Expedited Category Review
ALL research projects involving human subjects require review by the North Texas Regional Institutional Review Board (IRB). Note that this review process may involve several stages or levels of review, depending on the various features of the research project and the potential risk to the subjects.
What is Expedited Category Review
What is Expedited Category Review?
Some research projects that are “minimal risk” may qualify for a special category of IRB review, known as Expedited Review.
Federal regulations (45 CFR 46.110) allow for an expedited review procedure in which the IRB chairperson or one or more IRB members designated by the chairperson can review the protocol instead of a convened Full Board IRB meeting.
Although, in many cases, an expedited review can often be “faster” than a Full Board review, an Expedited review will be conducted with as much rigor and attention as a Full-Board review; however, the numbers of reviewers required for approval are fewer (usually the IRB Chair and perhaps one or two additional Board members). However, only certain categories of research can be approved via Expedited Review procedures.
What are the Criteria for Expedited Category Review?
Research may be reviewed by expedited procedures when the following two criteria have been met:
(1) presents no more than minimal risk to human subjects; and
What is the definition of minimal risk?
The regulatory definition of “minimal” risk is:
“The probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”
45 CFR 46. 102 (i) back to top
Who decides whether or not a project has “minimal risk”?
Risk to subject assessment is initially evaluated by the North Texas Regional IRB. Although the project’s Principal Investigator may indicate that the project is a “minimal risk” activity, federal regulations and guidelines, as well as institutional policies, specify that a third party make this determination: in our case, the North Texas Regional IRB.
If the IRB concurs that a project is “minimal risk“, it is then assessed for a specific category of research, again, based on federal regulations. If this category meets the regulations for Expedited Review, the IRB review process proceeds and the IRB chair (or designated Board member) grants final approval once it is determined the protocol meets regulatory requirements for approval. back to top
What research categories are eligible for an Expedited Category Review?
These research categories 1-9 apply regardless of the age of subjects, except as noted. Researchers are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) also apply to Expedited Review.
Also note that some of these categories have very specific requirements and elements. Contact the North Texas Regional IRB if you have any questions about whether or not your project may be reviewed under “expedited” procedures.
(1) Clinical studies of drugs and medical devices only when condition (1) or (2) is met.
1. 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.)
2. 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:
- from healthy, non-pregnant 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
- from other adults and children, 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.
As a reminder, 1 ml is equal to 1 cc. In addition, 1 cc is approximately 1/5 of a teaspoon. When reporting the total amount of blood drawn from a subject, it may be easier for potential subjects to understand “teaspoons” rather than ml or cc (using teaspoons is a more user-friendly term for participants). Here is another helpful conversion chart investigators may use when describing blood draw amounts in consent documents:
|10 cc or ml = 2 teaspoons|
|15 cc or ml = 1 tablespoon|
(3) Prospective collection of biological specimens for research purposes by noninvasive means.
- hair and nail clippings in a non-disfiguring manner;
- deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
- permanent teeth if routine patient care indicates a need for extraction;
- excreta and external secretions (including sweat);
- 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;
- placenta removed at delivery;
- amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
- 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;
- mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; sputum collected after saline mist nebulization.
*Note that collection of biospecimens may also require permission from agencies, offices and institutions (safety office, biohazard officials, hospitals, clinics, etc.) as well as from patients/research subjects. Also note that other “non-IRB” rules and regulations may be involved with the collection of biospecimens.
(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.)
- 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;
- weighing or testing sensory acuity;
- magnetic resonance imaging;
- electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, Doppler blood flow, and echocardiography;
- 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 nonresearch purposes (such as medical treatment or diagnosis).
Examplesof this type of research might involve:
- medical chart reviews
- analyses performed on existing databases where the information was originally generated for non-research purposes (such as clinical registries, clinical datasets, etc.)
- analyses performed on “discarded” specimens (blood, bone, tissue, proteins, genetic materials, etc.) which were collected as a part of a subject’s routine medical visit (not associated with any aspect of research)
(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 subjects. 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:
- 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
- where no subjects have been enrolled and no additional risks have been identified; or
- 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 2-8 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.
