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IRB
Guidelines
Table
of Contents
(Updated, July 2003)
| Part I | Mandate of the IRB |
| A. History | |
| B. Composition | |
| C. Jurisdiciton | |
| 1. What Research Must Be Reviewed? | |
| 2. Definition of Terms | |
| D. Charge | |
| E. Responsbilities of the IRB | |
| Part II | Application for IRB Review - General Information |
| A. Types of Applications | |
| B. Procedures | |
| C. Submission Schedule | |
| D. General Submission Requirements | |
| Part III | New Projects IRB Application - Full Board Review |
| A. General Information | |
| B. Specific Submission Requirements | |
| C. The New Projects IRB Application Form - | |
| Full Board Review | |
| Part IV | New Projects Application Form - Expedited Review |
| A. General Information | |
| B. Expedited Review Categories | |
| C. Specific Submission Requirements | |
| D. The New Projects Application Form - | |
| Expedited Review | |
| Part V | New Projects Application Form - Exempt Protocol Review |
| A. General Information | |
| B. Instructions | |
| C. Review Process | |
| D. Important Details About Exempt Approval | |
| E. Exempt Categories | |
| F. The New Projects IRB Application Form - | |
| Exempt Review | |
| Part VI | Annual Renewal/Final Report Form |
| A. General Information | |
| B. Specific Submission Requirements | |
| Part VII | Addendum Reporting |
| A. General Information | |
| B. Specific Submission Requirements | |
| Part VIII | Adverse Events Report |
| A. All Serious Events Require a Report | |
| B. What is an Adequate Adverse Event Report? | |
| C. Special
Requirements
for Research
Involving the Transfer of Genes |
|
| D. Which Events Require a Report? | |
| E. What is the Effect of Reporting? | |
| F. How Are
Adverse
Events and/or Incidents
Reports Reviewed? |
|
| G. What is the Effect of Failure to Report? | |
| H.
Incident Reports
Related to Other Research
Activities |
|
| Part IX | Consent Guidelines |
| A. Purpose of the Consent | |
| B. Elements of Consent | |
| C. Waiver of Signed Consent | |
| D. General Information | |
| E. Discussion of Each Consent Form Section | |
| Appendices | |
| Appendix A | DHHS General Requirements for Informed Consent |
| Appendix B | FDA Guidance on Significant and Non-Significant Risk Device Studies |
| Appendix C | Emergency Use of an Investigational Drug or Device |
| Appendix D | Significant Differences in FDA and HHS Regulations for Protection of Human Subjects |
| Appendix E | Medical Records Review |
| Appendix F | Special Subject Populations |
| 1. HIV-infected Indiviudals | |
| 2. Fetuses, Pregnant Women and In-Vitro | |
| 3. Minors | |
| 4. Prisoners | |
| 5. Those
Who Cannot
Read or Speak English
or Who Are Illiterate |
|
| 6. Those
Who Are Unable
to Consent for
Themselves |
|
| Appendix G | Use of Biological Materials (Tissue or Blood) for Research |
| Appendix H | Language to be Included for Tissue and/or Blood Banking |
| Appendix I | Sample Forms |
| 1. Protocol Application for Human Subjects | |
| 2. Annual Renewal/Final Report Form | |
| 3. Addendum Report Form | |
| 4. Adverse Event: Investigator's Report Form | |
| 5. Adverse Event: Reviewer's Report Form | |
| 6. Financial Disclosure Form | |
| Appendix J | Standard Consent Forms |
| 1. Format #1: Biomedical Study | |
| 2. Format #2: Behaviorhal Study | |
| 3. Format #3: Simple Venipuncture | |
| Appendix K | HIPPA Research Guidelines |
| OCR HIPPA - Research Guidelines | |
| HHS Proposed Rule Modification 3/02 | |
| Appendix L | USA Decision Tree for Determining if IRB Approval is Needed for the Use of Human Tissue or Cell Lines |
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