PREAMBLE

The broad principles that guide scientific 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 scientific community to the public and to itself is acknowledged. This responsibility is particularly important in the area of medical and health research.

The processes of scientific research protect the truth. Communication between collaborators; maintenance and reference to scientific records; presentation and discussion of work at scientific meetings; publication of results, including the important element of peer refereeing; and the possibility that investigations will be repeated or extended by other scientists, all contribute to the intrinsically self-correcting nature of science.

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 "logical-next-step" 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 research workers from possible misunderstandings.

1. It is a basic assumption of institutions conducting research that their staff members are committed to high standards of professional conduct. Research workers have a duty to ensure that their work enhances the good name of their institution and the profession to which they belong.
2. Research workers 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 from their colleagues or peers. Debate on, and criticism of, research work are essential parts of the research process.
3. Research workers 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.
4. If data of a confidential nature are obtained, for example from individual patient records or from certain questionnaires, confidentiality must be observed and research workers must not use such information for their own personal advantage or that of a third party. 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.
5. Secrecy may also be necessary for a limited period in the case of contracted commercial research.

Research projects requiring animal or human experimentation cannot be commenced until each project has been passed by the appropriate ethics committee.

ANIMAL: Application forms are available on the Web: http://www.ro.unsw.edu.au/ethics/animal.htm

Ms Margaret Wright is Executive Member of the Animal Care and Ethics Committee (ACEC), Ethics Secretariat, ext. 4234.

Professor Jim Kehoe, School of Psychology is the ACEC Chair and can be contacted by email at j.kehoe@unsw.edu.au

Applicant should carefully read the "advice to applicants" before completing the forms. Ask your supervisor for a sample copy of a successful application. Supervisors must approve the application.

After obtaining the appropriate signatures send:

1 full copy and 15 copies of pp 1-8 to Ms M Wright, ACEC.

HUMAN: Forms and procedures are available on disk from Ms M Wright, Executive Member of the Animal Care and Ethics Committee (ACEC), Ethics Secretariat, ext. 4234.

Venepuncture by Staff of the Department of Pathology

There are a large number of medical graduates within the Department of Pathology who would be able to assist with venepuncture as required. If other non-medically trained staff wish to learn to take blood they could be taught by the medical graduates in-house or they could attend the Pathology Outpatients at the Prince of Wales Hospital, where experience nurses could teach them the gentle art of blood-letting. See Professor A. Lloyd if you prefer the latter option.

It would be preferable to have registered medical practitioners taking blood under most circumstances.

I, ............................................................................................................... (insert name)

of .............................................................................................................. (insert address)

have voluntarily offered to donate to the Department of Pathology, UNSW samples of my blood and am aware of and hereby agree, in respect of each sample donated by me, to the Department’s procedure for taking of my blood.

I confirm that I have read, understood and agree to adhere to procedures outlined in the attached document "Procedures in the Event of Body Fluid Exposure".

I will abide by the Department’s recommendation that any single blood donation should not exceed 200ml and that the total blood donation over any three month period should not exceed 500ml.

I also agree to the following in respect of each sample donated by me at any time:

(a) that title to the blood will pass to the Department of Pathology at the time it is taken;

(b) that the Department of Pathology, UNSW may use the blood as it sees fit, provided the procedure meets all relevant guidelines of the Human Ethics Committee and NHMRC; and

(c) that I am not entitled to any information as to either the use of the blood or the results of any research, analysis or tests carried out and the Department is under no obligation to divulge such information to me or any other person.

Signed ............................................................................................. Date ...................................

1. Data gathering, storage and retention

1. Data must be recorded in a durable, and appropriately referenced and dated form.
2. Sound research procedures entail the discussion of data and research methods with colleagues. Discussion may also occur well after the research is complete, often because of interest following publication. If at all possible, it is in the interests of all research workers to ensure that original data are safely held for periods of at least five years.
3. Original data should be retained in the department or research unit in which they were generated.

In some cases, such as when data are obtained from limited-access data bases, or in a contracted project, it may not be possible to hold them in this way. In such cases, a written indication of the location of the original data, or key information regarding the limited-access data base from which it was extracted, must be kept in the department or research unit. Individual researchers should be able to hold copies of the data for their own use except for that obtained from projects with commercial, in confidence restrictions. Retention solely by the individual research worker provides little protection to the research worker or the institution in the event of an allegation of falsification of data.

