Principal Investigator Training ~ Module 1

Principal Investigator Training ~ Module 1

Introduction

This training, which consists of two separate modules, outlines your responsibilities in the following areas as a Principal Investigator at the University of New Hampshire (UNH) who receives external funds to conduct research:

  1. Responsible conduct of research and scholarly activity (Module 1)
  2. Financial management of sponsored programs (Module 2)

Each module consists of:

At the end of this first module, you need to certify your completion and then proceed to the second module on financial management of sponsored programs. In order to complete UNH's Principal Investigator training you need to complete and certify both modules (and you will receive via email a certificate of completion for each).

Introduction (cont.)

This first module on responsible conduct of research and scholarly activity covers the following topics:

  1. Values and norms of science
  2. Research integrity
  3. Misconduct in scholarly activity
  4. Data management
  5. Responsible authorship and publication
  6. Conflict of interest in research
  7. Protection of research subjects
  8. Intellectual property
  9. Export controls
  10. Lab/group leadership, management, and safety
  11. Respectful research environment

Values & Norms of Science

The integrity of the practice of science, from its inception to today, is based on a set of underlying values. According to the 2017 National Academies report, Fostering Integrity in Research, these values are:

According to the report, objectivity is a value that applies to researchers' approach to their own work, whereas the values of honesty, openness, accountability, and fairness relate to researchers' relationships with others in the enterprise. The final value, stewardship, relates to researchers' approach to their role and work within the framework of the society in which they function.

Values & Norms of Science (cont.)

Over the years, a set of general norms and best practices of research have developed based on these values. These include, but are not limited, to:

While the above are examples of best practices for researchers, there are also best practices for research groups, institutions, sponsors, journals, and professional societies.

Research Integrity

Collectively, this set of norms and best practices leads to the concept of conducting research with integrity.

The Fostering Integrity in Research report defines research integrity as, "planning, proposing, performing, reporting, and reviewing research in accordance with the values described above."

Researchers are responsible for ensuring that they and all the personnel whom they supervise and oversee conduct their research with integrity.

Research Integrity (cont.)

Research practices can be considered on a continuum.

Depending on their nature, most scientists consider actions or behaviors that do not conform to the values and norms of research minor infractions, detrimental to the research process, or serious violations. Three behaviors that directly contravene the values of science and almost universally are deemed as unacceptable are called misconduct.

Misconduct in Scholarly Activity

As in society, unethical behavior, such as lying, cheating, or stealing, is damaging to, and unacceptable within, the academic community.

In 1998, the University of New Hampshire (UNH) adopted a policy on Misconduct in Scholarly Activity (Misconduct Policy). This policy defines what actions comprise misconduct at UNH and details the procedures for handling misconduct allegations.

The UNH Misconduct Policy is applicable to all members of the UNH community, including, but not limited to, faculty, staff, and graduate students, and undergraduate students who are paid to conduct research on a federal grant.

Misconduct in Scholarly Activity (cont.)

The UNH Misconduct Policy states, "UNH does not condone and will not tolerate any act of misconduct in scholarly activity by a member of its community."

The UNH Misconduct Policy defines misconduct in scholarly activity as:

  1. Fabrication, falsification, or plagiarism in proposing, performing, or reviewing scholarly activities, or in reporting results from scholarly activities
  2. Retaliation of any kind against a person who has brought forth an allegation of misconduct or who has provided information about a suspected case of misconduct

Misconduct does NOT include honest error or differences in interpretations, judgments, or opinion with respect to scholarly issues.

Misconduct in Scholarly Activity (cont.)

Fabrication is defined as, "Making up data or results and recording or reporting them" (OSTP, 2000).

Examples of fabriation include, but are not limited to:

Misconduct in Scholarly Activity (cont.)

Falsification is defined as,"Manipulating research materials, equipment or processes, or changing or omitting data or results such that the research is not accurately represented in the research record"

The research record is the record of data or results that embody the facts resulting from scientific inquiry, and includes, but is not limited to, research proposals, laboratory records, both physical and electronic, progress reports, abstracts, theses, oral presentations, internal reports, and journal articles.

(OSTP, 2000).


Falsification includes, but is not limited to:

Misconduct in Scholarly Activity (cont.)

Plagiarism is defined as, "The appropriation of another person's ideas, processes, results, or words without giving appropriate credit" (OSTP, 2000).

Plagiarism includes, but is not limited to:

A type of plagarism called self-plagiarism or text-recycling involes including your own previously published findings or work in a publication without citing the earlier publication.

Plagiarism may also be a violation of copyright law.

Misconduct in Scholarly Activity (cont.)

UNH's definition of misconduct in scholarly activity includes, "Retaliation of any kind against a person who has brought forth an allegation of misconduct (complainant) or who has provided information about a suspected case of misconduct" (Misconduct Policy).

