As of July 2021, the IRB is prioritizing COVID-19 research UPON REQUEST. Please see section below entitled IRB Processing of COVID-19 / SARS COV-2 Related Research for details how to request priority review. 

Summer 2021 Phase III Research Resumption

As of May 21, 2021, Research Resumption has moved into Phase III. Centralized approval of research or resumption plans is not required; however, a school may elect to maintain its own policies regarding research activity.  Please check with your school representatives to ensure you are compliant with local policies.

Research at Penn and in the Greater Philadelphia area

The IRB expects Penn research teams to continue to follow any applicable and current federal and state guidelines, as well as local guidelines set forth by the City of Philadelphia, the University and associated Schools on the folllowing:  

  • Masking
  • Handwashing
  • Disinfecting high-touch surfaces and common areas they use
  • Physical distancing from others
  • Density
  • Symptom screening

Researchers should be prepared to respond to potential cycles in community transmission and local government directives, as well as University alerts, therefore, potential short-notice quarantines that would require ramp-downs of activity in labs, floors, and buildings should be anticipated.

Non-Local / International Research

The location in which the research is taking place will be relevant to the physical risk to participants depending on the local current transmission rate. Depending on the location, the IRB expects Penn research teams to follow any applicable and current country, state/province, and locality guidelines

COVID-19 Information Sheet

COVID-19 is a risk of daily life. The COVID-19 Information Sheet is no longer required to be used, but is available for anyone who would like to use it. The information sheet has been updated to reflect the availability of vaccines. Download the 2021 version here. 

IRB Processing of COVID-19 / SARS COV-2 Related Research

As of July 2021, the IRB is prioritizing COVID-19 research UPON REQUEST.

The IRB will prioritize 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: 

  1. Treatment / vaccine studies with potential for direct benefit to those enrolled
  2. Specimen collection studies for testing / development of COVID-19, variant, or antibody tests 
  3. Biomedical intervention studies that will help benefit healthcare workers, first responders, and essential personnel in relation to shortage of PPE
  4. Treatment studies in which there is unlikely to be direct benefit for enrolled participants
  5. Other biomedical intervention studies that do not fall into the categories above
  6. 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. The IRB is not responsible for delays on the part of Department Chairs.
  • Please contact Jessica Yoos or David Heagerty directly to request rush review of COVID-19 studies that fall under the six categories above. 
  • 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
  • Clinical Trials require review by the COVID-19 Committee, including those where Penn is the not the IRB of Record. Please contact Dr. Ian Frank for guidance. The IRB will withhold approval until COVID-19 Committee approval is given.

Requirements Surrounding the Use of COVID-19 Associated Data and Specimens

Penn Medicine has instituted mandatory COVID19 screening questions for all patients who are seen at Penn Medicine. 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 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. Likewise, the research study consent form should be updated to inform participants, as applicable.

If your research involves the collection and/or processing of samples from COVID-19 positive subjects, and the samples will be processed or stored in a Penn research laboratory, please consult with a Biosafety Officer from EHRS prior to commencing research. Please see https://ehrs.upenn.edu/about-ehrs/contact-ehrs for more information. 

Spring 2021 Semester Research Resumption

The Office of the Vice Provost for Research has released the Research Resumption Plan for the Spring Semester. The plan is effective January 11th. The plan continues most of the requirements of the Fall Semester Plan. The exceptions are: guidance for expanded research activity by undergraduates, and measures taken when a COVID positive case and/or cluster occurs in research spaces.

Penn Medicine Only: Research Resumption Plan approvals to school leaders are no longer required for clinical research, but investigators are encouraged to confirm that the necessary resources are available to support their studies. Please see the Research Resumption Plan for more details.

Additional information can also be found at https://research.upenn.edu/resources/resumption

IRB guidance remains unchanged. Researchers should continue to follow the Requirements for In-Person Research Resumption. 

