IRB develops pre-review screening process

Tabled reviews drop from 45% to 23%

IRBs have full schedules, and the little mistakes investigators make when applying for an approval can bog down the process, adding weeks and resulting in wasted time. As one IRB office has discovered, a solution that can reduce turnaround time and improve efficiency involves the use of a pre-review screening process.

"It's definitely challenging to provide a thorough review, crossing the t's and dotting the i's and turning around reviews in a timely fashion," says Donna Hoagland, LPN, BS, CIP, CCRC, CHRC, director of the New Brunswick/Piscataway campus IRB at the University of Medicine and Dentistry of New Jersey (UMDNJ).

The IRB's percentage of initial full board submissions that were tabled averaged 45%, and mistakes were often discovered at initial and continuing reviews, she says.

IRB staff looked at the tabled submissions to identify trends. They found that some questions on the submission forms were left unanswered, so they decided that any checklist would need to include the point that all questions should be answered, she says.

"We felt it was wasting the board's time and the investigators' time if protocol submissions were not complete," Hoagland says. "That was our challenge."

After making changes to the review process by adding an IRB staff administrative pre-review stage, the office measured the number of tabled submissions and found a significant reduction to 23% of new applications being tabled, she adds.

The IRB's solution was to start a pre-review process designed to catch the most common omissions and errors and have those fixed before the IRB reviewed the protocol.

"We had a good system, but everybody can make improvements," Hoagland says. "The trick with the pre-review process is that criteria under the regulations that only a reviewer, a fully appointed board member of the IRB can make decisions about."

So the IRB office would handle only the administrative issues, dealing with problems that did not require IRB member input.

"We came up with a pre-screen process that included pre-screen procedures, a staff administrative pre-review checklist, and an investigator submission checklist," Hoagland says.

They focused on these questions:

  • Was everything from the application complete?
  • Was every question answered or not applicable?
  • Was every required attachment included?
  • Were all sign-offs attached?
  • Was the department chair's signature included when required?
  • If the protocol was for a cancer study, was there an approval from the scientific review board?

"The other thing we were looking at was whether the research activities were occurring on UMDNJ-owned or -operated property. If not, did we have either the other institution's IRB approval letter or a request for an IRB authorization agreement to be the IRB of record for that site," Hoagland says.

The pre-review process also included an Initial IRB Paper Submission Application Checklist for principal investigators. (See sample PI application checklist below.)

IRB's initial submission checklist works for PIs

The New Brunswick/Piscataway campus IRB at the University of Medicine and Dentistry of New Jersey (UMDNJ) has developed an initial IRB Paper Submission Checklist, designed to help principal investigators in preparing their IRB submission.

The two-page checklist includes a list of items commonly included with submissions. Each question is followed by a box to check for "yes," "no," and "N/A." Here are the IRB's checklist questions:

  • Are all copies collated and stapled?
  • Is the application signed by the PI and all co-investigator(s)?
  • Is the application signed by the Department chair(s)?
  • Does the submission contain a separate protocol with a visible footer version that details specific studies activities?
  • How many CONSENT and ASSENT forms are being submitted? Enter in number of each below: Consent Forms, Assent Forms, HIPAA Auth. (if separate)
  • Have you included copies of each consent/assent form with a visible footer version on each?
  • Have you included copies of CITI Human Subjects Research certificates for all investigators and study staff listed on your application? http://www.umdnj.edu/hsp/education
  • Have you included a copy of the Investigator's brochure and 1572/1571? (required for all studies involving investigational drugs, devices/biologics)
  • Have you enclosed package inserts for each FDA-approved drug/device?
  • Have you included ALL recruitment materials (including flyers, brochures & printed advertisements, radio/TV ads, letters, telephone scripts, Internet postings, etc.)?
  • Have you included ALL Questionnaires/Surveys?
  • Have you submitted ALL DATA COLLECTION sheets for this study?
  • Check all that apply (AND include): If appropriate, did you include confirmation of University Committee; APPROVALS: CINJ SRB, UBHC , Radiation Safety and/or BioSafety?
  • Is a FULL GRANT (including budget) or a CONTRACT for outside funding attached to this submission?
  • Have you submitted the appropriate HOSPITAL/INSTITUTE SIGNOFF (e.g. KENNEDY MEMORIAL HOSPITAL, RWJUH -RUG form/ UH/UBHC, etc.)?
  • A) Have you enclosed the complete signed Investigator Financial & Other Personal Interests disclosure form? B) If you have disclosed a conflict, you MUST attach copies of part 2 of the disclosure form. http://www.umdnj.edu/hsp/forms/appendices.html.

The process began with the IRB's front desk staff looking at each submission for the most basic of details, such as whether all questions were answered and whether the protocol was attached, Hoagland says.

"Did they give us a copy of the investigational brochure? Was the disclosure form attached?" she says. "If these were missing they'd send the PI an email and get the items before the protocol was put on the agenda."

Once the front desk staff check submissions, they pass the protocols to the program assistant, who has additional training and can check to make certain recruitment materials, grants and contracts, and informed consent forms or waivers of consent are included, she adds.

"If there's a disclosure on the conflict of interest form, they send the disclosure to the conflict of interest committee so those reviews could go concurrently," Hoagland says.

Here are some additional examples of the items pre-reviewed by the management assistant:

  • Confirm UMDNJ paid faculty, staff or student of public health. If a student is listed as a Principal Investigator (PI) and is not from the School of Public Health, the student cannot be a PI. Return to PI.
  • Confirm that all Investigators and Study Personnel have completed the CITI Training Basic Course/Refresher, as required. If not, list names.
  • If funded, confirm that a Grant, Contract of Letter of Award is attached. If not, return to PI.
  • If this study involves the use of Embryonic Stem Cells, confirm that an ESCRO Committee Approval Letter is attached. If not, return to the PI.

IRB staff make sure reviewers and the board have a complete package with all of the information they need to complete the review, she notes.

"We developed new office procedures that go with the new pre-screen checklist," Hoagland says. "If something major is missing from the submission, like an attached protocol, then we do not accept the submission."

If the missing item is less significant, such as a human subjects protection training certificate, then the IRB office will email the PI about the missing item, copy the email and put it in the file so the IRB reviewer will see it, she adds.

"We made the investigator submission checklist available on our website along with the application so investigators could check off items as they complete the packet," Hoagland says. "We're hoping to expand pre-reviews in the future by developing a continuing review pre-screen, modification pre-screen, and a final study pre-screen checklist, as well."