Mar4

Let the Sunshine (Act) In

5116469For many of us in the healthcare industry, the advent of the Physician Payment Sunshine Act has loomed large and ominous. The mere mention conjures up visions of significant changes in the way we work with healthcare providers (HCPs), in addition to endless data collection and reporting. On March 31, 2014, healthcare manufacturers are required to submit their first annual federal reports; these reports will include data captured from August 1, 2013, through December 31, 2013. By September 30, 2014, CMS will publically disclose the information on their website. This regulation is associated with the Affordable Care Act, and as we have come to learn, there may be changes, revisions, or postponements to current guidance on reporting and timing of data review and corrections. Nevertheless, the industry needs to be prepared and many of our clients have been adapting for some time.

So to date, do we really know how this regulation will transform our corner of the healthcare geography? Are we prepared to adapt and innovate?

From a medical education and scientific publication perspective, we have already seen substantial changes in the way our clients collaborate with HCPs.  For example, in December of 2013, GSK announced that the company will begin a process that will effectively stop direct payments to HCPs for speaking engagements and for attendance at medical conferences. To fill this gap, it appears the company may expand its focus on developing multichannel capability to support the dissemination of information about its products and relevant disease states to healthcare professionals.

The effects of the Sunshine Act are also noticeable in the scientific publication realm. Due to the transparency requirements, academic research institutions are once again modifying their guidelines and tightening their restrictions on working with industry on clinical trials and subsequent data publication to avoid the perception of and potential for conflicts of interest. These restrictions also pertain to the development of disease-state articles that update standards of care and provide best practice approaches for HCPs and allied health professionals.

Clearly the Sunshine Act is meant to shine the light of transparency and public disclosure. But it also has the potential to hamper scientific exchange, which is the lifeblood of effective medical communications.

How do we as an industry respond? My vote is to adapt along with our clients and lead and encourage the innovation and continued delivery of robust scientific exchange. How will you respond?

CONTINUE THE CONVERSATION: Questions? Comments? You can contact the author directly at blog@ochww.com. Please allow 24 hours for response.

 

 

Also posted in Affordable Care Act, Clients, Healthcare Communications, medical affairs, Medical Education, Research, Science, scientific publication, Sunshine Act | Tagged , , , , | Leave a comment
Jan8

The Ethics of Online Observational Research

Ethics-of-Online-ResearchBlogs typically are not the avenue to explore issues of ethics, but recently someone asked if we had ever looked into the ethics of online research. Not the kind where you pay people to answer questions—rather, the kind where you read a ton of blogs, or tweets, or message board messages, and use these as a primary source of data. It’s a good question, and a topical one, as I see more and more research reports that are based in the analysis of web data, and am part of a team that generates our own ethnographic analyses of online communities of practice. Basically, my friend, who is something of a cyberhippy, was asking: are you conducting research, or are you snooping, or, to put it bluntly, are you spying? I’m not an ethicist, but as a researcher I spend a lot of time working with oversight committees to ensure the research we do is ethical, and his question sent me in search of answers.

It turns out, there’s a lot of ink spilled on this topic, and here’s the answer: yes, no, and depends. (I love ethics.)

Before I explain, I will introduce, and then avoid, the subject of reciprocity as an ethical imperative in field research. This is the somewhat new “what’s in it for them?” question, which asks, if you get tenure for spending 10 years with the headhunters in Borneo, or the Hutterites, or tattoo artists or short haul truckers (all communities who have been the subject of detailed study), what did they get from you? In our case, it’s: if you get a nice contract to study a community online, what’s in it for them? This gets into a larger question of what we’re doing in healthcare marketing, and my quick answer is, if we use the data with the intent to create better materials to serve that community, we’re on the side of the angels—but it’s too big a topic for a blog post, so I’ll skip it here.

