FAQs

Pearl IRB performs prospective and continuing review of human subject research to ensure it is conducted ethically and in compliance with applicable federal, state, local, and institutional requirements. Our Board has expertise in reviewing pharmaceutical, biologics, device, diagnostic and social science research. Pearl IRB cannot retrospectively review a study that has already started or been completed.

The IRB will be closed for the following holidays: New Year’s Day, Martin Luther King Jr. Day, Memorial Day, Juneteenth, July 4th, Labor Day, Thanksgiving, the day after Thanksgiving, Christmas Eve, Christmas, and New Year’s Eve. If a holiday falls on a weekend, the observed day may be on a Monday or Friday.

Yes. Pearl IRB maintains registration with both OHRP and FDA. The Pearl IRB Organization number is 0006471 and the IRB Registration number is 00007772. IRB Registration can be verified online via the Office for Human Research Protections (OHRP) Database for Registered IORGs & IRBs.

As an independent commercial IRB, Pearl IRB does not receive DHHS funding support or conduct human subject research and, therefore, does not have an FWA. Institutions that have an FWA may be required to designate Pearl IRB on their FWA in certain instances. Additional information can be found on the IRBs and Assurances and Federalwide Assurance Instructions pages of the OHRP website.

OHRP provides Human Subject Regulations Decision Charts, which are intended to aid those who need to decide if an activity is research involving human subjects that must be reviewed by an IRB. The Decision Charts also help determine what the appropriate level of review is likely needed by the IRB (e.g., exempt, limited, expedited, full Board).

NIH provides a Decision Tool: Am I Doing Human Subjects Research? to assist with determining if research involves human subjects, may be considered exempt from Federal regulations, or is not considered human subjects research. This tool should not be used as the sole determination of exemption.

In addition to a variety of consulting and writing services, Pearl IRB conducts the following types of new submission reviews:

• Human Subject Research Determinations
• Exemption Determinations
• Limited Review
• Expedited Review
• Full Board Review
• Informed Consent Waivers
• HIPAA Authorization Waivers
• General/Generic Recruitment (or Advertising) Material Review

And the following types of review associated with studies previously approved by Pearl IRB:

• Continuing Review
• Amendments/Modifications
• Deviations/Unanticipated Problems
• Close-Out

If you are a current user of our online submission system, the current Fee Schedule is always available once logged in. If you are planning to use Pearl IRB for future review, you can complete a Fee Schedule Request. Invoices for IRB review services are issued approximately two weeks following review, and payment is due upon receipt regardless of approval status. 

If you are a current user of our online submission system, the current IRB Roster is always available once logged in. If you are planning to use Pearl IRB for future review, you can complete a Pearl IRB Roster Request.

Sponsor/Investigators are responsible for submitting all relevant regulatory documentation with their submission for IRB review. This may include correspondence from FDA (e.g., an approved IDE or IND), all approved labeling (e.g., IFUs, package inserts, etc.), and information about the product’s regulatory status (e.g., a 510(k) notification downloaded from the internet or drug approval notice). 

Yes. Using Pearl IRB as the single IRB (sIRB) of record for non-exempt multisite studies that are conducting the same protocol may help streamline the IRB review process by eliminating the unnecessary repetition of those reviews across sites. If the site has a local IRB, each site can enter into formal agreements called Reliance Agreements, Cooperative Agreements, or IRB Authorization Agreements, allowing Pearl IRB to serve as the sIRB of record—that is, to be the IRB that assumes responsibilities for review of research activities conducted by researchers at multiple institutions.

Yes. Most changes to approved study documents and procedures must be submitted and reviewed by the IRB prior to implementation as they may impact the risk/benefit ratio of the study. This includes, but is not limited to, changes in principal investigator, addition of recruitment materials, addition of study site locations, and changes to study protocols. 

If the amendment/modification requires changes to approved study documents, they must be provided in Word format using track changes with both deleted and added text visible. A summary document explaining the study changes and rationale will also be required. 

If an advertisement has more than basic trial information (such as the title, purpose of the study, protocol summary, basic eligibility criteria, study site location(s), and how to contact the site for further information), IRB approval is needed prior to its use. IRB review is not needed for dear doctor letters, doctor-to-doctor letters (even when soliciting for study subjects), news stories, and financial page advertisements directed toward prospective investors.

Most studies approved by expedited review and all studies approved via full board review are required to submit continuing review and study closure reports. The IRB will communicate if and when such reports are due via the approval letter. You will also receive reminder email notifications to submit the appropriate report closer to the due date. 

Studies that receive exempt determinations are not required to submit continuing review and study closure reports.

Typically, Pearl IRB only reviews studies that have not yet started. If you are seeking to transfer IRB oversight of a study that is already in progress under the oversight of another institutional or independent IRB to Pearl IRB, please contact us to discuss your request.

Yes. We understand that most of our clients are new to the IRB review process, which is why we take a hands-on approach to reviewing your studies. An IRB Coordinator will be available as your main contact for the duration of your study. In the event that a document is missing or the IRB requires clarification, the IRB Coordinator or assigned reviewer will contact you to ensure that the outstanding information is collected so that the review can continue. Questions can also be submitted via a dedicated support email that is available for all active clients. 

Pearl IRB utilizes an online study submission system to better serve our research community. The web-based platform offers our clients a secure, streamlined method to complete and submit all Pearl IRB required forms and study documentation for single or multisite studies. Please note that the required submission documents may depend on the type of study and the review type needed. In general, you should expect to provide the staff credentials, study protocol, all subject facing documents (e.g., surveys, questionnaires, screeners, etc.), informed consent form (ICF), and recruitment/advertisement materials. 

Pearl IRB standard turnaround times are 1-3 business days for exempt or expedited reviews, and 8-10 business days for a full board review following receipt of a complete submission. Additional information on our typical review turnaround times can be found on the Pearl Board Review Turnaround Times page.

Pearl IRB schedules full board meetings weekly on Mondays. Completed submission materials must be provided by end-of-business on Monday (5pm EST) to be considered for review at the following Monday’s full board meeting. If you think your submission may be delayed, please contact us to discuss options that may allow you to still meet your timeline.

A site is traditionally defined as a physical location dedicated to human subject protection and the ethical conduct of clinical research. A site is characterized by participants physically arriving at a location to participate in the study, or by housing or analyzing study data or specimens. A site is typically under the control of an additional, local participating investigator. Individual site reviews are not typically necessary for studies that receive exempt determinations. 

Note: For studies involving online surveys, the physical location (e.g., homes, universities, etc.) of the participants will not be considered sites.

Yes. With adequate advanced notice at a mutually agreeable time, you or your company may come to the Pearl IRB office and review our SOPs. Virtual meets may also be arranged. Please contact us to arrange a visit.

The Family Educational Rights and Privacy Act (FERPA) is a federal law that protects the privacy of student education records and applies to all schools that receive funds under an applicable program of the U.S. Department of Education. Review the Applicability of FERPA in a Research Study decision chart to determine how FERPA applies to the study you are conducting or participating in.