Central Institutional Review Board
Purpose, Structure and Responsibilities
- IRB 1.0 Purpose, Structure and Responsibilities of the Powers Health Central Institutional Review Board
- IRB 1.1 Institutional Official
- IRB 1.2 Human Protections Administrator
- IRB 1.3 Determinations and Motions
- IRB 1.4 Responsibilities of the Powers Health CIRB Office
- IRB 1.5 Quality Assurance Activities: Audits and Monitors
- IRB 2 Conflict of Interest in Research
- IRB 3 Scientific Misconduct in Research
Federal Wide Assurance Number: FWA00031600
Community Foundation of Northwest Indiana IRB 1: IRB00013217
IRB Organization Information: IORG0011146
Powers Health CIRB Letter to Sponsors
Office Information
Kristin M. Wadkins
Manager, IRB-Reg Compliance
Community Hospital
901 MacArthur Blvd.
Munster, IN 46321
phone: 219-703-1546
fax: 219-836-6707
kristin.m.wadkins@powershealth.org
- Acronym List
- Glossary of Lay Terms
- IRB 12 Informed Consent
- IRB 12.01 Barriers to Informed Consent
- IRB 12.2 Re-Consenting Subject Guidance
- IRB 13 Waiver of Consent
- Formatting an Informed Consent Document - Addendum II
- HIPAA Authorization Template
- Financial Interest Disclosure Addendum
- Informed Consent: Additional Model Language: Addendum III
- Investigational Consent Template
- Consent to Participate in Research (Short Form)
- Consent to Participate in Research (Short Form, Spanish Version)
"The Review" Newsletter
- August 2018: Vol. 1, No. 1 - Demystifying the IRB Process
- September 2018: Vol. 1, No. 2 - Glossary of Clinical Trial Terms
- October 2018: Vol. 1, No. 3 - The Process of Informed Consent
- November 2018: Vol. 1, No. 4 - Reporting Adverse Events and Protocol Deviations
- December 2018: Vol. 1, No. 5 - HUDs, Emergence Use, Compassionate Use
- January 2019: Vol. 2, No. 1 - Federalwide Assurance Process
- February 2019: Vol. 2, No. 2 - Advertisements for Research
- March 2019: Vol. 2, No. 3 - Therapeutic Misconception
- April 2019: Vol. 2, No. 4 - Data Safety Monitoring Board (DSMB)
- May 2019: Vol. 2, No. 5 - So Many Reviews, Which One Do I Choose?
- June 2019: Vol. 2, No. 6 - Protecting a Subject's Privacy and Confidentiality
- July 2019: Vol. 2, No. 7 - Who is GINA?
FAQs
- IRB 4 Non-Compliance/Complaint: Investigating Allegations and Reporting
- IRB 5 Principal Investigator Responsibilities
- IRB 6 Engaged in Research
- IRB 7 Submission of a Research Study: Initial Review
- IRB 7.1 Continuing Review of a CHS CIRB Approved Protocol; Lapse of Approval
- IRB 7.2 CHS CIRB Q1/PE Decision Tree
- IRB 7.3 Exempt Review
- IRB 7.4 Expedited Review
- IRB 8 Review of a Protocol Involving a Medical Device
- IRB 9 Physician and Non-Physician Investigator Initiated Research/Projects
- IRB 10 Reliance Agreements for External IRBs for Multi-Site Research
- IRB 10.1 Individual or Institutional Investigator Agreement
- IRB 11 Closing a Research Protocol
- IRB 13 Waiver of Consent: Waiver or Alteration of Consent and Waiver of Documentation of Consent
- IRB 14 Guide to Creating and Submitting Recruitment Materials to the CHS CIRB
- IRB 15 Internal Adverse Event Deviations/Violation, Unanticipated Events: Reporting and Review
- IRB 16 Emergency or Compassionate/Humanitarian Use of a Test Article
- IRB 17 Humanitarian Use Device (HUD) Humanitarian Device Exemption (HDE)
- IRB 18 Education and Training of CHS CIRB and Investigators
- IRB 19 CHS CIRB Fees
- Facilitated Protocol Submission: Review for Local Context Form
HIPAA
- IRB 20 HIPAA Privacy Rule in Research; Use and Disclosure
- IRB 20.1 Use and Disclosure of PHI Preparatory to Research
- IRB 20.2 Research Involving Decedents PHI
- IRB 20.3 Research Involving a De-Identified Data Set or a Limited Data Set
- IRB 20.4 Waiver or Alteration of HIPAA Authorization
- IRB 20.5 Accounting of Disclosures of PHI for Research
- Form: PHI Disclosure for Research: Standard Accounting (Single Individual)
- Form: PHI Disclosure for Research: Alternative Accounting (50+ Individuals)
- Algorithm: Guidance for Investigators: HIPAA Accounting of Disclosures
- Algorithm: Guidance for Investigators: What Information is Required
- Accounting of PHI Disclosures and How Do I Report It?
- Abbreviated Protocol Submission Form
- Adverse Event Report Form
- Appeal of Study Closure
- Application/Report for the Emergency Use of a Test Article Form
- Institutional Authorization Agreement
- Checklist for Initial Review of Proposals (office)
- CIRB Fees Form
- Conflict of Interest Declaration Form
- Engagement Determination
- Non-Compliance/Complaint Investigation Form
- Non-Investigational Humanitarian Use Device (HUD) Application
- Request to Renew a Humanitarian Use Device (HUD)
- Request to Renew a Research Study Form
- Request to Close a Research Study Form
- Patient Acknowledgement of Receipt Form
- Protocol Submission Form
- Protocol Deviation/Violation Report Form
- Summary of External Adverse Event Report Form
- Summary of Clinical Trial Adverse Events
- US Department of Health & Human Services Office for Human Research Protections (OHRP)
- Food & Drug Administration (FDA)
- Veterans Health Administration (VHA), Office of Research Oversite (ORO)
- National Institutes of Health (NIH)
- NIH: Bioethics Resources on the Web - Tutorial - Protecting Human Research Participants
- CDC Plain Language Materials and Resources
- CDC Plain Language Thesaurus - Version 3, October 2007
- National Drug Abuse Treatment Clinical Trials Network Tutorial - Good Clinical Practice
- Collaborative Institutional Training Initiative
- Enrolling in the CITI Program Stepper