Page 169 - Academic and Research Book_WEB

4. The final protocol should form part of the research record.

5. The precise roles of the contributors and collaborators, and matters of authorship and
publication, should be agreed upon at the earliest.

6. Statistical issues should be considered early in study design, including power calculations, to
ensure that there are neither too few nor too many participants.

7. Formal and documented ethical approval from an appropriately constituted research ethics
committee is required for all studies involving people, medical records, and anonymized human
tissues.

8. Using human tissues in research has to conform to the highest ethical standards, such as those
recommended by the Nuffield Council on Bioethics.

9. Always seek fully-informed consent. It may not always be possible, however, and in such
circumstances, an appropriately constituted research ethics committee must decide if this form
of research is ethically acceptable. [please confirm, instead of saying ‘this’]

10. When participants are unable to give fully-informed consent, research should follow
international guidelines, such as those of the Council for International Organizations of Medical
Sciences (CIOMS).
11. Experiments with animals require full compliance with local, national, ethical, and regulatory
principles, and local licensing arrangements. International standards vary.

12. Formal supervision, usually the responsibility of the principal investigator, is essential for all
research projects: this must include quality control, and the frequent review and long-term
retention (may be up to 15 years) of all records and primary outputs.

Data Analysis

Definition

Data must be appropriately analysed, but inappropriate analysis does not necessarily amount to
misconduct. Fabrication and falsification of data do constitute misconduct.

Action

1. All sources and methods used to obtain and analyse data, including any electronic pre-
processing, must be fully disclosed; detailed explanations should be provided for any exclusions.

2. Methods of analysis must be explained in detail, and referenced, if they are not in common use.
3. The post-hoc analysis of subgroups is acceptable, but it must be disclosed. Failure to disclose that
the analysis was post-hoc is not acceptable.
4. The discussion section of a paper should mention any issues of bias which have been considered
and explain how they have been dealt with in the design and interpretation of the study.

Authorship

Definition

There is no universally agreed definition of authorship, although attempts have been made (see
Appendix). As a minimum, authors have to take responsibility for a particular section of the study.

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