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COMMUNITY

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IRB SERVICES

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INSTITUTIONAL REVIEW BOARD (IRB) SERVICES


SOLUTIONS TO SAFEGUARD TRIAL PARTICIPANTS

Regardless of your project’s scope, therapeutic niche, or number of
investigators, Advarra is your partner in the conduct of efficient, responsible
research. Objectivity and concern for participant well-being drive all review
decisions.

4:12











TRUSTED BY CLINICAL RESEARCH LEADERS



AS THE RESEARCH COMMUNITY’S PREFERRED INDEPENDENT IRB, ADVARRA IS ADVANCING
CLINICAL RESEARCH: SAFER, SMARTER, FASTER™.

4

BUSINESS DAYS FROM SUBMISSION TO DECISION

New protocol and initial informed consent for multisite studies (full board
review)

1-2

BUSINESS DAYS FROM SUBMISSION TO DECISION

New protocols and initial informed consent (minimal risk review)

1

BUSINESS DAY FROM SUBMISSION TO DECISION

New site for a multisite study

OUR PROCESSES ENSURE EFFICIENT DELIVERY OF QUALITY DOCUMENTATION, AND OUR PEOPLE
PROVIDE DEDICATED, ATTENTIVE SERVICE AND EXPERTISE TO SUPPORT YOUR RESEARCH.

Using technology, we create smarter and faster workflows while maintaining the
highest standards of transparency and quality.

 * Speed: Reviews of all submission types every day for faster decisions
 * Flexibility: Convenient electronic tools and dedicated staff for easy and
   efficient study administration
 * Accountability: A dedicated point of contact throughout your study
 * Expertise: Experienced IRB members and administrative staff ensure
   high-caliber reviews
 * Savings: Early engagement proven to save time and resources in trials

Advarra’s industry-leading IRB services employ technology and decades of
experience to ensure streamlined ethical review of your research program.
Facilitated by our electronic IRB management platform, the Advarra Center for
IRB Intelligence (CIRBI), you’ll gain:

 * Transparency and visibility into real-time review statuses and metrics
 * Efficient submissions and communications with easier, repeatable processes
 * Faster activation and review timelines enabled by concurrent workflows
 * Centralized IRB records delivered directly to your CTMS or other system via
   Advarra Connect

Learn More About CIRBI

Advarra can support the eConsent development process with your internal team as
well as third-party vendors. Advarra’s IRB is fully eConsent-capable and has the
experience to help you navigate the electronic informed consent review process.
We understand the technology’s potential, its limitations, and how it fits
within the regulatory requirements.

Learn More About eConsent


INTEGRATED, TECHNOLOGY-ENABLED REVIEWS

Advarra’s industry-leading IRB services leverage experience and technology to
ensure streamlined ethical review of your research. Enabled by the Advarra
Center for IRB Intelligence (CIRBI) Platform, our electronic IRB management
system, you’ll gain:

 * Transparency for real-time review status and metrics tracking
 * Efficient submissions with easier, repeatable processes
 * Faster startup and timely reviews supported by concurrent workflows
 * Centralized IRB records flowing through Advarra Connect to your eTMF platform

SPONSORS AND CROS

Biopharmaceutical, biotech, medical device, and diagnostic product developers
trust our expert guidance across every research phase and all major therapeutic
areas.

Read more

PRIVATE RESEARCH SITES AND SITE NETWORKS

Dedicated coordinators, real-time reporting, and web-enabled technologies
support transparent and efficient reviews to simplify collaboration.

Read more

INSTITUTIONS, HEALTH SYSTEMS, AND RESEARCH CONSORTIA

Advarra works with over 3,500 institutions, hospitals, health systems, and
academic medical centers (AMCs), supporting everything from single
investigational sites to multiple site research consortia and therapeutic
networks.

Read more

CANADIAN REVIEW

Based in Ontario, Advarra has the largest central REB/IRB in Canada that is
AAHRPP accredited to support research conducted exclusively in Canada and
cross-border studies.

