COVID-19: Human Subjects

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Updates on COVID-19: Human Subjects (IRB)

Effective March 15, 2020: Revised standards for Human Subjects-Related Research Visits during COVID-19

In the context of rapidly evolving circumstances regarding COVID-19, and the University’s focus on social distancing and the health and well-being of the community, the Office of the Senior Vice President for Research, in consultation with Vice Dean for Research and Graduate Studies in the College of Medicine, has issued these revised standards related to human subjects-related research visits.  In summary, research visits should be performed remotely (e.g., by phone or Zoom) whenever possible.  Studies involving face-to-face interaction with participants with no direct drug or device therapeutic benefit are to be postponed until further notice. 

Clarified March 27, 2020: For research at Penn State Health, any observational study (whether inpatient or outpatient) that requires any additional face-to-face contact with patients will NOT be allowed. In addition, to demonstrate stewardship of personal protective equipment that is necessary for the safety of our providers, any sample collection that requires any use of PPE (masks, gowns, face shields, etc.) is not allowed, except as part of an interventional study with the potential for direct patient benefit.  

Due to biosafety concerns, and in conjunction with the CDC recommendations for specimen handling from COVID-19 patients, any study that aims to enroll COVID-19 subjects will require a modification to the protocol for IRB approval, which will include a biosafety review. COVID-19 patients cannot be enrolled on existing protocols without this modification approved. 

 

This webpage addresses COVID-19-related questions as pertains to the Office for Research Protections, including the IRB and Human Subjects Protection Office. Penn State Health researchers and staff should also view Penn State Health-specific guidance. See the Penn State COVID-19 webpage for University updates.


Updated April 3, 2020 4:30 p.m. re: FDA guidance.  Last updated April 2 re: Zoom; March 27 with clarifcations re: allowable research for Penn State Health. 
 

Penn State Research Compliance Offices Remain Fully Operational

The Office for Research Protections (ORP) at University Park and the Human Subjects Protection Office (HSPO) at the College of Medicine, including the IRBs, are fully operational. We expect this to continue even if the University suspends operations. Many staff are working remotely and most meetings are being held virtually. If you plan to visit the office in-person, please make arrangements in advance. Staff are happy to arrange Zoom meetings or conference calls with researchers as needed. All ORP and HSPO email addresses and phones continue to be monitored with the same or greater frequency, however, responses to inquiries and applications that are not related to COVID-19 or its impact on research may be delayed somewhat. This website will remain the best source of information during this time; please plan to check back often.

Highest priority is being given to all inquiries, requests, applications, and modifications related to SARS-CoV-2 or COVID-19.  

For more information, contact your IRB analyst or the IRB office (Penn State Health and College of Medicine: hspo@pennstatehealth.psu.edu, Office for Research Protections: IRB-ORP@psu.edu).

 

See responses to frequently asked questions regarding human subjects research and COVID-19 below.

Clarified March 27, 2020: For research at Penn State Health, any observational study (whether inpatient or outpatient) that requires any additional face-to-face contact with patients will NOT be allowed. In addition, to demonstrate stewardship of personal protective equipment that is necessary for the safety of our providers, any sample collection that requires any use of PPE (masks, gowns, face shields, etc.) is not allowed, except as part of an interventional study with the potential for direct patient benefit.   Decision Chart.COVID19 Human Subjects Research.png

Yes. Even if the research is paused for the time being, the PI must still submit the Continuing or Administrative Review to ensure that the study stays active. This will allow research to begin again immediately when appropriate and/or permitted. Failure to submit will result in study closure. If the study is closed, the study cannot be re-opened and all human research activities must stop.

Protocol Changes and Modifications

If the PI would like to modify their procedures to replace in-person study visits with virtual/remote or phone options for administering procedures such as questionnaires, surveys, check-ins, screening, and consenting, these changes must be approved in advance by the IRB as a modification to the approved study.  Exempt studies do NOT need to submit a modification unless the change would alter the review level of the study, as per the Investigator Manual.

All modifications to research procedures require IRB review and approval prior to implementation, except those that are necessary to eliminate an immediate apparent hazard to a participant (these are then required to be submitted to the IRB afterward as an RNI).

ORP/HSPO IRB offices will prioritize modifications related to COVID-19. 

Important notes for COVID-19 related modifications:

When submitting a modification, please note in the submission to the IRB that the PI is adding the option to perform research remotely under the COVID-19 revised standards for human subjects research.  Include in the modification that once in-person research is allowed again, the study will return to previously approved procedures.  (Doing so will eliminate the need to submit another modification later when/if the PI wishes to resume normal study activities.)

In the modification, please consider and address the following, where applicable:

  • Potential impact on subject safety and protections
  • Potential privacy and confidentiality concerns.
  • Data security requirements and obtaining IT security approval.
  • Explain how recordings are to be made remotely. Non-Penn State Health investigators: Zoom is a viable option for Level 1 and Level 2 data; for Level 3 and 4 data, contact Office of Information Security Security@psu.edu. Please note the non-Penn State Health Zoom is NOT HIPAA compliant for storing Level 3 or Level 4 data.  
  • Potential impact on scientific integrity and/or benefits of the study
  • Plan for how existing subjects will be notified (if their participation will be affected by the Modification)

Information on how to submit a modification to an approved study can be found at https://www.research.psu.edu/irb-modification.