A list of cases involving findings of research misconduct is available here as well as on the Misconduct tab of the UNH RCR Library Guide (see the Cases tab in the Resources section).

Review the UNH web-based module on misconduct in scholarly activity for more information about misconduct in scholarly activity, and the process at UNH for investigating allegations of misconduct.

Data Management

Collection and generation of data are integral aspects of research and scholarly activity. In such activities, data:

The integrity of research and scholarly activity depend on accurate, detailed, organized, complete, and accessible data.

UNH is responsible for stewardship of data generated or collected as part of a funded project that is conducted:

In conducting research as part of the UNH community, researchers are obligated to assist UNH in fulfilling its responsibilities, including the management and sharing of research data.

Data Management (cont.)

To fulfill its stewardship responsibilities, UNH adopted a policy on Ownership, Management, and Sharing of Research Data. The UNH policy delineates rights to and responsibilities for research data, as well as required data management practices that ensure:

The UNH policy applies to all members of the UNH community, including, but not limited to, faculty, staff, and graduate and undergraduate students. It applies to research supported by federal and non-federal funds as well as to unfunded research activities undertaken at UNH.

Data Management (cont.)

In most situations, UNH owns research data generated by its faculty, staff, and students (see Section 5 of the policy for exceptions). UNH assigns custody of the research data that it owns to the faculty or staff principal investigator, or sponsoring principal investigator in the case of students, who is expected to discharge their custodial responsibilities

For purposes of the UNH policy, custodianship is the physical possession of and direct responsibility for protecting research data, including accurate recording and proper retention, maintenance, access, sharing, and disposition of the data.

in accordance with responsible data management practices.


Researchers and scholars are responsible for the recording, management, security, and retention of research data in activities that they conduct or oversee.

A data management checklist is a useful tool to employ at the start of a research project to ensure that all pertinent issues have been identified and addressed, and that an individual has been assigned to each

Data Management (cont.)

Research data management planning is essential to ensure efficiency in research projects, and to ensure long-term management of data. A data management plan (DMP) helps to organize all data-related activities, and to ensure that all individuals involved in a project are aware of their responsibilities. Federal agencies are increasingly requiring DMPs as part of funding applications.

A DMP should be a living document. It should be reviewed regularly to make sure it addresses changing needs and be updated as necessary (e.g., when a project changes or a new one begins). Leaders should train personnel on how (and why) to implement the plan, including discussing the impact of effective data management on the integrity of research and long-term usability of results.

The UNH Library has a created a Data Management Toolkit (DMT) to assist researchers and scholars with their data management responsibilities. Further, UNH has a Data Services website to provide the UNH research community with a centralized portal for information about all the data services available, include technology services, secure data storage and large dataset processing.

Review the UNH web-based module on data management for more information about responsible data management.

Responsible Authorship & Publication

Authorship plays a key role in a researcher's career, but is also frequently a source of conflict, misunderstanding, and controversy. Authorship is the primary mechanism for:

Authors willing to take credit for their contributions must also be willing to assume responsibility for the accuracy and integrity of the work as a whole. Authorship credit should reflect significant contributions to at least one of the following:

Responsible Authorship & Publication (cont.)

Authors are responsible for ensuring that both the process of preparing publications and the final results are characterized by:

Responsible Authorship & Publication (cont.)

Every listed author on a manuscript or other work should:

The "Acknowledgements" section of a manuscript provides an opportunity to recognize intellectual, technical, or other contributions that do not merit authorship, such as:

Responsible Authorship & Publication (cont.)

The significance of the order of authors' names differs among disciplines, and the appropriate acknowledgement of scholarly/research contributions has important personal career implications, as well as ethical implications for the profession as a whole.

Therefore, it is strongly recommended that all individuals in a group or proposing to collaborate on a work ensure that authorship criteria and decisions are discussed openly and frankly, and agreed upon, preferably in writing, in advance. If individuals' contributions to the research or scholarship change, then the initial agreement should be revised in a timely manner to reflect the new allocation of responsibilities.

Honorary authorship (guest or gift authorship) occurs when an individual who did not make a substantial contribution to the work is listed as an author, such as a laboratory director whose sole contribution was providing space or funding. Honorary authorship is strongly discouraged as it misrepresents the contributions of both the "honored" individual, and the actual author(s) responsible for the work.

Responsible Authorship & Publication (cont.)

Disputes about issues of authorship can become acrimonious, especially if a power differential exists between the individuals involved.

UNH has formal mechanisms to assist individuals with resolving such disputes. The first attempt to resolve the issue should be a frank and respectful discussion between those involved. If a dispute cannot be resolved among the individuals to the satisfaction of everyone involved, then it should be brought before the appropriate person(s) at a higher administrative level, in the following order:

Responsible Authorship & Publication (cont.)

The following are generally-accepted responsible publication practices, although differences may exist among disciplines or journals:

Responsible Authorship & Publication (cont.)

