a' Five days of the meeting date

1
Q
IRB minutes must be written and available for
review within
a. Five days of the meeting date
b. Six weeks of the meeting date
c. By the next RD Committee meeting
d. Three weeks of the meeting date
A
Three weeks of the meeting date
(Source VHA Handbook 1200.5 7.i(2))
ORO Research Facts
2
Did you know
If a research project involves the use of
personal data -- either identified or
de-identified -- the RD Committee must assess
the mechanisms to be used for
Security of data and all files
Confidentiality of data
Release of data in accordance with regulations
and policies
Appropriate controls over any reuse of data
(Source VHA Handbook 1200.1 10.e.)
ORO Research Facts
3
AAALAC Association for Assessment and
Accreditation of Laboratory Animal Care,
International AAHRPP Association for the
Accreditation of Human Research Protection
Programs ACOS/R Associate Chief of Staff for
Research and Development ACUP Animal Care and
Use Program AO/R Administrative Officer for
Research and Development APHIS Animal and Plant
Health Inspection Service (USDA) BMBL Biosafety
in Microbiological and Biomedical
Laboratories BSL Biosafety
Level CDC Centers for Disease Control and
Prevention CFR Code of Federal
Regulations CIO Chief Information
Officer CO Central Office (Department of
Veterans Affairs) COS Chief of Staff CRADO Chief
Research and Development Officer, VHA CVMO Chief
Veterinary Medical Officer DHHS Department of
Health and Human Services DTA Data Transfer
Agreement DUA Data Use Agreement FWA Federalwide
Assurance HIPAA Health Insurance Portability
and Accountability Act HRPP Human Research
Protection Program HSS Human Studies
Subcommittee (aka IRB) IACUC Institutional
Animal Care and Use Committee IBC Institutional
Biosafety Committee IO Institutional
Official IRB Institutional Review Board
ISO Information Security Officer NIH National
Institutes of Health (DHHS) OGC Office of
General Counsel OHRP Office for Human Research
Protections (DHHS) OHSP Occupational Health and
Safety Program OIT Office of Information and
Technology OIG Office of the Inspector
General OLAW Office of Laboratory Animal Welfare
(DHHS) ORD Office of Research and
Development ORO Office of Research
Oversight OSHA Occupational Safety and Health
Administration PDUSH Principal Deputy Under
Secretary for Health PHS Public Health
Service PO Privacy Officer RD Research and
Development RACO Research Assurance and
Compliance Officer RCO Research Compliance
Officer rDNA Recombinant DNA RIO Research
Integrity Officer RISP Research Information
Security Program RO Regional Office RSSP Researc
h Safety and Security Program SAT Select Agents
and Toxins SOP Standard Operating
Procedures SRS Subcommittee on Research Safety
USDA United States Department of
Agriculture USH Under Secretary for
Health VAMC Veterans Affairs Medical
Center VHA Veterans Health Administration VISN V
eterans Integrated Service Network VMU Veterinary
Medical Unit
ACRONYMS YOU SHOULD KNOW
ORO Research Facts
4
Q

• In human research, any legal or ethical
  ambiguities must always be resolved in favor of
  the
• a. Medical Center
• b. Human Research Subject
• c. Local Community
• d. General Counsel
• Human Research Subject
• (Source VHA Handbook 1200.5 4.e.)

A
ORO Research Facts
5
Did you know That RD Committee records must
be maintained for a minimum of 5 years? (Source
VHA Handbook 1200.1 12.b.)
ORO Research Facts
6
Q Who has the responsibility for carrying out
the risk assessment for a research laboratory?
a. The Laboratory Director or Principal
Investigator
b. The Hospital Safety Officer
c. The ACOS for Research
d. The Biosafety Officer
A The Laboratory Director or Principal
Investigator
(Source VHA Handbook 1200.8, Appendix B 1)
ORO Research Facts
7

