Common Protocol Development Errors (Part Three)

In the last of this three-part series, we explore common types of information or documentation that may be inconsistent in investigator-initiated protocol submissions to an IRB.

It is a common sentiment among clinical investigators that the process of developing and submitting a human subject research protocol for review and approval by an IRB is onerous, lengthy and complicated. For researchers writing investigated-initiated research, the process may seem like a labyrinth of regulatory and institutional requirements. Generally speaking, most IRB submission errors fall into these categories:

  • Incomplete submission
  • Missing documentation
  • Inconsistent information

Inconsistent Information

An IRB submission often requires the same information in multiple locations. Sometimes the study protocol or application contains information that is not consistent from one section of the submission to another. The most common inconsistencies include:

  • Number of participants to be recruited
  • Frequency or number of participant visits in the study
  • Amount that participants will be paid and schedule for payment
  • Type and frequency of procedures
  • Specific data that will be collected

Interchangeable Terminology

Certain words, including “anonymous” and “confidential” are often used interchangeably when they actually mean different things. Anonymous means that there is no link between the participants and the data they provide. Confidential means that there is a link between participants and the data they provide, but the link will be unknown to everyone except the researchers and parties specified during the consent process.

Misaligned Objectives and Endpoints

In some cases, a researcher with a well-defined research question and clearly stated study objectives may not follow through to reveal adequate endpoints.

Endpoints are the main way that the results of a trial will be assessed. They should be decided in the study design before any patients are enrolled.

For example, perhaps a physician uses a treatment off-label regularly in clinical care, and now wants to conduct a research study to gather data to support the treatment’s use. The researcher provides a protocol that contains detailed procedures, but doesn’t include the plan for assessing the results and determining whether the endpoint is achieved.

An effective clinical trial design results in the reduction of errors and bias. It also provides a high degree of credibility, reproducibility and validity. Having a clear, complete and simple protocol design allows investigators to advance clinical research while protecting human subjects.