HRPP Manual Section 8-2

Expedited Review Procedure

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.” 45 CFR 46.102(i)(Pre-2018 Requirements), 45 CFR 46.102(j)(2018 Requirements) 21 CFR 50.3(k)

Revised Common Rule (2018 Requirements)

“(a) The Secretary of HHS has established, and published as a Notice in the Federal Register, a list of categories of research that may be reviewed by the IRB through an expedited review procedure. The Secretary will evaluate the list at least every 8 years and amend it, as appropriate, after consultation with other federal departments and agencies and after publication in the Federal Register for public comment. A copy of the list is available from the Office for Human Research Protections, HHS, or any successor office.

(b)

(1)     An IRB may use the expedited review procedure to review the following:

(i)    Some or all of the research appearing on the list described in paragraph (a) of this section, unless the reviewer determines that the study involves more than minimal risk;

(ii)   Minor changes in previously approved research during the period for which approval is authorized; or

(iii) 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).

(2)     Under an expedited review procedure, the 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. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the nonexpedited procedure set forth in §46.108(b).: 45 CFR 46.110(2018 Requirements)

Pre-2018 Common Rule Requirements

“An IRB may use the expedited review procedure to review either or both of the following:

(1)     some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk,”

(2)     minor changes in previously approved research during the period (of one year or less) for which approval is authorized.

Under an expedited review procedure, the 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. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedure set forth in §46.108(b) [§56.108].” 45 CFR 46.110 (b)(Pre-2018 Requirements), 21 CFR 56.110(b) [FDA]

When the appropriate conditions specified by 45 CFR 46.110 and/or 21 CFR 56.110(b) are met, the expedited review procedure may be used for:

  • Non-exempt initial studies, modifications and continuing review.

  • For studies subject to the Revised Common Rule (2018 Requirements): exempt determinations that require limited Institutional Review Board (IRB) review, including review of modifications that may impact the limited IRB review criteria.

While initial review for use of a Humanitarian Use Device must occur at a convened IRB meeting, the IRB may use the expedited review procedures (21 CFR 56.110) for continuing review.

For non-exempt studies, the criteria for approval using the expedited review procedure are the same as those for review by the convened IRB. See the Human Research Protection Program (HRPP) Manual 6 “IRB Evaluation Criteria.”

The following sections apply to the non-exempt expedited review processes; see HRPP Manual 8-1 “Exemptions” for the requirements for exemptions that require limited IRB review.

Criteria for Use – Initial Studies and Renewed Approval

The expedited review procedure may be used for initial study submissions and renewed approval when:

  1. Research involves only procedures listed in one or more of the expedited review categories provided by the Office for Human Research Protections (OHRP);

  2. For studies that must comply with the Pre-2018 Common Rule Requirements and/or U.S. Food and Drug Administration Requirements, the research also must involves no more than minimal risk to subjects; and

  3. Research is not subject to limitations on the use of the expedited review procedure (e.g., classified research, initial/continuing review of prisoner research).

The expedited review procedure cannot be used in any of the following circumstances:

  1. Research study involves minimal risk but does not appear in the categories of research eligible for expedited review;

  2. Where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ 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. When research is classified (in general, classified research at MSU requires explicit permission from the Board of Trustees for the specific research study);

  4. Research involves prisoners unless the review involves a review for minor modifications only or the study is eligible for exemption (see HRPP Manual 6-8-B “Prisoners” or 8-1 “Exemptions”);

  5. Initial review of research involving individuals with diminished capacity and use of a legally authorized representative to obtain consent (see HRPP Manual 6-8-D “Individuals with Diminished Capacity”); and

  6. When the reviewer determines that the study involves more than minimal risk, even when some or all of the research appears on the expedited review category list, or the IRB determines that full board review is required even if the study is eligible for expedited review (e.g. determined to be minimal risk and some or all of the research appears on the expedited review category list).

If any of the above conditions exist or are not met, the research study may not undergo an expedited review procedure and must undergo a committee review.