So, on to the straight observational ethics. In the broadest sense, yes, it is legal, and ethical, to read online messages and analyze them. The Internet is a public forum, and as such provides no reasonable expectation of privacy—just like activity that takes place in, say, Central Park, if you’re doing whatever it is you do in public, you are a legitimate object of study (so be careful…). Key to this is the assumption that you are conducting research in good faith; while it’s legal to take pictures of sunbathers in Central Park, if you take hundreds of them and plaster your apartment walls with them, it’s creepy. But if you’re studying the culture of sun-worship in New York City, then, hey man, sounds boring to me, but go for it. It’s all in how you frame the research question. (The wallpaper example above doesn’t have an intent to answer a question, so beyond being creepy, it’s not really “research.”)

There are a number of other aspects of the “yes” answer, such as: it’s impossible to get informed consent if you can’t actually determine if the person you’re talking to is able to consent (say, if you’re talking to a 40-year-old man, who turns out to be a 15-year-old girl pretending, for whatever unfathomable reason, to be a 40-year-old man); or, the fact that community norms of most online communities of practice treat “lurkers” as “licensed overhearers,” not “eavesdroppers,” as evidenced by the common reaction to someone announcing they are finally posting after years of just reading (“Welcome! C’mon in!”). There’s more to it, but the analogy of ethnography in public spaces is apt: it’s ethical to study patterns of behavior in public without informed consent, provided you treat individual behavior collectively, i.e., don’t report on an identifiable individual but instead report on patterns of behavior as a whole (which applies if you are, say, studying a church ritual, like Easter Vigil, or are interested in describing the culture of roller disco in Golden Gate Park.)

In certain very clear situations, however, no, it’s not ethical to conduct observational research online without informed consent. For example, you can’t break into closed communities and analyze their posts—or if you can, you shouldn’t. Most of us don’t do this, but in case anyone wants to, a private community is to a public forum what a private home is to a public park: you have a reasonable expectation of privacy, and reading data found there is akin to spying. Even if we’re just dying to know what’s being said behind those closed doors, without permission, any attempt to pass those doors is clearly unethical (and possibly illegal).

The grey area is sort of interesting, to me, because it gets to the heart of a bigger ethical question: in a nutshell, is it ethical to pretend you’re something you’re not, to get something you want? If you put it that way, then no, it’s not, at least not unless there is a clear legal impetus to do so (think: undercover cop). It was highly unethical for Hannah Giles and James O’Keefe to pretend to be a prostitute and a pimp when visiting an ACORN office, because the intent was to entrap; no IRB in the world would have approved their “research,” regardless of their opinion of ACORN. But…was it unethical for John Howard Griffin to dye his skin in order to pass for “black” in 1961, so that he could write the book Black Like Me? Many Southern whites were incensed by his research, and Griffin had to move his family to Mexico for reasons of personal safety for many years after the publication of the book. Does anger of the community studied work as a good litmus test for whether research was ethical or not? Probably? Possibly? Reasonable people can disagree. This is a big area of “depends”: for the kinds of research we do, it’s probably unethical to pass yourself off as someone with cancer when you don’t have it (sort of like Brad Pitt and Helena Bonham Carter in Fight Club—it’s funny, but darkly weird, and definitely unethical, to go to support groups for diseases you don’t have); but it’s probably ethical for police officers or concerned citizens to pass themselves off as minors in online chat rooms in order to catch pedophiles.

So there you have it. The amount of observational research being conducted online, in the form of “social listening,” “digital ethnography,” and the like is, you will be relieved to know, by and large ethical, at least according to currently available ethnographic standards. But, and in ethics there is almost always a but, common sense should prevail—you can’t do whatever you want to collect the data you’re analyzing; it has to be public and readily available.

So the next time you’re tempted to break into Sermo, or whatever closed physician chat room it is that is popular today, do what the Dread Pirate Roberts counsels Inigo Montoya to do in The Princess Bride: no matter how much you want to know what’s being said, “Learn to live with disappointment.” For the rest, sleep easy—your conscience is clear.

CONTINUE THE CONVERSATION:
Questions? Comments? You can contact the author directly at blog@ochww.com.
Please allow 24 hours for response.

Also posted in Data, Research, Social Media | Tagged , , , | Leave a comment