The Notes for Contributors to the Journal of Orthodontics informs authors that articles involving clinical research should conform to the guidelines issued in the Declaration of Helsinki where applicable, and must have received ethical committee approval.
Several papers have recently been submitted to the Journal of Orthodontics which have not (apparently) gone through the ethical approval process and/or gained informed consent. Unfortunately these papers have had to be returned to authors with a request that evidence of ethical approval be submitted (i.e. a letter of confirmation from an appropriate ethics committee) if the paper is even to be considered for review. Alternatively, if authors consider ethical approval is not required then the Journal would require evidence of this too — once again, a letter of confirmation from an appropriate ethics approval committee.
This editorial is intended to highlight what is potentially an increasing problem and advises authors against such inappropriate submissions. Despite the ethical approval process becoming increasingly stringent and laborious (see Editorial J. Orthod. 2004 31: 167–168) nevertheless, it is essential that we not lose sight of the fact that a major purpose of the ethical review process is to provide an independent view of whether research we intend to undertake is indeed ethical or not. Authors are always likely to be at a disadvantage in determining this for themselves in relation to their own work as they are likely to be biased — hence the need for ethical approval.
This is not simply a matter for the UK. International agreements exist (notably the Declaration of Helsinki) to protect research subjects, no matter where in the world they live or whether they are in private, hospital or government practice. See for example:
http://www.corec.org.uk/applicants/help/guidance.htm#gcp then click World Medical Association Declaration of Helsinki). Furthermore, other major national and international bodies such as the Committee of Publication Ethics (COPE, http://www.publicationethics.org.uk/cope1999/gpp/gpp_study.phtmland and the World Association of Medical Editors (WAME): Recommendations on Publication Ethics Policies for Medical Journals (http://www.wame.org/pubethicrecom.htm#study) all make clear what types of research require ethical approval.
Authors should also bear in mind Paragraph 27 of the Declaration of Helsinki which states: ‘Both authors and publishers have ethical obligations………Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication.’
So, please be aware: don’t waste your time — authors must ensure that they seek and obtain appropriate ethical approval and gain informed consent. For studies involving people, medical records, and/or human tissues (now including teeth) — it is most unlikely that ethical approval was not or will not be needed.
Friedy Luther, Editor in Chief
Some other useful websites: http://www.corec.org.uk/ Central Office for Research Ethics Committees (COREC). http://www.corec.org.uk/recs/guidance/guidance.htm #audit For help distinguishing audit from research.
http://www.corec.org.uk/applicants/help/faqs.htm For advice including types of research that require ethical approval.
The Medical Research Council’s website has many helpful links including advice regarding the use of human tissues (see ethics series):
http://www.mrc.ac.uk/index/publications/publications-ethics_and_best_practice.htm.