Common Protocol Development Errors (Part One)

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. A protocol with missing, incomplete or incorrect information makes it difficult for an IRB to understand the trial, which can lead to increased protocol revisions, and delays in approval and enrolling participants.

There is much that an investigator can do to improve the efficiency and turn-around time of IRBs by simply having a thorough and compliant protocol submission.

The primary responsibility of an IRB is to safeguard human subject protection. To that end, the IRB reviews protocols in the context of adhering to principles of ethical research (respect for persons, beneficence, and justice), applicable laws, regulations and the institution’s own policies.

Generally speaking, most IRB submission errors fall into these categories:

  • Incomplete submission
  • Missing documentation
  • Inconsistent information

IRBs vary in their requirements, and each research institution may have requirements that may present common reasons for rejection by the IRB. In this three-part series, we will address the most commonly incomplete or missing pieces of information, as well as the most common inconsistencies in a protocol.

By far, the most commonly cited submission error is incomplete information.

Describing the research question

Investigators often provide an inadequate description of the research question or the background information required to support the need for the research. We’ve seen a number of protocols that specify, in great detail, procedures that will be followed, but the protocols do not include an adequate description of the research question and/or the background information to support the need for the research.

To conduct research in humans there must be sufficient justification for exposing subjects to risk.  A scientifically sound research hypothesis provides the basis for this justification.

IRBs will have difficulty determining whether risks to subjects are minimized or are reasonable in relation to the anticipated benefits if the research plan does not provide the necessary information.

Identifying all research sites and collaborators

If the research is taking place at multiple sites, it is important to provide clear information about them. Commonly missing is the explicit specification of other researchers or facilities that have agreed to participate in the study. This information is required so the IRB can ensure it has the appropriate jurisdiction to approve research for the collaborating entities, if needed.

Using dated information

Incomplete information can also include outdated information. Standard language requirements for a protocol, or consent form, relative to areas such as HIPAA, contraception, and compensation for research-related injury, are often updated. Simply cutting and pasting from a previous protocol may be fast, but it is not efficient if the requirements have changed.

Investigators and members of IRBs all want to proceed as efficiently as possible in reviewing and approving research protocols. The IRB has particular compliance and regulatory requirements that necessitate the careful scrutiny of protocols to ensure completeness. By carefully constructing the protocol and understanding the necessary information required, an investigator can mitigate the risk of rejection or delays by an IRB.

Next week we will post the most common missing elements from a protocol.

Contact us today to see how Protocol Builder can help solve protocol development issues and avoid delays.