The University of Pittsburgh Human Research Protection Office is monitoring the release of information related to COVID-19 from the University of Pittsburgh and from federal agencies. This information will be updated frequently. All questions regarding COVID-19 and its effects on human research operations should be directled to firstname.lastname@example.org
The staff for all ORP offices are working remotely and continue to operate as usual. Updates and Resources are available at Pitt Research
- Do I need to update my consent form with risks related to COVID-19 exposure?
- Essential information for Conduct of Research Involving Human Subjects
- How do I petition the IRB for an exception to the above policy for my Tier 1, 2 or 3 study?
- How do I register my Tier 1 study if I am continuing to see subjects in person?
- Do I need to petition to continue my expanded access protocol?
- Coordination of COVID-19 Research at Pitt and UPMC?
- Will HRPO continue to operate as usual?
- Do I need IRB approval in order to contact subjects to determine COVID-19 exposure or symptoms?
- Can I still conduct research procedures and interact with subjects?
- Can I move my consent process to remote or online?
- What platform should I use for video conferencing?
- Do I need to update my ClinicalTrials.gov study record?
- How do I notify the IRB about suspensions or changes on my External IRB (sIRB) protocol?
- Contingency plan development
- I need to monitor subjects for safety. Can I continue to do so?
- Do I need to modify my study to make changes for alternatives to in-person study visits?
- I need to temporarily pause study enrollment, certain study procedures, or the entire study. What do I do?
- Can I mail Vincent cards to participants?
- What if a subject reports possible COVID-19 exposure or symptoms during a study visit?
University of Pittsburgh
Food and Drug Administration (FDA) Information
- For questions on clinical trial conduct during the COVID-19 pandemic, please email the FDA COVID-19 email box: Clinicaltrialconduct-COVID19@fda.hhs.gov
FDA has created a guidance page for researchers engaging in convalescent plasma research. The Mayo Clinic IRB is serving as the central IRB for this study at the request of the U.S. Government. Investigators should visit https://www.uscovidplasma.org/ for full information on participation registration.
A separate IRB reliance agreement is not required but University of Pittsburgh researchers need to complete an External Submission (EXT) in OSIRIS. For questions on the process, contact email@example.com.
Note that no changes can be made to the Mayo Clinic IRB consent template. Local study teams can include a separate information sheet for participants.
Frequently Asked Questions
No. Consent documents should not be updated to include the risks of exposure to COVID-19. Researchers can instead hand out the the information sheet, "Important Information about COVID-19 and Research Participation"
Per the Senior Vice Chancellor for Research’s message “Restriction in University of Pittsburgh Research Operations to Only Essential Work on Campus” on March 18, all on-campus research work will be restricted, where possible, to only essential activities by 5 pm on Friday, March 20.
It is NOT intended that all non-critical research/scholarly activities should stop; indeed, those that can be carried out remotely (planning, writing, literature review, remote data collection, data analysis, remote meetings, etc.) should continue during this time. Studies with no face-to-face participant interactions such as chart review studies or on-line surveys can continue as approved as resources allow.
Please see the descriptions below to determine the disposition of your research. All questions should be directed to firstname.lastname@example.org
Tier 1 – High Direct Benefit to Research Participants or May Have a High Public Health Priority
All protocols involving or about COVID-19 and protocols in which serious or immediate harm could be caused to the research participants if stopped. Tier 1 also includes the class of studies that may not have the prospect of high direct benefit but carry the risk of serious or immediate harm if study interactions were to cease.
- Research protocols involving treatments for acute, life threatening health conditions (e.g. some treatment trials for cancers)
- Protocols where stopping the intervention (e.g., some investigational drugs or vaccines or preventative drug regimens) could be harmful
Research in Tier 1 can continue if the PI agrees the research can be conducted in a safe manner that protects subjects, researchers, and the community. If not done already, self-assessed Tier 1 protocols must register with the IRB through the RNI process if the PI intends to continue in-person activities even if the study will not enroll new subjects at this time.
PIs must petition the IRB to continue enrollment. Enrollment must be paused until the request is granted.
Tier 2 – Moderate Direct Benefit to Research Participants
Protocols which, if stopped, may pose a risk to the research participant.
