Responsible Official: VP for Research Administration
Administering Division/Department: Research Compliance
Effective Date: April 30, 2007
Last Revision: November 10, 2015
These guidelines describe a standard of practice for the conduct of scholarship and research at Emory University (the “University”). The University complies with all applicable laws and regulations. They are based on three important principles:
I. The University is obligated to protect and foster the academic freedom and intellectual integrity of all members of the University community in their pursuit of knowledge;
II. The University is accountable to outside funding sources that support the research and scholarship of its faculty; and
III. Every scholar has ultimate responsibility for the accuracy and validity of his/her own work and that of junior co-investigators, fellows, and students. Each scholar shares this responsibility with colleagues with whom she/he establishes collaborative relationships.
This document applies to research in all areas of intellectual inquiry. A separate section addresses issues specific to scientific research. These guidelines are intended to heighten awareness of potential ethical problems and to instruct individuals regarding appropriate procedures for resolving and documenting ethics-related matters. The focus is on the individual scholar; the purpose is to emphasize that his/her responsibility includes a duty to maintain high scholarly and ethical standards, and a commitment to instill those standards in co-investigators, students and trainees.
Scientific inquiry, scholarly contributions, creativity, and academic accomplishment can take many forms and may vary among disciplines. The subjects addressed by these guidelines are essential to all scholarly activity within the University community. Scholarly responsibility, quality of scholarly activity, security of scholarly contributions and their sources, responsible authorship, and provision for training in ethics of each discipline are issues inherent to all areas. The implications of these guidelines apply as fully to the scholar who co-authors a history textbook as to the laboratory scientist who reports a biological discovery, or the clinician who publishes a case report.
- The guidelines address the following concerns:
- the scholar's authority and responsibility for research activities;
- the establishment of the quality of research;
- the supervision of students and other trainees;
- the education of trainees in research ethics and integrity;
- access to and retention of scientific research protocols and data; and
- the social responsibility of the scholar.
In the event of a conflict between the provisions of this policy and any other applicable policies and/or laws/regulations, the most stringent of the applicable policy and/or law/regulation shall govern.
7.9.1 The Conduct of Research and Scholarship
A. Authority and Responsibility for Research Activities
The head of each division, department or program is responsible for assuring that each fellow or student has a specific faculty research director or dissertation advisor. Usually a dissertation advisor or research director will be a full-time faculty member of a University department. This responsibility should not be construed as carrying rights of authorship, consultation, or approval of manuscripts prior to publication.
B. Establishing the Quality of Research
1. Primary assurance of the quality of research stems from the scholarly qualifications of individual faculty members. All faculty members are ultimately responsible for the scholarly character, accuracy, and reliability of their own research and for that conducted under their supervision. Each scholar is also responsible for the integrity and originality of his/her own research. The most effective single process for ensuring research of high quality is peer review, both formal and informal. Informal review occurs through departmental and interest-group seminars and research discussion groups. Each division, department, or program should encourage such informal review procedures. Formal review will be accomplished by existing review committees (e.g., tenure and promotion committees) that are charged with the task of evaluation of the merit and relevance of research. (An example of an external committee is an NIH study section.)
2. Faculty should establish an intellectual atmosphere that promotes high academic and moral standards and in which issues of social responsibility and professional ethics are addressed.
3. Emory University's formal policy governing investigations of research misconduct ("Policy 7.8: Policy on Research Misconduct" Emory University) should be followed when allegations of research improprieties have been made. That document, which is incorporated by reference, should be on file in the office of each laboratory head and faculty member and should be distributed to all members of the research team.
C. Supervision of Student Scholarship
1. The academic institution's responsibility to educate and prepare students to enter society and to practice their disciplines with high ethical standards does not cease with formal course work. The University and its faculty have an obligation to the academic community, the public, and the student to ensure that all students and trainees engage in scholarship and research responsibly, using the highest professional standards.
2. Dissertation advisors, research directors and administrative heads share responsibility for guaranteeing an open
and equitable research environment that protects the interests of students, assistants and other trainees. They should ensure that students are given due recognition for original work, that demands made upon students are reasonable, and that they are treated in interpersonal relationships with the same professional courtesy granted peer colleagues. For students who feel their supervision or training is inadequate, avenues must be available to bring this to the attention of the advisor, director or, if necessary, to the head of the appropriate administrative unit.
