OBJECTIVE:

To describe the expedited initial review process and related procedures.

DESCRIPTION:

In addition to the standard VCU IRB Application process, the Expedited review process also requires:

1. Confirmation that the research poses no more than minimal risk and meets all other applicability criteria (research involving children and pregnant women, fetuses, neonates may be eligible for expedited review: research involving prisoners is not recommended for expedited review unless there is n direct intervention or interaction with incarcerated individuals);

2. Identification of the Expedited Research Category;

3. Determination of the requirement for continuing review and additional requirements;

4. Review of the informed consent process in accordance with 45 CFR 46.116, 45 CFR 46.117, 21 CFR 50.20, 21 CFR 56.25, and 21 CFR 56.27;

5. Review of any recruitment procedures involving advertisements; AND,

6. Documentation of the above findings.

1. Expedited Review – Full Panel Not Required:

Under expedited review, full Panel approval is not required under federal regulations.  Only those projects involving no more than minimal risk are considered for expedited review.  A principal investigator may request that his/her protocol be considered for expedited initial review and requests consideration under one or more of the 7 categories of expedited review listed below.  The primary reviewer makes the final decision as to whether or not the protocol meets the applicability criteria and qualifies for the category or categories noted (or another one or more of the 7 categories) and can make a decision to refer the review to the full board.

 

2. Minimal Risk Determination:

At initial review, the expedited review type applies to research projects that:

1. pose no more than minimal risk,  AND

2. involve one or more research activities (see 9 categories below) listed in the federal regulations as qualifying for expedited review.

 

NOTE: The activities listed should not be deemed to be of minimal risk simply because they are included in the federal regulations as qualifying for expedited review.  Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

 

Minimal risk is defined in 45 CFR 46.102(i): “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.”

 

The following SPECIAL CONDITIONS ALSO APPLY:

• The expedited review procedure is not used 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 are implemented so that risks related to invasion or privacy and breach of confidentiality are no greater than minimal.

• The expedited review procedure cannot be used for classified research.

 

3. Determination of Expedited Review Category:

Note: the following 9 categories include two categories (8 and 9) that specifically pertain to continuing review and NOT initial review.  VCU IRB WPP#: VIII-4 addresses Continuing Review, however the 9 categories are quoted here in their entirety as published at 63 FR 60364-60367 and referenced in 45 CFR 46.110(a).

 

The following research activities are listed in the federal regulations as qualifying for expedited review:

 

NINE CATEGORIES FOR EXPEDITED REVIEW: HHS 45 CFR § 46.110 FDA 21 CFR § 56.110   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.) or (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. [VCU NOTE:  Use of this category is EXCEEDINGLY RARE at VCU]   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.   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.   Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. NOTE:  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.   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.)   Collection of data from voice, video, digital, or image recordings made for research purposes.   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.)   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.   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.

 

4. Continuing Review of Research (Consideration at Initial Review):

The VCU IRB will plan for continuing review of research at intervals appropriate to the degree of risk, but not less than once per year, and will exercise the authority to observe or have a third party observe the consent process and the research, as appropriate (given the level or risk, experience of the investigator, vulnerability of subjects, or other concerns) [45 CFR 46.109(e)].  The IRB may require review more often than annually for ANY research activities, including:

1. Research that involves withdrawal of therapy when there may be significant morbidity or mortality.

2. Research that involves an invasive surgical procedure (that would not otherwise be done).

3. Research in which there are serious risks to participants and non potential benefits, or

4. More than minimal risk research involving a vulnerable population with no prospect of direct benefit to the individual participants.

 

5. Reviewer,  Approval, and Disapproval Guidelines:

The Panel Chairperson or Senior Chairperson may conduct expedited review, and will also appoint experienced reviewers from among the members of the Panel to conduct expedited review (to serve as primary reviewer).  The reviewer (chairperson, vice chairperson, or appointed primary reviewer) may (1) approve research submitted for Expedited review (as submitted) or may (2) require modifications prior to approval.  An experienced review is one who has served with the IRB for a duration that has allowed for an evaluation of the reviewer's understanding of the regulations and the VCU IRB written policies and procedures as they pertain to expedited review.  Official designation of a review's eligibility to serve as an expedited reviewer will be documented by letter and retained within the VCU Office for Research Subject's Protection.

 

Expedited research is assigned to a reviewer by the VCU ORSP staff, based upon a list of reviewers designated by the IRB chairperson (including the chairperson and vice chairperson) and by area of experience as documented to the staff. 

 

The reviewer (chairperson, vice chairperson, or appointed reviewer) may not disapprove projects that have been submitted for expedited review.  In cases where the research cannot be approved via expedited review, the reviewer must recommend resubmission for full board approval or forward to the VCU IRB panel for review as full board, with their written comments.

