Resumption of Research

Our guiding principle for resumption of research activity is to reduce our on-campus footprint as much as possible, including human subjects research.  

Guidance (updated July 20, 2020) from the Senior Associate Dean of Research (SADR) on clinical research outlines resumption of the types of clinical research which can now be initiated or resumed, more here: https://stanfordmedicine.app.box.com/s/llloxoji3atl3bbe9s6n7h4s0yrmt8sb.

For up to date information about the Conduct of clinical trials, clinical research and clinical human subject research, see https://med.stanford.edu/spectrum.html.  

Approval Process for NON-COVID Human Subjects Research

If essential CRC is required to conduct in-person, patient facing activities, follow this 2-step approval process for the clinical research components of the study:

Step 1 – Department Chair Approval

• Submit Pediatrics NON-COVID-19 Human Subjects Research Form HERE for both patient-facing and/or non-patient facing activities. If a CRC has already been tested for a previously Chair-approved study, indicate on the form and notify Mary Chen.

• Receive Chair approval (via email from Mary Chen) to proceed to Step 2, or reason for denial

• If no CRC is required for patient-facing activities (no additional personnel needed), approval for the patient-facing clinical research components requires only Step 1 (Chair approval).  Any non-patient facing work, either wet or dry lab (e.g. CRCs working on campus buildings for non-patient facing activities, must follow the Essential Smartsheet process describe below under “Basic Research.”

• Any research that can be done virtually must continue to be conducted virtually.

Step 2 – CRC COVID testing requirement to engage in patient-facing activities

• Submit Chair-approved studies to the SADR Essential & Clinical Research Approval Request Form HERE

• Ensure that personnel being referred for testing have been informed that they will be contacted by Mary Chen, on behalf of Pediatrics.

• Upon receipt of negative COVID test results, the CRC must forward this to Mary Chen.  Proceed on the study and any subsequent Chair-approved studies that the same CRC supports.

• Confirm that personnel identified for these essential clinical research and clinical trial projects have (a) experience with patient-facing research interventions in Stanford Health Care and Stanford Children’s Health; (b) have received all training in safety procedures required to conduct their work, including training on COVID-19 Hygiene Best and is completing daily Health Checks; and (c) have access to appropriate PPE.

(a) Patient-facing experience:  Clinical research personnel are expected to have experience working in the hospital/clinical setting.  They should be familiar with the hospital units they are working in, and satisfy any requirements of those units they work in (if any). 

(b) Training:  The requirements are online training COVID-19 Hygiene Best Practices (EHS-2470-WEB) and the daily Health Checks.  Other than these requirements, SCH highly encourages CRCs to keep informed with SCH intranet resources and the daily Stanford medicine COVID updates.

(c) PPE:  Before a CRC enters SCH, they will be asked to remove their own face coverings or mask, and be handed a hospital-provided surgical mask at the entry check points.  They cannot enter SCH check points with their own masks or masks that a PI provides.  However, PIs must ensure CRCs have appropriate face coverings to return onto campus.  Once inside, SCH units will provide the CRC with the PPE that is required for that unit before they enter (if beyond the mask provided is needed) and PPE usage will be monitored and tracked by those SCH units.

If downstream lab-based (wet or dry non-patient facing) research activities will occur, an additional, separate Chair approval process is required using the Lab Continuity Smartsheet.  After Step 1 (Chair approves clinical research components), any such components will be referred to John Whitin. For instructions on how to update the Lab Continuity Smartsheet.  See “BASIC RESEARCH” below for details.

COVID-19 Clinical Research are also required to complete a short survey here

Approval Process for COVID-19 Human Subjects Research

Under that heading, change “COVID-19 Clinical Research are also required to complete a short survey here” to: 

All COVID-19 clinical research studies are approved by a SoM committee called the COVID-19 Clinical Research Review Panel, or CCRRP.  This approval occurs in parallel with

Chair’s approval.  Follow these steps for COVID-19 research approval:

1.       Submit COVID-19 Clinical Research Review Panel (CCRRP) Form HERE.

2.       Check the box “Send me a copy of my responses.”

3.       Forward a copy of the submitted CCRRP Form to Mary Chen.

4.       Notify Mary Chen of CCRRP approval status.

5.       Mary Leonard’s approval status will be sent to PI via Mary Chen.

Stanford is currently in Stage 2 (started June 22) of the restart process. Only essential workers, authorized researchers and laboratory support personnel and those with permission to be on campus to prepare the campus for restart should be on campus at this time. All work that can be done from home should continue to be done remotely. Read more about Research Recovery: https://cardinalrecovery.stanford.edu/research/research-recovery/

At Stage 2 the following guidelines are in effect: 

• ALL personnel must be named and APPROVED by Department of Pediatrics on the Lab Continuity Smartsheet, before they come in to perform approved tasks. 