For initial study submissions, an IRB member will review the submission to determine if the study qualifies for expedited review. Reviewer comments may be generated if clarification or explanations are needed. An IRB member shall document the determination of whether the study qualifies for expedited review. A standard form shall be used for documentation. IRB members will notify the IRB staff if they believe that the submission does not qualify for expedited review. If the reviewer or IRB determines that the study involves more than minimal risk, even when some or all of the research appears on the expedited review category list, or the IRB determines that full board review is required even if the study is eligible for expedited review (e.g. determined to be minimal risk and some or all of the research appears on the expedited review category list), the rationale for the determination will be documented using a standard form.

For continuing review submissions, an IRB member will confirm that research that underwent expedited review during initial review continues to qualify for expedited review. Research that underwent committee review during the initial review will typically not be eligible for expedited review at the time of continuing review unless it meets the criteria for expedited review and the convened IRB determines that expedited review is appropriate. If the convened IRB determines that the study now qualifies for expedited review, a standard form shall be used for documentation. For studies subject to the Revised Common Rule (2018 Requirements), continuing review is eliminated for research eligible for expedited review in accordance with 45 CFR 46.110 (2018 Requirements), unless an IRB determines otherwise. See HRPP Manual 8-7 “Renewed Approval” for requirements.

Expedited Review Categories

A research study may undergo expedited review if it only involves subjects in one or more of the following categories from the Federal Register: November 9, 1998 (Volume 63, Number 216):

Category 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.”

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

“(a)     from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, 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 children2 considering 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. For these subjects, 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.”

Category 3: “Prospective collection of biological specimens for research purposes by noninvasive means.”

“Examples:”

“(a)     Hair and nail clippings in a nondisfiguring 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.”

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.)”

“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 subject or an invasion of the subject'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”

Category 5: “Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for nonresearch 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 subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)”

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

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 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 subjects 45 CFR 46.101 (b)(2) and (b)(3). This listing refers only to research that is not exempt.)”

Category 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 subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or”

(b)      “Where no subjects have been enrolled and no additional risks have been identified; or”

(c)      “Where the remaining research activities are limited to data analysis.”

Category 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.”

Criteria for Use of Expedited Review – Minor Changes

Expedited review may be used for minor changes in previously approved research during the period for which approval is authorized. See HRPP Manual 8-6 “Modifications to an Approved Research Study” for requirements.

Expedited Reviewer Assignment and Distribution of Materials

For evaluation criteria and specific documents required for submission, see the following sections of the HRPP Manual 8-5 “Initial Review,” 8-6 “Modifications to an Approved Research Study,” and 8-7 “Renewed Approval.”

The IRB chair or vice-chair will evaluate the research and determine who has the appropriate scientific or scholarly expertise to conduct an in-depth review of the research study. The chair or vice-chair will assign reviewer(s) and if needed, a consultant to the research study. Reviewer(s) may be the IRB chairperson or one or more experienced reviewers designated by the chairperson from among members of the IRB.” 45 CFR 46.110(b), 21 CFR 56.110(b). See HRPP Manual 5-3 “IRB Membership” for the procedure for designation by the IRB chair of IRB members who may conduct review using the expedited procedure, including the definition of experienced reviewer.

Expertise

While all IRB members have the general qualifications and training to review research studies submitted to the IRB, there are instances in which certain reviewers on the IRB have specific expertise in the area under study. Those reviewers will be assigned the research study when such expertise is needed, and whenever possible. At least one IRB member with scientific or scholarly expertise must be assigned to conduct an in-depth review of each research study. For research studies that will involve subjects vulnerable to coercion or undue influence (e.g., children, students, disadvantaged populations, individuals with impaired decision-making capacity), reviewers with appropriate expertise will be assigned. The roster may be used when making reviewer assignments. The IRB chair may determine that another individual on the IRB has appropriate expertise. If appropriate expertise is not available, additional expertise will be obtained as needed. See the HRPP Manual 5-4 “Additional Expertise” for policies and procedures.

The reviewer(s) is typically alerted of the assignment by email and typically has seven days in which to review the research study. If an experienced reviewer assigned by the IRB chair does not respond by the due date, the IRB administrator should send a reminder to the assigned reviewer and should notify the IRB chair. The IRB chair should determine if the review should be re-assigned to another individual, considering expertise needed to review the study.