Note that the different activities listed under each of these categories of research, does not automatically deem these projects as minimal risk simply because they are presented here. Providing an exhaustive list of all of the possible research activities eligible for expedited review would be, well, “exhausting.” The activities presented here only indicate that a significant portion of these types of research activities could be eligible for review through expedited review procedures. In addition, this eligibilityalso depends on whether or not the specific circumstances surrounding the proposed research activities involves no more than minimal risk to the participating subjects. Decisions regarding eligibility for expedited review will be made on a case-by-case basis, by the North Texas Regional IRB. back to top
What is the application process for submitting an Expedited Category Review research project?
When submitting your Expedited research to the North Texas Regional Institutional Review Board, please submit 2 complete, collated packets with the following information contained within EACH packet. NOTE: Protocols in which the Principal Investigator (PI) and research members are considered John Peter Smith Health Network (JPS) personnel MUST be initially submitted to the Office of Clinical Research (OCR) located at 1500 S. Main Street, Fort Worth. For additional assistance, please contact the JPS Office of Clinical Research at 817-702-3655.
(1) IRB Expedited Review Application Form (with original PI signature)
(2) Protocol Synopsis
(3) Informed Consent Form (if applicable)
(4) Conflict of Interest Form for all key personnel listed on the project
(5) CITI Human Subject Research Training Certificates for all key personnel listed on the project
(6) Recruitment Materials (flyers, emails, advertisements, etc.)
(8) Telephone scripts/oral scripts
(9) Assent Forms/Parental Permission Forms
(10) Research Agreements
(11) Letters of permission or cooperation, and/or approvals from other IRBs
(12) HIPAA Research Waiver
In order for the North Texas Regional IRB to make a timely and appropriate determination of the project, the documents and materials you submit must be thorough, clear and complete. If the application packet is missing some critical information or is otherwise incomplete, your entire set of IRB review documents and materials will be sent immediately back to you.
Please ensure that the needed information (listed above) is submitted in each packet for a more streamlined “speedy” review of your research project. In addition, please keep in mind that the review process takes time, and research may not be initiated until the application has been approved. In most cases, Expedited Review can be completed within approximately 7 working days, unless needed information is missing or incomplete. back to top
How (and When) Will I know that a Protocol has been Approved?
Once a protocol has been reviewed and approved, a formal written notice of approval will be sent to the Principal Investigator.
As soon as the project is approved as “Expedited”, a Letter of Approval along with a Board Action from the IRB Chair will be sent to the Principal Investigator. This notice may also specify the terms and conditions of the approval, as well as the continuing review period (6 months, 12 months, etc.) back to top
Who receives these IRB Board Action Notices / Letters of Approval?
The Principal Investigator of record is responsible for all aspects of a research protocol involving human subjects, and is the person who will receive formal correspondence from the North Texas Regional IRB.
The Principal Investigator may designate, in writing, other project personnel to receive copies of such notices or correspondence, and such designation should be sent directly to the IRB for inclusion in the protocol folder. However, the principal investigator is still fully responsible for acting on such correspondence from the North Texas Regional IRB. back to top
What happens if my “Expedited Review” project turns out not to qualify for Expedited Review?
In some cases, a protocol that was first thought to be “expedited review category” may actually meet the federal regulations to be classified as Exempt from IRB review. If that happens, you will be notified of this change and your proposed project will then be reviewed under those Exempt category regulations. Usually this results in a faster turn-around time for approval.
Occasionally, a protocol that was first thought to be “expedited review category” may NOT meet the federal regulations for Expedited Review: the project might be determined to have more than minimal risk, specific vulnerable populations might be involved, or the protocol has elements that do not meet any of the designated categories for such approval. The regulations state that protocols cannot be disapproved by Expedited Category, but must be then referred to a convened (Full Board) meeting of the IRB for consideration. If that happens, you will be notified by the North Texas Regional IRB that the protocol has been re-classified and you will be advised of any additional materials or copies needed for Full Board review. Note that a convened IRB meets once per month on a specific schedule (see link for IRB meeting dates and document submission deadlines). back to top