The following are generally-accepted responsible publication practices, although differences may exist among disciplines or journals (cont.):

Responsible Authorship & Publication (cont.)

At UNH, the policy on Openness, Access, and Participation in Research and Scholarly Activities addresses dissemination of research results and scholarly activities. Exceptions to the policy may be approved by the Vice Provost for Research.

Review the UNH web-based module on responsible authorship and publication for more information on this topic.

Conflict of Interest in Research

Trust is an integral feature of the scientific research enterprise. Any situation or action creating suspicion that the design, conduct, and/or reporting of research activities are biased erodes trust at all levels and is damaging to scientific research.

In the research setting, individuals often face competing obligations and conflicting interests. These may include, but are not limited to:

Conflict of Interest in Research (cont.)

In the research enterprise, a conflict of interest is defined as a situation where a researcher's personal interests, such as career, reputation, or finances, inherently conflict with their professional obligations to honest, objective, and responsible conduct of research activities (Pritchard, 2002).

Conflicting interests are inevitable in the conduct of research as researchers balance personal interests, such as career, reputation, and finances, with professional obligations, such as objectivity, openness, honesty, and accuracy.

Conflicting interests provide an incentive to engage in unethical behavior but not all lead to unethical action (Barnbaum and Byron, 2001). In general, conflicting interests themselves are not unethical. It is the course of action taken upon recognition of a conflict of interest that determines whether the conflict raises ethical concerns (Pritchard, 2002).

Conflict of Interest in Research (cont.)

Unethical action occurs when researchers who have a motivating self-interested reason that competes with a professional obligation act upon it. Examples of unethical action include, but are not limited to:

Conflict of Interest in Research (cont.)

Disclosure of a conflict can be a key factor in protecting an individual's reputation and career from potentially harmful allegations of unethical behavior. Although disclosure of a conflict of interest does not resolve the ethical issues presented by the conflict, it is an important first step.

Researchers should disclose to all colleagues and students with whom they work on a related project, and in all publications and public presentations any financial or personal interests that present a conflict of interest so that audiences are fully informed.

Some journals require that authors disclose all sources of financial support of the reported research at the time of manuscript submission.

A case involving financial conflicts of interest in research is Jose Baselga.

Conflict of Interest in Research (cont.)

Regulations (e.g., Public Health Service [PHS], National Science Foundation) exist governing financial conflicts of interest of researchers who apply for federal funds.

In accordance with these regulations, UNH has adopted two policies on financial conflict of interest in research:

  1. A policy for research projects proposed for funding, or funded, by the PHS or any other organization that requires compliance with the PHS regulations, and
  2. A policy for research projects proposed for funding, or funded, by any other external organization.

All researchers submitting proposals for external funding through the UNH Sponsored Programs Administration office must acknowledge on the Proposal Routing Form that they have read the UNH policy pertinent to the funding source and will abide by its terms.

Conflict of Interest in Research (cont.)

The UNH policy for PHS-funded projects applies to any individual who is responsible for the design, conduct, or reporting of research activities (investigator) funded, or proposed for funding, by PHS, UNH employee or otherwise (e.g., consultant).

The UNH policy requires that every investigator

The project director, principal investigator, key personnel, or any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by PHS, or proposed for such funding, which may include, for example, collaborators or consultants.

responsible disclose all their significant financial interests and those of their spouse or domestic partner and dependent children related to their institutional responsibilities no later than the time of application by UNH for PHS funds.


Conflict of Interest in Research (cont.)

Significant financial interests (SFIs) are defined in the UNH policy for PHS-funded projects (click on link to read definitions). They include:

Prior to UNH submitting a proposal to PHS for research funding, any investigator who has a significant financial interest that reasonably appears to be related to the investigator's institutional responsibilities must complete and submit to the Office of the Senior Vice Provost for Research (OSVPR) a Disclosure Statement for Financial Conflict of Interest in Research for Projects funded by the Public Health Service, with all required supporting documentation.

Conflict of Interest in Research (cont.)

Financial disclosure statements are reviewed by the UNH Disclosure Review Committee (DRC). The DRC determines whether an investigator's SFI is related to the PHS-funded research and if so, whether the SFI represents a financial conflict of interest (FCOI).

A SFI is related to the PHS-funded when the DRC reasonably determines that the SFI could be affected by the PHS-funded research, or is in an entity whose financial interest could be affected by the research.

An FCOI is a SFI that could directly and significantly affect the design, conduct, or reporting of PHS-funded research.

Conflict of Interest in Research (cont.)

If the DRC determines that a FCOI exists, the DRC requests the investigator submit a proposed conflict management plan that details steps that could be taken to manage, reduce, or eliminate the FCOI. The DRC reviews the proposed conflict of interest management plan and approves it or adds conditions to ensure that the conflict is managed, reduced, or eliminated.

