ACIRB Investigator Responsibilities

• Submissions should be complete, including all supporting documents (e.g., documentation of cooperation from project settings; proof of training in protection of human subjects for all project personnel, permission to use instruments, tools and resources created by others; approved project proposal for students), before the submission is certified for pre-review in Cayuse IRB.
• Student Principal Investigators (PI) are expected to respond to ACIRB queries within seven (7) business days.
• Non-student PIs are expected to respond to ACIRB queries within 30 calendar days.
• Responses to queries must consist of substantive changes or actions that address the queries. The response may not be merely an acknowledgement of the queries.
• For projects under review, failure to respond to ACIRB queries within the specified timeframe will result in closure of the application.
• For approved projects, failure to respond to ACIRB queries within the specified timeframe will results in suspension of approval. 
• Protect the rights and welfare of all participants in any project.
• Provide evidence of human subjects protections training from an approved source completed within five (5) years of the date of review application submission. Training must be current within five (5) years and renewed as necessary while the project is underway.
• Understand and follow the ethical standards and regulatory requirements that are used to govern project activities.
• Personally conduct or supervise the project.
• Ensure that all staff members, collaborators and colleagues assisting in the project are informed about the project, the regulations governing project and applicable institutional policies.
• Ensure that all activities in the project have ACIRB approval and other approvals required by the institution, including the UnityPoint Health enterprise, before involving participants.
• Implement the project exactly as it was approved by the ACIRB.
• If conducting research or projects that require consent, obtain informed consent from subjects or a waiver of such consent before the subjects are involved in the research or project and document the consent as required by the ACIRB.
• Maintain written records of ACIRB reviews and decisions and keep the documented evidence of informed consent of the subjects or their legally authorized representatives.
• Obtain ACIRB approval for any proposed changes to the project protocol prior to implementing the change.
• Comply with ACIRB requirements for timely reporting of unanticipated problems involving risks to subjects or others, which include adverse events, safety reports or data safety and monitoring summary reports.
• Obtain continued approval from the ACIRB for extended projects on the schedule prescribed by the ACIRB.
• Plan for secured retention of complete project records and all project materials.
• Verify the privacy and security of all information obtained from and about participants in the project setting during the project and after the project is completed.
• For projects conducted in non-Allen Hospital-affiliated settings, verify that appropriate IRB approval and documentation of institutional cooperation are obtained from those settings.