The Research Guides are comprehensive manuals for those conducting human subjects research.

Research Guide (Flipbook) (PDF) (Table of Contents List )
sIRB Research Guide (Flipbook) (PDF) (Table of Contents List)

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Research Guide Table of Contents List

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Do I Need to Submit to the IRB?
DEFINITIONS
    What Is Research (DHHS)?
    What Is Human Subjects Research (DHHS)?
    What is a Clinical Trial? (DHHS)
    What Is A Clinical Investigation? (FDA)
    Newborn Blood Spots
    Course Related Student Projects
QA/QI
    What Is QA/QI?
    When Is QA/QI Also Research?
    How HRPO Makes A Determination
    What If I Want To Publish The Results Of My QA/QI Project?
CASE STUDY/SERIES
    What Is A Case Study/Case Series?
    Do I Have To Submit My Case Study/Case Series?
    HIPAA Requirements
RESEARCH WITH EXISTING SPECIMENS or DATA
    What Makes Data/Specimens Identifiable?
    When Do I Need IRB Approval To Use Each Kind?
    What About Data Or Samples From Decedents?
    What If I Am Using Embryonic Stem Cells Or iPSCs?
OTHER
    Prime Awardee Of Federal Funds

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SBIR/ STTR Grants
    Institutional (Small Business) Engagement in Human Subjects Research
    Obtaining a Federal Wide Assurance (FWA)
    Pre-Grant Submission Information
    IRB Submission Information

Research Team
PRINCIPAL INVESTIGATOR ROLES & RESPONSIBILITIES
    What Is A Principal Investigator?
    Who May Serve As A Principal Investigator?
    Students As Principal Investigators
    General Responsibilities Of The Principal Investigator
    FDA Regulated Research – Additional Responsibilities For The Principal Investigator
    Changes To A PI’s Status
VISITING STUDENT GUIDANCE
    Purpose
    Applicability
    Determining Engagement
    Employment or Student Status Requirement
    Human Subjects and Protocol Specific Training
    Limited Access ID Request Instructions for Students
    Other Relevant Policies and Information

Single IRBs
RELYING ON AN EXTERNAL IRB
WU IRB AS THE REVIEWING IRB / SINGLE IRB

International Research Checklists
    Behavioral Prep Work Checklist – Prior to Creating IRB Application
    Biomedical Prep Work Checklist – Prior to Creating IRB Application

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Consent and Assent
INSTRUCTIONS FOR SIGNATURE LINES
    Parental Signature Requirements
    Using the Signature Lines for Assent
    Decisionally Impaired Adults
    Hearing Impaired Adults
    Visually Impaired Adults or Adults who Cannot Read
    Adults who are not able to Physically Sign the Consent
    Witness Signature Line
INSTRUCTIONS FOR WRITING A CONSENT FORM
    Making Your Consent Easy To Read
    Version Numbers, Headers, Signature Blocks, And Standard Language
    Revising Your Consent Form
    Consent Addenda
    Consent Forms For Studies With Minors
    Consent Forms For Adults Without Capacity To Consent
    Participants Or Partners Who Become Pregnant During Study Participation
KEY INFORMATION
    What Is “Key Information” In The Context Of A Consent Form?
    When Is A “Key Information” Section Required In A Consent Form?
    How Do I Write A “Key Information” Section?
ELECTRONIC INFORMED CONSENT (eIC)
    What Is eIC?
    Why Would A Research Study Use eIC?
    Which Studies Are Eligible For eIC?
    What Are The Necessary Components Of eIC?
    What Should Be Submitted To The IRB?
PHONE SCREEN CONSENT
    When Is Consent Required For Phone Screening?
    Phone Screening Consent Process
    IRB Review Requirements For Obtaining Consent Over the Phone
CONSENT FORM
    Basic Elements Of Consent
    Additional Elements Of Consent
    myIRB Consent Templates
    Consent Information Sheet
    Consent Letter
    Exempt Information Sheet
    Phone Screen Consent
ASSENTING MINORS
    Assent Definition
    Age Guidance For Assenting Minors
    Written Assent
    Verbal Assent
    Waiver Of Assent
LEGAL AGE TO CONSENT
    Determining The Legal Age To Consent
    Emancipated Minors
ENROLLING PARTICIPANTS WHO DO NOT SPEAK ENGLISH
    Inclusion of Non-English Speakers is Anticipated
WAIVERS OF CONSENT
    What Is A Waiver Of Consent?
    Criteria For Waiver Of Consent
    Retrospective vs. Prospective Data Collection
    Waivers Of Consent To Avoid Bias
    Alterations Of Consent & Deception Research
WAIVER OF DOCUMENTATION OF CONSENT
    Waiver of Consent vs. Waiver of Documentation
    When Can Documentation of Consent Be Waived?
    PHI and Waivers of Written Documentation of Consent
GUIDANCE ON CONSENT FOR GENOMIC DATA SHARING FOR RESEARCHERS
    Why Should I Care About Genomic Data Sharing?
    Is Genomic Data Sharing Ethical?
    Shouldn’t I Just Make Genomic Data Sharing An Optional Component Of My Study?
    Will I Have A Harder Time Recruiting Research Participants If I Require Genomic Data
        Sharing To Participate?
    What Happens If I Decide Not To Include Broad Sharing In My Research Design?

