Transcript Slide 1

Research Compliance:
Regulatory Implications for Researchers
Overview:
 Research Compliance topics include:
 Human Subjects Research
 Animal Care and Use
 Institutional Biosafety
 Radiation and Laser Safety
 Export Controls Program
Expectations:
 Developing an understanding of the
implications of federal, state, local, and
institutional laws/regulations in the conduct of
research
 Learning which tools are available and how
they are utilized
HUMAN SUBJECTS RESEARCH
Reasons for Legislation
 To establish the rights of research subjects
are protected
 Research involving human subjects does not
take place until protocols are reviewed and
found to comply with federal law
 To protect the rights and welfare of human
subjects
Background of Human Subjects
 Federal legislation was based upon improper
use of research subjects in the past, one
notable was the Tuskegee Syphilis Study
conducted between 1932 through 1972
 Used indigent sharecroppers with the disease
 Did not provide the participants with appropriate
care (medication, etc.) or knowledge
Federal Law
 National Research Act of 1974 (Pub. L. 93-348)
created the Commission for the Protection of
Human Subjects of Biomedical and Behavioral
Research (Belmont Report) – the basis for future
legislation
 General jurisdiction maintained by Health and
Human Services (DHHS) and Food and Drug
Administration (FDA)
Institutional Review Boards (IRBs)
 Were established and mandated that
membership be diverse and include at minimum
a scientific, non-scientific, and non-affiliated
community members
 IRBs have the authority to:
 Disapprove, modify, or approve studies
 Conduct continuing review; and/or
 Suspend or terminate approval
Review Criteria
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IRB training via CITI Training Program
Sound research design
Risks are minimized
Recruitment of human subjects is appropriate
Compensation is fair and not inductive to coercion
Participation is voluntary with informed consent
Maintain confidentiality and privacy
Additional safeguards for vulnerable subjects
Vulnerable Populations
 Children/Minors (under the age of 18)
 Prisoners
 Individuals with Mental Disabilities
 Pregnant Women and their Fetuses
Protocol Process
 Fill out the application form in its entirety
 Customize the informed consent form
 Provide other pertinent data, e.g.,
questionnaires, child assent forms, etc.
 Create an identity in IRBNet.org
(https://www.irbnet.org/release/index.html)
 Upload documents
 Sign and submit your protocol
Types of Review
 Exempt: Studies with minimal risk, informed
consent, no vulnerable subjects
 Expedited: Studies with minimal risk, requests
for wavier of consent, vulnerable subjects
included
 Full Board Review: Review with more than
minimal risk in addition of “expedited” factors
Review Process
 Once the protocol has been submitted for
review, the principal investigator may be
notified of:
 Needed modifications
 Additional documentation
 Change of review action
 Approved, disapproved, suspended, or terminated
Cont’d Review Process
 If the protocol is exempt, typical one reviewer
will be assigned and approval will be
administrative in nature
 If expedited, the protocol will be assigned to
2-3 members for review
 If full board review occurs, the protocol goes
to all members by IRBNet and meeting
IRB Approval Procedures
 Once the protocol has been approved,
electronic notification will be issued by IRBNet
 No changes can be made after approval has
been given unless an amendment request is
processed
 Protocols are kept for at least seven years
Continuation/Progress Report
 Changes in protocols must be approved
before research can continue
 Protocols are approved for one year only
unless board requires six month review
 Progress reports must be submitted before
protocols’ approvals expire
Questions?
