On Thursday, March 31, 2021, the Pittsburgh campus moved from Guarded to Elevated Risk Posture. Most standards do not vary between the guarded and elevated postures. Please read Rob Rutenbar, Senior Vice Chancellor for Research's full announcement regarding the implications for research. Here are a few important details:
- Human subjects research on-campus: Tier 1, 2 and 3 in-person research conducted on-campus that involves research participants may continue, provided EH&S recommended COVID mitigation is followed. Studies that have not been started can be initiated, provided an IRB protocol and research restart plan have been approved.
- Human subjects research off-campus: All in-person research involving human research participants may continue, including Tier 3 studies that take place in community settings like homes, churches, community centers, libraries, museums and nursing homes
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 page will be updated frequently. All questions regarding COVID-19 and its effects on human research operations should be directed to askirb@pitt.edu.
The staff for all ORP offices are working remotely and continue to operate as usual. Updates and Resources are available at Pitt Research. Educational programs will be conducted remotely.
updated 4/5/21
University of Pittsburgh
University of Pittsburgh comprehensive COVID-19 Information page
Pitt Research COVID-19 Operations Page
Frequently Asked Questions
Essential information for the the conduct of research involving human subjects
Pitt’s Pittsburgh, Bradford, and Titusville campuses moved from the Elevated to the Guarded Risk Posture on Thursday, March 11, 2021. This change has positive implications on the conduct of human subjects research (see the Senior Vice Chancellor for Research's message).
Human subjects research on-campus: All IRB-approved, in-person research conducted on-campus that involves research participants may continue provided EH&S recommended COVID mitigation is followed.
Human subjects research off-campus: All in-person research involving human research participants may be resumed, including Tier 3 studies that take place in community settings like homes, churches, community centers, libraries, museums, and nursing homes
Questions about the attestation letter should be directed to the PI’s Responsibility Center leader. All other questions should be directed to askirb@pitt.edu
Updated 3/15/2021)
Frequently Asked Questions
- Can I resume the conduct of reseach procedures and interact with subjects?
- What if my study includes procedures that are aerosol-generating?
- Are vaccinations required to resume in person visits with study participants?
- Are University of Pittsburgh students permitted to particpate in studies under the campus restrictions?
- What are the definitions of the study tiers (informational only)?
- I needed to temporarily pause study enrollment, certain study procedures, or the entire study. What do I do to resume?
- Do I need to modify my study to resume in-person study visits?
- What platform should I use for video conferencing if the study is going to continue remotely?
- If my study requires in-person contact with my subjects outside of clinical care encounters, can I still resume in-person activities?
- I need to monitor subjects for safety. How do I continue to do so?
- I have IRB approval to continue enrollment or conducting in-person visits, do I need additional approvals before resuming those activities?
- Contingency plan development
- Can I keep my consent process remote or on-line?
- Do I need to update my consent form with risks related to COVID-19 exposure?
- Do I need approval in order to contact subjects to determine COVID-19 exposure or symptoms?
- What if a subject reports possible COVID-19 exposure or symptoms during a study visit?
- Do I need to update my ClinicalTrials.gov study record?
Can I resume the conduct of research procedures and interact with subjects?
Yes. All IRB-approved, in-person research conducted on-campus that involves research participants may continue provided EH&S recommended COVID mitigation is followed.
Protocols conducted in community settings may also resume. Studies must comply with the EH&S recommended COVID mitigation plan as well as any facility or local requirements. Pitt’s Healthcare Advisory Group (HCAG) will continue to monitor the number of COVID cases and positivity rates in the community to ensure those studies can be carried out safely.
Please contact askirb@pitt.edu with IRB related questions. Questions about COVID-19 resources, PPE and space concerns should be directed to safety@ehs.pitt.edu
What if my study includes procedures that are aerosol-generating?
If your study includes aerosol-generating procedures that require close contact with a participant who is not wearing a minimum of a face covering (e.g. an exercise study where a face covering is contra-indicated, spirometry, sputum induction, singing or shouting) you must comply with EH&S’s PPE and Face Coverings Guidance. Direct questions to safety@ehs.pitt.edu
Are vaccinations required to resume in-person visits with study participants?
It is not required that the study team or study participants be vaccinated in order to resume in-person study activities. All EH&S recommended COVID mitigation must be followed. University experience since loosening of restrictions on in-person research activities has shown them to be safe even prior to broad vaccination efforts when those mitigation measures are followed.
Unvaccinated study staff cannot be excluded from in-person research activities provided they follow the appropriate mitigation measures because UPMC and University of Pittsburgh do not have a vaccination mandate for staff.
Studies should not require participant vaccination as part of study eligibility unless vaccination status is central to the study, e.g. evaluating immune-response after COVID vaccine. To do so may 1) unfairly exclude participants who can’t or don’t want to be vaccinated but may benefit from the study, and/or 2) create selection bias.