• Did you know

That VA animal research must only be conducted
where proper facilities, professional staffing,
and administrative support are in place?
(Source VHA Handbook 1200.7 4.b.(1))
ORO Research Facts
8
Q The terms of RD Committee members must be
staggered to a. Present growth opportunities
for staff b. Coincide with the RD Committee
chairs appointment c. Provide partial change in
membership annually d. Avoid a conflict of
interest
A Provide partial change in membership
annually (Source VHA Handbook 1200.1 6.j.)
ORO Research Facts
9

• Did you know
• That a VA facility may not conduct human subject
  research under an expired or inactivated
  Federalwide Assurance?
• (Source VHA Handbook 1058.03 5.e.(1))

ORO Research Facts
10

• Q The IACUCs semi-annual self-assessment
  review must include all facilities and
  investigator areas where VA-purchased laboratory
  animals are used in procedures, or are
• a. Housed longer than 12 hours
• b. Housed on VA property
• c. Housed longer than 24 hours
• A Housed longer than 12 hours
• (Source VHA Handbook 1200.7.8 d.(1)(a))

ORO Research Facts
11
Did you know
The Information Security Officer and the Privacy
Officer may
Serve together on the IRB or RD Committee
OR
One may serve on the IRB and the other on the RD
Committee.
(Source VHA Directive 2007-040 4.a.)
ORO Research Facts
12

• True or False?
• In animal research, the IACUC must conduct a
  complete re-review of each protocol every year.
• A False
• A complete re-review of each animal research
  protocol is required every three years.
• (Source VHA Handbook 1200.7 8.e.(2))

ORO Research Facts
13
Did you know That if the VHA Investigator is
conducting a review of individually-identifiable
information to prepare a research protocol, RD
Committee approval is not required? (Source
VHA Handbook 1605.1. 13.a.(1) (a))
ORO Research Facts
14
Q Who is responsible for reviewing accident and
injury trends reported by the Subcommittee on
Research Safety and for recommending and ensuring
the implementation of corrective action? a.
ACOS for Research b. RD Committee c. Hospital
Safety Officer A RD Committee (Source VHA
Handbook 1200.8 4. c. (2) (m))
ORO Research Facts
15

• True or False?
• Only VA facilities that carry out animal research
  funded by NIH are required to have an Assurance
  with the Office of Laboratory Animal Welfare
  (OLAW).
• A False
• Every VA facility with an animal research program
  must maintain an Assurance with OLAW.
• (Source VHA Handbook 1200.7 4.b.(4)(a))

ORO Research Facts
16
Did you know That under the minimum necessary
standard, individuals working in Operations
Support and Environmental Services
(e.g., Contracting, Education Services, Library)
have no need for access to Protected Health
Information?
(Source VHA Handbook 1605.2, Appendix A)
ORO Research Facts
17
Did you know That for VA research, an
investigator must be a VA employee, be a WOC
employee, or be an Intergovernmental Personnel
Act (IPA) employee? (Source VHA Handbook 1200.5
3.n.)
ORO Research Facts
18

• Q Portable computers that have sensitive
  information on their storage device(s) must
• Be secured under lock and key when not in the
  immediate vicinity of the responsible employee
• Not be transported in checked baggage
• Be encrypted
• Have approved anti-virus software installed
• All of the above

ORO Research Facts
19

• Did you know
• That protective clothing must be provided at no
  cost to employees working in the animal research
  facility?
• (Source VHA Handbook 1200.7 6.a.)

ORO Research Facts
20
Q The Health Insurance Portability and
Accountability Act (HIPAA) Privacy Rule allows
for the disclosure of health information without
authorization to a public health authority for
the purpose of a. Conducting public health
research b. Marketing new services c. Preventing,
or controlling disease d. All of the above A
Preventing, or controlling disease (Source VHA
Directive 2007-023 2.c.)
ORO Research Facts
21
Did you know That the VA IACUC Program and
Facility Self-Assessment must state any minority
views? (Source VHA Handbook 1200.7
8.d.(1)(d)4.)
ORO Research Facts
22
Q Names, addresses, and medical information
about patients with cancer are not disclosed to a
State Public Health Authority, such as a State
Cancer Registry, unless a. An appropriate
written request is received and a Data Transfer
Agreement is executed b. The Under Secretary for
Health has approved the transfers c. A HIPAA
authorization has been obtained A An
appropriate written request is received and a
Data Transfer Agreement is executed (Source VHA
Directive 2007-023 4.a.)
ORO Research Facts
23
Did you know That contact with veterans is
limited to those clinically essential or as
outlined in IRB approved protocols? (Source
PDUSH Memo, Researcher Contacts with Veterans,
July 10, 2006 )
ORO Research Facts
24

• Q Review of an animal research protocol may be
  carried out by a designated reviewer only if
• The research involves only Category B or C
  animals
• All members of the IACUC have had an opportunity
  to call for review by the full committee
• The veterinarian and investigator have discussed
  procedures to minimize pain and distress
• The procedure is approved by the ORD Chief
  Veterinary Medical Officer
• A All members of the IACUC have had an
  opportunity to call for review by the full
  committee
• (Source VHA Handbook 1200.7
  8.d.(2)(a) )

ORO Research Facts
25
Did you know That the RD Committee must
establish either a Subcommittee on Research
Safety or multiple subcommittees dealing with
different aspects of research safety? (Source
VHA Handbook 1200.8 4. c. (1))
ORO Research Facts
26
True or False?
A VA facility may not engage the services of
another IRB for the purposes of avoiding the
rulings of the IRB of record. A True (Source
VHA Handbook 1200.5 5.a.(3)(e))
ORO Research Facts
27

• Q In the VA, the investigator must consult with
  the facility veterinarian prior to IACUC review
  of the protocol
• If the protocol entails more than momentary pain
  or distress
• If covered species will be used
• For all protocols
• A For all protocols
• ( Source VHA Handbook 1200.7 8.d.(2)(b) )

ORO Research Facts
28
Did you know That every Department of
Veterans Affairs (VA) facility conducting
research must have, or establish, an RD
Committee? (Source VHA Handbook 1200.1 2.a.)
ORO Research Facts
29
True or False? Employees may not connect a
computer to the VA network simultaneously with
one or more non-VA networks. A True (Source
VA Handbook 6500 6.c.(3)(f))
ORO Research Facts
30
ORO Research Facts
31
Q The RD Committee is responsible for a.
Welfare and appropriate use of animals b.
Safety of personnel c. Maintenance of high
scientific standards d. All of the above A
All of the above (Source VHA Handbook 1200.1
10.a.(1-4))
ORO Research Facts
32
Did you know
Each VA facility with research laboratories must
have an emergency preparedness and response plan.
This plan must address, in addition to
VA-operated laboratories on site
Research laboratories at approved off-site
locations
VA research laboratories in leased space
Space leased to others
(Source VHA Handbook 1200.06 7.h)
ORO Research Facts
33
True or False? For an IACUC to have a quorum, a
non-scientific member must be present. A False
A majority of voting members must be present
for an IACUC quorum. (Source VHA Handbook 1200.7
8.d.(2))
ORO Research Facts
34
True or False?
Initial contact with prospective research
subjects must be made by telephone.
A False
During the recruitment process, researchers must
make initial contacts with veterans in person
and/or by letter prior to any telephone contact.
(Source PDUSH Memo, Researcher Contacts with
Veterans, July 10, 2006)
ORO Research Facts
35
Q Who is responsible for maintaining an
up-to-date inventory of all hazardous chemicals
located in the laboratory, and ensuring that all
laboratory personnel know the location of this
inventory? a. The ACOS for Research b. The
PI or Laboratory Director c. The Biosafety
Officer
ORO Research Facts
36

• True or False?

At least one member of the IACUC must be a member
of the RD Committee.
A True
(Source VHA Handbook 1200.7 8.a.(4))
ORO Research Facts
37

• Q The __________ is responsible for ensuring
  the facility HRPP has the resources and support
  necessary to comply with all federal regulations
  and guidelines that govern human subjects
  research.
• a. ACOS for Research
• b. Chief of Staff
• c. Institutional Official
• d. CRADO
• A Institutional Official
• (Source VHA Handbook 1200.5 3.i.)

ORO Research Facts
38
True or False?
The RD Committee is required to carry out an
annual quality assurance review of research
employees involved in human subject research to
ensure the employees are working within their
scopes of practice and their privileges.
A True
(Source VHA Handbook 1200.1.9.g(4))
ORO Research Facts
39

• True or False?
• The IACUC does not review the conduct of approved
  animal research protocols until the triennial
  renewal.
• A False
• The IACUC must review the conduct of all animal
  protocols annually.
• (Source VHA Handbook 1200.7 8.e.)

ORO Research Facts
40
True or False?
VA sensitive information may be sent by email
without encryption to email addresses within the
VA network.
A False
VA sensitive information may not be transmitted
over the Internet or VAs Intranet without
security mechanisms that meet government
encryption criteria.
(Source VA Handbook 6500 6.c(3)(a))
ORO Research Facts
41
True or False? The Subcommittee on Research
Safety is responsible for annually reviewing all
active research protocols involving biological,
chemical, physical, and radiation hazards,
regardless of funding status or source. A
True (Source VHA Handbook 1200.8 4. d (3))
ORO Research Facts
42

• Did you know
• That the report of the IACUCs semi-annual
  self-assessment must be discussed with the
  medical center Director by the IACUC Chairperson,
  veterinarian, and one or more research
  administrators?
• (Source VHA Handbook 1200.7.8 d.(1)(e))

MUST
ORO Research Facts
43

• Did you know
• That the Medical Center Director is responsible
  for ensuring
• That all Research personnel are included in the
  facility Occupational Safety and Health program?
• and
• That research space is included in annual
  workplace inspections?
• (Source VHA Handbook 1200.8 4. a. (2))

ORO Research Facts
44

• Q Who is responsible for annually evaluating
  the effectiveness of the Chemical Hygiene Plan
  and making necessary revisions?
• a. Subcommittee on Research Safety
• b. ACOS for Research
• c. Responsible Official
• d. Laboratory Director or Principal Investigator
• A Subcommittee on Research Safety
• (Source VHA Handbook 1200.8 4. d (14))

ORO Research Facts
45
Q Who must approve requests for tours of the
animal research facility by members of the
media? a. The Veterinary Medical Officer b. The
Public Affairs Officer c. The Medical Center
Director d. The ACOS for Research
A The Medical Center Director
(Source VHA Handbook 1200.7 7.j.(1))
ORO Research Facts
46

• Did you know
• That a continuing review by the RD Committee
  must assess
• the research activities that have occurred,
• the progress of the research, and
• any issues that may impact on the progress of the
  research including compliance issues?
• (Source VHA Handbook 1200.1 10.d.(2))