Resolution of the conflict or approval of the management plan must take place prior to expenditure of any funds from a PHS award. All financial disclosures must be updated by the investigator during the period of the award as significant financial interests change.

Conflict of Interest in Research (cont.)

The second UNH financial conflict of interest in research policy applies to any individual who is responsible for the design, conduct, or reporting of research activities funded or proposed for funding by external sources other than the PHS.

This UNH policy requires that all participants in a project who are responsible for the design, conduct, or reporting of research activities disclose any significant financial interests that would reasonably appear to be affected by the research.

Conflict of Interest in Research (cont.)

A significant financial interest (SFI) is defined in this UNH policy as:

Examples of SFIs might include, but are not limited to:

Conflict of Interest in Research (cont.)

Prior to submitting a proposal for external funding, a researcher who has a SFI that might be affected by the research must complete and submit to the OSVPR a Financial Conflict of Interest in Research Disclosure Statement and all required supporting documentation.

Disclosure Statements are reviewed by the UNH DRC. The DRC determines whether the SFI could reasonably be expected to affect the design, schedule, conduct, or reporting of the activities funded or proposed for funding, and, if so related, whether the SFI represents a financial conflict of interest (FCOI).

A researcher's SFI is related to the research when the DRC determines that the SFI could be affected by the research; or is in an entity whose financial interest could be affected by the research.

Conflict of Interest in Research (cont.)

If the DRC determines that a FCOI exists, the DRC requests the researcher submit a proposed conflict management plan that details steps that could be taken to manage, reduce, or eliminate the FCOI. The DRC reviews the proposed conflict of interest management plan and approves it or adds conditions to ensure that the conflict is managed, reduced, or eliminated.

Review the UNH web-based module on conflicts of interest and commitment activity for more information about this topic.

Protection of Research Subjects: Humans

The last century witnessed multiple cases of the unethical treatment of human subjects in research studies. These and other cases dramatized the need for a system to protect the rights and welfare of humans subjects in research.

In the United States, public outrage over the Tuskegee Syphilis Study prompted Congress to pass the National Research Act in 1974. This initiated federal regulations to protect human subjects in research, including requiring institutions accepting federal funds for research involving human subjects to institutionalize mechanisms for protecting subjects from harm. These regulations have been revised and amended several times.

Further, the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued in 1979 the Belmont Report. Building on the Nuremberg Code (developed after World War II in response to Nazi atrocities) and the World Medical Association's Declaration of Helsinki, the Belmont Report identified three fundamental ethical principles for the protection of human subjects in research:

Protection of Research Subjects: Humans (cont.)

Respect for persons recognizes the personal dignity and autonomy of individuals, and requires special protection of those with diminished autonomy (vulnerable populations):

Respect for persons requires these practices:

Protection of Research Subjects: Humans (cont.)

Beneficence obliges researchers to protect persons from harm by maximizing the research's anticipated benefits and minimizing its possible risks. Beneficence requires:

Justice necessitates that the benefits and burdens of research be distributed fairly and equitably. It requires these practices:

https://www.unh.edu/research/institutional-review-board-protection-human-subjects-research-irb

Protection of Research Subjects: Humans (cont.)

The administrative body in an institution for ensuring the protection of human research subjects is the Institutional Review Board (IRB). The IRB's mission is to protect the rights and welfare of human subjects who participate in research studies.

At UNH, research involving human subjects requires prior review by the UNH IRB and receipt of written, unconditional approval from the IRB, regardless of discipline and whether the project is funded (see here for definitions of a "human subject" and "research"). Use of human subjects in research without IRB approval is a violation of UNH policy. Appropriate sanctions are administered by the Institutional Official (Senior Director for Research).

At UNH, all research activities involving the prospective collection of information about individuals via intervention

Includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.

or interaction

Includes communication or interpersonal contact between researcher and subject.

are considered using human subjects and thus require UNH IRB approval before commencing.


When studies involve the use of secondary/existing data (data/information that exist(s) at the time the research project begins [e.g., previously collected survey data, school records, medical records]) and if the secondary/existing data do not contain private information, UNH IRB approval is NOT needed to use such data for research purposes.

Protection of Research Subjects: Humans (cont.)

UNH faculty, staff, or students who plan to conduct research involving human subjects must submit an application to, and receive written, unconditional approval from, the IRB prior to starting a study, including recruitment of participants. Researchers should submit completed applications (with signatures) for IRB review to Research Integrity Services (RIS). RIS provides administrative support to the IRB and assists researchers with IRB applications.

Studies qualifying for Exempt or Expedited level review are reviewed by the IRB as they are received, usually within two (2) weeks (allow 3 weeks during semester breaks). The IRB meets twice a month during the academic year and once each month during the summer to review studies qualifying for Full Board review. Studies requiring Full Board level review must be submitted according to the posted schedule.

