Regulatory Compliance

Contents

Our Regulatory Compliance Requirements

Institutions and researchers must comply with internally and externally imposed requirements related to the management of research projects. We must assure that our researchers and administrative staff follow best practices for sound research management.

What’s in This Regulatory Compliance Section?

This section covers the content listed under Topics above or in the list below. To review all of the materials, scroll through this page. To jump to particular sections, click the linked sub-section titles listed below.

The following regulatory related systems information is covered in OTHER SECTIONS of the SPA Guide:

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IRB Section

Institutional Review Board (IRB) – Human Subjects

The purpose of the Institutional Review Board (IRB) is to protect the rights and welfare of human research subjects.

The IRB reviews all research projects at NCSU that use human subjects to ensure that we meet this goal and are compliant with the related federal regulations.

Background

There were a number of significant historical events that preceded the formulation of the regulations that govern our use of human subjects in research here at the University.

The following are three of the more significant events. Note that even though these are all medical examples, the resulting regulations apply to behavioral and social research, also.

Nuremberg TrialNuremberg Code

The medical experiments conducted by German doctors and prosecuted in the so-called Doctors’ Trial led to the creation of the Nuremberg Code, a set of research ethics principles for human experimentation.

The Nuremberg code includes such principles as:

  • informed consent and absence of coercion;
  • properly formulated scientific experimentation; and
  • beneficence towards experiment participants.

Henry Beecher Article

Henry Beecher was an important figure in the history of anesthesiology and medicine, receiving awards and honors during his career. His 1966 article on unethical practices in medical experimentation within the New England Journal of Medicine was instrumental in the implementation of federal rules on human experimentation and informed consent.

In this 1966 paper, Beecher described 22 published medical studies where patients had been experimented on with no expected benefit to the patient. In one study, for example, patients infused with live cancer cells had been told they were receiving “some cells” without specifying that they were cancer. Though identities of the authors and institutions had been stripped, the 22 studies were later identified as having been conducted by mainstream researchers and published in prestigious journals within the previous decade.

The paper has been described as “the most influential single paper ever written about experimentation involving human subjects.” The Office for Human Research Protections credits this paper as “ultimately contributing to the impetus for the first NIH and FDA regulations.”

Beecher also worked both in defining the rules and conditions for informed consent and in establishing institutional review boards as an additional layer of oversight regarding research protocols.

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Tuskegee Syphilis Experiment

The Tuskegee syphilis experiment (also known as the Tuskegee syphilis study or Public Health Service syphilis study) was an infamous clinical study conducted between 1932 and 1972 in Tuskegee, Alabama by the U.S. Public Health Service.

Syphilis Experiment

The experiment was conducted to study the natural progression of untreated syphilis in poor, rural black men who thought they were receiving free health care from the U.S. government. When the press exposed the study, the US Congress appointed a panel that determined that the PHS Syphilis Study should be stopped immediately and that overseeing of human research was inadequate.

Belmont ReportThe Tuskegee Syphilis Study, cited as “arguably the most infamous biomedical research study in U.S. history,” led to the 1979 Belmont Report and the establishment of the Office for Human Research Protections (OHRP) within the US Department of Health and Human Services (HHS).

The Belmont Report identifies three basic ethical principles that underlie human experimentation (the Belmont Principles):

  • Respect for persons
    • Respect of subject autonomy
    • Informed consent
  • Beneficence
    • “Do no harm”
    • Risks balanced with benefits
  • Justice
    • Equality in participation
    • Fair distribution of costs and benefits to potential research participants

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Concepts, Rules, and Regulations

The main regulation that governs our research conduct involving human subjects is 45 CFR 46, a set of federal regulations for Institutional Review Boards called the “Common Rule.” It applies to all research projects at an institution, regardless of the funding source.

DefinitionsFor us that means that any research we conduct at the University involving human subjects must be compliant with this federal regulation and must be reviewed by the Institutional Review Board. IRB approval must be obtained before any contact with potential subjects is made.

Review the University definitions on the right that are fundamental to our basic understanding of the broad scope of research and the way we categorize “human subjects” in a research setting (taken from 45 CFR 46).

In addition, note that continued analysis of identified data that was collected previously is considered ongoing research and is subject to review and approval by the IRB committee just as the original collection of the data is classified as research.

To clarify further, the following notes also expand on two of the terms under the Human Subject Definition:

  • Interaction means ANY contact between investigator and subject, even via mail, websites, or telephone.
  • Studies in which a particular environment is manipulated and then the subjects are observed counts as an intervention.
  • Private information includes school records, financial records, health records, or anything personal such as belief systems, material preferences, etc.

Anonymity vs. Confidentiality

Anonymous data means that not even the researcher can trace a subject from his or her data. Coded data is not anonymous because there is a traceable link between the subject and his or her data.

3rd Party Subjects
3rd party subjects are people about whom information is gathered, but who are not actually participating in the study. For example, if a study asks about a subjects’ family members, those family members are considered 3rd party subjects and they must have their confidentiality protected also.

Informed Consent
The cornerstone of research ethics when working with human participants is the idea of informed consent. It is a legal requirement that we give complete information to every potential research subject about the research – including any potential risks. The potential research subjects have the right to make their own decisions about whether or not to participate. If they decide to participate in the research, they must sign a consent form.