ORO Research Facts
47
Q Every VA medical center conducting research
with human subjects or human biological specimens
applies for a Federalwide Assurance (FWA) through
_____ to _____ prior to conducting any such
research. a. ORO to OHRP b. ORO to VA ORD c.
ORO to FDA d. ORO to NIH A ORO to OHRP
(Source VHA Handbook 1200.5 5.a.(2))
ORO Research Facts
48
AAALAC Association for Assessment and
Accreditation of Laboratory Animal Care,
International AAHRPP Association for the
Accreditation of Human Research Protection
Programs ACOS/R Associate Chief of Staff for
Research and Development ACUP Animal Care and
Use Program AO/R Administrative Officer for
Research and Development APHIS Animal and Plant
Health Inspection Service (USDA) BMBL Biosafety
in Microbiological and Biomedical
Laboratories BSL Biosafety
Level CDC Centers for Disease Control and
Prevention CFR Code of Federal
Regulations CIO Chief Information
Officer CO Central Office (Department of
Veterans Affairs) COS Chief of Staff CRADO Chief
Research and Development Officer, VHA CVMO Chief
Veterinary Medical Officer DHHS Department of
Health and Human Services DTA Data Transfer
Agreement DUA Data Use Agreement FWA Federalwide
Assurance HIPAA Health Insurance Portability
and Accountability Act HRPP Human Research
Protection Program HSS Human Studies
Subcommittee (aka IRB) IACUC Institutional
Animal Care and Use Committee IBC Institutional
Biosafety Committee IO Institutional
Official IRB Institutional Review Board
ISO Information Security Officer NIH National
Institutes of Health (DHHS) OGC Office of
General Counsel OHRP Office for Human Research
Protections (DHHS) OHSP Occupational Health and
Safety Program OIT Office of Information and
Technology OIG Office of the Inspector
General OLAW Office of Laboratory Animal Welfare
(DHHS) ORD Office of Research and
Development ORO Office of Research
Oversight OSHA Occupational Safety and Health
Administration PDUSH Principal Deputy Under
Secretary for Health PHS Public Health
Service PO Privacy Officer RD Research and
Development RACO Research Assurance and
Compliance Officer RCO Research Compliance
Officer rDNA Recombinant DNA RIO Research
Integrity Officer RISP Research Information
Security Program RO Regional Office RSSP Researc
h Safety and Security Program SAT Select Agents
and Toxins SOP Standard Operating
Procedures SRS Subcommittee on Research Safety
USDA United States Department of
Agriculture USH Under Secretary for
Health VAMC Veterans Affairs Medical
Center VHA Veterans Health Administration VISN V
eterans Integrated Service Network VMU Veterinary
Medical Unit
ACRONYMS YOU SHOULD KNOW
ORO Research Facts
49
Did you know That the provision of IRB
services by an affiliate IRB must be established
through a
Memorandum of Understanding
or other written agreement that outlines the
responsibilities of the VA and the
affiliate? (Source VHA Handbook 1200.5
5.a.(3)(b))
ORO Research Facts
50
A voting member of the RD Committee may fill
more than one criterion for required membership.
A (Source VHA Handbook 1200.1 6.d.)
TRUE OR FALSE?
TRUE
ORO Research Facts
51

• Did you know
• That the PI or Laboratory Director is responsible
  for
• Investigating safety-related deficiencies cited
  during all inspections of work areas?
• and
• Submitting a written abatement plan for all
  deficiencies cited during inspections to the
  Subcommittee on Research Safety?
• (Source VHA Handbook 1200.8 4. e. (16))

ORO Research Facts
52
True or False? Research misconduct does not
include honest error or differences of
opinion. A True (Source VHA Handbook 1058.2
3.b.)
ORO Research Facts
53

• Did you know
• That the Chief Veterinary Medical Officer must
  approve the design plans for all animal facility
  construction or renovations costing more than
  100,000?
• (Source VHA Handbook 1200.7 7.a.(4))

ORO Research Facts
54

• True or False?
• Each IRB must include at least one member
• who is not otherwise affiliated with the VA
  medical center and
• who is not part of the immediate family of a
  person who is affiliated with the medical center.
• A True
• (Source VHA Handbook 1200.5 6.f.)

ORO Research Facts
55
Q Nominations for RD Committee membership may
come from a. Current RD Committee members b.
Subcommittee members c. Facility staff d. All of
the above A All of the above (Source VHA
Handbook 1200.1 6.a.)
ORO Research Facts
56
Did you know That the IRB must take into
account the validity of the research design in
determining the risk/benefit ratio? (Source VHA
Handbook 1200.5 7.a.(2))
ORO Research Facts
57
True or False? Fabrication is manipulating
research materials, equipment, or processes, or
changing or omitting data or results such that
the research is not accurately represented in the
research record. A False Fabrication is
making up data or results and recording or
reporting them. (Source VHA Handbook 1058.2
5.c.)
ORO Research Facts
58

