Let's see what trouble Rose can get into today.

There is an article in the July 2009 issue of JAMA entitled, The Obligation to Participate in Biomedical Research. I would provide the link but, as JAMA is a subscription-only service, that would be against the rules. I would hope that JAMA is available to borrow from public libraries; one could also ask one's doctor.

Anyway, the article seems to represent a sea change in thinking. Here's an excerpt from the authors' overview, the sharing of which hopefully will not get me grounded till homecoming:

"The current prevailing view is that participation in biomedical research is above and beyond the call of duty....we propose a novel public goods argument for an obligation to participate....biomedical knowledge is a public good, available to any individual even if that individual does not contribute to it...Participation in research is a critical way to support an important public good....Consequently, all have a duty to participate...."

It's a good read.

Authors Schaefer, Emanuel and Wertheimer cover a lot of ground. They describe the standard view (participation is above and beyond the call of duty). They present 2 arguments for the obligation view: beneficence anid free-riding. Then they discuss implications of the obligation view: enforcement, personal obligation, cultural change, and paying others to participate in one's stead. Finally they consider likely objections.

What do you think?

Are we obligated to participate in research? If so, why? How much? What exceptions are there? If you've participated already, what inspired you?

Would so-called newbies or so-called old-timers be differently obligated? Parents of young children versus nonparents? Who would define the acceptable level and parameters of participation?

Do you wear your badge of participation proudly...why or why not? If you could somehow ensure that you didn't get the placebo would you? If you are able to access the therapy without the study would you? Why or why not? Is subcontracted (paid) participation ethical; does it get us off the hook? If yes, how so?

What other questions does this topic raise for you? Everyone is invited to reply based on your sense of ethics, philosophy or personal experience.

Rose

Rose - terrific brain teaser - here's my immediate reaction to one of the quotes from the article; hope this turns into a great discussion!

JAMA says: "The current prevailing view is that participation in biomedical research is above and beyond the call of duty....we propose a novel public goods argument for an obligation to participate....biomedical knowledge is a public good, available to any individual even if that individual does not contribute to it...Participation in research is a critical way to support an important public good....Consequently, all have a duty to participate...."

If this is true, then isn't good health a public good? If we have a duty or responsibility to participate, then don't the medical advances that result belong to everyone and not just to those with good insurance or more money?

In other words, it can be argued that the logical extension of JAMA's provocative idea would have major implications for the health care delivery system as well. The case for universal care would be strengthened. It would be difficult to argue that health care be denied for any reason if everyone were responsible to participate in trials. I kind of like it!

Hi Rose,

AMA says: "The current prevailing view is that participation in biomedical research is above and beyond the call of duty....we propose a novel public goods argument for an obligation to participate....biomedical knowledge is a public good, available to any individual even if that individual does not contribute to it...Participation in research is a critical way to support an important public good....Consequently, all have a duty to participate...."

I see where they are coming from, sort of, but the reasoning doesn't hold up IMHO, which these replies can only be - individual opinions about an individual decision.

Here's why I do not see trial participation as an obligation. Where are the public goods? and --why? I don't see them.

People sometimes die from clinical trials, with very little to show for it. Strokes, etc. can cause irrepairable damage. No treatments.

The trial is more likely to get cancelled and those with the placebo don't get the chance.

Since it has become public knowledge that business is determining our health outcome, I could not in good conscience ever consider it obligatory. It 's kind of like me making someone feel obligated to be married or to have children. It's a personal decision.

I do think every pwp ought to have a look at clinical trials.
Most doctors never mention them. So the new approach would take much work with the physicians.

Trust needs to be re-established for a real shift to be seen in trial paticipation. Trust comes from communication.

We aren't there yet. I definitely do not want the govt make clinnical trial decisions for anyone.......visions of the man from germany with the mustache....not comparing our pres. to him in anyway, but do not want a research czar telling me what to do either.

It's a personal decision and no judgement or guilt should be attached. on te other had, those who have and will do it are most appreciated. But it still doesn't obligate anyone else.

Now if there were treatments coming out of the trials I may think differently. But pd has a gold standard to beat? Curious minds want to know the answer to that question.


paula

I did say I see where they are going and a suggestion that comes to mind is -then cover them with insurance. Start to finish. Some of the testing gets covered now by medicare.