3. Dissertation advisors and research directors should meet regularly with students, fellows, and other collaborators to review their work and progress.
4. Dissertation advisors and research directors should serve as role models and maintain the highest standards in performance of research. They should encourage students to be open and to share ideas and information with other members of the scholarly community. They should ensure that the experience of their students serves to prepare them to become independent scholar and researchers.
D. Education of Graduate Students in Research Ethics and Integrity
1. Ethical issues and questions in the conduct of scholarship should be made an integral part of the education of all graduate students. Research directors are responsible for establishing a training environment in which value-related issues are discussed freely. The director should expect and foster at least a minimal level of familiarity with ethics
related to scholarship. The goals should be to teach students and other trainees how to identify ethical issues and how to address the common ethics-related questions that arise in the course of investigation and publication.
2. Heads of departments, divisions, and programs are responsible for fostering the teaching of ethics within their units. An ethics component of the curriculum should provide students and faculty with the intellectual tools and interactional skills to apply ethical thinking to everyday problems encountered in their research. Ethical issues, concepts and theoretical grounding should be introduced as part of the orientation of all graduate students and trainees.
E. The Social Responsibility of the Scholar
Scholars have a social obligation to conduct research and scholarship work responsibly and with integrity, and work to ensure that their contributions are not misused. Scholars are also responsible for being familiar with all University policies related to research including copyright and patent policies, the Policy on Research Misconduct, and these guidelines.
7.9.2 The Conduct of Scientific Research
The following paragraphs refer specifically to scientific research and serve as an addendum to the broader guidelines described above.
A. Responsibility for Scientific Research Activities
The head of each division, department, or program is responsible for assuring that (1) every laboratory or research unit has a designated preceptor (i.e., supervisor, mentor, or director), and (2) that each trainee (e.g., post-doctoral fellow, junior investigator, graduate or undergraduate student) has a specific faculty research preceptor. Usually a research preceptor will be a full-time faculty member of a University department or a laboratory head in an Emory-affiliated research facility or hospital.
B. Establishing the Quality of Scientific Research
1. The research director is responsible for assuring close personal supervision of the research of students including the design of research protocols, approval by appropriate committees, data gathering and recording, statistical analysis, interpretation of results, preparation of manuscripts, submission and revision of manuscripts for publication, and presentations at scholarly meetings.
2. The laboratory head is responsible for informing each new staff person and investigator (faculty, student, or fellow) of applicable federal, state and institutional regulations for conduct of studies involving humans, animals, radioactive and other hazardous materials, and recombinant DNA. Laboratory heads are responsible for informing personnel in their laboratories about existing Emory University policies and these guidelines. The laboratory head is also responsible for explaining and discussing the relevant requirements for the responsible conduct of research with trainees, fellows, and visiting scientists in the laboratory, and to ensure that such requirements are met.
3. The distinction between intellectually-driven inquiry and commercially-targeted research is sometimes vague. Many respected faculty are committed to developing and to studying tools, techniques and processes whose primary purpose is to promote the health or welfare of society in areas having potential commercial value. The preceptor is responsible for assuring that such investigations meet the same standards of quality and reproducibility as investigations of a more basic nature. Furthermore, any faculty member that has financial interests in a company sponsoring his/her research should disclose such financial interests to the chair and dean/director to avoid potential or real conflicts of interest, as well as following any other laws, regulations, or University policies regarding conflicts of interest.
4. In keeping with the principle of fostering reproducibility in science, and in the absence of patent, copyright, contractual or regulatory considerations, novel compounds and reagents used for experiments should be made available or appropriately described means for obtaining these should be given to other competent members of the research community upon request and after execution of a material substance transfer agreement. The senior investigator should have the latitude to make a fair and balanced response to requests for all research substances, including novel compounds and reagents. Additionally, investigators are expected to comply with any applicable data or material sharing requirements set forth by research sponsors or applicable laws and regulations.
5. Clinical research requires special attention to issues of informed consent and confidentiality. Physician-investigators should disclose significant alternatives and risks to participants so that they can make an informed judgment about participation. Signed copies of informed consent concerning research that involved medical treatment must be placed in the participant’s clinical records as well as with research records, unless otherwise required by an Institutional Review Board or rules/regulations governing medical records. Clinical research records remain the property of the University and/or Emory Healthcare if such records are contained in a participant’s medical records. With respect to University records, the administrative heads of the department/division of the faculty conducting clinical research are responsible for maintenance of such records. Subject to the limitations of any research sponsors and/or authorizations or consents signed by clinical research participants, faculty members may make copies of the records upon departure from the University.