Protection of Research Subjects: Humans (cont.)

Federal regulations define levels of IRB review and the categories of research they encompass. At UNH, the IRB uses three levels of review::

At UNH, the IRB, not the researcher, decides which review level the research must undergo.

Exempt level review may be used for studies presenting no greater than minimal risk, including those that involve:

Protection of Research Subjects: Humans (cont.)

Expedited review may be used for specific kinds of research also presenting no greater than minimal risk, such as:

Full Board review is required for studies involving special populations and/or presenting greater than minimal risk, such as those involving:

Protection of Research Subjects: Humans (cont.)

To approve the use of human subjects in a study, the IRB determine that eight criteria are met. Researchers must:

  1. Minimize risks to subjects
  2. Balance risks with anticipated benefits
  3. Select subjects equitably
  4. Seek informed consent, where appropriate
  5. Document informed consent, where applicable
  6. Make adequate provisions for monitoring data
  7. Make adequate provisions to protect subjects' privacy and maintain confidentiality of data
  8. Ensure protections for vulnerable populations

Cases involving problematic research involving human subjects include Mani Pavuluri, He Jiankui, and a San Diego VA liver study.

Review the UNH web-based module on the ethical use and treatment of human subjects in research for more information about this topic.

Protection of Research Subjects: Vertebrate Animals

In the United States, the conservation, use, care, and welfare of research animals are governed by the following:

Protection of Research Subjects: Vertebrate Animals (cont.)

Both the AWA and the USPHS Policy mandate the establishment of and specific rules for an Institutional Animal Care and Use Committee (IACUC). The IACUC is an institutional committee that oversees the animal care and use program within each institution that carries out research, testing, or teaching involving animals.

At UNH, the IACUC oversees the institution's program for the humane care and use of animals, including inspection of vertebrate animal facilities.

At UNH, advance review and approval by the IACUC is required for all work involving vertebrate animals:

Use of vertebrate animals in research, testing, or teaching without IACUC approval is a violation of UNH policy.

Protection of Research Subjects: Vertebrate Animals (cont.)

At UNH, there is only one level of IACUC review:

Full committee review at a convened meeting of the IACUC.

Only UNH faculty (including emeriti) and staff members (including post-doctoral researchers) with appropriate authority and access to facilities and resources may serve as a principal investigator/instructor (PI) for applications submitted to the IACUC. IACUC approval for student projects must be requested by and granted to a UNH faculty/staff member who will accept and retain responsibility for compliance with applicable regulations as the PI.

Protection of Research Subjects: Vertebrate Animals (cont.)

There are two different IACUC application forms, and PIs must ensure that the correct form is used for the intended animal use:

The IACUC meets monthly. Completed applications (with signatures) for review must be submitted to RIS at least two weeks prior to the date of the next scheduled meeting. RIS provides administrative support to the IACUC and assists PIs with IACUC applications.

PIs must receive written, unconditional IACUC approval before starting their work with vertebrate animals; that is, they must satisfy any contingencies stipulated by the IACUC resulting from the review of the application.

Protection of Research Subjects: Vertebrate Animals (cont.)

PIs who propose to use vertebrate animals in research must address the three Rs:

Review the UNH web-based module on the ethical care and use of vertebrate animals in research and instruction for more information about this topic.

Intellectual Property

Intellectual assets is a collective term for intellectual property, intellectual property rights, and know-how.

Intellectual property are intangible products of creative effort. Examples include: technical information, inventions, software, databases, designs, models, methods, and literary works. Like tangible real or personal property, intellectual property may be bought, sold, or leased.

Intellectual property rights are legal protections for different forms of intellectual property, and include:

Know-how is the expertise (technical knowledge and skill) in knowing how to make things (products or processes) work effectively. Know-how can be protected through a variety of contracts, including Non-Disclosure Agreements (NDAs)/ Confidentiality Disclosure Agreements (CDAs), Consulting Agreements, or License Agreements (LAs).

Intellectual Property (cont.)

A patent for an invention is the grant of a property right to the inventor, issued by the United States Patent and Trademark Office (USPTO). Patents are limited and temporary monopolies granted by the government in return for full disclosure by inventors of the details of their invention.

Seeking patent protection is important because it safeguards innovation by excluding others from making, using, selling, offering to sell or importing the patented invention (35 USC 271). Patenting also affords protection that allows for a return on investment without compromising the cumulate nature of scientific endeavor.

Intellectual Property (cont.)

In order to qualify for a patent, the invention must be:

At UNH, individuals who wish to seek patent protection should file an invention disclosure form with UNHInnovation.

UNHInnovation strongly urges innovators to file invention disclosures early in the course of their research project. With the America Invents Act (AIA) in effect as of March 16, 2013, patent applications must filed before the inventor publishes, presents, or even has a discussion with anyone outside of UNH, with limited exceptions. Otherwise, the ability to seek patent protection may be forfeited, both in the US as well as in the rest of the world.

