quorum review irb’s guide to understanding … protocol review categories 3 prospective collection...

Quorum Review IRB’s Guide to

UnderstandingExpedited Review

September 2014

What is expedited review?What is expedited review??w?ewevieditepeexisW

Which research qualifies?Which research qualifialiquqrcheaeeschWhat is the process?

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1501 Fourth Ave. , Ste. 800 | Seattle, WA 98101www.QuorumReview.comT (877) 472-9883 or (206) 448-4082

Email: [email protected]

Contents

2

Understanding the Expedited Review of Research Protocols

18

Submission Requirements and Review Turnaround Times

7Expedited Review Examples

3Expedited Protocol Review Categories

19Get Started with Expeditable Research Review

17Key Take-aways: Planning & Analysis

19How to Get More Information

Understanding the Expedited Review of Research Protocols

Expedited Review allows the review of certain types of research through an “expedited” process in lieu of a convened IRB meeting. As described in the fed-eral 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 mini-mal risk to human subjects

2. The research involves only the procedures or interventions listed in one or more of the catego-ries (the study can’t “partially” fi t in the catego-ries)

What is Minimal Risk?Minimal risk means that the probability and mag-nitude 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.

What is Expedited Protocol Review?

Can protocols meet the applicability re-quirement 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 classifi ed

1

3) Biologic Specimens

What categories qualify research for expedited protocol review?The research procedures and interven-

tions must fully meet the criteria for one or more of the following seven catego-ries:

2) Blood Samples

4) Data via Noninvasive

Procedures

6) Recordings

5) Materials Collected Previously or for Non-research

7) Characteristics or

Behavior

1) Studies of drugs without an IND or devices without an IDE

Expedited Protocol Review Categories

2

Clinical studies of drugs and medical devices ony whencondition (a) or (b) is met.

Research on drugs for which an investigational new drug applica-tion (21 CFR Part 312) is not required. (Note: Research on marketed drugs that signifi cantly increases the risks or decreases the ac-ceptability of the risks associated with the use of the product is not eligible for expedited review.)

(a)

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.

(b)

1) Studies of drugs without an IND or devices without an IDE

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

(a)

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 col-lected. 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.

(b)

2) Blood Samples


3

Prospective collection of biological speciemens for research purposes by noninvasive means

3) Biologic Specimens

hair and nail clippings in a nondisfi guring manner; (a)

deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;

(b)

permanent teeth if routine patient care indicates a need for extraction;

(c)

excreta and external secretions (including sweat);(d)

uncannulated saliva collected either in an unstimu-lated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue;

(e)

placenta removed at delivery;(f)

amniotic fl uid obtained at the time of rupture of the membrane prior to or during labor;

(g)

supra- and subgingival dental plaque and calculus, provided the collection procedure is not more inva-sive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques;

(h)

mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;

(i)

sputum collected after saline mist nebulization.(j)


4

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.

4) Data via Noninvasive Procedures

physical sensors that are applied either to the sur-face of the body or at a distance and do not involve input of signifi cant amounts of energy into the sub-ject or an invasion of the subject’s privacy;

(a)

weighing or testing sensory acuity;(b)

magnetic resonance imaging;(c)

electrocardiography, electroencephalography, ther-mography, detection of naturally occurring radio-activity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood fl ow, and echocar-diography;

(d)

moderate exercise, muscular strength testing, body composition assessment, and fl exibility testing where appropriate given the age, weight, and health of the individual.

(e)

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).

5) Materials Collected Previously or for Non-research Purposes

*Not involving general anesthesia or sedation.


5

Collection of data from voice, video, digital, or imagerecordings made for research purposes.

6) Recordings

Research on individual or group characteristics or behavior, including (but not limited to)…

7) Characteristics or Behavior

• Perception• Cognition• Motivation• Identity

Research employing the following methodologies:

• Language• Communication• Cultural bliefs or practices,

and social behavior

• Survey• Interview• Oral history• Focus group

• Program evaluation• Human factors evaluation• Quality assurance

Example 1

6

Here’s the scenario. . .