ANIMAL CARE AND USE
Reasons for Legislation
 To protect the safety and welfare of University
employees and stakeholders
 To ensure that animals are cared for and used
in a manner consistent with all federal
regulations and policies
Federal Regulations
 The Laboratory Animal Welfare Act of 1966
 The Animal Welfare Act of 1970 (amended
1976,1985, 1990, 2002, and 2007)
 Public Health Service Policy (1979, 1985,
2002)
 The PHS Act (Health Research Extension
Act) of 1985
Guiding Agencies
 The Office of Laboratory Animal Welfare
(OLAW) and U.S. Department of Agriculture
(USDA) oversee the use of all animals for
teaching and research purposes
 These agencies have a Memorandum of
Understanding (MOU) concerning inspections
and violations pertaining to the use of animals
IACUC
 Federal law requires establishment of an
Institutional Animal Care and Use Committee
where animals are used
 The IACUC includes at least:
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One scientist
One non-scientist
A veterinarian
A member of the community
IACUC Responsibilities
 Review protocols
 Conduct reviews of previously-approved, ongoing
activities at least once every three years
 Review ASU’s Animal Care and Use Program every
six months
 Inspect the Animal Care Facility and laboratories
researching with animals every six months
 Suspend activities in violation of laws/regulations
Protocols
 Principal investigators must develop protocols
and submit them in IRBNet for review and
approval
 Research cannot begin until approval has
been granted
 IACUC can approve, suspend, or terminate
with a majority vote
AWA Standards
 Procedures will avoid or minimize discomfort, distress, and pain
 Sedation utilized to minimize discomfort or pain
 Appropriate living conditions for the species used in research
settings
 Medical care must be provided
 Avoid duplication of unnecessary experiments
 Only one animal per major operative procedures unless can be
justified in writing
 Euthanasia will be consistent with guidelines established by the
American Veterinary Medical Association
Reports of Mistreatment
 Alleged animal mistreatment must be reported to
IACUC immediately
 IACUC will investigate the allegations and make
recommendations to correct identified problems
 The findings will be submitted to the Institutional
Officer (IO), OLAW, and/or USDA, including a
descriptions of the actions endorsed by IACUC
Occupational Health
 Personal protective measures when working with
animals include:
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Medical evaluations for all Animal Care Facility personnel
Hepatitis B & other vaccinations
Maintain good personal hygiene where animals are housed
Adhere to signs and labels in those areas
Prevention of transmission of Zoonosis by surveying personnel
Proper handling techniques
Questions?
INSTITUTIONAL BIOSAFETY
Reasons for Oversight
 To protect the public health and safety
 Environmental impacts from the uses of
recombinant DNA
 Potential ethical and social implications
Federal Guidelines
 NIH Guidelines for Research Involving
Recombinant DNA (1976, 1978, 1984,1994,
2002, 2013)
 Enhancing Public Access (1978)
Governing Agencies
 Health and Human Services (HHS)
 Office of Human Research Protections (OHRP)
 National Institutes of Health (NIH)
 U.S. Department of Agriculture (USDA)
 Environment Protection Agency (EPA)
 Food and Drug Administration (FDA)
IBC Membership
 The IBC was established to specifically review
the use of recombinant DNA in research
 Must have five members
 Appropriate recombinant DNA expertise
 Have a plant and animal experts
 Biosafety and Compliance Officers are required
 At least two members not affiliated with the
institution
IBC Responsibilities
 Review protocols regarding recombinant DNA,
infectious agents, carcinogens, and other
biohazards
 Assess potential risk to environment and
public safety
 Containment levels per NIH guidelines
 Adequacy of facilities, SOPs, PI and lab personnel
 Institutional and investigator compliance
IBC Review
 Expedited or designated reviews are initial
process where the chair or IBC staff or a
subcommittee makes a determination:
 if the research is exempt or is subject to the NIH
Guidelines
 If subject to the NIH Guidelines then a full board
review will occur through IRBNet or convene of a
board meeting
Noncompliance Issues
 Potential consequences of noncompliance
with the NIH Guidelines
 Suspension, limitation, or termination of external
funding for research at the institution, or
 Prior NIH approval before engaging in
recombinant DNA research
Questions?
Radiation and Laser Safety
Reasons for Establishment
 State of Arkansas requires a license to use
radioactive materials in educational and
research setting
 Provide personnel training and safety during
laser use on campus
Regulations/Policies
 To comply with the terms of the license and all
regulations that govern the use of radioactive
materials in regards to:
 Safe use of radionuclides
 Provide guidance for all ancillary staff and research
personnel involved in radiation and laser research
 Appointments of radiation safety (RSO) and laser
safety (LSO) officers to assure compliance
Protocols
 The Radiation/Laser Safety Committee must
evaluate protocols prior to the start of the
research that use:
 Radioactive materials
 Class 2, 3, or 4 lasers
 For radiation safety training and purchase orders
please contact Dr. Ron Johnson, RSO
 Laser Safety training is provided by Mr. Starr Fenner,
LSO
Questions?
Export Controls Program
Purpose of Regulation
 Technological superiority is a significant
element in the defense of the United States,
along with research, innovation, and
development of critical technologies. There
are significant economic interests of the
government that might be compromised by
unauthorized exports.