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Institutional Review Board (IRB) Committee

PI ResponsibilitiesReview the following overview information on IRB responsibilities and processes and note the contact information in the “E-Mail Contacts” links at the end of this section of the guide for any questions you may have.

Remember the following important fact:

IRB approval must be obtained before any contact with potential subjects is made.

The following are the basic components of an IRB review:

  • Risks to subjects are minimized
  • Risks are balanced with benefits
  • Selection of subjects is equitable
  • Informed consent is sought and documented
  • Adequate provisions are made to protect the privacy of subjects and to maintain the confidentiality of data

The IRB also ensures that additional safeguards are in place for research involving vulnerable populations including:

  • Children
  • Prisoners
  • Pregnant women and fetuses
  • Employees/Students

After the IRB reviews each research protocol, they will make one of four possible decisions:

  • Approve
  • Approve with modifications
  • Defer
  • Disapprove

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Level of Risk

The IRB has some flexibility regarding research involving human subjects. The amount of flexibility is based on the risk of the research – the riskier a project is, the less flexibility is allowed. Those studies deemed “minimal risk” can receive simpler, faster reviews, and have more flexibility than other research. The IRB rather than the PI makes a determination of the risk of the research and flexibility of the rules.

Minimal risk is defined by the regulations as “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”

IRB Review Process
Review the notes in the following chart regarding the IRB review process.

IRB Timeframes

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Submitting Research Details to the IRB for Review

The researchers’ IRB submissions are the blueprints for their research. They must describe all study activities and components on the IRB form, including full details about their research along with specific, practical information on how procedures will be carried out, confidentiality protected, etc. Any research activities that deviate from the details described in the IRB submission are not approved and are considered noncompliant.

Review the following overview of the steps researchers must take to get IRB approval:

  • Obtain the proper form from the SPARCS IRB website
  • Complete the application, describing the study’s intent, procedures, and collection of identifiers as fully as possible
  • Include any materials given to subjects (advertisements, surveys, forms, etc.), and/or interview outlines
  • Include any necessary informed consent or parental permission forms

You can find further details including forms and access to further training in the “Further Exploration” section that follows.

Further Exploration

To explore further than the overview information presented on this IRB topic, click the SPARCS IRB web site pictured/linked below (opens in a new tab or window).

IRB Web Page

For more information, you may also access an online tutorial on Human Subjects in research. You must enter your Unity ID and password to access the tutorial.

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IACUC Section

Institutional Care & Use Committee (IACUC) – Animal Care

The USDA logo below illustrates just one of the governing bodies responsible for the rules and regulations that exist to ensure that we respect and treat animals humanely when used for research here at the University.

Introduction The federal regulations and policies ensure that the following occurs when animals are used in research:

  • Animals are only used in research when it is absolutely necessary. This includes the following stipulations:
    • There are no other alternatives available to conduct the research study
    • Confirmation that the planned research activities are not duplicating previously conducted experiments
    • The experiments are relevant to human or animal health, will advance scientific knowledge, or will be conducted for the good of society
  • The animals are treated humanely, which includes:
    • Avoiding or minimizing discomfort, distress, and pain whenever possible
    • Using appropriate measures such as sedatives or anesthesia when more than momentary or slight pain is involved
    • Ensuring that any necessary transport activities are comfortable and involves as little stress as possible for the animals
    • Living conditions are clean and appropriate for the species

The University provides guidance, oversight, monitoring and a mandated committee review and approval process to help maintain our high standards of ethical and humane treatment and conditions.

Review the topics that follow for a broad overview and explore or save the links to more information on each segment if you are involved in this area of the University’s research projects.

Optional Video

You may choose to watch the following optional video (less than 2 minutes) for a brief introduction to one of our research facilities here at the University. The center conducts research studies that benefit human health as well as animal health. (Take a moment before clicking the play arrow to grab your ear buds or adjust your computer’s volume up or down to listen to the audio track in your work environment – also has closed captioning text to view without sound).

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Background

The best practices, rules, and regulations surrounding humane animal treatment in the field of research as it is today evolved from scientific study as well as historical events and “front page news” that brought past animal mistreatment issues into the public view.

The following are some historical events that were important milestones in this area:

  • 1600′s – cadaver studies reveal understanding of blood circulation
  • 1700′s and 1800′s – development of smallpox, anthrax, and rabies vaccines as well as advancement in the understanding of how diseases are transmitted using animal studies and subjects
  • 1920′s to 1960′s – formulation of review codes and boards such as the Nuremberg Code, Animal Care panel, guides, and accreditation panels for animal care labs

Life Magazine Article PhotoMedia Headlines

Animal care issues that made headlines such as the following also brought animal care research to the forefront, leading to public outcries and pressure for oversight and regulations:

  • A congressman’s failed attempt to help a family prevent their “kidnapped” family dog’s death as part of a local hospital’s research experiment
  • A Life magazine article titled “Concentration Camp for Dogs”
  • A publicized raid on a dog dealer’s premises that led to the enactment of the federal Laboratory Animal Welfare Act of 1966

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Rules and Regulations

The University must comply with numerous rules and regulations regarding animal use and care. The two main governing regulations are these:

  • Animal Welfare Act
    • Series of laws regulating animal use activities
    • Enforced by the US Department of Agriculture
    • Violations can lead to research program suspensions, fines and/or imprisonment
  • Public Health Service Policy (PHS) on Humane Care and Use of Laboratory Animals
    • Applies to any research funded by Public Health Service funds
    • PHS Policy administered through the Research Extension Act, administered by the Office of Laboratory Animal Welfare and National Institutes of Health
    • Deviation from the PHS Policy could result in loss of funding from Public Health Service organizations

The SPARCS Animal Care and Use Division web site linked in the “Further Exploration” segment at the end of this section contains links to all of the policies and supporting regulations.