 

6. Document Distribution and Board/Reviewer Actions (Written Comments):

1. Documents for expedited review are distributed on an ongoing basis to primary reviewers.

2. If the reviewer(s) disagree with the applicability of expedited review for a given protocol, the reviewer(s) may defer to full board review by notifying the IRB coordinator of their recommendation.   The review will consult with the Chairperson or the OECO Director if he or she requests consultation in order to complete the review.

3. In reviewing the research, the reviewers may exercise all of the authorities of the Panel except disapproval.  If the reviewers do not wish to approve the research being reviewed, they must refer it to the full Panel for action in accordance with non-expedited procedures (45 CFR 46.108(b)).

4. If there is any protocol-related information requiring clarification, the expedited reviewer should contact the principal investigator (or student/trainee conducting the activity) directly.

5. FINAL review comments by the expedited reviewer must be documented in writing and forwarded to the IRB coordinator for processing (email documentation is strongly recommended).  This documentation must include:

1. Expedited category(ies)

 

2. Comments on review of consent process and document (unless waiver of consent was requested).

1. If a waiver of consent (45 CFR 46.116(c-d)) or waiver of documentation of informed consent (45 CFR 46.117(c)(1-2)) is requested/approved, the required determinations must be included along with protocol specific findings justifying each of those determinations.  [The VCU IRB requires that the protocol include the precise information that justifies the findings of the IRB and that this information be part of the IRB application].

 

3. If children are involved as research participants (in Virginia, individuals under the age of 18 years unless legally emancipated), the following information must be documented:

 

1. The category of children's research (under 45 CFR 46 Part D).  Note:  Only category 45CFR45.404 can be used for expedited research AND children who are in court-appointed or state custody may not be included unless specifically requested by the PI.  For information regarding wards of the state, see VCU IRB WPP#: XV-3:  Children in Court-Appointed or State Custody and Emancipated Minors. For information on state law applicability of children in research, as well as applicability for research conducted outside of Virginia, see WPP #XV-1 Children as Research Participants: Permissible Categories.

 

2. The unique determinations required by the regulations (for the children's category or categories of research) must be documented.  This documentation must include protocol specific findings justifying each of those determinations.  [The VCU IRB requires that the protocol include the precise information that justifies the findings of the IRB and that this information be part of the IRB application.  PIs must complete the Children’s Supplement Form for research involving Children.  The Form is available at the IRB Forms website].

 

3. The requirements for ASSENT and documentation of assent;

 

4. The determination of whether permission of both parents is required (unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child), or whether the permission of one parent is sufficient.  [See WPP XV-2 Assent and Parental/Guardian Permission Considerations for more information about assent and parental permission].

          

4. If pregnant women and/or fetuses are, or could be, involved as research participants, confirmation of determinations required under 45 CFR 46 Part B along with protocol specific findings justifying each of those determinations must be included.  [The VCU IRB requires that the protocol include the precise information that justifies the involvement (even if inadvertent) of pregnant women and fetuses and that this information be part of the IRB application].   See WPP XIII-1 Pregnant Women, Human Fetuses, and Neonates for more information regarding these special populations.

 

5. If prisoners are included (and the research is permitted for Expedited review with the involvement of prisoner subjects as per VCU IRB WPP#: XIV-1) confirmation of determinations required under 45 CFR 46 Part C along with protocol specific findings justifying each of those determinations must be included.  Note:  The VCU IRB requires that the principal investigator submit a written justification that serves as the foundation for this documentation.  The final IRB-approved protocol must include a comprehensive final justification (e.g., may be in the form of an updated prisoner submission form and/or written comments by the primary reviewer).

 

6. If subjects with impaired decisional capacity are to be involved, confirmation of criteria about the informed consent process with an LAR, and additional protections within the research setting, as described in WPP #XI-3 Legally Authorized Representative (Inclusion in Consent Process), WPP #XVII-7 Evaluating Consent / Persons with Limited Decision-Making Capacity, and the Expedited Review Sheet.

 

7. Approval period dates (if less than annual continuing review is recommended) or detailed limitations to approval periods (such as limitations to enrollment numbers prior to reporting back for continuing review). 

 

6. Final documentation of approval will be generated by the ORSP staff and signed by the Panel Chairperson.

7. Protocols approved via expedited procedure are reported to the IRB and either listed as part of the agenda or as an attachment to the agenda of each meeting.  Information provided includes the VCU IRB number, principal investigator name, title of the research activity, reviewer name, and approval date. 

RESPONSIBILITY:

The principal investigator is responsible for determining if their research MIGHT qualify for expedited review, and requesting expedited review at time of submission.  Typically, each VCU IRB Panel conducts its own expedited reviews.  It is the responsibility of the Panel Chairperson and another Panel member to confirm that a research protocol qualifies for expedited review or recommend full board review/action and document all findings.

REFERENCES:

HHS 45 CFR § 46.110

FDA 21 CFR § 56.110

VCU IRB Submission Form

Expedited Review Sheet