FAQs

What types of studies do we review?

Our Board has expertise in reviewing pharmaceutical, biologics, device, diagnostic and social science research.

 Pearl IRB conducts the following types of new submission reviews:

    • Full Board Review
    • Expedited Review
    • Expedited Review with Waiver of Consent
    • Exemption determinations
    • General/Generic Recruitment (or Advertising) Material

 And the following types of review associated with previously approved submissions

    • Continuing Review (for submissions previously approved by Pearl IRB)
    • Amendments (to previously approved Pearl IRB submissions)
    • Close-Out

Can our institution use Pearl IRB to review some of our research studies, while maintaining local oversight for other studies?

Yes. Pearl IRB can serve as a CENTRAL IRB or the LOCAL IRB depending on your specific needs.  Please review the requirements of your institution related to which IRB’s are acceptable.

How often does your board meet?

Pearl IRB has scheduled full board meetings on a weekly basis

How long will it take for my study submission to be reviewed?

Day 1 (Monday) Completed Documents received by Pearl IRB (by 5pm EST)
Day 7 (Tuesday) Board members complete review
Day 8 (Wednesday) Full Board Meeting 5pm EST
Day 9 (Thursday) Communication of IRB determination sent to you

 

 

 

What is your submission deadline?

Completed materials must be submitted by end-of-business on the Monday (5pm EST) of each week to be considered for review the following Wednesday at 5pm EST.  Incomplete documents will result in a delayed submission and, therefore, a delayed review. If you think your submission may be delayed, contact Pearl IRB (info@pearlirb.com) or 317-602-5917) to discuss options that may allow you to still meet your timeline.

What documents are required for a new study submission?

New Submissions:

Are annual IRB reviews required on all studies?

The IRB will let you know how often they would like to see an update on your study.  An update will be required on an annual basis (unless otherwise determined by the Pearl IRB).  Pearl IRB will send you a report template and a timeline for the submission of materials back to Pearl IRB for review.  It is important that you keep the IRB current on any protocol changes, deviations, or unanticipated problems.  Even if you have stopped the research; we need to know.  If you have any questions, contact Pearl IRB and we will assist you in the decision making process.

Is Pearl IRB registered with FDA and OHRP? Do you have a Federal Wide Assurance number?

FDA and Federal Wide Assurance:

The following information from HHS gives direction on Federal Wide Assurance numbers: “Under 45 CFR part 46, subpart E, IRBs (including Pearl IRB) must be registered with OHRP before the IRB may be designated on an FWA as reviewing proposed research for the FWA-holding institution.”(http://www.hhs.gov/ohrp/assurances/irb/index.html; accessed 05Jul2013). “Before obtaining an FWA, an institution must either register its own IRB, (an “internal” IRB), or designate an already registered IRB operated by another organization, (an “external” IRB), after establishing a written agreement with that other organization.  An institution must have an FWA in order to receive HHS support for research involving human subjects. Each FWA must designate at least one IRB registered with OHRP.” (http://www.hhs.gov/ohrp/assurances/index.html; accessed 05Jul2013).”

As an independent commercial IRB, Pearl IRB currently does not receive HHS support for research involving human subjects.  Institutions using Pearl IRB which accept HHS support are required to list Pearl IRB as on their FWA.

OHRP:

Pearl IRB is registered with OHRP as IRB00007772.  Information can also be found on the OHRP website athttp://ohrp.cit.nih.gov/search/search.aspx or by contacting OHRP using the contact information at http://www.hhs.gov/ohrp/daqi-staff.html or by telephone at 1-866-447-4777.

Will I have a main point of contact for the duration of my study?

Yes. Our IRB Coordinator will be your main contact for the duration of your study.

Does Pearl IRB have a web portal for posting approval documents?

Yes. After your contract for IRB services has been executed you will receive information about our secure web-portal which is used for IRB submission purposes and is Title 21 CFR Part 11 compliant.

What are your fees for reviewing studies?

      Please see our fee schedule here.

Can we come to visit Pearl IRB to see the facility and look at SOPs?

Yes. With adequate advanced notice at a mutually agreeable time, you or your company may come to the Pearl IRB office and review our SOP’s.

Do you have questions that aren’t answered here?  Contact us at info@pearlirb.com.