Use of a Single IRB of Record Case StudyHallie Kassan, MS, CIPDirector, Human Research Protection ProgramNorthwell Health

February 6, 2018

DisclaimerThe views and opinions expressed in this presentation are those of the individual presenter and do not necessarily reflect the views of the Clinical Trials Transformation Initiative.

The presenter is an Employee of Northwell Health.

Northwell Health – Feinstein Institute for Medical Research

New York Metropolitan Area Health System

23 Hospitals

650 Outpatient Facilities

1 Research Institute

More than 66,000 employees

Service nearly 11 million people

Schools School of Medicine School of Graduate Nursing and Physician Assistant Studies

Northwell Health Clinical Research Portfolio

Mid size clinical research institution

2300 open clinical research studies

1500 research employees

Adoption of CTTI recommendations

Acquiringnew

hospitals

Investigators requesting

reliance

Investigators requesting Northwell IRB to serve

as single IRB

Moving ForwardInvestigators – yes!

Institutional Leadership – yes!

HRPP/IRB Staff – yes!

CTTI Take Aways

Relying Institution Reviewing IRB

IRB Authorization Agreement Template IRB Authorization Agreement Template

Defining Institutional Policies Creation of External Site Questionnaire

Creation of Institutional Approval Process

Serving as Single IRBServe as Single IRB for 2 major psychiatric studies

Relying sites are mostly community hospitals

NIH funded study – each site still needed to establish its own FWA

Relying Institution Role

Institutional vs IRB ResponsibilitiesPolicies needed revising HRPP Policy and Procedure Manual vs. Institutional

Level Policies

Processes needed revising

Education, education, education!!!

Institutional Approval – Submission Process

HRPP office reviews consent and personnel

Pharmacy notified

Biosafety notified

HIPAA security team notified

Initial Application Received

Institutional Approval – Finalization

IRB Approval

HIPAA Security Approval

Pharmacy Approval

Radiation Safety Approval

Institutional Approval Granted

Measuring ImpactNumber of submissions using a single IRB

Time from study start to completion/publication of results

Time from submission to Institutional approval

Resources/Scalability

Number of Submissions to External IRBs

0

20

40

60

80

100

120

140

2012 2013 2014 2015 2016 2017

Num

ber o

f New

Sub

mis

sion

s

Year

Time to Results

Reference: Carey, B (2015, October 20). New Approach Advised to Treat Schizophrenia. The New York Times. Retrieved from http://www.nytimes.com

“…it’s worth noting that it usually takes about 17 years for a new discovery to make it into clinical practice; or that’s the number people throw around. But this process only took seven years.”

- Robert K. Heinssen, director of services and intervention research at the National Institute of Mental Health

Time to Study Start Up Measures

0

50

100

150

200

250

Site to IRBCycle

Site toPatient Cycle

Time toInstitutional

Approval(Northwell)

Day

s

Measure Sample Size Median Range

Site to IRB Cycle* 234 109 0-621

Site to Patient Cycle*

151 222 27-639

Time to IA 97 63 0-232

* Used hospital-based metrics

Reference: Abbott, D, Califf, R, Morrison, BW, Pierre, C, Bolte, J and Chakraborty, S. (2013) Cycle Time Metrics for Multisite Clinical Trials in the United States. Therapeutic Innovation and Regulatory Science, 47(2), 152-160.

Resources Needed

0

100

200

300

400

500

600

700

800

900

2012 2013 2014 2015 2016

New Submissions By Year

Year Number of FTEs

2012 9

2013 9

2014 9

2015 9

2016 10

ChallengesAs Relying Institution Getting investigators to understand institutional

responsibilities vs IRB responsibilities Tracking submissions and reliance agreements Balancing amount of oversight still needed Communication between reviewing IRB, HRPP office,

local site investigators

As Reviewing IRB Teaching HRPP staff and IRB members institutional vs

IRB responsibilities How to handle external site information in

electronic system

Challenges

Lessons LearnedMeasure study start up time from submission to institutional approval for internal IRB vs external

Study start up is dependent on more than just the IRB review

Metrics for impact need to be defined.

www.ctti-clinicaltrials.org

THANK YOU.