research compliance:
DESCRIPTION
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:. - PowerPoint PPT PresentationTRANSCRIPT
![Page 1: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/1.jpg)
Research Compliance:Research Compliance:Regulatory Implications for Researchers
![Page 2: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/2.jpg)
Research Compliance topics include: Human Subjects Research Animal Care and Use Institutional Biosafety Radiation and Laser Safety Export Controls Program
Overview:Overview:
![Page 3: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/3.jpg)
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
![Page 4: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/4.jpg)
HUMAN SUBJECTS RESEARCH
![Page 5: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/5.jpg)
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
![Page 6: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/6.jpg)
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
![Page 7: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/7.jpg)
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)
![Page 8: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/8.jpg)
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
![Page 9: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/9.jpg)
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
![Page 10: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/10.jpg)
Vulnerable PopulationsVulnerable Populations
Children/Minors (under the age of 18) Prisoners Individuals with Mental Disabilities Pregnant Women and their Fetuses
![Page 11: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/11.jpg)
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
![Page 12: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/12.jpg)
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
![Page 13: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/13.jpg)
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
![Page 14: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/14.jpg)
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
![Page 15: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/15.jpg)
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
![Page 16: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/16.jpg)
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
![Page 17: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/17.jpg)
Questions?
![Page 18: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/18.jpg)
ANIMAL CARE AND USE
![Page 19: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/19.jpg)
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
![Page 20: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/20.jpg)
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
![Page 21: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/21.jpg)
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
![Page 22: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/22.jpg)
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
![Page 23: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/23.jpg)
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
![Page 24: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/24.jpg)
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
![Page 25: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/25.jpg)
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
![Page 26: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/26.jpg)
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
![Page 27: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/27.jpg)
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
![Page 28: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/28.jpg)
Questions?
![Page 29: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/29.jpg)
INSTITUTIONAL BIOSAFETY
![Page 30: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/30.jpg)
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
![Page 31: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/31.jpg)
Federal GuidelinesFederal Guidelines
NIH Guidelines for Research Involving Recombinant DNA (1976, 1978, 1984,1994, 2002, 2013)
Enhancing Public Access (1978)
![Page 32: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/32.jpg)
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)
![Page 33: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/33.jpg)
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
![Page 34: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/34.jpg)
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
![Page 35: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/35.jpg)
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
![Page 36: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/36.jpg)
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
![Page 37: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/37.jpg)
Questions?
![Page 38: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/38.jpg)
Radiation and Laser Safety
![Page 39: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/39.jpg)
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
![Page 40: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/40.jpg)
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
![Page 41: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/41.jpg)
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
![Page 42: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/42.jpg)
Questions?
![Page 43: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/43.jpg)
Export Controls Program
![Page 44: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/44.jpg)
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.
![Page 45: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/45.jpg)
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
![Page 46: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/46.jpg)
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)
![Page 47: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/47.jpg)
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
![Page 48: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/48.jpg)
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
![Page 49: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/49.jpg)
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.
![Page 50: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/50.jpg)
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
![Page 51: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/51.jpg)
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.
![Page 52: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/52.jpg)
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.
![Page 53: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/53.jpg)
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
![Page 54: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/54.jpg)
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
![Page 55: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/55.jpg)
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:
![Page 56: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/56.jpg)
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
![Page 57: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/57.jpg)
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
![Page 58: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/58.jpg)
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)”
![Page 59: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/59.jpg)
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
![Page 60: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/60.jpg)
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;
![Page 61: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/61.jpg)
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.
![Page 62: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/62.jpg)
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
![Page 63: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/63.jpg)
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
![Page 64: Research Compliance:](https://reader034.vdocuments.us/reader034/viewer/2022042703/56812fee550346895d95645d/html5/thumbnails/64.jpg)
Questions?