- Protocols in which research participants are receiving interventions or clinical care that is very interrelated to their research participation (e.g., test results coming back that might have clinical implications for their care)
- Some protocols evaluating treatments for chronic conditions (e.g., asthma, hypertension, depression, etc.).
- Protocols involving assessment of the safety or efficacy of an intervention in which, if stopped, the potential societal benefit of the science would be significantly and adversely impacted, for example where a research assessment (blood collection or imaging study) is only valuable if collected at a very specific time. This must be measured against the risk to participants and staff, including the risk of exposure of COVID-19.
Research in Tier 2 can continue but must cease in-person interactions. PIs must pause on enrolling new research participants into Tier 2 stuides. PIs may petition the IRB if they have a compelling reason to continue in-person interactions. Approved in-person contact will be limited to the minimum necessary.
Tier 3 – Low Direct Benefit to Research Participants and Other Impacts to Research
- Cohort and natural history studies where delays in data collection have limited impact on scientific objectives
- Protocols in which delays to starting or pausing of research does not substantively impact on research objectives of the research protocol
- Protocols in which risks to research participants are higher (e.g., potentially exposing elderly vulnerable individuals to COVID) and benefits of the study to the participants remain minimal
- Research with healthy volunteers
- Any minimal risk studies that require research subjects to travel, that involve undergraduate students, or that are in a community setting and require direct interaction with researchers
Research activities in Tier 3 must not enroll new participants in studies requiring face-to-face interaction nor continue to conduct face to face visits. On-line visits or data collection that does not require participant interaction may continue. PIs may petition the IRB if they have a compelling reason to continue in-person interactions (or conduct in-person enrolment).
Please contact email@example.com with questions and concerns.
(adapted from Johns Hopkins University)
If PI feels there is a compelling justification to continue enrollment into a Tier 1 study or continuing in-person enrollment or in-person interaction in a Tier 2 or Tier 3 study, the study team should follow the Reportable New Information (RNI) procedures in PittPRO to explain the justification. The IRB will review the submissions in order of priority.
The submission should contain the following information:
- What is the direct benefit to the subject that cannot be obtained outside the study? (Tier 1)
- Why can’t the enrollment be postponed until restrictions are lifted?
- What is the harm to subject or value of data lost if in-person visits are to cease or be delayed until restrictions are lifted? (Tier 2 and 3)
- What measures are being taken to minimize in-person visits, e.g. visits may be done remotely or coincide with clinical visits?
- Any other pertinent information
Self-assessed Tier1 protocols must register with the IRB when continuing in-person visits so that the IRB can track face-to-face research activities that are taking place in order to ensure compliance with applicable regulations, policies, and governmental orders. Study team should follow the Reportable New Information (RNI) procedures in PittPRO or the Reportable Event procedures in OSIRIS to explain the ongoing visits.
The submission should contain the following information:
- Why the study visits cannot be postponed or completed remotely until restrictions are lifted
- The harm to subject or value of data lost if in-person visits are to cease or be delayed until restrictions are lifted
- Any measures being taken to minimize in-person visits, e.g. remote visits or coordinating with clinical visits
- Any other pertinent information
Expanded access refers to the use of an investigational drug with the primary purpose to diagnose, monitor, or treat a patient’s disease or condition rather than to obtain the kind of information about the drug that is generally derived from clinical trials.
Because expanded access protocols are for patient treatment and are not research, they can continue without petition to the IRB. Institutional COVID-19 policies for patient contact must be followed.
Research teams at the University of Pittsburgh and UPMC have mobilized to plan and implement clinical trials and clinical research studies related to COVID-19. Principal investigators planning or conducting COVID-19 related studies, please submit a brief description of your proposal.
For more detailed information, please visit the Clinical and Translational Science Institute (CTSI) COVID-19 research coordination site.
The Human Research Protection Office and IRB Committees are operating through modified procedures. HRPO staff are working remotely and are conducting regularly scheduled and ad hoc IRB meetings via online conferencing.
Educational programs in the Learning Resource Center have been cancelled until further notice.
No. If you implement procedures in order to identify subjects whose visits should be postponed, modified, or delayed, you do not need to modify the IRB application because this activity is not a research procedure. You should follow the recommendations for the institution that you work in. This includes administration of questionnaires or other procedures to determine COVID-19 exposure or symptoms.
