In 2004, the study (SHOAMP) collected blood serum samples from F-111 aircraft maintenance personnel and control groups who were study participants. Many, but not all, participants gave consent* for their blood serum samples to be stored beyond the period of the study and used for research (as detailed to study participants at the time).
In 2005, a Serum Management Committee was established to manage the long term storage of, and access to, the blood samples collected. This Committee advises and makes recommendations to the Repatriation Commission on the merits of any future research applications seeking to access the serum samples. The Committee is chaired by the Repatriation Commissioner.
* It is important to note that any future proposed research that was not part of the initial research requires further consent from each participant.
Throughout 2010 the SMC has been active in ensuring that management and oversight of the blood serum samples is placed on a sound footing. The Committee’s Terms of Reference, Governance rules and contractual arrangements have been reviewed, and periodic reporting to key stakeholders has been introduced. Specific Committee activities include:
Managing storage of serum samples: Approximately 1000 SHOAMP participants donated blood. Their blood is stored at QML Pathology, Brisbane, in the following forms:
- Blood serum samples;
- B cell Lymphoblast (BCL) specimens (cell lines);
- Peripheral Blood Mononuclear Cells (PBMC) specimens (cell lines);
- Guthrie cards – a drop of blood on a piece of card.
There are 6000 samples, and just under 1000 Guthrie cards, stored at QML Pathology. The 6000 samples include one duplicate sample for each participant. The number of stored samples has not changed since the 2004 study. A key is used to link the samples to the donors – that is, the samples are not labelled with the participant’s name, for privacy reasons.
Inspection of samples: The last inspection of the samples found that the storage arrangements met all contractual requirements and relevant “industrial” standards, to ensure safe and secure storage of the serum samples and Guthrie cards.
Purchase of Freezers: As an added safeguard, the Committee has determined that the duplicate samples and cell lines will be stored in separate containers. To this end, DVA has purchased two freezers that:
- Operate at minus 80 degree Celsius chest freezers;
- Have capacity to hold 2,000 blood serum samples i.e. effective internal capacity of between 80-100 litres;
- Have keyed locks on doors; visual and audible alarms which indicates high/low temperature conditions, power failure and fault conditions; battery back-up for alarms and temperature displays; and Voltage - Standard 240V.
Destruction of Samples: There has been no destruction of SHOAMP serum samples and no requests from study participants to have their samples destroyed.
Access to Samples: To date there have been no research or other requests to access the SHOAMP blood serum samples.
The SHOAMP Serum Management Committee (the Committee) is responsible to the Repatriation Commission in terms of its operational activities.
The Committee provides annual reporting to the Commission, Chief of Air Force and nominated representatives of the veteran community (including the Returned and Services League Australia (RSL), RAAF Association, Defence Force Welfare Association (DFWA) and SHOAMP participants) on the continued storage of the samples.
The Committee or a representative nominated by the Committee undertakes annual on-site inspection of the samples.
The Committee evaluates the merits of continued retention of the samples and makes recommendations to the Repatriation Commission on the advisability of continued storage. (If it is decided not to retain the samples, the samples will be destroyed according to the Standard Operating Procedures for destruction of blood samples, as approved by the Serum Management Committee).
The Committee ensures that all research proposals have in-principle approval from the DVA Human Research Ethics Committee (HREC) and other relevant Ethics Committees. The Committee will, if required, seek expert opinion on the merit of any research proposals seeking access to the samples. The Committee advises and make recommendations to the Repatriation Commission on the merits of future research applications seeking access to individual or pooled samples.
The Committee meets at least every two years, and as necessary, to consider research applications and/or other issues, either face to face or by electronic means. The Committee Secretariat reports via e-mail to Committee members at least every six months.
The Committee members are representatives of the Department of Veterans’ Affairs, Australian Defence Force, and the veteran community. The Committee also comprises an Ethicist. The Committee monitors management of the long-term storage of blood samples to ensure that the storage contractor meets its contractual obligations.
The contractors who conducted the 2004 Study for which the samples were collected, and the contractor responsible for the storage and safe keeping of the samples, act as “observers” on the Committee. Observers participate in all Committee meetings but have no input into any recommendations made by the Committee related to future research proposals.
The Committee abides by the National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research (2007) and complies with the Information Privacy Principles.
The Committee will consult with DVA’s Human Research Ethics Committee prior to the destruction of any samples belonging to deceased donors.
The Committee is responsible for ensuring that research proposal applicants are advised of any decision related to the proposal.
The Committee maintains detailed records pertaining to the request for use of the samples.
The Committee ensures that an appropriate mechanism is established to handle complaints related to storage, Committee operation or any new research proposals.
- Major General Mark Kelly AO (Chair)
- Wing Commander Ron Usher (Retd)
- Wing Commander Lance Halvorson (Retd)
- Mr Geoff Curl
SHOAMP Deseal/Reseal Support Group
- Dr Malcolm Parker
University of Queensland
- Dr Victoria Ross
Department of Defence
- Dr Graeme Killer
- Dr Warren Harrex
- Ms Peta Stevenson
- Professor Cate D’Este
University of Newcastle, Observer
- Professor John Attia
University of Newcastle, Observer
- Mr John McKechnie
QML Pathology, Observer
To contact the SHOAMP Serum Management Committee Secretariat please email research [at] dva.gov.au or phone (02) 6289 6236.