Intellectual Property (cont.)

A trademark is a word, name, symbol or device used to distinguish one entity's goods or services from those of others.

Reasons for registering a trademark include:

Only "distinctive" words, phrases, logos, domain names, graphic symbols, slogans or other devices that are unique enough to help customers recognize the source of a particular product in the marketplace may be trademarked.

Intellectual Property (cont.)

The ™ symbol is used when an entity regards the name or slogan to be their trademark. The ® symbol is used when a trademark is registered by the USPTO. Examples of trademarks include Coca-Cola®, University of New Hampshire®, and UNH®.

Servicemarks are similar to trademarks, except that they identify and distinguish the source of a service rather than a product (denoted as SM or ® upon registration). Examples of servicemarks include: Kinko's® and Amazon.com®.

At UNH, individuals who wish to pursue trademark registration should file a trademark disclosure form with UNHInnovation.

Intellectual Property (cont.)

Copyright is the doctrine of federal law that invests the "author" of an original creative work that is "fixed in a tangible medium of expression" with certain exclusive rights to that work for a limited period of time and subject to certain defined and certain implied limitations.

Copyright protection covers published and unpublished literary, scientific and artistic works, whatever the form of expression, provided such works are fixed in a tangible or material form.

Copyrights for individual authors last for the life of the author plus 70 years. For works-for-hire, the copyright lasts for 95 years from the date of publication, or 120 years from the date of creation, whichever is shorter. Copyright protection is automatically granted to authors when they fix their ideas in a tangible form.

When authors submit articles to academic journals for publication, many times journals require authors to sign over copyright of the article to the journal.

Intellectual Property (cont.)

Copyright protection gives the copyright owner the exclusive right to do and to authorize others to:

Copyright exists as soon as a work is fixed in a tangible medium. Placing a notice of copyright on works is recommended but not required. Recognized forms of copyright notice are:

Intellectual Property (cont.)

Authors may register work with the U.S. Copyright Office. Doing so:

Prompt registration of copyrights can maximize the statutory damages and attorney fees that a copyright owner can seek in cases of copyright infringement.

At UNH, individuals who wish to pursue copyright registration or commercialization (including software) should file a copyright disclosure form with UNHInnovation.

Intellectual Property (cont.)

The UNH Intellectual Property Policy describes UNH's responsibilities for intellectual property, and states its responsibilities in protecting the intellectual property assets and rights of the institution, faculty, staff, and students.

The UNH Intellectual Property Policy applies to all members of the university community including, but not limited to, all faculty, administrators, staff, students; visiting scholars, scientists, and postdoctoral fellows; and any other persons at UNH involved in carrying out the university's mission at or under the auspices of UNH. In the policy, these individuals are called "Covered Individuals."

The UNH policy applies regardless of the whether the research/scholarly activity is funded, except where specific sponsor requirements prevail.

Intellectual Property (cont.)

All UNH faculty, visiting faculty or other visitors using research facilities; postdoctoral employees or fellows; graduate students and undergraduate students participating in sponsored research as employees or otherwise; and all salaried employees must execute an Acknowledgement of Intellectual Property Policy and Assignment as a condition of employment, participation in sponsored research, or use of university resources.

This agreement assigns the intellectual property made in the course of employment at UNH, from work directly related to employment responsibilities at UNH, or from work carried out on UNH time or at UNH expense, or with use of UNH resources under grants or otherwise, to UNH.

Review the UNH web-based module on intellectual property for more information about intellectual property.

Export Controls

Export controls are a complex set of laws and implementing regulations through which the U.S. Government controls the physical export of, and limits access by certain foreign entities and foreign persons to, sensitive equipment, software, technical data, technology and services.

Export control laws apply to all activities and technologies - not just sponsored research - and they constitute a major element of the University's overall compliance program. Violations can result in significant civil and criminal penalties for the individual as well as the institution.

Researchers need to know about export controls because they define the elements of a research project, which in turn establish how export controls apply to that project (e.g., technologies under consideration and involvement by foreign personnel).

Export Controls (cont.)

In addition to the considerations concerning research projects, export controls can impact scholarly activities by limiting:

There are three major regimes of U.S. export control regulations that may impact UNH research and instruction:

Export Controls (cont.)

The EAR governs the export or transfer of "dual use" items; that is, materials, technology, and software that may have both military and significant commercial/civilian applications (e.g., acoustic systems, lasers, and magnetometers).

In effect, unless subject to another agency's jurisdiction (e.g., ITAR controlled) any item made in the U.S. and/or containing U.S. origin technology or software is subject to regulation under the EAR.

