Study Design Considerations

Determining Study Feasibility

Researchers who need to access PHI, other than from their own patients for the purpose of designing a research study, determining feasibility for a research study or identifying potential research subjects, must get prior permission via the Preparatory to Research Review Application. Submission of this form helps researchers and SLU be compliant with HIPAA regulations.

For clinical trial feasibility support, contact clinical-trial-office@health.slu.edu.

Designing a Research Protocol

To ensure an efficient review by the Institutional Review Board, a full description of the planned research must be submitted for initial review. This information is captured in the IRB application, and includes background information of the problem under study, including the study rationale; study objectives/hypotheses; study design, sample size, methods of analysis; detailed study and data collection procedures; inclusion/exclusion criteria and recruitment procedures; the consent process and forms; methods of analysis; anticipated risks, benefits, and alternatives; and supplemental study materials (e.g., advertisements and study instruments). 

The IRB uses the regulatory criteria for approval to determine whether a proposed study can be approved, and researchers should take these criteria into consideration when designing a study. For example, you should consider whether the choice of population results in an equitable distribution of the burdens and benefits of research (45 CFR 46.111(a)(3); 21 CFR 56.111(a)(3)), and you’ll be asked to provide justification when recruiting vulnerable populations such as prisoners, pregnant women, and minors. The IRB application will also ask for consent process details to ensure that unless waived, informed consent will be sought and appropriately documented from each prospective subject/LAR (45 CFR 46.111(a)(4-5); 21 CFR 56.111(a)(4-5)).

The IRB application will also ask about potential risks, benefits and alternatives to ensure criteria approval are met. Risks should be minimized by using procedures that are consistent with sound research design and that do not expose participants to unnecessary risks, and whenever appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes (45 CFR 46.111(a)(1); 21 CFR 56.111(a)(1)), and risks should be reasonable in relation to anticipated benefits (45 CFR 46.111(a)(2); 21 CFR 56.111(a)(2)). When appropriate, the research plan should have adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data (45 CFR 46.111(a)(7); 21 CFR 56.111(a)(7)), and should make adequate provision for monitoring data collected to ensure the safety of subjects (45 CFR 46.111(a)(6); 21 CFR 56.111(a)(6)).

Sample Protocols

The IRB maintains an internal Google Site of sample protocols approved by the SLU IRB, posted with permission of the principal investigators, that you are welcome to reference  as you complete your IRB Application.

For those developing clinical trials, the following NIH tools may assist you when developing the study protocol:

IRB Guidelines & Resources

The following list of topical guidelines may help you design components of your study:

PI and Research Team Member Considerations

Principal Investigator

  • All studies submitted to the IRB must identify a principal investigator (PI), who will have ultimate responsibility for the study. The PI should be a SLU affiliate unless an exception was granted, and only one PI can be listed on the SLU application.
  • The PI is responsible for obtaining IRB and other necessary institutional approvals prior to beginning their research, and holds the ultimate responsibility for the conduct of the research.
  • The PI can delegate study responsibilities to other study personnel, but must assure that all personnel under his or her supervision have appropriate training and credentials to perform duties, and are adequately mentored and supervised throughout the course of the research. 

Research Team/Study Personnel

  • The research team listed on the IRB application should include individuals who are directly involved in the performance of interventions or interactions required by the protocol, including obtaining consent, and/or the collection of research data (for investigational drug studies, this would be similar to those listed on the Form FDA 1572). Investigators can include physicians, scientists, nurses, administrative staff, teachers, and students, among others.
  • For biomedical studies, nurses or residents who provide intermittent care but who do not make a direct and significant contribution to the research do not need to be listed individually on the IRB application. This would include technicians performing standard clinical procedures that may be part of the research protocol, or even persons administering investigational agents that they are accustomed or trained to administer, but not otherwise having any role in the research. Because it may be difficult to prospectively identify these types of individuals, the names of rotational individuals and the procedures they are expected to perform should be included in the clinical study records rather than be listed on the IRB application.
Policy Considerations

Researchers should be aware of SLU policies as they design and conduct their research.