Forms and Policies

*Common Rule Changes*

Presentation on the Common Rule Changes;  Audio File

IRB Forms and Templates
Short Form - English 
Short Form - Spanish 
Short Form - Bosnian 
Short Form - Vietnamese 
Short Form - Italian 
Short Form - French 
Short Form - Korean 
Short Form - Arabic 
Translation Request Form 
General IRB Information 
Protocol Deviation Tracking Log - To be completed for minor protocol deviations at the time of Continuing Review.  
IRB Fees - Applies to all studies where funding is available to support the IRB activities and includes but is not limited to submissions, continuing review, and amendments/substantial modifications. 
 Letter of Assurance of Compliance

Pre-IRB Submission Tools & Templates

 IRB Contact Roster
 Protocol Template 
 Retrospective Protocol Template
 Informed Consent Template
 Minimal Risk Informed Consent Template
 Expanded Access-Compassionate Use Consent Form
 Informed Consent Information Sheet
 Assent for Children Template 
 Required Elements of Informed Consent and HIPAA 
 HIPAA Authorization for Reimbursement Purposes
 Reliance Screening Form
 Submission Quick Guides

Human Research Guidance & Forms
Investigator Manual
Letter to the Research Community


Form Name
General Research Policies
Common Rule SOP
SOP: Review of Electronic Informed Consent 

Qualifying "Engagement" in Human Subjects Research

Investigator Responsibilities
Policy for Approval
Spectrum Health IRB - Jurisdiction and Authority
Informed Consent and Legally Authorized Representatives for Research
Spectrum Health Research Program Overview
Human Subjects Research Protection Training Requirements
COI - Research and Sponsored Programs
OSP Conflict of Interest Reporting Management Procedures
Research Conflict of Interest Committee Procedures 
Overview of HRPP 
Investigator Manual
Consenting During Pandemics
Electronic Communication with Participants
Case Report Guidance
Humanitarian Use Device (HUD) FAQs
Re-consenting Participants
HIPAA & Research FAQs
Personalized Medicine
Protecting Patient Privacy in Research
QI vs. Research Guidance
Request for FCOI Information
Recruitment Advertising
Protocol Deviation Policy Guidance
Reportable New Information Quick Guide 
Consenting Limited English Proficiency Subjects

IRB Member Forms

IRB Contact Roster
IRB Membership Roster
Eligibility for Review Using the Expedited Procedure
Engagement Determination
Exemption Determination
Human Research Determination
Non-Committee Review
Non-Significant Risk Device
Research Involving Children
Research Involving Adults with Diminished Decision Making Capacity 
Research Involving Neonates of Uncertain Viability
Research Involving Non-Viable Neonates
Research Involving Pregnant Women
Research Involving Prisoners
Waiver of the Consent Process for Planned Emergency Research
Waiver of Written Documentation of the Consent Process
Waiver or Alteration of HIPAA Authorization
Waiver or Alteration of the Consent Process
Contract Items Related to Human Subject Protections
Criteria for Approval and Additional Considerations for HUD
Criteria for Approval and Additional Considerations
Additional Federal Agency Criteria
Emergency Use of a Test Article
HIPAA Authorization for Research
Scientific or Scholarly Review
Review of Information Items
Short Form of Consent Documentation
Other Resources
Research Acronym Tool 
Writing A Review Summary
45 CFR 46: DHHS - Protection of Human Subjects 
FDA 21 CFR 50 Protection of Human Subjects 
FDA 21 CFR 56 Institutional Review Boards 
FDA Information Sheets: Guidance for IRBs and Clinical Investigators 
The Belmont Report 
GINA law information sheet 
Jesse's Intent 

Researcher Tools
Immunohistochemistry (IHC) 
Contact Jane Tol for any questions regarding IHC 
Human Subjects Research
Interpretation and Clarification of Regulations
Research Ethics
Government Web sites