The IRB has identified the most common omissions and deficiencies in submissions. Attention to these details “up front” should speed the review of your protocols. Feel free to contact the IRB office for assistance or for “pre-review” of your submission documents.
Some submissions lack a detailed description about the consent process, including who will initially approach participants about the study. The recruitment section of the IRB initial application, as well as the protocol, should contain explicit details about how participants are identified and how, when, where and by whom participants are approached about participation. 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.
Starting with our consent form template will 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.
Medical terminology should be kept 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. Consent forms have been submitted with terms like “secondary amenorrhea” rather than “missed menstrual period” and “syncope” rather than “fainting.”
A 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.
Often studies have non-physician study staff designated as able to obtain consent. 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.
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."
Protocols sometimes have no comments on adverse event reporting or monitoring. 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. See the instructions for the adverse event report form for details on this important investigator responsibility.
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.
Protocols sometimes lack any rationale for the selected sample size or detailed descriptions about how data will be analyzed. Even “pilot studies” require statistical considerations or comment. What is the hypothesis that you are testing? What are the variables? How will you analyze the data collected? How do you know that the number of participants requested will allow you to answer the research questions posed? All protocols must consider statistical issues; calling a study a “pilot study” does not exempt it from these considerations entirely.
This includes protocol, data collection sheets, surveys, questionnaires, brochures, advertisements and minor assent forms, and remember to obtain all necessary signatures.
This includes stored biological materials or data as described in the protocol and IRB initial review form.
Consent documents are returned or have approval delayed because the final copy of the consent document is not proof read before being submitted. The IRB has received consent documents with missing pages; pages printed illegibly or in symbols; and pages copied so that only part of the page appears.
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