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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:.

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Research compliance

Research Compliance:

Regulatory Implications for Researchers


Overview

Overview:

  • Research Compliance topics include:

    • Human Subjects Research

    • Animal Care and Use

    • Institutional Biosafety

    • Radiation and Laser Safety

    • Export Controls Program


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


Research compliance

HUMAN SUBJECTS RESEARCH


Reasons for legislation

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

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

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

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

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

Vulnerable Populations

  • Children/Minors (under the age of 18)

  • Prisoners

  • Individuals with Mental Disabilities

  • Pregnant Women and their Fetuses


Protocol process

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

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

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

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

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

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


Research compliance

  • Questions?


Research compliance

ANIMAL CARE AND USE


Reasons for legislation1

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

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

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

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

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

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

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

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

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


Research compliance

  • Questions?


Research compliance

INSTITUTIONAL BIOSAFETY


Reasons for oversight

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

Federal Guidelines

  • NIH Guidelines for Research Involving Recombinant DNA (1976, 1978, 1984,1994, 2002, 2013)

  • Enhancing Public Access (1978)


Governing agencies

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

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

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

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

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


Research compliance

  • Questions?


Research compliance

Radiation and Laser Safety


Reasons for establishment

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

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


Protocols1

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


Research compliance

  • Questions?


Research compliance

Export Controls Program


Purpose of regulation

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

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

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

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

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 technology

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


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?

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

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

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

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

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

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 (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

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

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

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

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

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


Research compliance

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