conducting research with covid-19: navigating the approval

Conducting Research with COVID-19: Navigating the Approval ProcessesResearch MattersSeptember 15, 2020

Joshua Fedewa, MS, CIPAssociate Director, HRPP

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Outline

Metrics

Announcements

Conducting Research with COVID-19

Metrics: VolumeTotal Items Submitted

Last 6 Months Last 30 days

New Studies 672 101

Continuing Review 1,551 231

Modifications 3,797 580

Reportable Events 98 28

Total 6,118 940

Last 365Days FY20 Last 90

days March April May June July August

Median 33 41 25.5 37 32 38.5 28.5 23.5 40.5Goal 45 45 45 45 45 45 45 45 45

0

5

10

15

20

25

30

35

40

45

50

Cale

ndar

Day

sFull Board New Studies

Median Turnaround in Calendar Days(Submission to Final Approval)



Median 35 36 23 29 8 37 15.5 29.5 21Goal 21 21 21 21 21 21 21 21 21

0

5

10

15

20

25

30

35

40

Cale

ndar

Day

sExpedited New Studies




Median 23 36 16 21.5 13 14 16 16 14Goal 21 21 21 21 21 21 21 21 21

0

5

10

15

20

25

30

35

40

Cale

ndar

Day

sExempt New Studies




Median 26 25.25 50 19 35 26 31.5 12 24.5Goal 10 10 10 10 10 10 10 10 10

0

10

20

30

40

50

60

Cale

ndar

Day

sReliance New Studies



Days March April May June July August

Median 28 28 20 26 27 17 20 20 21Goal 30 30 30 30 30 30 30 30 30

0

5

10

15

20

25

30

35

Cale

ndar

Day

sMajor Modifications

Median Turnaround in Calendar Days(Submission to Final Approval


Days March April May June July August

Median 14 14 8 13 8 8 9 8 4Goal 10 10 10 10 10 10 10 10 10

0

2

4

6

8

10

12

14

16

Cale

ndar

Day

sMinor Modifications


Announcements

HRPP and OCTM Virtual Office Hours

Debuted on May 5th and will continue until further notice via Zoom

Tuesday and Thursday from 10-11 AM

HRPP and Office of Clinical Trial Management staff will be available to help with all questions

Zoom meeting links are sent out via the HRPP Events Listserv

Any questions, contact Erik Soliz

HRPP Staffing Updates

New Hires

–Rasija Nambiar joined on September 8th as Sr. Regulatory Associate

–Jazmyn Nobles joined on September 14th as Regulatory Assistant

Updates

–Scott Meyers (formerly of IRB Team) will move to Quality and Monitoring Team as Regulatory Monitoring Analyst

–Sr. Regulatory Analyst will be posted soon

HRPP Website Updates

FY21 IRB meeting schedule uploaded to IRB webpages

–Reference this schedule for assigned IRB meeting date

Karen short form and certificate uploaded to Forms page

Guidance documents formerly on Main page added to Policies and Guidance webpage

–Enrolling and Consenting Non-English Speaking Subjects

–IRB Review of Pregnant Partners

Conducting Research with COVID-19

COVID-19 Study Pre-Approval

Why additional approvals for studies researching COVID-19?

–Reduce burden on research participants

–Reduce burden on hospital resources and staff

–Make best use of valuable and limited specimens

These approvals may not apply to all COVID-19 research

–Additional approvals at affiliate sites may be necessary

There may be variations to required approvals on a study by study basis

COVID-19 Studies and Existing Approvals

These additional approvals do not alter existing requirements

–IRB review and approval

–Performance Site review and approval

–Coverage analysis

–Clinical Trial Agreement

–Ancillary review committees (PRMC, SHUR, IBC, etc.)

