Welcome to the IRB Homepage. Please note that the news posted here is always the most recent, but there are more news items on the News page that may be important to you.
12/23/2019 - PRINCIPAL INVESTIGATOR COMPLIANCE ASSESSMENT (PICA) UPDATE:
The Office of Clinical Research (OCR) has updated the process for completing the PICA at continuing review.
A new version of the PICA has been published to the IRB website with updated instructions. Please start using the most recent version as soon as possible. Click Here to Download an Updated Copy
The Standard Continuing Review form has been updated to reference that PICA forms are filed in the regulatory binder and submitted directly to OCR.
- Study teams conducting greater than minimal risk, biomedical research who do not have a sponsor appointed study monitor for quality control of site activities are expected to use the PICA.
- This form should be completed annually and filed in the regulatory binder for the study.
- All study teams who are required to complete an annual PICA must submit a copy directly to OCR - ComplianceTeam@o365lists.upenn.edu
- Do not submit completed PICA forms to the IRB via HSERA.
Questions about the PICA should be directed to OCR: firstname.lastname@example.org or call (215) 662-4484
12/23/2019 - UPDATING EMAIL ADDRESSES SHOWN IN HSERA:
As a result of the PMACs initiative to migrate email servers for Penn Medicine, many email addresses for investigators and research support staff are now showing incorrectly in the HSERA system. The email address reflected in HSERA is the address that will receive automated emails from the IRB. This includes alerts about expirations, available determinations and submissions being returned. The IRB staff may reference these email addresses for individual direct correspondence as well.
Email accounts including the following suffixes, may need to be manually updated in HSERA:
The IRB is requesting that Penn Medicine affiliates review the PennERA information and update their email addresses if necessary, to avoid missing important IRB correspondences.
To update this information:
- Log in to PennERA at https://www.pennera.upenn.edu/
- Click "My Profile" on the left menu.
- Click "Edit" to revise your email address.
- Once edits are complete, click the "Save" button in the top right corner.
This will push the revisions to your HSERA account. If you have issues or questions about updating PennERA, please contact the HSERA Helpdesk: email@example.com
If you have issues or questions about the Migration and how it has affected you, please contact PMACs https://www.med.upenn.edu/pmacs/O365-faq.html
NEW GUIDANCE FOR RESEARCHERS UTILIZING MTURK:
New guidance has been developed to ensure that the ethical principles of respect for persons, beneficence, and justice are being upheld for research involving MTurk Research participants.
Please see https://irb.upenn.edu/mission-institutional-review-board-irb/guidance/ty... for complete information.
CITI Training Alternative Now Available from the Penn Division of Medical Ethics
The Division of Medical Ethics at Penn has developed an online research ethics training course, which is available free to Penn and CHOP faculty, staff, and students/trainees. The course takes about 4.5 hours to complete, comprised of engaging videos, supplemental resources, and brief quizzes. Continuing education credits are available.
The Penn IRB has approved this course as sufficient to satisfy institutional requirements for human subjects protection training, as an alternative to the CITI course. For Penn-based staff at CHOP, the course will satisfy CHOP’s initial and re-certification requirements. For CHOP-based staff, the course will satisfy the re-certification requirement only (to be reassessed in Fall 2020).
The course does not interface with KnowledgeLink, but you will be provided with a certificate of completion that may be presented as needed.
Ethics of Research with Human Subjects Course Details: https://improvinghealthcare.mehp.upenn.edu/continuing-education/ethics-o...
Penn and CHOP faculty, staff, and student/trainee free enrollment: https://improvinghealthcare.mehp.upenn.edu/penn-med-chop