Fall 2020 Semester Research Resumption Phase

The Office of Vice Provost for Research published the Fall Semester Plan on September 14, 2020 which outlines current research requirements during COVID-19. The majority of the requirements in the Phase II plan remain in place during the Fall Semester Phase. These include the requirements for school and faculty research resumption plan approval, exception approval for research related travel, office use approval, field work approval, and processes for clinical and non-clinical studies involving human subjects. Researcher's should review this plan.

IRB guidance remains unchanged. Researchers should continue to follow the Requirements for In-Person Research Resumption. 

Requirements for In-Person Research Resumption during Phase II, Fall 2020 Phase, and Spring 2021 Phase

This guidance applies to Phase II, Fall 2020 Semester Phase, and Spring 2021 Phase.

Originally posted 7/23/2020

On July 13, 2020 Penn moved to Phase II of research resumption as outlined in the University of Pennsylvania Research Resumption Strategy Master Plan, Research Resumption Phase II, available online here: https://research.upenn.edu/wp-content/uploads/Research-Resumption-Strategy-Master-Plan-revision-6.30.20_final.pdf.  In order to streamline the research resumption process, the IRB has re-examined its review process and is providing updated information regarding its expectations and requirements. 

Remote Conduct of Research

All biomedical and social-behavioral human subjects’ activity that can be performed remotely, should be carried out remotely. Permission to conduct remote research activities does not require notification or re-approval by the IRB. All research activities conducted remotely may continue as planned as risks to subjects are considered to be appropriately mitigated.

The IRB expects the following types of research procedures to be conducted remotely with research participants:

  • Interactions involving survey procedures, interview procedures, oral history, focus groups,  educational tests (cognitive, diagnostic, aptitude, achievement), etc.
  • Research involving behavioral interventions
  • Collection of data from voice, video, digital, or image recordings (when possible)

Any in-person contact with research participants for the above types of research procedures requires prospective IRB approval prior to commencing in-person contact, even if the study previously qualified as exempt. This applies to research being conducted on or off campus. The following information must be provided:

  • Rationale for why the research must be conducted in person at this time and why it cannot be conducted remotely
  • Confirmation that the “IRB Required General Precautions for In-Person Engagement with Research Participants” will be followed.
  • Approval from the associated Penn school leadership. An email from the appropriate designated leadership personnel within each school is acceptable. The IRB will not review the submission without this email approval being provided to the IRB . Please do not submit until this approval has been obtained. Department Chair approval does not constitute Research Resumption Plan approval. NOTE: This is not required for clinical research during Spring 2021 Phase.
  • An assessment of how the risk of exposure to COVID-19 and any study related risks are appropriately balanced by or outweighed by the benefit(s) of research participation.
  • If the research involves field work performed at an outside facility (e.g., a primary or secondary school, community center, etc.), you must obtain a letter of support from the facility authorizing research to resume at that facility in light of COVID-19. This documentation must be submitted to the IRB.

The IRB also recommends that the following types of research procedures be conducted remotely when possible:

  • Prospective collection of some biological specimens for research purposes when collection devices can be shipped to participants (e.g., hair/nail clippings, saliva collection, stool/urine/sweat collection).
  • Research involving the collection of data through noninvasive procedures, such as the use of wearable devices when they can be shipped to participants homes (e.g., blood pressure, pulse oximeter, heart monitor, wellness devices, etc.) 

Requirements for In-Person Research

All Penn researchers are expected to follow their associated School’s research resumption plans including any necessary requirements to submit to school leadership for research resumption as applicable and outlined by their school. All Penn researchers are also expected to follow the University’s COVID-19 Response Plan, which is based upon current guidance from the Centers for Disease Control, Pennsylvania Department of Public Health, and the Philadelphia Department of Public Health.

The IRB is releasing “Required General Precautions for In-Person Engagement with Research Participants.” The IRB expects all researchers to follow these minimum requirements, irrespective of IRB of Record and the location of research. Teams may utilize additional precautions without IRB approval. Any reduction in these minimum requirements will require prospective approval from the IRB to assess the potential risk to participants. 