Study team should screen participants for COVID-19 exposure, diagnosis, or related symptoms prior to and on the day of study visit as part of the EH&S recommended COVID mitigation
Similarly, studies should enquire about subject vaccination status for data collection only if it relevant to the study, e.g. health outcome for vaccinated vs unvaccinated participants. This information should be treated similarly as with other private health information.
updated 5/27/21
There are no restriction for students to take part in research during the shelter in place. All EH&S recommended COVID mitigation must be followed.
Updated 4/5/21
What are the definitions of study tiers?
Note that the tier structure does not affect the conduct of research under the Guarded Risk Posture. The desccriptions remain for reference only.
TIER 1 – HIGH DIRECT BENEFIT TO RESEARCH PARTICIPANTS OR MAY HAVE A HIGH PUBLIC HEALTH PRIORITY DURING THE PANDEMIC
Examples:
Research protocols involving treatments for acute, life threatening health conditions (e.g. some treatment trials for cancers), especially if the study population does not have satisfactory treatment options or cannot obtain treatment outside the research setting
Protocols involving or about COVID-19 (See Coordination of COVID-19 Research at Pitt and UPMC)
TIER 2 – MODERATE DIRECT BENEFIT TO RESEARCH PARTICIPANTS
Examples:
Protocols where stopping the intervention (e.g., some investigational drugs or vaccines or preventative drug regimens) could be harmful
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.
TIER 3 – LOW DIRECT BENEFIT TO RESEARCH PARTICIPANTS AND OTHER IMPACTS TO RESEARCH
Examples:
Research with healthy volunteers
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., requiring elderly or other vulnerable individuals to travel and potentially be exposed to COVID) and benefits of the study to the participants remain minimal.
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
Cohort and natural history studies where delays in data collection have limited impact on scientific objectives
Clarifications on Tier 3 (1/15/2021)
Tier 3 human subjects studies with <6 feet of separation between investigator and subject are permitted, provided that both the investigator and subject are wearing a mask, even if the contact is for over 15 minutes. Close contact should be minimized as much as possible.
Studies involving the distribution of samples to off-campus locations such as a home, or retrieval of samples, are permitted provided that no entry into the facility or direct interaction with subjects occurs)
I needed to temporarily pause study enrollment, certain study procedures, or the entire study. What do I do to resume?
Document the change in your research records, along with any pertinent details. This status change does not need to be reported to IRB
If you are sending a letter to study participants informing them of the pausechange, please send the letter to askirb@pitt.edu for quick review. A modification does not need to be submitted to add this letter.
Do I need to modify my study to resume in-person study visits?
If you modified your study to remove in-person visits and now would like to resume in person visits, you will need to submit a modification to have the change approved. If your protocol is approved for in-person visits or in-person and remote visits, you do not need to submit a modification.
Remember 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 askirb@pitt.edu with questions.
What platform should I use for video conferencing if the study is going to continue remotely?
Data 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 is 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.
If my study requires in-person contact with my subjects outside of clinical care encounters, can I still resume in-person activities?
Yes. All IRB-approved, in-person research conducted on-campus that involves research participants may continue provided EH&S recommended COVID mitigation is followed.
Protocols conducted in community settings may also resume. Studies must comply with the EH&S recommended COVID mitigation plan as well as any facility or local requirements. Pitt’s Healthcare Advisory Group (HCAG) will continue to monitor the number of COVID cases and positivity rates in the community to ensure those studies can be carried out safely.
I need to monitor subjects for safety. Can I continue to do so?
Yes. Because all IRB-approved, in person research can continue, you can monitor your subjects either in person or remotely, according to your IRB approved protocol.
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.
Unless you modified your study to remove in-person visits, you do not need to modify your protocol to resume them.
I have IRB approval to continue enrollment or conducting in-person visits, do I need additional approvals before resuming those activities?
You do not need additional IRB approval provided that you are following your IRB-approved protocol. Contact your departmental representatives to determine if additional permission needs to be obtained.
For studies involving UPMC sites, please contact Office of Sponsored Programs and Research Support (OSPARS) at OSPARS@upmc.edu.
Contingency Plan Development
Study teams should proactively prepare contingency plans for their active research protocols in the event that risk posture again elevates. Assess if the disruption of a research protocol might impact the safety of your research participants.
Can I keep my consent process remote or on-line?
As long as you are following your IRB-approved protocol, you may continue to conduct the consent process or study visits remotely. In appropriate situations, the consent process can be conducted over the phone or by using other technology (See What platform should I use for video conferencing?).
Greater than Minimal Risk Studies: 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 Skype or other similar service. Contact askirb@pitt.edu 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: If your research can be conducted remotely or entirely online, you may continue to do so 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.
Do I need to update my consent form with risks related to COVID-19 exposure?
No. Consent documents should not be updated to include the risks of exposure to COVID-19. Researchers can instead hand out the information sheet, "Important Information about COVID-19 and Research Participation" in the A-Z Guidance
Do I need IRB approval in order to contact subjects to determine COVID-19 exposure or symptoms?
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.
What if a subject reports possible COVID-19 exposure or symptoms during a study visit?
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).
Do I need to update my ClinicalTrials.gov study record?
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.
(v.3/15/2021)