Training Requirement
All personnel - faculty, research fellows, students, and staff - engaging in human research must have documented discipline-appropriate training in human research protections. The Collaborative Institutional Training Initiative (CITI) web-based modules satisfy this requirement
To access the program, visit http://knowledgelink.upenn.edu
Questions? Contact Patti Cooper at patricia@upenn.edu or 215.573.1222.
What if I've already completed POR training?
Your certification will remain in force until its expiration (3 years after its completion date). When your training is due for recertification, you will take the CITI Refresher Training to recertify.
What if I've partially completed POR training? Will I need to start all over with the new CITI training program?
If you have completed portions POR certification program, but have yet to fully complete and obtain certification, you have until June 30th to complete the program and obtain full training certification.
Do CHOP and the VA Medical Center accept the CITI training? Yes.
A currently active POR certification training will continue to be honored by both CHOP and the VAMC until its expiration date. As reminder, the VAMC requires yearly renewal of certification in human research protections training, and that requirement remains unchanged. If you are a VA based faculty member with a Penn faculty appointment, select the VA as your affiliated institution when registering with CITI. Once you have completed training, submit your certificate of completion to Patti Cooper.
IRB Member Training
The following documents and links are provided to assist you in your review of IRB materials by providing tools and templates that remind you of what factors should be considered while reviewing IRB materials. The documents will be automatically updated when newer versions are released from the IRB.
| Title |
Link |
IRB Staff Contact List |
 |
IRB Member Training Checklists
- IRB Member Training Checklist
- New Member Checklist
- IRB Confidentiality Statement
- IRB Member Self-Evaluation Form
- IRB Member Responsibilities (see section 3.3.1)
|
IRB Chairs
- IRB Chair Qualifications
- IRB Chair Self-Evaluation Form
- IRB Chair Responsibilities
|
| Declaration of Helsinki |
 |
| The Belmont Report |
|
| The Nuremberg Code |
|
| Primary Reviewer Worksheet, v 26-Mar-2007 |
|
| Guidance for IRB Review |
|
Vulnerable Populations Checklists
- Pregnant Women
- Prisoners
- Children, v 26-Mar-2007
|
|
| Informed Consent Checklist, v 19-Jan-2007 |
|
Completeness Check & Appendices
- Completeness Check, v 26-Apr-2007
- Drugs & Biologics/Devices, v 26-Mar-2007
- Concurrent IRB Administrator Review
|
|
| IRB Review of Monitoring Plan |
|
| Continuing Review Checklist, v 19-Apr-2007 |
|
Modification Review Checklist - Amendment, v 4-Jan-2007 |
| Modification Review Checklist - Deviation/Exception, v 26-Mar-2007 |
| Expedited Review Worksheet, v 30-Mar-2007 |
|
| Expedited Review Categories |
|
| Standard Operating Procedures |
|
| Guide to Daily Operations - (Under Revision) |
 |
| Categories of Action from IRB Review of Research, v12Dec2006 |
|
| Guidance on Emergency Use |
|
| Guidance on Recruitment Materials |
|
| Guidance on Humanitarian Use Devices |
|
| Guidance on Pennsylvania Laws that May be Relevant to Human Research |
|
| Guidance on Payment for Recruitment of Human Subjects (Finder's Fees) |
|
Guidance on Re-Consenting of Research Subjects
The Federal Regulations require that research subjects be provided with any significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation (45 CFR 46.116(b)(5)). While not specifically addressed in the regulations, The Belmont Report provides an additional ethical requirement to provide research subjects with significant new findings that might affect their long-term health even after they have completed participation in a research study. Finally, neither the Federal Regulations, nor The Belmont Report provide guidance on the type or extent of documentation required to satisfy these regulatory or ethical responsibilities.
The University of Pennsylvania IRBs have developed the following Guidelines for investigators as to the appropriate mechanisms to use to provide and document the provision of such significant new findings to research subjects. Investigators enrolling subjects using surrogate consent (IRB Policy IC 705), or assent (IRB Policy IC 704) should be aware of the special requirements for re-consent in these subjects.
|
| DHHS Regulations (45 CFR 46) |
|
| FDA Regulations |
|
| Office of Human Research Protections (OHRP) |
|
| Federal Wide Assurances |
|
| OHRP Guidance Documents |
|
Center for Drug Evaluation and Research (CDER) --
- CDER Home
- Regulatory Guidance
- IND - Guidance on the preparation of an investigator-held Investigational New Drug (IND) Application.