IBC Review of Studies with COVID-19 Samples

All studies submitted to the IRB that will collect, store, handle, analyze, or use in any fashion biological samples containing or suspected to contain COVID-19 must be registered with the Institutional Biosafety Committee (IBC) for approval

For how to submit to IBC, contact Patrick Conley, Maria LaBandeira-Rey, or Carlos Vaccaro

IBC Review of Studies with COVID-19 Samples (cont.)*

Ensure that you select the appropriate option in eIRB question 6.7

IBC is a blocking review in eIRB so start your submission with IBC ASAP

Studies not involving an interaction or intervention will not see question 6.7

–IBC registration is still required for studies without an interaction or

intervention

COVID-19 Study Pre-Approval Decision Tree

COVID-19 Study Pre-Approval Decision Tree

Is the study investigating treatment for COVID-19?

COVID-19 Ad-hoc Committee

Approval Required (Email Dr. Nancy

Rollins for approval)

Submit Project for Review

Studying Effects of COVID-19 or Pandemic?

COVID-19

Pandemic

Is this an externally funded or collaborative

study?

No

Yes

Approved?

Yes

Project will not proceed

No

SARS-CoV2 Biorepository Stewardship Committee

Approval Required(https://

www.utsouthwestern.net/intranet/services/

communications/covid19/biorepository.html)

COVID Registry Collaborative Approval

Required (https://covid19rps.swmed.edu/crc/index.php?route=proposal/

create)

No

Will study collect or study

COVID-19 specimens?

Yes


COVID-19 data?

No

Yes

What is the study researching?

Effects of COVID-19 or the Pandemic?

Studies researching effects of the pandemic do not require additional approvals prior to IRB submission

Effects of COVID-19:

–Treatments for COVID-19 infections

–Mechanisms of infection of COVID-19

–Effect of COVID-19 infections on a disease

Effects of the Pandemic:

–Impact of pandemic on socialization of young children

–Is pandemic causing patients to avoid healthcare visits

–Effects of pandemic on productivity and costs

Submit Project for Review

Studying Effects of COVID-19 or Pandemic?

COVID-19

Pandemic

COVID-19 Ad-Hoc Committee Review and Approval

Studies researching treatment or interventions

–Remdesivir, dexamethasone, etc.

Externally funded (e.g., NIH, industry sponsored) or collaborative studies

–External registries or repositories

Email Dr. Nancy Rollins for review

Decision will be communicated to PI and to HRPP leadership

Is the study investigating treatment for COVID-19?

COVID-19 Ad-hoc Committee

Approval Required (Email Dr. Nancy

Rollins for approval)

Is this an externally funded or collaborative

study?

No

Yes

SARS-CoV2 Biorepository

Any study collecting or studying samples with COVID-19

Biorepository is collaborative effort between UTSW, Children’s Health, and Parkland Hospital

Contains de-identified and identifiable blood (and blood products), sputum, stool, and urine specimens and clinical data from COVID-19 positive patients

Biorepository Stewardship Committee oversees safety and oversight of samples

–To access samples and data, a one page letter of intent should be sent to [email protected]

SARS-CoV2 Biorepository Stewardship Committee

Approval Required(https://

www.utsouthwestern.net/intranet/services/

communications/covid19/biorepository.html)


COVID-19 specimens?

Yes

mailto:[email protected]

COVID Registry Collaborative (CRC)

Any study collecting or studying COVID-19data from the medical record

CRC is collaborative effort between UTSW, Children’s Health, Parkland Hospital, and Texas Health Resources

Contains clinical data of patients with suspected or confirmed COVID-19

CRC Review Committee has been established to review and prioritize requests

–To access samples and data, complete an online application



create)


COVID-19 data?

Yes

https://covid19rps.swmed.edu/crc/index.php?route=proposal/create

COVID Registry Collaborative (CRC) (cont.)

CRC Review Committee will issue approval

–Notification is auto-generated to HRPPinbox

HRPP will confirm that CRC approval has been issued

–Review will include confirmation that data request of CRC matches the IRB application



create)


COVID-19 data?

Yes

Questions?

26

conducting research with covid-19: navigating the approval

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