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IRB Approval from 1 25 2013 to 1 24 2014 UNIVERSITY OF PENNSYLVANIA HEALTH SYSTEM A5298, Version 2 -

IRB Approval from 1 25 2013 to 1 24 2014 UNIVERSITY OF PENNSYLVANIA HEALTH SYSTEM A5298, Version 2 --2025

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The document outlines a research study approved by the University of Pennsylvania Health System, focusing on a Phase III trial to evaluate the effectiveness of the quadrivalent HPV vaccine (Gardasil) in preventing anal HPV infection among HIV-infected men and women aged 27 and older. It details the study's purpose, procedures, participant requirements, potential risks, benefits, and confidentiality measures. Participants will undergo various medical evaluations and receive either the vaccine or a placebo over a period of 3 to 4 years.

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What happens after IRB approval?

After IRB approval, any subsequent changes to the study must be reviewed and approved by the IRB prior to implementation. This includes changes to the research team, recruitment process or material, consent procedures or materials, participant payment, data collection procedures, and target population.

What happens if a project is conducted without IRB approval?

Data collected without IRB approval may be ineligible for use in a study and subject to review and discussion by the convened IRB at the next regularly scheduled meeting.

How do I contact the Penn IRB?

Although institutions engaged in research involving human subjects will usually have their own IRBs to oversee research conducted within the institution or by the staff of the institution, FDA regulations permit an institution without an IRB to arrange for an outside IRB to be responsible for initial and continuing

What are the 3 key principles for IRB approval?

When reviewing research IRBs are guided by three ethical principles that are fundamental to human subject protection - respect for persons, beneficence, and justice.

What does IRB approval mean?

If you require faster assistance, please call the IRB mainline at 215-573-2540. Please note that the IRB does not have time nor resources to provide 1-on-1 walkthroughs of the online submission system. If you need this type of assistance, please sign up for an IRB 101 session.

What is IRB approval status?

IRB Full Board Determinations Final approval status is granted when the IRB has reviewed and approved all requested changes. The date of the approved with contingencies determination is deemed the date of approval.

IRB Approval from 1 25 2013 to 1 24 2014 UNIVERSITY OF PENNSYLVANIA HEALTH SYSTEM A5298, Version 2 --2025

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