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Dealing with ethical situations.

Q-When is it time to run away from a client who is not behaving ethically? What do I do when I learn that my client is engaging in unethical practices?

A-The short answer: as soon as you realize your own personal code of ethics is being violated irrevocably. However, in truth these situations are rarely so simple. First, what do we mean by "not behaving ethically"? Is the client hiding data from FDA reports or published articles on clinical studies? Knowingly plagiarizing or using another's material without permission and/or attribution? Giving a byline to "authors" who had little or nothing to do with planning and creating the manuscript? Hiding financial relationships? Not paying you for your work in a timely manner? Violating confidentiality or noncompete agreements?

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Communication is the first step: it is essential to discuss your observations with the client before passing judgment or burning a bridge forever. Be sure you are correct; ie, that the person is indeed consciously doing something unethical! Possibly he or she is simply unaware. It is part of our role as consultants to point out possible errors and discuss ways to remedy the situation. I have found most often that the person has made this mistake without quite realizing it; once I bring it to his/her attention, she or he will make appropriate changes. If the client refuses to make the change, then you need to decide how to proceed. It is a personal decision. Do you tell the client you do not want to work with the company anymore because of unethical behaviors? Do you report him/her to a higher authority? Do you complete the project but insert clear notes pointing out the problems and leave it to them to do the right thing? Or do you just quietly quit without saying anything (other than you have other pressing commitments, or suddenly have an illness that requires you to take a long leave, etc)?

-- Cathryn Evans

A-Obviously, this situation is very tricky, and it may be prudent in some cases to consult a lawyer. It is important and helpful to document what you are finding and feeling in a notebook. If there is an opportunity to do so, you could question your client's practices in a nonthreatening way, and an e-mail note may be a good way to do this, but keep in mind this may eventually be part of a chain of evidence. Do not put anything in an e-mail note that you would not want someone specific or anyone in general to know about and certainly if you do not have real proof of wrongdoing. (I hate to say it, but imagine you may have to testify someday--let that guide whatever you write down in your notebook or in an e-mail note.) It could be hard to walk (or run!) away, depending on your contractual obligations. You will also have to be prepared to forfeit payment if you do walk away. However, it is better to stand on your principles or at least listen to your gut!

Many years ago, I was contracted to write a manuscript on a study that had a very questionable design that I felt should not be ignored in a discussion of the limitations of the study and its conclusions. After several attempts to discuss this in conference calls, I was abruptly removed from the project (which was fine by me!). About 2 years after that, someone associated with that project (who was now at a new company) called me for a new job because she remembered what I did and said and had agreed with me and respected my standing ground!

-- Sherri Bowen

A-If a client is behaving unethically, is aware of this, and persists in the unethical behavior, it is time to run away. First, though, you need to tactfully and clearly explain why this behavior is unethical. The client may not know that the behavior is unethical or can be persuaded to stop when presented with the facts. If the client persists in the unethical behavior once you have done this, it is time to run away; that is, fire that client. Continuing to work with an unethical client can only damage your reputation, cause you aggravation, and possibly lead to legal issues. I once had a client who wanted me to include only the benefits and leave out the risks of participating in clinical trials in a newsletter for people with cancer. This is clearly unethical. I explained this to the client, who was a physician, and cited the required elements of informed consent described in the Code of Federal Regulations (21 CFR 50.25). The client still insisted on including only the benefits. I documented this conversation. In the article I turned in, I included both the risks and benefits, with a comment about why both were necessary. And then, I fired the client.

If you are legally committed to finishing a job with an unethical client, be sure to put your explanation of the unethical behavior to the client in writing (eg, in an e-mail note) and document your attempts to resolve the problem in phone calls and e-mail messages. Keep a copy of this documentation. When you have finished the job, run to the land of ethical clients.

-- Lori De Milto

A-My short answer: as soon as you realize the unethical actions. However, you must determine if the unethical behavior stems from lack of knowledge of the rules or is something that came down from a higher authority. Years ago, I was working on a pharmacy program with a young, new product manager who had been a highly recognized pharmaceutical representative. Once promoted to corporate headquarters, he was looking to make a name for himself. He wanted to sponsor a multihospital program that only discussed his company's product and ignored the competition. When I explained "fair balance" to him, he then decided he wanted to use his product's branded name and refer to the competition only by the drugs' generic names. After I told him that only generic names for all products were permitted, he told me that the product's advertising agency representative had suggested the scenarios and he thought they were valid and legal. Needless to say, the advertising agency is no longer in business and he has become a valued client.