Read more

ALIGNED WITH THE NEEDS OF THE GROWING AND INCREASINGLY COMPLEX FIELD OF
ONCOLOGY, ADVARRA’S CENTRAL ONCOLOGY REVIEW (COR) PROVIDES THE ROBUST HUMAN
SUBJECT PROTECTIONS REVIEW THAT CANCER RESEARCH INSTITUTIONS EXPECT. 

Learn More
 * Early Phase
 * Phase II
 * Phase III
 * Phase IV
 * Device Research


EARLY PHASE

ADVARRA UNDERSTANDS EARLY PHASE RESEARCH IS UNIQUE, AND WE HAVE DEVELOPED
SPECIALIZED SERVICES TO SUPPORT EARLY PHASE TRIALS AND DEDICATED PHASE I SITES.
GIVEN THE TIMELINES IN PHASE I/HEALTHY, A STUDY CAN START WITHIN DAYS OF AN
INITIAL IRB APPLICATION.




PHASE II

ADVARRA’S IRB MEMBERS AND STAFF ARE FAMILIAR WITH THE RANGE OF PHASE II STUDIES.
OUR REGULATORY TEAM CAN PROVIDE ASSISTANCE IN PREPARING THESE MEDIUM-SIZED,
FAST-PACED STUDIES FOR SUBMISSION, AND OUR OPERATIONS TEAMS PROVIDE GUIDANCE IN
IRB REVIEW PROCESS MANAGEMENT AND OVERSIGHT.




PHASE III

ADVARRA EXCELS IN MANAGING AND OVERSEEING PHASE III STUDIES. OUR EARLY
ENGAGEMENT SERVICES REDUCE THE TIME NEEDED TO DESIGN, ORGANIZE, AND LAUNCH A
STUDY. OUR FAST REVIEW TIMELINES AND DOCUMENT DELIVERY KEEP YOU ON SCHEDULE, AND
OUR KNOWLEDGEABLE STAFF IS THERE TO HELP WHEN YOU NEED THEM.




PHASE IV

ADVARRA SUPPORTS A WIDE VARIETY OF PHASE IV TRIALS, INCLUDING REGISTRIES,
OBSERVATIONAL STUDIES, AND ONLINE RESEARCH. PHASE IV STUDIES FREQUENTLY ARE
MINIMAL RISK AND WITHOUT INTERVENTIONS, AND CAN OFTEN QUALIFY FOR EXPEDITED
REVIEW.




DEVICE RESEARCH

ADVARRA HAS REVIEWED ALL DEVICE STUDY CATEGORIES, WITH IRB REVIEW EXPERIENCE
INCLUDING IMPLANTABLE AND PORTABLE DEVICES, DIAGNOSTIC TOOLS, MOBILE MEDICAL
DEVICES AND APPS, HUMAN FACTORS TESTING, AND HUD/HDE STUDIES. OUR REGULATORY
TEAM CAN HELP DETERMINE THE APPROPRIATE CLASSIFICATIONS FOR YOUR PRODUCT AND HAS
EXPERIENCE REVIEWING THE LATEST IN HEALTHCARE TECHNOLOGY.




TRAINING SOLUTIONS FOR EVERY NEED

Clinical research conduct

Study specifics

Virtual investigator meetings

Custom eLearning

Site technology training

Activate sites and studies faster with Advarra’s training solutions.

Learn More


LEADING INTELLIGENCE FOR EVERY RESEARCH PROGRAM


VACCINES

Vaccine trials can be large, and they often need to be fast. Advarra’s IRB and
institutional biosafety committee (IBC) have a long history of reviewing vaccine
trials, including supporting 100% of Operation Warp Speed vaccine trials for
COVID-19. From our experience with vaccine trials, we know how to support them:
through early engagement to meet critical enrollment milestones and scientific
expertise for robust and insightful reviews.


ADAPTIVE TRIAL DESIGN

Adaptive trials present unique challenges for investigators and regulators
alike, accommodating rapid adjustments to study events. With researchers
pursuing the flexibility of stopping dosing arms, changing randomization
proportions, or combining multiple phases into a single trial, finding an IRB
with the proper knowledge and understanding is crucial. Advarra has the right
experience to oversee a study with an adaptive trial design. 


