IACUC
Penn's Animal Care and Use Committee reviews all research and training activities involving animals
IRB
The Institutional Review Board (IRB) reviews research involving human research participants.
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Required Training

CITI Training Requirements: Investigators, Research Staff, & Students Engaged in Human Research

The CITI-Protection of Human Subjects Research Training courses fulfill the University's requirement for training in human research protections.

You must follow the instructions below in order to receive credit for completing the CITI course.
  1. Open the www.citiprogram.org web site. It is recommended that you keep this page open so you can refer to it as you complete the registration process.
  2. From the login and registration page, select “New users-Register here”.
  3. Choose the University of Pennsylvania as the participating university.
    Select Univeristy of Pennsylvania from the Participating Institutions drop-down list
  4. Select a user name and password. Provide all requested contact information.
  5. You must enter your correct PennID in the PennID field in order to receive credit for completing a course. (Your Penn ID is the group of 8 numbers prominently displayed under your name on your Penn Card).
    Enter your PennID in the PennIF field when registering

    If you do not have a Penn ID, enter your date of birth MMDDYYYY. If your data does not appear in Knowledge Link after one week, or if you have any other questions, contact Kadeda Burgess This e-mail address is being protected from spam bots, you need JavaScript enabled to view it or call 215-573-2540.
  6. Select the Learner Group that is most appropriate for your research activities. If you are a Faculty/Staff member, please select your appropriate group below. You will be enrolled in the basic course for that group.
    • Biomedical Research
    • Social/Behavioral Research
    • IRB Member
    • Students - Class projects
    • Refresher 101 - Biomedical Research
    • Refresher 101 - Social & Behavioral Research
  7. Under My Courses, click Enter next to the course "Human Research"
    Click Enter next to Human Research
  8. You must complete all modules in order to get a certificate of completion.
 
Fall 2009 IRB Educational Series

To register for an IRB Fall Educational Series Workshop, please visit KnowledgeLink at http://knowledgelink.upenn.edu

The Fall Workshops are available under the "Optional Training" tab.

Workshop Descriptions

Social & Behavioral Research -Exempt, Expedited, & Convened IRB Review & Application Basics

6 October, 1:00-2:30 p.m.

Van Pelt Library, Room 241

Biomedical Research - Exempt, Expedited, & Convened IRB Review & Application Basics

13 October, 1:00-2:30 p.m.

Hospital of the University of Pennsylvania, Flyers/Sixers Auditorium 

Determining which Events Must be Reported to the IRB

3 November, 10:00-11:30 a.m.

HUP, Flyers/Sixers Auditorium

Biomedical Research - Consent Form Writing Workshop

6 November, 10:00-11:30 a.m.

ORA/IRB Conference Room

Social & Behavioral Sciences - Consent Form Writing Workshop

10 November, 10:00-11:30 a.m.

ORA/IRB Conference Room


IRB Member & Administrative Staff Tools & Resources  
Title
Link

IRB Staff Contact List

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IRB Member 

  • IRB Confidentiality Statement
  • IRB Member Self-Evaluation Form


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IRB Chairs

  • IRB Chair Self-Evaluation Form

 
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Declaration of Helsinki gif
The Belmont Report gif
The Nuremberg Code gif

Primary Reviewer Worksheet

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Primary Reviewer Reference
WRK-14

Vulnerable Populations Checklists

  • Pregnant Women
  • Prisoners
  • Children

 

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Informed Consent Worksheet
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Completeness Check & Appendices

  • Completeness Check
  • Drugs & Biologics/Devices
  • Significant Risk/Nonsignificant Risk Device Determinations

 

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Continuing Review Worksheet 

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Continuing Review: Criteria for Approval Reference WRK-17-1
Modification Review Worksheet
word document
Modification Review Reference
WRK-16
Human Research/Exemption Determination Worksheet
WRK-3
Expedited Review Worksheetword document
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Standard Operating Procedures gif
Guide to Daily Operations gif
Categories of Action from IRB Review of Researchword doc
DHHS Regulations (45 CFR 46) gif
FDA Regulations gif
Office of Human Research Protections (OHRP) gif
Federal Wide Assurances gif
OHRP Guidance Documents gif

Center for Drug Evaluation and Research (CDER) --

    • CDER Home
    • Regulatory Guidance
    • Drug Development & Approval Process

 

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Center for Devices and Radiological Health (CDRH) --

    • CDRH Home
    • Device Advice
    • IDE - Guidance on how to obtain an investigational device exemption (IDE).

 

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Center for Biologics Evaluation and Research (CBER) --

    • Vaccines, Blood, & Biologics Home
    • Guidance and Guidelines

 

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Clinical Trials & GCP --

    • Home
    • Guidance and Information Sheets

 

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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. 

 

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