Initial Study Submissions

See HRPP Manual 8-5 “Initial Review” for materials provided to assigned reviewers.

Submissions for Renewed Approval

See HRPP Manual 8-7 “Renewed Approval” for materials provided to assigned reviewers.

Modifications – Minor Changes

See HRPP Manual 8-6 “Modifications to an Approved Research Study” for materials provided to assigned reviewers.

Review Comments Procedure

Modifications or clarifications requested by the reviewers are communicated to researchers in writing via the MSU online system. If a reviewer has any questions or concerns or is requesting modifications to the research study, s/he should draft a reviewer comment and submit it to the IRB office via the MSU IRB online system. The IRB staff posts the reviewer comment(s) to the MSU IRB online system and the researcher is notified via e-mail. See HRPP Manual 3-1 “MSU Human Research Protection Program Plan” for a description of the MSU IRB online system.

Once the researcher responds, the reviewer is notified. If the reviewer is satisfied with the response, the reviewer may issue his/her approval through the MSU online system. If the reviewer has additional questions or concerns, another reviewer comment is submitted to the IRB office and the same process as above is followed.

If the reviewer and the researcher are unable to come to resolution over the issue raised, the IRB chair will mediate such discussions. If a resolution cannot be reached, the IRB will discuss the research study at its next convened meeting.

Recommending Disapproval

If a reviewer indicates that he/she does not approve a research study, the IRB staff notifies the IRB administrator and the research study will be added to the IRB meeting agenda for review by the convened IRB.

“A research activity may be disapproved only after review in accordance with the non-expedited procedure set forth in 45 CFR 46.108(b).” 45 CFR 46.110(b)(Pre-2018 Requirement), 45 CFR 46.110(b)(2)(2018 Requirements)

See HRPP Manual 5-5 “Meetings” for the IRB process to report its findings and actions of disapprovals to researchers in writing.

Review and Documentation of Waivers and Certain Vulnerable Populations

Additional criteria must be met and documentation must be maintained if the research involves the following:

  • Children

  • Pregnant women, fetuses, or neonates

  • Prisoners

  • Waiver or alteration of the consent procedure

  • Waiver of documentation

  • Informed consent exception for recruiting, screening, or determining eligibility

  • Alteration to, or waiver, in whole or in part, of the individual authorization required by 164.508 for use or disclosure of protected health information (PHI)

The relevant criteria should be addressed throughout the IRB submission. The reviewer shall review the submission to determine if the appropriate criteria have been satisfied. Reviewer comments may be generated if clarifications or explanations are needed.

If the applicable criteria have been satisfied, an IRB member shall document that each criteria have been met and provide research study specific information justifying why the research met each criteria. Standard forms shall be used for documentation.

For applicable criteria, see the following sections of the HRPP Manual:

6-4-B       Waiver or Alteration of Informed Consent

6-4-C       Parental Permission and Child Assent

6-4-D       Waiver of Documentation

6-4-E       Informed Consent Exception for Screening, Recruiting, and Determining Eligibility

6-8-A       Pregnant Women, Human Fetuses, and Neonates

6-8-B       Prisoners

6-8-C       Children

7-6           Health Insurance Portability and Accountability Act Compliance in Human Research

7-6-B       Alteration or Waiver of Individual Authorization

Actions and Communication of Actions for Expedited Review

Expedited approvals are issued after all criteria necessary for approval have been met. Expedited approvals do not require convened IRB review.

A standard approval letter shall be used to communicate such approval to researchers in writing. The approval letter and IRB approved consent form(s) if applicable will be made available to the researchers through the MSU IRB online system. The MSU IRB Online system includes the ability to finalize documents. Finalizing documents converts the document from a Word document to a PDF document, and for consent forms, adds a watermark. While documents included as part of the submission are approved, only consent forms are finalized. After a submission is approved, the approved documents are in the Documents tab in the main study workspace in the Draft column. Finalized consent forms, if applicable, are in the Documents tab in the main study workspace in the Final column, and when applicable, investigators must typically use this finalized consent form with the watermark.