Items for which export is controlled under the EAR are identified in the Commerce Control List (CCL) with a 5-digit alphanumeric sequence (e.g., 7A994). The CCL is organized into ten broad categories of technology,

EAR Commodities
Category 0 - Nuclear Materials, Facilities, and Equipment [and Miscellaneous Items]
Category 1 - Special Materials and Related Equipment, Chemicals, “Microorganisms,” and “Toxins”
Category 2 - Materials Processing
Category 3 - Electronics
Category 4 - Computers
Category 5 Part 1 - Telecommunications
Category 5 Part 2 – “Information Security”
Category 6 - Sensors and Lasers
Category 7 - Navigation and Avionics
Category 8 - Marine
Category 9 - Aerospace and Propulsion

and each category includes five product groups.

Product Groups
A: Systems, Equipment and Components
B: Test, Inspection and Production Equipment
C: Material
D: Software
E: Technology



Export Controls (cont.)

The U.S. Department of State, through its Directorate of Defense Trade Controls (DDTC), administers the ITAR.

The ITAR governs the provision of "defense services" and the export of defense articles that are inherently military in character or "specially designed" for military applications and enumerated on the U.S. Munitions List (USML). Defense items and defense services identified on the USML are items, technologies, software, and services with primary specific military uses or purposes. The USML has 21 different categories. A license is required for export of defense articles and services regulated by the ITAR to any country outside the U.S.

OFAC administers the U.S. embargoes and sanctions programs (codified at 31 CFR §§500 - 599). These programs:

Export Controls (cont.)

In the context of export control regulations, the term "export" is more expansive than the prevailing concept of a tangible article being shipped out of the United States. As defined in the EAR, an "export" is an actual shipment or transmission of EAR-controlled items out of the United States, or the release of EAR-controlled technology or software to a foreign national (a "deemed export"), whether such release occurs in the U.S. or elsewhere. Deemed exports are the principal export control issue facing university researchers.

Export Controls (cont.)

The EAR and ITAR do not apply to all exports and deemed exports: Both the EAR and ITAR exclude large classes of "publicly available" items from their scope of regulation. Specifically, "publicly available" technology and software are not subject to export control regulation. This includes technology, technical data, information and software that:

Even if one of these exclusions or exemptions from the EAR and ITAR applies, the OFAC sanctions/embargoes still apply.

Export Controls (cont.)

Most activities at UNH fall under the fundamental research exclusion or education exemption, and thus fall outside of the export control requirements of the regulations. Compliance, however, often requires UNH to document its determination that an exclusion/exemption is being used appropriately.

Similarly, certain activities carried out in support of UNH's research and education objectives should be considered export compliance red flags, warranting discussions with UNH's Export Controls staff.

"Fundamental Research" includes basic or applied research in science and/or engineering at an accredited institution of higher learning in the United States where the resulting information is ordinarily published and shared broadly in the scientific community.

Export Controls (cont.)

In the case of the ITAR, the expectation is that the resulting information has been or is about to be published. The expectation that research results will be broadly shared marks fundamental research as distinct from research results that are restricted for proprietary reasons (industrial development, design, production, and product utilization) or pursuant to specific U.S. government access and dissemination controls (for national security reasons).

The ITAR exempts information concerning general scientific, mathematical, or engineering principles commonly taught in schools, colleges, and universities. Similarly, the EAR exempts information released by instruction in catalog courses and associated teaching laboratories of academic institutions. Dissertation research must meet the standards for "fundamental research" to be exempt.

Review the UNH web-based module on export controls for more information about this topic.

Group Leadership, Management, & Safety

Information for this section is taken from the UNH RCR Committee's Simple Guide to Starting a Research Group.

Responsible conduct of research and scholarly activity can be established, valued, and passed on through thoughtfully-formed and managed labs, teams, or collaborative groups (this training will use the term "group," but one might reasonably substitute "team" or "lab").

Group Leadership, Management, & Safety (cont.)

In order to pursue research goals effectively and efficiently, core members of a research group should agree upon a primary leader. While a manager may oversee many day-to-day operations, the leader accepts ultimate responsibility for activities and the conduct of the group.

The group leader is:

The Lab Leadership and Management Best Practices Checklist is a simple self-assessment to help identify management strengths.

Group Leadership, Management, & Safety (cont.)

A strong communication network among group members is critical for research success.

In managing interaction among members, group leaders should:

Group Leadership, Management, & Safety (cont.)

Whether the mission is to continue work based on earlier efforts, or to open up a fundamentally new line of inquiry, groups must map out plans for reaching both long-term and short-term goals. Once the group has devised a clear research agenda, it should then focus on outlining how that agenda will be implemented.

The planning process should include a strategy for sharing results with appropriate members of the research community, and, in some cases, with the broader public.

Group Leadership, Management, & Safety (cont.)

Safety and compliance are of prime importance. All members of the group should be familiar with relevant safety regulations and compliance requirements, particularly in labs. Accordingly, group leaders should:

For more information, see the UNH Office of Environmental Health & Safety's website.

