A well-developed protocol is essential for successfully executing a research study.
When developing a study protocol, investigators are tasked with describing every aspect of their study and providing just the right level of detail and clarity to secure approval from the University of Minnesota’s institutional review board (IRB) — all while limiting unrelated or redundant content that causes confusion or leads to inconsistencies.
IRB protocols should include sufficient scientific and methodological details to meet regulatory requirements, clearly describe the study conduct and procedures for a wide range of reviewers, and provide the study team with pertinent information needed to carry out their research duties through each phase of the project — from recruiting and enrolling participants to analyzing data and disseminating results.
The four C’s of protocol development
A well-developed research protocol should be:
Below, we’ve detailed how you can achieve these four qualities in your protocol.
Completeness: All protocol sections have been addressed
- All applicable sections include a description or response that directly relates to the proposed study.
- The section content answers all applicable prompts in the protocol template’s red instructional text.
- Sections that do not apply have been marked “N/A” (or deleted, when allowed).
- Every question in the ancillary review matrix has been answered.
- Each line of the protocol cover page is filled in.
Comprehensive: All study aspects are described in full detail
- Background information and scientific relevance demonstrate what is known, what stands to be discovered, and the importance of answering the research question(s).
- A detailed description of study procedures, interventions, and participant interaction is provided, including study conduct from recruitment and screening through study completion. This should be done for both the active and inactive (e.g., long-term chart monitoring, data analysis) phases of participation.
- Study data to be collected are clearly defined and directly related to the study aims and endpoints/outcomes.
- Participant eligibility criteria are sufficiently described so as to include all individuals that the research question is targeting without including those for whom the study may not be appropriate or safe, nor unduly excluding those who should otherwise be eligible.
- There’s detail about how study data will be analyzed in order to evaluate the study endpoints and answer the research question. This includes, but is not limited to, the method of analysis and a plan for handling missing or incomplete data.
Compliant: Adheres to federal, state, and local IRB requirements
- The potential risks associated with participation, how those risks will be mitigated and any potential benefits to participants or society as a whole are described. The investigator has provided information to justify the risk-benefit ratio in the targeted population.
- Plans to obtain informed consent follow the requirements set forth in 21 CFR Part 50 Subpart B “Informed Consent of Human Subjects.”
- The protocol includes plans to protect participant privacy and maintain the confidentiality of protected health information in accordance with HIPAA (Health Insurance Portability and Accountability Act) regulations and privacy practices.
- The proposed procedures, including screening and recruitment strategies follow organizational policies and practices (e.g., Fairview research opt-out).
Consistent: No contradictions across sections or between documents
- The results of any proposed screening procedures for determining eligibility are consistent with and reflected in the participant inclusion/exclusion criteria. Additionally, any screening procedure required to determine eligibility (e.g., urine pregnancy test for pregnancy status, PHQ-9 for depression symptoms) should be described in the appropriate sections, as applicable.
- The study data described as part of data collection procedures are directly relevant to the proposed aims and endpoints and reflected in the statistical analysis plan.
- Recruitment materials and screening questionnaires provided for review are consistent with the proposed plans for participant recruitment and screening.
- Study details included in the consent form (e.g., number of study visits, duration of participation, compensation amounts, potential risks) match those outlined in the protocol.
Dos and don’ts
|Do use the term “participant.”||Don’t use the term “subject.” “Participant” is a more humanizing, person-first term that’s generally preferred.|
|Do use terms like “unaffected control” or “participants without [condition name]” in the inclusion criteria.||Don’t use the term “healthy control” to describe eligibility of participants. “Healthy” is a subjective term that may not accurately reflect the potential participant population.|
|Do let the IRB make all risk assessments and determinations.||Don’t directly assert a determination of risk, such as, “this study poses minimal risk.” Instead, consider comparing the risk posed by participation to that of standard care or everyday life to provide a point of reference for reviewers.|
|Do mark sections or subsections that don’t apply to the study as “N/A.”||Don’t delete any sections, unless the instructions say it is okay to do so, and don’t restructure the format of the template.|
|Do download the most recent protocol template version from the IRB website.||Don’t start from a previous study’s protocol. This helps avoid the need to transfer the protocol to a new template if the template has changed.|
Our clinical research experts offer guidance on protocol development and IRB submissions. To get started, contact the Clinical Research Support Center:
Clinical Research Support Center
Don’t know where to start? Contact CTSI’s Research Navigators: