Review of the Joint NHMRC / AVCC Statement and Guidelines on Research Practice (1997)
A Working Group comprising representatives from the National Health and Medical Research Council (NHMRC), Australian Vice Chancellors' Committee (AVCC) and the Australian Research Council (ARC) was established in August 2003 to review the existing Joint NHMRC/AVCC Statement and Guidelines on Research Practice. Please see this document's replacement, the Australian Code for the Responsible Conduct of Research.
The rescinded Joint NHMRC / AVCC Statement and Guidelines on Research Practice (1997) (below) has been provided here for archival purposes only.
This “Joint Statement and Guidelines” replaces the “NHMRC Statement on Scientific Practice” (1990) and the AVCC ‘Guidelines for Responsible Practice in Research and Problems of Research Misconduct’ (1990). The Statement and Guidelines exist to guide institutions in developing their own procedures and guidelines, by providing a comprehensive framework of minimum acceptable standards.
The broad principles that guide research have been long established. Central to these are the maintenance of high ethical standards, and validity and accuracy in the collection and reporting of data. The responsibility of the research community to the public and to itself is acknowledged. This responsibility is particularly important where professional practice or public policy may be defined or modified in the light of research findings.
The processes of research protect the truth. Communication between collaborators; maintenance and reference to research records; presentation and discussion of work at meetings of experts; publication of results, including the important element of peer review; and the possibility that investigations will be repeated or extended by other researchers, all contribute to the intrinsically self-correcting and ethical nature of research.
Competition in research can have a strong and positive influence, enhancing the quality and immediacy of the work produced. However, competitive pressures can act to distort sound research practice, if they encourage too-hasty preparation and submission of papers, the division of reports on substantial bodies of work into multiple small reports to enhance the ‘publication count' of the author(s), or an undue emphasis on safe but mundane research at the expense of more creative and more innovative lines of study. Accordingly each institution should give due emphasis to quality and originality of research, as well as to quantity of research output, and set up codes of conduct which are seen as a framework for sound research procedures and for the protection of individual researchers from possible misunderstandings.
It is a basic assumption of institutions conducting research that their researchers are committed to high standards of professional conduct. Researchers have a duty to ensure that their work enhances the good name of their institution and the profession to which they belong.
Researchers should only participate in work which conforms to accepted ethical standards and which they are competent to perform. When in doubt they should seek assistance with their research from their colleagues or peers. Debate on, and criticism of, research work are essential parts of the research process.
Institutions and researchers have a responsibility to ensure the safety of all those associated with the research. It is also essential that the design of projects takes account of any relevant ethical guidelines.
If data of a confidential nature are obtained, for example from individual patient records or from certain questionnaires, confidentiality must be observed and researchers must not use such information for their own personal advantage or that of a third party. Secrecy may also be necessary for a limited period in the case of contracted research or of non-contractual research which is under consideration for patent protection. In general, however, research results and methods should be open to scrutiny by colleagues within the institution and, through appropriate publication, by the profession at large.
1. General Principles
1.1 Institutions must establish procedures and guidelines on good research practice, and on steps to be followed if suspicions or allegations exist regarding research misconduct. Those procedures and guidelines must meet the standards set out in this document.
1.2 Institutions should establish and maintain practices and policies which promote the highest possible standards and discourage misconduct and fraud. These policies should encourage the open presentation and discussion of results via peer review mechanisms.
1.3 Institutions must have clearly formulated policies on the maintenance of records, retention of data, publications and authorship, management of intellectual property, research training (where appropriate), confidentiality and conflict of interest.
1.4 Researchers have an obligation to achieve and maintain the highest standards of intellectual honesty in the conduct of their research.
1.5 Researchers must be aware of and adhere to ethical principles of justice and veracity, and of respect for people and their privacy and avoidance of harm to them, as well as respect for non-human subjects of research. Research must comply with established guidelines such as the NHMRC Statement on Human Experimentation and Supplementary Notes. 1
1.6 Where research procedures are of a kind requiring approval by a human or animal experimentation ethics committee, or by other safety or validly constituted regulatory committees, research must not proceed without such approval.
