IRB Services

Sitero IRB and IBC services are committed to protecting the rights, safety and welfare of study participants and the community.

We provide an unparalleled level of expertise and unmatched level of personal service by providing a single-point-of-contact from start to finish. We will work with you to get your trial up-and-running quickly, but most importantly, properly.

IRB Services:


    A full board review is required when a proposed research project is “greater than minimal risk” (in other words, the project does not meet certain criteria for an expedited review or exempt determination) and is reviewed by a duly-convened meeting with a quorum of voting members present.

    Sitero IRB will review your project at one of our regularly scheduled IRB meetings or we can provide a Sitero IRB On-Call™ review for an on-demand review.


    According to Miriam-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. The IRB Chairperson or designee can review the submission and has the full authority of the duly-convened IRB with the exception that the Expedited Reviewer cannot disapprove a project. When a reviewer cannot approve a submission under the expedited process, the item is referred to the full board for discussion.

    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 new recruitment materials and administrative changes. Generally, non-scientific submissions that do not change the risk/benefit ratio are considered minor changes.


    The Code of Federal Regulations identifies several different categories of minimal risk research as being exempt from the regulatory requirements and IRB oversight.

    This does not mean that they are exempt from IRB review, simply that the research project is exempt from ongoing, periodic IRB oversight.


    45 CFR 46.102 lists very specific definitions about what constitutes “research” and what is meant by a “human subject”.
    Although the federal regulations do not require official IRB review of studies that do not involve human subjects research, investigators may be required to obtain documentation that their project either is not research and/or does not involve human subjects (Journal editors, for example, may require this determination prior to publication of a manuscript).
    If it is determined that the submission does constitute research involving human subjects, the project will be referred to an Expedited reviewer for further consideration.


    Sitero IRB can assist you with development and editing of informed consent/assent documents specific to your study or site.

    We can also provide certified translations of all study documents related to the initial and continuing review of your project.


    Sitero IRB offers services that include Protocol Development, Site Audits, and Human Research Protection Program (HRPP) evaluation for academic research institutions, hospital systems, and practice-based research programs.

    Clinical Quality Assurance (CQA), GxP Training, Regulatory Affairs, and other specialized consulting services are also available.