[Peetwo]

The quiet, but persistent beating of distant drums.  The Mandarin is a superb publication which just as quietly and persistently keeps presenting top quality reporting of important matters.  I don’t even begin to understand ‘politics’ and apart from the antics of our ‘aviation agencies’ have little interest in the machinations of the governmental departments; but reading the Mandarin is becoming a habit.  It simply gives you a clear window into the ‘the way things are’. 

Anyway, FWIW I thought it worth it’s own thread.

For example – HERE.  Now to my simple mind, this is a warning of clear and present danger for the ASA.

Federal agencies are still falling short of full compliance with a Senate Standing Order introduced in 2001 to improve the public transparency of government contracting, according to the auditor general Grant Hehir.

The order requires ministers to table lists of all significant contracts and agreements in their respective portfolio areas, highlighting those that contain confidentiality clauses of any sort and outlining the justifications for them.

Then, there’s this:-

“It’s all led by the tone at the top. When we started we had wonderful support at senior levels of government, so you got a real culture change. But after about a year or so it became clear – and this is during Labor – that government doesn’t like FOI and it’s acceptable, it’s culturally, acceptable to thwart FOI requests.

“Except in the early days, when the initiative was being led by John Faulkner and Joe Ludwig, the tone was as antagonistic to FOI as it has been under the present government.”

“There’s a lot of political horse-playing around who is the most secretive government. In my experience there was a lack of enthusiasm from both sides of politics. Senior people in government just don’t like FOI."

One of the greatest bug-bears and most complained about features of dealing with ‘the agencies’ is obtaining essential information under the FOI act.  

Are the winds of change actually starting, under Turnbull to blow about the ‘corridors of power’; or is it just more meaningless rhetoric?  

Time will tell, but thank you Mandarin for keeping us well informed.  Cyber Tim Tams for morning tea; delivered...

From Stevie E today...

Ethics in program evaluation, from Nuremberg to the NHMRC

---

by
Stephen Easton
06.10.2015



Ethics, as it applies to any research involving humans, cannot be ignored by public servants running policy and program evaluations. But if the slow process of going through an ethics committee can be avoided, perhaps it should be.

All research using human subjects or information about specific people must respect the enduring ethical principles famously enshrined in the 1947 Nuremberg Code, and that includes policy and program evaluations.

In the Australian Public Service, the PGPA reforms have triggered a need for agencies to brush up on evaluation and quality assurance activities. With that in mind, Canberra Evaluation Forum participants discussed human research ethics in the context of evaluation at their most recent get-together, and heard from two public servants who are knee-deep in the subject.

“Examples of human research include interviews, surveys, focus groups, observations, chat rooms, testing,” explained Gary Kent, who heads up the Australian Institute of Health and Welfare’s governance unit. Kent gave the CEF a general overview of the subject and the work of the AIHW ethics committee.

“You can also talk about obtaining specimens from people, like DNA or blood or something else. All of that is human research. It doesn’t have to involve the physical body. It can even be interviewing someone, because there are ethical issues even in talking to someone. Even in a focus group, issues arise.”

Of course, there are no ethical problems with using aggregate data which genuinely cannot be linked back to individuals.

The current Australian version of the principles set out in Nuremberg is contained in a National Health and Medical Research Council statement, last updated in May. The four key values are: respect, research merit and integrity, justice, and beneficence.

At the same time, other laws like the Privacy Act and those that define and govern public services also demand high standards of ethics and respect for the rights of the individual. Such concepts are pretty clear and well established, but what about the rights of whole communities, wondered Australian National Audit Office senior audit director Richard Lansdowne.

“The one that comes quickly to mind is indigenous communities, and there’s about eight or nine sets of rules and regulations governing how you relate with those communities,” Kent explained.

“[Some regulations] are about how you engage with the indigenous people as a whole. They require, for example, that you have an indigenous expert as a consultant or on your committee [and] you’re encouraged to have a relationship with the local indigenous community structure of some sort. There is an indigenous human research committee of South Australia, for example.”

A practical example

Kyleigh Heggie from the Department of Veterans Affairs Human Research Ethics Committee presented an overview of a recent telehealth trial. The DVA committee, which has been around since 1993 and will merge with the broader Defence committee (ADHREC) in 2017, had to decide if the trial would do more harm than good for its elderly participants.

Ethical reviews are no a tick-and-flick process, Heggie explained.

“A lot of proposals that come by us are probably under par, and our ethics committee has a definite interest in robust, rigorous research; that means it must be ethical,” she said, adding that in a past job, she saw lots of proposals for “pretty cowboy” research that involved criminals in custody and victims of crime.

