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Institutional Review Board
(IRB)
Basic Information About the PVAMC IRB
Within the VA system, an Institutional Review Board is
a subcommittee to the Research & Development (R&D)
Committee, which is the primary governing body of a research
program conducted at a VA medical center. The R&D
Committee is responsible for the scientific quality and
appropriateness of all research conducted at the Portland
VAMC. The Portland VA has two Institutional Review Boards,
which both report to the single R&D Committee.
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Guiding Philosophies of the IRB
The IRB is required by federal, state and VA regulations
to review proposed human studies protocols in order to
determine if they have been designed in a safe and ethical
manner, and to assure that the risks to human participants
will be reduced as much as possible. There is a long history
to the review of human studies research.
In April, 1979, the National Commission for the Protection
of Human Subjects of Biomedical and Behavioral Research
published The
Belmont Report, (Federal Web Site) which serves
as one of the primary guiding documents for the Portland
VAMC Institutional Review Board. The Belmont Report outlines
the ethical principals and guidelines for research involving
human subjects, primary among which are respect for persons,
beneficence, and justice. Each of these are applied through
the requirement for informed consent, assessment of risks
and benefits, and selection of subjects, respectively.
It is strongly recommended that all principal investigators,
and others, conducting human studies research read the
nine page Belmont Report.
The World
Medical Association Declaration of Helsinki was
initiated in 1964, and has been updated regularly since.
Although the Declaration of Helsinki has not been fully
accepted by the United States, it provides a strong outline
for the ethical principals for medical research involving
human subjects.
A more thorough history of human subjects research is
provided on the NIH computer-based training module at
http://cme.nci.nih.gov
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Policies and Procedures
The IRB
Standard Operating Procedures Revised
6/08 (652KB, PDF) at the PVAMC provides
the background for each IRB, including ethical principles
and the regulatory mandate to protect human subjects,
and information on how the IRBs are administered. This
includes types of IRB review, review and approval considerations,
and required elements of informed consent.
Clinical
Site-Monitoring Visit Requirements (35KB, MSWord)
The Veterans Health Administration has specific requirements
regarding the conduct and reporting of study site-monitoring
visits conducted by entities external to the VA.
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Useful Websites
http://www1.va.gov/resdev/fr/PRIDE/about/
(VA Web Site)
The Program for Research Integrity Development & Education
(PRIDE) is a new VA office whose mission is to protect
participants in VA human research. PRIDE is responsible
for all policy development and guidance, and all training
and education in human research protection throughout
the VA. PRIDE Works with the Center for Advice and Compliance
Help to assist in preparation for NCQA accreditation.
http://www1.va.gov/resdev/fr/PRIDE/resources/
(VA Web Site)
This website offers insight into the informed consent
process and ethical issues surrounding Institutional Review
Boards. It also includes links to VA and FDA forms.
http://grants1.nih.gov/grants/policy/coc/index.htm
(Federal Web Site)
This website provides information regarding Certificates
of Confidentiality. Certificates of Confidentiality are
issued by the National Institutes of Health (NIH) to protect
identifiable research information from forced disclosure.
They allow the investigator and others who have access
to research records to refuse to disclose identifying
information on research participants in any civil, criminal,
administrative, legislative, or other proceeding, whether
at the federal, state, or local level. Certificates of
Confidentiality may be granted for studies collecting
information that if disclosed could have adverse consequences
for subjects or damage their financial standing, employability,
insurability, or reputation.
http://www.fda.gov/
(Federal Web Site)
US Food and Drug Administration web site
http://www.hhs.gov/ohrp/
(Federal Web Site)
Department of Health and Human Services Office for Human
Research Protections. This web site includes information
regarding regulations, policy guidance, education opportunities
and compliance oversight.
http://www.clinicaltrials.gov/
(Federal Web Site)
This website provides regularly updated information about
federally and privately supported clinical research in
human volunteers. The site provides information about
a trial's purpose, who may participate, locations, and
phone numbers for more details.
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IRB Roster
The rosters for the two Portland VAMC Institutional Review
Boards are available by selecting roster
#1 (67KB, MSWord) or roster
#2 (69KB, MSWord). Study sponsors may require the
study coordinator/principal investigator to keep an IRB
roster on file with the study paperwork.
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IRB Deadlines and Meeting Schedules
Request for Expedited Initial Review:
2nd Monday of the month
All other forms for new studies, amendments,
revisions, etc.: 3rd Monday
of the month
Response to tabled review from IRB #1:
Close of business Friday before
last Monday of the month (exceptions for 2008:
deadlines for April, July and October meetings) - see
specific dates below.
2008 due dates: January 25, February 22, March 21,
April 25, May 23, June 20, July 25, August 22, September
19, October 24, November 21, December 26 (for January,
2009 meeting)
Response to tabled review from IRB #2:
Close of business Friday before
1st Monday of the month (exceptions
for 2008: deadlines for April, July, September and October
meetings) - see specific dates below.
2008 due dates: February 1, February 29, March 28,
May 2, May 30, June 27, August 1, August 28, September
26, October 31, November 28, January 2 (for January,
2009 meeting)
A Request for Expedited Initial Review: Any requests
received on time, i.e., by the 2nd Monday of the month,
that are rejected for expedited review will be placed
on the IRB docket for full review the following month.
Because of the time required to prepare for full IRB review,
any requests received after the 2nd Monday will likely
be deferred until the IRB meeting two months after.
The deadline for submitting all other new paperwork for
IRB review is the 3rd Monday of each month. This includes
submissions of new protocols as well as submission of
new amendments, revisions, etc. The Grants Program Specialist,
in conjunction with the IRB Coordinators, will assign
each new protocol to either PVAMC IRB #1 or #2. Once assigned
to an IRB, a study will remain with that board for the
life of the study.
IRB #1 meets the first Wednesday of each month and IRB
#2 meets on the second Wednesday. However, the deadline
for submission of new IRB paperwork remains the 3rd Monday
of each month regardless of IRB assignment. NOTE: in cases
where an IRB meeting falls on a federal holiday, the meeting
will be rescheduled.
The deadline for submission of revisions requested by
IRB #1 to address a review that was “tabled”
is generally the close of business on the Friday prior
to the last Monday of each month. This applies to initial
review submissions as well as tabled amendments, etc.
The IRB #2 deadline to address a tabled review is generally
the close of business on the Friday prior to the first
Monday of the month. Please see the specific dates listed
above.
These deadlines have been created in order to allow sufficient
time for IRB agendas to be created and packets to be copied
and to allow IRB reviewers time to complete a thorough
review of all materials.
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Forms
Visit the R&D
Forms page to access all IRB forms.
Flag
System Instructions (29KB, MSWord)
This document includes instructions for
activating and deactivating research flags in CPRS for
participants on studies that require a flag, as indicated
by the IRB.
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