-Introduction
-Supervision of reserach trainees
-Data gathering, storage, and retention
-Study design
-Authorship

Introduction

These recommendations are not intended as rules but rather as guidelines from which each group of investigators can formulate its own set of specific procedures to ensure the quality and integrity of its research.

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Supervision of Research Trainees

Careful supervision of new investigators by a senior investigator is in the best interest of the institution and the new investigator. The complexity of scientific methods, the necessity for caution in interpreting possibly ambiguous data, and the need for advanced statistical analysis, require an active role for the senior investigator in the guidance of new investigators.

It is recommended that new investigators should be supervised. The senior investigator should supervise the design of experiments and the processes of acquiring, recording, examining, interpreting, and storing data. (A senior investigator who limits his/her role to the editing of manuscripts does not provide adequate supervision.)

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Data Gathering, Storage and Retention

A common denominator in most cases of alleged scientific misconduct has been the absence of a complete set of verifiable data. The retention of accurately recorded and retrievable results is of utmost importance for the progress of scientific inquiry. A scientist must have access to his/her original results in order to respond to questions including, but not limited to, those that may arise with any implication of impropriety. Moreover, errors may be mistaken for misconduct when the primary experimental results are unavailable.

Complete and accurate data are an essential part of the record of any clinical research. Since serious problems can occur when data are missing or are not consistent with source medical records, each study should include a plan for the keeping of accurate and well documented data not subject to loss through computer failure or insecure storage.

For research involving primary data collection, the principal investigator should retain original data for as long as practically possible, but never for less than five years from the first major publication or from the completion of an unpublished study. The data should be made available to the Research or Ethics Committee when the need arises. All data should be kept in the Institution of Mental Health & Woodbridge Hospital in which they are gathered at all times and should be preserved as long as there is any reasonable need to refer to them. In no instance, however, should primary data be destroyed while investigators, colleagues, or readers of published results may raise questions answerable only by reference to such data.

After notification to Research Committee, the principal investigators may make copies of original data for personal use or when moving to another research unit or institution.

If primary data are kept on a computer file, backup files should be maintained, preferably at a second site, to prevent loss from computer failure.

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Study Design

Every prospective or retrospective clinical study should have a written protocol or research plan that states the goals of the study, provides a background and rationale for the study, specifies the criteria for inclusion or exclusion of cases, outlines the methods and timing of follow-up, gives a precise definition of the types of anticipated outcome measures, and gives the details of the statistical design. The study design should minimize the possibility for investigator bias in the interpretation of the results. In the case of prospective trials, the protocol should describe in detail how patients are to be treated or managed.

In randomized clinical trials, the sequence of treatment assignments should be prepared by a statistician or other experienced investigator associated with the trial and kept confidential. In no instance should the investigator treating patients on the trial know the sequence of potential treatment assignments.

Every prospective clinical study should contain an Informed Consent form that explains in clear, non-technical terms the possible risks and benefits for subjects participating in the trial.

Ethical and legal considerations require careful attention to the protection of a patient's anonymity in case reports and elsewhere. Identifying information such as names, initials, hospital numbers, and dates must be avoided. Also, authors should disguise identifying information when discussing patients' characteristics and personal history.

Investigators participating in clinical trials are urged not to sign agreements with pharmaceutical companies that have clauses which prevent them from publishing both positive and negative results or from collaborating with other investigators to pool data across sites in multi-center trials. Additionally, investigators are urged not to sign agreements that forbid them from publishing without the approval of the sponsor.

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Authorship

Clinical studies often involve investigators from several subspecialties, and it may not always be possible for a single investigator to confirm each piece of data used in the report of a trial. While each participating investigator must be actively involved in verifying the sections of a manuscript that discuss his/her specialty area, there must nevertheless be a primary author who is responsible for the validity of the entire manuscript.

All persons designated as authors should qualify for authorship. Each author should have participated sufficiently in the work to take public responsibility for the content.

Authorship credit should be based on substantial contributions to 1) conception and design or analysis and interpretation of data, and 2) drafting the article or revising it critically for important intellectual content, and on 3) final approval of the version to be published. Conditions 1, 2, and 3 must all be met. Participation solely in the acquisition of funding or the collection of data does not justify authorship. General supervision of the research group is also not sufficient.

Only those with key responsibility for the material in the article should be listed as authors; others contributing to the work should be recognized in an Acknowledgement.

The concept of "honorary authorship" is deplorable.

All forms of support, including drug company support, must be acknowledged.

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