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Frequently Asked Questions

The following FAQ page also contains a specific question and answer related to the changing nature of the guidelines we must follow.

IACUC FAQ Page

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Institutional Animal Care and Use (IACUC) Committee

All research universities must have this type of committee to ensure that all of the regulatory requirements are met. Our University committee has these mandated duties and criteria:

  • Empowered by law to ensure all research activities involving animals comply with all applicable federal, state, and local regulations and policies
  • Comprised of at least five members:
    • Chairperson
    • Veterinarian
    • Scientist – must be experienced in using research animals
    • Non-Scientific Member – conducts protocol evaluations not based on the science
    • Nonaffiliated Member – represents the general interests of the community

The IACUC reviews and approves all research, teaching or testing activities that involve animals before our researchers begin their experiments.

The committee must ensure that all of the following conditions or requirements are met:

  • There are no alternatives to using animals
  • The research is not being unnecessarily duplicated
  • The experiment is relevant to human or animal health and will be for the good of society
  • The number of animals used for the research will yield statistically valid results
  • The appropriate species of animals are being used for the project
  • Humane experimental endpoints have been established
  • Appropriate methods of euthanasia are being utilized

The committee also makes sure that the animals’ living quarters are inspected at least twice per year to ensure that all of the following conditions or requirements are met:

  • Animals are checked daily, their housing facilities are clean, and they regularly receive fresh food & water
  • The facilities are appropriate for the species being housed
  • The animals are receiving appropriate veterinary care

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Further Exploration

To explore further than the overview information presented above, click the SPARCS Animal Care and Use Division web site pictured below (opens in a new tab or window). Note the menu items accented below by the red box including forms and policies.

IACUC Web Page

For more information, you may also access an online tutorial on Animal Care and Use in research. You must enter your Unity ID and password to access the tutorial.

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COI Section

Conflict of Interest (COI)

Our projects’ federal and non-federal sponsors “closely scrutinize” our sponsored projects for real or potential conflicts of interest. So, we must follow their requirements to closely look into our research staffs’ potential conflicts of interest that could bias the design, conduct, or reporting related to the research projects.

To meet this requirement, the university has established standards and procedures that include a mandatory disclosure requirement for all covered employees. We remind our faculty and staff that the COI disclosure is not a “bad thing” but rather a way to manage any potential problems. By disclosing any possible conflicts in advance and having an approved management plan in place, the University and our researchers have protections in place in case any questions arise.

For this topic, review the following “Who, What, When, Where, Why, and How” segments to get a clear understanding of how to manage this requirement for faculty and staff who work on our sponsored projects.

COI System Instructions and Public Health Services (PHS including NIH) Funded Projects

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WHO is required to Complete a Conflict of Interest Declaration?

The following employees are required to complete the COI declaration:

  • Every EPA employee
    • Faculty
    • Professionals
    • Post docs
  • Adjunct and Emeritus faculty on appointment
  • Anyone paid in whole or in part from a sponsored project (5-account) – including, but not limited to SPA employees and Graduate Assistantships

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WHAT is the Disclosed in the Conflict of Interest Declaration?

The potential Conflicts of Interests that must be disclosed include:

  • Significant Financial Interests with an external entity that does business with the University, sponsors projects, or hires students or other employees for which the university employee (or a family member living in the same household) is responsible, when one or more of the following situations exist:
    • Income of $10,000 or more including: Salary, consulting fees, honoraria, royalty payments dividends, interest income, or the proceeds from the sale of equity the discloser may own
    • Investments including: Stocks, bonds, or other equity instruments worth at least $10,000 market value or 5% equity interest (regardless of market value)
    • Positions including: Founder, partner, director, manager, officer, trustee, employee, or any other position of management with the entity
  • Textbooks:
    • Textbooks and other classroom materials authored and required in NCSU courses taught by discloser
  • Intellectual Property (IP) rights
    • Patents, copyrights, and royalties from these rights
    • IP owned by the discloser and licensed to the university
  • Associations
    • Professional – related to University employment
  • Textbooks
    • Textbooks and other classroom materials authored and required in NCSU courses taught by discloser

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WHAT is a Management Plan?

If any of the circumstances listed above exist, the disclosers may be required to file a management plan to ensure optimal objectivity in carrying out their project related activities. The management plan is included in the COI disclosure process. The plan details the actions and safeguards that the staff and department will undertake to ensure that their objectivity is maintained.

