Human Subjects The following materials comprise the MSC Manual on the Protection of Human Subjects. POLICIES: MSC Human Subjects Policy (WORD.doc) Types of Human Subjects Research (WORD.doc) Responsibilities of the Principal Investigator/Researcher in the Conduct of Research Involving Human Subjects (WORD.doc) The Federal Policy (45 CFR 6) The Belmont Report Research Involving Individuals with Questionable Capacity to Consent PROCEDURES: Consent of Participating Agencies (WORD.doc) Human Subject Protocol Renewal/Review Procedures (WORD.doc) Human Subject Protocol Modification/Change Procedures (WORD.doc) Adverse Event Reporting (WORD.doc) Human Subject Protocol Closure (WORD.doc) Instructional Demonstration Activities (WORD.doc) Student Research (WORD.doc) FORMS: Application for Exempt Review of a Human Subject Protocol (WORD.doc) Application for Standard or Expedited Review of a Human Subject Protocol (WORD.doc) Human Subject Annual Renewal/Review Form (WORD.doc) Application for Modification or Change to an Approved Human Subject Protocol (WORD.doc) Adverse Event Reporting Form (WORD.doc) Human Subject Protocol Closure Form (WORD.doc) INFORMED CONSENT: Informed Consent Process (WORD.doc) How to Construct a Written Consent Form (WORD.doc) Tips on Informed Consent (WORD.doc) INFORMED CONSENT FORMS: Informed Consent Form (WORD.doc) Sample Assent Form for Minors (WORD.doc) Sample Parental Signature for a Minor Format (WORD.doc) Short Form Written Consent Document for Subjects Who Do Not Speak English (WORD.doc) INSTITUTIONAL REVIEW BOARD (IRB) PROCEDURES: IRB Operating Procedures (WORD.doc) Checklist Used by IRB for Review of Protocols (WORD .doc) Decision Charts TRAINING MATERIALS: NIH Computer Based Training for Researchers using Human Subjects OTHER LINKS OF INTEREST: DHHS Office for Human Research Protections Glossary of Lay Terms for use in Preparing Consent Forms for Human Subjects (*Note: This glossary is created by Standford University and is on the UC-Davis website.) Office of Sponsored Programs Mesa State College 1100 North Ave. Grand Junction, CO 81501-3122 Phone: (970) 248-1424 Fax: (970) 248-1076
Human Subjects The following materials comprise the MSC Manual on the Protection of Human Subjects.
The Belmont Report
Research Involving Individuals with Questionable Capacity to Consent
Consent of Participating Agencies (WORD.doc)
Human Subject Protocol Renewal/Review Procedures (WORD.doc)
Human Subject Protocol Modification/Change Procedures (WORD.doc)
Adverse Event Reporting (WORD.doc)
Human Subject Protocol Closure (WORD.doc)
Application for Exempt Review of a Human Subject Protocol (WORD.doc)
Application for Standard or Expedited Review of a Human Subject Protocol (WORD.doc)
Human Subject Annual Renewal/Review Form (WORD.doc)
Application for Modification or Change to an Approved Human Subject Protocol (WORD.doc)
Adverse Event Reporting Form (WORD.doc)
INFORMED CONSENT:
Informed Consent Process (WORD.doc)
How to Construct a Written Consent Form (WORD.doc)
INFORMED CONSENT FORMS:
Informed Consent Form (WORD.doc)
Sample Assent Form for Minors (WORD.doc)
INSTITUTIONAL REVIEW BOARD (IRB) PROCEDURES:
IRB Operating Procedures (WORD.doc)
Checklist Used by IRB for Review of Protocols (WORD .doc)
TRAINING MATERIALS:
OTHER LINKS OF INTEREST:
DHHS Office for Human Research Protections
Glossary of Lay Terms for use in Preparing Consent Forms for Human Subjects (*Note: This glossary is created by Standford University and is on the UC-Davis website.)
Office of Sponsored Programs Mesa State College 1100 North Ave. Grand Junction, CO 81501-3122 Phone: (970) 248-1424 Fax: (970) 248-1076
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