Topics and Definitions for the Responsible Conduct of Research

Beneficence

A basic ethical principle protecting human participants in research, which states that researchers have an obligation to maximize benefits and reduce risks to subjects. This principle is articulated by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the Belmont Report in 1979.

Collaborative research

Research that involves multiple researchers working together in a joint intellectual effort. Includes topics concerning setting ground rules regarding roles and relationships and management of the project, authorship disputes, sharing materials and information with internal and external collaborating partners.

Conflict of interest and commitment (Office of Research Integrity (ORI) definition)

Conflicts of interest are competing obligations and interests that can lead to competing responsibilities and bias. Conflicts of commitment occur when situations create competing demands on a researcher’s time and loyalties. Includes topics such as conflicts associated with collaborators, publication, financial conflicts, work commitments, intellectual and personal matters, ways of reporting and managing conflicts of interests.

Data acquisition, management, sharing and ownership (ORI definition)

Accepted practices for acquiring and maintaining research data. Proper methods of record-keeping and electronic data collection and storage in scientific research. Includes the following: defining what constitutes data; keeping data notebooks or electronic data; privacy and confidentiality; data selection, retention, ownership, and data as legal documents and intellectual property, including copyright laws.

Exempt review

The level of review for human subject research projects that pose little, if any, risk to human subjects. At the University of Missouri, exempt projects are reviewed and approved by the Campus Institutional Review Board compliance officer.

Expedited review

A level of review for human subject research that poses no more than minimal risk for human subjects. This review is conducted by the Campus Institutional Review Board (IRB) chair or other voting Campus IRB members designated by the chair at the University of Missouri. Federal regulations permit expedited review for certain types of research (e.g., surveys and/or interviews that contain personal identifying information, focus groups, program evaluation).

Fabrication (ORI definition)

Making up data or results and recording or reporting them.

Falsification (ORI definition)

Manipulating research materials, equipment or processes, or changing or omitting data or results so that the research is not accurately represented in the research record.

Fiscal responsibility

Managing project budgets and task responsibilities. Topics include: managing research appropriated funds, complying with terms and conditions of the financial sponsor, ensuring necessary budgetary approvals, purchasing and reporting policies, and effort assignments and certifications.

Full board review

A level of review for human subject research that presents greater than minimal risk or significant risk, or that involves research with vulnerable populations. This proposal would be reviewed by the entire Institutional Review Board at the University of Missouri and must receive the approval of a majority of those members present at the meeting.

Human participants

Human subjects are living individuals from whom a researcher obtains data through intervention/interaction with the individual or acquires identifiable private information.

Informed consent

Participants in research projects give their informed consent to participate. Informed consent is an understanding and willingness to participate in the study. Prospective participants understand the purpose, the procedures, the potential risks and benefits of their involvement, and their alternatives (if any) to participation.

Intellectual property

Property that enjoys legal protection and stems from the exercise of the mind. Includes patents, trademarks, copyright, design protection and some minor rights. Includes topics such as types of intellectual ownership of intellectual property, faculty and student rights to intellectual resources for patenting and licensing intellectual property, and intellectual issues related to consulting and entrepreneurial activities.

Justice

A basic ethical principle protecting human participants in research that states that researchers have an obligation to distribute benefits and risks equally without prejudice to particular groups, such as the mentally disadvantaged or members of a particular race or gender. This principle is articulated by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the Belmont Report in 1979.

Mentor/trainee relationship

Topics include: the qualities of a mentor and trainee (mentee), responsibilities and relationship between the mentor and mentee, collaboration and competition, selection of a mentor.

Peer review

A system using reviewers who are the professional equals of the principal investigator or author who determine the merits of a project/manuscript for research funding or publication. Includes topics such as the definition of peer review, impartiality, how peer review works, assessing quality, editorial boards and ad hoc reviewers, responsibilities of the reviewers, privileged information and confidentiality.

Plagiarism (ORI definition)

Appropriation of another person’s ideas, processes, results or words without giving appropriate credit.

Publication practices and responsible authorship

The purpose and significance of publication including the responsibility of authors and reviewers. Includes topics such as collaborative work and assigning appropriate credit, description of methods, elements of publications, peer review, authorship issues.

Research involving animals (Public Health Service (PHS) definition)

An animal is defined as any live, vertebrate animals used or intended for use in research, research training, experimentation or biological testing or for related purposes. Topics include ethical principles for conducting research involving animals, federal regulations governing animal research, institutional animal use committees and treatment of animals.

Research misconduct (ORI definition)

Fabrication, falsification, or plagiarism in proposing, performing or reviewing research, or in reporting results. Includes topics such as policies, guidelines and regulations governing research misconduct, error vs. intentional misconduct, institutional misconduct, identifying misconduct, procedures for reporting misconduct, protecting whistle blowers, and outcomes of investigations.

Research with hazardous materials

Issues important to conducting research in a manner that promotes safety for researchers, research participants and the environment. Topics include the appropriate approvals for use, ensuring adequate training, inspections and certifications, properly disposing of hazardous materials, complying with regulations.

Respect for persons

A basic ethical principle protecting human participants in research that states that they have the right to make decisions for and about themselves without undue influence or coercion from researchers. This principle is articulated by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the Belmont Report in 1979.

Significant financial conflict

A conflict of interest that arises as a result of financial interests and defined by the Department of Health and Human Services as additional earnings in excess of $10,000 a year of equity interests in excess of 5 percent in an entity that stands to benefit from the research. The financial interests of all immediate family members are included within these figures. State and local policies may use different values for defining what constitutes a significant financial conflict.

Sources

Definitions have been derived from the following sources:

• Steneck, N. H. (2004). Office of Research Integrity. Introduction to the responsible conduct of research. U.S. Department of Health and Human Services.
• University of Missouri Office of Research.