Telehealth equipment allows health professionals to remotely monitor certain vital signs of patients, and has been shown to assist with the management of certain chronic conditions. But the DVA trial would also involve risks of harm: significant intrusion into the homes and lives of veterans with chronic diseases, as well as digital collection, transmission and storage of their medical information.

One of the key questions the committee looked at was how much merit there was in the proposal. Telehealth has its success stories, but as with most emergent technology, it also has its cheer squad of companies that make money from it whether it works or not.

“Were we being sucked in to this new wave of technology? Was it worth it? This was something the ethics committee were very keen to address,” said Heggie.

The trial has apparently been successful for at least some of the participants, and has been extended by 18 months. The forum heard DVA has had complaints from the participants or their families. Heggie also confirmed that the evaluation of the telehealth trial and the trial itself needed separate ethics approvals.

“We don’t allow any programs [involving veterans] to operate without ethics approval,” she said. “The evaluation … may have very different approaches to dealing with the participants, so any evaluation has to have independent ethics approval as well.”

When to worry about ethics, and how much to worry

As one CEF participant pointed out, the NHMRC offers guidance on ethics in evaluation and recognises a difference between quality assurance activities and more complex human research. But makes no clear distinction between the two:

In some circumstances, attempts to clearly separate QA from research are unhelpful. Moreover, QA, evaluation and research exist on a continuum of activity, and work that begins as one form of activity can evolve into another over time.
Importantly, QA and evaluation commonly involve minimal risk, burden or inconvenience to participants, and, while some level of oversight is necessary, Human Research Ethics Committee (HREC) review processes are often not the optimal pathway for review of these activities.
What really matters is that:

• participants in QA/evaluation are afforded appropriate protections and respect;
  
• QA and/or evaluation is undertaken to generate outcomes that are used to assess and/or improve service provision;
  
• those who undertake QA and/or evaluation adhere to relevant ethical principles and state, territory and Commonwealth legislation;
  
• organisations provide guidance and oversight to ensure activities are conducted ethically including a pathway to address concerns.
  

DVA “doesn’t see the difference” between the two, according to Heggie.

“This is my opinion, not DVA’s: there’s a fine line between research and evaluation and a lot of companies skirt around it, saying it’s evaluation when it’s possibly research; actually, mainly research,” she said. “And there’s much more structure around ethical research than ethical evaluation.”

The Department of Immigration and Border Protection doesn’t have an ethics committee, explained one delegate, but relies on the ethical guidelines for Australasian Evaluation Society members. DIBP has also availed itself of private firms that can be employed to provide independent ethical oversight for “a large international project” that involved identifiable individuals, the forum heard.

The AIHW does not link evaluation and ethics and if it does undertake evaluation, it’s a separate process the ethics committee isn’t involved in, according to Kent. “We don’t have any concept of ethically approved evaluation at the Institute,” he said.

Former senior public servant Stephen Bartos, fresh from a stint as parliamentary budget officer in New South Wales, suggested ethical approvals could be avoided altogether for some quality assurance work.

“Almost every evaluation involves some research of some sort, but it in many cases requires no ethical clearance at all, even if it involves human subjects,” Bartos contended.

“As Gary knows, I did some work for AIHW that involves human subjects and I never got ethical clearance, mainly because the subjects were the members of the AIHW board, so we considered they were big and bold enough to make informed consent for themselves.”

The public administration pundit reminded the forum that ethics committee processes have a downside: they slow everything down. He said that as a university professor, he avoided going through the process whenever he could because it could have delayed the work by about six months.

“Committees are a wonderful mechanism for taking good evaluation ideas down a long corridor and slowly smothering them to death under paperwork,” said Bartos. “It’s absolutely needed in the areas like health research that our speakers have been talking about, but there’s a range of others where probably the more appropriate mechanism is independent advice or assurance.”

CASA & ethics?- Yeah right!   

As usual very insightful from Stevie E but I am afraid ethics & CASA in the same sentence is laughable, especially when you consider who Chairs the Ethics and Conduct Committee:

2. Composition

2.1 The E&CC is comprised of six (6) permanent members and one or more non-permanent members.

2.2 The permanent members are:

2.2.1 the Associate Director of Aviation Safety (Chair of the E&CC);

2.2.2 the Deputy Director of Aviation Safety

2.2.3 the Manager, Governance Systems Branch

2.2.4 the Head, People and Performance

2.2.5 the General Counsel; and

2.2.6 the Industry Complaints Commissioner

Maybe the veracity & integrity of this committee could be severely tested with the introduction of OST's ten commandments, especially 8-10?

However given the dodgy past history of the ECC - & with the Doc still in charge - it is hard to see the 9th principle being given much oxygen, especially with Hoodoo's weasel words laced throughout - FFS!

