Each university member is expected to report actual or suspected violations of laws, regulations, VCU policies and procedures or other misconduct. Management has a special duty to recognize and report violations.
To describe the policies and procedures of the VCU IRB pertaining to document distribution to the IRB membership.
Description
All submitted materials are distributed as follows (prior to review). Each item is included, as it is provided by the investigator. The primary and secondary reviewers and other panel members and alternates (as appropriate) receive review materials at least five (5) business days in advance of the convened IRB meeting. The primary reviewer conducting an expedited or exempt review receives review materials within 5 business days, in general, of when the Intake Coordinator and IRB Coordinator determine that the submission is complete.
Initial Review by the convened IRB Document Distribution Chart:
Documents are distributed to:
Review Documents
Primary Reviewer, Secondary Reviewer, and Chairperson
All Other IRB Members
Preliminary Meeting Agenda
X
X
Minutes
X
X
VCU IRB Initial Review Submission Form
X
X
VCU Research Plan
X
X
Sponsor's protocol
X
X
Complete DHHS-approved protocol and sample informed consent documents if DHHS funded
X
Advertisements/Recruitment Materials if the project involves the use of these materials
X
X
Informed Consent and Assent Documents if the project does not involve waiver of consent or assent
X
X
VCU IRB Children-Subject Form if the project involves children
X
X
VCU IRB Pregnant Women, Fetuses, Neonates-Subject Form if the project targets these populations
X
X
VCU IRB Prisoner-Subject Form if the project involves prisoners
X
X
Drug Labeling/Brochure if the project involves a drug or device and the IND or IDE is held by the sponsor
X
FDA Form 1572 if the project involves investigational drugs
X
IND or IDE Application if the project involves a drug or device and the IND or IDE is held by the PI
X
Radiation Safety Approval if the project involves the use of any procedures exposing the subject to ionizing radiation for research purposes only
X
Massey Cancer Center Approval if the project is a cancer treatment research project
X
Research Funding Proposal when provided by PI
X
Conflict of Interest Disclosure Statement (distributed to all if a potential COI is identified)
X
X
Disclosure Supplement Form if a potential COI is identified by an investigator
X
X
Principal Investigator CV or Biosketch
X
Medical Monitor CV or Biosketch if the project involves a Medical Monitor
X
Continuing Review by the convened IRB Document Distribution Chart:
Documents are distributed to:
Review Documents
Primary Reviewer, Secondary Reviewer, and Chairperson
All Other IRB Members
VCU IRB Continuing Review Form and attachments (if PI answered yes to any questions from 8 to 21)
X
X
VCU Research Plan
X
X
Sponsor's Protocol (if applicable)
X
X
Status report on progress of research
X
X
Informed Consent and Assent Documents if the project does not involve waiver of consent or assent, or it is not closed to enrollment
X
X
Amendments when provided by PI
X
X
Research Funding Proposal when provided by PI
X
Amendment Review by a convened IRB Document Distribution Chart:
Documents are distributed to:
Review Documents
Primary Reviewer, Secondary Reviewer, and Chairperson
All Other IRB Members
VCU IRB Change in Research Submission Form and copies of proposed changes to protocol, consent/assent forms, and/or advertisements
X
X
VCU IRB Change in Research Submission Form and investigational drug brochure amendments, package inserts, or new or competing continuation grant applications
X
VCU IRB Change in Research Submission Form and copies of CV and COI Disclosure Statement if the PI proposes a change in PI and/or Medical Monitor
X
Initial Review, Continuing Review or Amendment Review by Expedited or Exempt Procedures:
The primary reviewer conducting an expedited or exempt review receives and reviews all submitted documents including the information that the primary reviewer would have received for review by the convened IRB.
Responsibility
It is the responsibility of the principal investigator to ensure that a complete submission has been prepared for the VCU IRB. It is the responsibility of the ORSP to ensure that submitted materials are distributed in accordance with this policy.
