Ethical considerations

This trial involved measuring and teaching yoga to a medically compromised group of women ie those with lymphoedema from breast cancer treatment. Before commencing the current trial, approval was obtained from the University of Tasmania Social Sciences Human Research Ethics Committee (HREC) (H0011534), which required yearly progress reports and prompt notification of any adverse events. The trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12611000202965,

http://www.anzctr.org.au/default.aspx). The trial was conducted in accordance with the values and principles of the National Health & Medical Research Council National Statement on Ethical Conduct in Human Research (2007) by following the guidelines for fairness and equity, gaining informed consent, freedom from coercion, risk and harm minimisation, beneficence and confidentiality. The researchers declared no conflict of interest and no financial interest in the trial. The entire trial was carried out with integrity and respect for the participants and sensitivity for their welfare, following legal and ethical requirements (National Health and Medical Research Council & Australian Vice Chancellors' Committee, 2007). All assessors were also trained in these requirements before the trial commenced.

Participants were recruited according to a fair and equitable process (full details are given in section 3.2.4). Informed consent and freedom from coercion were carefully

considered by giving clear information in written and oral form (full details are given in 3.2.5). All potential participants were given a detailed information sheet outlining the purpose, methods, dates, possible benefits, and strategies for the minimisation and management of risk and harm – Appendix A. Written in clear, plain English, this sheet allowed potential participants to fully understand the level of commitment required and to make an informed decision whether to participate or not. (One participant, who had low literacy skills, was given a special session explaining the details in full after her baseline measurements). The voluntary nature of participation was emphasised, the individual’s right to decline without giving a reason respected. It was also clearly stated that, should a participant decide to withdraw from the trial at any time, she would be free to do so without consequences and without the need to provide an explanation. Subsequent communications with the actual participants were also in plain language and gave them the opportunity to seek further information and clarification from the principal investigator.

The thoracic spine mobility tests necessitated the placement of nine translucent markers on the skin of the participant’s back. It was felt that this might be invasive for some women

who had been treated for breast cancer and participation in this particular series of measurements was totally optional.

Measures for risk and harm minimisation were followed (National Health and Medical Research Council & Australian Vice Chancellors' Committee, 2007). All participants received an information manual, specifically developed for this trial, on the best current practice for the management of secondary lymphoedema, based on the guidelines of the Australasian Lymphology Association (2009) and the Lymphoedema Framework (2006). Risks of

lymphoedema exacerbation were managed by following the guidelines set out by the National Lymphedema Network in its Position Statement on Risk Reduction Practices (2011). The participants were advised to continue with their usual treatment plan during the trial and to seek medical help in the case of an infection or a flare-up of lymphoedema. Participants were further advised that, should infection or flare-up occur, they could continue in the trial if they chose to but that their measurements would not be included in the results, as it would change their status with regard to the eligibility criteria.

Further, at baseline, medical information for each individual was collected so that appropriate modification could be made during the measurement sessions or in the yoga classes. Participants were also encouraged to raise concerns at the measurement sessions. Time was made available at every class for the discussion of any medical concerns resulting from the yoga. In addition, participants were advised that they could talk with a local breast care nurse or the Executive Officer of the UTAS Ethics Committee. Full contact details were provided.

The principles of beneficence (do good not harm) (National Health and Medical Research Council & Australian Vice Chancellors' Committee, 2007), were followed diligently in this trial, as this is the underlying philosophy of yoga. The medical information was collected to ensure each individual’s medical conditions could be addressed. Further, baseline

questionnaires were sent pre-baseline measurement so that women could fill them in at their leisure, as they were long. To ensure women were not fatigued during the measurement sessions, refreshments were available, and magazines were provided for women to read in a comfortable seat while waiting their turn. At measurement sessions, extra staff ensured any problems could be addressed immediately. All women were escorted to and from their cars during both the yoga and the measurement sessions. Occupational Health and Safety Guidelines from UTAS were adhered to; for example, the floor was kept clear of obstacles, all equipment was hygienically cleaned between measurements and space was provided for bags, coats etc. UTAS insurance, which covered public indemnity and medical negligence, was sent to the venues where measurements and yoga were held. Participants were also offered a debriefing session at the completion of the trial.

Anonymity and confidentiality were ensured in this trial. Participants were assured that all personal information they provided (in questionnaires, interviews, logbooks and from the measurements) would be held in strict confidence and nothing disclosed without their permission. Access to this data would be restricted to the principal investigator. Participants’ names would be coded in such a way that no individual would be identifiable from the information given. Anonymity was also pledged in any presentations or publications arising from the trial. No names or photos would be used without the permission of the participant(s).

During the period of the trial, paper-based data was stored in a locked filing cabinet in the Department of Rural Health’s CML building in Hobart and other information for analysis kept on a password-protected computer. On completion of the trial, data will be securely stored for five years then destroyed, as required by the UTAS Ethics Committee.