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.

    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

    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

    Consent

     Continuing Noncompliance

    Continuing Review

    Copies of IRB Documents- Copy Request Form

    Contract Requirements

    Convened Review- see Full Board (Convened) Review


     

    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

    Emancipated Minor

    Embryonic Stem Cell Research- See Human Embryonic Stem Cell Research

    Emergency Use

    Employees-Vulnerable Populations

    Engagement in Human Subject Research

    Enrollment

    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

    Expedited Review

    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

    H

    HIPAA

    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

    Human Research Protection Program: Standard Operating Procedure

    Humanitarian Use Device

    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

    Improvement Project vs Research- UVA Guidance

    Inspections

    Internal Event

    International Research

    Institutional Animal Care & Use Committee (IACUC)

    Institutional Biosafety Committee (IBC)

    Investigational Drugs and Biologics

    Investigational Medical Devices

    Investigator-Initiated Investigational New Drug Application (IND) AG 3-23

    Institutional Review Board (IRB)

    IRB Meetings

    • Minutes of IRB Meeting Meetings AG 4-5
    • Conduct and Agenda of IRB-HSR Meetings AG 4-4
    • Verification of Research Activities Since Previous IRB Review- AG 4-6

    IRB Reliance Agreements

    J

    K

    Keeping Data/Samples for Future Research

    L

    Lay Terminology -

    Learning Shots

    Legally Authorized Representative- see Surrogate Consent / Use of a Legally Authorized Representative (LAR)

    • Use of Legally Authorized Representative (LAR) AG 3-15

    Leaving UVA?

    Levels of Review

    N

    Neonates - Vulnerable Populations

    New Protocol Submission Process

    New Researcher to UVA

    Non- Compliance Reporting

    Noncompliance

    Non-Engagement in Human Subject Research- see Engagement in Human Subject Research

    Non- English Speaking Subjects - See Consenting Subjects Who Do Not Read, Speak or Understand English

    Non-UVA Batch AE Submission Form

    Notifications

    • Notification of Federal Regulatory Agencies, Institutional Officials and Funding Agencies see AG 2-7

    O

    Office Information- IRB-HSR Office Information

    Office Management

    • IRB-HSR Office Management During a Pandemic/Emergency see AG 2-25
    • IRB-HSR Naming Nomenclature- see AG 2-26
    • Updating and Maintaining OHRP/FDA IRB Registration/Authorization- see AG 2-27
    • Protocol Development Process- see AG 2-29
    • Correcting Assurance/Approval Forms and Minutes- see AG 2-31
    • Protocol Builder Administrative Process- see AG 2-32
    • IRB-HSR Communication with Upper Administration- see AG 2-33

    Office of Sponsored Programs (OSP)/ School of Medicine Grants and Contracts Office

    Org Chart

    P

    Parental/Guardian Permission-definition

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

    Partner Offices see UVA Research Compliance Committees/ Oversight Offices

    Pharmacy- see Investigational Pharmacy Requirements

    Personnel Change Modification Form

    Principal Investigator (PI)

    Placebo Controlled Studies

    Planned Emergency Research with Exception from Informed Consent

    Planned Emergency Research with Exception from Informed Consent AG 3-36

    Post Approval Monitoring

    Post Debrief Release Form for Deception Studies

    PRC- see Cancer Center Protocol and Review Committee (PRC)

    Pregnant Women- see Vulnerable Populations - Pregnant Women

    Pregnant Partner Addendum Template

    Preparatory to Research Activities

    Prescreening Document / Screening Log / Enrollment Log

    Prisoner- seeVulnerable Populations 

    Protected Health Information (HIPAA)

    Protocol Builder

    Protocol

    Protocol Deviations

    Public Health Sciences @ the Library (PHS@Library)

    Privacy and Confidentiality

    Public Data Sets

    Q

    Quality Improvement- see Improvement Project vs Research- UVA Guidance

    Quality Improvement- (IRB-HSR) see Improvement and Assessment of IRB Administrative Procedures

    R

    Radiation Exposure

    Rebuttal or Appeal of IRB Decisions

    Receiving Data/Specimens from Outside UVA

    Record Keeping

    Recruitment of Study Subjects

    Regulations

    Related/Possibly Related Event

    Retention Incentives

    Reopening a Protocol

    Required Submissions- see IRB Required Submissions-PI Responsibilities

    Requirements for Research Conducted at non- UVA Facilities by UVA Personnel

    Reporting

    Research Participant Compensation Procedure

    Research Performed With Other Institutions

    Responsibilities: Principal Investigators

    Review Process

    Review Types

    S

    Serious Adverse Events (SAEs) definition

    Serious Noncompliance

    School of Medicine

    Screening Log- see Prescreening Document / Screening Log / Enrollment Log

    Sending Data/ Specimens Outside of UVA

    Single IRB

    Specimen Banking

    Sponsor Addition Form

    Staff Directory (IRB-HSR)

    Standard Operating Procedures

    Statistical Consultations

    Status Change

    Students- Vulnerable Populations

    Student Researchers

    Subjects-

    Submission of protocols

    Substudies- Definition and Submission Guidance

    Suicide- See Participants in Harmful Situations: Abuse, Suicide and Threat of Harm- PI Responsibilities

    Surrogate Consent / Use of a Legally Authorized Representative (LAR)

    T

    Templates: Protocol, Consent, Consent Addendum and Consent Short Forms

    Tissue Banking- see Specimen Banking

    Tracking Protocol Status

    U

    Urgent Review

    Unaffiliated Investigator agreement

    Unanticipated Problems

    Unexpected Event

    Unrelated Event

    Use of Data/ Specimens in Future Research

    UVA Partner Offices for Research

    UVA Research Compliance Committees/Oversight Offices

    UVA Agent

    V

    Verbal Consent- Waiver of Documentation of Consent

    Vice President for Research (VPR)

    Vulnerable Populations

    W

    Wards of State