tools, templates, and checklists for streamlining … › pnmresources › pid-136 ›...

5/3/2016

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Tools, Templates, and Checklists for

Streamlining IRB Protocol Review

Sharon Freitag, BSc

Megan Kasimatis Singleton, JD, MBE, CIP

May 5, 2016

Welcome!

Nora Murphy

Online Learning

Coordinator

PRIM&R

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Content Copyright

This webinar is the property of PRIM&R, and is protected by United States and

international copyright laws. Certain materials are used by permission of their

respective owners, and those are marked accordingly. The webinar may not be

copied, reproduced, republished, linked, uploaded, posted, transmitted, or

distributed in any way without the prior written permission of PRIM&R. Reuse of

the webinar for commercial purposes, or for audiences beyond the purchasing

institution, are prohibited.

Permission would be based on your agreement to keep intact all copyright,

trademark, and other proprietary notices. Modification of this content or use of

this content for any other purpose is a violation of the rights of PRIM&R or third

parties. Access to this presentation should not be construed as a license or right

under any copyright, patent, trademark or other proprietary interest of PRIM&R

or third parties.

Sharon Freitag

Director, Research

Ethics Office

St. Michael’s

Hospital, Toronto

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Megan Kasimatis Singleton, JD, MBE, CIP

Associate Director, Human

Research Protections

University of

Pennsylvania

Disclosures

Sharon Freitag:

I have no relevant personal/professional/financial

relationship(s) to disclose with respect to this

educational activity

Megan Kasimatis Singleton:

I have no relevant personal/professional/financial

relationship(s) to disclose with respect to this

educational activity

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Learning Objectives

1. Learn how to best utilize tools, templates and

checklists to improve the protocol review

process

2. Obtain tips for adapting pre-existing tools to fit

your institution’s needs

3. Understand the benefits and shortcomings of

using checklists and templates in the IRB

review process

Overview

Review common uses of tools, templates, and

checklists

Discuss a strategy for tool use, implementation and

evaluation

Review Case Examples for the use of Tools,

Templates and Checklists

o Protocol/Submission Screening

o IRB Member Reviews

o IRB Minute-taking

o IRB Correspondence

o Review Available Resources

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What are Tools, Templates &

Checklists Used for?

IRB Staff Review Processes [e.g. screening studies or

submissions to ensure completeness]

IRB Member Review Processes [e.g. review of the approval

criteria and documentation of review recommendations]

Documenting specialized determinations [e.g. Subpart

determinations, non-significant risk device determinations]

Standardizing and Facilitating IRB Correspondence

Verification that essential review functions were performed

Guiding submitters through IRB submission/review process

Communicating IRB expectations

A “Strategy” for Tool Use,

Implementation, and

Evaluation

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A Five-Step Strategy

1. Identify your problem/purpose

2. Determine which type of tool will address

your need

3. Develop your tool

4. Implement your tool

5. Evaluate your tool [and refine it!]

Step 1: Identifying your Challenge/Objective

Identify the problem…what are you trying to achieve?

o Completeness

o Consistency

o Compliance

Challenges should be discrete – What is not working about

current practice that needs to change?

Example: You conduct a QA review of studies processed at the

expedited level at your institution and identify that Subpart

Determinations for research involving children are not routinely

documented.

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Step 2: Determining Which Type of Tool Will

Address your Need [and if a tool is the solution]

Once you have defined your need, consider how

best to achieve that goal

o Option 1: Retrain your staff- [SOLUTION: NO TOOL]

o Option 2: Revise the staff screening checklist for expedited

reviews to create a new section specific to vulnerable

populations. This section must be completed by IRB staff prior

to placing a study up for final approval. [SOLUTION: REVISED

STAFF SCREENING CHECKLIST]

o Option 3: Create a new reviewer form for the IRB “approver”

asking that the approver verify and document if the study

involves a vulnerable population at the time of final review.

