R&D Form - Request to Review Research Proposal (RRRP)

IRB Initial Review Application

Research Plan

Request for Exemption from IRB Review

Request for Expedited Review

Investigational Drug Form VA Form 10-9012

CONSENT DOCUMENTS

Consent Form Guidance

Oral Script/Letter/Information Sheet Guidance Document

Assent Guidance Document

Request for Consent Waivers

VA Form 10-3203 - Consent for Use of Picture and/or Voice

MODIFICATION, ADVERSE EVENTS AND CONTINUING REVIEW

Request for Modification of IRB Approved Research

Request for Change in Principal Investigator and/or Responsible Investigator

Request for Study Staff Change

Unanticipated Problem Reporting Form

Tracking Log for Non Reportable Events

Continuing Review Report

Study Closure Form

REVIEWER CHECKLISTS

Reviewer Checklist for Initial IRB Review

Reviewer Checklist for Continuing IRB Review

Reviewer Checklist for Modifications to IRB Approved Research

Human Subjects Research/Exempt Determination Form - FDA

Human Subjects Research/Exempt Determination Form – non-FDA

ADDITIONAL FORMS

Research Safety Protocol Survey

Research Safety Protocol Survey EXPEDITED

Conflict of Interest

Application for Human Subject Research Involving Ionizing Radiation Exposure

Participant Invitation for Research Day

Application for on Off-Site Tissue Banking Waiver

Letter of Support for Services

HIPAA FORMS AND INFORMATION

Authorization For Release of Protected Health Information for Research Purposes

Instructions for completing Authorization For Release of Protected Health Information for Research Purposes

Request for a Waiver of Authorization to Release of Protected Health Information for Research Purposes

Investigator Representation for Research on De-Identified Health Information

Investigator Representation for Limited Data Sets of Protected Health Information

Participant Revocation of Authorization for Release of Protected Health Information

IRB REFERENCE MATERIALS

Human Research Protection Program (HRPP) Standard Operating Procedures

Thesaurus of Lay Terminology to Commonly Used Medical Terminology (For use in preparing informed consent documents)