Page 36 - Recommendations-for-biostatisticians-in-managing-and-conducting-medical-research-consultations

7.1 Collaboration and co-authorship

It is sometimes possible for a research client to invite the biostatistician to become part of
the study group and to be a co-author of the work. It is up to the biostatistician to reject or
accept the offer after considering many factors especially his/her work commitments and
his/her abilities to fulfil the requirements of a co-author. If the biostatistician accepts the
offer, then it is first necessary to ensure that all the investigators in the study group have
been informed and a consensus has been reached by the whole study group, especially the
principal investigator. If the study is being conducted for a Postgraduate Master’s or
Doctorate’s degree program, then the supervisor will also need to be informed and he/she
will also have to agree with such an arrangement. This agreement can be sought by sending
a formal or an informal invitation letter, either in a hard copy or via email to the
biostatistician. This to avoid any future conflicts pertaining to authorship matters, once the
paper is ready for submission to a journal for publication.

Secondly, the author wishes to emphasize the importance of adhering to the guideline
for authorship, which is set by the ICMJE, a reputable working group which is recognized
internationally. The ICMJE is a small working group of self-funded general medical journal
editors and representatives of selected related organizations working together to improve
the quality of medical science and its reporting, by meeting annually to refine their criteria
and requirements for reporting and publishing medical science and research. To qualify as
an author, the ICMJE sets 4 criteria, namely:
-Substantial contributions to the conception or design of the work; or the
acquisition, analysis, or interpretation of data for the work; AND
-Drafting the work or revising it critically for important intellectual content; AND
-Final approval of the version to be published; AND
-Agreement to be accountable for all aspects of the work in ensuring that questions
related to the accuracy or integrity of any part of the work are appropriately
investigated and resolved.

In other words, a biostatistician will need to comply with all the four criteria in order to
qualify for authorship. This means that in order for a biostatistician to be granted
authorship, it will be necessary to expand the role of the biostatistician beyond that of a
research consultant. Based on the first criterion (a) for authorship set by ICMJE, a
biostatistician is able to fulfil this criterion by providing series of biostatistical consultation
to the research client or the study group. In addition, the biostatistician will most probably
also be involved in the statistical analysis(es). To fulfil the second criterion (b) for
authorship set by ICMJE, a biostatistician will need to write at least part of the section on
research methodology (especially the section pertaining to statistical analysis and/or
sample size calculation) and also on the section pertaining to interpretation of data after
performing statistical analysis.