2. Publication and Authorship

1. Where there is more than one author of a publication, one author (by agreement among the authors) should formally accept overall responsibility for the entire publication. Formal acceptance must be in writing, and kept on file in the department or unit of that author, together with the names and signatures of all other authors.
2. The criteria for authorship of a publication must be determined and announced by each research unit or department. Minimum requirement for authorship would be participation in conceiving and/or executing and/or interpreting at least that part of the publication in a co-author’s field of expertise, sufficient for him/her to take public responsibility for it. Each co-author must acknowledge his/her co-authorship in these terms, in writing, and that this must be kept on file in the department or unit of the responsible or executive author. This requirement must be met, at a minimum, by all authors signing a statement that they are "authors" of a specified publication in the terms defined by the research unit or department. Such statement must include an indication that there are no other "authors" of the publication, according to this definition. If, for any reason, one or more co-authors are unavailable or otherwise unable to sign the statement of authorship, the head of the research unit or department may sign on their behalf, noting the reason for their unavailability.
3. ‘Honorary authorship’ occurs when a person is listed as an author of a publication when he/she has not participated in a substantial way in conceiving and/or executing and/or interpreting at least part of the work described in the publication. ‘Honorary authorship’ is an unacceptable practice.
4. Due recognition of all participants is a part of a proper research process. Authors should ensure that the work of non-authors, including research assistants and technical officers is properly acknowledged.
5. Publication of multiple papers based on the same set(s) or subset(s) of data is improper unless full cross-referencing occurs within the papers (for example, by reference to a preliminary publication at the time of publication of the complete work which grew from it). Simultaneous submission of papers based on the same set(s) or subset(s) of data to more than one journal or publisher should be disclosed to each journal or publisher at the time of submission.

3. Disclosure of potential conflicts of interest

1. Procedures regarding disclosure of affiliation with, or financial involvement in, any organization or entity with a direct interest in the subject matter or materials of research workers must be formulated and advertised within institutions. These procedures must cover the full range of interests. These would include those involving benefits in kind such as the provision of benefits (eg travel and accommodation expenses to attend conferences). The procedures should include guidelines on confidentiality of disclosures, and any limits on this. They should address the matter of disclosure of such interests to the editors of journals to which papers are submitted for consideration for publication (some editors require such disclosure now before consideration can commence), to the readers of published work, and to eternal bodies from which funds are sought.

4. Procedures where serious departures from sound scientific practice may have occurred

Scientific practice may fall short of desirably high standards in a variety of ways. At one end of the spectrum would be honest errors and various manifestations of carelessness, including poor record-keeping, or errors in the reading or calculation of data. At the other end of the spectrum would be scientific misconduct and fraud. UNSW has provisions for dealing with a range of possible forms of misconduct (see guide St. George Handbook p.32).

The NH & MRC Statement, and the closely related AVCC document on ‘Guidelines on Responsible Practices in Research’, aim to ensure a research environment that minimises the incidence of misconduct in research. It is inevitable, however, that there will be some allegations of misconduct. It is essential that procedures for dealing with such allegations should be in place before the event.

Definitions:

"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 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 judgements of data.

Protection of interested parties

Allegations of research misconduct require very careful handling. When an allegation is made, the protection of all interested parties is essential.

Interested parties may include:

Adequate protection of the complainant and the accused demands absolute confidentiality and reasonable speed in the early stages of investigation. On the other hand, the protection of other parties may involve some disclosure. Such judgements should be made by the Head of Department.

4.1 The Receipt of Complaints

Allegations of misconduct in research may originate inside the institution, from other institutions, in learned journals or in the press. Allegations from outside the institution should be dealt with directly by the Head of Department. Inside the institution, allegations may come from other members of staff or from research students. The latter may feel themselves to be in a difficult situation because their degree and their future career can depend on interaction with a supervisor.

1. Advisers on Integrity in Research

The task of the adviser, Professor, is to give confidential advice about what constitutes misconduct in research, the rights and responsibilities of a potential complainant, and the procedures for dealing with allegations or research misconduct within the institution.

2. Designated People to Receive Formal Complaint

Allegations should be made to: Professor Carolyn Geczy or Dr Nick Hawkins. The Head of Department should be informed immediately a complaint is received and be kept informed as the case progresses.

The designated persons should consider the material provided by the complainant and should decide whether the allegation should be dismissed or investigated further. If a preliminary investigation is to proceed, it must be authorised by the Head of Department.

4.2 The Preliminary Investigation

If there is the possibility of a charge of misconduct, the Head of Department must organise a preliminary investigation and then take action in accordance with the provisions of subclause 9(c) of the Australian Universities Academic Staff (Conditions of Employment) Award 1988.

Action with staff member/student concerned

1. As good practice, if there is to be a preliminary investigation of the allegation under subclause 9(c) of the Award, the staff member concerned should be informed in writing and given an opportunity to respond in writing. The name of the complainant should not be released.
2. The Head of Department may require the student/member to produce experimental data files or other material to be kept secure, but not disclosed during the preliminary investigation.

Form of the investigation:

The form of the preliminary investigation will depend on the case and must be decided by the Head of Department who has the power to conduct the preliminary investigation in person, if appropriate. In some cases, there will need to be a small committee from inside the Institution, from areas not affected by the research in question. In extreme cases, it may be necessary to seek expert help from outside the institution.

The preliminary investigation should be limited to determining whether a sufficient case exists for formal charges of misconduct to be laid.

