FAQs

Where an IRB is concerned with protecting the rights, safety, and welfare of human subjects, an Institutional Biosafety Committee (IBC) is responsible for reviewing projects that involve biologic agents such as recombinant DNA, RNAi, pathogens, and other potentially infectious material, as well as transgenic animals. 

An IBC provides recommendations to community in matters pertaining to the control of biohazards associated with the use of microbiological agents and their vectors. It also represents the interests of the surrounding community with respect to public health and protection of the environment.
 

Recombinant DNA (rDNA) is a technology that uses enzymes to cut and paste together DNA sequences of interest. The recombined DNA sequences can be placed into vehicles called vectors that ferry the DNA into a suitable host cell where it can be copied or expressed.  

Yes.  

PrimeIRB has established a strategic partnership with an industry-leading provider in registering and administering IBC reviews.  Prime Review Board Services will manage and coordinate the concurrent IRB/IBC review process in compliance with all NIH guidelines.

Please contact us for additional information.
 

No.

In 2019, the NIH removed the stipulation that the IBC consider the informed consent related to an IBC-qualifying protocol.  As a result, the IRB and IBC reviews can now happen concurrently.
 

An Individual Investigator Agreement (IAA) is similar to a Reliance Agreement but it is between PrimeIRB and an individual that may not have access to an IRB of record (a physician’s private practice, for example).  

Yes.

Although PrimeIRB is a central IRB, PrimeIRB relies on the CRO/Sponsor and local Investigator to provide requires documentation from each site that details any relevant local considerations that may impact the IRB’s decision-making process.  
 

No.  

Both OHRP and the FDA permit an IRB to rely on the review of another IRB. When this occurs, the two institutions enter into a written agreement referred to by various terms:  a Cooperative Agreement, an IRB Authorization Agreement or an IRB Reliance Agreement. These agreements explicitly state the roles and responsibilities of each IRB. The agreements can be for a single research study or for multiple studies (e.g., a Master Reliance Agreement).
 

Yes.  

Please email us for more information about ways we can work with your institution.
 

Federal regulations require that IRB-approved research projects be reviewed at a frequency of not less than once per year.  In addition to the regulations, an IRB has the authority to require re-review of any study.

Each study is assigned an approval expiration date.  Generally, a study’s approval period is about  12 months but sometimes (depending on the risk level of the study), the approval period is shorter.  All of your approval documents from PrimeIRB will stipulate the expiration date and review frequency.

Please make sure to submit your Continuing Review application through our LINQ eIRB portal in time to answer any questions the IRB may have about the study prior to its expiration date.   
 

No.  

Federal regulations prohibit the continuation of research activities after the study expiration date except to eliminate immediate hazard to the study participants.  There is no “grace period”.  If your study has expired and you have to continue research proceduresto ensure the safety of study participants (such as administer a drug on a specific time schedule), contact PrimeIRB immediately.
 

Under federal regulations, an Institutional Review Board (IRB) is group that has been formally designated to review and monitor research involving human subjects.  An IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.

The purpose of IRB review is to assure that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.

In 1974, the National Research Act codified 45 CFR 46, the regulations related to the Protection of Human Subjects that established the IRB.  In 1979, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research published the Belmont Report which established the ethical principles underlying the use of human research subjects and created guidelines both for medical as well as psychological and behavioral research.

The U.S. Department of Health and Human Services Office for Human Research Protections (OHRP) is the federal administrative agency that monitors IRBs, their activities, and compliance.
 

IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure protection of the rights and welfare of human subjects of research and evaluates the risk/benefit ratio for a proposed research project.  The risk/benefit ratio is evaluated many ways – the informed consent process, psychological risks in addition to physical risks, any conflicts of interest, and the prospect of coercion, for example.  A proposed research project must meet certain criteria defined by the federal regulations for IRB approval.

