REVIEWS
Frequently Asked Questions
Find answers to our most frequently asked ethical review questions here. Can’t find what you need? Check our IRB Handbook (available via CIRBI login in Reference Materials), or reach out below.
What does an Institutional Review Board (IRB) do?
An IRB reviews study materials and investigator credentials to ensure the rights and welfare of human research participants are protected. For more information on the participant’s role in research, you can find additional resources here.
How often does Advarra’s IRB meet?
Advarra’s U.S.-based IRB meets daily, Monday through Friday. The Canadian-based IRB meets three times each week on Tuesday, Wednesday, and Friday.
Do I have a point of contact for my study?
Yes, Advarra assigns a dedicated point of contact to all your studies, ensuring any questions are addressed promptly.
What items can an IRB review by expedited review?
Advarra’s IRB follows expedited review procedures for research presenting no more than minimal risk, as defined in OHRP guidance. Additionally, minor changes to previously approved research during the approval period (one year or less) can be reviewed in an expedited manner. Advarra uses expedited review procedures for most new research site submissions, recruitment materials, study-related materials, and certain amendments.
Is Advarra a central or local IRB?
Advarra can serve as both a central IRB (single IRB) for multisite studies and a local IRB for individual sites. If a site does not have a local IRB or prefers to defer oversight to Advarra, we can serve as that site’s local IRB.
Does Advarra provide translation services?
Yes, Advarra offers certified translation services through an approved vendor. We also accept a valid certificate of translation from external sources. Please contact us for more details regarding translation services.
What are the IRB’s possible review determinations?
The IRB can make several determinations for each study, including approval, approval with modifications (conditional approval), deferral for additional information, or disapproval. Approved studies are approved for up to one year, unless continuing review is not required under the revised Common Rule. The IRB may also approve research with modifications, requiring specific changes to be made to study elements. Deferred studies are held until the principal investigator (PI), sponsor, or CRO provides additional requested information. If a study is disapproved, the IRB will issue a formal disapproval letter explaining the reasons behind the decision.
In cases of approval, approval with modifications, or deferral, the submitting party will be notified. Advarra’s IRB has the authority to determine the adequacy of all consent form wording, in accordance with 21 CFR 56.109 and FDA’s informed consent guidance. The approved consent will be included with the initial approval documents.
If an IRB disapproves a study, can the sponsor or pI submit the study to another IRB?
Yes, the sponsor or PI may submit the study to another IRB. However, the FDA recommends the second IRB be informed the study was previously disapproved by another IRB.
Can Advarra provide retroactive IRB approval for research already conducted?
No, federal regulations do not allow IRBs to retroactively approve research that has already been conducted. IRB approval must be obtained before research begins. If you anticipate publishing research potentially exempt from IRB review or qualifies as non-human subject research (NHSR), we recommend obtaining an official exemption or NHSR determination from an IRB before starting the study.
What could delay the approval process for my study or site?
The IRB approval process may be delayed due to incomplete submissions, missing documents, or issues identified during review. Delays can result from missing submission documents, protocols lacking key information, or complications in finalizing the informed consent form (ICF). Additional delays may occur if site-specific issues are identified, such as incomplete site submission forms, missing curriculum vitae (CVs), unresolved investigator conflicts of interest, or compensation issues for study participants. The IRB will not provide site approval until the study is approved and the ICF is finalized.
How do I submit information to Advarra?
All submissions to Advarra are managed through our paperless CIRBI Platform. From the start of the study through to termination, all required documents must be submitted electronically via CIRBI.
What is the IRB’s mission?
The IRB’s mission is to protect the rights and welfare of human subjects participating in research. The IRB operates as an independent body, and its decisions can only be made by IRB board members through exempt, expedited, or full board procedures. The IRB reviews all research activities following Advarra’s IRB Policy Manual and IRB Handbook.
Advarra’s IRB members come from a wide range of backgrounds, ensuring diverse ethical perspectives. Our network includes scientists and consultants who have expertise in vulnerable populations, such as pediatrics, critically ill patients, and cognitively impaired participants. We also have experts who have pioneered techniques and methodologies in various scientific fields.
When was Advarra’s IRB established?
Advarra’s IRB services were established in 1983 through the merger of several legacy IRB organizations. Since then, Advarra has been providing high-quality IRB review services.
Where can I find Advarra’s IRB compliance statement?
You can find Advarra’s compliance statement in the “Reference Materials” section of the CIRBI Platform (login required).