In brief, try to determine if the client is truly "in the know" to all the rules and regulations and take the time to educate him or her. If the client persists in an unethical manner, run away as fast as you can. Follow your gut. It is better to lose a project or a client than to compromise your own ethics. If you are not sure of the ethics involved, pose the question to one of us on this panel or go to the AMWA freelance business listserve folks.

-- Elizabeth L. Smith

A-Fortunately, I have never had to deal with a client who was engaging in blatantly unethical practices, so I hesitate to speculate about how I would handle this situation. Obviously, I would not risk my reputation by participating in anything that is clearly unethical, but the issue is not always black and white. A freelance is not always in the position to know if clients are being completely ethical in all their business dealings, but, at the very least, it is our responsibility to make sure we are fully and accurately credited for our substantial contributions to journal articles, books, book chapters, white papers, etc. Unfortunately, fulfilling this responsibility is not always as easy as it sounds. With all the negative media attention to the issue of so-called ghostwriting in medical writing, clients are aware that giving credit where credit is due is an ethical issue, but the way they choose to give that credit is not always completely accurate. Recently, a medical communication company hired me to write an article for a dermatology journal. A pharmaceutical company paid for the article and the "author" was a well-known dermatologist. I requested that my contract include language indicating that I would get writing credit for the article, and the client readily agreed. The dermatologist was fully engaged in the process, providing references, talking with me on the phone, reviewing drafts and making a few editorial changes, but I did all the writing. As a final step, the pharmaceutical company approved the article but suggested it might be too long for the journal they were targeting. I deferred to the dermatologist to decide what information he wanted to cut. The article was finally published this past July, and, although it was slightly shorter, the article was exactly as I wrote it. However, my name did not appear on it. Instead, my contribution was acknowledged in the Disclosures section as follows: " ... initial editorial assistance was obtained from Donna Miceli." Clearly, that statement does not begin to reflect my contribution, but was it unethical? The issue of how best to credit freelances who do the writing for physicians and other scientists is a difficult one, and, in some ways, is out of our hands. We can insist on a clause in our contract, but once we have completed the final draft and given it to our client, it is out of our control.

-- Donna Miceli

Q-Much of my work has been done for the pharmaceutical industry, and confidentiality does not allow me to use that work as samples. What's your advice on showing samples?

A-Although I do not write in the regulatory environment, I do write a lot of materials that are confidential, including sales training materials, executive summaries of internal and expert advisors meetings, and other internal documents. It can be a real challenge when I am speaking with a potential new client who wants to see for himself/herself what I have done in one of these areas.

To overcome the problem, I have found it very effective to diffuse the situation by explaining that I am ethically bound to not show confidential information even if it is detrimental to the growth of my business to do so, and that I will respect the potential new client's confidentiality with equal fervor. Then, and this is the best part, I acknowledge this makes it difficult for the person to assess whether or not to work with me, and I offer the names and telephone numbers of several of my clients who can independently tell the person about their experience with me on these types of projects.

Not only does this give the person I am interviewing with a way to verify my abilities, but it does so with an air of personal recommendation. It also strokes my current clients' egos by acknowledging how much I think of them, and everyone likes to be on the delivery end of a great recommendation.

-- Brian Bass

A-I never show samples. I have a list of my projects (with all protocol titles redacted) that I show to clients, and if they need further proof that I know what I am doing, I give them a list of references they can contact about my job performance. In my experience, people who ask for samples more likely don't know how to put together such a document and are looking for a way to do it themselves based on your work--they are not looking for proof of your writing abilities!

-- Sherri Bowen

Q-How do I handle assignments for conflicting brands from my clients?

A-Every so often, I will get a call from a client to work on a project in a therapeutic area in which I am already working for another client. With the amount of competition out there in the pharmaceutical marketplace, it is actually surprising this situation does not arise more often. I have to keep an especially close eye on this because I use a subcontracting business model, so it is not just me working on assignments that could conflict with new work coming in.

