Ethical Issues

Guest Expert Connie Ulrich: Ethics of clinical research participation~three questions for us to discuss

Last Updated: Aug 30, 2012

Dr. Connie Ulrich, is an Associate Professor of Bioethics and Nursing at the University of Pennsylvania School of Nursing. Connie's research is all about clinical trial participation. I hope you find her insights as useful as we have. Please review her comments below and let us know your thoughts.

Dr. Ulrich's Post:

As a nurse bioethicist, I am particularly interested in the ethical issues associated with the recruitment and retention of cancer patients into clinical trials and how we can best understand what helps or hinders research participation. Recruiting and retaining subjects is a complex problem that impacts many different stakeholders. This includes the funders of our research, clinicians who use our research to improve clinical practice, and importantly, the public citizens who participate in, or are consumers of, research. Indeed, without public support, research would suffer. There are many ethical concerns associated with research participation; what is not clear, however, is how these issues influence the willingness of the public to participate in clinical research or clinicians to recommend it.

In my current research, I am interviewing and surveying cancer patients on clinical trials and clinicians. I have been struck by the candor and willingness of cancer patients to help me and my colleagues shed some light on the problem of recruitment and retention as well as the views of clinicians who are critical to engaging patients and translating our science (specifically nurse practitioners in primary care).

What have I heard from cancer patients? Some patients worry that the “researcher is not telling them everything” and that there is a generalized “fear of the public to participate in research.” Or, they feel burdened by the uncertainty of the research and whether it is helping or hurting them. Trust and confidence in the researchers as well as open, transparent communication in the research process are vital to participation. Without a doubt, integrity is integral to scientific inquiry; how, then, do we improve our image with the public? Second, what have I heard from clinicians? Clinicians have also expressed concerns about recommending clinical research because patients might be used as guinea pigs; it might be an additional burden for patients to consider; and patients might not understand randomization or be randomized to the non-active arm of the trial. Additionally, clinicians reported ethical concerns about the scientific value of the proposed research.

As one subject enrolled in a cancer clinical trial commented to me “there is no future without clinical trials.” I believe that we need to help the public and clinicians understand the importance of research and translate our science in a way that is beneficial to them. Thus, I pose three questions for us to ponder and dialogue on these issues.

  • What can we do to improve our public image as researchers?
  • How can we best engage the public and clinicians to better understand the scientific value of research?
  • What could a researcher do to gain your trust if you were part of a clinical trial?

Looking forward to your thoughts!

Connie

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Originally posted by: Anonymous on the former AccrualNet site on Oct 04, 2010.

I think we really need to get the word out that research- especially in cancer - is not always last line treatment. Some people may be scared that once they enter the research zone, they are in the terminal stages, yet there are many young cancer pts with good prognoses that are under research protocols. They are surviving as well as, if not better than the standard approaches (I\'m thinking chemo drugs). The physicians, in my opinion, play a larger role in recruitment because they can explain the mechanisms of drugs more in depth but nurses can help reinforce the MD\'s approach by not acting confused or nonchalant about collecting labs for research protocols. \"I have to collect some random lab I\'ve never heard of for this research protocol\" doesn\'t sound very comforting to a patient.

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Originally posted by: Anonymous on the former AccrualNet site on Oct 05, 2010.

In response to Dr. Ulrich\'s posed questions, I believe that two factors are key to improving our public image as researchers and gain trust with participants: 1) Transparency of the trial, and 2) Enhancing communication between researchers and participants. Transparency of the trial, as long as it does not influence the integrity of the trial, can serve as a great way in which to reassure participants and the overall public about the intent, methods, and goals of clinical trials. Related to this is communication between researchers and participants. Promoting an ongoing communication, as applicable, during a clinical trial can help address concerns that participants may have and enhance their overall security with the process and study. Facilitating an ongoing conversation with participants will likely reduce the common concern of being \"just a number\" rather than an autonomous person contributing to critical researcher.

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Originally posted by: Anonymous on the former AccrualNet site on Oct 07, 2010.

I believe the most important answer to your question is that we need to study issues that the public finds important. If we can engage them about the sort or long term impact, and they find it relevant to their health, then we generally are able to recruit. It\'s only when our questions are so esoteric or unimportant that we have trouble making an argument for enrollment, or we feel coercive, perhaps?? When the public engages with our science and \"gets\" it, I think we so help our image as scientists contributing to the greater good.

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Originally posted by: Anonymous on the former AccrualNet site on Oct 08, 2010.

I think there are a number of factors that affect our public image as researchers that we have little control over, but I would love to find ways to manage. First, problems that occur with marketed drugs. Patients have expressed to me their disinterested in study participation because they feel as though drugs like Vioxx, Avandia etc. were studied, doctors said they were \"OK\", pharmaceutical companies marketed them, and voila! many people are injured. That seems to be how patients believe drugs make it onto the market. That doctors \"OK\" the drugs. The next image issue is a result of media portrayal of injuries related to research participation or commercially available drugs. The topic is mostly approached as a \"conspiracy\". We all want to become rich and famous at the expense of our patients. Not to mention the legal services ads. Finally, as noted in the above posts, ongoing transparency relating their trial activity to their participation.

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Originally posted by: Anonymous on the former AccrualNet site on Oct 21, 2010.

At the ASCO Cancer Trial Accrual Symposium in April 2010, Peter Mitchell gave an interesting presentation on applying social marketing to clinical trials accrual. I was curious to hear from Dr. Ulrich (and anyone else who would like to dialogue on this subject) about whether or not a social marketing campaign could be successful in changing the public\'s image of research and researchers, and what ethical issues may be encountered in the process.

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Originally posted by: Anonymous on the former AccrualNet site on Nov 05, 2010.

Social marketing is one tool that could be used to better inform the public about research. Whether it would increase accrual, however, is not clear. More research would need to be conducted to identify how this type of strategy would change behavior or increase enrollment in clinical research. There are always ethical concerns that one would need to think about, especially the groups that would be \"targeted\" for the research and whether they would be vulnerable in any way.

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Originally posted by: kendra-f on the former AccrualNet site on Jul 14, 2011.

What could a researcher do to gain your trust if you were part of a clinical trial?

I believe it all starts with rapport. Develop rapport with the patient by showing empathy and care. Tell them what you can and cannot do for them. Give them options. Share your opinion about those options. Give them the chance to think on (and sometimes sleep on) the information. Sometimes putting the patient\'s wishes first and not being in such a rush to enroll pays dividends over time. A well informed patient is a compliant patient. Remember that informed consent is not just a one time thing. It is a continual process.

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