Compliance
Research Administrators Training Series
Humane Care & Use of Vertebrate Animals in Research & Instruction
Federal Regulations Governing Care and Use of Animals
- Laboratory Animal Welfare Act, 1966 (Public Law 89-544). Amended in 1970, 1976, and 1985, and standards finalized in 1991. Known as the Animal Welfare Act (AWA)
- Health Research Extension Act of 1985 (Public Law 99-158). Mandates institutions abide by the PHS Policy on the Humane Care and Use of Laboratory Animals. Institutions sign an Assurance committing them to operate according to the principles in the Guide.
Ethical Considerations
- Roots in British animal welfare law
- Based on U.S. Government Principles for the Utilization and Care of Vertebrate Animals in Testing, Research, and Training, and the Guide for the Care and Use of Laboratory Animals (Guide).
- Cover: Transportation; care, use and housing; animal distress; procedures; animal selection; appropriate sedation, analgesia or anesthesia; euthanasia; qualifications of research personnel; and appropriate review
UNH Policy on the Care and Use of Animals
- Applicable to all University community members, regardless of funding source.
- Policy statement: At UNH, all activities proposed to involve the care and use of live vertebrate animals must be reviewed and receive written, unconditional approval from the Institutional Animal Care and Use Committee (IACUC) before commencing.
Be Aware That…
- Applicants must receive written, unconditional IACUC approval BEFORE starting the activity, incl. ordering of animals
- Full IACUC review only
- Review may take a month or more
- Only faculty & staff may apply to the IACUC
- No $ released before IACUC approval granted
- Animals may be housed only in IACUC-approved facilities
Be Aware That…(cont.)
- New animal facilities must be approved by IACUC before animals housed
- Only authorized individuals may order animals
- In-person training & occupational health program approval required for all individuals handling vertebrate animals
- Animals may not be sourced from pet shops
- Flow through $$ involving vertebrate animal work requires IACUC approval at UNH
- Animal Resources Office (ARO) staff available to help with all aspects of research involving vertebrates
Protecting Human Subjects in Research
Selected Triggers for Human Subjects Protections
- Nazi experiments in WWII
- Tuskegee Syphilis Study
- US Government Human Radiation Experiments
- Stanley Milgram’s Obedience Study
- Stanford Prison Experiment
- Tearoom Trade Study
- Jesse Gelsinger case
- Ellen Roche case
Foundational Codes of Ethics
- The Nuremberg Code (1947)
- Declaration of Helsinki (1964)
- The Belmont Report (1979)
- Respect for Persons: Maintain dignity and autonomy, and provide protection for those with diminished autonomy
- Beneficence: Maximize potential benefit and minimize potential harm
- Justice: Fair distribution of research benefits and costs
Laws & Regulations
- National Research Act, 1974
- Code of Federal Regulations, Title 45 Part 46: Federal Policy for the Protection of Human Subjects
- Code of Federal Regulations, Title 59, Part 59: NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research
- FDA regulations
- Agency-specific regulations
- State laws
UNH Policy on the Use of Human Subjects in Research
- Applicable to all members of University community, regardless of funding source.
- Policy statement: All UNH research activities proposing to involve human subjects must be reviewed and receive written, unconditional approval from the Institutional Review Board (IRB) before commencing.
Be Aware That…
- Applicants must receive written, unconditional IRB approval BEFORE starting the activity
- Completion of online training required of applicant in order to submit application
- Three levels of IRB review
- Exempt is a level of review
- Depending on activity, IRB approval may take a month or more
- No $ released before IRB approval granted
- Flow through $$ involving human subjects research requires IRB approval at UNH
When Are Approvals Needed?
IRB & IACUC approvals needed when activities:
- Are sponsored by UNH;
- Are conducted by employees, students in connection with UNH responsibilities;
- Are conducted by employees, students using UNH property; or
- Involve collaborators and/or subrecipients
Research Integrity Services
- Administrative offices for human subjects protections, animal care & use, financial conflict of interest in research, HIPAA, RCR & export controls programs
- Located in Service Building & Rudman Hall
- 8:00 - 4:30, Monday- Friday
- Julie.simpson@unh.edu ~ 2-2003
- Dean.elder@unh.edu ~ 2-4629
- Melissa.mcgee@unh.edu ~ 2-2005
- Website: http://www.unh.edu/research/compliance-safety (meeting schedules, application materials, resources, training, contact information, etc.)
