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 Reviewer Tools
Reviewer Checklist
Criteria for Approval
Elements of Consent
Documentation for Children as Research Participants
Placebo Documentation
Medical Device Documentation
General Forms
Conflict of Interest Disclosure Form
Conflict of Interest Disclosure Form Instructions
Local Serious Adverse Event and Unanticipated Problem Reporting Form
Non-Local Serious Adverse Event and Unanticipated Problem Reporting Form
Adverse Event and Unanticipated Problem Reporting Form Instructions
Protocol Deviation Reporting Form
Protocol Deviation Form Instructions
Revisions Form
Investigator Revision Form
Revisions For Instructions
ECU Unaffiliated Investigator Agreement
PCMH Unaffiliated Investigator Agreement
Unaffiliated Investigator Agreement Instructions
Consent/Assent Document Templates
Informed Consent Document Template - more than minimal risk studies
Informed Consent Document Template - no more than minimal risk studies
Informed Consent Document Template Instructions
Parental Consent for Using Research Data Template
Assent Requirements
Assent Template for Children Over 7 Years of Age - more than minimal risk studies
Assent Template for Children Over 7 Years of Age - no more than minimal risk studies
***Templates to be used for an unexpectedly encountered non-English speaking subject:
Short Form Consent Document (Translation template for non-English speaking subjects)
Short Form Consent Document (Spanish translation template)
Short Form Consent Document Instructions
Biomedical Forms
Biomedical Research Form - Full and Expedited
Biomedical International Research Form - Full and Expedited
Biomedical Research Form - Full and Expedited Instructions
Biomedical Research Form - Exempt
Biomedical Research Form - Exempt Instructions
Biomedical Research Continuing Review and Closure Form
Biomedical Research Continuing Review and Closure Form Instructions
Financial Services Review Form
Institutional Approval for Research Form
Financial Services Review Form and Institutional Approval for Research Form Instructions
Clinical Trial Participant List
PCMH Research Registration Form
Policy & Procedure for PCMH Registration Form
Behavioral & Social Science Forms
Behavioral & Social Science Research Form - Full and Expedited
Behavioral & Social Science International Research Form - Full and Expedited
Behavioral & Social Science Research Form - Full and Expedited - Instructions
Behavioral & Social Science Research Form - Exempt
Behavioral & Social Science Research Form - Exempt Instructions
Behavioral & Social Science Research Continuing Review and Closure
Behavioral & Social Science Research Continuing Review Form and Closure Form Instructions
HIPAA Forms and Information
Research Participant Authorization Form
Research Participant Authorization Form - Spanish Version
Application for Waiver Form
Research on Decedents Information Form
Request for Review of Protected Health Information in Preparation for Research
ECU and PCMH HIPAA Policies
Limited Data Set Policy
***For more information regarding the HIPAA Privacy Rule and research, please visit the Office for Civil Rights webpage. There is also a PowerPoint presentation that may be helpful.
College of Education Research Resource Material
***These templates do not take the place of the required UMCIRB processing forms above.
IRB for dummies sheet
Letter to Parents
Teacher's Letter
Principal's Letter
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