Click the screen shot below to access this section of the SPARCS web site for specific guidance on writing the plan:

COI Management Plan

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WHEN are Conflict of Interest Declarations Completed? October 1st Deadline

Annual Disclosure Period

The COI disclosure period is August 16th through August 15th of each year, so a new disclosure is required annually. Covered employees are asked to complete the COI each year by October 1st.

Updates

As circumstances change, our faculty and staff are required to update the COI system disclosure information with any new potential conflicts of interest that arise during the year.

College and Department Research Administrative staff should keep the following in mind to facilitate this updating requirement:

  • Be sure to watch for any EPAP (External Professional Activity for Pay) that could create a conflict of interest and remind your faculty and staff to update their information online.
  • Be sure that the COI disclosure is added to any checklists or processes you use involving new hires, transfers, resignations, and retirements.
  • Update approver status as necessary including adding new approvers and deleting any incorrect approvers from the COI system.

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WHERE are Conflict of Interest Declarations Completed?

The university uses an electronic COI system to record and approve any potential conflicts of interest. The specific instructions for completing the online COI disclosure are in the “Systems” section of this SPA Guide.

Once the on-line form is complete, the COI system electronically routes the disclosure to the employee’s Department Head, Director, Dean or Vice Chancellor for review and approval. If the employee completes the declaration with nothing to disclose, the approver is only notified that the declaration has been completed.

We use this electronic certification process in our COI system as our signature authority under the following categories:

  • Discloser: Certifies that it is complete, accurate, and if relevant, commits to the designated management plan
  • Department Head/Dean: Reviews the disclosure for completeness and approves it along with any required management plan

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WHY are Conflict of Interest Declarations Completed?

The Right Thing to Do

The university’s mission to transfer knowledge also includes an entrepreneurial spirit to encourage faculty’s outside endeavors. At the same time, we are upholding our obligation to assure our objectivity by guarding against any biases (or perceived conflicts) due to potential competing interests of faculty who “wear two hats” in university research and private business pursuits.

Preserving the Public Trust

We comply with the regulations that require us to declare any potential conflicts of interest for a number of reasons including:

  • Protecting the integrity and respect of our research and faculty members
  • Preserving the public’s trust in the University and its research findings
  • Guarding the University’s continued public support and funding for academic science

Regulations Require It

The original language of the federal 1995 regulations includes this phrase: “that the design, conduct, or reporting of research is not biased by any conflicting financial interests of the investigator.” There are a number of regulations that adhere to this basic concept including:

  • Requirements by federal sponsors including the National Institutes of Health (NIH) and National Science Foundation (NSF)
  • Criminal Statutes of NC
  • UNC System Policies

Acknowledge It, Then Manage It!

Our attitude centers around managing any potential conflicts of interest rather than any unsound practices of discouraging private partnerships to the detriment of progressive research. We manage potential conflicts as we have described in this SPA Guide section on COI as well as specific COI guidance and references on the SPARCS web site.

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HOW are Conflict of Interest Declarations Managed?

Department and College or Division staff are responsible for the oversight and management of the COI process by carefully reviewing, monitoring, and approving COIs

Review the following information to make sure that you are aware of these issues:

  • Watch for the following new or ongoing activities that may create a conflict of interest:
    • Association Memberships
    • Publications
    • Oversight of staff and students
    • Intellectual property
  • Remember that electronic COI records are protected by the same confidentiality rules as other personnel records and be sure to follow these guidelines:
    • Safeguard against against unauthorized access of other employee’s COI electronic records.
    • Do not use the Unity ID or password of another employee or approver to access COI information.
  • Use an ongoing monitoring and follow-up system to make sure all COI disclosures are completed by the October 1st deadline using methods such as:
    • Periodic e-mail reminders to those who have not completed disclosure
    • Reminders to approvers when disclosures are ready for review or approval
    • E-mail messages at least twice a year to all staff reminding them to update their COI records if necessary with any change in circumstances

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HOW are PHS/NIH Conflict of Interest Declarations Managed?

The following additional requirements apply only to investigators or employees funded by a Public Health Service (PHS) agency (or agencies following PHS guidelines) including the National Institute of Health (NIH). You may access this list of agencies that use PHS regulations.

Additional Questions

  • Employees complete a PHS-specific set of questions when they go into the COI system if they
    are being paid from PIH/NIH funds.
  • The system automatically presents the PIH/NIH questionnaire based on the employee’s
    Employee # and Unity ID, requiring no additional action from the employee to specify their
    funding sources.

Lower Financial Thresholds

  • Financial thresholds requiring disclosure are lower than general COI requirements.

Travel Reporting Requirements

  • Employees answer questions related to reimbursed or sponsored travel concerning the purpose,
    sponsor, destination, duration, and monetary value.

Periodic Training Required

  • Employees who have been funded OR submitted a proposal to a PHS related agency must
    complete an initial online training class and repeat the training every 4 years.
  • To meet this requirement, employees access the training, complete it online, and email the final
    Certificate of Completion to SPARCS COI personnel.

Institutional Compliance Review

  • Whenever a proposal or award action from a PHS agency (or other entities following PHS
    requirements) is initiated by SPARCS, a notification email is sent to SPARCS COI personnel to
    determine if the personnel listed on the proposal or award has a COI with management plan.
    If so, SPARCS COI personnel complete a review to determine if the disclosed information is
    reportable to NIH.