Introduction to HIPAA and the Privacy Rule at UNH
A brief history…
HIPAA sets standards for:
- Electronic transactions and code sets
- Privacy of individually identifiable health information
- Security of individually identifiable health information
- Unique identifiers such as provider ID numbers
What does HIPAA cover?
- Past, present or future mental or physical health.
- Payment and billing information relating to your care
- Personal identifying information (PII) kept by a covered entity – a health care provider, health care plan or health care clearinghouse
- Any information that identifies you (e.g. your name, address, telephone number and Social Security number) as it relates to your medical care – this is "protected health information" (PHI)
Who must comply with HIPAA?
- “Covered entities”
- Health Plans
- Health Care Providers
- Claims clearinghouses
- “Business Associates” and Vendors of Covered Entities
What is “PHI?”
- Anything that identifies an individual (e.g. name, address, telephone number, Social Security number, etc.); such information, as it relates to the individual’s medical care, is "protected health information" or PHI
- PHI can be oral, handwritten, printed, recorded or electronic
- Electronic protected health information is referred to as “ePHI”
Notice of Privacy Practices
“This Notice describes how medical information about you may be used and disclosed and how you can get access to this information. Please review it carefully…”
If you want to know more about HIPAA…
- UNH Research Integrity Services website, www.unh.edu/research/compliance-safety
- HIPAA FAQs
- UNH HIPAA Policy
- Contact information for HIPAA Privacy and Security, and IRB
- US DHHS Office of Civil Rights, www.hhs.gov/ocr/privacy
- Enforces HIPAA regulations
- HIPAA Privacy Rule regulations:
- 45 CFR Part 160
- 45 CFR Part 164, Subparts A and E
HIPAA questions?
Melissa L. McGee, JD
Compliance Officer
HIPAA * Export Controls * FCOIR
862-2005
melissa.mcgee@unh.edu
International Issues and Export Controls
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Victor Sosa
Director
Sponsored Programs
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Melissa McGee
Compliance Officer
Research Integrity Services
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Regulations Overview
- International Traffic in Arms (ITAR)
- Export Administration Regulations (EAR)
- Foreign Assets Control Regulations (OFAC)
- All based on US national security and trade policies, and multi-lateral export controls regimes and treaties
Scope of Export Controls
- Export controls laws govern the movement of US-origin items and the activities of US persons
- What is an “export?”
- Physical goods, information (data), software, certain services
- What is a “US Person?”
- Citizen, permanent resident, certain asylees, US corporations
Scope of ITAR
- International Traffic in Arms Regulations
- Administered by the Directorate of Defense Trade Controls (DDTC) at the US State Department
- Military items
Scope of EAR
- Export Administration Regulations
- Administered by the Bureau of Industry and Security (BIS) at the US Department of Commerce
- “Dual Use” items
- both commercial and military applications
Scope of OFAC
- Office of Foreign Assets Control regulations
- Administered by the OFAC in the US Treasury Department
- With references by BIS and DDTC
- Sanctions and embargoes
- Entire nations, governments, corporations and individuals
- Updated frequently
What is a “Deemed” Export?
Good Question!
Why Comply?
- Because we want to
- Export controls considerations can protect business interests, such as IP
- Reputational damage
- Because we have to
- Serious civil and criminal penalties
- Individual and institutional liability
Potential Export Controlled Items and Activities
- Equipment, software, services, data, information…
- Payments, shipments to non-US destinations
- International collaborations and conferences
- Foreign Travel
- Visiting Scholars
Considerations
- Affiliations: People and Organizations
- Where are they from, i.e. citizenship?
- “U.S. person” or a “foreign person”
- Where do they do business?
