Guidance for Researchers

These IRB guidance documents provide researchers with essential information for meeting the ethical standards and regulatory requirements for conducting research involving human participants. Additional topics are added on an ongoing basis.

PI Eligibility

Other Approvals Required

PI Responsibilities after IRB Approval

Continuing Review of Human Research

Concluding Human Research

Modifying Approved Research

Exempt Minimal Risk Research

Flexible Review

Limited IRB Review

Single IRB Review

Recruitment and Advertisements

Enrollment and Accrual of Study Participants

Increasing Access to Enrollment

Informed Consent

Compensation of Subjects

Access to Records

Certificates of Confidentiality

Data Security and Records Retention

Honest Broker

Record Reviews

Zoom Security Guidelines

What is Human Research

Case Reports

Abbreviated IDE Requirements

Clinical Trials

EFIC & Planned Emergency Research

Investigational Device Exemption (IDE)

Investigation New Drug (IND)

Pre-Screening of Potential Subjects

Repositories - Storing Research Information for Future Use

Return of Incidental Findings

Software as a Medical Device

Sponsor Investigator

TMS & tDCS Brain Stimulation

Classroom Research and Independent Projects

Research in K-12 Settings

Deception and Incomplete Disclosure

DoD Research

DOE Research

Federal Data Management Plans

International Research

GDPR

Amazon MTurk

Social Media and Research

Research Involving Children

Research Involving Adults with Cognitive Impairments

Research Involving Native Americans or International Indigenous Populations

Research Involving Neonates

Research Involving Pregnant Women

Research Involving Prisoners

Mandatory Reporting

Adverse Event Flowchart

Audit Preparation

Corrective and Preventive Action Plans

Reportable New Information