Restarting Research Plans
General Restart Guidelines
Operational Steps for Receiving Approval for Research Restart:
Each PI must develop a plan that covers 7 main topics to restart research (see Table below)
Click the research categories below to view more information about restarting research.
School of Medicine:
Principles and Guidelines for Restarting Clinical Research - Updated 5/29/20
Human participant research activities at the University of Pittsburgh School of Medicine can be broadly classified into four categories based on study location, participant characteristics, and oversight authority. Restarting research in each category is dependent on a different set of Pitt and UPMC policies and guidelines, as tabulated below. Applicable policies and guidelines and updates are provided on this website.
| Human Participant Research Study Category | Pitt Principles & Guidelines for Restarting Clinical Research |
Completion of IRB Qualtrics Survey (Pitt) |
Pitt Facilities & Environmental Health & Safety Policies/Guidelines |
Pitt Human Resources Policies |
OSPARS Policies | UPMC Facilities & COVID-19 Safety Policies |
| Industry-sponsored, industry-initiated studies overseen by UPMC OSPARS and activities conducted in a UPMC facility | X |
X |
X | X | ||
| Pitt studies involving UPMC patients with activities conducted during a clinical encounter in a UPMC facility | X | X | X | X | ||
| Pitt human participant research studies with activities conducted in a UPMC facility but outside of a clinical encounter | X | X | X | X | ||
| Pitt human participant research studies with activities conducted outside of a UPMC facility | X | X | X | X |
For restarting clinical research activities in the school of medicine, department chairs or center directors will be responsible for evaluating each protocol to attest that the PI is:
- Following Pitt and/or UPMC facilities policies, as applicable
- Following Pitt and/or UPMC safety policies, as applicable (e.g., has proper and enough PPE for staff and participants, proper set up and cleaning supplies)
- All employees and visitors coming to a University of Pittsburgh campus, and students sheltering-in-place are required to complete the Daily COVID-19 Health Check.
- Resourced with sufficient staff to conduct study and is following Pitt HR policy
- Training for Employees on COVID-19 Response is required to be completed in full of all employees at the University of Pittsburgh prior to an individual returning to campus. Those who are already working on campus will also need to complete this training. Visit this page to access the training.
- In compliance with regulatory requirements and has completed the IRB Qualtrics survey according to guidance on the IRB Ramp up website
- Review Clinical Research Resilience Plan and include details in your restart plan
The process for restart approval is follows:
- PIs must develop plans for restarting each of their human participant study protocols and complete a PI Checklist, which must be submitted to their department chair or institute director for review and approval.
- Department chairs or center directors will submit a daily roster of newly approved protocols using the attached spreadsheet to restart.clinicalresearch@pitt.edu.
- Rosters will be reviewed for approval by the SVC for HS’ office to confirm completion of the IRB Qualtrics survey.
- Final Approval will be given by dean of the school of medicine and communicated to the responsible Department chair or center director.
- Checklist for developing a research restart plan
- Example: Department of Medicine Early Restart Plans for Research
Clinical Trial Monitoring Visit Guidance:
Clinical Trial Study Monitoring Visits during the COVID-19 pandemic must be modified based on the current Pitt Operating Posture.
FAQs:
- Where can I find risk assessment information?
Risk assessment information based on CDC guidance as of March 22 can be found at: https://www.coronavirus.pitt.edu/risk. The CDC has also developed a tool for checking symptoms to provide further guidance. - Where can I find information on PPE, cleaning and other environmental health and safety questions?
Environmental Health and Safety has guidance on their EH&S COVID-19 Resources website.
UPMC OSPARS Clinical Trials
The process for restarting UPMC OSPARS actively suspended clinical trials is as follows:
- Each principal investigator will complete the “Clinical Research Restart Principal Investigator Approval Form” for their suspended trials and they will attest that all named studies listed have met the criteria on the form . The principal investigator will then have their Department Chair/Center Director sign the approval form.
- Each principal investigator will also complete and sign the “Safety Checklist Principal Investigator” form.
- Both forms should be submitted to ospars@upmc.edu as one submission.
- Once the Covid-19 training is available, each principal investigator will be required to complete.
UPMC OSPARS Forms:
School of Medicine:
Principles and Guidelines for Restarting School of Medicine Pre-Clinical Research - Updated 5/29/20
Criteria for Early Restart of Research
All COVID-19 related work is not part of the restart process. For restarting lab research activities in the school of medicine, department chairs or center directors will be responsible to evaluate each protocol to determine whether they meet at least one of the following criteria for generating public health impact or being time sensitive:
- Will the work contribute to resolving the current public health crisis or support socio-economic recovery?
- Will the work have material non-COVID-related public health implications?
- Is there another reason why a two-week delay will result in missed critical public impact?
- Will a two-week delay lead to missing a critical funding/publication deadline?
- Will taking a pause limit the ability to complete the research (e.g., funding restrictions)?
- Will taking a pause cause undue harm or cost (e.g., derailing long-term research, preventing maintenance of vital equipment, etc.)?
Operational Steps for Receiving Approval of Early Restart:
Each PI must develop a plan that covers 7 main topics to restart research (see Table below):
All PIs who believe they are eligible for early restart should be working on their individual restart plans and submitting them to their chairs for review starting now.
Process for restart approval:
- Each lab/PI must develop plans based on the 6 early restart criteria and the 7 operational guidelines above and submits to their division chief/department chair/institute director for review.
- The department chair/ institute director submits to the Office of Space Management Health Sciences for review. (Please contact Jaime Cerilli - jcerilli@hs.pitt.edu if you need floor plans or have building questions and her office can assist.)
- The Office of Space Management Health Sciences reviews, makes sure all criteria are met, and submits to the Dean of the appropriate HS school (for SOM to Dr. Berg and Dr. Reis).
- Final Approval is given by the SLT (Senior Leadership Team – Provost, SVC for Research, SVC for HS and VC for HR)
Preliminary restart timelines:
- If all PPE and cleaning supplies arrive next week as planned, 1/3 of building employees per department if approved by SLT of BST3 will be permitted to return on Friday, May 29, 2020.
- 1/3 of building employees per department if approved by SLT of BST and BST-S will open on 6/1/2020.
- 1/3 of building employees per department if approved by SLT of Scaife will open on 6/2/2020.
These buildings were chosen to open first because a majority of PI draft plans already were submitted, and building readiness - all of the hands free dispensers in bathrooms and COVID signage will be installed. We will be opening the remaining research buildings in orderly fashion soon after these dates.
Preparing for DLAR Activities:
There will be some early logistics that need to be worked out by each lab with the DLAR facilities, but those labs approved to start can begin ordering their animals as early as May 26th.
The Guidelines for Restarting Animal Research, which have been developed by the University’s Working Group on Restarting Animal Research and approved by the Senior Vice Chancellor for Research, are posted on the DLAR website: https://web.dlar.pitt.edu/bcms-media/Files/Download?id=ef646add-82d4-40a9-b5e8-abc201773eaf.
If you have any questions, please contact the DLAR Director, Dr. Frank Jenkins (fjenkins@pitt.edu).
FAQs:
- Where can I find information on PPE, cleaning and other environmental health and safety questions?
Environmental Health and Safety has guidance on their EH&S COVID-19 Resources website.
Forms:
UPMC Guidelines
COVID 19 Pitt Research General UPMC Guidelines - Updated 6/9/20