If a subject endorses answers that may indicate exposure or symptoms, they should contact their PCP.
Procedures that do not require in-person contact with subjects can continue as approved in the IRB application. Some clinical studies require in-person study visits in order to conduct safety monitoring of the subjects. For example, subjects in a drug treatment study may need to have regular examinations, interviews, or laboratory tests for monitoring of specific possible side effects.
Researchers must discontinue in-person interaction with subjects in most cases and consider alternative ways to continue study procedures. For example, interviews may be conducted by phone or the schedule of visits may be safely modified or delayed. (See “Do I need to modify my study to make changes for alternatives to in-person study visits?”) The protocol will need to be modified through the regular pathway in PittPRO if the study is not exempt and the approved application prohibits the activity from taking place in that manner.
Modifications to safety monitoring procedures should be approved in advance by the IRB through the regular modification process in PittPRO, except when necessary to eliminate immediate apparent hazards to a participant and there is not sufficient time to obtain IRB approval.
If you do need to change an approved study visit in order to eliminate apparent immediate hazards to research participants, please report it to Pitt IRB within 10 days, following the Reportable of New Information (RNI) procedures in PittPRO.
Visits that are postponed or subjects seen out of window should also follow the Exception Request pathway if time allows or Reportable New Information if time does not allow.
Please contact firstname.lastname@example.org with questions
If my study requires in-person contact with my subjects, can I continue to do so?
Effectively immediately, all human subject research requiring in-person contact with subjects will be categorized into the three tiers described in Essential information to ramp down research involving human subjects. Principal Investigators should consider each of their protocols and decide into which tier each falls. Research teams must implement actions associated with the corresponding tier. Please contact email@example.com with questions.
In appropriate situations, the consent process can be conducted over the phone or by using other technology. Unless your protocol specifically states that consent will be done in person or otherwise prohibits the change, you do not need to modify your protocol.
Greater than Minimal Risk Studies: Consider whether it is necessary to enroll a new subject into the study at this time. Per the announcement of the Senior Vice Chancellor for Research on 3/16/2020, “we recognize that there are some studies that are critical to a particular patient population and need to be sustained for treatment or ethical reasons, while other studies (e.g., those not targeting a direct therapeutic benefit) might be suspended.”
If it is determined that it is necessary to enroll new subjects in this study, there are options for remote execution of the consent process. For most studies that involve a drug, device, or surgical procedure, the consent process must be done face to face by a licensed physician. In those cases, the process can be carried out via Facetime, Skype or other similar service. Contact firstname.lastname@example.org if you are unsure if your study requires face to face consent. For those not requiring face to face, the consent process can be carried out over the phone by the persons approved to obtain consent. In all cases, the signed consent form must be received prior to beginning any study procedures.
Minimal Risk Studies: Per the announcement of the Senior Vice Chancellor for Research on 3/16/2020, “If your research or scholarship can be conducted remotely or entirely online, you are free to sustain these activities, if you choose.” This includes the consent process. As stated above, you do not need to modify your protocol unless it prohibits carrying out the process remotely. If your study is approved to obtain signed informed consent, the signed consent form must be received prior to beginning any study procedures.
In certain minimal risk situations, it may be appropriate to request a waiver to document informed consent. The waiver allows consent to take place verbally with no signed consent form necessary. In order to operate on a verbal consent, you must modify your protocol and justify the waiver. This can be done by selecting “Waiver to document consent” in the Study Scope, #2 section of PittPRO. If your study is already approved under a waiver to document consent, you do not need to modify unless you are making other changes to the process.
If the Overall Recruitment Status and/ or Individual Site Status of a University of Pittsburgh investigator-initiated clinical study registered on ClinicalTrials.gov is changing due to the COVID-19 situation, you should update the study record as you normally would, within 30 days of the change. If enrollment and/ or other study activities are “on pause” rather than under an official IRB suspension, consider still selecting Suspended, which will populate the Why Study Stopped data element, where you may then more clearly explain the status. Additional information regarding study record maintenance requirements is available on the Office for ClinicalTrials.gov website. Contact CTgov@pitt.edu with questions.
