Systems and Regulatory Issues

THE WEDNESDAY ACCRUALNET POST (04-10-13): 10 Things You Can Do To Cut Protocol Review Time

Last Updated: Apr 11, 2013

You Can Cut Protocol Review Time

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Institutional Review Boards know that they are often at least partially blamed for slowing down the protocol start-up process.  There have probably been times when every one of us has felt  that  our IRB's modification requests were  unpredictable and petty (Whitney 2008) and that IRB approvals were too hard to obtain.  But did you know that  repeated submissions not only cause delays in protocol activation, but that delayed protocol activation  may actually lead to incomplete accrual.  Cheng and colleagues conducted an in-depth analysis of the development time of CTEP-sponsored oncology clinical trials as it affects trial accrual performance during an 8-year period.  And what they found was that studies that take longer to get started are less likely to complete accrual (Cheng 2010).

To address the problem of the lengthy review process, the University of Mississipi Medical Center (UMCC) Human Research Office has identified the most common omissions and deficiencies in submissions at their center and put together a list of suggestions for avoiding them. Following their advice might just  shave off some review time and as a result increase your chances of completing accrual. Below is an adaptation of  the UMCC IRB tips.  Let us know if these common sense reminders  work for you. 

Thank you and kudos to University of Mississippi Medical Center Human Research Office!

10 Things You Can Do To Cut Protocol Review Time

  1. Include participant recruitment process details

Provide explicit details about how participants are identified and how, when, where and by whom participants are approached about participation, in the recruitment section of the IRB initial application, as well as the protocol. If participants are targeted based upon confidential medical information (i.e. known disease), they must be contacted through or by their health care provider or someone directly involved in their care and would reasonably be expected to have firsthand knowledge of the potential participant’s diagnosis or medical condition.

  1. Consent form simplification/clarification

Use the institution’s consent form template to help ensure that all required elements are included. Consent forms should be written at an eighth grade reading level, and should simply, clearly, and chronologically describe the study procedures, time duration, risks, benefits and alternatives.

Keep medical terminology to a minimum. When it is necessary to include medical terminology, a lay person’s definition or explanation must follow. Risks that may be difficult to understand, for example, “decrease of white blood cells” should be followed with additional information to explain the expected physiological consequences. UMCC's list of commonly used medical terms and corresponding lay terms can be found by clicking here, and it is updated frequently. Please note, when revising the consent document you should start with the current approved version and remember to submit a current stamped copy with the revised consent document. Revising an older version results in additional revisions and unnecessary delay.

  1. Who obtains consent?

Often studies have non-physician study staff designated as able to obtain consent. This practice varies from institution to institution but for most studies with any significant risk, and all studies involving experimental drugs or devices, a licensed physician, pharmacist, or nurse practitioner investigator should obtain informed consent. Study nurses or others qualified by training and experience may assist the investigator, but investigators should be actively involved and not delegate this vital investigator responsibility. In non-interventional studies, or minimal risk studies it may be appropriate for nurses or other study staff to obtain consent, with “back up” provided by physician investigators, taking into account the qualifications and training of the relevant study staff. Check with your local IRB to find out the signature requirements (PI only , PI and co-PI, study type-dependent, etc.)

  4. Inclusion and exclusion criteria

Adequate and specific details about inclusion and exclusion criteria must be included in the protocol. It is recommended that these be explicitly laid out in a list or “bulleted.” Even studies with minimal interventions (e.g. phlebotomy only) must include inclusion and exclusion criteria. For example, provide details in the protocol showing how “significant cardiac, hepatic or renal disease” is determined, based upon clinical events (or their absence) or specific laboratory values, instead of identifying the inclusion or exclusion criteria as “significant cardiac disease."

  1. Adverse event reporting

Describe the adverse event reporting and monitoring process. This element is most often missing in investigator-initiated studies not regulated by the FDA. Adverse event reporting must be described and adverse event reports must be submitted, as appropriate to the IRB and other relevant regulatory bodies (sponsor, FDA, NIH, etc.), depending upon the study.

  1. Protocol/consent form discrepancies

Submissions sometimes contain discrepancies between the protocol and the consent form(s). The procedures outlined in the protocol should be accurately described in the consent form(s) and all information that appears in both documents should match.

  1. Statistics

Include a clear rationale for selected sample size  and detailed descriptions of how data will be analyzed. Even “pilot studies” require statistical considerations or comment. Be sure the hypothesis, variables and methods are clearly stated.

  1. Include required documents

Review your checklist of required documents. Checklist Example:  protocol, casereport forms, surveys, questionnaires, brochures, advertisements and minor assent forms. And remember to obtain all necessary signatures.

  1. Describe anticipated future uses

Don’t forget to include potential uses of both stored biological materials and stored data.

  1. Proof-read consent documents

How disappointing to have  approval delayed  because  of  errors caused by rushing through the submission process (e.g., missing pages, ineligible printing).  Check and double-check your submission!

Thank you and kudos to University of Mississippi Medical Center HUman Research Office!

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