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 firstname.lastname@example.org.
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)).
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:
The following list of topical guidelines may help you design components of your study:
Researchers should be aware of SLU policies as they design and conduct their research.
The following guidelines are in place to help you design studies in ways that best protect potentially vulnerable participants. If your study involves one of the following populations, please consult the guidelines and incorporate protective strategies where possible.