A-Z Index

Human Subject Topics A - Z Index

Preface

The IRB-HSR A-Z Index is a resource for University of Virginia researchers, UVA IRB-HSR staff and UVA IRB-HSR members involved in the conduct of human subject research. The information found in the index is based on the,UVA HRPP Standard Operating Procedures, applicable federal regulations, Virginia state statutes, and University of Virginia policies.

Introduction

In accordance with federal, state and local regulations and institutional policies an IRB must review all research regardless of sponsorship, involving human subjects prior to initiation of the project in order to ensure the rights and welfare of the subjects. This is applicable to all human subject research regardless of sponsorship and performed by UVA faculty, staff or students as an agent of the University. This includes advertising, recruitment and/or screening of potential subjects.

A

Abused Subjects- see Participants in Harmful Situations: Abuse, Suicide and Threat of Harm- PI Responsibilities

Acronyms

Adverse Events (Serious)

Non-UVA Batch AE Submission Form

Advertising

Age of Majority

Age of Majority Cover Letter and Consent Addendum

Agent of UVA- see UVA Agent

Agreement Tip Sheet

Aggregate Review

Aggregate Review Form

Aids/HIV (Subjects with..) Vulnerable Populations

Appeal of IRB Determinations- seeRebuttal or Appeal of IRB Decisions

Archival Data

Assent-definition

B

Biologics- see Investigational Drugs and Biologics

Biorepository and Tissue Research Facility

C

Calendars- IRB-HSR

Cancer Center Protocol and Review Committee (PRC)

Capacity to Consent Determination- SOM Form

Learning Shot: Clinical Researcher’s Role and Responsibility

Center for Biomedical Ethics & Humanities

Certificates of Confidentiality

Changing Status of Protocol - See Modifications

Children- See Vulnerable Populations Children

CITI Training

Clinical Data Repository (CDR)

Closing a Protocol

Closure Form for Grants
Closure Form for Protocols
Closing a Protocol- Managing Protocol After Initial Approval
Closure AG 3-6

Cognitively Impaired Persons

Compensation for Subjects- Research Participant Compensation Procedure

Concerns, Comments, Complaints- Research Concerns, Reporting Research Concerns or Questions

Confidentiality and Privacy- Privacy and Confidentiality

Conflict of Interest

Conflict of Interest Committee Website
Conflict of Interest- IRB Review Website
Conflict of Interest- PI Responsibilities
IRB Member or Consultant Conflict of Interest AG 1-6
HRPP SOP Sections:
- Conflict of Interest in Research: HRPP SOP Section 21: Conflict of Interest in Research
- Investigator Conflicts of Interest HRPP SOP Section 7.5.6
- Institutional conflicts of Interest HRPP SOP Section 7.5.8

Consent

HRPP SOP Section 11: Obtaining Informed Consent from Research Subjects and SOP Addendum Section 8.
Capacity to Consent Determination

Consent Addendum: Age of Majority
- Age of Majority Consent Addendum and Cover Letter
Consent Addendum: Adult or Minor
Consent Addendum- Pregnant Partner see Pregnant Partner Addendum Template
Consent Addendum: Prisoner
Consent Observation- see AG 2-19
Consent Observation- see Post Approval Monitoring
Consenting Process- Examples
Consent Form Posting
Consent Short forms for non-English Speaking Subjects
Consenting Subjects Who Do Not Read, Speak or Understand English
Consenting Process
Learning Shot : "The Informed Consent Process for Clinical Research "
Learning Shot: Use of Electronic Informed Consent

Continuing Noncompliance

Continuing Review

Continuation- Aggregate Review Form
Continuation AG 3-5
Consent Addendum- Pregnant Partner see Pregnant Partner Addendum Template
Consent Observation- see Post Approval Monitoring
Consent Short forms for non-English Speaking Subjects
Consenting Subjects Who Do Not Read, Speak or Understand English

Copies of IRB Documents- Copy Request Form

Contract Requirements

Convened Review- see Full Board (Convened) Review

D

Data Breech

Data and Safety Monitoring Boards

DSMB Charter Template

Data Use Agreement with Instructions to PI

Data Management and Sharing Plans (NIH)

dbGaP- Use of Data From dbGaP

Deadlines- - see IRB-HSR Deadlines

Debrief Release Form- see Debriefing Script For Deception Or Incomplete Disclosure

Deception Studies

Debriefing Script For Deception Or Incomplete Disclosure

Department of Defense Funded Research

Determination of Human Subject Research

Definition of Human Subject Research- Information on Website
Determination of Human Subjects Research Form