Observational Registry Drug Study with Survey

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 pa-

tients 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?

Example 1

7

Answer. . .

Yes. The research is expeditable under categories 1 and 7:


1) Drugs/Devices

7) Characteristics or BehaviorResearch employing survey methodologies.

Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that signifi cantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)

(a)

Example 2

8


Consumer Preference Study of a Diagnostic Device

Individuals are asked to look at the display on a glucometer and answer ques-

tions 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).


Example 2

9

Answer. . .

Yes. The research is expeditable under category 1(b) and category 7:


1) Drugs/Devices

7) Characteristics or BehaviorResearch employing survey and interview methodologies.

Research on medical devices for which (i) an inves-tigational 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.

(b)

Example 3

10


Blood Glucose Test System

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 sam-

ples. Each subject will require 3 fi nger sticks.


Example 3

11

Answer. . .

The researchmay be expeditable under category 2, provided the blood

draws are not conducted more frequently than allowed:


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 col-lection may not occur more frequently than 2 times per week; or

from other adults and children2, considering the age, weight, and health of the subjects, the collection pro-cedure, 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) Blood Samples

Example 4

12


Follow-up Registry Study

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 (de-

scribed as 2-3.5 tbsp in ICF).


Example 4

13

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


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 col-lection may not occur more frequently than 2 times per week; or

from other adults and children2, considering the age, weight, and health of the subjects, the collection pro-cedure, 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) Blood Samples


1) Drugs/Devices

Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that signifi cantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)

(a)

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.

4) Data via Noninvasive Procedures

Example 5


Observational-Longitudinal Assessment Study

The sponsor proposes to evalu-

ate individuals that have received a

drug due to reported heart problems.

Subjects will be asked to have an-

nual 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.


14

Example 5

Answer. . .

No. At fi rst glance, it may appear that a study using an MRI, which does not pro-

duce 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

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 re-

search 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

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 Re-

search (Qualifying Minimal Risk) and have no consent

forms or participant recruitment materials for review, Quo-

rum 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 ca-

tions 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.

Two Fast Turnaround Times Available

Four-Day Review and LOA Delivery

For qualifying protocols that fall under Expeditable Re-

search (Qualifying Minimal Risk) and do have consent

forms and/or participant recruitment materials for review,

Quorum offers FOUR DAY delivery of your Letter of Ap-

proval (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 ca-

tions (or mandatory follow-up) and consent form negotia-

tions must be complete. If your study meets these require-

ments, the LOA will be posted to our OnQ Portal by 5:00pm

(Pacifi c Time) on the 4th business day.

17

Get Started with Expeditable Research Review How do I get started with expedited review?

Once I submit a protocol, how long will it take to fi nd out whether it qualifi es for 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 email as follows:

For Central Studies

Email to: [email protected]

Subject: Request Expeditable Research Review Information--Central Study Startup

For Single Site Studies

Email to: [email protected]

Subject: Request Expeditable Research Review Information--Single Site Study Startup

We’ll quickly respond via email with all the details you need to submit your study protocol for

expedited review. The email will include links to all required Quorum Review forms. It will

also explain how to submit your document online in three-easy steps!

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 expe-

dited 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.

18

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.

mailto:[email protected]?subject=Request Expeditable Research Review Information--Single Site Study Startup

mailto:[email protected]?subject=Request Expeditable Research Review Information--Central Study Startup

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 can-

not 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:

19

Where can I get more information about Quorum Review’s ExpditableResearch Review Services?

If you need more information on Quorum Review’s Expeditable Review Services, our pric-

ing, or whether your research qualifi es, please email us at: [email protected].

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 Promptly to 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.

1501 Fourth Ave. , Ste. 800 | Seattle, WA 98101www.QuorumReview.comT (877) 472-9883 or (206) 448-4082

Email: [email protected]

quorum review irb’s guide to understanding … protocol review categories 3 prospective collection...

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