PEDIATRIC

Researchers must take special considerations when evaluating the risks and
benefits of a clinical trial involving children. Protocols for this vulnerable
population require extensive safeguards, and researchers must approach the
consent of the parents as well as the assent of the minor with care.

Advarra has pediatricians as IRB members and as consultants. We can engage
pediatric researchers early to ensure they are equipped to conduct a pediatric
protocol and protect young study participants.


BIOLOGICS

The study of biologics — medical treatments manufactured from living cells —
represents one of the most exciting areas of clinical research today. When a
study has to start or change quickly, Advarra can help. Our experienced IRB
members, service-oriented staff, and knowledgeable regulatory teams appreciate
the unique needs of biologic research.


INTERNATIONAL RESEARCH

This section applies to research outside of the United States and Canada. For
Canadian research, please read about our Canadian review services.

Advarra has experience reviewing international studies and can support it in the
following ways:

 * * Review to ensure compliance with US standards (with local ethics committee
     review)
   * Collaborate with local ethics committee review
   * Serve as the sole IRB of record for online research not targeted at a
     specific country and certain other minimal risk research

Advarra can translate informed consent forms (ICFs) and other study documents
into the appropriate languages. We can also provide consulting services to help
you prepare for research abroad and assess local regulatory requirements.

*Note: Advarra does not review research conducted in India.


FEDERALLY FUNDED RESEARCH

Ensure expert oversight and experienced guidance when you select Advarra as your
IRB of record in your federal grant proposal. Advarra has overseen more than
1,000 federally funded studies, both as a local IRB for a single investigator
and as a designated single IRB (sIRB) for multisite studies. We can provide a
budget estimate for IRB and more, as well as documentation for your National
Institutes of Health (NIH) grant application to identify your project’s sIRB and
outline responsibilities and communication tactics.


MINIMAL RISK STUDIES

Not every study protocol needs to be reviewed by a fully convened IRB. Advarra
has fully compliant, AAHRPP accredited criteria for appropriately referring
research to expedited reviewers instead of a full board meeting. Qualifying
minimal risk studies — such as retrospective chart reviews or some Phase IV
observational studies — have substantially faster review and approval timelines
than other reviews. We can respond to qualifying submissions as soon as the next
business day.


EXEMPTIONS

Not all research is subject to IRB oversight. Some projects do not meet the
criteria for research. Some meet the criteria for research but do not involve
human subjects, and others involve human subjects but qualify for exemption from
IRB review. The determination can be complex, but Advarra’s regulatory and IRB
experts can assess and confirm whether your project requires IRB oversight. This
type of assessment can provide these determinations for research conducted in
the US or in Canada.


RETROSPECTIVE CHART REVIEW

By examining and assessing existing medical data, retrospective chart reviews
can reveal unexpected insights. But this type of research requires an
understanding of the regulations around accessing medical information and — if
applicable — a proven IRB’s careful review. With a wealth of research industry
experience, Advarra offers a customized approach to handling the ethical and
regulatory implications of these studies.


NEED THE CURRENT IRB ROSTER?

Login to the Advarra CIRBI Platform and select the
“Reference Materials” tab.

Login to CIRBI

Use our Contact Us form to request the latest
IRB roster.

Contact Us

Go Direct with Advarra Connect

 * No manual loading or document manipulation of documents before export
 * Map files, indexing information, and metadata to the correct filing structure
 * Ensure your IRB documents are always in-sync

Replace manual, error-prone processes by automating the secure transfer of
IRB-related documents directly to your electronic trial master file (eTMF).

Learn More


IRB FAQS


WHAT DOES AN INSTITUTIONAL REVIEW BOARD (IRB) DO?

An IRB reviews study materials and investigator credentials to ensure human
research participants’ rights and welfare are properly protected. Learn more
about the participant’s role in research here.


HOW OFTEN DOES YOUR IRB MEET?

Our US-based IRB meets daily (Monday through Friday). Our Canadian-based IRB
meets three times each week (Tuesday, Wednesday, Friday).


