CARILION CLINIC INSTITUTIONAL REVIEW BOARD
Standard Operating Guidelines
Title: 6.7: Conduct of Research: POST-APPROVAL EDUCATIONAL ACTIVITIES
Original Date: April 2009
Primary Sponsor: Department of
Biomedical and Research Ethics
Date of Last Revision:
Approved By: Director of Biomedical and
Research Ethics, IRB Chair
OBJECTIVE:
To review research organization and procedures to ensure adherence with IRB policies and
federal regulation, and to provide education to Principal Investigators and research team
members.
GENERAL DESCRIPTION:
The Carilion IRB, in its efforts to fulfill its mandate of protecting human subjects, will provide
education for research organization to Principal Investigators and research team members
involved in investigator-initiated projects that have received Carilion IRB approval. The
following methods may be used:
1) The Carilion IRB Research Organization Checklist will be mailed to all Principal Investigators
and Research Coordinators after IRB approval of an investigator-initiated research study.
2) Investigator-initiated studies may be selected for a Research Education Session. If selected,
the IRB Regulatory Affairs Administrator will meet with the Principal Investigator and
research team members after IRB approval to review the following:
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Roles and responsibilities of the Principal Investigator and research team members
Recruitment procedures
Consent process and proper documentation of consent
Enrollment tracking
Study procedures
Reportable events
Storage of study documents, data, and specimens or samples
Privacy and confidentiality protections
IRB processes for submitting change/updates and continuing reviews
Review of Research Organization Checklist
3) Investigators involved in IRB-approved research projects may request an education
session similar to the Research Education Session.
PROCEDURE:
All Principal Investigators and Research Coordinators involved in investigator-initiated research
studies will receive the Carilion IRB Research Organization Checklist in the mail along with the
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IRB approval letter at the time of initial IRB approval. The checklist should be used as a guide
to the research organization and set-up of the study.
At the time of IRB approval or immediately following approval, the IRB chair or Human
Protections Administrator may select an investigator-initiated study for a Research Education
Session with the IRB Regulatory Affairs Administrator. Once selected, the Principal Investigator
will be sent a written notification. The IRB Regulatory Affairs Administrator will schedule the
session within 2 months of the initiation of enrollment for the study. The sessions will take
about 2-4 hours and will include a meeting with the Principal Investigator, Research
Coordinator, and/or other key research team members.
Upon arrival at the site, the IRB Regulatory Affairs Administrator will review the site’s research
records and documentation including, but not limited to, the protocol and any amendments, the
original consent and any revised versions, subject records, signed consents, source
documentation, and research database, if applicable. The site will be toured for suitability with
regard to privacy and confidentiality for subject records.
The IRB Regulatory Affairs Administrator will then meet with the Principal Investigator,
Research Coordinator, and/or other key research team members to discuss the progress of the
study, answer questions, and provide further guidance and education based on the individual
needs of the investigators and the project.
Following the on-site Research Education Session, the IRB Regulatory Affairs Administrator will
provide a written summary of the session to the research team. A copy of the summary also
will be provided to the IRB Chair.
A ‘By Request’ Education Session similar to the Research Education Session may be requested
by the Principal Investigator or research team members at any time during a study. If a
research team requests an Education Session, the above-mentioned procedures will be
followed.
The primary purpose of education sessions is to promote understanding of good research
practices. If evidence of serious or continuing non-compliance or a serious protocol violation is
found during an education session, then the procedures in the appropriate SOG will be
followed.
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