Is Advarra registered with the FDA and OHRP?
Yes, Advarra is registered with both the FDA and OHRP. Our IRB Organization (IORG) number is 0000635, and our IRB Registration number is 00000971.
Does Advarra have a Federalwide Assurance (FWA) number?
Yes, Advarra’s FWA number is 00023875.
What information should I enter about Advarra for ClinicalTrials.gov registration?
When registering a study on ClinicalTrials.gov, enter the following details for Advarra:
Board Approval: Select the applicable option (e.g., request not yet submitted, submitted pending, submitted approved, etc.).
Approval Number: Enter the Advarra approval date (mm/dd/yyyy).
Board Name: Advarra
Board Affiliation: Independent
Board Contact: 410.884.2900
Where can I find more information about working with Advarra’s IRB?
More information, including the IRB Handbook and guidelines, can be accessed through the “Reference Materials” section of the CIRBI Platform (login required).
What is an Institutional Biosafety Committee (IBC)?
An IBC performs biosafety risk assessments for research involving engineered genetic material, such as recombinant DNA (rDNA) or synthetic nucleic acid molecules (sNA). The committee evaluates the risks associated with genetic modifications and experimental procedures, focusing on occupational and environmental safety.
The IBC must include at least five members who collectively have the expertise to assess these risks. At least two members must be local community members unaffiliated with the institution or site. IBC registrations are updated annually with the NIH Office of Science Policy.
When is IBC review required?
IBC review and oversight are required for research involving genetically engineered treatments and vaccines to mitigate risks to study participants and researchers. NIH Guidelines mandate IBC oversight if the research involves rDNA, mRNA, sNA molecules, or other genetically engineered treatments, and if the site or sponsor has received NIH support for rDNA or sNA research.
This requirement applies to sites both within and outside the U.S. Even if NIH support is not involved, IBC review is considered best practice. Privately sponsored studies often employ IBC services to qualify for NIH support, meet third-party regulatory requirements, or enhance research safety oversight. NIH Guidelines also encourage those not covered by the guidelines to adhere to these standards.
What does the IBC do?
The IBC reviews research involving the introduction of rDNA, sNA, or mRNA into a living being, such as genetically engineered material in mRNA vaccines. IBC review is required when NIH has supported the research or if the site has received NIH support. IBC review is conducted in addition to IRB review. While the IRB focuses on the rights and welfare of human research participants, the IBC evaluates risks to study personnel, the community, and the environment posed by genetically modified materials.
Who serves on an IBC?
An IBC must include at least five members who collectively have the necessary expertise to assess the risks of the research. At least two members must be local community representatives unaffiliated with the institution. These community members represent public health interests and environmental protection. The IBC must demonstrate to the NIH Office of Science Policy it is knowledgeable about local institutional characteristics, such as investigator training, laboratory conditions, and operating procedures. IBC membership is registered with NIH annually, along with member CVs, as part of the IBC setup and registration process.
How do I submit a new application to the IBC?
All IBC submissions are processed through Advarra’s dedicated IBC Portal. For more information on the materials required to submit a clinical study protocol and site credentials for IBC review, visit our “Materials Required for Submitting a Study” page. For non-clinical studies, such as those involving genetically engineered plants or animals, please contact us for additional submission requirements.
What is a Data Monitoring Committee (DMC)?
A DMC, also known as a Data Safety Monitoring Board (DSMB), is an independent group of experts responsible for conducting periodic reviews of accumulated data during a clinical trial. The primary goal of a DMC is to identify early evidence of benefit or harm, ensuring the safety of participants and the validity of trial data.
It is crucial that DMC members are independent, with no conflicts of interest potentially compromising the impartiality of their reviews and recommendations to the sponsor.
When is DMC or DSMB review required?
DMC or DSMB review is required when clinical trials need robust data safety monitoring. This can be due to several reasons, such as a study endpoint that may result in early termination due to a highly favorable or unfavorable result, safety concerns related to the treatment being studied, or when the trial involves a vulnerable population (e.g., children, pregnant women, the elderly, or individuals with diminished mental capacity).
Other factors include studies involving a population at elevated risk of death or serious outcomes, or studies that are large, long in duration, blinded, or conducted across multiple centers or nations. If your trial involves any of these elements, establishing an independent DMC or DSMB is advisable and may be required by regulatory bodies or IRBs.
What is the difference between a DMC and a DSMB?
