BACKGROUND

The impetus for developing a code of responsible conduct of research for the American Pediatric Society (APS) and Society for Pediatric Research (SPR) grew from the recommendations and guidelines developed by the Committee on Research Integrity of the American Association of Medical Colleges (AAMC). This committee advises the AAMC on policy positions and new initiatives to assist medical schools in maintaining the integrity of their research programs. In February 1997, after extensive consultation with leading members of the academic community, the committee issued a call for scientific and professional societies to further their important roles in promoting research integrity through the development of codes of ethics. The committee's recommendations were then codified in the AAMC publication "Developing a Code of Ethics in Research: A Guide for Scientific Societies," which was an invaluable resource in informing our own process of developing a code of ethics for the APS/SPR(1).

The development and dissemination of a code of responsible conduct of research serves several purposes for the APS/SPR: to reduce members about professionalism in their scientific discipline, to create standards that academic institutions will find helpful in reviewing alleged misconduct, and to serve as a public statement about the importance our professional societies and their members place on responsible research practice. In approving and publishing this code, the APS/SPR have now joined the many academic societies that have already published similar codes of responsible and ethical research behavior for their members(2–4).

APS/SPR CODE OF RESPONSIBLE CONDUCT OF RESEARCH

Members of the APS/SPR should be guided by the fundamental principles of ethical conduct of research. These include a responsibility to use knowledge and skills to promote the general welfare of humankind, with particular emphasis on the special needs of children; to share their results with others through discussion, presentations, and publications; to be honest and impartial in their interactions with trainees, patients, and colleagues and when engaged in peer review activities; to recognize the role of collaborators, trainees, and other personnel who have made contributions to the research; and to give proper attribution to the work of others. The following sections provide guidelines to promote and sustain these vital responsibilities.

Creating and maintaining a positive research environment. Creating a positive research environment that promotes responsible and ethical research conduct is one of the fundamental ways in which scientists can prevent unacceptable behavior. The research environment includes not only the laboratory or clinic, but encompasses broadly the realm in which members accomplish their scientific endeavors: the classroom; clinical sites; scientific meetings; scientific, academic, and peer review committees; and journals. The research environment should not only respect the scientific process but also those who participate, including subjects of research (both human and animal), laboratory workers and students, regardless of ethnic origin, gender, or rank. Systems governing academic advancement should be encouraged to develop standards that value scientific quality and originality above quantity as a way of further encouraging ethical scientific behavior.

Mentoring of trainees. Effective mentorship of trainees and young investigators is important to guarantee the transfer of the ideals of a productive and ethical research environment to future generations of researchers. It is the responsibility of the mentor to plan for the transition to independence of the trainee. This includes removal of the mentor's name from publications at an appropriate time during this transition.

Applying for research support. Science is a cumulative endeavor and our current base of knowledge almost always has been built on the previous insights of others. Researchers should strive to uncover the prior work of others, provide accurate attribution of this work, and recognize the contributions of trainees and collaborators for their intellectual contributions. Applications for research support should honestly state the scope of the proposed work, its relevance, the degree to which part of the work has already been completed, the research budget, and the level of effort devoted by the principal investigator and others to the project.

Participation in scientific or editorial peer review. Members participating in peer review of research proposals or manuscripts describing original research should possess the scientific qualifications to evaluate the merit of the work and be able to provide timely, fair and impartial consideration of the material. They should ask to be recused if they cannot do so or if they possess a conflict of interest. Grant applications, manuscripts and similar material and the ideas contained therein should be kept confidential and the ideas or data contained within should not be used to further the reviewer's own research.

Conducting research. Ethical conduct in research should be accomplished with a formal research design in which appropriate controls are used to protect against investigators bias. The potential complications and risks of the research should be considered, and appropriate use of consultants, particularly those with statistical expertise, should be encouraged. Data should be accurately recorded and archived in a manner that retains its original defining characteristics to permit analysis by others. Sharing of data, biological or other materials, or techniques is part of good research practice and should be encouraged as far as practicable.

Research on human subjects must be performed with informed consent, by which participants (or, if a minor, their parents) have been notified of the risks and benefits of their participation. To the extent that a subject who is a child can comprehend the purpose, risks, and benefits of the study, the nature of his or her participation should be explained and consent sought in language commensurate with the child's maturity. Participants must not be coerced in any way to participate. Human subjects should be treated with beneficence, justice, and respect for their autonomy. All human research must meet with approval by an Institutional Review Board and should follow all institutional and federal regulations.

Animal research should be conducted to advance knowledge. Alternatives should be sought when possible. Animals should be treated with respect and concern for their health and welfare. Laboratory personnel should be adequately trained in animal care and experimental procedures. Institutional and federal guidelines should be followed, and research must be approved by the Institutional Animal Care and Use Committee.

Research in human genetics and molecular biology should be conducted in a manner to protect the confidentiality of those individuals who supply genetic material, to help avoid discrimination in health care, insurance, or employment based on genetic information, and to provide counseling to patients about diagnoses of genetically based diseases. Researchers should understand the potential legal, ethical, and social implications of genetic research.

Reporting of research. Authorship of a scientific publication or presentation implies participation in the research, the author's ability to defend all or part of the data and conclusions, and responsibility for the work of his/her collaborator(s). The first and/or senior author has the special responsibility to maintain records of the primary data and for stewardship of potentially sharable resources. In all circumstances, the use of other's words or ideas must be accompanied by appropriate attribution.

Publication of research should provide sufficient methodological detail to allow confirmation of the research results and use of specific research methods by others. Research should be published in meaningful, complete units that maximize contribution to the literature and justify their publication. Dividing research results into multiple small units that diminish the full scope of a project is undesirable. Publication of the same results in different journal is unacceptable.

Avoiding and correcting violations of good conduct. Misconduct in research undermines the scientific process, threatens the base of knowledge upon which others may build, and threatens the loss of public support of the research enterprise as a whole. Researchers have an obligation to take appropriate action when they become aware of violations of good research practice. Initial challenges to research results should be able to take place in an open environment and should be performed constructively and without suggestion of deliberate misrepresentation. If this cannot be accomplished successfully, then suspicions should be reported to the appropriate institutional official. Individuals who honestly and responsibly report research misconduct should be treated fairly and not be subject to reprisal.

Researchers must avoid conflict of interest, which occurs when personal considerations have the potential to compromise professional judgment. Commercial or other support that could lead to the perception of such a conflict must be acknowledged at the time of presentation or publication of research results. Researchers should contribute to the responsible conduct of research by actively educating their students and trainees on all elements of responsible research practice.