Research Versus Freedom of Choice?

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After writing, Who Will Speak for the Voiceless, I realized it was necessary for me to do a follow up story to provide more pertinent information regarding the proposed experiment that I had not covered in my first two articles.

The Resuscitation Outcomes Consortium (ROC), a group of medical centers forming a collective to experiment on more than 20,000 unconscious patients without informed consent, as authorized by the National Institutes of Health (NIH) and the Food and Drug Administration (FDA), plans to conduct clinical trials using treatments for cardiac arrest and severe trauma.

Initial funding for ROC, 50 million dollars, has been provided for the study by the NIH. Additional funding agencies include: The National Heart, Lung and Blood Institute (NHLBI), a branch of the NIH and the lead federal sponsor, in partnership with the U.S. Department of Defense (DOD), the NIH's National Institute for Neurological Disorders and Stroke, the Institute of Circulatory and Respiratory Health of the Canadian Institutes of Health Research, Defence Research and Development Canada, the Heart and Stroke Foundation of Canada and the American Heart Association (AHA).

According to NIH News, in a release dated March 24, 2006, in the “typical trial scenario”, first responders will be confirming the patients' diagnosis of injuries qualifying for the study, when they, the responders, arrive at the scene.

It will be the emergency medical technician (EMT), in the field, who will determine if the patient meets the criteria for inclusion in the study and if that is the case, the EMT will treat the patient within the parameters of whatever experimental treatment is to be used for the study.

The news release states that the studies are to be blind studies, meaning the EMTs will not be aware which treatment a patient will receive. As an example, for the saline study, all solutions of saline will look alike but will not be alike. The solutions will be numbered for identification and analysis at a later time by scientists in the study.

Dr. Al Hallstrom is identified as the principal investigator for the study, which will be coordinated by investigators at the University of Washington, Seattle.

Participating cities included in the study are:

Birmingham, Alabama: coordinated through the University of Alabama.

Principal investigator: Tom Terndrup, MD

Dallas, Texas: coordinated through the University of Texas Southwestern Medical Center

Principal investigator: Ahamed Idris, MD

Iowa City, Iowa: coordinated through the University of Iowa

Principal investigator: Richard Kerber, MD

Milwaukee, Wisconsin: coordinated through the Medical College of Wisconsin

Principal investigator: Tom Aufderheide, MD

Ottawa, Ontario/Vancouver, BC: coordinated through the Ottawa Health Research Institute, University of Ottawa, Ontario and St. Paul's Hospital, University of British Columbia

Principal investigator: Jim Christenson, MD

Pittsburgh, Pennsylvania: coordinated through the University of Pittsburgh Medical Center

Principal investigator: Clif Callaway, MD, PhD

Portland, Oregon: coordinated through the Oregon Health and Science University

Principal investigator: Jerris R. Hedges, MD

San Diego, California: coordinated through the University of California, San Diego

Principal investigator: David Hoyt, MD

Seattle and King County, Washington: coordinated through the University of Washington

Principal investigator: Peter Kudenchuk, MD

Toronto, Ontario: coordinated through the University of Toronto

Principal investigator: Arthur Slutsky, MD

Co-Principal investigators: Laurie Morrison, MD and Paul Dorian, MD

As this study is currently designed, with first on the scene responders, EMTs, responsible for making assessments in the field on the way to the hospital, it is virtually assured, if the patient is unconscious or unresponsive and severely injured, the criterion outlined by the AMA's ethics board, the Council on Ethics and Judicial Affairs, will easily be met.

Any statements here are not meant to cast doubt on the expertise or professionalism of first on the scene responders. The intent is to highlight that, in these sets of circumstances, unless a representative or loved one is present at the time an injury occurs to a patient, chances are the waiver of informed consent, for the sake of expediency, could and would logically be considered a course of action to pursue.

Because this is a blind study, and in the case of the first treatments to be tested on trauma patients exhibiting signs of blood loss or brain injury, with patients receiving one of three saline solutions, with saline solutions meant to compensate for blood loss and to “buy time” as the patient is taken to a hospital, it seems the patient's representative should be included in choosing, if it has already been determined that two of the three solutions may be more beneficial in the long run to the patient. Can it be reasonably expected that, given the choice between getting the most beneficial treatment and the least effective one, that anyone would choose the least effective course of action?

In the NIH press release, Tracey Hoke, MD, ScM, NHBLI project officer for the ROC states:

A federal exception of informed consent can only be granted when patients are in a life threatening situation, when obtaining individual informed consent is impossible and when current therapy is unproven or unsatisfactory. The most critical stipulation of the exception is that there must be the potential for direct benefit to patients enrolled. In the case of ROC, this means that preliminary evidence of direct survival benefit must be shown prior to development of any trial.

If it is deemed that the current therapy for the condition of a trauma patient is “unproven or unsatisfactory”, given the previous two statements by Dr. Hoke, regarding potential benefit and the Resuscitation Outcomes Consortium's stipulation of evidence of “direct survival benefit” being shown before any trial, how can it be said that this study is in federal compliance if the patient may or may not receive this beneficial treatment?

This study all but guarantees the use of helpless patients, unable to speak for themselves, furthering the goals of scientific research, without any say or input into the process in their treatment or care, by them or any family member or representative, until after they have been enlisted in a study not of their choosing, with an option to withdraw from the experiment after it has begun, an option that may not occur given the possible severity of their injuries.

A possible solution to eliminate short circuiting individual choice would be some form of prior consent to be devised, to be kept on file, where a patient would state, much like in the case of organ donation, that they choose or do not choose to participate in experiments if they are unable to speak for themselves and time prevents family or representation for the patient to be contacted for informed consent.

In the case of individuals who do not have adequate health care, or no health care at all, as a great many do not have in the U.S., whenever these individuals are seen, usually on an emergency basis, they may be asked to complete the form. Current technology provides for the option of an on line declaration of one's choice to be involved in or not involved in an experiment as well. Some form of outreach should be devised to attempt to address this crucial issue.

Freedom of choice to not be experimented upon must not be given away simply because it may be difficult or impossible to acquire consent from an incapacitated patient or the unfortunate factor of time stands between an experimenter and distraught family members or representatives needing to be included in decisions regarding the injured patient, who is in need of the best medical services that can be provided to them.

www.nih.gov/news/pr/mar2006/nhlbiv1-24.htm