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.
PLEASE NOTE: Beginning Monday, 3/16 the IRB Office will be physically closed to the research community with IRB staff working remotely. IRB staff will be available during this time by phone and email. Please reference the staff directory.
- Electronic Submissions: The IRB staff is working remotely, and we are still available to review electronic submissions made via HSERA. Please submit all electronic submissions for review as usual.
- Paper Submissions: Because the IRB office is closed until further notice, please submit scanned versions of all relevant study documents for paper submissions to PROVOST-IRB@pobox.upenn.edu so that submissions may be reviewed electronically.
Guidance on Remote Consent Procedures- UPDATED 5/22/20
In the event of a health pandemic (i.e. COVID-19 declared on March 11, 2020) documenting consent from subjects utilizing methods other than pen and paper will be permitted. The IRB has collaborated with the PSOM Office of Clinical Research to develop a guidance on Remote Consent Procedures during the current pandemic. This document contains guidance on documentation and consent discussions.
Penn Medicine and Penn Dental: Please review the attached guidance document for more information.
All other schools: Remote Consent Guidance for non-Penn Medicine and non-Penn Dental Schools
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:
- 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 (email@example.com). The form has been enhanced to capture use of FDA regulated products.
- 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.
- 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.
- 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.
What is an Emergency Use Authorization?
Congress created the Emergency Use Authorization (EUA) in the Project BioShield Act of 2004 to give the public health system access to a greater range of medical products during a declared emergency. An EUA is intended to allow for faster use of a product compared to an IND/IDE.
An EUA is not an Emergency Use IND. An EUA is a regulatory authorization from the FDA for the use of unapproved medical products (drugs, biologics [e.g., vaccines], and devices [e.g., diagnostics]) or the use of approved medical products in unapproved ways to diagnose, treat, or prevent serious diseases or conditions caused by chemical, biological, radiological, or nuclear (CBRN) agents.
An EUA has its own distinct statutory and regulatory requirements.
- FDA Approval: FDA is required to review and approve the request for EUA.
- IRB: Does not require IRB review and approval.
- Informed Consent: May be required at the discretion of the FDA commissioner. Distribution of information (e.g., fact sheets) for healthcare professionals and recipients that contains information on product safety, available alternative products, and the right to refuse administration of the EUA product is required.
- Duration of Approval: Up to one year from the date of the declaration of emergency or for as long as the §564 emergency declaration is in effect, whichever is shorter.
4/8/2020: INFORMED CONSENT UPDATES
New Informed Consent Language for Greater than Minimal Risk Clinical Studies Researching COVID-19
The DHHS Secretary issued a Public Readiness and Emergency Preparedness (PREP) Act declaration for COVID-19 countermeasures on March 10 which restricts the subjects ability to sue related to “countermeasures” described in the declaration. The Secretarial declaration is available at: https://www.govinfo.gov/content/pkg/FR-2020-03-17/pdf/2020-05484.pdf. The CICP program is explained at: https://www.hrsa.gov/cicp/about/index.html. Due to this, the following language should be added to the injury section of the informed consent:
Due to the coronavirus public health crisis, the federal government has issued an order that may limit your right to sue if you are injured or harmed while participating in this COVID-19 clinical study. If the order applies, it limits your right to sue the researchers, healthcare providers, any study sponsor or manufacturer or distributor involved with the study. However, the federal government has a program that may provide compensation to you or your family if you experience serious physical injuries or death. To find out more about this “Countermeasures Injury Compensation Program” go to https://www.hrsa.gov/cicp/about/index.html or call 1-855-266-2427.
3/17/2020: IMPORTANT IRB UPDATES
Protocol Changes Related to COVID-19
The IRB continues to receive questions about what changes require IRB review and approval related to mitigating risk to participants during the pandemic.
If you are changing the protocol procedures temporarily, to eliminate immediate hazards to subject safety due to the pandemic, there is no need to wait for IRB approval. However, the IRB would ask that you submit documentation of the changes in HSERA within a reasonable timeframe, so the IRB is aware of the changes. The IRB is not providing a specific timeline because patient care should be prioritized during this time and the situation changes daily.