[SOLUTION: NEW REVIEWER FORM]

Step 3: Developing your Tool

Create checklists that prompt thought rather than

rote completion

Consider annotated templates with instructions and

suggested language (be clear what is mandatory

and what is optional)

Ensure the tool facilitates the process- Don’t simply

add extra work!

Ask for permission to ‘borrow’ from originators and

give credit

Customize for YOUR needs

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Step 4: Implementing your Tool

Consider whether completion is “required”

Consider a “pilot” period for implementation- test

with “friendly” end-users

Define in your SOPs how the documents will be

used

Step 4: Example

Example for Defining Use of Forms in SOPS- Identify

whether the forms are considered controlled/non-

controlled:

Controlled Forms are regulatory documents that

become part of the permanent record of IRB

review.

Non-controlled forms are management tools

designed to assist with the IRB review process and

do not become a formal part of the IRB submission.

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Step 5: Evaluating your Tool

Assess end-user satisfaction

Assess impact on performance/process through

a quality assessment post-implementation

Don’t be afraid to make changes/incorporate

feedback

o Not everything you try will be successful!

Example 1: Using Tools,

Templates, and Checklists

For Protocol Screening

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Submission Checklists

Useful to ensure completeness of submission

Helps to ensure that all regulatory requirements

at time of submission are met

Can include request for documentation of

institutional training requirements (e.g. GCP,

NIH)

Downside can lead to focus on form over

substance

Checklists: Helpful Hints

Create a checklist that prompts thought rather

than just rote completion

o Avoid using only check boxes: ask for version dates of

documents

Define the purpose of the checklist up front

o Is it to document criteria for approval?

Consider whether completion of the checklist is

“mandatory”

o Is the checklist “controlled” or “non-controlled”?

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Submission Checklist Example

Challenge:

Convened IRB was over-burdened by incomplete

submissions and were focusing on administrative issues

rather than substantive issues that affected criteria for

approval

Solution:

Develop a “submission checklist” which can be utilized

by both researchers and/or IRB staff to determine if a

submission is complete and review ready


Templates, and Checklists to

Facilitate IRB Member

Reviews

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IRB Member Review Template

Different approaches

Can be used as a training tool for new IRB

members

Lead by example (share exemplary IRB reviews)

Mandatory vs. Optional

Should facilitate rather than hinder a good review

Organize in a format that will facilitate the

drafting correspondence post meeting

o Substantive concerns up front

IRB Member Template

Challenges:

o New IRB member is unfamiliar with the review process

and what is required

o IRB reviews are inconsistent in quality

o Review is disorganized, reviewer gets side tracked

o Reviewer comments difficult to draft correspondence

from

o Review is missing key elements and/or

criteria for approval

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IRB Member Review Template

Solutions:

Solution 1: Provide reviewer template in package/electronically

[TEMPLATE]

Solution 2: Use a short form to address substantive issues in

advance of convened meeting [CHECKLIST]

Solution 3: Provide ‘de-identified’ samples of exemplar reviews

[NO TOOL- PROCESS CHANGE]

Solution 4: Discuss reviewer expectations at time of new IRB

member orientation [NO TOOL – PROCESS CHANGE]

Be flexible – not all members tackle reviews the same way

Can enhance or facilitate discussion at the convened meeting

Consider a combination of the above



Facilitate IRB Meeting

Minutes and Documentation

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The Challenge: IRB Minutes

Need to meet regulatory requirements for

minute-keeping

Need to document all special determinations in

compliance with regulatory requirements o Waivers of consent/Waivers of documentation of consent

o Non-significant risk device determinations

o Subpart determinations

IRB Record Keeping: Regulatory

Requirements

§46.115 IRB records.

(a) An institution, or when appropriate an IRB, shall prepare and

maintain adequate documentation of IRB activities, including the

following:....

