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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Click section links to navigate to Research Guide flipbook
Do I Need to Submit to the IRB?
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
What Is QA/QI?
When Is QA/QI Also Research?
What If I Want To Publish The Results Of My QA/QI Project?
What Is A Case Study/Case Series?
Do I Have To Submit My Case Study/Case Series?
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?
Prime Awardee Of Federal Funds
SBIR/ STTR Grants
Institutional (Small Business) Engagement in Human Subjects Research
Obtaining a Federal Wide Assurance (FWA)
Pre-Grant Submission Information
IRB Submission Information
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
Employment or Student Status Requirement
Human Subjects and Protocol Specific Training
Limited Access ID Request Instructions for Students
Other Relevant Policies and Information
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
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 Forms For Studies With Minors
Consent Forms For Adults Without Capacity To Consent
Participants Or Partners Who Become Pregnant During Study Participation
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
Basic Elements Of Consent
Additional Elements Of Consent
myIRB Consent Templates
Consent Information Sheet
Exempt Information Sheet
Phone Screen Consent
Age Guidance For Assenting Minors
Waiver Of Assent
LEGAL AGE TO CONSENT
Determining The Legal Age To Consent
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?
RECONSENT OF RESEARCH PARTICIPANTS *****NEW*****
Why A Research Team May Need to Reconsent
How to Reconsent
Children Who Reach the Age of Majority
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
Do’s And Don’ts
Posting Of Recruitment Materials
Materials Provided By A Sponsor Or Lead Site
Recruitment Materials Created By Vendors
Stamping Recruitment Materials
Collection And Storage Of Information About Individuals Who Do Not Consent
Sharing The Screening Log
Return of Results
Return Of Primary Findings
Return Of Secondary (a.k.a., Incidental) Findings
Requirements For Informed Consent
WARDS OF THE STATE (FOSTER CHILDREN)
Role of Foster Parents in Research
Additional Information for Review of Categories I-III
Emergent or Life-threatening Situation: CD Procedure
INVESTIGATOR REPORTING REQUIREMENTS
What must be reported?
DEVIATIONS IN APPROVED RESEARCH
Report What and When
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?
When Should I Close My study?
Prepare For Study Closure
Closing The Study
When A PI Leaves The Institution
sIRB Research Guide Table of Contents Lists
Search tip: “Control+F” (or “Command+F” on a Mac)
Click section links to navigate to sIRB Research Guide flipbook
Relying on an External IRB
Principal Investigator (PI) Responsibilities when using and External IRB
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
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
Content current as of 10/5/2022