Most often, the potential for conflict crops up when a therapeutic area is hot with new drug development and competitors are fighting to be the first to get the word out, communicate their science, and train their sales representatives. When conflict does arise, my only recourse (and the only ethical thing to do) is to turn the conflicting work down. I do not like to turn any work down, but there is really no option here. So I do my best to turn the situation into a marketing opportunity.

I explain to the client with the conflicting project that I (or my team) is already working on a project in the therapeutic area for a competing product, adding that, as they can see, we have current relevant experience should the need arise again. Then I offer to help the client find a suitable alternate writer for the project using my AMWA connections. This way, although I cannot be the solution I can still be a part of the solution. I make it a point to tell the client how disappointed I am that I cannot help them this time, and stress that when I am working on a project for them, these ethical standards protect them and their clients as well.

Yes, I am pulling a small victory from the jaws of defeat. But it is a victory I am happy to win because it strengthens my reputation and my partnership with my clients.

-- Brian Bass

A-Freelance writers sign a confidential disclosure agreement (CDA) before beginning any project with pharmaceutical/biotech companies or their agencies. In it, we agree not to disclose any information about the client's products, research, marketing plans, and anything else that is not public information. We do not agree that we will not work on their competitors' products. We agree not to disclose what we know. This should be sufficient.

A freelance medical writer working on small projects here and there would jeopardize his/her own livelihood if she/he agreed not to work on competitors' projects. Moreover, it is unreasonable for a company to prevent an individual consultant from working on a competitor's product unless the client intends to pay for such exclusivity.

Thus I would not agree to "not accept" other work while working for a single client unless that client agreed to pay me substantially to turn down the other projects. My signed CDA should cover any potential problems associated with working for a competitor. I did have a situation where I was working for two companies developing a drug in the same class; the second client wanted me to tell him private information about the first--my reply was no, of course, to which I added, "How would you feel if I agreed to give your confidential information to your competitor?" The topic was never brought up again; both clients knew about the other and trusted me not to reveal confidential information. I wrote papers and monographs for both clients for a number of years without violating that trust.

Ad agencies, on the other hand, receive very high annual retainers (seven figures in many cases), along with generous project fees. They are designing marketing plans and advertising campaigns for the client and may not do similar work for a competitor--even if the products in question are not in direct competition. These contracts between agency and client vary, depending on their agreements.

-- Cathryn Evans

Q-Last month, I wrote sales training materials for a new drug. This month, a different client wants me to write CME materials for the same drug. What do I do?

A-Switching between promotional and CME writing is a no-no. The Code of Conduct of the National Association of Medical Education Companies (NAMEC) (www.namecassn.org/conduct) specifically states "Staff and/or freelancers who control content for promotional education should wait an appropriate length of time (eg, a 'washout' period of 6 to 12 months) before working on educational content in the same therapeutic area. Accredited providers should verify this 'washout' for staff who control content."

Arguably, this may be an infringement of freelances' right to fair trade. But given the potential ethical issues that could arise when a writer switches gears between promotional and CME work in the same therapeutic area, some washout period seems both reasonable and advisable. Note that the wash-out period does not apply to writers moving from CME writing to promotional writing.

I do a lot of CME writing, and I come from a promotional writing background, so I also do a fair amount of branded writing during the course of any given year (including advertising and sales training). I may just be lucky that, to date, I have not encountered a conflict. But if and when I do, just as I do not hesitate to decline work on conflicting brands, I would not hesitate to inform my client that I am, or have recently been involved in promotional work in the same therapeutic area. The washout period stated in the NAMEC Code of Ethics is a range, so I would work with the client to determine what a suitable washout period is, then if this precludes me from working on the CME project, I would respectfully decline, help the client find a suitable alternate writer, and try to use the situation as a marketing opportunity to promote my commitment to high ethical standards.

-- Brian Bass
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Title Annotation:FREELANCE FORUM
Publication:American Medical Writers Association Journal
Geographic Code:1USA
Date:Mar 1, 2012
Words:2901
Previous Article:Ethics in regulatory writing.
Next Article:Point-counterpoint: industry sponsorship of CME: introduction to the debate.
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