As noted in the Required General Precautions, all research teams interacting in person with participants are expected to inform subjects of the potential risks of in-person contact related to COVID-19.

The IRB is releasing a COVID-19 Informational Sheet for In-Person Participation that research teams across the whole University may use if they do not already have a study specific consent addendum or a revised consent form that contains this information. NOTE: If you already have study specific consent addendum or a revised consent form already approved by the IRB, use of this newly released addendum is not required.

The COVID-19 Informational Sheet does not need to be submitted to the IRB for approval. It is considered to be approved for use.

Teams are required to document in the research record that the COVID-19 Informational Sheet (or study specific consent addendum/revised consent form, etc.) has been provided to participants prior to their interaction with Penn researchers.

Please review the Remote Consent Guidance for approved methods of sharing this document with participants: https://irb.upenn.edu/mission-institutional-review-board-irb/guidance/recruitment-and-consent

Also noted in the Required General Precautions: Participants must complete a Symptom Questionnaire both 24 hours prior to an in-person visit and at the time of the visit. Please see the “Required General Precautions for In-Person Engagement with Research Participants” for more guidance surrounding this. 

Phase II / Fall Semester Phase Research Resumption Requirements FAQs

WHAT REQUIRES SUBMISSION AND/OR APPROVAL?

What is required for submission to the IRB?

Research resumption plans are only required to be submitted to the IRB if you are conducting research procedures in person that the IRB expects to be conducted remotely:

  • Interactions involving survey procedures, interview procedures, oral history, focus groups,  educational tests (cognitive, diagnostic, aptitude, achievement), etc.
  • Research involving behavioral interventions
  • Collection of data from voice, video, digital, or image recordings (when possible)

If you are not conducting any of the above procedures in person, a research resumption plan is not required to be submitted to the IRB. If you must conduct these procedures in person, please submit to the IRB so the IRB may re-evaluate the risk-benefit ratio.

Any deviations from your approved protocol should be submitted to the IRB. 

What do we have to report to the IRB if a participant and/or research team member tests positive for COVID-19? 

Exposures should be reported to EHRS at 215-898-4453 or ehrs@ehrs.upenn.edu. IRB reporting would be required under the following circumstances: 

  • The incident was caused by a deviation from university policies or the IRB approved protocol. In this case, a deviation should be submitted to the IRB. See: https://irb.upenn.edu/Deviation for guidance. 

OR

  • If the incident suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized, the event may be an unanticipated problem that requires reporting to the IRB. See https://irb.upenn.edu/reportable-event for guidance on how to report. 

What if we need to deviate from the IRB’s Required Precautions for In-Person Research?

Deviations from the required minimal precautions that may increase risks to subjects require approval from the IRB. Supplemental precautions that increase safety do not require submission to the IRB. The IRB requirements are considered to be minimum requirements and designed to align with what is already occurring at Penn Medicine.

Do I need to submit a plan to school leadership?

A plan may be required to be submitted to your school leadership. Non Penn Medicine researchers should consult their school resumption plan for more information.

Penn Medicine research staff should note that Phase II research resumption was already sent to school leadership at the department level prior to the initiation of Phase II.

Is anything required to be submitted to the IRB if we will go back to following our approved protocol?

No. HOWEVER, the 3/10/2020 Penn Medicine Guidance on Human Subjects Protections Considerations Related to COVID-19 has not been rescinded. The IRB still expects teams to consider approaches to reduce risk of COVID-19 to all participants, when feasible. Examples include:

  • Conducting phone or virtual visits in lieu of in-person visits
  • Allowing the conduct of research procedures at other sites so that participants do not have to travel to Penn (surveys, imaging procedures, lab testing, etc.)
  • Permitting “out of window” visits and/or canceling nonessential research participant visits
  • Removing non-essential research procedures
  • Shipping investigational medication to participants homes

If our study requires an in-person visit because of a procedure that cannot be conducted remotely, may we also conduct other procedures that the IRB expects will be conducted remotely? Do we have to request approval from the IRB for this? 