Federal Laws/Regulations
 Export Administration Act of 1979
 Implementing : The Export Administration
Regulations (EAR) 15 CFR 730-774
 Arms Export Control Act (Pub. L. 90-629)
 Implementing: International Traffic in Arms
Regulations (ITAR) 22 CFR 120-130
Regulatory Agencies
 U.S Department of Commerce
 Bureau of Industry and Security (EAR)
 Patent and Trademark Office
 Bureau of the Census (trade statistics and AES)
 U.S. Department of State
 Directorate of Defense Trade Controls (ITAR)
 U.S. Department of Treasury
 Office of Foreign Assets Control (OFAC)
Cont’d Regulatory Agencies
 U.S. Department of Energy
 Nuclear Regulatory Commission
 U.S. Department of Interior
 Food and Drug Administration
 U.S. Department of Homeland Security
 Border and Transportation Security
 U.S. Customs Service
What is export controls?
 Various reasons for
 Export controls are a
controlling these items:
set of federal laws,
 National Security
policies and regulations
 Chemical and Biological
which restrict the
 Nuclear Non-Proliferation
export of controlled
 Missile Technology
items, technology and
 Regional Stability
software.
 Crime Control
 Anti-terrorism
What is an export?
A shipment or transfer of items, software, or
technology to a foreign person, foreign entity or
foreign destination.
Definition of Technology
Technology includes information that can be used or
adopted for the development, production, or use of
a controlled item. This information can take the
form of technical data or assistance.
 Examples include but are not limited to:
 blueprints, sketches, models, drawings, software,
manuals, training and technical services
How technology is transferred?
 Controlled information can be exported
through transmittal in various ways including:
 verbal, written, electronic and/or visual disclosure
or exposure
 When information is transmitted to a foreign
person within the U.S., it is considered a
deemed export.
What is a deemed export?
A “deemed export” is a transfer of technology or
source code to a foreign person in the U.S.
 The export is deemed to
be an export to that
individual’s country of
citizenship
 Methods of transfer
include: telephone,
email, conversation,
training sessions, facility
tours, etc…
Who is considered a foreign person?
 Any foreign government,
 Foreign corporation or organization that is not
incorporated or organized to do business in
U.S., and
 Any person who is not a U.S. citizen, lawful
permanent resident (green cardholder), or
individual given asylum
Examples of Situations
 Carrying a laptop containing controlled
information or encryption software on foreign
travel
 Transmitting unpublished research results or
data with foreign persons
 Training a foreign person in the design,
development, use, or testing of controlled
equipment
Areas of Particular Concern
Research in the following areas:
Engineering
Space Sciences
Computer Sciences
Research with encrypted
software
 Agricultural Research
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Biomedical Research
Energy Research
Laser Research
Research with controlled
chemicals, biological
agents, and toxins
Public Domain Exclusion (Sect 734.7)
 Published information that is generally
accessible to the public does not require a
license
 Examples Publication in periodicals, books, print, electronic, or
any other media available for general distribution to
the public or community of interested persons
Cont’d Public Domain Exclusion
 Examples Ready availability at libraries open to the public or at
university libraries
 Through published patents and patent applications;
 Through release at an open conference, meeting,
seminar, trade show or exhibition
Fundamental Research Exclusion (Sect 734.8)
 Fundamental Research Exclusion
 Basic and applied research in science and
engineering conducted in the U.S. where the
resulting information is ordinarily published and
shared broadly within the scientific community
“National Security Decision Directive 189 (NSDD
189)”
Other Exclusions
 Patent Information (Sect 734.10)
 Education/Teaching Exclusion (Sect 734.9)
 Instruction in sciences, mathematics, agricultural,
and engineering courses listed in course
catalogues may be conducted without a license
Encryption Software Exclusion
 “Publicly available” mass market encryption
object code software with a symmetric key
length greater than 64-bits;
 “Publicly available” encryption object code
classified under 5D002 on the CCL when
corresponding source code meets the criteria
specified under license exception TSU;
Cont’d Encryption Exclusion
 “Publicly available” mass market encryption
software with a symmetric key length of 64
bits or less; and
 “Publicly available” encryption software that is
classified under ECCN 5D992 for reasons
other than “mass market” determination.
Penalties for Non-Compliance
Failure to comply with export controls
 Civil penalties:
 $250,000 (or twice the
transaction value) fine
imposed for each violation
of International Emergency
Economic Powers (IEEPA)
 Applies to individuals and
organizations
 Criminal penalties:
 Up to $1,000,000 fine for
individuals/ entities and/or
up to 20 years
imprisonment
OFAC Penalties for Violations
 Civil Penalties (Statutory Maximums)
 Trading with the Enemy Act
 $65,000
 Foreign Narcotics Kingpin Designation Act
 1,075,000
 Anti-Terrorism and Effective Death Penalties
 $55,000
Questions?