NOTE: Any changes or deviations that may increase risk of harm to participants or adversely affect the scientific integrity of the data should wait for IRB review.
- E.g., A total suspension of a therapeutic trial would have to be reported to the IRB if participants are enrolled and may be at risk due to the discontinuance of study procedures, with a plan for managing those risks.
- E.g., If individuals are not able to travel for an in-person visit because of concerns related to COVID-19, AND it adversely impacts the risk to the participant.
Remote Visits to Substitute for In-Office/Hospital/Clinic visits
Remote visits via telephone, tele-medicine, or other appropriate virtual communication may be substituted for a visit to an office, hospital or clinic. The above note applies in terms of risk to participants and effect on scientific integrity and whether this needs to wait for IRB review. We recommend that participants be advised of any related changes.
- Re-consent is not necessary unless the changes to the research are such that the original consent is no longer valid.
- Participants may be verbally apprised of risks related to COVID-19 if in-person contact is still necessary in some fashion.
- Subjects may also be notified of changes to the research via a letter or other form of communication. This does not require submission to the IRB.
Permanent changes should be submitted via an amendment. Temporary changes should be submitted via exception request. Deviations identified after the fact should be submitted per usual IRB policy. The IRB will be flexible with submission timelines given the circumstances.
Guidance on Emergency Use/Compassionate Use of Drugs/Devices
Guidance and submission instructions related to the Emergency Use/Compassionate use of investigational drugs/devices is available online here: https://irb.upenn.edu/how-submit-penn-irb/expanded-access
If consent cannot be obtained due to both incapacity of the patient and unavailability of an LAR, an exception from prospective informed consent requirements may be appropriate.
Exception from Informed Consent Requirements [21 CFR 50.23(a)]
- The subject is confronted by a life-threatening situation necessitating the use of the product,
- Informed consent cannot be obtained because of an inability to communicate with, or obtain legally effective consent from, the subject,
- Time is not sufficient to obtain consent from the subject's legal representative, AND
- No alternative method of approved or generally recognized therapy is available that provides an equal or greater likelihood of saving the subject's life.
Note: Exception from informed consent requires an independent assessment from an uninvolved physician prior to or within 5 working days of the use of the article.
A plan should be in place to consent the individual /LAR as applicable after the fact, when they are available to provide informed consent. An enrollment note should document the situation and be filed with the signed ICF.
IRB SUBMISSION PROCESSING INFORMATION DURING THE COVID-19 PANDEMIC
Rush Processing of COVID-19 Research
The IRB is prioritizing all COVID-19 research that furthers the scientific understanding of COVID19/SARS COV-2 and provides potential for direct benefit to enrolled or future patients. This includes the following:
- Treatment studies with potential for direct benefit to those enrolled
- Specimen collection studies for testing / development of critically needed COVID 19 or antibody tests
- Biomedical intervention studies that will help benefit healthcare workers, first responders, and essential personnel in relation to shortage of PPE
- Treatment studies in which there is unlikely to be direct benefit for enrolled participants
- Other biomedical intervention studies
- Chart reviews
Please note the following:
- Research teams are responsible for contacting their department chairs to ensure prompt receipt of applications to the IRB office. Please directly contact your department chair upon PI approval in HSERA to facilitate IRB processing.
- Whenever possible, please try to coordinate the submission of research requiring convened review to be received by the IRB within 4-5 days of an IRB meeting date. Meeting dates are available online here: https://irb.upenn.edu/announcements
- Studies that plan to prospectively enroll participants require review by the COVID-19 Committee. Please contact Dr.’s Ian Frank or Daniel Radar for guidance.
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:
- Is the protocol ‘essential research’ that must continue during this pandemic? Please see the IRB home page for the definition of essential research under 3/17/2020: Important: Message from Emma Meagher, MD - Clinical Research Update #3
- 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 member 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.
IRB Approval vs. Authorization to Initiate/Continue Research During the Pandemic
While the IRB is permitting and processing submissions during the pandemic, approval by the IRB at this time DOES NOT constitute authorization to initiate a protocol, protocol amendment, or continue research procedures (as applicable).
