Conducting Research After IRB Approval

An e-mail will be sent from Saint Louis University's eIRB system letting you know when the study has been approved. IRB approval is documented by a full approval letter, which is accessed in the eIRB system. 

Do not start your research project until the approval letter has been issued and all other applicable institutional or hospital approvals are in place.

Importantly, researchers are expected to carry out their research in accordance with the procedures and using the materials, approved by the IRB. Any deviations will require approval by the IRB prior to implementation of the change(s).

PI/Study Team Responsibilities

Saint Louis University investigators are responsible for conducting research in an ethical and professional manner, and in accordance with federal regulations (both the general regulations pertaining to human subjects protection in 45 CFR 46 and 21 CFR 50 and 56, and any specific regulations that may be imposed by the federal agency funding the research), local, state, and federal laws, Saint Louis University policies, and the IRB-approved protocol.

Any non-compliance must be promptly reported to the IRB.

The principal investigator (PI) is also responsible for the timely and proper administration of the research project.  Beyond the scientific and clinical conduct of the study, responsibilities include:

  • Fiscal management of the project
  • Training and supervision of research team members
  • Compliance with the sponsor’s terms and conditions (e.g., non-disclosure of sponsor confidential information)
  • Submission of study amendments and continuing review applications in a timely manner
  • Obtaining approval for protocol changes prior to implementation
  • Timely submission of post-approval reporting requirements
  • Disclosure of any potential conflicts of interest (for self and research team members)*

 * Disclosures of potential conflicts of interest are reviewed and managed by institutional COI committees or designees; however, the IRB has the final authority to decide whether the potential conflict of interest and its management, if any, allows the research to be approved. 

Post-Approval Forms and Guidelines

Please be aware of post-IRB approval submission requirements for more information on the types of events, when to submit, and the appropriate form to use.  The following activities require further submission to the IRB. Submissions should be done in eIRB; for paper SLU IRB studies, links to paper forms are below. 

Amendments

Modifications to the approved research may not be implemented without prior IRB review and approval, except when necessary to eliminate immediate hazards to research participants.  Modifications include revisions to any protocol, research procedure, recruitment plan, study instrument, research personnel, study site, or related study document.  For studies not in eIRB: Change-in-Protocol/For Information Form.

Continuing Review

IRB review is required at least annually for all non-exempt research unless a shorter approval period was determined by the IRB. The purpose of continuing review is to monitor the progress of the study and ensure that it continues to meet the requirements for approval.  It is the principal investigator's responsibility to complete the continuing review form in a timely manner or study approval may expire. For studies not in eIRB: Continuing Review Form/Notice of Study Closure.

Reportable Events

Serious adverse events, unanticipated problems, protocol violations, complaints and other events must be reported as detailed in the IRB Reportable Events Guidelines. For studies not in eIRB: Change-in-Protocol/For Information Form or Serious Adverse Event (SAE) Report Form.

Study Closure

If all research-related interventions or interactions with human subjects have been completed and all data collection and analysis of identifiable private information described in the IRB-approved protocol has been finished, the human subjects research study has been completed and the investigator should close the study. Studies should be closed in accordance with the SLU IRB Closure Guidelines. Please note record retention requirements specified in that guidance. For studies not in eIRB: Continuing Review Form/Notice of Study Closure.

Other Guidelines and Resources

Study Resources

Industry-sponsored studies often are run with organizational binders provided by the study’s sponsor/CRO. For investigator-initiated studies, researchers can refer to the Regulatory Binder Guidance to put an organizational system in place. In addition, SLU provides some sample logs, though units are welcome to develop their own.

Sample Forms/Logs