One of the required precautions is that the length of interactions with participants be minimized and to allow adequate time in between participant visits to thoroughly disinfect the research area. The situation will vary from study to study. PIs should consider this element when proposing to conduct these procedures in-person. For example, if the study requires the completion of self-report questionnaires, it depends on how long they take to complete. If the duration of participation is not being significantly extended due to the administration of this research procedure, it should be acceptable (e.g., a brief survey that takes a few minutes to complete). However, some self-report questionnaires or interviews can be quite long (20 minutes +).  In these cases, the PI should consider whether remote conduct of those procedures might be appropriate, OR if the participant can be left alone in a room to complete them to minimize staff contact. A submission to the IRB would be required for the latter scenario so the IRB may evaluate the risk-benefit ratio. 

 

INFORMATION SHEET / INFORMING PARTICIPANTS ABOUT RISKS OF COVID-19

Is use of the COVID-19 Information Sheet Required?

The requirement is that participants be informed of potential risks of in-person contact related to COVID-19. Previously during Phase I, our guidance had stated participants may be verbally apprised of risks related to COVID-19 when in-person contact is made. The intention of the information sheet was to provide material to facilitate this process.

It is intended for research where in-person contact occurs. It doesn’t apply when there is no in person contact.

Alternatives may be appropriate and may be submitted to the IRB for approval, OR the IRB may be queried about whether an established alternative is acceptable.  If you already have a study specific consent addendum or a revised consent form already approved by the IRB, use of this newly released information sheet is not required.

FDA Regulated Research: Would the risks of COVID-19 need to be discussed by a physician investigator or could they be discussed and documented by other research team members (e.g., CRC or Research RN)?

Given the intention is to inform about risks of COVID-19 in relation to in person contact, and not an investigational intervention of some sort, any trained member of the research team may conduct this process.  

Should already enrolled participants be provided the COVID-19 Information Sheet?

All participants should be informed about the risks of COVID-19 if engaging in in-person contact. This would apply to those who are currently enrolled, if they were not previously informed during Phase I. The IRB expects all participants to be informed about the risks of COVID-19 at least once during the course of the research. This applies regardless of where they are in terms of enrollment status.

If a patient comes in for a research only visit, can this information be given to them when they arrive at the hospital, or does it have to be given in advance?

If feasible, it would be preferred to send to participants in advance so they may have time to consider the risks of leaving their home to attend an in-person visit.

Is the COVID-19 Information Sheet required for combined clinical/research visits, when the patient would be coming in anyway and is scheduled through the clinic?

As noted above, all participants should be informed of potential risks of in-person contact related to COVID-19. Alternative approaches may be appropriate. Documentation that this occurred should be placed in the research record.

 

SYMPTOM SCREENING

My study patients are scheduled via the Epic appointment desk. Does this mean that I do not need to do a symptom screening because it will be done automatically?

Yes. If your study utilizes scheduling through Epic/PennChart, the subjects coming in will be sent questions via text message ahead of the appointment, and they will also be asked symptom and travel screening questions by front desk staff when they check in for their appointment.

 

RELIANCE AGREEMENTS/MULTI-SITE RESEARCH

Are the precautions required for relying sites / non-Penn sites?

The guidance applies regardless of IRB of record, because these precautions are a local institutional requirement. Hence, it applies to Penn sites. Penn is not dictating what happens at other research sites and CHOP because the risk of the virus may be different in other cities and states. Likewise, local requirements may vary.

The precautions do apply to Penn researchers who may be conducting fieldwork research in other institutions such as schools, community centers, etc.

If our study relies on central IRB do we have to submit to both the central and local IRBs?