- Are they employees, students, visitors, vendors…
- All must be “screened” to ensure they are not debarred, sanctioned or excluded
- Screening is part of due diligence and can be a quick process
Useful Information
Contact Us:
Financial Conflicts of Interest in Research
Purpose
- Federal regulations governing financial conflicts of interest of researchers who apply for federal funds
- National Science Foundation
- Public Health Service
- Protect the integrity of sponsored research by maintaining the objectivity of research
UNH Policies
UNH has adopted two policies on financial conflict of interest in research:
- Research projects proposed for funding, or funded, by the Public Health Service (PHS) or any other organization that requires compliance with the PHS regulations, and
- Research projects proposed for funding, or funded, by any other external organizations
All researchers submitting proposals for external funding through the UNH Sponsored Programs Administration office must acknowledge on the Internal Approval Routing Form (a/k/a Yellow Sheet) that they have read the UNH policy pertinent to the funding source, and will abide by its terms.
The Process
A conflict of interest exists when it can be reasonably determined that an investigator’s personal financial concerns could directly and significantly influence the design, conduct, or reporting of sponsored research activities
Goal of the process is to identify, and eliminate or manage, any possible threat to research objectivity
Who Must Comply
- Any UNH employee (and immediate family) responsible for the design, conduct, or reporting of research activities funded or proposed for funding by external sources
- PDs/PIs are responsible for ensuring that all “Investigators” on a project disclose any significant financial interests that would reasonably appear to be affected by the research
Who Must Comply (cont.)
- Collaborators, sub-contractors, sub-recipients, and visiting scientists must either comply with UNH’s policies or provide a certification that their institutions are in compliance with pertinent federal policies and that they in turn are in compliance with their own institutional policies
Key Definitions
- Research: A systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug)
- Investigator: The project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by external sources, or proposed for such funding, which may include, for example, collaborators or consultants
WHAT IS A “SIGNIFICANT” FINANCIAL INTEREST?
Public Health Service projects: A financial interest that reasonably appears to be related to the Investigator’s institutional responsibilities, including:
- Remuneration from, or equity interests in, publicly traded entities
- Aggregated value exceeding $5000 in the 12 months preceding the disclosure
- Includes salary, consulting, honoraria, stocks, options, ownership interests
- Remuneration from, or equity interests in, non-publicly traded entities
- Remuneration exceeding $5000 in the 12 months preceding the disclosure
- Any equity interest
- Intellectual property rights and interests (e.g., patents, copyrights)
- Upon receipt of income related to such rights and interests
- Reimbursed or sponsored travel related to institutional responsibilities in the preceding 12 months
PHS “SIGNIFICANT” FINANCIAL INTEREST
PHS significant financial interests DO NOT include:
- Salary, royalties, or other remuneration paid by UNH to the investigator if the investigator is currently employed/appointed at UNH, including intellectual property rights assigned to UNH and agreements to share in royalties related to such rights
- Income from investment vehicles, such as mutual funds and retirement accounts, as long as the investigator does not directly control the investment decisions made in these vehicles
PHS “SIGNIFICANT” FINANCIAL INTEREST (cont.)
PHS significant financial interests DO NOT include:
- Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education
- Income from service on advisory committees or review panels for a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education
Non-PHS SFIs
- Any current financial interest of the researcher and his/her immediate family that could reasonably appear to be affected by the activities proposed for funding, or
- Any interest held by the researcher and his/her immediate family in a business entity who financial interests might reasonably appear to be affected by such activities
Non-PHS SFIs (cont.)
Examples of non-PHS significant financial interests include:
- Salary, consulting fees, or honoraria over $10,000 in the preceding 12 months (aggregated for Investigator and immediate family)
- Stock, stock options, or ownership interests valued over $10,000 and representing more than 5% ownership interest (aggregated for Investigator and immediate family)
- Patents, copyrights, and royalties from such rights
Non-PHS SFIs (cont.)
Non-PHS significant financial interests DO NOT include:
- Salary, royalties, or other remuneration from UNH, including IP royalties
- Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities
- Income from service on advisory committees/review panels for public or nonprofit entities
Steps in the Process
- Disclosure
- Committee Review
- Management Plan
- Semi-annual or annual reports and review
Thank you.
Questions?
Knowledgeable research administrators are essential to the management of the research enterprise and play a critical role in research administration at the University.
Next Session:
When: February 17th
- Session I 9:00-10:15 am
- Session II 10:30-11:45 am
Where: MUB Room 338/340
What: Intellectual Property and Technology Transfer
