Information for DHHS (OHRP) Personnel
Information for FDA Personnel
1. Introduction
1.1 Purpose of this Manual 1.2 Definitions 1.3 The Role and Duties of the Committee on Human Studies (CHS) 1.3.1 Designated Institutional Official 1.3.2 Executive Secretary 1.3.3 Compliance Officer 1.3.4 IRB Chair 1.3.5 Vice Chair 1.3.6 IRB Members/Alternate Members 1.3.7 Conflicts of Interest 1.3.8 Training of IRB Chair and Members 1.3.9 Operations of CHS IRB’s 1.3.10 Types of CHS IRB Action 1.3.11 CHS Record Keeping
1.1 Purpose of this Manual
1.2 Definitions
1.3 The Role and Duties of the Committee on Human Studies (CHS)
1.3.1 Designated Institutional Official 1.3.2 Executive Secretary 1.3.3 Compliance Officer 1.3.4 IRB Chair 1.3.5 Vice Chair 1.3.6 IRB Members/Alternate Members 1.3.7 Conflicts of Interest 1.3.8 Training of IRB Chair and Members 1.3.9 Operations of CHS IRB’s 1.3.10 Types of CHS IRB Action 1.3.11 CHS Record Keeping
2. Submitting Protocols for CHS Review
2.1 Application forms 2.2 Cooperative Agreements 2.3 Guidelines for Submitting Protocols for IRB Review. 2.4 Investigator Responsibilities
2.1 Application forms
2.2 Cooperative Agreements
2.3 Guidelines for Submitting Protocols for IRB Review.
3. Types of IRB Review and Procedures
3.1 Exempted Research 3.1.1 Exemption Review Procedures 3.2 Expedited Review 3.2.1 Expedited Review Procedures 3.2.1.1 Review of Subject Compensation 3.3 Full Review 3.3.1 Full Review Procedures 3.4 Continuing (Reapproval) Review 3.4.1 Continuing Review Procedures 3.5 Unanticipated Problems and Adverse Events 3.5.1 Unanticipated Problem/Adverse Event Reporting Procedures 3.5.1.1 Sponsor Notification 3.5.1.2 Procedures for Cooperative Research 3.5.1.3 Record Keeping Procedures 3.5.1.4 IRB Decisions and Actions on Adverse Event Reports 3.6 Modifications to Currently Approved Research 3.6.1 Review of Modifications During the Approval Period 3.6.1.1 Ensuring Compliance with CHS 3.7 Non-Compliance with CHS 3.7.1 Procedures for Handling Non-Compliance 3.7.1.1 Submission of an Allegation 3.7.1.2 Inquiry 3.7.1.3 Suspension And Reporting 3.7.1.4 Serious Non-Compliance: Formal Investigation 3.7.1.5 Appeals/Reconsideration 3.7.1.6 Dissemination of Findings 3.8 Termination of a Protocol 3.9 Transferring a Protocol to Another Investigator
3.1 Exempted Research
3.1.1 Exemption Review Procedures
3.2 Expedited Review
3.2.1 Expedited Review Procedures 3.2.1.1 Review of Subject Compensation
3.2.1.1 Review of Subject Compensation
3.3 Full Review
3.3.1 Full Review Procedures
3.4.1 Continuing Review Procedures
3.5 Unanticipated Problems and Adverse Events
3.5.1 Unanticipated Problem/Adverse Event Reporting Procedures 3.5.1.1 Sponsor Notification 3.5.1.2 Procedures for Cooperative Research 3.5.1.3 Record Keeping Procedures 3.5.1.4 IRB Decisions and Actions on Adverse Event Reports
3.5.1.1 Sponsor Notification 3.5.1.2 Procedures for Cooperative Research 3.5.1.3 Record Keeping Procedures 3.5.1.4 IRB Decisions and Actions on Adverse Event Reports
3.6 Modifications to Currently Approved Research
3.6.1 Review of Modifications During the Approval Period 3.6.1.1 Ensuring Compliance with CHS
3.6.1.1 Ensuring Compliance with CHS
