UPenn - Office Of Regulatory Affairs

	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.

	Human Research Participants
	Learn more about research participation

	ERA Help

	News
	Keep up to date with the ORA

	Links
	Listing many important Links related to the ORA

	Site Map
	Quickly find site content

	Contact
	How to get in touch with our staff

Search:

Advanced Search »

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.

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.
From the login and registration page, select “New users-Register here”.
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.
Select a user name and password. Provide all requested contact information.
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.
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
Under My Courses, click Enter next to the course "Human Research"
You must complete all modules in order to get a certificate of completion.

IRB Spring 2013 Educational Series

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

Beginner Course

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.

*New date added*

Tuesday

June 4, 2013

1:00 P.M. – 3:00 P.M.

Location:

3624 Market

St.

Suite 301S ORA

Conference

Room

Advanced Courses

Using Blood and Tissue for Research: Ethical Implications, Procedural Requirements and Practical Considerations

This session, co-hosted by the IRB and the Pathology/Laboratory Research Support Committee, will provide insight into the ethical considerations regarding the use of specimens in research. Additionally, this session will review the procedural requirements related to the use of blood and tissue at Penn for research purposes when the resources of the Department of Pathology/Laboratory Medicine are utilized. This session will provide submission guidance related to the forms required for Path/Lab Committee review and the specific questions related to use of specimens that must be addressed within the HS-ERA application to the IRB. A question/answer session will follow the presentations.

Tuesday

April 23, 2013

1:00 P.M. – 3:00 P.M.

Location: Medical Alumni Hall

1 Maloney,

3600 Spruce

Street

Consenting Special Populations: Lessons Learned and Strategies for Success

This comprehensive workshop will provide submitters with helpful

guidance related to the regulatory requirements for the informed consent form and process. The IRB staff will review the regulations related to informed consent, discuss the initial and ongoing consent process, and discuss potential challenges that require consideration when developing an informed consent form and process for studies involving special populations. Finally, this workshop will feature a panel of experienced researchers/research personnel who will share their experiences and

advice related to consent with special populations.

Friday

May 17, 2013

10:00 A.M. – 12:00 P.M.

Location: Class of ’55

Van Pelt

Library

Room 241

For questions about this series, please e-mail Megan Kasimatis Singleton at mkasimat@upenn.edu.

IRB Member & Administrative Staff Tools & Resources

Title	Link
IRB Staff Contact List
IRB Member IRB Confidentiality Statement IRB Member Self-Evaluation Form
IRB Chairs IRB Chair Self-Evaluation Form
Declaration of Helsinki
The Belmont Report
The Nuremberg Code
Primary Reviewer Worksheet
Primary Reviewer Reference
Vulnerable Populations Checklists Pregnant Women Prisoners Children
Informed Consent Worksheet
Completeness Check & Appendices Completeness Check Drugs & Biologics/Devices Significant Risk/Nonsignificant Risk Device Determinations
Continuing Review Worksheet
Continuing Review: Criteria for Approval Reference	WRK-17-1
Modification Review Worksheet
Modification Review Reference	WRK-16
Human Research/Exemption Determination Worksheet	WRK-3
Expedited Review Worksheet
Expedited Review Categories
Standard Operating Procedures
Guide to Daily Operations
Categories of Action from IRB Review of Research
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 Drug Development & Approval Process
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) -- Vaccines, Blood, & Biologics Home Guidance and Guidelines
Clinical Trials & GCP -- 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.

IACUC

IRB

Human Research Participants