Clinical Trials: During the COVID-19 Pandemic, permitted clinical trial activity is limited to essential clinical trials. Essential clinical trials are those that enroll or follow patients with life threatening or serious conditions for which participation in the clinical trial holds out the clear prospect of the patient directly benefiting. Patients already enrolled into clinical trials who are undergoing safety assessments fall into this definition. Please review the Message from Emma Meagher, MD - Clinical Research Update #3 on the IRB website here for further details: https://irb.upenn.edu. Please consult with Emma Meagher at firstname.lastname@example.org for non-oncology trials or Bob Vonderheide at email@example.com for oncology trials for guidance if you wish to open a new trial, or if you are unclear whether your protocol constitutes essential research.
Research studies with procedures that may be conducted remotely or virtually (e.g., electronic survey research, record reviews, secondary data analysis) may be conducted at this time, as long as their conduct does not interfere with clinician duties and patient care during the pandemic. Please consult with OCR for authorization to conduct such research. Please ensure that you have adequate study staff and resources.
Only research studies with procedures that may be conducted remotely or virtually may be conducted at this time (e.g., electronic survey research, record reviews, secondary data analysis). Please also refer to any guidance provided by your school.
5/11/20: PHASED RETURN TO PENN MEDICINE CLINICAL RESEARCH ACTIVITIES
Please read the attached document that outlines the considerations for a phased return to clinical research. Timing will be at the direction of the State, City, University and PSOM.
3/23/2020: COVID-19 FDA GUIDANCE ON CLINICAL TRIALS & NIH FUNDING INFORMATION DURING COVID19 PANDEMIC
- The Food & Drug Administration (FDA) has issued guidance relating to Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic for March. Please see the linked guidance document for details on this update.
- The National Institue of Health (NIH) has issued information for NIH applicants and recipients of NIH funding. Please see the linked website for further details on NIH funding.
3/17/2020: CLINICAL RESEARCH UPDATE #3: Important Message from Emma Meagher, MD
The requirements regarding the execution of clinical research will apply until further notice.
- Permitted clinical trial activity is limited to essential clinical trials. Essential clinical trials are those that enroll or follow patients with life threatening or serious conditions for which participation in the clinical trial holds out the clear prospect of the patient directly benefiting. Patients already enrolled into clinical trials who are undergoing safety assessments fall into this definition.
- No new clinical trials may be initiated at this time unless it meets the definition of an essential clinical trial. Please consult with me (Emma Meagher) for non-oncology trials or Bob Vonderheide for oncology trials for guidance if you wish to open a new trial.
- No new enrollment of research participants into existing clinical trials may occur unless it meets the definition of an essential clinical trial. Please consult with me (Emma Meagher) for non-oncology trials, or Bob Vonderheide for oncology trials for guidance if you wish to enroll new participants.
- In-person research visits should continue for participants already enrolled in essential clinical trials if it is essential for patient safety and/or the participation in the clinical trial is an integral part of the patient’s treatment plan. The study physician, in consultation with the study team, the patient’s physician, the patient, and the patient’s family should carefully assess the necessity and risks of an in-person visit. All other in-person clinical research visits must be postponed.
- Research staff should make efforts to use alternative methods to conduct research visits or perform testing such as check-ins with participants by phone and/or performing research-related lab testing at lab testing centers, where feasible.
- Research staff should work remotely, unless their presence is required for the safe conduct of the trial.
- Principal Investigators should let commercial sponsors know that opening new ‘non-essential’ clinical trials and enrollment into ongoing ‘non-essential’ clinical trials is temporarily postponed.
3/13/2020 Penn Medicine Updated Clinical Research Guidance in relation to COVID-19 (Corona Virus)
Note: Although the below guidance applies to Penn Medicine, we recommend that non-Penn Medicine researchers review the guidance for any procedures that may be prudent or necessary to ensure the safety of participants and research staff.
Based on the March 13th, 2020 communication from Penn Medicine we are updating the guidance regarding the execution of clinical research.
- Non-essential ‘in-person’ clinical research appointments and procedures for research participants should be canceled.
- Research staff should make efforts to use alternative methods to conduct research visits or perform testing such as check-in with participants by phone and/or performing research-related lab testing at lab testing centers, where feasible.
- Research visits that are directly linked to treatment and/or essential for the clinical care of existing research participants should continue to take place.