The terms DMC and DSMB are essentially synonymous and used interchangeably. While the U.S. FDA and EU EMA guidelines often use the term DMC, the term DSMB is more commonly used in North America. Both terms refer to the same independent oversight function.
What is a DMC or DSMB charter?
A DMC or DSMB charter outlines the procedures the committee will follow throughout the clinical trial. This includes the committee’s membership requirements, meeting timelines, and the statistical methods that will be used to prepare data for review. Since every clinical trial is unique, the DMC is customized for each specific trial, and the charter defines how the DMC will conduct its reviews. At Advarra, we collaborate with sponsors or CROs to create a DMC charter, ensuring a rapid startup process for the committee.
Who serves on a DMC?
DMC members are selected based on their expertise in the relevant areas of the clinical trial. The committee typically consists of three or more members, including at least one experienced biostatistician and two or more individuals with specific scientific or medical expertise to evaluate the safety of the study population. The final DMC membership is outlined in the DMC charter and is tailored to the needs of the specific trial, in collaboration with the sponsor or CRO.
How long has Advarra provided DMC services?
Advarra has over 20 years of experience providing DMC services globally. We have supported biopharmaceutical and device trials of all sizes, conducted by sponsors ranging from small biotech companies to large global pharmaceutical firms.
Which therapeutic areas can Advarra’s DMC services support?
Advarra’s DMC services can support all therapeutic areas. Our extensive international network ensures we can find the right expertise for any trial, regardless of the complexity or niche therapeutic focus.
Does Advarra provide “rescue” services for DMCs or DSMBs?
Yes, Advarra offers rescue services for DMCs and DSMBs. If you are experiencing issues with your current data safety monitoring solution, Advarra’s experienced team is available to assist and help get your trial back on track.
What is an Endpoint Adjudication Committee (EAC)?
An EAC is an independent group of experts responsible for evaluating trial data to determine if participants have met protocol-defined endpoints, assess relatedness, or address other questions posed by the sponsor. In complex clinical trials, expert judgment is often required to determine whether an event meets an endpoint, considering factors such as underlying medical conditions, comorbidities, and environmental factors. Utilizing an independent EAC helps eliminate bias and enhance the credibility of trial data.
When is endpoint adjudication required?
Endpoint adjudication is essential in trials where endpoints are complex and require medical judgment to determine if they have been met. It is also necessary when specific therapeutic expertise is needed beyond what the PI or the sponsor’s medical monitor can provide. FDA guidance suggests an independent EAC is an effective component of the overall safety monitoring plan for complex clinical drug or device trials. Establishing an independent EAC mitigates bias and enhances regulatory and public trust in the trial process.
What is the difference between an EAC and a Clinical Events Committee (CEC)?
The terms EAC and CEC are often used interchangeably. While U.S. FDA guidelines typically refer to the committee as an EAC, these committees are occasionally called CECs or Clinical Events Evaluation Committees (CEECs) in practice. In Advarra’s experience, “adjudication panel” is the most commonly used term.
What is an EAC charter?
An EAC charter outlines the adjudication procedures, specific determinations, and overall plans the committee will follow. Since each clinical trial is unique, the adjudication plan is developed specifically for the trial in question. The charter includes details such as committee membership requirements, meeting and review timelines, procedures for summarizing reviews, and the methods for preparing medical and endpoint data for the committee’s review. Advarra collaborates with the sponsor or CRO to create the charter, which is a key part of our rapid EAC startup process.
Who serves on an EAC?
EACs are composed of experts who collectively have the necessary clinical and medical expertise to assess the endpoint events of the trial. Typically, an EAC includes at least one experienced clinician in the therapeutic area, one or more members with scientific or medical expertise to evaluate the event, and at least one non-scientific member to represent the perspective of research participants. The final membership details are outlined in the EAC charter, developed in collaboration with the sponsor or CRO.
How long has Advarra provided EAC services?
Advarra has over 20 years of experience administering EACs for biopharmaceutical and device trials globally. Our services support sponsors of all sizes and levels of complexity.
Which therapeutic areas can Advarra’s EAC services support?
Advarra’s EAC services can support all therapeutic areas. With our extensive international network, we can provide the expertise needed for any trial, no matter how complex.
Does Advarra provide “rescue” services for EACs and CECs?
Yes, Advarra offers rescue services for EACs and CECs. If there are concerns with your current adjudication solution, Advarra’s team is available to assist and ensure your trial is running smoothly.
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