DO I HAVE A POINT OF CONTACT FOR MY STUDY?

Yes. Advarra has a dedicated point of contact assigned to all your studies to
ensure any questions you have are rapidly addressed.


WHAT ITEMS CAN AN IRB REVIEW BY EXPEDITED REVIEW?

Per regulations, Advarra’s IRB can follow expedited review procedures for:

 * Research presenting no more than minimal risk. These categories are listed in
   OHRP Guidance; and
 * “Minor changes” to previously approved research during the period (one year
   or less) for which approval is granted.

Advarra reviews most new research site submissions, recruitment, and
study-related materials, as well as some amendments and new study submissions
using expedited review procedures.


IS ADVARRA A CENTRAL OR LOCAL IRB?

Advarra can serve as both. For multisite studies, Advarra can serve as the
central or single IRB for all participating sites. For a site who does not have
a local IRB or who would like to defer oversight to Advarra, Advarra can serve
as that site’s local IRB.


DOES ADVARRA PROVIDE TRANSLATION SERVICES?

Yes. Advarra can assist with certified translation using our approved vendor, or
we can accept a valid certificate of translation. Please contact us for
additional information.


WHAT ARE THE IRB’S POSSIBLE REVIEW DETERMINATIONS?

Each study will be given one of the following designations:

 * Approved: The IRB approves the study as submitted for up to 1 year. This is
   not applicable for studies that do not require continuing review under the
   revised Common Rule.
 * Approved with Modifications: The IRB may approve research with modifications,
   also known as a “Conditional Approval,” with IRB-required restrictions or
   alterations of specific elements and/or documents.
 * Deferred: The IRB defers a decision on the study to seek additional
   information from the PI, sponsor/CRO, or a consultant.
 * Disapproved: The IRB cannot approve the study and will issue a formal letter
   of disapproval stating the basis for its decision

In the case of an approved, approved with modifications, or deferred decision,
the submitting party will be notified. Advarra’s IRB has the responsibility and
authority to determine the adequacy and appropriateness of all the wording in
the informed consent form. (See 21 CFR 56.109 and FDA’s A Guide to Informed
Consent.) Advarra will provide proposed consent revisions to the submitting
party.

Approval for studies and sites will last for the period specified in the
approval documentation but will not exceed 1 year (not applicable for studies
that do not require continuing review under the revised Common Rule). Advarra
will specify the expiration date in your approval letter. The Advarra-approved
consent will be included with the initial approval documents.

The IRB will issue a formal letter if the study is disapproved. The recipient
has the right to submit a written appeal to the IRB. If you submit the study to
a second IRB after disapproval by Advarra, you must notify the other IRB of
Advarra’s disapproval.


IF AN IRB DOESN'T APPROVE THE STUDY, CAN THE SPONSOR/CRO OR PRINCIPAL
INVESTIGATOR SUBMIT THE STUDY TO A SECOND IRB?

Yes. However, the FDA states the sponsor/CRO or investigator should inform the
second IRB of the other IRB previously disapproving the study.


CAN ADVARRA PROVIDE RETROACTIVE IRB APPROVAL FOR RESEARCH ALREADY CONDUCTED?

No, the federal regulations do not provide for IRB approval for research already
conducted; IRB can only grant approval prior to research initiation. If you
anticipate publishing research that may be considered exempt from IRB review or
non-human subject research (NHSR), we recommend obtaining an official exemption
or NHSR determination from an IRB prior to beginning the study.


WHAT COULD SLOW THE APPROVAL PROCESS FOR MY STUDY OR SITE?

 * Incomplete submission documents: Please refer to the submission form to
   ensure you are submitting all required documents for the review of new
   studies and additional sites.
 * Study protocol missing key information: The IRB may identify areas of concern
   with the protocol and defer study approval or require modifications as part
   of the approval.
 * Delays in ICF finalization: After formal IRB review, additional
   Advarra-internal or sponsor/CRO/institution review of the ICF may be required
   prior to finalization. Approval documents will not be sent to sites until the
   ICF is finalized.
 * IRB concerns with site submission information: Upon review of additional
   sites conducting a previously approved protocol, the IRB may note an area of
   concern with the site’s responses on the submission documents. If concerns
   are noted or the compensation for participation information is unclear, an
   Advarra representative will contact the site. The site must provide
   satisfactory resolution of the identified issues before approval process
   completion.
 * Site-specific ICF revisions: If a site submits a request for additional
   site-specific revisions, an IRB member must review the requested revisions to
   determine their appropriateness. In some instances, the sponsor/CRO may also
   require approval.


