What is Responsible Conduct of Research?

What is Responsible Conduct of Research? The Nine Core Areas and What You Need to Know and Teach

The Nine Elements • Advisor/Mentor Role • Treatment of Data • Research Misconduct • Human Subjects • Animal Welfare • Conflict of Interest/Commitment • Publication Practices/Authorship • Peer Review • Collaborative Science

Advising & Mentoring • Keep in mind that a Mentor can be an Advisor • The role of the Mentor is to guide the mentee, as a Mentor you will have influence over the Mentee • Areas to pay close attention to as a Mentor: • Allocation of credit • Publication practices • Proper division of responsibilities

Role of Mentor/Advisor • a clear understanding of mutual responsibilities, • a commitment to maintain a productive and supportive research environment, • proper supervision and review, and • an understanding that the main purpose of the relationship is to prepare trainees to become successful researchers

Mentee/Advisee Responsibility • Gather a diverse collection of mentors • Seek out an initiate interactions with advisors • Consider the possibility that they may become a mentor or advisor in their careers • Participate in the process, ask questions, seek opportunities to grow

Treatment of Data Data management has become a formalized process for many sponsors addressed in applications. Elements of Data Management include: • Ownership • Accurate-how will it be collected • Accessible (able to share data) • Security (storing)

Research Misconduct Misconduct in Research is defined by the U.S. Office of Research Integrity as: “fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. (a) Fabrication is making up data or results and recording or reporting them. (b) Falsification is 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. (c) Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. (d) Research misconduct does not include honest error or differences of opinion.

Research Misconduct • All recipients of federal research funding must have a policy on research misconduct • Due process is a key element of this policy as well as protection of the accuser and the accused until a determination is made on the allegation • CNU’s policy is located on the Sponsored Programs website under Policies and Procedures

Human Subjects • All research involving human subjects must be reviewed by the institution’s Institutional Review Board (IRB) • "Human subject research" is research where the investigator obtains from a living human individual (1) data through intervention or interaction with the individual; or (2) identifiable private information. • “Generalizable knowledge” means that the intent of the research is to add information to a field of study; the results can be applied beyond the subject population to other settings. It doesn’t matter if the results will be published or not, if the research activity is designed with the aim of discovering information that can be applied in other settings, it can be considered research.

Human Subjects Cont’d • “Intervention or interaction with the individual” includes performing physical procedures on a person, manipulating the person, manipulating the person’s environment, communicating with a person, or having interpersonal contact with a person • considered “identifiable private information” two criteria must be true. First, the information must be private, meaning it is either about behavior that occurs in a context where the individual reasonably expects no observation is taking place or the individual has provided the information for a specific purpose and reasonably expects the information will not be made public. Second, the information must be individually identifiable, meaning the identity of the person is or may be readily ascertained by the investigator or the identity of the person is or may readily be associated with the information.

Human Subjects • Examples of activities that aren’t considered Human Subjects Research • The following are specifically excluded from the definition of Human Subject Research and do not need to be reviewed by the IRB: • interviews used to provide quotes or illustrative statements, such as those used in journalism; • collection(s) of oral histories and cultural expressions (e.g., stories, songs, customs, and traditions and accounts thereof) to document a specific historical event or the experience of individuals without intent to draw statistically or quantitatively-based conclusions or generalizations; • gathering of information from a person to assess suitability for and/or supplement a public program, publication, or cultural performance

Animal Welfare • Federal regulations define the parameters in which animal research can take place and provide guidance on institutional care and use committees (IACUC), and the proper treatment of animals. • The Public Health Service (PHS) defines an animal as “any live, vertebrate animal” • Protocols must be submitted to the IACUC for “animal used or intended for use in research, research training, experimentation, or biological testing or for related purposes.”

Conflict of Interest(COI)/Commitment • Conflicts of interest are not only sponsor regulatory issues but issues for institutions • All potential conflicts and in the case of NIH Significant Financial Interest must be disclosed • As a matter of course financial conflicts and other external commitments are not necessarily prohibited, but still require disclosure and mitigation • CNU’s Policy on Conflict of Interest is located on the Sponsored Programs website under Policies and Procedures

Examples of Possible COI • Conducting a sponsored activity for a company in which the Pi, Co-PI, and//or their families have a financial interest in the company • Hiring/supervision of family members on contract or grant or the inclusion of family members as Co-PI, key personnel, or subcontractors at another institution

More Examples of Possible COI • Subcontracting or procuring services from a company owned by the PI, Co-PI, or family members • Serving as a consultant or other outside activities with a company or entity that funds sponsored research at the University • Serving as a consultant or PI on an award not made to your institution while using the resources of your institution

Publication Practices and Authorship The Office of Research Integrity describes Authorship and Publication as: Whether structured or informal, controlled or free ranging, responsible publication in research should ideally meet some minimum standards. All forms of publication should present: • a full and fair description of the work undertaken, • an accurate report of the results, and • an honest and open assessment of the findings.

Publication Practices and Authorship • In assessing the completeness of any publications, researchers should ask whether they have described: • what they did (methods), • what they discovered (results), and • what they make of their discovery (discussion). • It is, however, not as easy as one might anticipate to meet these expectations.

Peer Review ORI’s discussion of peer review is as follows: Peer review—evaluation by colleagues with similar knowledge and experience—is an essential component of research and the self-regulation of professions. The average person does not have the knowledge and experience needed to assess the quality and importance of research. Peers do. Therefore many important decisions about research depend on advice from peers, including: • which projects to fund (grant reviews), • which research findings to publish (manuscript reviews), • which scholars to hire and promote (personnel reviews), and • which research is reliable (literature reviews and expert testimony).

Peer Review The quality of the decisions made in each case depends heavily on the quality of peer review. Peer review can make or break professional careers and directly influence public policy. The fate of entire research programs, health initiatives, or environmental and safety regulations can rest on peer assessment of proposed or completed research projects. For peer review to work, it must be: • timely, • thorough, • constructive, • free from personal bias, and • respectful of the need for confidentiality. Researchers who serve as peer reviewers should be mindful of the public as well as the professional consequences of their evaluations and exercise special care when making these evaluations.

Collaborative Science • Define roles and responsibilities • On-board administrative staff early • Avoid authorship disputes • Deal with potential issues of sharing materials and information with internal and external collaborating scientists at the start • Be sure that you are understanding your collaborator especially if from a different discipline

Resources • CNU Provides access to CITI RCR compliance modules which can be used in conjunction with in person training to certify student compliance • The OSP website has a link to EthicsCore which functions in the same capacity as CITI • The Office of Research Integrity has created a Case Study resource. The link is: http://ori.hhs.gov/rcr-casebook-stories-about-researchers-worth-discussing & can be found on the OSP website.

What is Responsible Conduct of Research?