There are currently three IRB panels constituted at the Health Center
that meet on a monthly basis.
Panel 01 meets for the first convened meeting of the month, Panel 02 meets for the second convened meeting of the
month and Panel
3 meets for the third convened meeting of the month. With one
exception studies requiring full board review are initially assigned to Panel 01, 02 or 03 based
on submission date of the application. The one exception is that any
study proposing to involve prisoners as subjects (including via chart
reviews) must be reviewed by Panel 02 which has a prisoner advocate as a
member. Once a study has been assigned to a panel it remains under that same
panel's oversight for the life of the study. IRB Panel 4 meets on an
as needed basis and only reviews studies involving research with embryonic
stem cells.
All documents submitted to the IRB must be typed. Cells on the forms will
expand to accommodate text. If you cannot access the documents, experience a
problem with the formatting, or have general questions about preparing a
submission to the IRB contact any of the following individuals for
assistance:
|
Forms
for Determining Whether IRB Review is Required: |
|
Human Subject Research Determination Form (7/10/08)
|
|
Performance
Improvement/Quality Improvement Determination Form
|
| Quality
Improvement/Performance Improvement Determination Form |
|
INSTRUCTIONS
for IRB Applications, Closures, Continuations, Modifications: |
|
Instructions for Application for Initial and Continuing (rev.
7/11/08) |
|
Instructions for Addendum to Application to Request Continuing Review
(4/8/08) |
|
Instructions for Application for Registry/Repository (3/6/6) |
|
Instructions for Appendix B, Application for DSMP/B (rev. 8/15/05) |
|
Instructions for Request for Closure/Completion (8/15/05) |
|
Instructions for Request for Modification (rev. 6/16/08) |
|
Instructions for Application for Expedited Continuation Under Category 8A or
8C Only, (4/8/08) |
| FORMS
- Routine IRB forms (Application, Closure, Continuing Review,
Modification Review etc. ): |
| Checklist
for Initial and Continuing Review (rev. 7/15/08) |
|
Application for Initial and Continuing Review (rev. 3/06) |
|
Application Addendum to Request Continuing Review (3/7/07) |
| Application for Expedited Continuation Under Category 8A or 8C Only
(5/7/07) |
| Application Appendix
A (GCRC Resource Request) (Rev. 3/20/07) |
|
Application Appendix B (DSMP/B Template) (Rev. 8/15/05) |
|
Application Appendix C (UCHC as Coordinating, Lead or Statistical Center)
(8/15/05)
|
|
Application
Appendix D (Enrollment Targets)
|
| Conflict
Disclosure Form (required with 4/13/06 submission deadline) |
|
IDE
Statement of Investigator Obligations |
| IND
Statement of Investigator Obligations
|
| Principal Investigator's
Appointment of Personnel for Coverage |
| Request for Exemption
(Rev. 7/8/08) |
| Request
for Expedited Review (Rev. 8/15/05)
|
| Request for
Modification
(Rev. 6/16/08) |
| Request for Study
Closure / Completion (Rev. 8/15/05)
|
|
Individual Investigators Agreement
|
| Problem Report
Form (03/06) |
|
CONSENT
- IRB Templates for Standard Consent / Assent & Requests for
Waivers |
| Informed Consent
Checklist
(rev. 3/28/08) |
| Standard
Informed Consent Template
(03/28/08) |
|
Short Form Consent Documents (from U. Minnesota) |
| Assent
Document (UMass) |
| Assent
Document (UCLA) |
| Acceptable Contract
Vs. Consent Language |
| Sample Pregnancy
Language for inclusion in consent forms |
|
Request for Waiver or Alteration to Requirements of Consent
(rev. 1/07) |
|
Request for Waiver or Alteration of Consent for Projects Conducted by or
Subject to the Approval of State or Local Government Officials (rev.
3/06) |
|
Request for Waiver of Consent for Planned Emergency Research (rev. 3/06) |
| Request to
Waive Documentation of Consent (03/06) |
| HIPAA
Forms: |
| HIPAA Authorization to
Use & Disclose
(9/26/2007)
|
| HIPAA
Authorization to Add PHI to a Research Registry (10/07) |
| HIPAA Request for Waiver of
Authorization |
| HIPAA Certification of
De-Identification |
| HIPAA Assurance of
Preparatory to Research or Decedent Research |
| HIPAA Limited Data Set
Certification |
| HIPAA Data Use Agreement
(external)
|
| PROTOCOL
- Sample Documents |
|
Protocol Design (ICH Guidelines - Chapter 6) |
| Guidelines
for Writing a Protocol
|
| VULNERABLE
POPULATIONS |
| Protections for Pregnant
Women, Fetuses and Neonates - Forms B204-207 (Rev. 3/06) |
|
Protections for Prisoners - Form C (3/06) |
|
Protections for Children / Decisionally Impaired Adults - From D404-407
(rev. 3/06)) |
|
Protections for Other Vulnerable Groups - Form S (3/06) |
|
TRACKING
- IRB Tracking Templates |
| Adverse Event Log |
| Protocol Deviation Log
|
|
REGISTRIES
/ REPOSITORIES* |
|
Application for Registry/Repository Initial and Continuing Review (3/6/06) |
| Application
Addendum for Registry/Repository Continuing Review
|
| Sample Consent
for Registry |
| Sample
Protocol for Research Registry (University of Pittsburgh) |
|
Sample Protocol for Research Registry (New York University Medical
School) |
|
HUMANITARIAN
USE DEVICE* |
| Humanitarian
Use Device Application Form
|
| Humanitarian Use Device
Consent Template
|
| Humanitarian Use
Device Continuation Form
|
|
Humanitarian Use
Device Modification Form
|
| MISCELLANEOUS
Documents |
| Adverse Event
Reporting Policy - Memo for Sponsors
|
|
Guidelines for Assessing Risk
|
| Sample IRB Key
Personnel Training Letter
|
|
Brochures
|
| Employee
Orientation (pdf
version) |
| Rights and
Responsibilities of Research Volunteers - English (pdf
version) |
|
Rights and Responsibilities of Research Volunteers - Chinese (pdf
only) |
|
Rights and Responsibilities of Research Volunteers - French (pdf
version) |
|
Rights and Responsibilities of Research Volunteers - German (pdf
version) |
|
Rights and Responsibilities of Research Volunteers - Greek (pdf
version) |
|
Rights and Responsibilities of Research Volunteers - Italian
(pdf
version) |
|
Rights and Responsibilities of Research Volunteers - Polish (pdf
version) |
|
Rights and Responsibilities of Research Volunteers - Portuguese (pdf
version) |
|
Rights and Responsibilities of Research Volunteers - Russian (pdf
version) |
|
Rights and Responsibilities of Research Volunteers - Spanish (pdf
version) |
| Student Tips (pdf
version) |
|
Document
Change Reference Log |
| CHANGE LOG
|
|
| *Also review sections for routine IRB
forms, HIPAA forms and vulnerable populations for additional forms
that may be required (e.g. checklist, HIPAA Authorization, Appendices
etc.) |