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Recruitment
RECRUITMENT METHODS
    Existing Registries/Databases
    Subject Pool
    Colleague Referrals
    EPIC
    Recruitment Enhancement Core (REC)
ACCESSING PROTECTED HEALTH INFORMATION (PHI)
    What Is Protected Health Information (PHI)?
    How Do I Request Access To Existing PHI For Recruitment?
    PHI From A Research Study/Registry
    Creation Of PHI During A Phone Screen
    Information Considered To Be Identifiers
RECRUITMENT MATERIALS
    Do’s And Don’ts
    Posting Of Recruitment Materials
    Materials Provided By A Sponsor Or Lead Site
    Recruitment Materials Created By Vendors
    Telephone Scripts
    Websites
    Social Media
    Emails
    Stamping Recruitment Materials
SCREENING LOGS
    Collection And Storage Of Information About Individuals Who Do Not Consent
    Sharing The Screening Log
    Identifiers

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Return of Results
GENETIC/GENOMIC DATA
   Return Of Primary Findings
   Return Of Secondary (a.k.a., Incidental) Findings
   Requirements For Informed Consent

Vulnerable Populations
WARDS OF THE STATE (FOSTER CHILDREN)
   Purpose
   Role of Foster Parents in Research
   Additional Information for Review of Categories I-III
   Regulations
   Definitions
   Task Force
   Emergent or Life-threatening Situation: CD Procedure

Reportable Events
INVESTIGATOR REPORTING REQUIREMENTS
   What must be reported?
   PI Responsibilities
DEVIATIONS IN APPROVED RESEARCH
   Definitions
   Report What and When
   Examples
ICH-GCP

Continuing Review
   When Is Continuing Review By An IRB Required?
   How Should I Prepare For A Continuing Review Submission?
   What Do I Do After My Continuing Review Form Is Approved?
   What Happens When A Study Expires?
   Requests To Continue Treatment During A Lapse In IRB Approval
   What Happens If A Continuing Review Form Is Not Submitted?

Check In Forms
   What is a Check-In form?
   How Will I Know When I Need to Complete My Check-In Form?
   What Do I Need in Order to Complete My Check-In Form?

Study Closures
   When Should I Close My study?
   Prepare For Study Closure
   Record Retention
   Closing The Study
   When A PI Leaves The Institution
   Expired Studies

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sIRB Research Guide Table of Contents Lists

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Click section links to navigate to sIRB Research Guide flipbook

APPLICABILITY
Relying on an External IRB
GENERAL INFORMATION
   Principal Investigator (PI)    Responsibilities when using and External IRB
   Modifications/Amendments
   Exceptions
   Continuing Reviews
   Reportable Events
   Platform Trials
   Study Closure
RTR SUBMISSION PROCESS
   Relying on an Independent IRB
   Relying on the NCI CIRB
   Relying on another External IRB
WU as Reviewing IRB/ Single IRB (sIRB)
REQUESTING WU BE THE IRB AND sIRB BUDGETING
EXEMPT RESEARCH
STUDY MANAGEMENT
RELIANCE AGREEMENTS
HOW TO SUBMIT A SINGLE IRB STUDY IN MYIRB
   sIRB New Project
   sIRB Site Application
SITE SUBMISSIONS AND SITE MANAGEMENT
   sIRB New Site Application
   Reviewing Site Information
sIRB STUDY MODIFICATIONS
sIRB CONTINUING REVIEWS
   Submitting a Continuing Review
sIRB REPORTABLE EVENTS
sIRB EXCEPTIONS
sIRB CLOSURES
Appendix: Definitions

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Content current as of 10/5/2022