No, consent forms do not need to be modified unless the modifications to the study protocol change the risks to participants.

If it is in the best interest of the subject to eliminate an immediate apparent hazard to one or more participants and there is no time to obtain prior IRB approval, a researcher may do so. The PI must then submit this modification as reportable new information (RNI) within 5 business days to the IRB for review.

To ensure timely processing of submissions related to COVID-19, we ask that the researcher identify a submission in the following way:

New Study Submission:

  • Include COVID-19 in the short title (question #2 in the short form)

Reportable New Information (RNIs):

  • Include COVID-19 in the RNI short title (question #1)

Modification:

  • Use the “Add Comment” feature in CATS IRB to add “COVID-19” as a comment to your submission and check “IRB Coordinator” under item #3 in the pop up box. Note: The “Add Comment” button is found left side of the screen on the main study workspace in CATS IRB. 

Failure to identify a submission as outlined above may result in delays in review.

Yes, the PI may decide voluntarily pause, delay, or reschedule interactions with subjects because of COVID-19 ; in such cases, there is no need to inform the IRB, regardless of review level. This is a temporary change to the IRB’s policy regarding submission of an RNI in these situations specifically related to the impact of COVID-19. However, you must:

  • ensure the voluntarily pause does not increase any risk to study subjects if the your study is a greater-than-minimal risk study that involves some type of patient care.
  • contact study subjects who will be affected by this suspension (e.g., a study visit will be cancelled, etc.).

Investigators should notify the study sponsor and any others necessary, as required.

Investigators are required to document the voluntary pause in the study records along with the justification and any actions taken in the event that this is needed during an audit.

Research with Patients

The procedures for a single patient emergency use of an investigational drug or device remains unchanged during this time. The policy for Emergency Use of an Investigational Drug or Device is on the HSPO website. Read about the FDA Guideline.

For clinical studies requiring in-person study visits in order to conduct safety monitoring of the participants, researchers should plan for alternatives to in-person monitoring visits, if possible. For example, interviews could be conducted by phone or email or perhaps the schedule of monitoring could be safely modified or delayed. Modifications to safety monitoring procedures should be approved in advance by the IRB, except when necessary to eliminate apparent hazards to a participant and there is not sufficient time to obtain IRB approval.

If a PI does need to change an approved monitoring procedure to eliminate immediate possible danger, please report it to the Penn State IRB within 5 business days, following the Reportable New Information (RNI) procedures described in the Investigator Manual (HRP-103) on page 52. 

Other

Studies registered at the federal site ClinicalTrials.gov that are modifying their research procedures to include testing for SARS-CoV-2 and/or assessment of COVID-19 symptoms should update the ClinicalTrials.gov information to include these new procedures, if they are done for research purposes. If new procedures are being added as public health surveillance activities in coordination with public health authorities, the registration information does not need to be modified. Any research-related changes that are communicated to the subjects (past, ongoing, future) must be added to the study’s ClinicalTrials.gov registration with 30 days after IRB approval of the modification.

In those cases where research visits must be postponed (i.e., cannot be performed remotely and are not essential to a participant's health and have a direct therapeutic benefit) and graduate student researchers are involved whose research for their degree will be impacted, faculty/investigators should work with their students to develop revised/alternative plans to enable continued progress towards their degree. Read more from the graduate school: http://gradschool.psu.edu/covid19/.

When making any decisions about international research, please keep in mind Penn State’s travel restrictions. International research must also abide by the revised standards of conducting research remotely when possible.The Penn State IRBs will continue to review human subjects research submissions as staffing levels permit. IRB approval of human subjects research proposing to conduct activities at an international location should not be construed as approval to override Penn State University or CDC/WHO guidelines on travel. Researchers must comply with institutional requirements as documented on the Penn State University Coronavirus Updates websites (College of Medicine and Penn State Healthall other University locations) and the latest guidelines issuesdby the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO). 

Researchers are reminded to follow proper safety procedures for handling human specimens that may contain COVID-19.  Human specimens are handled at Biosafety Level 2 (BSL-2). Researchers are reminded that appropriate PPE (lab coats, gloves, eye protection and face shields) should be worn in BSL-2 laboratories and procedures should be performed within a biological safety cabinet if there is a risk of infection. See also the CDC guidance

For Penn State Health: Due to biosafety concerns, and in conjunction with the CDC recommendations for specimen handling from COVID-19 patients, any study that aims to enroll COVID-19 subjects will require a modification to the protocol for IRB approval, which will include a biosafety review. COVID-19 patients cannot be enrolled on existing protocols without this modification approved. 

Penn State is ready to assist researchers and clinical care providers who are planning COVID-19-related activities that may intersect or overlap with public health authority activities and/or FDA emergency authorizations for diagnostics. In some cases, IRB approval will not be required. Penn State can assess the circumstances, provide advice, and issue determination letters (if warranted).