An IRB ensures that:
•    Risks to study participants are minimized
•    Risks are acceptable in relation to possible benefits
•    The Informed consent document accurately reflects the study procedures
•    The informed consent document appropriately describes the risks 
•    There are adequate plans to protect the privacy of research volunteers
•    There are adequate plans to maintain the confidentiality of research data 
•    Research conduct is both ethical and lawful
 

Federal regulations require that an IRB have at least five (5) members with varying backgrounds that will allow for an adequate review of the proposed project.  The IRB must have at least one non-scientific member (such as clergy, social workers, or other community representatives).  Generally, an IRB is composed of health care personnel, such as doctors, psychologists, nurses, pharmacists, and other allied healthcare professionals. 

PrimeIRB has expertise in the following areas:

•    Single-Site and Multi-Site studies
•    Phase I-IV investigational drug trials 
•    Federally-funded research 
•    retrospective chart reviews
•    device studies 
•    registries 
•    behavioral research
•    investigator-initiated projects.  

Our reputation for performance has allowed us to develop relationships with global experts in almost any therapeutic field.

According to Merriam-Webster, “expedited” means fast.  But in the IRB world, “expedited” means that the research project presents not more than minimal risk and does not have to be reviewed by a Full IRB Committee.  A list of categories of research that are eligible for an “expedited” review can be found on the OHRP Website.

Any “minor change” to previously-approved research may also be eligible for an expedited review, such as recruitment materials, some site amendments, and administrative changes.  Generally, non-scientific submissions that do not change the risk/benefit ratio are considered minor changes. 

No.  

Although some IRBs will review a research project that has been disapproved by another IRB, this practice is generally frowned upon by regulators.  If it is discovered that PrimeIRB is reviewing a research project that has been disapproved by another IRB and the CRO/Sponsor (or investigator) failed to disclose that fact, coverage from PrimeIRB will cease immediately.
 

We recognize that data privacy for sites is important.  PrimeIRB will only obtain what is necessary to evaluate the site for a specific research project.  This information includes, for example, things such as the education and training of study personnel, the results of any federal audit or inspection, and appropriate safeguards for study volunteers.  

PrimeIRB will not share your site performance data with any third-party.
 

All applications for IRB review can be found at our LINQ™ eIRB portal.  The type of application you are requesting will depend on the required documentation.  However, PrimeIRB generally requires (at a minimum) the CV and training record of the Principal Investigator, the proposed consent document, and study protocol.  More detailed information can be found in the PrimeIRB Investigator Handbook.

As a rule, PrimeIRB will not provide hard copies of IRB documentation.  All current IRB documentation is available at our LINQ™ eIRB portal for your study.  If you need hard copies of historical documents for a study, please contact us.

PrimeIRB is a paperless IRB.  Effective November 1, 2020, PrimeIRB will no longer accept paper submissions.  All submissions must occur via our LINQ™ eIRB portal.

Yes.  

PrimeIRB will assign someone as a dedicated contact for all IRB-related questions throughout the course of the study.  If your question is not IRB-related but is a billing-related question, you will also have someone assigned from our Business Development team for those issues.  

PrimeIRB recognizes the value of exemplary service but also recognizes the need to have a bright line between the business side of the house and the operations side of the house.  
 

A Federalwide Assurance (FWA) is an assurance of compliance with the U.S. federal regulations for the protection of human subjects in research. And FWA is approved by the Office for Human Research Protections (OHRP) for all human subjects research conducted or supported by the U.S. Department of Health and Human Services (HHS). 

The FWA is also approved by OHRP for federalwide use, which means that other U.S. federal departments and agencies that have adopted the U.S. Federal Policy for the Protection of Human Subjects (also know as the Common Rule) may rely upon the FWA for the research they conduct or support.

No.  

Only institutions or entities that receive federal funding for human subject research are required to have an FWA.  However, PrimeIRB does have an FWA which allows us to review research for U.S. federal departments and agencies.

Please see our Statement of Compliance for more information.
 

While the DoD is a signatory to the “Common Rule”, DoD-conducted and -supported research is subject to 32 CFR 219, which adds unique considerations to the review and approval of research projects.

In addition to 32 CFR 219, DoD research is subject to the Department of Defense Instruction (DoDI) 3216.02.

Please email us if your research involves a DoD Component.
 

While the VA is a signatory to the “Common Rule”, VA-conducted and -supported research is subject to 38 CFR 16, which adds unique considerations to the review and approval of research projects.