3.7.1 Procedures for Handling Non-Compliance 3.7.1.1 Submission of an Allegation 3.7.1.2 Inquiry 3.7.1.3 Suspension And Reporting 3.7.1.4 Serious Non-Compliance: Formal Investigation 3.7.1.5 Appeals/Reconsideration 3.7.1.6 Dissemination of Findings
3.7.1 Procedures for Handling Non-Compliance
3.7.1.1 Submission of an Allegation 3.7.1.2 Inquiry 3.7.1.3 Suspension And Reporting 3.7.1.4 Serious Non-Compliance: Formal Investigation 3.7.1.5 Appeals/Reconsideration 3.7.1.6 Dissemination of Findings
3.8 Termination of a Protocol
4. Informed Consent: Process and Documentation
4.1 Written Consent 4.1.1 Emergency Waiver of Consent 4.2 Short Form Consent 4.3 Oral Consent (Waiver of Documentation Requirements) 4.4 Waiver of Informed Consent in Non-Emergency Situations 4.5 Other Special Populations 4.5.1 Students 4.5.2 Employees 4.5.3 Cognitively Impaired 4.5.4 Pregnant Women and Fetuses 4.5.5 Children/Parental Consent 4.5.5.1 When Must the Parent’s Permission be Obtained? 4.5.5.2 When is Parental Permission not Required? 4.5.5.3 When is a Minor’s Assent not Required? 4.5.5.4 How can Assent be Obtained? 4.5.5.5 Research in Schools, Childcare Facilities or other Organized Children’s Activities 4.5.5.6 Wards 4.5.6 Non-English Speakers and Persons with Limited Literacy 4.5.7 Prisoners 4.5.8 Different Cultural Mores
4.1.1 Emergency Waiver of Consent
4.2 Short Form Consent
4.3 Oral Consent (Waiver of Documentation Requirements)
4.4 Waiver of Informed Consent in Non-Emergency Situations
4.5 Other Special Populations
4.5.1 Students 4.5.2 Employees 4.5.3 Cognitively Impaired 4.5.4 Pregnant Women and Fetuses 4.5.5 Children/Parental Consent 4.5.5.1 When Must the Parent’s Permission be Obtained? 4.5.5.2 When is Parental Permission not Required? 4.5.5.3 When is a Minor’s Assent not Required? 4.5.5.4 How can Assent be Obtained? 4.5.5.5 Research in Schools, Childcare Facilities or other Organized Children’s Activities 4.5.5.6 Wards 4.5.6 Non-English Speakers and Persons with Limited Literacy 4.5.7 Prisoners 4.5.8 Different Cultural Mores
4.5.5.1 When Must the Parent’s Permission be Obtained? 4.5.5.2 When is Parental Permission not Required? 4.5.5.3 When is a Minor’s Assent not Required? 4.5.5.4 How can Assent be Obtained? 4.5.5.5 Research in Schools, Childcare Facilities or other Organized Children’s Activities 4.5.5.6 Wards
5. Special Categories of Research
5.1 Collection, Storage and Use of Human Biologic Material 5.1.1 CHS Review of Research on Stored Tissue 5.1.2 Required Information to be Submitted by the PI 5.1.3 Suggested Guidelines for Repositories 5.1.4 Exceptions 5.1.5 Use of Pre-Existing Collections 5.2 Investigational New Drug 5.3 Investigational Device Exemption 5.4 Use of FDA-Approved Therapeutic Agents for Unapproved Purposes 5.5 Emergency Use of Investigational Drug or Device 5.6 Student Research Practica 5.7 Deception in Research
5.1.1 CHS Review of Research on Stored Tissue 5.1.2 Required Information to be Submitted by the PI 5.1.3 Suggested Guidelines for Repositories 5.1.4 Exceptions 5.1.5 Use of Pre-Existing Collections
5.2 Investigational New Drug
5.3 Investigational Device Exemption
5.4 Use of FDA-Approved Therapeutic Agents for Unapproved Purposes
5.5 Emergency Use of Investigational Drug or Device
5.6 Student Research Practica
5.7 Deception in Research
