preparing single irb grant submissions utilizing the · pdf filepreparing single irb grant...

Preparing Single IRB

Grant Submissions

Utilizing the RSRB as the

Reviewing IRB

Kelley O’DonoghueAssociate Vice President for Human Subject Protection

&Tiffany Gommel

Executive Director, RSRBApril 20th 2017

Multiple IRBs Review a Multi-Center Study

Multi-center research protocol

Site #1 Site #1 IRB review

IRB #1 approves the

study

Site #2 Site #2 IRBIRB #2

approves the study

Site #3 Site #3 IRBIRB #3

approves the study

Single IRB Review of a Multi-Center Study

Multi-center research protocol

Single IRB reviews and

approves research

study

Site #1

(inst. review)

Site #2

(inst. review)

Single IRB approves

amendment to add Site #1, #2,

and #3

Site #3

(inst. review)

NIH Final Policy: Single IRB (sIRB) Review for Multi-Site Research

Purpose:

“To enhance and streamline the process of IRB review and reduce inefficiencies so that research can proceed as expeditiously as

possible without compromising ethical principles and protections for human

research participants.”

Definitions

• Single IRB (sIRB) = Central IRB = Reviewing IRB

• Reviewing IRB – The Institutional Review Board (IRB) designated to review and approve human subject research.

• Relying IRB – The Institutional Review Board (IRB) that delegates the responsibility of IRB review and approval to another IRB.

OHSP Policy 504 - RSRB Reliance for Review

Scope of the Policy• NIH-funded, non-exempt research• Grant submissions on/after 09/25/2017

• Two or more domestic sites conducting the same protocol– same research questions, involve the same

methodologies, and evaluate the same outcomes – accruing research subjects for studies that are

identical except for variations due to local context consideration

– Talk to your Program Officer

Scope of the Policy• Exclusions

– Foreign sites– Career development (K), institutional training

(T), and fellowship awards (F) – When federal, state, tribal, or local requirements

require local review

• Exceptions are considered when there is a compelling justification – Probably rare and very site-specific

Selecting the sIRB

Selecting the sIRB

• Application includes a plan for who will be the sIRB– Participating sites – letter of support to indicate

willingness to rely on sIRB• Reliance agreement not required prior to submission

or prior to funding– Delayed onset research (intent is to conduct

future human subjects research) –• include a statement that you will follow policy and

communicate plan prior to conduct• But what about the $$$...talk to Program Officer

Selecting the sIRB

1. Lead PI’s institutional IRB – Lead PI at UR…RSRB

2. A participating site’s institutional IRB3. Independent IRB

Must be registered with OHRP and have membership to adequately review the

proposed study

Planning for your Grant Submission

Planning for your Grant Submission

• Required to meet with Kelley and Tiffany• Who are my Team Members???• Budget and budget justification• Oversight plan

– Training– Communication plans– Distribution of Materials– Monitoring

Who are my Team Members?

Oversight Team

Who is going to oversee the research at all the sites (similar to a Coordinating Center)?• Lead Principal Investigator• Project Manager• Site Monitor (if needed)• Safety Monitor (if needed)

Enrolling Team

Who is going to enroll subjects at the UR?• Site Principal Investigator• Sub-investigators• Study Coordinator

Oversight Team• Lead Principal Investigator

– Primary responsibility for oversight and management of the study at all participating research sites

• Project Manager– Manages sites, training, ensures distribution of

materials, oversees enrollment/compliance at all sites• Site Monitor (if needed)

– Visits sites to monitor data/data collection– Remote monitoring– Checks compliance at sites

• Safety Monitor (if needed)– Oversees research events and safety across all sites– Could be the Lead PI

Enrolling Team

• Site Principal Investigator(s) – Individual at each site who agreed to participate in

the study and responsible for the oversight and conduct of the study at the local site

– Could be the Lead PI at the Rochester site• Sub-investigator(s)• Study Coordinator

– Manages the activities at the local site– Ensures institutional review at the local site– For a very small study, this could be the Project

Manager but need to be very careful about dedicated time and ensure the percent effort is there.

Budgeting

NIH Guidance on sIRB CostingPrimary activities

(Indirect costs/F&A)

• UR site – Review and approval of the

protocol, model consent approval (Initial, CR, amendments, etc.)

