The links below will allow you to open a Microsoft Word version of the form. These forms are password protected. Marshfield Clinic Health System staff can access the forms electronically from the Policy & Handbook Library - Forms, found on the Marshfield Clinic Intranet. All forms in the Forms Library are Microsoft Word document templates. You must have Microsoft Word installed on your computer in order to open and complete forms.

DOES IRB REVIEW APPLY?

IRB Review Determination Request  - Complete for determination.

PROTOCOL APPLICATIONS

IRB Exemption Request - Use for research that meets criteria for exempt review 

IRB Application - New Research - Use for minimal risk and or greater than minimal risk New studies to be reviewed Expedited or Full Board review

IRB Application - Data Collection-Retention for Protocol Development - Use for feasibility/protocol development

IRB Application - Humanitarian Use Device (HUD) - Use for requesting to use Humanitarian Use Device

IRB Expanded Access to Investigational Drug Request - Use for review of expanded access drug/device

POST - APPROVAL

IRB Change or Update to Original Submission - Use when making changes to an existing approved study

IRB Continuation Request - Use to renew your expedited or full board reviewed study

IRB Unanticipated Problem Involving Risks to Participants or Others Report - Use to report unanticipated study problems

IRB End IRB Oversight Request - Use when all human subject activities are complete

IRB ICH GCP Adverse Event Report - Use if study is ICH regulated for AEs

SAMPLE INFORMED CONSENT

IRB Consent - Template - (see also IC Research Tissue Bank, if applicable)

IRB Consent - Research Tissue Bank - (see also IRB Consent template, if applicable)

IRB Consent - Short Form (Hmong Version)

IRB Consent - Short Form (Spanish Version)

IRB Cover Letter - Subjects Who Have Turned 18 Years of Age

IRB Addendum for Reconsenting Subjects Who Subsequently Turn 18 Years of Age

ASSENT

IRB Assent - Non-therapeutic Research Minor Subjects Age 7 and Above - Use if children in research
IRB Assent - Therapeutic Research Minor Subjects Age 12 and Above - Use if children in research

HIPAA AUTHORIZATION

IRB Waiver - Consent and-or Authorization  - Complete if requesting to not have an informed consent or HIPAA authorization
IRB Waiver - Documentation of Consent and Authorization - Complete if requesting to not having signature on Informed Consent or HIPAA Authorization

MULTI-SITE COLLABORATIONS

IRB Reliance Request - Use when collaborating with external sites and requesting to rely on a single IRB

IRB Institutional Certification Form for IRB Deferred Studies - Complete along with Reliance Request

EMERGENCY USE Forms

IRB Emergency Use - Exception From Informed Consent
IRB Emergency Use Report - Use to report Emergency use of drug or device

OTHER

IRB Protocol Requirements - MCHS - Use as template to create new protocol

IRB Consistency Review Checklist

Request to Not Be Contacted for Research