In the iRIS application form, the Principal Investigator may indicate that the proposal qualifies for expedited review. The ORSC staff screens the submission and determines if the research proposal qualifies for expedited review. If the ORSC Staff determines that the proposal does not qualify for expedited review, the proposal will be designated Exempt or referred for Full Board Review. If the ORSC Staff determines that the proposal qualifies for expedited review, the ORSC Staff will assign the proposal to a Reviewer through iRIS. The ORSC Staff chooses a reviewer in consultation with the IRB Chair and ORSC Director.

9.2. The Reviewer has access to all protocol related documents via iRIS. The Reviewer shall follow the same process, the criteria for approval including scientific review, as the initial review process outlined in policy and procedure Initial Review. In addition, the Reviewer will evaluate whether the proposal meets the applicability criteria for expedited review and determine the expedited category for the research proposal. If the Reviewer has a conflict of interest policy and procedure Conflict of Interest for CPHS members and Consultants, the Reviewer will disclose the conflict and the ORSC staff will reassign the proposal to another Reviewer.

10. Possible Outcomes of Review

10.1. In reviewing the research, the Reviewer may approve, approve pending and defer. The Reviewer may not disapprove the research proposal. If the Reviewer has concerns about the research proposal, the Reviewer may request a second reviewer, scientific pre-reivew, a consultant or refer the research proposal to the Full Board for further review.

10.2. When the Reviewer recommends approval or approval pending, the Reviewer also determines the approval period as outlined in the policy and procedure Initial Review.

10.3. The ORSC staff will convey the decisions and stipulations as per P and P on Initial Review Item 10 on Reporting.

11. Documentation: The ORSC Staff will ensure that the following information is documented during the initial review of an expedited protocol:

1. The specific permissible category;
2. A description of the review;
3. A description of action taken by the reviewer;
4. For those requiring protocol specific determinations:
   i. The determination
   ii. Protocol specific findings that justify the determination
   iii. Protocol specific findings

12. Notification to the CPHS – When a proposal is approved by expedited review, all the members of the IRB Panel will be notified of the actions taken via expedited review at the next convened meeting. The ORSC Staff will include a list of the expedited approvals that were reviewed and approved on the next meeting agenda.

RESPONSIBILITY

13. The ORSC Director/Designee is responsible for assigning a Reviewer for expedited review.

14. The Reviewer is responsible for determining the expedited category. The Reviewer shall follow the same process as the initial review process outlined in policy and procedure Initial Review.

Applicable Regulations and Guidelines

1. 45 CFR 46.102(i)
2. 45 CFR 46.110
3. 21 CFR 56.102(i)
4. 21 CFR 56.110
5. 63 FR 60364-60367; 63 FR60353 – 60356 DHHS-FDA list published in Federal Register November 9, 1998

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