(2) Minutes of IRB meetings which shall be in sufficient detail to show

attendance at the meetings; actions taken by the IRB; the vote on these

actions including the number of members voting for, against, and

abstaining; the basis for requiring changes in or disapproving research;

and a written summary of the discussion of controverted issues and

their resolution.

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IRB Minutes: New OHRP/FDA

Guidance

In November 2015, the OHRP/FDA released draft guidance about

expectations related to IRB meeting minutes

This is the first draft guidance on this topic published jointly by

OHRP/FDA

Sets forth expectations regarding specific items that must be included in

IRB meeting minutes and the level of detail required for each item

This guidance is still in draft form and may be treated as

“recommendations” however, its release presents a unique opportunity

to evaluate existing practices related to IRB meeting minutes- Are there

gaps between local practice/the guidance?

IRB Minutes: New OHRP/FDA

Guidance

Specific Areas of Obligation addressed in OHRP/FDA

guidance:

Attendance, including the participation of members,

consultants, and guests

Documentation of Quorum

Documentation of IRB approvals, disapprovals, requests for

modification, and suspensions/terminations

Documentation of controverted issues and their resolution

Documentation that criteria are met related to overall

approval criteria, subparts, and other special determinations

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Solutions to Ensure Meeting Minutes meet

Regulatory Requirements

Solution 1: Create a “cheat sheet” for staff to help educate them about

all items that must be covered in the meeting minutes [CHECKLIST]

Solution 2: Create a minutes template and sample set of minutes to

guide IRB staff. Include template language for special determinations,

format, etc. and detailed instructions for the additional information that

must be documented on a protocol-specific basis to support the

determinations made [MINUTES TEMPLATE]

Solution 3: Charge a member of the IRB staff (in addition to the Chair)

with confirming all special determinations have been made prior to the

final vote and documenting this [NO TOOL- PROCESS CHANGE]

**Be cautious that tool development is not too “reactionary” and only

emphasizes “form” over “substance”.

Implementation & Evaluation

Consider that a multi-faceted approach may be needed

that involves both tool implementation and process

changes to improve IRB meeting minutes

How will those process changes be operationalized into

practice? Where do you document that this is how you

are doing things?

Ensure minutes taking processes and policies of the

HRPP are in alignment so finalized minutes and what

is/is not included is supported by your policy/practice

documents.

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Facilitate IRB

Correspondence

The Challenge: Facilitating IRB

Correspondence

Correspondence is used for many purposes

o Education

o Communicating IRB determinations

o Setting forth IRB expectations

Critical information must be highlighted:

o Special determinations

o Expiration dates, deadlines for response

Delivery of information is critical [format should

be concise and clear]- standardization helps

build familiarity and understanding

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Tool-Based Solutions

Templates:

o Letter templates may be created for a variety of action

types/decisions- format should remain consistent so

researchers understand how the IRB communicates

o Consider how formatting may serve as an educational

opportunity

Separate out substantive issues that speak to the

criteria for approval from those that are more

administrative in nature

Use correspondence as a way to connect with

researchers who may not otherwise reach out to

the IRB for assistance

Sample Letter Structure for

Communicating Requirements

Primary Stipulations

Administrative Issues

Recommendations

Notes/Reminders

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Tool-Based Solutions

Checklists

o Consider using a checklist to identify common

administrative items that may need to be addressed

as conditions for approval and standardizing the

language to communicate these requirements

Implementation & Evaluation

Wide- scale changes to the formatting of IRB

correspondence many need to be broadly

communicated prior to implementation

o Consider the impact if communication templates change

dramatically

o Consider publishing a “mock” IRB correspondence letter

on your IRB’s website as a communication tool

identifying where critical information is located

o Develop mechanisms to solicit feedback on

correspondence- Are certain items routinely confusing?

How will you collect and review this feedback?

