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 ResearchUpdated 10/12/20

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
(if study is conducted by Pitt staff)

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:

The process for restart approval is follows:

  1. 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.
  2. Department chairs or center directors will submit a daily roster of newly approved protocols using the attached spreadsheet to restart.clinicalresearch@pitt.edu.
  3. Rosters will be reviewed for approval by the SVC for HS’ office to confirm completion of the IRB Qualtrics survey.
  4. Final Approval will be given by dean of the school of medicine and communicated to the responsible Department chair or center director.

Forms:

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

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 ResearchUpdated 5/29/20

School of Medicine Preclinical Research | Activity Area Plan

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:

  1. 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.
  2. 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.)
  3. 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).
  4. Final Approval is given by the SLT (Senior Leadership Team – Provost, SVC for Research, SVC for HS and VC for HR)

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).

COVID19 Training PowerPoint

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