In this, the second in a three-part series, we will look at the typical types of information or documentation that may be missing in investigator-initiated protocol submissions to an IRB.
Subject Recruitment and Informed consent
Some investigators are unclear about what to include in a research protocol vs. what is supplementary information. For example, some investigators may consider recruitment materials to be supplementary information. However, a complete protocol should specify the “recruitment plan,” describing how potential subjects will be identified and contacted. This description should contain details about how, when, where and by whom identified individuals will be approached about possible participation in the study.
If, for example, the investigator needs to access medical records to identify potential subjects, the need to access protected health information (PHI) prior to obtaining consent and authorization need to be considered. The IRB or privacy board may need to grant a partial HIPAA waiver to allow access to the records if the investigator is not a member of the work force of the organization that has the medical records. A protocol containing a detailed recruitment plan will help investigators and the IRB to identify and facilitate approval of the procedures that will be necessary to carry out the research. It is helpful if investigators include all the subject recruitment materials—emails, phone scripts, advertisements, flyers, and so on.
Investigators must be explicit about the process for obtaining informed consent. Who will obtain consent, and in what setting will the consent discussion occur?
IND and IDE
Another reason that protocols may not be approved by an IRB is that an IND (investigational new drug) or IDE (investigational device exemption) is missing. Investigators might not always realize the proposed intervention may be an FDA-regulated clinical investigation. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated. In the case of an investigator-initiated trial on a drug, a physician must submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population.
Inclusion and Exclusion Criteria
Sometimes the inclusion and exclusion criteria are missing or insufficient for adequate review. IRBs require these to be explicitly listed. All studies, even those with minimal interventions, must include detailed eligibility criteria so the intended subject population is clear and the IRB can determine that appropriate safeguards are in place. Investigators should avoid vague descriptions, such as “significant cardiac disease.” Instead, outline specific lab or radiological values.
Monitoring and compliance
Most FDA regulated research must also include a plan for monitoring and reporting adverse events and unanticipated problems. But some protocols are missing details about how information will be collected and to whom it will be reported. Protocols should include details about how adverse events will be reported to other investigators, the IRB, and regulatory agencies. Investigators should also include how those participants will be cared for in the case of a serious adverse event.
Investigators who are initiating their own trials are responsible for assuring the adverse event monitoring plan is followed.
A protocol with missing, incomplete or incorrect information makes it difficult for an IRB to understand the research study objectives, which can lead to increased protocol revisions, and delays in approval and enrolling participants.
Next week we will post the most common inconsistent elements from a protocol.
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