C. Access to and Retention of Scientific Research Protocols and Data
1. Both the research director and the University have responsibilities and rights concerning access to, use of, and maintenance of original research data. Consistent with the precepts of academic freedom and intellectual integrity, the investigator/scholar has the primary authority to make judgments involving the use and dissemination of the data consistent with applicable laws, regulations, policies and contractual obligations.
2. Each faculty member/preceptor is ultimately responsible for the maintenance and proper retention of research records. These records should include sufficient detail to permit examination for the purposes of replicating the research, responding to questions that may result from unintentional error or misinterpretation, establishing their authenticity, and confirming the validity of the conclusions.
3. Each preceptor should maintain a laboratory manual that describes all major procedures. Correspondence with institutional review committees and records of the use of controlled substances and radioactive materials should be maintained as part of the research record in accordance with governmental, regulatory, and University policies.
4. A standardized system of data organization should be adopted and should be communicated to all members of a research group and to the appropriate administrative person. The appropriate administrative person should be determined by the sub-unit.
5. Where feasible, the faculty member, or his/her designee, shall retain all original primary data. Accepted practices for retaining data vary among disciplines and depend on the perishability, nature and logistics associated with each type of data. Each investigator should treat data properly to ensure authenticity, reproducibility and validity and to meet the requirements of relevant grants and other agreements concerning the retention of data. Primary data should be preserved for the period and under conditions specified by the most stringent of applicable federal regulations, University policy and record retention schedules, and/or grant/contractual requirements. In circumstances in which there are no federal, University, or other record retention requirements, sub-units of the University should establish uniform standards and procedures for retention and destruction of data. Data should not be destroyed without proper notification of and approval by an appropriate administrative person. In unusual cases (e.g., data used for a patent application filed by the University), it may be necessary for original data to be kept only at offices specified by the University. Potentially patentable data should be signed and dated by the preceptor at the time they are entered into notebooks or maintained by other methods of retention in the event the results are questioned.
6. Unless otherwise agreed to in writing by an authorized representative of the University, the University retains ownership of all research data, samples, and materials generated or collected in the course of University research. In the event of disputes between scholars with regard to control, access, and use of such data, samples, and materials, the University, through the procedures described under 7.9.3 of this Policy, shall ultimately determine disposition. If a scholar leaves the University, he/she shall cooperate with his/her department chair/director to negotiate appropriate agreements governing the transfer of any research data, samples, or materials to the entity to which the scholar is moving, consistent with any legal, policy, grant or contractual requirements. The transfer of any data, samples, or materials shall be contingent upon the execution of such agreements between the University and new entity (e.g., material transfer agreements, data transfer agreements) When practicable and permitted, agreements shall preserve the scholar's right to access and copy (where practical) such data. Any potential transfer, disclosure, right of access, or use of data, samples, or materials collected from human subjects is subject to the provisions of the informed consents and authorizations executed by those human subjects.
7.9.3 Resolution of Policy Violations
Resolution of alleged violations of this Policy 7.9 shall be resolved at the local level by the head of the relevant department, division, or program, in consultation with the dean of the relevant school, as appropriate. To the extent that the subject matter of alleged violations falls within the scope of another University policy or falls under the jurisdiction of another University unit, such matters shall be handled in accordance with the relevant University policy and referred to the relevant University unit as appropriate. Non-limiting examples include referrals to the following units:
- Institutional Review Board (IRB) for matters falling within the scope of the Emory University Institutional Review Board Policies and Procedures;
- Institutional Animal Care and Use Committee (IACUC) for matters falling within the scope of IACUC policies, procedures, and guidelines;
- Conflict of Interest (COI) for matters falling within the scope of Policy 7.7: Policy for Investigators Holding a Financial Interest in Research;
- Office of Compliance (OC) for matters falling within the scope of Policy 7.8: Policy on Research Misconduct;
- Handling of authorship disputes by the appropriate unit(s) in accordance with Policy 7.30: Policy on Authorship Guidelines and Dispute Resolution.
"Policy 7.8: Policy on Research Misconduct", Emory University.
- Current Version of This Policy: http://policies.emory.edu/7.9
Subject Contact Phone Clarification of Policy Office of Research Compliance 404-727-2237 firstname.lastname@example.org