Devices- see Investigational Medical Devices

Directions to IRB-HSR

Document Submission Form

Drugs and Biologics See-Investigational Drugs and Biologics

Dry Run Consent Form- see MRI Dry Run Consent Template

DSMB Charter Template

E

Economically Disadvantaged- See Vulnerable Populations Economically and/or Educationally Disadvantaged

Education

CITI Training
In Person Education
- IRB-HSR In person Education see AG 6-3
Learning Shots
- IRB Online Education Learning Shots see AG 6-4
Staff Member Education- see AG 2-9
IRB Member Education- see AG 6-1
Investigator Education- see AG 6-2

Use of Electronic Informed Consent

Emancipated Minor

Embryonic Stem Cell Research- See Human Embryonic Stem Cell Research

Emergency Use

Employees-Vulnerable Populations

Website-Vulnerable Populations-Employees
Additional Protections for Students and Employees AG 3-46

Engagement in Human Subject Research

Engagement in Human Subject Research AG 3-24
Not Engaged in Human Subject Research
See Levels of Review

Enrollment

Website-Protocol Exceptions
Protocol Deviation, Noncompliance, and Protocol Exception Reporting Form
Protocol Deviations, Noncompliance and Protocol Exceptions AG 3-22
Enrollment Log- see Prescreening Document / Screening Log / Enrollment Log
Enrollment Change Modification Form

Environmental Health and Safety (EHS)

Ethical Principles

Exception from Informed Consent (EFIC)
-See Planned Emergency Research with Exception from Informed Consent

Exempt Review

Exiting UVA- see Leaving UVA

Expanded Access

Emergency Use or Expanded Access Consent Investigational Drug, Biologic, Device
Request for IRB Concurrence for a Single Patient Non-Emergency Use of an Investigational Drug/Device/Biologic
Single Patient Treatment Follow-up
Expanded Access to Investigational Medical Devices
Expanded Access to Investigational Medical Devices AG 3-25
Expanded Access to Unapproved Drugs and Biologics
Expanded Access to unapproved Drugs and Biologics (Intermediate and Large Groups) AG 3-12

Expedited Review

Expedited Review
Expedited Review Criteria
Risk Assessment Tool: Expedited vs Full Board Review
Approval of Expedited Studies- AG 3-2

External Event

F

FDA Regulated

Federal Wide Assurance and IRB-HSR Registration Information see FWA Information

Fetuses- see Vulnerable Populations-Fetuses

Forms

Frequently Asked Questions

Full Board (Convened) Review

Risk Assessment Tool: Expedited vs Full Board Review
Approval of New Study by Full Board- AG 3-3

G

Gene Transfer- see Human Gene Transfer Research

Genetic Research

Genomic Data Sharing

Genomic Submission Certification Request Form

Glossary

GMEC: Graduate Medical Education Committee

Grants

GRIME Committee: Group on Research in Medical Education

Guidance- see Regulations

Guidance: Research in Patient Care Settings

H

HIPAA

Protected Health Information (HIPAA)
Learning Shot: HIPAA Best Practices: How to follow your privacy plan
Learning Shot: HIPAA & Waiver of Consent: Terminology
HIPAA Authorization - Stand Alone
HIPAA Authorization - Stand Alone: Spanish
Data Use Agreement with Instructions to PI
45CFR Part 160 and 164, Standards for Privacy of Individually Identifiable Health Information; Security Standards for the Protection of Electronic Protected Health Information (HIPAA Privacy and Security Rules)

Hours- IRB-HSR Office - see IRB-HSR Hours

Human Subjects Research(Scroll down page to Humanitarian Use Device)

Human Research Activities Performed at Other Institutions

Research Performed With Other Institutions

Human Research Protection Program: Standard Operating Procedure

Humanitarian Use Device

Humanitarian Use Device (HUD) Information Form
Humanitarian Use Device (HUD) Patient Information Template
Humanitarian Use Device-Non Emergency AG 3-17

I

Improvement and Assessment of IRB Administrative Procedures

QC of AE Reporting to IRB-HSR- AG 5-1
QC of Expiration Dates for Active Studies AG 5-2
Annual Review of SOPS AG 5-4
QC of Inactive Protocols Without Closed Events AG 5-5
Internal Administrative Assessment AG 5-6
QC of Protocols and Grants with Incorrect or Duplicate Approval/Closure Events AG 5-7
QC of the IRB-HSR database AG 5-8
QC of Scanned Files AG 5-9
IBC Verification AG 5-10
Verification of Approval Dates AG 5-11
PRC Registration Report AG 5-12
Wards of the State Verification AG 5-13
Alternative Payment Verification AG 5-14
QC of IRB-HSR Agenda and Minutes AG 5-15
QC of Modification Submissions AG 5-16
QC of Read Only Access to IRB Online AG 5-17
QC of Next Meeting Date AG 5-18
Post-approval Monitoring AG 5-19