1.7 Institutions should ensure that a person with appropriate authority is responsible for monitoring the observance of these guidelines.
2. Data storage and retention
2.1 Data (including electronic data) must be recorded in a durable and appropriately referenced form. Data management should comply with relevant privacy protocols, such as the Australian Standard on personal privacy protection. 2
2.2 The department or research unit must establish procedures for the retention of data and for the keeping of records of data held.
2.3 Data must be held for sufficient time to allow reference. For data that is published this may be for as long as interest and discussion persists following publication. It is recommended that the minimum period for retention is at least 5 years from the date of publication but for specific types of research, such as clinical research, 15 years may be more appropriate. 3
2.4 Wherever possible, original data must be retained in the department or research unit in which they were generated. Individual researchers should be able to hold copies of the data for their own use. Retention solely by the individual researcher provides little protection to the researcher or the institution in the event of an allegation of falsification of data.
2.5 Data related to publications must be available for discussion with other researchers. Where confidentiality provisions apply (for example, where the researchers or institution have given undertakings to third parties, such as the subjects of the research), it is desirable for data to be kept in a way that reference to them by third parties can occur without breaching such confidentiality.
2.6 Confidentiality agreements to protect intellectual property rights may be agreed between the institution, the researcher and a sponsor of the research. Where such agreements limit free publication and discussion, limitations and restrictions must be explicitly agreed.
2.7 It is the obligation of the researcher to enquire whether confidentiality agreements apply and of the Head of the Department or research unit to inform researchers of their obligations with respect to these provisions.
2.8 All confidentiality agreements should be made known at an early stage to the head of the research institution, or nominated representative.
2.9 The procedures formulated by institutions must include guidelines on the establishment and ownership of and access to databases containing confidential information, and any limits on this.
2.10 When the data are obtained from limited access databases, or via a contractual arrangement, written indication of the location of the original data, or key information regarding the database from which it was collected, must be retained by the researcher or research unit.
2.11 Researchers must be responsible for ensuring appropriate security for any confidential material, including that held in computing systems. Where computing systems are accessible through networks, particular attention to security of confidential data is required. Security and confidentiality must be assured in a way that copes with multiple researchers and the departure of individual researchers.
3.1 Each institution must establish a written policy on the criteria for authorship of a research output. Minimum requirement for authorship should accord with the “Vancouver Protocol”. 4 Authorship is substantial participation, where all the following conditions are met: a) conception and design, or analysis and interpretation of data; and b) drafting the article or revising it critically for important intellectual content; and c) final approval of the version to be published. Participation solely in the acquisition of funding or the collection of data does not justify authorship. General supervision of the research group is not sufficient for authorship. Any part of an article critical to its main conclusion must be the responsibility of at least one author. An author’s role in a research output must be sufficient for that person to take public responsibility for at least that part of the output in that person’s area of expertise. No person who is an author, consistent with this definition, must be excluded as an author without their permission in writing.
3.2 Authorship of a research output is a matter that should be discussed between researchers at an early stage in a research project, and reviewed whenever there are changes in participation.
3.3 When there is more than one co-author of a research output, one co-author (by agreement amongst the authors) should be nominated as executive author for the whole research output, and should take responsibility for record keeping regarding the research output.
3.4 Where the research is published, including electronically, all co-authors of a publication must acknowledge their authorship in writing in terms of, at least, the minimum acceptable definition at 3.1, above. This signed statement of authorship must specify that the signatories are the only authors according to this definition. It must state that the signatories have seen the version of the paper submitted for publication.
3.5 The written acknowledgment of authorship must be placed on file in the department or unit of the executive author, at the time of submission of the research output for publication, and must remain in safe keeping in that department.
