Institutional Review Board for Health Sciences Research (IRB-HSR)

A - Z Index

A - Z Index

Preface

The IRB-HSR Index is a resource for UVa researchers, IRB staff and IRB members at the University of Virginia involved in the conduct of human subject research. The information found in the index is based on the IRB-HSR 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

Advertising

Age of Majority

Agent of UVa- see UVa Agent

Agreement Tip Sheet

Aggregate Review

Aids/HIV (Subjects with..) Vulnerable Populations

Appeal of IRB Determinations- see Rebuttal or Appeal of IRB Decisions

Archival Data

Assent-definition

Authorization Agreements- see IRB Reliance Agreements

B

Biologics- see 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

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

Compassionate Use

Compensation for Subjects- Research Participant Compensation Procedure

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

Confidentiality and Privacy- See 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

D

Data Breech

Data and Safety Monitoring Boards

Data Use Agreement with Instructions to PI

dbGaP- see Use of Data From dbGaP

Deadlines- - see IRB-HSR Deadlines

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

Deception Studies

Department of Defense Funded Research

Determination of Human Subject Research

Devices- see Investigational Medical Devices

Directions to IRB-HSR

Document Submission Form

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

Emancipated Minor

Embryonic Stem Cell Research- See Human Embryonic Stem Cell Research

Emergency Research

Emergency Use

Employees- See Vulnerable Populations-Employees

Engagement in Human Subject Research

Enrollment

Environmental Health and Safety (EHS)

Ethical Principles

Exempt Review

Exiting UVa- see Leaving UVa

Expanded or Continued Access

Expedited Review

External Event

F

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

Fetuses- see Vulnerable Populations-Fetuses

Five Year Updates

Forms

Frequently Asked Questions

Full Board (Convened) Review

G

Gadolinium- see Guidance on use of Gadolinium in Research Subjects

Gene Transfer- see Human Gene Transfer Research

Genetic Research

Genomic Data Sharing

Genomic Submission Certification Request Form

Glossary

Grants

Guidance- see Regulations

H

HIPAA

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

Human Subjects Research

Human Research Activities Performed at Other Institutions

Humanitarian Device Exemption (HDE) or Humanitarian Use Device (HUD)

I

Improvement and Assessment of IRB Administrative Procedures

Improvement Project vs Research- UVa Guidance

IND' see Investigational Drug, Biologics and Device Studies

Informed Consent- Definition

Inspections

Internal Event

International Research

Institutional Animal Care & Use Committee(IACUC)

Institutional Biosafety Committee (IBC)

Investigational Drug, Biologics and Device Studies

Investigators Agreement

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

IRB

IRB Meetings

IRB Reliance/Authorization Agreements - Non- UVa IRB serves as IRB of Record

J

K

Keeping Data/Samples for Future Research

L

Lay Terminology - see MedTerms.com or UVa Glossary of Suggested Lab Wording

Learning Shots

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

Leaving UVa?

Levels of Review

M

Medical Records

Membership Lists- see IRB-HSR Membership Lists

Minor - see Vulnerable Populations -Children/Minor

Minorities- see Vulnerable Populations-Minorities

Minutes

Modifications

MRI Dry Run Consent Template

Multi-Site Studies

N

Neonates- Vulnerable Populations

New Protocol Submission Process

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

O

Office Information- IRB-HSR Office Information

Office Management

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

Org Charts

P

Parental/Guardian Permission-definition

Patient Care Exceptions

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

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- see Vulnerable Populations Consent Addendum: Prisoner

Protected Health Information (HIPAA)

Protocol Builder

Protocol

Protocol Violations

Public Health Sciences @ the Library (PHS@Library)

Prisoners- Research with..

Privacy and Confidentiality

Public Data Sets

Q

Quality Improvement- see Improvement Project vs Research- UVa Guidance

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

Reliance Agreements - see IRB Reliance Agreements

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

Routing Form

S

SAEs - see Serious Adverse Events

Serious Adverse Events definition

Serious Noncompliance

School of Medicine

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

Sending Data/ Specimens Outside of UVa

Specimen Banking

Sponsor Addition Form

Staff Directory (IRB-HSR)

Standard Operating Procedures

Status change

Students- Vulnerable Populations

Student Researchers

Subjects-

Subjects who do not speak English

Subjects who Turn 18- Reach Age of Adulthood

Submission of protocols

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

Terminally Ill Subjects see Vulnerable Populations -Terminally Ill Subjects

Tissue Banking- see Specimen Banking

Tracking Protocol Status

Treatment Use

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 (non- IRB) (general)

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

Waiver of Consent

Websites

Last Modified: Thursday, 13-Jul-2017 07:13:56 EDT