Group Leadership, Management, & Safety (cont.)

Group leaders should hire strategically with the goal of building a strong, collaborative team. Leaders should hire people who fit with the professional culture, are genuinely interested in the research, and are hardworking team players. When hiring, leaders should consider not only research skills and experience, but also individual characteristics and interpersonal interactions.

If funding allows, group leaders should consider hiring a manager to take care of the day-to-day running of the group, including supervising personnel. A good manager will prevent myriad headaches, and will free other group members to attend to their responsibilities. If unable to hire a manager, the group leader should seek training in personnel management early on.

Group Leadership, Management, & Safety (cont.)

The group leader should plan adequate time to train new personnel and oversee their work, create a clear outline of all training requirements, and assign a group member responsibility for ensuring that everyone is trained appropriately. The group leader should be involved in training whenever possible. In addition to developing technical skills, all personnel should have a grounding in research ethics, and assistance to help them connect that information to their everyday research activities.

Group leaders should talk with members about standards and expectations, and encourage them to ask questions and to own their mistakes, as openness helps to promote an atmosphere of integrity. To introduce new hires to the group's research culture and ethos, the leader or manager can develop a contract that outlines the group's requirements, standards, and expectations that all personnel review and sign can.

The group leader should ensure that standard operating procedures (SOPs) for all research procedures are documented, describing in detail how core activities will be performed, as SOPs are necessary for fostering good research practice and establishing reproducibility.

Group Leadership, Management, & Safety (cont.)

The leader of a research group should mentor everyone in the group, at all levels. Leaders should also themselves seek mentoring from more experienced colleagues. Neglecting mentoring can be costly, whether in lost time, wasted research, or emotional investment.

Review the UNH web-based module on mentoring for more information on this topic.

For more information about lab or group management, consult the Howard Hughes Medical Institute's Making the Right Moves: A Practical Guide to Scientific Management for Postdocs and New Faculty (2nd Edition).

Respectful Research Environment

UNH is committed to supporting and affirming the dignity of its members. Group leaders and researchers do this by creating and maintaining research environments that allow science and scientists to flourish through respectful, inclusive, and equitable treatment of everyone. Not only are such environments healthy and productive, they are ones where integrity in research is fostered.

The UNH RCR Committee has endorsed the American Geophysical Union's (AGU) Code of Conduct (starts on page 6 of the PDF), which includes language about respectful behavior.

UNH has a policy on Discrimination and Discriminatory Harassment. UNH does not condone any behavior that is disrespectful, discriminatory, harassing, or bullying in nature. Not only does such behavior dishonor individuals, it is antithetical to the conduct of high quality science, and diminishes individuals' ability to fully engage in their education and work, and to conduct their research with integrity.

Respectful Research Environment (cont.)

Researchers are responsible for creating respectful and healthy research environments. This includes, but is not limited to:

Review Question 1

Which one of the following is not a core value of science according to the National Academies’ Fostering Integrity in Research report?
Incorrect.
Incorrect.
Incorrect.
Correct.
Incorrect.
Incorrect.

Review Question 2

What are the three actions that constitute scholarly misconduct according to the UNH policy on Misconduct in Scholarly Activities (Which of the following is correct)?
Incorrect.
Incorrect.
Correct.
Incorrect.
Incorrect.

Review Question 3

Which one of the following is not true?
Incorrect.
Incorrect.
Correct.
Incorrect.

Review Question 4

Every listed author on a manuscript or other work should: (Which of the following is the best answer?)
Incorrect.
Incorrect.
Incorrect.
Correct.

Review Question 5

In the research enterprise, a conflict of interest is defined as a situation where a researcher's personal interests, such as career, reputation, or finances, inherently conflict with their professional obligations to honest, objective, and responsible conduct of research activities.
Correct.
Incorrect.

Review Question 6

At UNH, a researcher must obtain written, unconditional approval from the Institutional Review Board (IRB) before starting a study that involves human subjects, including recruitment of participants.
Correct.
Incorrect.

Review Question 7

At UNH, the policy on Care and Use of Animals applies to both vertebrate and invertebrate animals.
Incorrect.
Correct.

Review Question 8

The UNH Acknowledgement of Intellectual Property Policy and Assignment agreement assigns the intellectual property made in the course of employment at UNH, from work directly related to employment responsibilities at UNH, or from work carried out on UNH time or at UNH expense, or with use of UNH resources under grants or otherwise, to UNH.
Correct.
Incorrect.

Review Question 9

Which one of the following is not a function of a research group leader at UNH?
Incorrect.
Incorrect.
Correct.
Incorrect.
Incorrect.

Congratulations

Once you have finished all the review questions click "Certify Completion', and then proceed to complete the second module in this training on financial management of sponsored programs. In order to complete UNH's Principal Investigator training requirement, you need to complete and certify both modules.

Certify Completion