Quorum Review IRB s Guide to Understanding expedited review? What is the process?

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1 Quorum Review IRB s Guide to Understanding Expedited Review What is expedited review? Which research earch qualifies? What is the process? September 2014

2 This page intentionally blank 1501 Fourth Ave., Ste. 800 Seattle, WA T (877) or (206) BusDev@QuorumReview.com

3 Contents Understanding the Expedited Review of Research Protocols 2 Expedited Protocol Review Categories 3 Expedited Review Examples 7 Key Take-aways: Planning & Analysis 17 Submission Requirements and Review Turnaround Times Get Started with Expeditable Research Review How to Get More Information 19

4 Understanding the Expedited Review of Research Protocols What is Expedited Protocol Review? Expedited Review allows the review of certain types of research through an expedited process in lieu of a convened IRB meeting. As descirbed in the federal regulations, expedited review consists of review of research by the IRB chairperson or one or more experienced reviewers. When is Expedited Protocol Review Applicable? The regulations allow Expedited Review for research that meets the following two criteria: 1. All research activities present no more than minimal risk to human subjects 2. The research involves only the procedures or interventions listed in one or more of the categories (the study can t partially fit in the categories) What is 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. Can protocols meet the applicability requirement and still not qualify for expedited review? Even if research is otherwise minimal risk and meets the category requirements, an expedited review is not allowed if: The research puts people at risk of criminal or civil liability or could be damaging to the subjects financial standing, employability, insurability, reputation, or could be stigmatizing The research is classified What categories qualify research for expedited protocol review? The research procedures and interventions must fully meet the criteria for one or more of the following seven categories: 1) Studies of drugs without an IND or devices without an IDE 2) Blood Samples 3) Biologic Specimens 4) Data via Noninvasive Procedures 5) Materials Collected Previously or for Non-research 6) Recordings 7) Characteristics or Behavior 1

5 Expedited Protocol Review Categories 1) Studies of drugs without an IND or devices without an IDE Clinical studies of drugs and medical devices ony when condition (a) or (b) is met. (a) (b) 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.) 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) Blood Samples Collection of blood samples by fi nger stick, heel stick, ear stick, or venipuncture as follows: (a) (b) 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 from other adults and children 2, 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. 2

6 Expedited Protocol Review Categories 3) Biologic Specimens Prospective collection of biological speciemens for research purposes by noninvasive means (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) (d) permanent teeth if routine patient care indicates a need for extraction; excreta and external secretions (including sweat); (e) (f) (g) (h) 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; (i) (j) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; sputum collected after saline mist nebulization. 3

7 Expedited Protocol Review Categories 4) Data via Noninvasive Procedures Collection of data through noninvasive procedures* routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (a) (b) (c) (d) (e) 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. *Not involving general anesthesia or sedation. 5) Materials Collected Previously or for Non-research Purposes 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). 4

8 Expedited Protocol Review Categories 6) Recordings Collection of data from voice, video, digital, or image recordings made for research purposes. 7) Characteristics or Behavior Research on individual or group characteristics or behavior, including (but not limited to) Perception Cognition Motivation Identity Language Communication Cultural bliefs or practices, and social behavior Research employing the following methodologies: Survey Interview Oral history Focus group Program evaluation Human factors evaluation Quality assurance 5

Example 1 Observational Registry Drug Study with Survey Here s the scenario... Observational study of individuals receiving an approved birth control pill.

9 Example 1 Observational Registry Drug Study with Survey Here s the scenario... Observational study of individuals receiving an approved birth control pill. Patients will be recruited and asked to consent online to data collection from their doctors. Sponsor has requested a waiver of documentation. At the time of consenting patients will also be asked if they would be willing to participate in an anonymous survey about their experience with the drug. Is this research expeditable? 6

10 Example 1 Answer... Yes. The research is expeditable under categories 1 and 7: 1) Drugs/Devices (a) Clinical studies of drugs and medical devices ony when condition (a) or (b) is met. 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.) 7) Characteristics or Behavior Research employing survey methodologies. 7

Consumer Preference Study of a Diagnostic

questions about the user interface (e.g.