9. CASA demonstrates proportionality and discretion in regulatory decision-making and exercises its powers in accordance with the principles of procedural fairness and natural justice

CASA will seek optimal safety outcomes in the exercise of its regulatory powers. On that basis and to that end, CASA will ensure that its actions and responses are appropriate and proportional to the circumstances.

In the first instance, and in the absence of demonstrable safety-related reasons for doing otherwise:

• CASA will adopt an approach to regulatory compliance based on the encouragement of training and education, with a view to remedying identified shortcomings and correcting specified deficiencies.
  
• Where the interests of safety require that a person's aviation-related privileges need to be limited, curtailed or suspended pending the rectification of identified shortcomings or specified deficiencies (including the satisfactory demonstration of requisite levels of skill or competence), voluntary mechanisms to achieve those objectives will be developed and employed.
  
• Where it is necessary in the demonstrable interests of safety for CASA to exercise discretionary powers in order to achieve a specified safety-related outcome, CASA will employ the least intrusive and least disruptive means consistent with the achievement of that outcome.
  
• CASA will not utilise its discretionary powers to vary or suspend a civil aviation authorisation for punitive or disciplinary purposes, but only for purposes reasonably calculated to achieve specified safety-related objectives, including the protection of persons and property pending the satisfactory demonstration by the person whose privileges have been, or are to be, varied or suspended, that the shortcomings or deficiencies giving rise to CASA's action have been effectively addressed.
  
  

In determining whether and how to exercise its regulatory discretion in a particular matter, CASA will have regard to:

• the seriousness of the safety-related implications of the instance of noncompliance under scrutiny;
  
• mitigating or aggravating circumstances impacting on the appropriateness of the responsive regulatory action(s) contemplated;
  
• the history and background of the person whose acts or omissions are under scrutiny, in relation to that person's demonstrated ability and willingness to comply with regulatory requirements;
  
• the passage of time since the acts or omissions under scrutiny occurred, and when they were discovered by, or otherwise came to the attention of, CASA;
  
• the degree of responsibility of the individual(s) whose acts or omissions are under scrutiny;
  
• the effect on the wider aviation community (including the general public) and confidence in CASA’s administration of the civil aviation legislation in the interests of safety;
  
• the obsolescence or obscurity of the law;
  
• whether the a contemplated regulatory response would be perceived as counter-productive, for example, by bringing the civil aviation legislation or CASA into disrepute;
  
• the availability and efficacy of appropriate alternatives to a particular regulatory response;
  
• whether the consequences of the regulatory action contemplated would be unduly harsh or oppressive;
  
• whether the matter is one of considerable public concern;
  
• the actual or potential harm occasioned to an individual or the damage to property; and
  
• whether the person whose acts or omissions are under regulatory scrutiny is (or has been) willing to co-operate with CASA in the efforts to address the particular matter to hand and/or to address relevant safety-related issues more generally.
  
  

The applicability of and weight to be given to these and other factors will depend on the particular circumstances of each case.

Beyond its legal obligation to do so in most cases, in all cases in which CASA exercises discretion in determining whether, and if so to what extent, a requirement will be imposed on a person, except where the interests of safety prevent it or it is otherwise demonstrably impracticable to do so, CASA will afford persons affected, or likely to be affected, by a decision with an appropriate measure of procedural fairness and natural justice.

To highlight the confusion in definition the 9th C is already creating, here is an email from Sandy to various parties posing perfectly valid QONs:

Dear (??????),


In light of the fact that much of CASA's regulation is now part of the criminal code and codified as strict liability.

Quote (in part) from no. 9 of the new CASA code of conduct.

• In determining whether and how to exercise its regulatory discretion in a particular matter, CASA will have regard to:
  
•  the history and background of the person whose acts or omissions are under scrutiny, in relation  that person's demonstrated ability and willingness to comply with regulatory requirements;
  

Is this procedural fairness? By my understanding previous history is not taken into account in criminal proceedings until sentencing. I expect the reasoning is to avoid prejudice. 

Should CASA have "regulatory discretion" as opposed to "discretion"? 

What does this mean? When the law is so complex, harsh in penalties, intolerably lengthy, prescriptive and ever changing then we definitely have rule by discretionary interpretation, not the rule of law. The practical limits of law making have been well and truly exceeded, at enormous cost to General Aviation.

Sandy

In addition to Sandy's excellent QON?? If industry is to believe there is now a fundamental change - in the previous Sociopathic persecution culture - within CASA (with OST's 10C), then there needs to be an amnesty on all obvious past & current cases of embuggerance, i.e. a clearing of the decks.

If this doesn't occur then I would suggest that Oliver's 10C will be seen as yet another cynical attempt to placate the IOS until such time as resistance is eroded through attrition...
 
 
MTF...P2