If a submission is necessary as outlined above, we would ask that it be submitted to the Penn IRB given this is an institutional policy. The Penn IRB defers to central IRBs as to whether they want a submission or not.

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.

Guidance on the Need to Make Protocol Changes Due to the COVID-19 Pandemic

The IRB has received questions about what changes require IRB review and approval related to mitigating risk to participants during the pandemic. 

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 (45 CFR §46.108(a)(3)(iii)) and by FDA regulations (21 CFR §56.108(a)(4)). 

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 when cases are high, 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. 

Re-consent Guidance

Re-consent about changes in the research is not necessary unless the changes to the research are such that the original consent is no longer valid. 

Subjects may be notified of changes to the research via a letter or other form of communication. 

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 Remote Consent Procedures

Documenting consent from subjects utilizing methods other than pen and paper will be permitted and recommended. Guidance on Remote Consent Procedures during the COVID-19 pandemic contains information on documentation and consent discussions. Remote consent guidance for Penn Medicine/Dental and other schools is available online here: https://irb.upenn.edu/mission-institutional-review-board-irb/guidance/recruitment-and-consent.

Authorization to Initiate/Continue Research During a COVID-19 Pandemic Lockdown (Research Cessation)

While the IRB permits and processes submissions during the pandemic lockdown (research cessation), approval by the IRB during this time DOES NOT constitute authorization to initiate a new protocol, protocol amendment, or continue research procedures (as applicable). 

Penn Medicine

Clinical Trials: During lockdown, 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. 
  • No new enrollment of research participants into existing clinical trials may occur unless it meets the definition of an essential clinical trial. 

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 non-essential in-person clinical research appointments and procedures should be postponed during lockdown. 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.

Please consult with Emma Meagher at emma@upenn.edu for non-oncology trials or Bob Vonderheide at rhv@upenn.edu for oncology trials for guidance if you wish to open a new trial, or if you are unclear whether your existing 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 during lockdown, as long as their conduct does not interfere with clinician duties and patient care during the pandemic. Please consult with OCR as necesssary for authorization to conduct such research. Please ensure that you have adequate study staff and resources.

  • Research staff should work remotely, unless their presence is required for the safe conduct of the trial. 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. 
  • Monitoring and auditing of research studies should be conducted remotely. 
  • Principal Investigators should let commercial sponsors know that enrollment into ongoing trials is temporarily postponed during lockdown.

If you have questions about this guidance, please send inquiries to:

Other Schools

Only research studies with procedures that may be conducted remotely or virtually may be conducted during a pandemic lockdown (e.g., electronic survey research, record reviews, secondary data analysis).  

  • Research staff should work remotely. 
  • Monitoring and auditing of research studies should be conducted remotely. 
  • Principal Investigators should let their funding sponsors know that enrollment into ongoing trials is temporarily postponed during lockdown.

If you have questions about this guidance, please send inquiries to PROVOST-IRB@pobox.upenn.edu. Please also refer to any guidance provided by your school.

What is an Emergency Use Authorization (EUA)? Can I use or Investigate a Product with an EUA in a Research Study?

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 or IDE. 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 and EUA to treat or diagnose patients.
  • IRB: Does not require IRB review and approval to treat or diagnose patients. 
  • Informed Consent for treating or diagnosing patients: 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.

An EUA product can be used or investigated in a research study. However, the FDA may rescind an EUA at any time if it is determined that the product is not effective. Please be aware that research studies utilizing these products may require IND or IDE, or exemption determination from FDA IND/IDE regulations if FDA rescinds approval. Penn Medicine researchers should seek guidance from the Office of Clinical Research, Sponsor Support Unit.

FDA Guidance on the Conduct of Clinical Trials During the COVID-19 Pandemic & NIH Issued Information on Funding

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 FDA continues to update this guidance throughout the pandemic. 

The National Institue of Health (NIH) has issued information for NIH applicants and recipients of NIH funding during the pandemic. Please see the linked website for further details on NIH funding.