from the IDE regulations on Quorum Review

11 Consumer Preference Study of a Diagnostic Device Example 2 Here s the scenario... Individuals are asked to look at the display on a glucometer and answer questions about the user interface (e.g., how do you like the colors? and is it easy to read? ). The sponsor indicated the study is exempt from the IDE regulations on Quorum Review s Device Study Submission Form (Form F-019). Is this research expeditable? 8

12 Example 2 Answer... Yes. The research is expeditable under category 1(b) and category 7: 1) Drugs/Devices Clinical studies of drugs and medical devices ony when condition (a) or (b) is met. (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. 7) Characteristics or Behavior Research employing survey and interview methodologies. 9

13 Example 3 Blood Glucose Test System Here s the scenario... The sponsor proposes a study intended to: 1) demonstrate that the performance of a blood-glucose test system meets accuracy guidelines and 2) assess the lay-user s understanding of operating instructions. The study will enroll subjects with diabetes (no gestational diabetes and otherwise healthy ). Subject and HCP will take samples. Each subject will require 3 fi nger sticks. Is this research expeditable? 10

14 Example 3 Answer... The researchmay be expeditable under category 2, provided the blood draws are not conducted more frequently than allowed: 2) Blood Samples Collection of blood samples by fi nger stick, heel stick, ear stick, or venipuncture as follows: 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 from other adults and children 2, 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. 11

Example 4 Follow-up Registry Study Here s the scenario... The sponsor proposes an observational study of individuals who received a drug for Hepatitis C.

15 Example 4 Follow-up Registry Study Here s the scenario... The sponsor proposes an observational study of individuals who received a drug for Hepatitis C. The study will conduct long-term monitoring for signs of kidney problems. Subjects will be asked to attend 1 initial visit and follow-up visits every 6 months for the fi rst 2 years, every year for years 3-5, and phone visits thereafter. While visiting the clinical researchers will collect vital signs and blood samples (described as tbsp in ICF). Is this research expeditable? 12

16 Example 4 Answer... Possibly. The research as described is likely expeditable under categories 1(a), 2, and 4 provided the blood draws do not exceed the quantities allowed under category 2 1) Drugs/Devices Clinical studies of drugs and medical devices ony when condition (a) or (b) is met. (a) 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. 2) Blood Samples Collection of blood samples by fi nger stick, heel stick, ear stick, or venipuncture as follows: 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 from other adults and children 2, 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. 4) Data via Noninvasive Procedures Collection of data through noninvasive procedures* routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. 13

Example 5 Observational-Longitudinal Assessment Study Here s the scenario... The sponsor proposes to evaluate individuals that have received a drug due to reported heart problems.

17 Example 5 Observational-Longitudinal Assessment Study Here s the scenario... The sponsor proposes to evaluate individuals that have received a drug due to reported heart problems. Subjects will be asked to have annual visits for an MRI with contrast and will complete a questionnaire. They are also asked to allow access to medical records and will subject to periodic phone interviews. Is this research expeditable? 14

18 Example 5 Answer... No. At fi rst glance, it may appear that a study using an MRI, which does not produce x-rays or microwaves, is expeditable under category 4; However, this is not the case. Because intravenous contrast dye or sedation increases odds of harm the study would not meet the threshold of minimal risk. 15

19 Key Take- Aways : Planning & Analysis Analysis of Expeditable Review The analysis of whether a study can be expedited involves three parts: 1. Determine whether the research is minimal risk. 2. Assess whether all parts of the research fi t into one or more of the expeditable categories. 3. Ensure the research is not classifi ed or puts individuals at risk for criminal or civil liability or could be damaging to the subjects fi nancial standing, employability, insurability, reputation, or could be stigmatizing. Project planning Ultimately, federal regulations require an IRB member to determine whether the research qualifi es for expedited review. Thus, sponsors and CROs should be aware that the IRBs will sometimes determine that a submitted protocol is not expeditable and plan for cost and schedule contingencies. 16

Expeditable Research Review Submission Requirements Two Fast Turnaround Times Available Quorum Review IRB offers two options for expedited review, Next-Day Review and Four- Day Review: Next-Day

offers NEXT DAY review and delivery of your Letter of Approval (LOA) within 2 business days.

