FAQ Topics
FAQ Topics
Institutional Review Boards (IRBs)
Adapted from FDA’s “Institutional Review Boards (IRBs) and Protection of Human Subjects in Clinical Trials”
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
Sitero IRB 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.
- Decentralized Clinical Trials (DCT)
- Artificial Intelligence/Machine Learning
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 Sitero IRB 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 Sitero IRB will cease immediately.
We recognize that data privacy for sites is important. Sitero IRB 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.
Sitero IRB will not share your site performance data with any third-party.
All applications for IRB review can be found at our Mentor portal. The type of application you are requesting will depend on the required documentation. However, Sitero IRB 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 Sitero Investigator Handbook.
As a rule, Sitero IRB will not provide hard copies of IRB documentation. All current IRB documentation is available at or our Mentor portal for your study. If you need hard copies of historical documents for a study, please contact us
Sitero IRB is a paperless IRB.
All submissions must occur via our Mentor portal.
Yes.
Sitero IRB 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.
Sitero IRB 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.
Federalwide Assurance (FWA) & DoD/VA Research
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, Sitero IRB 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.
HIPAA
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.
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 Sitero IRB’s expectation that all research study volunteers will be provided with and sign an Informed Consent.
Please contact Sitero IRB if you have questions about HIPAA and your research project.
Informed Consent
Institutions
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.
An Individual Investigator Agreement (IAA) is similar to a Reliance Agreement but it is between Sitero IRB and an individual that may not have access to an IRB of record (a physician’s private practice, for example).
Yes.
Although Sitero IRB is a central IRB, Sitero IRB 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.
Continuing Review
Federal regulations require that some 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 Sitero IRB will stipulate the expiration date and review frequency.
Please make sure to submit your Continuing Review application through our Mentor 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 procedures to ensure the safety of study participants (such as administer a drug on a specific time schedule), contact Sitero IRB immediately.
State-specific Requirements
Adapted from UCI Office of Research
No.
CROs/Sponsors and Investigators should be familiar with any state or local issues where 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 Sitero IRB is familiar with some of the differing requirements, it is the responsibility of the CRO/Sponsor or Investigator to advise Sitero IRB 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.
Sitero IRB can provide a copy of the Bill of Rights through our Mentor portal.
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.
ClinicalTrials.Gov
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 for a detailed guidance about what information to provide for your registration.