PUBLICATION PROCEDURES

Refer to appropriate section of guidelines in UNSW Student Guide.

An important goal of research is to publish the findings in a reputable journal, or patent any findings which can be commercially exploited. Discuss the authorship of publications with your supervisors. As your supervisor has usually initiated the project on which you are working and has an ongoing role in overseeing the project, it should be the accepted practice to include your supervisor's name, as with that of any other colleague who has significantly contributed to the research, on all publications. No work should be submitted for publication without the consent of your supervisor. Where the work being reported is primarily your thesis work, it is expected that you would be the first author. If any outcome of the research is likely to be patented you should discuss your involvement with your supervisor and keep a record of the outcome of this discussion.

Your obligations as a person* accredited to the Department regarding rules pertaining to publication of data.

* A person accredited to the Department includes, Undergraduate and Postgraduate Research personnel employed, affiliated with or registered for any degree with the Department.

These rules are intended to provide procedures which are simple and reasonable to comply with and to provide a reasonable degree of protection for the Department against charges of scientific fraud. It is appreciated that it is extraordinarily difficult to detect deliberate acts by a clever person determined to perpetrate scientific fraud, nevertheless the University, Faculty, and the NH&MRC expects all Schools and Departments to have a reasonable and appropriate set of procedures in place.

AUTHORSHIP

In essence our Rules require that before any final manuscript is submitted for publication:

1) The Senior Author shall invite a Full Time or Conjoint Member of Staff of the Department of Pathology to act as Reviewer. The Reviewer may not be a person who is either an author, co-author or a collaborator cited or acknowledged in the paper.

2) The Senior Author, shall fill in Part A of the Department Document entitled Scientific Ethics Committee-Department of Pathology : Manuscript Pre-submission Review Form (available from your supervisor) and submit it with the manuscript to the nominated Reviewer

3) It is expected that the Reviewer shall normally complete his/her review of the paper, according to the requirements included in Part A of the Review Form within one week of receipt and to forward the completed Parts A and B of the Review Form together with the manuscript to the Secretary, Department of Pathology. The Reviewer is required to satisfy him/herself that the experiments etc. were done and that data presented corresponds to the records in the lab. books etc. An attempt should be made to assess the validity of interpretation: this is the responsibility of an editor or editorial panel.

4) The Review Form, together with the copy of the paper, will then be filled as a permanent record in the Department.

5) A copy of the approved Review Form will be returned to the Senior Author The paper may thereafter be submitted to the appropriate Journal etc., enclosing for the benefit of the Editor a copy of the aproved Review Form (optional), provided that no significant modification of the paper has been made since review.

6) In the event that significant data modifications are made or that significant editorial modifications are required by the Journal, the revised final manuscript should be re-submitted to the original reviewer. If for any reason, this should not be possible or reasonable, then a "new reviewer" is advised as to why the original reviewer is unable to serve.

Any Author/Co-Author who is concerned that the Reviewer has not carried out the allocated duties in a fair and impartial manner has the right to appeal to the Head of Department or Acting Head, according to the circumstances with prevail.

In signing the UNSW (Research 1993) statement of authorship and location of data sheet, authors undertake to take administrative responsibility for the paper, certifying that the manuscript, accompanied by appropriate Figures, Tables & Illustrations is submitted in the sincere belief:

a) that the data is original and genuine, and based on results obtained from legitimate research.

b) that the material from which the data was obtained is available for review and has not been modified in any fashion which might alter its content or validity.

c) that those persons who have significantly contributed to the conceptual development, procurement of data or interpretation of data have been appropriately included in the list of authors or in the acknowledgements.

d) that appropriate valid Registrations for Human/Animal Ethics, consistent with the period over which the studies were undertaken are available for review.

e) that for purposes of access for review, all relevant records/data on which this paper was based must be retained or access provided for a minimum period of 5 years or deposit same with the Head of Department. Where material is obtained from limited access data bases or from contracted projects, if required, details of the location of original data or key information on the limited access data base must be guaranteed.

f) the data reported must not be used in part or in toto for multiple papers without cross referencing.

g) that any source of conflict of interest by affiliation, financial involvement, or overt/potential benefit in kind, involved between the author and or co-authors with any organisation or entity with a direct interest with the subject matter of this paper, has been fairly and accurately disclosed. The author must guarantee to convey details to the Editor of the Journal to which the paper is addressed.

Publications Acknowledgement Form

I/we the co-author(s) of the above paper, acknowledge by my/our appended signatures (below) that I/we acknowledge and comply with the requirements delineated for co-authorship by NH&MRC/AVCC and assign administrative responsibilities for processing the paper to ________________________________________.

In the circumstance in which one or more author(s) is/are unable to sign, then an explanatory note from the Head of School/Department/Unit should be appended (in the space provided below).

Name (block) Date

Nominated administrative author:________________________________________________