• Allowable research activities include essential on-campus research functions and associated support activities that cannot be done remotely because it requires access to facilities or materials that are only available on campus. Most faculty and staff members will continue to work off-site, including theoretical, computational, and other researchers who have not yet been granted access to on-campus facilities, consistent with County guidance.

• As Stage 2, each academic unit may adjust research activity levels depending on staffing and readiness, while adhering to the broader Stanford guidance. PIs may gradually increase the number of on-site personnel in their labs with approval from the academic unit. Headcount will be limited mainly by laboratory space considerations, with up to one person per 250 square feet of laboratory space permitted while maintainingphysical distance requirements with a minimum distance of 6 feet. The sizes and maximum room density of all wet bench research and associated rooms in the Department of Pediatrics can be found (link). 

• All personnel must complete the “COVID-19 Hygiene Best Practices” course in the Stanford Training and Registration System (STARS Course Code EHS-2470-WEB).

• Before coming to campus each day, all persons must obtain a daily virtual Online Access Badge from the Stanford University online tool called Health Check to screen for fever and other COVID-related symptoms. This is a different site than the Stanford Health Care tool required for entering the hospitals.

• Follow the face covering guidelines posted on the Healthalerts.stanford.edu website here Face Covering Guidance 0513.

• Standard Operating Procedures (SOP template) are shared with lab members. 

• No student or postdoctoral scholar is to be required to go into the laboratory. Anyone with concerns should contact Pediatrics department chair (Mary Leonard), student services staff (Margaret Murphy), or John Whitin.

SMARTSHEET GUIDE FOR LAB CONTINUITY

Instructions for Requesting Minimum Basic Operations status in Stage 1 for PI lab and project in Smartsheets.

1) Log in to your Smartsheets page for Lab Continuity Smartsheet. See the “Smartsheets How To for PIs” for detailed instructions.

2) Click on your row of information. A new editing window will open on the right. All your edits must be in this editing window.

3) Scroll way, way down to the section “Minimum Basic Operations Overview”. If not previously done, enter a narrative with specifics about what you are proposing to do, why it needs to start now, who will perform the work, how often it will be done, and what other lab, department, or school resources/cores are needed, including key personnel from other labs. Add a sentence similar to “we will observe the limit of 1-2 people/PI/shift at this stage”. Indicate whether you are separately sending an email or document with more detail to John Whitin and Mary Leonard.

4) Enter the information in the section “Minimum Basic Operations Key People” even if they were entered in other sections above.

5) To request permission from Pediatrics to perform work under Stage 1 guidelines, enter the narrative from “Minimum Basic Operations Overview” or an alternative in the “Stage 1 Overview” section. Mention how many shifts/day are planned, how scheduling will be managed (calendar), and the maximum number of Key People/shift.

6) Enter the information in the section “Stage 1 Key People” even if they were entered above.

7) Check the relevant boxes in the pull-down menu for “Critical Needs”.

8) Change “Lab Status” to Reduced Operation.

9) Click the SAVE button on the bottom. No edits are saved otherwise.

After you click the SAVE Button and close the editing window, an automated message is sent to the Chair (Mary Leonard) and John Whitin. A check mark will appear in the Chair’s View of the Lab Continuity Smartsheet for “Minimum Basic Operations Indicated” and/or “Stage 1 indicated”, which you (the PI requester) cannot see. When she approves it, the box marked “Minimum Basic Operations Validated and Approved” and/or “Stage 1 Validated and Approved” in your PI view will be checked. At this time Smartsheet does not send an automated approval message to the PI.

Let John Whitin know if you have trouble, or you can write to research_ops@lists.stanford.edu for help.