Online References

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NOI Section

Notice of Intent (NOI)

The University not only encourages external professional activities of our EPA professionals and faculty but expects these outside activities. Why? Because they provide opportunities for our faculty and staff to add “real-life” knowledge to their intellectual and research base of knowledge. It is a privilege enjoyed by academics that must also be carefully monitored to remain in compliance with our governing regulations.

The State of North Carolina and University regulations require that the University monitor our EPA professionals’ and faculty’s potential conflicts of commitment (time) or External Activities for Pay (EPAP) that could impact their responsibilities to the University.

To assess any potential issues, the university has established standards and procedures that include a mandatory disclosure requirement using our “Notice of Intent” system to record and get approval for any EPAP or potential conflicts of time commitments for outside consulting or similar activities.

For more information on this topic, review the following “Who, What, When, Where” segments to get a clear understanding of how to manage this requirement for faculty and staff who work on our sponsored projects.

NOTE: The specific instructions for completing the online NOI disclosure are in the “Systems” section of this SPA Guide.

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WHO is required to Complete a Notice of Intent Declaration?

All EPA and faculty members who are planning to do some consulting or engage in any other activities outside the University for pay (EPAP), must complete the online Notice of Intent to get prior approval from their department heads.

Note the prior notice requirements in the “When” section below for more information on the specific time frame and process.

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WHAT is the Notice of Intent?

Engaging in external professional activities for pay is a privilege of serving in an EPA Professional or Faculty position. The Board of Governor’s policy and NC State University regulations require faculty and EPA staff to provide prior-notification of their intent and get approval by their Deans or Department Heads.

When completing the required fields in the NOI system, they will be asked to provide the following information:

  • The nature of their activities for the outside entity.
  • Any and all duties they will miss on campus. If necessary, they must outline any reasonable arrangements they have made to cover their university obligations such as arranging for a post-doc or senior graduate student to handle their classes on certain days.
  • They must disclose any use of university resources beyond incidental use of office personal computers in the Notice of Intent. Any usage of university resources beyond that level would require a separate facilities use contract.
  • If the outside entity has a business relationship with the university (such as sponsoring research or providing other goods or services) and the faculty member also has a possible role in selecting (or supervising those who select) that entity’s sponsored research funds, goods, or services, then the faculty member must also update the Conflict of Interest disclosure prior to submitting the Notice of Intent or certify that the current Conflict of Interest information is complete and proper.

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WHEN are Notice of Intent Declarations Completed?

10-Day Notice Requirement
All EPA and faculty members who plan to do some consulting or engage in any other activities outside the University for pay (EPAP), are required to complete the online Notice of Intent at least 10 calendar days prior to the start date.

Exceptional Circumstances
If faculty or staff cannot meet the 10-day rule for some unforeseen circumstance, they should submit the request as soon as possible. In rare cases where they did not submit the NOI before beginning the outside work, they must complete the NOI after the fact with an extra-ordinary justification clearly noted.

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WHERE are Notice of Intent Declarations Completed?

The university uses an electronic NOI system to record and get approval for any consulting or work outside the University for pay (EPAP). The specific instructions for completing the online NOI disclosure are in the “Systems” section of this SPA Guide

Once the on-line notice is complete, the NOI system electronically routes the disclosure to the employee’s Department Head, Director, Dean or Vice Chancellor for review and approval.

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Export Controls

spa-export-handcuffsResearchers who run across the words “Export Controls” may skip that reference because they immediately think that they don’t export anything. You can help the researchers that you work with realize that they could be dealing with less evident forms of Export Controls as part of their research and a dismissive attitude toward Export Controls is not the best way to approach this subject!

Extreme Penalties

Knowingly or unknowingly violating Export Control laws can result in extreme penalties that can include:

  • Criminal sentences for individuals of up to 10 years in prison
  • Fines up to $1 million dollars
  • Civil fines of up to $500,000 for violating Export Control laws

Review the basic overview information that follows and be sure to visit and bookmark the Export Controls section of the SPARCS web site for specifics. Keep in mind, also, that the introductory information in this Export Controls section of the SPA Guide applies to all university business and activities, not just research-related functions. For example, shipping a controlled substance without a license is illegal whether or not the shipment is related to a research project.

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What Research Related Activities are Impacted by Export Controls?

The following are examples of situations that we might commonly find in our Sponsored projects that may be subject to Export Controls:

  • Shipping controlled materials, supplies, or samples to other countries
  • Carrying controlled materials, samples, or GPS equipment in checked or carry-on luggage on foreign travel
  • Sharing information disclosed under confidentiality agreements with foreign persons, including students, staff, and faculty
  • Carrying a university-owned laptop computer containing controlled information or encryption software on foreign travel
  • Exchanging unpublished research results or data with foreign persons located overseas or in the US by any means, including e-mail, file transfers, etc.
  • Training a foreign person in the design, development, use, or testing of controlled equipment
  • Conducting research under a grant or any contractual agreement that restricts the participation of foreign nationals or requires approval to publish results

To better understand the examples above, review the following definitions.

