Submissions received after 12/14/2020 will likely not be processed until after we return from the Winter Holiday break. Please be mindful of deadlines and expiration dates for your protocols and submit accordingly, as there is no guarantee that items submitted after 12/14/2020 will be checked/assigned/reviewed until after 1/5/2021. 

If you know you have a rush item and have missed the deadline, please email Dave Heagerty (heagerty@upenn.edu) and Jessica Yoos (jessyoos@upenn.edu) and we will do our best to assist you.  Only items that meet appropriate criteria to be assessed as a rush (i.e. requests related to a grant deadline, expiring research, single patient compassionate use requests, exception requests, etc.) will be reviewed. 

We hope you all have a wonderful holiday season.

This guidance is applicable to both social-behavioral and biomedical research. The IRB will begin screening initial submissions for the need to comply with posting on clinicaltrials.gov. A flow chart that outlines when posting is required has been added to the IRB website here:  https://irb.upenn.edu/initial. 

IRB staff will flag any study not initiated by an industry sponsor that appears to meet the NIH definition of a clinical trial: “A research study in which one or more human subjects are prospectively assigned to one or more interventions to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.” 

NOTE: 

• “Interventions” may include, but are not limited to, a drug or device product, a treatment procedure or surgery, social-behavioral intervention, etc.
• The regulatory sponsor is responsible for making the decision about: 1) whether posting is applicable and 2) posting on CT.gov. 
• Please be aware that the International Committee of Medical Journal Editors (ICMJE) and affiliated journals may also require registration on clinicaltrials.gov as a contingency for publication.
• Studies meeting the NIH definition require study teams to complete Good Clinical Practice training. The IRB will not monitor compliance with this requirement. Penn Medicine researchers should continue to reach out to OCR Operations regarding GCP training. Researchers from non-Penn Medicine schools are responsible for compliance with these requirements.

IRB Requirements

1. The following language must be placed into the consent form for studies that require posting: “A description of this clinical trial will be available on http://www.clinicaltrials.gov, as required by U.S. Law.  This web site will not include information that can identify you.  At most, the web site will include a summary of the results.  You can search this web site at any time.” 
2. At initial review, teams will be required to provide the NCT registration number, or an explanation of why the study does not require posting, before IRB approval will be given.  Penn Medicine researchers may require consultation with OCR compliance for concurrence of studies not posted on CT.gov. 
3. At the time of closure with the IRB, the study team will be asked to confirm that results have been posted on CT.gov. A copy of the confirmation that results were received must be submitted. Closure with the IRB will not be accepted without this confirmation. 

On-going research: if your research was previously approved and you are unsure whether you are required to post on CT.gov, please contact the following individuals for guidance: 

• Penn Medicine:  ocrctgov@pobox.upenn.edu
• All other schools:  PROVOST-IRB@pobox.upenn.edu 

Updates to Forms

The IRB has updated the following submission forms outlined below. Please utilize the most recent version of these forms when submitting to the IRB:  

1. Quality Improvement Project Application: To be used to help determine if an activity qualifies as quality improvement. Completed forms should be submitted to the QI IRB email inbox (qiirb@upenn.edu). The form has been enhanced to capture use of FDA regulated products. 
2. Human Subjects’ Research Determination Form: To be used to help determine whether IRB submission is required. Completed forms should be sent to an IRB Analyst. The form has been enhanced to specifically delineate the differences between de-identified and coded data. 
3. Devices in Research Form: To be used to help the IRB determine whether a study is exempt from IDE regulations as well as the risk of the device. The form has been enhanced to provide additional guidance. 
4. Continuing Review Form: The continuing review form has been updated to collect additional information on recruitment. 

The forms are available for download online here: https://irb.upenn.edu/forms. Submissions utilizing older versions of these forms will be returned starting 9/1/2020. 

 IRB Review and Processing of Research During the Pandemic

• All continuing review submissions will continue to be processed normally. 
• All minimal risk, expedited and exempt research will continue to be processed normally.

Biomedical research requiring convened review will be screened by the IRB staff in light the following: 

1. Is the protocol ‘essential research’ that must continue during this pandemic? Please see COVID related 19 Guidance for the definition of essential research. 
2. If a modification submission: the IRB staff will assess whether the change is critical to the safety and well-being of participants. 

If clinician IRB members become unavailable for reviews during this time, the IRB will prioritize all essential research so that clinician IRB members may primarily focus on patient care during this time. Non-essential research that requires convened review may be submitted, but may be held by the IRB office until there is availability to review. 

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 (the most recent version corrects the reported error with the contact email address)

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. (click here to download the most recent copy)
• All study teams who are required to complete an annual PICA must submit a copy directly to OCR - psom-ocrcompliance@pobox.upenn.edu
• Do not submit completed PICA forms to the IRB via HSERA.

Questions about the PICA should be directed to OCR: psom-ocr@pobox.upenn.edu or call (215) 662-4484

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:

@uphs.upenn.edu

@mail.med.upenn.edu

@pennmedicine.upenn.edu

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:

1. Log in to PennERA at https://www.pennera.upenn.edu/
2. Click "My Profile" on the left menu. 
3. Click "Edit" to revise your email address. 
4. 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: hsera_help@lists.upenn.edu 

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 

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