- Monitoring and auditing of research studies should be conducted remotely.
- New clinical research studies and trials that involve utilization of Penn Medicine facilities should not be initiated during this time. COVID 19 related studies are exempt from this requirement.
- New participant enrollment onto existing studies should only proceed if the principal investigator believes it is in the best interest of the research participant.
- Principal Investigators should let commercial sponsors know that enrollment into ongoing trials is temporarily postponed.
- As a reminder, when working remotely with PHI, you should only use approved and compliant options, such as Secure Share, PennBox, or other Penn-managed shared drives.
If you have questions about this guidance, please send inquiries to:
3/10/2020 Penn Medicine Guidance on Human Subjects Protections Considerations Related to COVID-19
Penn Medicine has instituted mandatory COVID19 travel-screening questions for all patients who are seen at Penn Medicine. Because many patients are also research participants, the Penn IRB and OCR are providing the following clarifications to the Penn Clinical Research Community.
- COVID-19 Mandatory Screening in the Health System: Mandatory PennChart screening procedures/questionnaires are not considered part of the “IRB-approved procedures” for your protocol, and therefore do not trigger the need for an amendment to the protocol. These screening procedures do not constitute a change in IRB-approved research procedures unless you choose to incorporate the data collected under the mandatory screening into your research plan. If you do wish to include data obtained from health system-required screening procedures, an amendment or new protocol should be submitted to the IRB to use that data.
- Changes to IRB-Approved Protocols: According to IRB policy, any changes in IRB-approved research procedures must be reported to the IRB and may not be implemented prior to review and approval by the IRB, except when necessary to eliminate apparent immediate hazards to the subject. This is permitted by both the Common Rule (38 CFR §16.108(a)(3)(iii)) and by FDA regulations (21 CFR §56.108(a)(4)). Beyond the regulation, Penn Medicine also has a responsibility to ensure the safety of its employees. As such, interim measures to reduce immediate hazards to research participants and staff – which may involve deviating from IRB-approved study procedures prior to securing IRB approval – may be warranted to relieve an immediate hazard and to ensure consistency with Penn Medicine polices during this time.
Examples include considering approaches that would reduce the need for “at risk” research participants to visit Penn Medicine facilities such as:
- Conducting phone visits in lieu of in-person visits
- Research procedures that might be completed without requiring that participants travel to Penn Medicine (surveys, imaging procedures/ lab testing be done at other sites)
- Permitting “out of window” visits and/or canceling nonessential research participant visits
- Please note that the IDS will ship investigational medication to participants’ homes if requested.
Examples include considering approaches that would reduce the number of external vendors visiting Penn Medicine facilities, such as:
- Conducting remote monitoring visits
- Conducting remote site initiation visits or other sponsor visits/meetings
- PI and/or sponsor temporarily stopping recruitment or placing the study on a temporary hold
For all of the examples above, and any other protocol modifications, research teams should work with their funding and regulatory sponsors to develop plans for research participants and research procedures, in light of the current circumstances.
- Research Staff Prepare to Work Remotely: Privacy and confidentiality provisions remain of paramount importance at all times. Consistent with University and Penn Medicine communications, clinical research staff should prepare for the possibility of working remotely.
- Research teams should maintain secure contact information for research participants should they need to reach out to them. This should be stored on Penn-managed shared drives or PennBox for remote access. As an alternative, teams can use MyPennMedicine to reach out to research subjects.
- Ensure that access to PHI and other protected clinical research information is enabled with all required securities in place.
- Do not use personal email to conduct clinical research activities or communicate with patients.
If apparent immediate hazards will be sustained for a duration that would practicably allow for an amendment to cover such changes to be developed by an investigator and reviewed and approved, as appropriate, by the IRB, then approval of a protocol amendment must be sought.
If you have questions about this guidance, please send inquiries to:
2/3/2020 - PRINCIPAL INVESTIGATOR COMPLIANCE ASSESSMENT (PICA) UPDATE (and correction)
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 - firstname.lastname@example.org
- Do not submit completed PICA forms to the IRB via HSERA.
Questions about the PICA should be directed to OCR: email@example.com 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: firstname.lastname@example.org
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