  • Export
    • An Export is the shipment or transmission of items outside of the United States. An item is defined as commodities, software (source code), and technology (technical information).
  • Controlled Export
    • Transfers of controlled information, including technical information, to foreign persons and entities outside the United States
    • Controlled physical items (that require export licenses from the U.S to a foreign country) that are shipped or included in checked or carry-on luggage – including any item that is “inherently military in character” or specifically designed or adapted for military use or any of the hundreds of commercial items that may also be used for military or terrorist applications (dual use) such as:
      • Nuclear Materials, Facilities and Equipment
      • Materials, Chemicals, Microorganisms, and Toxins
      • Electronics, Computers
      • Materials Processing
      • Telecommunications and Information Security
      • Lasers and Sensors
      • Navigation and Avionics
      • Marine
      • Propulsion Systems, Space Vehicles, and Related Equipment
      • Weapon systems, Unmanned Vehicles, Detection Systems, Crypto Systems
    • Verbal, written, electronic, and/or visual disclosures of controlled scientific and technical information related to export controlled items to foreign national outside or inside the United States (“deemed exports”)
  • Deemed Export
    • The transfer of technology or source code by any method to a foreign person in the U.S. or abroad is “deemed” to be an export to that individual’s country of citizenship
    • Methods of transfer include fax, telephone discussions, e-mail, computer data disclosure, face-to-face discussions, training sessions, or facility tours which involve visual inspections of controlled technology
  • Foreign Person
    • Any person who is not a US citizen or lawful permanent resident of the United States (green card holder)
    • Any foreign corporation or other entity or group that is not incorporated or organized to do business in the United States
    • Any foreign government
  • Embargoed Nations
    • Office of Foreign Asset Control (OFAC) administers and enforces programs based on U.S. foreign policy and national security goals that (1) Regulate the transfer of items or services to embargoed nations; (2) Impose trade sanctions and trade and travel embargoes aimed at controlling terrorism, drug trafficking, and other illegal activities; and (3) Restrict payments or providing anything of value to nationals of sanctioned countries and to specific foreign entities and individuals.
    • The following countries/areas have been (and may currently be) on OFAC’s sanctions list: Balkans, Belarus, Burma, Cote d’Ivoire (Ivory Coast), Cuba, Democratic Republic of Congo, Iran, Iraq, Liberia, North Korea, Sudan, Syria, and Zimbabwe.

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University Exemptions

The good news is that approximately 95% of the research activities performed at the University are exempt from Export Controls.

Federal regulations include exemptions for the University under these categories:

  • Education of information concerning general scientific, mathematical or engineering principles commonly taught to all students or information that is already in the public domain.
  • Fundamental Research which is already published and which is generally accessible or available to the public as well as fundamental research in science and engineering where the resulting information may be freely published and shared broadly in the scientific community.
  • Exceptions also exist for other activities. For example, faculty who wish to take their laptops out of the country to use in a project that qualifies as fundamental research may be able to do so under the license exception for temporary export (TMP) if s/he retains control of the laptop at all times and does not travel to an embargoed country.

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Penalties for Non-Exempt Export Control Violations

The bad news is that penalties for violating Export Controls that are not exempt are severe as described in the introductory paragraphs of this section. Remember also that these potential penalties (including fines and incarceration) are applied to individuals rather than just the University.

The following cases are real situations involving penalties in university settings. The last example relates to one of our own (former) private business partners on Centennial Campus.

Example 1
In September, 2008, Dr. J. Reece Roth was convicted on 18 counts of conspiracy, export control violations, and wire fraud. Roth utilized foreign nationals from Iran and the PRC to work on a controlled Air Force-sponsored SBIR research project without prior authorization and licenses. He was sentenced to 48 months in prison for violating the Arms Export Control Act by conspiring to illegally export, and actually exporting, technical information relating to a U.S. Air Force (USAF) research and development contract.

The illegal exports by Dr. Roth of military technical information involved specific information about advanced plasma technology that had been designed and was being tested for use on the wings of drones operating as a weapons or surveillance systems. The Arms Export Control Act prohibits the export of defense-related materials, including the technical data, to a foreign national or a foreign nation.

Example 2
In March 2004, Dr. Tom Butler was sentenced to 2 years imprisonment, 3 years supervised release, and a $50,000 fine. He had reported to the FBI that vials of a potentially deadly plague bacteria were missing and presumed stolen from his university research lab. The report sparked a bioterrorism alert in the western portion of his state.

The investigation proved that Dr. Butler had illegally shipped the vials of bubonic plague bacteria to Tanzania without the required export licenses. Among the numerous charges of which Dr. Butler was found guilty at trial, two were export control related: making false, fraudulent and fictitious statements regarding the exports to federal agents and making an unauthorized export to Tanzania.

Example 3
Allied Telesis Labs Inc., based on the University’s Centennial Campus, was sentenced to two years probation and a $500,000 fine in August, 2008 after pleading guilty to one count of conspiracy to export to Iran.

Specifically, ATL and its related corporate entities conspired to acquire and execute a $95,000,000 contract with the Iranian Information Technology Company to rebuild and upgrade the telecommunications systems of approximately 20 Iranian cities, including Tehran.