• Q An overheat test must be
• performed in the animal
• research facility to test
• emergency response
• a. Every month
• b. During the semi-annual review
• c. Every 3 years
• d. Every year
• A Every year
• (Source VHA Handbook 1200.7. 7.a.(2)(c))

ORO Research Facts
59
True or False? In small research programs a
Research Coordinator may be appointed in lieu of
an ACOS for RD. A True (Source VHA Handbook
1200.1 2.b.(1))
ORO Research Facts
60
Did you know
That the RD Committee is responsible for
appointing a Research Safety Coordinator who is
responsible for supervising and operating the
Research Safety Program? Specific
responsibilities for this position must be
specified in the written local policy of the
Research Safety Program. The ACOS for RD or
Coordinator for RD generally assumes this role.
(Source VHA Handbook 1200.8 4. c. (2) (d))
ORO Research Facts
61
True or False? VA employees whose research
misconduct allegation or cooperation with an
Inquiry or Investigation is not in good faith
may be subject to disciplinary measures. A
True (Source VHA Handbook 1058.2 8.h.)
ORO Research Facts
62
Q VA is guided by the ethical principles
regarding all research involving humans as
subjects, as set forth in the a. Declaration of
Helsinki b. Code of Federal Regulations c.
Nuremburg Code d. Belmont Report A
Belmont Report (Source VHA Handbook 1200.5
4.a.)
ORO Research Facts
63
The Subcommittee on Research Safety is
responsible for ensuring that all laboratory
personnel receive annual research specific safety
training. (Source VHA Handbook 1200.8 4. d
(10))
ORO Research Facts
64

• Q The IRB has the authority to
• a. Conduct audits of recurring processes
• Review research records
• Monitor the informed consent process
• All of the above

A All of the above (Source VHA Handbook 1200.5
7.e.)
ORO Research Facts
65
Did you know That in misconduct cases,
respondents who are not found guilty of
committing research misconduct must be afforded
reasonable assistance in restoring their
reputations to the extent that the VA medical
center management deems appropriate, and within
the scope of the VA medical centers authority?
(Source VHA Handbook 1058.2 9.h.)
ORO Research Facts
66
Q An IRB member may be considered present if
participating through a. Internet b.
Teleconferencing or videoconferencing c. Ad hoc
reviewer d. All of the above A
Teleconferencing or videoconferencing (Source
VHA Handbook 1200.5 7.f.(2))
ORO Research Facts
67
True or False? If the continuing review does not
occur within the timeframe set by the IRB, the
research is automatically suspended.
(Source VHA Handbook 1200.5 7.g.(2))
A True
ORO Research Facts
68
Did you know That if criminal ethics statutes
are violated, civil fines and imprisonment can
result? Severe administrative disciplinary
action can result from violating ethics
regulations, including suspension from
employment, termination of employment, and/or
other administrative punishment. (Source
VHA Handbook 1200.1 7.a.)
ORO Research Facts
69
Q Research misconduct is defined as _______,
________, or _________ in proposing, performing,
or reviewing research, or in reporting research
results. a. Falsification, cheating, or
misrepresentation b. Unethical practices,
plagiarism, or immoral actions c.
Fabrication, falsification, or plagiarism d.
All of the above A Fabrication, falsification,
or plagiarism (Source VHA Handbook 1058.2
3.a.)
ORO Research Facts
70
Q The IRB must ensure that additional
safeguards have been included in each study to
protect the welfare of a. Vietnam veterans b.
PTSD subjects c. Vulnerable subjects d. Research
staff A Vulnerable subjects (Source VHA
Handbook 1200.5 7.a.(8))
ORO Research Facts
71
Q The RD Committee is responsible, through the
_________ to the Medical Center Director. a.
Chief of Staff (COS) b. ACOS for Research c.
Institutional Review Board Chairperson d.
Veterans Integrated Service Network Director
ORO Research Facts