|
|
Center for Devices and Radiological Health (CDRH) --
- CDRH Home
- Device Advice
- IDE - Guidance on how to obtain an investigational device exemption (IDE).
|
|
Center for Biologics Evaluation and Research (CBER) --
- CBER Home
- Guidance and Guidelines
|
|
Clinical Trials & GCP --
- Clinical Trials Home
- Guidance and Information Sheets
|
|
Guidance for Institutional Review Boards and Clinical Investigators
- Compilation of current FDA Guidance documents for IRBs, including investigator responsibilities. Includes information on both drug and device studies.
|
|
IRB Staff Training
The following documents and links are provided to assist you in processing of IRB correspondence and completion of IRB meeting tasks. In addition, the documents that are necessary to provide to the IRB members to complete protocol reviews are included. As new versions of the documents are released, they will replace the older version.
| Title |
Link |
IRB Staff Contact List |
|
| Declaration of Helsinki |
|
| The Belmont Report |
|
| The Nuremberg Code |
|
| Initial Review Application Process |
|
| Human Research/Exemption Determination Form, v 1-Jan-2007 |
|
| Human Research Determination Worksheet, v 16-Jan-2007 |
|
| Primary Reviewer Worksheet, v 26-mar-2007 |
|
| Guidance for IRB Review |
|
Vulnerable Populations Checklists
- Pregnant Women
- Prisoners
- Children, v 26-Mar-2007
|
|
| Informed Consent Checklist, v 19-Jan-2007 |
|
Completeness Check & Appendices
- Completeness Check, v 26-Apr-2007
- Drugs & Biologics/Devices, v 26-Mar-2007
- Concurrent IRB Administrator Review
|
|
| IRB Review of Monitoring Plan |
|
| Continuing Review Application Process |
|
| Continuing Review Checklist, v 19-Apr-2007 |
|
Modification Review Checklist - Amendment, v4Jan2007 |
| Modification Review Checklist - Deviation/Exception, v 26-Mar-2007 |
| Expedited Review Worksheet, v 30-Mar-2007 |
|
| Expedited Review Categories |
|
| Expedited Review Application Process |
|
| Standard Operating Procedures |
|
Guide to Daily Operations - (Under Revision) |
|
| Penn IRB Quality Assurance Plan, version 22-Apr-2007 |
|
| Penn IRB Minutes Template, version 11-Apr-2007 |
|
| Categories of Action from IRB Review of Research, v12Dec2006 |
|
| Guidance on Emergency Use |
|
| Guidance on Recruitment Materials |
|
| Guidance on Humanitarian Use Devices |
|
| Guidance on Pennsylvania Laws that May be Relevant to Human Research |
|
| Guidance on Payment for Recruitment of Human Subjects (Finder's Fees) |
|
Guidance on Re-Consenting of Research Subjects
The Federal Regulations require that research subjects be provided with any significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation (45 CFR 46.116(b)(5)). While not specifically addressed in the regulations, The Belmont Report provides an additional ethical requirement to provide research subjects with significant new findings that might affect their long-term health even after they have completed participation in a research study. Finally, neither the Federal Regulations, nor The Belmont Report provide guidance on the type or extent of documentation required to satisfy these regulatory or ethical responsibilities.
The University of Pennsylvania IRBs have developed the following Guidelines for investigators as to the appropriate mechanisms to use to provide and document the provision of such significant new findings to research subjects. Investigators enrolling subjects using surrogate consent (IRB Policy IC 705), or assent (IRB Policy IC 704) should be aware of the special requirements for re-consent in these subjects.
|
| DHHS Regulations (45 CFR 46) |
|
| FDA Regulations |
|
| Office of Human Research Protections (OHRP) |
|
| Federal Wide Assurances |
|
| OHRP Guidance Documents |
|
Center for Drug Evaluation and Research (CDER) --
- CDER Home
- Regulatory Guidance
- IND - Guidance on the preparation of an investigator-held Investigational New Drug (IND) Application.
|
|
Center for Devices and Radiological Health (CDRH) --
- CDRH Home
- Device Advice
- IDE - Guidance on how to obtain an investigational device exemption (IDE).
|
|
Center for Biologics Evaluation and Research (CBER) --
- CBER Home
- Guidance and Guidelines
|
|
Clinical Trials & GCP --
- Clinical Trials Home
- Guidance and Information Sheets
|
|
Guidance for Institutional Review Boards and Clinical Investigators
- Compilation of current FDA Guidance documents for IRBs, including investigator responsibilities. Includes information on both drug and device studies.
|
|
|
|
