research compliance: regulatory implications for researchers

64
Research Research Compliance: Compliance: Regulatory Implications for Researchers

Upload: homer-garrett

Post on 27-Dec-2015

217 views

Category:

Documents


0 download

TRANSCRIPT

Research Compliance:Research Compliance:Regulatory Implications for Researchers

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

HUMAN SUBJECTS RESEARCH

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

Questions?

ANIMAL CARE AND USE

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

Questions?

INSTITUTIONAL BIOSAFETY

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

Questions?

Radiation and Laser Safety

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

Questions?

Export Controls Program

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

Questions?