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Foreword

Chapter I. GUIDELINES FOR PROTOCOL PREPARATION

Clinical Research Protocol

The Principal Investigator

Federal Regulations

Preliminary Thoughts on Writing a Protocol

Clinical Research Protocol: Initial Review Application

Protocol Face Sheet

Body of Protocol

Clinical Center Resource Use

Chapter II. OFFICES AND COMMITTEES INVOLVED

Office for Protection from Research Risks

Office of Human Subjects Research

Clinical Research Infrastructure

Pre-IRB Scientific Review

Institutional Review Boards

Human Subjects Research Advisory Committee

Medical Executive Committee

Radiation Safety Program

Radioactive Drug Research Committee

Institutional Biosafety Committee

Recombinant-DNA Advisory Committee

Office of Recombinant-DNA Activities

Chapter III. INFORMED CONSENT AND ASSENT

What are Informed Consent and Assent?

Protocol Consent Document and Required Elements

Assent Document and Required Elements

Editing the Protocol Consent and Assent Documents

Electronic Protocol Consent and Assent Document

Informed Consent for HIV Testing

Durable Power of Attorney

Chapter IV. STATISTICAL CONSIDERATIONS FOR PROTOCOLS

Specifying the Objectives

Measuring the Objectives

Defining the Patient Population

Study Design

Randomization

Stratification

Determination of Sample Size

Evaluation of Results

Data Management

Statistical Considerations in the Protocol Body

Conclusion

Chapter V. PROTOCOLS USING INVESTIGATIONAL NEW DRUGS OR DEVICES

Use of Test Articles in the Clinical Center

Circumstance A. Use of an Investigational New Drug in a Clinical Research Study

Circumstance B. Use of an Investigational New Drug for Individuals Who Do Not Meet Protocol Criteria

Circumstance C. Use of an Approved Drug in a Clinical Research Study

Circumstance D. Use of an Approved Drug in an Unapproved Manner in the Practice of Medicine

Filing an "Investigational New Drug Application"

Reporting an Adverse Experience

Annual Progress Reports to the FDA

Chapter VI. PROTOCOLS USING RADIATION FOR RESEARCH

Ionizing Radiation Usage: Medically Indicated or Indicated for Research Purposes

Authorized User and Individual User of Radioactive Materials

Informed Consent for Radiation Exposure

Radiation Safety Committee Review

Radioactive Drug Research Committee

Amendment and Triennial Reviews

Chapter VII. APPROVAL PATH OF NEW PROTOCOLS

Pre-IRB Scientific Review

Institutional Review Board Review

Approval by the Clinical Center Director

Expedited Review

Activities Exempt from Institutional Review Board Review

Human Gene Therapy

Chapter VIII. CLINICAL CENTER SERVICE ELEMENTS

Protocol Coordination Service Center

Department of Clinical Bioethics

Patient Recruitment and Public Liaison Office and Clinical Research Volunteer Program

Medical Information System

Medical Orders and "Per Protocol Order Sets"

Data Gathering

Clinical Information Utility

Pharmacy Department

Nursing Department

Rehabilitation Medicine Department

Clinical Pathology Department

Nutrition Department

Chapter IX. ONGOING REVIEW OF THE PROTOCOL

Continuing Review of a Protocol

Clinical Research Protocol: Continuing Review Application

Continuing Review Process

Continuing Review Notification Memorandums

Extensions

Amendment Review of a Protocol

Change of Principal or Medical Advisory Investigator

Reporting Unanticipated Problems or Unexpected Harm

Chapter X. TERMINATION OF A PROTOCOL

Terminating a Protocol

Informing Research Subjects

Chapter XI. CONCLUSION

Directory

References and Their Internet Links

Protocol Checklist for Initial Reviews

Protocol Checklist for Continuing Reviews

Protocol Consent and Assent Document Checklist

Appendices

Acronyms

Appendices

Appendix A: Common Toxicity Criteria

Appendix B: Protocol Map Planning Purposes

Appendix C-1: Lay Language and Terms

Appendix C-2: Lay Descriptions of Common Research Procedures

Appendix C-3: Clinical Research Concepts

Appendix D: Investigational New Drug Application

Appendix E: Statement of Investigator

Appendix F: Application for Authorization to Use Radiation in Research Involving Human Subjects

Figures

Figure 1: NIH-1195 Ц Clinical Research Protocol: Initial Review Application

Figure 2: Protocol Face Sheet

Figure 3: Compensation for Healthy Clinical Research Volunteers

Figure 4: Institutional Review Board Chairs and Protocol Coordinators

Figure 5: NIH-1225-1 Ц General Admission Consent

Figure 6: NIH-2514-1 Ц Consent to Participate in a Clinical Research Study

Figure 7: Consent to Participate in a Clinical Research Study: Signature Page

Figure 8: NIH-2514-3 Ц Inclusion of HIV Testing in Consent to Participate in a Clinical Research Study

Figure 9: NIH-200 Ц Durable Power of Attorney

Figure 10: Authorization to Administer Radiation in Research Involving Human Subjects

Figure 11: The Protocol Approval Process

Figure 12: Request for Review of Research Activity Involving Human Subjects

Figure 13: NIH-1195-1 Ц Clinical Research Protocol: Continuing Review Application

Figure 14: NIH-2704 Ц Request for Change of Principal Investigator and/or Medical Advisor

Figure 15: NIH-527 Ц Authorization for the Release of Medical Information

Tables

Table 1: Eight Elements Mandatory in Every Protocol Consent Document

Table 2: Additional Concepts for the Protocol Consent Document

 
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