20 Expeditable Research Review Submission Requirements Two Fast Turnaround Times Available Quorum Review IRB offers two options for expedited review, Next-Day Review and Four- Day Review: Next-Day Review and LOA Delivery For qualifying protocols that fall under Expeditable Research (Qualifying Minimal Risk) and have no consent forms or participant recruitment materials for review, Quorum offers NEXT DAY review and delivery of your Letter of Approval (LOA) within 2 business days. Next-day review is contingent on a complete protocol submission being submitted to Quorum by 2:00pm (Pacifi c Time) Monday through Friday (excluding holiday closures). In addition, your study must be approved with no modifi cations or mandatory follow-up. If your study meets these requirements, the LOA will be posted to our OnQ Portal by 5:00pm (Pacifi c Time) on the second business day. Four-Day Review and LOA Delivery For qualifying protocols that fall under Expeditable Research (Qualifying Minimal Risk) and do have consent forms and/or participant recruitment materials for review, Quorum offers FOUR DAY delivery of your Letter of Approval (LOA). Four-day review is contingent on a complete protocol submission being submitted to Quorum by 2:00pm (Pacifi c Time) Monday through Friday (excluding holiday closures). In addition, your study must be approved with no modifi cations (or mandatory follow-up) and consent form negotiations must be complete. If your study meets these requirements, the LOA will be posted to our OnQ Portal by 5:00pm (Pacifi c Time) on the 4th business day. 17

21 Get Started with Expeditable Research Review How do I get started with expedited review? Whether yours is a Central Study or a Single Site Study, getting started with an expedited review is easy. Simply send us an as follows: For Central Studies to: InitialStudySupport@QuorumReview.com Subject: Request Expeditable Research Review Information--Central Study Startup. For Single Site Studies to: InitialStudySupport@QuorumReview.com Subject: Request Expeditable Research Review Information--Single Site Study Startup. We ll quickly respond via with all the details you need to submit your study protocol for expedited review. The will include links to all required Quorum Review forms. It will also explain how to submit your document online in three-easy steps! Once I submit a protocol, how long will it take to find out whether it qualifies for expedited review? Sometimes protocols that are submitted for expedited review are found not to qualify. This can happen anytime during the expedited review period. What happens if the board reviewer determines my study does not qualify for expedited review? If the board reviewer determines that your study does not qualify for expedited review, either because it is not minimal risk or does not appropriately fall within one or more expedited review categories, your protocol will be scheduled as a late submission to the next available Board meeting. This means you would be on the same timeline as if you had submitted your study for standard review and subject to standard pricing. Is Expedited Review pricing the same with or without a consent form? No. Under expedited review, study protocols that do not have a consent form enjoy lower pricing and shorter turnaround times than studies with a consent form. 18

22 Get Started with Expeditable Research Review What Can I Do to Ensure my Expedited Review Avoids or Minimizes Delays? Expedited Reviews are much faster than normal review timelines. However, Quorum cannot begin our review until a complete submission is recieved. In our experience, keeping the following in mind will help you avoid the most common delays that prevent the board s review clock from starting: Submit complete forms In order to ensure your submission is reviewed expeditiously, you should double check that all submitted forms have been fi lled out completely. Submit the consent form or consent form waiver If your study will consent participants then it is critical that we receive copies of the consent form with your submission. If you are asking participants to waive consent, then we must have a copy of the consent waiver. Omitting these documents will delay the start of your expedited review. Respond to Promptly IRB Information Requests When an incomplete submission is received, our study-startup team proactively contacts the customer to obtain the needed information. Responding quickly with the requested information will allow our board to begin reviewing your study sooner. Where can I get more information about Quorum Review s Expditable Research Review Services? If you need more information on Quorum Review s Expeditable Review Services, our pricing, or whether your research qualifi es, please us at: BusDev@quorumreview.com. 19

23 1501 Fourth Ave., Ste. 800 Seattle, WA T (877) or (206) BusDev@QuorumReview.com

Levels of IRB Review

IRB Member s Handbook Page 41 Levels of IRB Review All research involving humans that falls under the jurisdiction of the IRB for review and approval must meet the criteria for one of the following methods