The University severed its ties with Allied Telesis Labs, Inc. in 2008.

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What Can We Do to Avoid Export Control Violations?

There are a number of things you can do to help our research community avoid Export Control violations.

Awareness

Review the information presented here and on the Export Control section of the SPARCS web site linked below so that your awareness level is advanced to notice any red flags or potential issues that need further clarification.

Be sure to save the web site linked below and note the “Decision Tree” option in the menu. That section provides a step-by-step set of questions to help research staff analyze their projects in relation to any Export Control issues.

PINS Entries

Encourage faculty to check yes if they have any doubt related to the three Export Control related questions in the PINS record illustrated below. Checking yes will alert the SPARCS Export Controls expert to get involved early in the negotiations phase to investigate any potential problems.

View PINS Screen »

Export Section of PINS

Foreign Travel

The SPARCS Export Control expert looks at all online foreign Travel Authorizations submitted by faculty and sends them a one-page information sheet of information including locations of consulates as well as information on the country’s specific requirements related to laptops, cell phones, etc. For this reason, it is important to remind faculty in your college to submit their online travel information well in advance to receive this important trip-specific information before departure.

A Quick Call Is Best!

Whether you are involved with travel, shipping, or other issues that could be related to Export Controls, encourage your faculty or colleagues to call before taking action. They can make sure that shipping that item overseas does not violate any laws or signing for that UPS delivery will not land anyone in jail!

Keep in mind that even although 98% of such actions are probably okay, the severe penalties for violating the law in the other 2% of the situations are not worth taking a chance.

E-mail or contact Richard Best in SPARCS at 919.515.0158 or via e-mail at export_controls@ncsu.edu.

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Environmental Health & Safety Section

Introduction

NCSU’s Environmental Health & Safety department is dedicated to helping us manage health, safety, and environmental aspects of our research projects at the University. As a member of the research community, you can help our researchers comply with the safety rules and regulations by learning more about these requirements as well as how to direct PIs and other research staff to valuable online and campus resources.

For this topic, review the following “Who, What, Where, and Why” segments to get a clear understanding of how to manage these health and safety requirements for faculty and staff who work on our sponsored projects.

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WHY Do We Have Such Stringent Environmental Health and Safety Requirements and Oversight at the University?

Beyond Sponsored Projects

Although this SPA Guide is focused on managing sponsored projects, it is important to understand the overall importance and critical nature of Environmental Health and Safety awareness on campus.

The following are a few facts to keep in mind:

  • Our university has over 1100 laboratories on campus with reports of 10 fires per month on average. (The reported fires may be small and properly extinguished, but this illustrates the potential for problems on a large campus.)
  • On any given day, our campus may have 47,000 people or more on campus or traveling through our campus.
  • University personnel who handle “select agents” are fingerprinted and their prints are sent to the FBI.

Safety Examples

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Research Compliance Regulations

Beyond our need to support all Environmental Health and Safety “best practices” on campus, we are required under federal, state, county, and university regulations to maintain ongoing committee reviews of our documentation and procedures.

The following chart lists our committees and their associated authorities: Safety Committees

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WHO Should be Concerned with Environmental Health and Safety Compliance?

Campus Facilities

Generally, the following types of campus facilities that use hazardous materials, hazardous processes, and storage of these items must file Safety Plans and comply with the associated health and safety requirements:

  • Machine shops
  • Facilities Zone shops
  • Utility and facility chemical storage areas
  • Agricultural locations (research farms, field labs, and extension locations)
  • Laboratories (teaching, research, and clinical).

Materials or Equipment

Staff who work on research projects that involve any of the following types of materials or equipment must comply with their prescribed protocol and safe handling requirements:

Materials Chart

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WHAT Environmental Health and Safety requirements do we have for our research projects?

In some colleges, research administrative staff are involved in coordinating or submitting safety approvals.

Review the following chart for more specifics. You may also click any of the links in the following bullet points for more information.

Safety Plans

  • Required for research that is conducted in areas that use hazardous materials, hazardous processes, and storage of these items
  • Online Completion of required information : http://www.ncsu.edu/ehs/safetyplan/index.html
  • Annual update required

Radiation Safety Reviews

  • Expedited Approval – one week
  • Complete applicable forms
  • Submit to Radiation Safety Officer
  • Review completed by Radiation Safety Committee Chair
  • Regular Approval – 6 weeks
  • Reviewed by Radiation Safety Sub-committee members
  • Web Page with Forms: http://www.ncsu.edu/ehs/radsafety.htm

Biosafety/ Recombinant Approval

  • Complete applicable paperwork online
    • Two week approval unless special circumstances
    • One week review – Biosafety Officer
    • One week review – Chair Biosafety Committee
  • Web Page with Forms & Biosafety Manual: http://www.ncsu.edu/ehs/biosafety.htm

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WHERE Do We Go to Access the Forms and Information We Need?

MyPack Access

You can easily access the Environmental Health and Safety forms and information through MyPack.

Log on to MyPack using your Unity ID and then click the “Environmental Safety” folder under the “My Projects” tab (as illustrated below in #1) for direct links to each section of the Environmental Health and Safety web site (as illustrated below in #2).

