COVID-19 Protocol Review Process for Clinical Research

What

A COVID-19 protocol review committee has been established to enhance the research that is being performed at Mount Sinai and ensure that we can provide resources to accommodate as many meritorious studies as possible by minimizing redundancies and competition for finite resources and promoting team science and collaboration. Review is required for the following clinical research studies:

  • Interventional/therapeutic trials
  • COVID-19 Biobank Specimens/Data
  • COVID-19 Registry

Cancer Focused Studies are no longer required to go through the COVID-19 Committee Review process. Investigators conducting cancer related studies that require the consent of subjects must be reviewed and approved by the Tisch Cancer Institute’s Disease Focus Groups (DFG) and the Protocol Review and Monitoring System (PRMS). For detailed guidance, refer to the Tisch Cancer Institute.

When

All COVID-19 related studies must be submitted for review by the COVID-19 Protocol Committee prior to registering or signing agreements (contracts, collaborations, etc.), to conduct a clinical trial.

Non-Cancer Related Interventional Studies: Review is required prior to submission to the IRB. Upon notification of COVID-19 Subcommittee approval, study teams may submit to the IRB/PPHS via RUTH.

Non-Interventional Studies: As of Monday, June 27, 2022, COVID investigators submitting new proposals of an observational nature will no longer need to submit to the Observational-Non-interventional Steering Committee for review. You can submit directly to the IRB or the processes required by your specialty’s research review. Projects currently under review by the committee will be processed.

COVID-19 Biobank Studies: The Mount Sinai COVID-19 Biobank is a joint effort between the Mount Sinai Clinical Intelligence Center (MSCIC) and Human Immune Monitoring Center (HIMC) that collected biological specimens from over 600 individuals with COVID-19 and controls from April through May 2020. These specimens and datasets generated from them are being made available upon request to the Mount Sinai community. In an effort to prevent the duplication of work, as well as to maintain the quality of research associated with these samples and datasets, this committee was formed to review all studies proposing to utilize these resources. Upon proposal approval, the user will be asked to review and sign the data use agreement to gain access to the data. If you have questions about the approval process or how to access data, please contact Steven Ascolillo at steven.ascolillo@mssm.edu.

COVID-19 Registry Studies: The Mount Sinai COVID-19 Registry is a system wide initiative that is currently enrolling patients who have previously been diagnosed with COVID-19 and a sample of COVID-19 negative controls. Registry participants undergo a baseline survey to collect information regarding sociodemographics, comorbidities, health behaviors, medications, access to care, mental health, cognitive function, and quality of life. Data are also collected about the acute episode of COVID-19 and biometric measurements are performed, as well as EKG and basic labs. Blood samples (plasma, serum, and PBMCs) and urine are obtained and maintained in a dedicated biorepository. Participants are followed every 6 months for the first year and then yearly thereafter.

How

Submission process:

1. To ensure that similar studies aren’t requested, prior to submitting a study for review, please refer to:

2. To initiate a review, complete and submit either of the following forms. Include a protocol and other relevant study information in your submission.

Document Access: The study trackers and submission forms, are located in SharePoint. You may be prompted to enter your MSHS credentials to open the SharePoint environment.

Timelines

The turnaround time to review interventional trials is approximately 10 business. The PI will receive email notification of the decision.

COVID Clinical Trials Unit (CTU)

After receiving approval from the COVID-19 Protocol Review Committee all COVID-19 related clinical trials at MSHS should then coordinate the study through the COVID Clinical Trials Unit (CTU). All COVID-19 related protocols must be submitted to the COVID CTU for review and implementation. The COVID CTU will work directly with investigators to submit budgets, contracts, and other regulatory needs. Furthermore, the COVID CTU can provide research staffing support at most MSHS hospitals if additional staffing is needed.

Questions

COVID-19 Review Questions and General Inquiries:
Research 411

SharePoint Technical Issues:
Academic IT Support Center
212-241-7091
ASCIT@mssm.edu

Resources

FAQ

I’m considering doing a chart review study (pre-existing data with no direct patient contact) Do I still need to go through all the steps?

Yes, we are reviewing retrospective studies to catalogue the projects, prevent overlap between similar studies, and promote collaborations when possible. 

We have applied for funding but still haven’t received a decision. Is it still ok to submit this form?

Yes, please go ahead and submit for review.  Some of the institutional funding sources may request that the project have COVID-19 Review Committee Approval.

Based on the Flow Chart, this process seems to be quite specific to interventional trials, not for observational studies. We propose an observational survey study, do we still need to follow all the steps?

We are reviewing observational studies as well to catalogue the projects, prevent overlap between similar studies, and promote collaborations when possible. 

If we plan on making a modification to an already IRB-approved, ongoing study (pre-COVID) to include a COVID data collection tool, do we need to submit it to the COVID-19 Protocol Review Team? The study is not a clinical trial.

If you are looking at COVID-19 cohorts, we are requesting that these amendments be submitted for review to catalogue the projects, prevent overlap between similar studies, and promote collaborations when possible.  Harmonization of COVID data collection tools and questionnaires across multiple studies could enhance all of our science!

If we plan to recruit healthcare workers from all campuses, do we need to list all the sites involved? If so, can I list the same PI?

For resource management and allocation, it is best to list the sites that will be involved and who will be the point person at each site.  The overall PI will remain the PI for each site.

Is it necessary we wait until we have a finalized protocol to begin the REDCap?

We prefer a finalized protocol, but if this is an industry-sponsored trial and the sponsor has not sent the final protocol, you can submit a near-final version for the sub-committee review.  A final protocol is necessary for the COVID-19 Oversight Committee review before IRB submission.

Regarding the relevant documents to upload: I have not yet submitted an IRB application. What would you recommend for me to include? Would a brief couple of paragraphs outlining the study suffice?

Please submit what you would send the IRB to describe your project, including the patient population to be studied, the research question, the dataset to be used, etc.

Regarding relevant subcommittees: Would any of the subcommittees have an epidemiologist /cardiologist/ study specific specialist?

We have 9 Subcommittees with expertise from across the specialities. 

  1. Plasma
  2. Antivirals
  3. Pulmonary/ARDS
  4. Immune modulation
  5. Prophylaxis
  6. Vaccine
  7. Diagnostics
  8. Biorepository/Big Data
  9. Population Health

Is this part of the InfoEd submission? Or just this REDCap form? Do you need an IF number?

Our submission is just a REDCap form. All sponsored project and research proposals, excluding projects in which BRANY serves as the IRB and negotiates the clinical trial agreement on behalf of Mount Sinai, must be submitted to the GCO/ InfoEd. You do not need to submit the IF number.

Does this process takes the place of RUTH and I do not have to submit via RUTH as well?

This process does not take the place of RUTH. In order to submit to the IRB, you will still need to submit it through RUTH.