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
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:
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:
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
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?