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Wednesday, July 16, 2008

Transparency for HRECs in the public interest

Although not of a binding nature, a decision by the Acting Information Commissioner in Western Australia, that documents about the consideration of an application to the Human Research Ethics Committee at Curtin University of Technology were not exempt under the Freedom of Information Act, should make for lively discussion at universities and other organisations around the country where such committees consider research proposals.

The Acting Commissioner decided that the submission to the Committee, including supporting documents about the conduct of research, documents containing comments on the proposal by Committee members (other than a small amount of personal information) and information about funding from partners should all be disclosed.

The case concerned documents about a ongoing research program into Attention Deficit Hyperactivity Disorder(ADHD) and a comparison ofthe effects of stimulant medication (Dexamphetamine or Ritalin) with the new nonstimulant medication, Strattera, on cognitive, educational and social outcomes in boys and girls, diagnosed with ADHD.” The University gave the applicant access to 18 of the 42 relevant documents, but refused access to the rest on the grounds that they were all exempt under one or more of clauses 4(3) (commercial or business information); 6 (deliberative processes); 8(2) (confidential communications); and 11(1) (effective operation of agencies) of Schedule 1 to the FOI Act.

The Acting Commissioner's decision was based on a number of considerations and conclusions including that some information claimed exempt was already in the public domain, and that the assertions of the University in some instances about the need for confidentiality was "unsupported speculation and conjecture". In considering the familiar argument about the need for frank advice, he said:
"By way of example, if I were to accept the agency’s assertion that members of the HREC must be free to act “ a full and frank manner” when considering research proposals, that would mean that I accept as reasonable the agency’s claim that professional academic members of the agency, and other like agencies, will only make honest, and sometimes adverse comments and criticisms about research proposals submitted to the HREC for ethical approval if they can do so behind the cloak of confidentiality. In my view, such a claim is inconsistent with the ethical standards expected of professionals in the academic world and elsewhere and, as with all of the other claims made by the agency, it is not supported by credible evidence. The agency’s views do not, in my view, establish that disclosure of the disputed documents would, on balance, be contrary to the public interest. In effect, the agency has given those statements as a basis for claiming that because of the inherent “checks and balances” in the HREC ethical approval processes the public generally and the complainant in particular, should take the agency’s word that the proper processes have been followed and that it should not be subject to further scrutiny and be held further accountable by disclosure under the FOI Act."[86-87]
The Acting Commisioner said the response to the application was
"inconsistent with the objects and intent of the FOI Act. Little weight was given, both at the initial decision stage and the internal review stage, by the agency to promoting the purposes and objects of the FOI Act. The reasons given by the agency for refusing access to the disputed documents are not, in my opinion, enough to justify refusing further access....The FOI Act is intended to enable the public to participate more effectively in governing the State and to make the persons and bodies that are responsible for State and local government more accountable to the public."[92]
The nature of the research was also an important factor in weighing public interest considerations:
"There is a strong public interest in agencies being accountable for their decision-making and in the public having access to information about university research projects, particularly where, as here, the Project involves academic research involving the medication of children with drugs. I agree with the complainant’s submission that obtaining information about research of the kind being undertaken in relation to the Project is a strong public interest factor in favour of the public being able to scrutinise the approval given by the HREC of the agency and make its own judgment as to whether the HREC is discharging its functions properly. I also consider that disclosure of the disputed documents would serve the public interest in keeping the community informed and in promoting the discussion of matters of the kind relating to research about research that may improve the educational and personal outcomes of children diagnosed as suffering from ADHD."[94]

The Acting Commissioner acknowledged a "public interest in ensuring that the community has confidence that universities have integrity and ethical standards in relation to their research and that the HREC must be free to act in a full and frank manner when considering research proposals. I accept the agency’s advice that it has stringent internal and external reporting requirements and that research processes are closely monitored and sub-standard research practices are not tolerated. In my view, stringent internal and external reporting requirements as described by the agency are both necessary and appropriate but I would expect that to be the case in any event."
"However, the fact that such processes exist at the agency does not mean that individuals such as the complainant should be denied access to the same documents, in an effort to satisfy themselves that such internal and external reporting requirements are appropriate and being adhered to. An assertion that the complainant and the public at large should “take the agency’s word for it” that all the necessary checks and balances are being adhered to is not sufficient to persuade me that the public interest is best served by non-disclosure."[96].

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