The IRB-HSR Researcher Guide provides topic-specific content to help researchers navigate issues that are specific to their research. If you are new to human subject research, start with Education and Training for an orientation of the basics. While some topics will apply to most researchers, the guide also includes sections like that are geared to specific research disciplines. Have a subject you would like us to address? Contact us with your suggestion!

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Clinical Trial Topics

Clinical Trial Start-up and Maintenance Costs
Investigational Drugs and Biologics
Placebo Controlled Studies
FDA Regulated Studies

 

Consent Topics

Informed Consent
Consent Considerations for Certain Types of Studies
Surrogate Consent /Use of a Legally Authorized Representative (LAR)
Consenting Subjects Who Do Not Read, Speak or Understand English
Consenting Subjects that Understand English, but Cannot Read or Write
Re-Consenting Requirements

 

Common Research Topics

Protocol Submission Process
Protocol Elements
Study Team Members Listed on the Protocol
Elements Required on the Consent Form
Protected Health Information (HIPAA) Regulations and Research
IRB-HSR Board Members
Required Reviews from our Partner Offices for the IRB-HSR
Research Record-keeping Requirements
Leaving UVA?

 

Compensation Topics

Subject Compensation
Compensation vs Reimbursement
Retention Incentives
Contract Requirements

 

Device Study Topics

Device Summary Table
Expanded Access to Unapproved Medical Devices
Investigational Medical Devices
Humanitarian Use Device

 

Enrollment, Recruitment and Subject Selection Topics

Investigator Responsibilities for Selection of Subjects
Recruitment of Human Research Subjects
Prescreening Documents, Screening Logs, and Enrollment Logs

 

Expanded Access

Expanded Access for Unapproved Drugs and Biologics
Expanded Access to Unapproved Medical Devices

 

Funding Topics

Grant Submission Process
IRB-HSR Grant Application Submission

 

Genetic Research, Stem Cell Research & Specimen Banking Topics

Genetic Research
Genomic Data Sharing (GDS)
Human Gene Transfer Research
Human Embryonic Stem Cell Research
Specimen Banking
What do I need to do to keep data/specimens for future unspecified research?

 

Protocol Review Process for Initial Study Submissions

Levels of Review
Determination of Exemption
Expedited Review
Full Board Review

Protocol Management Topics

Protocol Deviations, Non-compliance and Protocol Exceptions
Data Breach
Serious Adverse Events
Unanticipated Problems
Continuing Review Process
Data and Safety Monitoring Plans and Data Safety Monitoring Boards
Modifications to Approved Research - Background
Modifications to Approved Research - Process
Amending a Protocol vs. Submitting a New Protocol

 

Single IRB, Multi-Site and Reliance Agreement Topics

Multi-Site Studies
Reliance on the IRB-HSR to serve as the Single IRB (sIRB) of record
Reliance on a Non-UVA IRB to serve as the Single IRB (sIRB) of Record

 

Special Issue Topics

Certificates of Confidentiality
International Research
Radiation Exposure for Research Purposes
Sub-study Guidance for Submissions
EMERGENCY USE
Planned Emergency Research and Exception from Informed Consent (EFIC)
Medical Record Review
Inspections by an Outside Agency: Investigator Guidance for FDA Inspections
Archival Data
Public Data Sets
Sending or Receiving Specimens/Data

 

Vulnerable Populations

Vulnerable Subjects
Vulnerable Subjects - Pregnant Women
Vulnerable Subjects - Prisoners
Vulnerable Subjects - Children / Minors
Wards of State
Additional Categories of Vulnerable Subjects