With respect to the protection of human subjects participating in research activities supported directly or indirectly by grants or contracts from the U.S. Department of Health and Human Services (DHHS) or any other public or private granting agency, including Butler Hospital, the Institutional Review Board and Butler Hospital will comply with the U.S. Public Health Service Act (as amended by the Health Research Extension Act of 1985) (Public Law 99-158), as implemented in the Code of Federal Regulations, Title 45, Part 46 - "Protection of Human Subjects." The Institutional Review Board for Human Subjects Research will be assigned the responsibility to determine for each research activity as planned and conducted that:
- Subjects are equitably selected, given the purposes of the research and the setting in which it is to be conducted.
- The rights and welfare of subjects are adequately protected.
- The risks to subjects are outweighed by potential benefits.
- The informed consent of subjects will be obtained by methods that are adequate and appropriate.
- A timely review of each project will be conducted.
Instructions for Submitting Documents to the IRB Office
The Butler IRB processes all research submissions through the IRBnet website: IRBNet.org. IRBNet is secure, web-based, and may be accessed from virtually any computer using a web browser.
All users will need to self-register in the IRBnet system and affiliate with Butler Hospital IRB. Training Energizer Documents are available in IRBnet, on the IRB website or by contacting your IRB Administrative Office. Current versions of all required IRB forms and templates can be found in the "forms and templates" library within IRBNet. All investigators are required to download and use the latest version of the protocol form, consent form, and adverse event reporting form for submission of a new research project for IRB review. Guidelines, local IRB requirements, Butler and CNE policies, and IRB submission deadlines and IRB meeting dates are found here well as within IRBnet.
- All Users must self-register in IRBNet.
- All project submissions must be signed by the PI before submitting to the IRB.
- Training documents are required to be uploaded into your User Profile in IRBNet.
Read the latest IRB Newsletter.
If you have any questions, please contact Cheryl Cordeiro.
Forms & Templates (File type: Word)
- IRB Research Protocol Form
- IRB Research Waiver Form
- IRB Research Consent Form
- IRB Research Consent and PHI Authorization
- IRB Research Assent for Minors Form
- IRB Research Parental Permission Form
- IRB Short Form for Consenting non-English Participants: Spanish
- IRB Short Form for Consenting non-English Participants: English Translation
- IRB Prep to Research Template
- IRB Application for Exempt Status or Confirmation of Non-Research
- IRB Certification for Research on PHI of Decedents
- Amendment/Modification Request Form
- Primary Reviewer Checklist
- Continuing Review/Study Closure Form
- Event Reporting Form
- Conflict of Interest Disclosure Form
- CNE Assurance of Compliance Form
- Butler Significant Financial Interests (SFI) Disclosures Form
- Butler FCOI Faculty Disclosure Statement for Students and Trainees
- IAA Request Form
- Researcher Request to review EMR
- IRB Research Email Consent Form
- IRB Research Text Consent Form
- IRB Research Radiation Exposure Template Language
- IRB Research Table of Contents Template for Consent Forms
- CNE Vulnerable Population Appendix 1A Minors
- CNE Vulnerable Population Appendix 1B Prisoners
- CNE Vulnerable Population Appendix 1C Pregnant Women/Fetus
- CNE Vulnerable Population Appendix 1D Decisionally/Cognitively Impaired
IRB Guidelines and Policies (File type: PDF)
- BH Read me First Document: Researchers
- Definitions & Abbreviations
- IRB Guidelines
- BH IRB Compliance Statement
- CNE FCOI Policy
- Scientific Misconduct Policy
- Medical Records Policy
- Guidelines for Data and Safety Monitoring
- Guidance for ClinicalTrials.gov
- Guidance for ClinicalTrials.gov: Identifying an Applicable Clinical Trial under FDAAA
- Flow sheet for IRB/HIPAA