3.6 If, for any reason, one or more co-authors are unavailable or otherwise unable to sign the statement of authorship, the head of department or unit may sign on their behalf, noting the reason for their unavailability.
3.7 The authors must ensure that others who have contributed to the work are recognised in the research output. Courtesy demands that individuals and organisations providing facilities should also be acknowledged.
3.8 Institutions should establish procedures to resolve conflicts arising through disputes about authorship.
4.1 Publication of multiple papers based on the same set(s) or subset(s) of data is not acceptable, except where there is full cross-referencing within the papers (for example, in a series of closely related work, or where a complete work grew out of a preliminary publication and this is fully acknowledged).
4.2 An author who submits substantially similar work to more than one publisher must disclose this to the publishers at the time of submission.
4.3 As a general principle research findings should not be reported in the public media before they have been reported to a research audience of experts in the field of research - preferably by publication in a peer-reviewed journal, except where there is a contractual arrangement.
4.4 It is acknowledged that where issues of public policy and concern make prior advice desirable, such advice must be tendered first to the public or professional authorities responsible, and the unreported status of the findings must be advised at the same time. Only where responsible authorities fail to act can prior reporting to the media be justified, and again the unpublished status of the findings must be reported at the same time.
4.5 Where there is private reporting of research that has not yet been exposed to open peer-review scrutiny, especially when it is reported to prospective financial supporters, researchers have an obligation to explain fully the status of the work and the peer-review mechanisms to which it will be subjected.
4.6 Publications must include information on the sources of financial support for the research. Financial sponsorship that carries an embargo on such naming of a sponsor should be avoided.
4.7 Deliberate inclusion of inaccurate or misleading information relating to research activity in curriculum vitae, grant applications, job applications or public statements, or the failure to provide relevant information, is a form of research misconduct. Accuracy is essential in describing the state of publication (in preparation, submitted, accepted), research funding (applied for, granted, funding period), and awards conferred, and where any of these relate to more than one researcher.
4.8 All reasonable steps must be taken to ensure that published reports, statistics and public statements about research activities and performance are complete, accurate and unambiguous.
5. Supervision of students / research trainees
5.1 Institutions should ensure that there is a specific, responsible and appropriately qualified supervisor of each research trainee and researcher new to research in the institution.
5.2 Institutional policy should ensure that the ratio of trainees to supervisors is low enough to assure effective intellectual interaction and effective oversight of the research at all times.
5.3 Each trainee should be provided with written material on applicable government and institutional guidelines for the conduct of research, including those covering ethical requirements for studies on human or animal studies, requirements for confidentiality, and occupational health and safety matters.
5.4 Supervisors should be obliged to provide guidance in all matters of good research practice.
5.5 The supervisor must ensure, as far as possible, the validity of research data obtained by a student under his/her supervision.
6. Disclosure of potential conflicts of interest
6.1 Institutions must have clearly formulated policies regarding potential conflicts of interest.
6.2 Institutions must formulate and advertise to their staff policies and procedures regarding appropriate disclosure of affiliation with, or financial involvement in, any organisation or entity with a direct interest in the subject matter or materials of researchers. These procedures must cover the full range of potential interests, including the direct benefits such as sponsorship of the investigation or indirect benefits such as the provision of materials or facilities or the support of individuals such as provision of travel or accommodation expenses to attend conferences. Such disclosure should cover any situation in which the conflict of interest may, or may be perceived to, affect any decision regarding other people.
6.3 The procedures should require disclosure to editors of journals, to the readers of published work, and to external bodies from which funds are sought.
6.4 Researchers have an obligation to disclose at the time of reporting or proposing research (for example, in a grant application), any conflict of interest which has the potential to influence research and investigations, publication and media reports, grant applications, applications for appointment and promotion.
7. Research misconduct
This document retains the previous definition of “Research Misconduct” but notes the latest US definition. 5
“Misconduct” or “Scientific Misconduct” is taken here to mean fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It includes the misleading ascription of authorship including the listing of authors without their permission, attributing work to others who have not in fact contributed to the research, and the lack of appropriate acknowledgment of work primarily produced by a research student/trainee or associate. It does not include honest errors or honest differences in interpretation or judgments of data.