Before anyone argues these points, remember it's my opinion. so use the argument to state your opinion, not refute mine. Let's be good debaters.

Paula - this is why I argue that if they want universal participation in clinical trials, then the price is universal access to the fruits of that participation.

"Here's why I do not see trial participation as an obligation. Where are the public goods? and --why? I don't see them." - Paula

Universal, duitiful participation is only half of the equation.

You do have to wonder if there was more participation in clinical trials, would we be ahead of the game in disease cure and treatment right now?

We can't be required (not simply asked) to sacrifice our health for the greater good unless there is some benefit. I would argue the benefit would be access to the best health care without fear of bankruptcy or even lesser financial hardship.

i hope i understood what you are saying, which is basically what they are proposing right? public goods for all so let's do our public duty and all reap the benefits. but i don't see - oh you referred to them with the words fruits of the participation?

i do have to wonder with you whether more clinical trial participation would have us farther along. I don't know the answer, but know that a lot goes on overseas.

so i' m back to communicate with us first.........so we can develop trust.

That's the problem with the JAMA article - they are not proposing what I am proposing.

I think we are talking about the same thing, Paula - if I must be responsible for clinical trials, then I will also reap the benefit of the health care system built on our participation.

I have not read the entire JAMA article; Rose - is there mention of what benefit besides advancing science would be the benefit?

Other questions are popping up now.

Carey, When you say we'd reap the rewards of universal healthcare - with quality - do you mean in exchange for us participating or as a natural result from getting rid of disease?

Could this be a terminology thing again? Changing drug treatments or therapies to public goods? Indoctrination for other changes to come?

Public goods wouldn't be owned or controlled by the public. They would still be yanked for not outperforming either the placebo or the gold standard??

just typing as i think of them, good post rose,
paula

This is why I do not "recruit for trials", I advocate for and provide awareness and education for patients.

Paula -

bottom line - if they want universal participation in clinical trials, I want assurance that my medical care be univerally and equally provided.

Quid pro quo. Something for something.

Presently, the investors as a group make big profits and the academics advance their careers from today's work, but the patient benefits from yesterday's work. If I take part in a trial, any progress is likely to be incremental and benefit future patients but not me. That's how the system is designed. If I hear "More research is indicated..." one more time...

In that system, if I choose to take part it is altruism. If I am forced to take part it is a crime against humanity. Redesign the system so that I benefit more than anyone else and get out of the clinic doorway 'cause I'm coming through.

This is a great discussion! I would say that JAMA's call to action of patients seems a step in the right direction for a "novel public good", but how is this public good going to work when we can't even settle on having a truly, equitable public health care system? Instead we're bandying about with the status quo by maintaining private insurance and adding fuller public coverage for those who need it (amped up Medicaid and Medicare).

My thoughts are limited on this topic because JAMA holds their ideas hostage; we have to pay for access, so I have a limited idea of their vision. Let's see, patients may be expected to undergo extremely risky procedures or treatments for the sake of humankind (I don't think this is necessarily wrong), but what does any other key player give up in kind? When asking patients to act on a moral obligation, shouldn't we explore the role of patients in research within an entirely new paradigm based on a sense of what is right? I wish JAMA felt a moral obligation to provide free access to information. Questions that arise:

Patients are obligated to participate. Does this mean pharma, or any other proprietary researcher, is obligated to gift all intellectual property to a common "public good" research collective or database?

Would certain pharmas be acting in the public good by withholding potential curatives or novel treatments based on potentiality of profit?

What is the role of non-profit orgs like PDF?

How do we "recruit" (or do we "draft) PWP into research trials? Honestly, I didn't even know that non-participation was an issue until this forum.

Let's see journals like JAMA and other scientific research pubs and private databases pool together to develop a "public good" clearinghouse with epidemiology data and scientific articles for researchers. The patient would have free access to info written by specialists including annual reviews of key promising research leads, literature reviews on what we do know about PD, and treatment standards.

These are just a few questions that come to mind. I think that having more PWP involved in research actually might empower the patient- something that I think we all advocate. Is the patient considered a primary player in this and respected?

This is a great opportunity for research, clinical, and patient communities to all come together toward a humanistic goal of eradicating disease, but there's so much more to it than just expecting patients to have the moral obligation to ease suffering.

Laura