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  1. Research Compliance: Regulatory Implications for Researchers

  2. Overview: • Research Compliance topics include: • Human Subjects Research • Animal Care and Use • Institutional Biosafety • Radiation and Laser Safety • Export Controls Program

  3. 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

  4. HUMAN SUBJECTS RESEARCH

  5. 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

  6. 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

  7. 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)

  8. 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

  9. 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

  10. Vulnerable Populations • Children/Minors (under the age of 18) • Prisoners • Individuals with Mental Disabilities • Pregnant Women and their Fetuses

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. Questions?

  18. ANIMAL CARE AND USE

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. Questions?

  29. INSTITUTIONAL BIOSAFETY

  30. Reasons for Oversight • To protect the public health and safety • Environmental impacts from the uses of recombinant DNA • Potential ethical and social implications

  31. Federal Guidelines • NIH Guidelines for Research Involving Recombinant DNA (1976, 1978, 1984,1994, 2002, 2013) • Enhancing Public Access (1978)

  32. 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)

  33. 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

  34. 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

  35. 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

  36. 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

  37. Questions?

  38. Radiation and Laser Safety

  39. 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

  40. 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

  41. 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

  42. Questions?

  43. Export Controls Program

  44. 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.

  45. 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

  46. 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)

  47. 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

  48. 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

  49. What is an export? A shipment or transfer of items, software, or technology to a foreign person, foreign entity or foreign destination.

  50. Definition of Technology Technology includes information that can be used or adopted for the development, production, or use of a controlled item. This informationcan 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