Examples of research misconduct include but are not limited to the following :
Misappropriation: A researcher or reviewer shall not intentionally or recklessly:
- plagiarise, which shall be understood to mean the presentation of the documented words or ideas of another as his or her own, without attribution appropriate for the medium of presentation;
- make use of any information in breach of any duty of confidentiality associated with the review of any manuscript or grant application; or
- intentionally omit reference to the relevant published work of others for the purpose of inferring personal discovery of new information.
Interference: A researcher or reviewer shall not intentionally and without authorisation take or sequester or materially damage any research-related property of another, including without limitation the apparatus, reagents, biological materials, writings, data, hardware, software, or any other substance or device used or produced in the conduct of research.
Misrepresentation: A researcher or reviewer shall not with intent to deceive, or in reckless disregard for the truth:
- state or present a material or significant falsehood; or
- omit a fact so that what is stated or presented as a whole states or presents a material or significant falsehood.
Procedures where research misconduct is suspected or alleged
Note, many of the matters in this section are covered by academic awards.
7.1 Institutions must have in place procedures for dealing with instances of suspected or alleged research misconduct, whether or not such instances have arisen in those institutions.
7.2 The procedures and guidelines must provide for:
- nomination of persons to be advisers on integrity in research who are familiar with this document and with issues surrounding research integrity/misconduct; AND
- nomination of a small number of persons to whom allegations of research misconduct are to be directed.
7.3 There must be provision for a preliminary investigation of cases in which a charge of research misconduct may be made. Such preliminary investigation must make provision for a written statement of any allegations to be provided to the person(s) against whom such allegations are directed, and for a written response from that person to be received and considered. A preliminary investigation should be limited to determining whether a case exists that research misconduct may have occurred.
7.4 If a case for consideration of research misconduct is found in the preliminary investigation to exist, there must be provision for advice of this to be given, in confidence, to the secretary of any funding agency currently supporting the person supported, on the understanding that the agency will not terminate its support.
7.5 There must be provision for a formal investigation if preliminary investigation finds that a case exists.
7.6 If research misconduct is found to have occurred, there must be provision for findings of research misconduct to be reported to any funding agency that funded work in respect of which such misconduct occurred, or which is currently supporting the person found to have engaged in research misconduct, and to journals and other media through which the research in question was reported.
7.7 There must be provision to continue any such investigation to establish the facts of a matter in which research misconduct is alleged to have occurred, even if the person accused of such misconduct resigns from the institution. Distortions of the research record must be rectified, whether or not the persons involved remain in the institution.
7.8 Institutional procedures and guidelines must be framed in such a way as to protect the interests of all interested parties. Such fair dealing must consider the protection of persons making allegations in good faith, and of persons accused of misconduct. "Interested parties" include:
- a person bringing an allegation;
- a person against whom an allegation is made;
staff, students and trainees working with persons making an allegation, or with persons against whom an allegation is made;
- journals and other media reporting research subject to suspected, alleged, or found research misconduct;
- funding bodies supporting persons or research involved; and
- the public.
1 NHMRC Statement on Human Experimentation and Supplementary Notes, 1992.
2 Personal privacy protection in health care information systems, Australian Standard AS 4400-1995.
3 The December 1991 Guidelines for Good Clinical Research Practice in Australia, published by the Therapeutic Goods Administration of the Commonwealth Department of Health and Family Services, recommends retention of data for at least 15 years.
4 Uniform Requirement for Manuscripts Submitted to Biomedical journals as presented in JAMA 1997: 277:927-934.
5 In the Report of the Commission on Research Integrity ("Integrity and Misconduct in Research") to the U.S. Secretary of Health and Human Services: U.S. Department of Health and Human Services, 1995.
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