This toolbox has been created to assist Principal Investigators and study staff who are submitting research protocols to the HealthONE IRB for review and approval. The templates have been designed to be for guidance only. Protocols and Informed Consent Documents should be customized with information applicable to your research study. The IRBNet User’s Manual is a valuable reference to guide you in the process of electronically submitting your study documents to the IRB. The HCA-HealthONE IRB requires that all research protocols and subsequent documents be submitted electronically through IRBNet (www.IRBNet.org).
- Corrective Action Plan (CAP) Guidance
- Elements of a Research Protocol
- HIPAA Template for Consents
- IRBNet User’s Manual
- Informed Consent Guidance Document
- Informed Consent Template
- Protocol Template for Chart Review Studies
Regulatory Binder Instructions
A Regulatory Binder assists sites in achieving and maintaining regulatory compliance and ensuring the highest standards of human subject research. The binder also provides:
- Guidance for organization and record keeping
- Assistance with proper study documentation and successful study management
General Guidance for Using the Regulatory Binder:
- The Regulatory Binder should be established at the beginning of the study, prior to enrollment.
- Keep the Regulatory Binder current and up-to-date.
- Identify individual(s) responsible for maintaining the binder. Ensure that this person is on file with the IRB as contact person to ensure that all IRB correspondence and documents are received/filed in a timely manner.
- Store binder in a safe and secure location, but accessible to study staff at all times. If sections of the binder are stored in a separate location (centrally filed) or maintained electronically, write a signed and dated note-to-file indicating the location and who maintains them. File the note behind the tab to which it applies.
- Subject-specific documentation and information, e.g., signed consent forms, test results, and completed case report forms, should be maintained separately within the subject-specific binder/file
- Customize the binder to meet the needs of your protocol. This Regulatory Binder is a template. Include only sections pertinent to your protocol. Omit unused sections and add sections as needed. See “Applicable sections” below for more information.
Depending on the nature of the research, some tabs may not be required. Use the list below to ensure that the applicable sections are maintained.
- Staff CVs
- Staff Licensures
- Logs, including Delegation of Authority
- IRB Documents
- Consent Forms
- Data Collection/CRFs
- Lab Documents
- Drug/Device Accountability
- Financial Disclosure