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Finding Resources

Checklist Resources

OHRP Checklists: http://www.hhs.gov/ohrp/regulations-and-

policy/guidance/checklists/# (Informed consent)

FDA Self-Evaluation Checklist:

http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinical

Trials/GuidancesInformationSheetsandNotices/ucm118063.htm (IRB

Policies and Procedures)

AAHRPP IRB Evaluation Instrument:

http://www.aahrpp.org/apply/resources/evaluation-instrument-for-

accreditation (Used to determine whether IRB meets accreditation

standards)

Many individual IRBs have created wonderful checklists- Consider

utilizing available resources!

Remember to ask for permission and credit originators

http://www.hhs.gov/ohrp/regulations-and-policy/guidance/checklists/







http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm118063.htm



http://www.aahrpp.org/apply/resources/evaluation-instrument-for-accreditation








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Template Examples

Protocol Template

o Tufts University - Guidance Document and Protocol Template

http://viceprovost.tufts.edu/HSCIRB/forms-and-

templates/irb-forms/protocol-template-document/

Consent Form Templates – including Parental

Permission, Assent and Debriefing Templates

o University of Chicago

https://sbsirb.uchicago.edu/page/consent-form-

templates-and-examples

Template Examples

Consent Forms

o Consent Form Do’s &

Don’ts : Stanford (annotated)

http://researchcompliance.

stanford.edu/hs/research/

documents/consent_form

_tips_AID-C1.pdf

http://viceprovost.tufts.edu/HSCIRB/forms-and-templates/irb-forms/protocol-template-document/













https://sbsirb.uchicago.edu/page/consent-form-templates-and-examples









http://researchcompliance.stanford.edu/hs/research/documents/consent_form_tips_AID-C1.pdf






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Additional Resources

OHRP Decision Tools - 11 in total

http://www.hhs.gov/ohrp/re

gulations-and-

policy/decision-

trees/index.html


FDA Device Advice - Regulatory Advice

http://www.fda.gov/MedicalDevices/DeviceR

egulationandGuidance/

HIPAA requirements - Comprehensive

Health Information Privacy Guidance

http://www.hhs.gov/hipaa/index.html

http://www.hhs.gov/ohrp/regulations-and-policy/decision-trees/index.html










http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/







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ListServ – IRBForum

Company web sites – IRBNet,

WIRB, Huron

oNewsletters


Guidance, policy documents, and standard

operating procedures developed by individual IRBs

PRIM&R Knowledge Center

Other informational tools (e.g. OHRP, PRIM&R,

CITI)

o Videos

o Apps

o Podcasts

o Webinars

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Using Non-Traditional Resources

Many emerging areas in human subjects research require IRBs to

expand their knowledge base into domains that traditional IRB

resources may not sufficiently address:

o Examples:

Use of social media for research - What is an IRB to look for? USC

https://oprs.usc.edu/education/internet/

The inclusion of research-related information in the medical record -

FDA Guidance

http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.ht

m

Storage of data on third party cloud providers – University of

Pittsburgh http://www.irb.pitt.edu/electronic-data-security

Consider where the “field” expertise rests

Consider your local “human” resources

Overall “Pros” to Consider

Useful as a training/learning tool

Excellent organization tool, helps prioritize

Provides a guide to items needing attention

Helps in formalizing and implementing

standardized review processes

Helps to ensure review is compliant with

regulatory requirements

Useful in facilitating program/process evaluations

https://oprs.usc.edu/education/internet/

http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm

http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm

http://www.irb.pitt.edu/electronic-data-security





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Overall “Cons” to Consider

Can lead to focus on form over substance

Over reliance – used as a crutch

May misrepresent actual practice

Rubber stamping

One size does not fit all, no two studies are the

same

Should not just be a cut and paste exercise…still

requires thinking and proofreading

Need to be regularly reviewed and revised

Conclusions

No need to reinvent the wheel (just make sure

you give credit)

Should facilitate the process, not hinder it

Should reflect your actual practices/SOPs

Are living documents

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Questions?

To submit a question,

simply click on the Q & A menu

at the top of the screen.

[email protected]

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