For externally sponsored studies with an unexecuted contract that includes terms that could impact the consent form (e.g. subject injury language), the consent form is not finalized and released at initial approval unless the contract is executed prior to IRB approval. To assure congruence between the contract and consent form, the consent is not finalized and released until a modification with an executed contract is approved. See HRPP Manual 3-1, MSU Human Research Protection Program Plan for more information about the contract and consent review process.

Researchers will be sent a notification of the approval and of the availability of the approval letter and consent form(s) if applicable from the MSU IRB online system. Members will be notified of research studies approved using an expedited review procedure. These research studies do not require any actions at the convened IRB meeting.

Initial Study Submissions

All assigned reviewer(s) must issue an approval before the research study is given IRB approval. If there are multiple reviewers and they do not issue their approval on the same day, the date of approval will be the latest date of reviewer approval. The approval period is 364 days, unless otherwise noted. See HRPP Manual 8-8 “Flexibility Initiative” for policies and procedures on issuing approval periods that are greater than 364 days.

Renewed Approval (When Required)

The renewed approval date is the date the last assigned reviewer issues his/her approval. The approval period is 364 days, unless otherwise noted. This approval period replaces the research study’s last approval period.

Modifications – Minor Changes

The modification approval date is the date the assigned reviewer issues approval. The modification approval date does not change the approval period.

Approval Action Definitions

The following definitions apply to approval actions:

Initial approval date: Date the research study is initially approved.

Initial effective date: Date the research study is initially approved or the date modifications required to secure initial approval was met.

Approval period: Period from which the research study is approved to the research study expiration date.

Approval end (expiration date): When renewed approval is required, the last date the research study has approval or renewed approval. Approval expires at 11:59 P.M. of the expiration date. All human research activities must stop and may not be conducted if a research study’s approval has expired. See HRPP Manual 8-7 “Renewed Approval” or 8-9 “Closure” for requirements.

Calculation of the expiration date: Typically, date of approval to the same date in the following year less one day. However, if the IRB requires continuing review more or less often than annually, then expiration date is calculated from the date of approval to the period the IRB sets less one day.

Modification approval date: Date the modification is approved. This is the date the modification may be implemented. Modification approval does not alter the research study’s expiration date.

Effective date: The effective date is the most recent initial study approval date, modification approval date, renewed approval date, or date modifications required to secure approval were met.

Further Institutional Review

Research covered by this policy that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. University officials, however, may not approve the research if it has not been approved by an IRB. 45 CFR 46.112, 21 CFR 56.112.

Typical Review Time

Initial Studies: 2 – 4 weeks

Modifications to An Approved Research Study: 10 – 15 working days

Renewed Approval: 10 – 15 working days

Applicability of the Revised Common Rule (2018 Requirements)

See HRPP Manual Section 4-11 “Applicability of the Revised Common Rule (2018 Requirements)” for a description of whether the Revised Common Rule (2018 Requirements) or the Pre-2018 Common Rule Requirements apply.

Additional Requirements

For research studies subject to the requirements of the U.S. Department of Education, see HRPP Manual 2-2-D “U.S. Department of Education.”

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 4-21-2005. Revision 1 approved by VP Research & Graduate Studies on 4-5-2006. Revision 2 approved by VP Research & Graduate Studies on 3-9- 2008. Revision 3 approved by VP Research & Graduate Studies on 5-6-2008. Revision 4 approved by VP Research & Graduate Studies on 9-3-2009. Revision 5 approved by VP Research & Graduate Studies on 1-11- 2010. Revision 6 approved by VP Research & Graduate Studies on 7-22-2011. Revision 7 approved by VP Research & Graduate Studies on 3-4-2013. Revision 8 approved by VP Research & Graduate Studies on 2-25-2015. Revision 9 approved by Assistant VP Regulatory Affairs on 10-6-2015. Revision 10 approved by Assistant VP Regulatory Affairs on 12-9-2015. Revision 11 approved by Assistant VP Regulatory Affairs on 6-27-2018. Revision 12 approved by Senior VP for Research and Innovation on 1-18-2019. Revision 13 approved by Assistant VP Regulatory Affairs on 8-26-2020.  

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