In addition to 38 CFR 16, the conduct and oversight of VA research is subject to the Veterans Health Administration (VHA) Directive 1200.05

Please email us if your research involves a Veterans Administration facility or site.
 

No.  CROs/Sponsors and Investigators should be familiar with any state or local issues were the research will occur such as:

•    Does the Informed Consent need to include specific language?
•    What constitutes the Age of Majority (Adulthood)?
•    Who can serve as Legally authorized Representative (LAR)?
•    What are the HIV/STD reporting requirements if any?
•    Are there any restrictions on the ability to delegate authority to perform certain procedures?

Although PrimeIRB is familiar with some of the differing requirements, it is the responsibility of the CRO/Sponsor or Investigator to  advise PrimeIRB that local considerations may be required.
 

The California Health and Safety Code Sections 24170–24179  (“Protection of Human Subjects in Medical Experimentation Act”) describes the informed consent process and requires that the "experimental subject's bill of rights" be provided to all research subjects in medical experiments. This chapter also describes the hierarchy of surrogate decision makers who are able to provide informed consent for individuals that are unable to consent in emergency room and non-emergency room environments.

PrimeIRB can provide a copy of the Bill of Rights through our LINQ eIRB system.  
 

Yes.  

According to the “Confidentiality of Medical Information Act” (California Civil Code Section 56.11) HIPAA Authorizations must be separate from any other language on a page and the signature on that document must serve no other purpose than to execute the Authorization.

In addition, the typeface for the HIPAA Authorization must be not smaller than 14 points

Please see the California Attorney General’s website for more information about California Informed Consent Guidelines .
 

The Health Insurance Portability and Accountability Act (HIPAA) includes a Privacy Rule that establishes Federal standards for safeguarding the privacy of individually identifiable health information that is held by a “covered entity”.  Researchers are obligated to comply with the HIPAA Privacy Rule when they access, use, disclose, and/or create “Protected Health Information” (PHI).

Researchers must usually obtain the research volunteer’s written authorization or permission to access their PHI, but there are certain circumstances where HIPAA can be waived or altered.
 

PrimeIRB can provide a complete or partial waiver to the HIPAA Authorization or alter the Authorization in certain circumstances.  Please refer to the PrimeIRB Investigator Handbook for more detailed information.

PrimeIRB prefers that a stand-alone HIPAA Authorization document be used that satisfies HIPAA requirements rather than a combined Informed Consent/HIPAA Authorization document.  In addition, the State of California has specific requirements about HIPAA Authorizations.  

Please contact PrimeIRB if you would like a HIPAA Authorization template.
 

No.

Only trials that meet the definition require registration.  Please see the FAQ list at ClinicalTrials.Gov to determine if your trial needs to be registered.
 

No.

It is the responsibility of the CRO/Sponsor or Investigator to remain compliant with any ClinicalTrials.Gov requirements, including registration and posting of the Informed Consent.

Please email us if you have any questions about registration at ClinicalTrials.Gov
 

Please email us for a detailed guidance about what information to provide for your registration.
 

No.  

Under certain circumstances, federal regulations allow for certain waivers of Informed Consent; however, without a waiver being specifically requested by the CRO/Sponsor or Investigator and the IRB approval of that waiver request explicated in the approval documentation, it is PrimeIRB’s expectation that all research study volunteers will be provided with and sign an Informed Consent.
 

The Informed Consent must be signed by the study volunteer (or their Legally authorized representative), the person conducting the consent discussion on behalf, and if necessary, an  impartial witness. 

Federal regulations require certain information in the document.  In addition the informed consent must be easy to read and the risks must be clearly and objectively stated.  If an IRB does not feel any of these benchmarks are met, they may ask for revisions and make suggestions on how to change the document. 

Developed in partnership with TechSoftware, LINQ™ is PrimeIRB’s secure online portal for electronic submissions, IRB reviews, and notifications. 

LINQ stands for Last IRB Notification and Query

To access the LINQ™ , you may select the LINQ icon on the PrimeIRB website homepage or navigate directly to https://prime.my.irbmanager.com   

After providing the requested information on the registration page, you will be able to submit your study documents or retrieve approval documents 24/7 (upon confirmation of registration).
 

You only need to register once.