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

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

CRCWM Form

Reliance Screening Form

Human Research Guidance & Forms

Investigator Manual

Letter to the Research Community

Miscellaneous

Template-Budget

Form Name

General Research Policies

Common Rule SOP

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

Guidance

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

Guidance
IRB Contact Roster
IRB Membership Roster
Checklists
Devices
Drugs
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
Worksheets
Advertisements
Contract Items Related to Human Subject Protections
C riteria 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
Payments
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