Is Amending the Patients’ Bill of Rights in Our Future? - Part One

Is Amending the Patients’ Bill of Rights in Our Future? - Part One

By Rob Laurens on Wed, Dec 18, 2013

R Laurens 3 web resized 600This is the first of a two-part blog that looks at the extent to which a patient’s rights can and should include access to information about clinical trials for which they may be eligible.

In passing conversation, my colleague, Joan F. Bachenheimer, relayed an anecdote to a few BBKers and myself about how she recently ran into a mentor of hers, Dr. Rabkin. Dr. Rabkin, renowned physician and hospital administrator who led Boston’s Beth Israel Hospital to flagship status within the prestigious Harvard Medical System, was one of the primary movers behind the development of the Massachusetts Patients’ Bill of Rights.

As you know, a Patients’ Bill of Rights is a summary of rights and responsibilities of patients who are receiving care at a hospital or other health institution. The Bill may or may not be law, depending on the state. And, institutions often craft their own Bill or elaborate on one that is law or otherwise in common practice.

Talking with my colleagues about the Patients’ Bill of Rights and the practice-changing discussion it prompted nationally during the Clinton years got me wondering: is clinical research included in any way shape or form? If so – and given that we in this industry understand that clinical trial participation offers treatment options for the right patient at the right time – how are study opportunities addressed? A few Google searches later, here’s some of what I found.

First, here’s a brief reminder of what you may be most familiar with – the essentials of the Bill that almost became federal law in 2001. That Bill stated that patients with healthcare plans have the right to:

    • have their medical decisions made by a doctor;
    • see a medical specialist;
    • go to the closest emergency room;
    • designate a pediatrician as a primary care doctor for their children;
    • keep the same doctor throughout their medical treatment;
    • obtain the prescription drugs their doctor prescribes;
    • access a fair and independent appeals process if care is denied; and
    • hold their health plan accountable for harm done.

As you can see, there is no mention of clinical research. However, the first time a Patients’ Bill of Rights was adopted by the American Hospital Association (as far back as 1973), the document contained (and still contains) this clause:

The patient has the right to consent to or decline to take part in research studies or human experimentation affecting care and treatment or requiring direct patient involvement, and to have those studies fully explained prior to consent. A patient who declines to take part in research or experimentation is entitled to the most effective care that the hospital can otherwise provide.

We see the essence of this clause executed every day in the informed consent process. However, it doesn’t guarantee that patients will be informed of clinical studies for which they may be eligible, only that they have a right to know all about the study that they are choosing to participate in.

Well, what if the Bill stated that patients have the right 1.) To be informed about all clinical research studies for which they might be eligible and that are being conducted by the facility in which they are receiving care, and 2.) To be provided with the essential information they need to know in order to decide whether or not they might be interested in participating?

As we will see in the next installment of this blog, the idea may not be as far-fetched as you might think.

To read more of Rob's blogs about the ethics of patient recruitment and other trending industry topics, click here.

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