UW Medical Consents to Talk About Controversial Studies

Participants in this kind of research cannot provide consent "after the fact" -- since at that point the treatments have already been administered and consent is therefore moot. Hence the federal guidelines state they must be informed after the fact, but recognize that consent to the treatment they already received isn't realistic. Because of this issue, there are strict federal guidelines that are rigorously applied to studies involving exception to informed consent. These include: the study treatments can only given in circumstances where there is no other proven effective therapy, -and- that the study treatments must hold promise of being better than standard treatments, -and- must have reasonable risk, -and- the life-threatening emergency circumstances must make it impossible to delay such treatment in order to obtain consent, such that it would be impossible to conduct the study in its absence. Put another way, both the point of informed consent AND exception to informed consent is to protect patients/subjects from potentially dangerous treatments. If anything, the guidelines pertaining to exception to informed consent are even more rigorous than those pertaining to informed consent. Studies that meet all these strict exception to informed consent guidelines are also required to have approval from and ongoing oversight by the FDA, a local Investigational Review Board, and an independent Data Safety and Monitoring Board, who monitor its progress and have authority to modify or halt the trial. And such studies must satisfy the requirements of these oversight bodies in terms of have performed appropriate community consultation and notification about the proposed reseaerch. Finally, all subject and/or their families must be notified in timely fashion of their participation, have opportunity to ask questions, and, if desired, to decline further participation in the study (such as long-term follow-up of their subsequent health status). You're correct that opting out loses opportunity to obtain full information, which is why all efforts are made to fully notify, inform and address questions. It seems that once folks like this or their families understand the importance of the emergency research being done, the strict rules under which it had to be conducted, and that in addition to the experimental treatment, they received all other standard care measures and the best possible care ... most folks appreciate that they are not only contributing to their own care, but potentially impacting the lives of thousands of future patients and elect to continue participation in the research. Those who don't are given full respect of that decision, including it being made clear that such a decision (either way) does not alter the care to which they would otherwise be entitled.

How do you address the issue of an individual who may have limited cognitive abilities and thus not be able to grant informed consent? If such a patient is suffering from severe trauma or cardiac arrest, how would the administers of his or her treatment determine that? Or will the test results simply be discarded upon making that determination later?

At the time someone sustains a cardiac arrest, their cognitive abilities can't be known by care providers. Hence the Federal Regulations about waiver of consent (described above) fall into place and apply. However, afterward, if cognitively impaired, a legally authorized representative (family member, or court appointed) is provided with the same information, on behalf of the patient, in the same manner as if the patient himself/ or herself were cognitive.

Can you confirm whether changes were made to the web page regarding "opting out" of the study within the past seven days to include language that "You will have to wear this bracelet during the time the study is being conducted – through 2009." And: "Even if you wear this bracelet there is no guarantee that under emergency circumstances the bracelet will be read by those providing care for you. You might still get the enrolled in the study."

The year was corrected to 2010, although the community would be notified if the trial ended sooner. Persons could also periodically access the website which would provide such information. I believe the statement following the last one you quoted relates to the fact that their information will be destroyed from the standpoint of the study if they were inadvertently enrolled. Please appreciate that this disclaimer (that they might still be enrolled in the study) is given because under extreme emergency conditions where seconds count to save a life, a bracelet might go unnoticed by the paramedics in the process of providing needed emergent care or only evaluated closely once the patient has been stabilized enough to learn more about their medical background. We anticipate this being a rare if ever occurrence, but want folk to understand that it might still be possible.

Can you provide details on your program of "community consultation and public disclosure"--where and when any ads appeared, where they appeared, what they said, and are they still up?

Telephone Survey – Hebert Research, Inc. (independent research firm)

• Conducted September, 2006


• Random survey of 210 households in King County


• 73.9% favorable response for receiving experimental CPR treatment

Website: www.uwheartroc.org

• Online October, 2006


• Accessed 55 times by 46 unique visitors. There were 8 hits on 11/2/06.
  
• Average time spent on website was 2.5 minutes. 75% of visitors left the site without accessing other links. According to the webmaster, this signifies that visitors found all of the information they were looking for on the webpage.


• No direct response to website

Metro Bus Ad

• Posted in 200 metro buses throughout King County 10/25/06 thru 11/23/06


• No direct response (e-mail or phone) from the ad - Reports that some ads have remained in buses thru April 2007

Press release: November 1, 2006
Recipients:

• Seattle Times; Seattle P-I; KOMO TV; King 5 TV; KIRO TV; KCPQ FOX TV; KUOW Radio; KOMO Radio; NPR radio; AP wire services; Reuters News Service; Bloomberg News Service; LA Times; NY Times; San Francisco Chronicle; Washington Post

One telephone inquiry (11/6/06) from NPR followed by radio report below

NPR radio report: Ken Seinfeld – KPLU Health & Science editor

• Objective but favorable report


• Aired 11/7/06 four times (2 morning & 2 afternoon times)


• No direct response from radio story

Targeted Minority Advertising

Real Change – Homeless newspaper – Circulation approx. 40,000

• 10/25/06, 11/1/06, 11/8/06 - quarter page ad


• 2 direct responses to e-mail address from one individual wanting to eliminate the use of sirens on cardiac calls

NW Asian Weekly– Targets Asian community – Circulation approximately 10,000

• 10/28, 11/10 – quarter page ad


• No direct response to ad.

The Prinicipal investigator of the study (Dr. Peter Kudenchuk) wrote editorials to both Times and PI with details regarding the project (including waiver of consent) in October, 2006. They were never published.