Instructions for updating a study record:
- Login to the ClinicalTrials.gov PRS (Organization: UPittsburgh)
- Open and update the record, then click “Entry Complete” on the Record Summary page.
- The Responsible Party must follow all prompts in the “Next Step” box on the Record Summary page, until the “Release Confirmation” page appears, to approve and submit the updated record for review and posting to the public study record.
For studies that are approved by an external IRB and are in OSIRIS, complete the following steps to update the IRB on changes from in-person to remote visits, any type of suspension, or general changes being made due to COVID-19:
- Open the study
- Under My Activities, choose “Update Application
- Under Update Options, choose “Submit Reportable Event Information”
- Provide details in the box
- EXT1.0 – Upload any documentation related to the request
- Press OK at the bottom of the page
Study teams should proactively prepare contingency plans for their active research protocols. Assess if the disruption of a research protocol might impact the safety of your research participants.
Investigational Drugs: If research participants are on investigational drugs, work with the IDS to determine what the plan would be if the investigational drug could not be dispensed to your research participants. If the investigational drugs cannot be dispensed to research participants, you should make plans to transition research participants back onto their most appropriate clinically available medications. This transition should include consultations with the investigational drug service and the clinical team caring for the research participants.
Research Procedures: PIs need to assess whether any reduction in staff makes it unsafe to complete the planned research procedures. Even starting IVs might not be easy or safe if experienced staff are not available.
Timely review of research data: If research team members are not available, integration of research care such as reviewing lab results in a timely manner might not be possible and will require special attention under the direction of the study PI. Study teams should consider the availability of appropriate back-ups to the PI to make safety assessments.
Some clinical studies require in-person study visits in order to conduct safety monitoring of the subjects. For example, subjects in a drug treatment study may need to have regular examinations, interviews, or laboratory tests for monitoring of specific possible side effects.
Researchers should plan for alternatives to in-person monitoring visits, when possible. For example, interviews could be conducted by phone or email. Visits to participants’ homes might be an alternative location for examinations or specimen collection. A modified or delayed schedule of monitoring may also be possible.
These modifications to safety monitoring procedures should be approved in advance by the IRB through the regular modification process in PittPRO, except when necessary to eliminate apparent hazards to a participant and there is not sufficient time to obtain IRB approval.
If you do need to change an approved study visit in order to eliminate apparent immediate hazards to research participants, please report it to Pitt IRB within 5 days, following the Reportable of New Information (RNI) procedures in PittPRO.
Visits that are postponed or subjects seen out of window should also follow the pathway Exception Request if time allows or Reportable New Information if time does not allow.
Please contact email@example.com with questions
Modifications to adjust procedures to online or remote are not necessary. You will need to request an exception if the study is not exempt and the application specifies in person visits.
You do not need to modify or request an exception in order to hold visits remotely or change the schedule of study visits if the study is exempt or if the IRB application does not describe whether the visit would be in person or remote or give specifics about visit schedule.
If you submit a modification related to COVID-19, you should email your IRB Analyst to prioritize these modifications. Remeber that any other changes to a non-exempt study must be approved in advance by the IRB as a Modification to the study, unless they are necessary to eliminate immediate apparent hazards to participants. Modifications should be submitted through the regular process in PittPRO. Please contact firstname.lastname@example.org with questions.
Security is recommending that researchers use Microsoft Teams, Zoom, Vidyo, or Skype for video conferencing. Agreements with those vendors provide us with a level of confidence that they will be secure. Facetime it not recommended for research studies.
If you plan on recording the sessions on one of the above platforms, please make sure it is in a storage location that is managed and has access controls in place.
I need to temporarily pause study enrollment, certain study procedures, or the entire study. What do I do?
Make note of the temporary pause in your research records. This does not need to be reported to IRB unless the study hold is initiated at the request of an external funding agency or the study’s Data and Safety Monitoring group (if there is one).
If you are sending a letter to study participants informing them of the pause, please send the letter to email@example.com for quick review. A modification does not need to be submitted to add this letter.
Please follow institutional policy. If possible, place a surgical mask on the subject and direct them to a private room with a door that can close. At UPMC locations, contact the Infection Prevention Team through MedCall at 412-647-7000. At non-UPMC locations, contact the local health department for guidance (Allegheny County Health Department 412-578-8062).