HOW DO I SUBMIT INFORMATION TO ADVARRA?

Advarra is a paperless IRB. All submissions, from beginning to termination,
needs to occur through the Advarra CIRBI Platform (login required).


DOES ADVARRA PROVIDE IRB EXAMPLE DOCUMENTS OR TEMPLATES TO ASSIST WITH
SUBMISSIONS?

Yes, the References section of the Advarra CIRBI Platform (login required)
provides additional guidance materials and templates.


WHAT IS THE IRB’S MISSION?

The mission of the institutional review board is to protect the rights and
welfare of human subjects enrolled in research. The IRB operates as an
independent body. IRB decisions may only be made by IRB board members following
the exempt, expedited or full board procedures.

The IRB shall review and have authority to approve, require modifications in (to
secure approval), or disapprove all research activities submitted to Advarra for
review. All research submitted to Advarra for review by the IRB follows the
processes and procedures set forth in the Advarra IRB Policy Manual and IRB
Handbook.

Advarra’s IRB members have extensive, varied backgrounds, including service on
institutional, academic, and independent IRBs. This diverse membership ensures
we hear the full range of ethical perspectives, and we maintain a network of
consultants to provide additional insights when necessary. IRB members are
versed in examining research for its ethical implications, including research
involving vulnerable populations such as pediatrics, critically ill, and
cognitively impaired participants. Review groups and service teams include
scientists who have pioneered techniques, methodologies, and discoveries in
their fields.


WHEN WAS THE IRB ESTABLISHED?

Advarra was formed through the merger of several legacy IRB organizations and
has been providing IRB review services since 1983, making it the second oldest
independent IRB organization in the US.


WHERE CAN I FIND THE IRB’S COMPLIANCE STATEMENT?

You can access Advarra’s statement of compliance in the Reference Materials
section of CIRBI (login required).


IS ADVARRA REGISTERED WITH FDA AND OHRP?

Yes. Advarra’s IRB Organization (IORG) Number is 0000635 and IRB Registration
number is 00000971.


DOES ADVARRA HAVE A FEDERALWIDE ASSURANCE (FWA) NUMBER?

Yes, Advarra’s FWA number is 00023875.


WHERE CAN I FIND MORE INFORMATION ABOUT WORKING WITH ADVARRA’S IRB, LIKE IRB
GUIDELINES, IRB RESPONSIBILITIES, AND THE INVESTIGATOR MANUAL?

Login to the Advarra CIRBI Platform and click the “Resources” tab to access the
IRB Handbook and other guidance.

ARE YOU A RESEARCH PARTICIPANT?

Find out how the IRB helps protect your rights and welfare.

Learn More


RELATED RESOURCES

 
Blog


BEGINNER’S GUIDE TO INSTITUTIONAL REVIEW BOARDS (IRBS)

In the U.S., there is an independent group overseeing clinical research,
ensuring participants’ rights and welfare are protected.


Read Now
5 min. read
Read more
 
Case Study


LEVERAGING A CENTRAL IRB OFFICE TO IMPROVE TURNAROUND TIMES AND CONSISTENCY

March 18, 2021




Read Now
Read more
 
Webinar


EVALUATING PAYMENT TO PARTICIPATE IN RESEARCH: ETHICAL AND REGULATORY ISSUES

In this webinar, Luke Gelinas, IRB Chairperson at Advarra, proposes a practical
framework for evaluating offers of payment and applies it to case studies to
yield guidance on challenging ethical and regulatory issues involved in paying
research subjects.


Watch Now
Read more

Visit the Resource Library


READY TO MAKE RESEARCH SAFER, SMARTER, FASTER?

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