“The [DHS] has sent you this letter because its records show that you may have been prescribed lithium at some time in the last five years,” the letter read. Recipients were invited to complete an online questionnaire and, if eligible, supply a saliva sample from which the researchers would extract DNA. The project could potentially be crucial for bipolar treatment and is reminiscent of the world-first study published last week in which an international team of researchers - including QIMR investigators - identified a number of genes linked to anorexia. Scientia Professor Gordon Parker Credit:UNSW But the anorexia study's call for participants relied on a news and social media campaign.

Professor Parker said he was “gobsmacked and seriously concerned” by the recruitment method, which raised serious ethical questions. “I had no idea [the DHS] kept such a database on people dispensed lithium, and I suspect many don’t know Medicare is holding this private, identifying data,” he said. Fellow psychiatrist Professor Philip Boyce at the University of Sydney was also contacted by a handful of upset patients who mistakenly believed he had disclosed their private information without permission. The letter stated in bold text that the DHS had not provided any identifying information about recipients to the researchers, and their information was protected by privacy and health legislation. But several patients expressed anger at receiving a letter linking them to lithium and - by proxy - a psychiatric disorder they had not disclosed to anyone but their psychiatrist, GP and close family, Professor Boyce said.

Others were concerned that a housemate or their new partner could have opened the letter by mistake. “For someone with a severe mental illness, it’s not exactly comforting to receive a letter like this,” Professor Boyce said. "It’s a fairly bold approach." Maurice Blackburn medical negligence lawyer Tom Ballantyne said the case showed there should be greater clarity about what information is stored by government agencies and whether such recruitment methods are appropriate. "Just because it's legal doesn't mean it's appropriate," he said. “You can imagine that getting a letter like this could be quite confronting, and you would be very sympathetic to them,” he said, particularly in the context of recent health information data breaches, and the concerns around My Health Record.

Mr Ballantyne said the case highlighted a need for more rigorous informed consent and greater transparency from the government about the rules governing how health data is stored and used. “But this would all need to be weighed against the really important potential benefits that can come from this type of research," he said. The study’s lead researcher Professor Sarah Medland deeply apologised to recipients who were upset or uncomfortable about receiving the letter. “We did not intend for there to be any upset or concern,” Professor Medland said. “The aim of the study is to try and improve our knowledge of bipolar and find better ways that people can navigate the treatment journey. “We were aiming to ensure our sample was as representative as possible so the results were meaningful to the largest number of people.”

The research team aimed to recruit 5000 people. Approximately 6000 people had consented to take part, and 4500 had participated, Professor Medland said. Roughly 1000 people had called the research team, asking whether the investigators had their details, more information about the study and eligibility criteria or to request paper copies of the questionnaire to avoid submitting online. Many participants had also thanked the researchers for the opportunity to participate, Professor Medland said. She said the mail-out was likely crucial. Bipolar affects both men and women evenly, but a media recruitment campaign had largely attracted young female respondents in capital cities. It was only after the mail-out that the project received more responses from males, and individuals in regional areas.