MELBOURNE HIV patients were denied access to a potential treatment unless they allowed their doctors to harvest extra genetic material from them for future research.
Documents obtained by Fairfax Media show patients at The Alfred hospital were excluded from a 2009 clinical trial if they did not consent to the unusual, and, according to some critics, unethical, demand from their treating doctors to give extra blood and urine for research.
The study - which involved HIV patients whose immune systems were not responding to traditional antiretroviral medications - offered access to a new drug that was not available anywhere else and which was being promoted to them in documents as a ''treatment''. Those who took part had to agree to end the treatment they were on.
An Alfred hospital patient information and consent form, dated February 23, 2009, states: ''If you do not agree to having blood taken for future research relating to the treatment of HIV you will not be able to participate in this study.''
The document states that about 108 millilitres of a patient's blood would be stored and that it would be up to The Alfred hospital's ethics committee ''to determine, whether, or not, your consent should be obtained at that time for a particular research project''.
Other Alfred patient consent forms for similar research work do not have this stipulation and carry a contrary disclaimer stating that the hospital's human research ethics committee would seek consent before using any remaining blood from studies.
Documents lodged by the researchers with the Australian government's register of clinical trials did not include the stipulation that patients could only participate if they agreed to provide extra blood samples in the section that details the criteria upon which subjects were excluded from the study.
Leading medical ethicist, the Australian National University's Thomas Faunce, said great care had to be taken with vulnerable subject groups, such as HIV patients.
He said the requirement that the new drug could only be accessed by agreeing to provide extra blood for future research created ''pressure points and potential conflicts of interest''.
''This is the sort of situation an ethics committee needs to be very protective of the subjects,'' Professor Faunce said.
Well-placed medical sources aware of the HIV trial were also critical that access to a potential new treatment was made conditional on the provision of extra blood.
''At the time of the trial the drug [Merck's Raltegravir] was licensed for trial use only, so was not available for prescription,'' a source said.
''The only way to have a chance at improving your health was to sign up for the trial. But patients who were experiencing poor HIV recovery were prevented by the doctors from accessing the drug unless they would contribute extra blood for the doctors to use for their own research projects.''
A spokesman for the Alfred said the HIV study was part of a multi-site trial led by the National Centre in HIV Epidemiology and Clinical Research at the University of New South Wales, now known as the Kirby Institute.
He said the original ethics approval was granted by St Vincent's Hospital Human Research Ethics Committee in October 2008. It was later approved by the Alfred's ethics committee.
''As a multi-site trial, the study protocol implemented at The Alfred was identical to the other 19 sites in Australia. Storage of specimens for future use for this study and other studies related to the treatment of HIV was a requirement of the study steering committee,'' the spokesman said.
''The Alfred's ethics office asked the researchers to clarify the relationship between enrolment in the study and storage of blood samples for future research by making it explicit on the local consent form.''
The patient consent form for the HIV project states that neither Merck nor Andis, a company that provided colostrum products for the research, ''is making any financial contribution to the trial or to the investigators''.
However, the HIV research was funded by the National Centre in HIV Epidemiology and Clinical Research. This organisation received a $636,808 donation from Merck Sharp and Dohme in 2008, the year the HIV project was funded.