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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.
    • NOTE for VA and CHOP Affiliates: If you have an appointment at the VA or CHOP, you should register under the VA or CHOP. Upon completion of the training, please send your certificate to This e-mail address is being protected from spam bots, you need JavaScript enabled to view it to credit your training in Knowledge Link.
    • NOTE: Penn requires CITI training every 3 years. If you previously completed the School of Medicine's POR training or CITI training, the CITI Refresher 101 course satisfies the training requirement.
  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).
    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 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"
  8. You must complete all modules in order to get a certificate of completion.

 

 

IRB Fall 2013 Educational Series

To register for an IRB Fall Educational Series Workshop, please visit KnowledgeLink at http://knowledgelink.upenn.edu.  The IRB Fall Workshops can be located by title.

HS-ERA 101

Human Subjects Research Application (HS-ERA) is a secure, web-based system used to submit applications to the IRB for review and is mandatory for all new IRB applications. This Spring, the IRB will host a training session for new users of the system. This workshop will explain the different sections of the initial application for both biomedical and social behavioral research. Additionally, this session will provide tips for submitting modifications to existing protocols, continuing review applications and reportable events through the electronic submission system. IRB staff members will provide answers to frequently asked questions about the HS-ERA system and will offer helpful hints to attendees.  This session is intended for users who have little experience submitting through HS-ERA but also can also serve well as a refresher for the more seasoned submitters.

 

Wednesday

October 30, 2013

1:00 P.M. – 3:00 P.M.

 

 

 

Location: 3624 Market St.

Suite 301S

ORA Conference Room

 

Social and Behavioral Research Consent Writing Workshop

Consent form development can often be challenging. In this workshop, the IRB will provide tips for writing a consent form, review different consent formats, and address common mistakes in consent forms. The IRB will also review the template consent form for social and behavioral research and discuss how the template may be modified so that it reflects the information you need to provide to participants. This workshop will also address hot consent topics in social/behavioral research including waivers/alteration of consent, research involving deception and web-based consent.  

 

Thursday

November 14, 2013

9:30 A.M. – 11:30 A.M.

 

Location: 3624 Market St.

Suite 301S

ORA Conference Room

 

Biomedical Research – Consent Writing Workshop

Consent form development can often be challenging. In this workshop, the IRB will provide tips for writing a consent form, review different consent formats, and address common mistakes in consent forms. The IRB will also review the template consent form for biomedical research and discuss how the template may be modified so that it reflects the information you need to provide to participants. This workshop will address hot consent topics in biomedical research such as combined informed consent forms and HIPAA authorizations, consent for collection, storage and future use of specimens, the inclusion of research information in the electronic medical record (EMR) and genetic testing.

 

Wednesday

December 11, 2013

 9:30 A.M. – 11:30 A.M.

 

Location: 3624 Market St.

Suite 301S

ORA Conference Room

 

 

 

 

 

 

 

For questions about this series, please e-mail Megan Kasimatis Singleton at This e-mail address is being protected from spam bots, you need JavaScript enabled to view it .

 

 

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
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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
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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
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FDA Regulations gif
Office of Human Research Protections (OHRP) gif
Federal Wide Assurances gif
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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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