MyPack Acess to Safety References

Access Through the Environmental Health and Safety (EHS) Web Site

You may also use the A to Z index on the EHS web site to access the same information as illustrated in the site linked below (opens in new tab or window).

EHS Web Page

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Research Integrity Section

Research Integrity

Integrity IllustrationUnfortunately, the number of research misconduct investigations in universities across the nation is increasing.

Accusations of misconduct can produce disruptive to devastating results or repercussions for all parties involved.

publication link - opens in new window ORI Link

It is important for our research administrative staff to understand what constitutes research misconduct and what our responsibilities are in this area.

Some potential misconduct actions are intentional and others may be errors in judgement by researchers under tremendous pressure or time constraints.

If the potential misconduct is unintentional, we may be able to help our research staff recognize when they are treading into unsafe territory and possibly help prevent potential misconduct allegations.

Review the following information to explore this important topic, thinking about how you can support and encourage our NCSU scholars in the area of research integrity by:

  • recognizing potential problem areas,
  • understanding how this misconduct often arises, and
  • what we may be able to do to help.

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What if You Suspect that Research Misconduct May be Occurring?

NC State’s administrative regulation 10.00.2 requires requires reporting of observed, suspected, or apparent research misconduct. The university’s Research Integrity Officer encourages concerned staff to report observed, suspected, or apparent research misconduct to the senior administrator responsible for research programs within the college, school or unit where the alleged misconduct is occurring.

Review the SPARCS Whistleblower and Respondent Obligations and Protections web page for more detailed information on the various responsibilities, confidentiality requirements, protections, and resources.

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What is Research Misconduct?

After reviewing the following definitions and potential contributors to misconduct accusations, roll your mouse pointer over the image to view the common terminology that often applies to these issues.

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Research Misconduct – The Video

Click on the screen shot below to open a Federal Office of Research Integrity web page (opens in a new tab or window), and then click the “Play Full Video” button circled below to watch a 3-minute introductory video. It is an excellent portrayal of an instance of research misconduct. Pay particular attention to the reference to “people with responsibility for oversight who did not properly exercise their responsibility” to note how you could potentially become part of a research misconduct investigation in your Research Administration role.

Optional Follow-Up: If you decide to continue at the end of the introductory video, you can select the role of the Research Integrity Officer, the PI, the Lab Assistant, or the Grad Student to “play out” their part of the scenario, selecting what actions you would take in their situations and discovering what the results might be. Taking any one of the roles will probably take 30 minutes or more, so you may want to bookmark the site to come back to it later if necessary. Completing the entire video interaction section is optional, but highly recommended for a compelling and valuable learning experience.

Note: Take a moment before clicking the play arrow on the web site to grab your ear buds or adjust your computer’s volume up or down to listen in your work environment. The video starts playing automatically when you click the “Play Full Video” button. (If you need to stop, pause, or go back, roll your mouse pointer over the bottom of the screen to activate a play bar.)

Link to Video

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Our University’s Misconduct Investigations

Review the following list of common misconduct allegations and the underlying problems that have contributed to the allegations. As you review the list, think about how you might be able to observe, take note of any potential issues, and express your concerns appropriately in your work environment. Your proactive attention might raise awareness and possibly prevent or diffuse misconduct that may be eminent or emerging.

  • Adversarial Relationships: Most of the allegations have been the result of adversarial relationships – often fueled by the extremely competitive nature of our faculties’ status in the field of research.
  • Conflict of Interest: Failure to disclose a Conflict of Interest constitutes 30% of prosecutions (per federal statistics) and this percentage generally matches our University’s misconduct allegation ratios.
  • Miscommunication: Many of the misconduct allegations have roots in miscommunication, including researchers relying solely on e-mail – putting complicated instructions in e-mail to lab assistants with English as a second language, for example.
  • Inadequate Documentation: Lack of adequate documentation is also a major issue, stemming from using electronic files that are not adequately identified and categorized and often difficult to prove that they have not been altered. Review the links on the SPARCS Scholarly Data Management and Ownership web page for more detailed information on the use of lab notebooks and other methods of adequate documentation practices.

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What Can We Do on Campus?
Here are several topics on best practices for our researchers to note and review further on the SPARCS site linked below:

  • Documentation is key! Promote safe/adequate documentation practices by reviewing the tips in the SPARCS page referenced in the last Inadequate Documentation bullet point above. Go to the Scholarly Data Management and Ownership page for details on:
  • Set regular meeting schedules! Promote discussions and verify that everyone understands their duties and instructions for their part in responsible research practices:
    • Reschedule if needed
    • Establish an agenda and keep minutes
    • Schedule and keep one-on-one meetings

For more information on maintaining Research Integrity here at the University, click the web page image below to visit the SPARCS Research Integrity web page (opens in new tab or window).

SPARCS Scholarly Research Integrity Page

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spa-related-contacts-header

  • Send an e-mail to a University expert if your College Business Office cannot help on questions related to:
    • Institutional Review Board (IRB – Human Subjects)
    • Institutional Care & Use Committee (IACUC – Animal Care)
    • COI or NOI requirements
    • Export Controls
  • Send an e-mail to a University expert if your College Business Office cannot help on questions related to Environmental Health and Safety.
Last Update: February 11, 2014