– UR site approval documents

• Other sites– Institutional review by local

institutions/local IRB

Secondary activities

(Direct costs)

• UR RSRB costs of review of the other sites– Initial approval– Continuing Review – Amendments

NIH guidance document includes 12 scenarios

sIRB Budget and Budget Justification

sIRB Budget and Budget Justification

• Base costs determined from operating budget for FY 2017– $ / review items– Determined “work unit cost”– Cost for review

• Determined by work per item• Estimate based upon knowledge

sIRB Budget Creation

• “Demographic data” needed– Sites– Expected consent documents

Consent = Work for the RSRB = Costs – Years for the grant and years for active study

conduct• Relate to the number of continuing reviews

sIRB Budget Creation

• “Study Amendment data”– Protocol only

• Single cost/single review– Recruitment only

• Single cost/single review– Consent form only

• Cost per site– Protocol and Consent form

• Cost per site

Use your Best Guesstimate:

1. What experience do you have? Colleagues have?

2. What do you know about the population?

3. What do know about this type of study?

4. Review amendments from past similar studies to compare and make an informed guess

Use what you can to make the most informed decision possible!

What does your information tell you?

• Initial Review– Breakdown of indirect and direct costs– Consents = more work

• Consent documents = consent, parent permission, etc.• Spreadsheet calculates costs

– Accounts for subtracting out indirect costs out of direct• If less than 2 consent documents, delete “Per site per

additional consent” line item

What does your information tell you?

• Continuing Review– Breakdown of indirect and direct costs– Costs factor in years of study conduct– Notice per year and per site

What does your information tell you?

• Amendment – Breakdown of indirect and direct costs– Costs factor in number of amendments/type– Notice

• per amendment • Per amendment/site

sIRB Budget Justification

• Use the excel spreadsheet to justify costs• Include any supporting information related

to the number and types of amendments– Justify your numbers with previous “real-life”

examples

Oversight Plan

Refer to OHSP Guideline for Coordinating Centers Studies

Oversight Plan - Training

• Consistency in study conduct across sites• Protocol compliance• Protecting subjects• Reporting of events• RSRB Reviewing IRB

– Other sites understand IRB requirements, reporting responsibilities

Oversight Plan – Communication Plan/Distribution of Materials

• Team meetings– With oversight team– With other sites

• Safety events• IRB communications• Collecting information for continuing

reviews• Institutional reviews

Oversight Plan – Data Collection/Monitoring

• How will data be collected and monitored– Database?– Forms?– Source Verification (100% vs. a percentage)

• Site Monitoring• Remote Monitoring

Points to Remember

• Refer to OHSP Guideline for Coordinating Centers Studies

• Remember to budget for your oversight plan– Project Manager– Training (time and resources)– Monitoring– Communication/Distribution of Materials

Scenario #1: 2-Yr Grant for Feasibility Study

• Study to evaluate feasibility of utilizing a non-invasive device to assess visual acuity in children

• 80 subjects enrolled over a 1-year period at 4 sites in the United States

• Subject participation will consist of 1 visit only (during routine eye screening)

• 1 parent permission form, 1 verbal assent• Projected amendments:

– Protocol only: 3– Recruitment only: 0– Consent form only: 0– Protocol and consent form: 2

Scenario #1: 2-Yr Grant for Feasibility Study

Scenario #2: 10-Yr Grant for Longitudinal Study

• GTMR observational study of Disease Z• 2000 subjects plus 500 controls & 500 caregivers

enrolled over a 5-year period at 20 domestic and 10 international sites

• Baseline screening and follow-up will last 5 years• 7 consent forms: 4 subjects (primary study, future

contact database, genetic testing consent, optional procedure consent); 2 caregiver (primary study, genetic testing consent); 1 healthy controls

• Projected amendments:– Protocol only: 7– Recruitment only: 35– Consent form only: 5– Protocol and consent form: 18

Scenario #2: 10-Yr Grant for Longitudinal Study

Scenario #3: 5-Yr Grant for Phase 2

Investigational Drug Study

• Double-blind, placebo-controlled study of Drug X in Condition Y

• 215 subjects enrolled over a 2-year period at 15 sites in the United States, one site is located in the Nevada desert that includes a large Native American reservation

• Screening, treatment and follow-up phase will last 40 weeks

• 1 subject consent form• Projected amendments:

– Protocol only: 3– Recruitment only: 7– Consent form only: 1– Protocol and consent form: 2

Scenario #3: 5-Yr Grant for Phase 2

Investigational Drug Study

Questions

References

• NIH Single IRB Policy (FDP 9/22/2016)• OHSP Policy 504 - RSRB Reliance for

Review• NIH Final Policy - Single IRB Review for Multi-site

research• NIH Guidance on sIRB costing• NIH Single IRB Policy FAQs for Extramural

Community