Research Compliance topics include: Human Subjects Research Animal Care and Use Institutional Biosafety Radiation and Laser Safety Export Controls Program
Overview:Overview:
Expectations: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
Reasons for LegislationReasons 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 SubjectsBackground 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 LawFederal 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)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 CriteriaReview 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 PopulationsVulnerable Populations
Children/Minors (under the age of 18) Prisoners Individuals with Mental Disabilities Pregnant Women and their Fetuses
Protocol ProcessProtocol 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 ReviewTypes 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 ProcessReview 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 ProcessCont’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 ProceduresIRB 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 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
Reasons for LegislationReasons 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 RegulationsFederal 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 AgenciesGuiding 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
IACUCIACUC
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 ResponsibilitiesIACUC 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
ProtocolsProtocols
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 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 MistreatmentReports 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 HealthOccupational 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
Reasons for OversightReasons for Oversight
To protect the public health and safety Environmental impacts from the uses of
recombinant DNA Potential ethical and social implications
Federal GuidelinesFederal Guidelines
NIH Guidelines for Research Involving Recombinant DNA (1976, 1978, 1984,1994, 2002, 2013)
Enhancing Public Access (1978)
Governing AgenciesGoverning 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 MembershipIBC 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 ResponsibilitiesIBC 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 ReviewIBC 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 IssuesNoncompliance 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
Reasons for EstablishmentReasons 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/PoliciesRegulations/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
ProtocolsProtocols 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
Purpose of RegulationPurpose 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/RegulationsFederal 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 AgenciesRegulatory 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 AgenciesCont’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?What is export controls?
Export controls are a set of federal laws, policies and regulations which restrict the export of controlled items, technology and software.
Various reasons for controlling these items: National Security Chemical and Biological Nuclear Non-Proliferation Missile Technology Regional Stability Crime Control Anti-terrorism
What is an export?What is an export?
A shipment or transfer of items, software, or technology to a foreign person, foreign entity or
foreign destination.
Definition of TechnologyDefinition 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?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?What is a deemed export?
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…
A “deemed export” is a transfer of technology or source code to a foreign person in the U.S.
Who is considered a foreign person?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 SituationsExamples 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 ConcernAreas of Particular Concern
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
Research in the following areas:
Public Domain Exclusion (Sect 734.7)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 ExclusionCont’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 (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 ExclusionsOther 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 ExclusionEncryption 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 ExclusionCont’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-CompliancePenalties for Non-Compliance
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
Failure to comply with export controls
OFAC Penalties for ViolationsOFAC 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
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