Topic: Risk
November 30, 2015 | Posted By Jane Jankowski, DPS, LMSW

Risk, defined in the dictionary as the “exposure to the chance of injury or loss; a hazard or dangerous chance,”   finds a home in the daily dialogue of bioethics when we weight the consequences of decisions, usually related to healthcare decision making. Environmental factors are not commonly prominent in our discussion of risk considerations – we leave these decisions to the architects and designers who create healthcare spaces. In treatment spaces where deeply personal and intimate life experiences take place, we may need to consider the importance of a multi-stakeholder perspective when new spaces are created or existing spaces are re-designed.

Birth experiences, end of life experiences, and acute crises mark the psyche of patients and families permanently. People come into hospitals with expectations of safe, high quality, accessible care. Birth centers and maternity units increasingly offer family centered care with multiple security measures to assure that newborns, neonates, and family members are as safe and protected as possible. End of life experiences may be enhanced by privacy, increased flexibility in time spent at the patient’s side, physically comfortable surroundings, and appropriate levels of emotional support. Times of acute crisis are less well honored in the physical setting of hospitals, as evidenced in behavioral health care crisis units, which seem to be a lagging priority when it comes to assuring patient centered needs of health and healing are enhanced by environmental considerations.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

June 4, 2015 | Posted By Bruce White, DO, JD

On May 7, 2015, The New York Times reported that Johnson & Johnson (New Brunswick, New Jersey) had asked Arthur Caplan, PhD, Professor of Bioethics at New York University School of Medicine to create a new panel “that will make decisions about patients’ requests for potentially lifesaving medicine, responding to an emotional debate over whether companies should allow desperately ill people to have access to the drugs before they are approved [by the FDA].” 

Compassionate use” experimental drugs have been available for some time. In the recent Ebola crisis, last year the FDA “allowed the makers of ZMapp, an experimental treatment, to be used on a handful of patients, but the company quickly exhausted its limited supply.” Of late, several states have enacted “Right to Try” statutes in an attempt to craft a legally-recognized right to early access to drugs still in clinical trials.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

October 8, 2013 | Posted By John Kaplan, PhD

My last blog, written just a few weeks ago, discussed the case of two neurosurgeons who had purposely introduced bowel bacteria into the brains of patients with glioblastoma, a process they termed “probiotic intracranial therapy”. In that blog I expressed the opinion that the physicians had inappropriately exposed their patients to excessive risk and compared the incident to assault. In the brief time since then high risk research has been covered in both the biomedical literature and the popular press. We have also seen more news regarding treatments with bowel bacteria indicating that fecal bacteria may well have their place in medical treatment. Their place, however, is in the gut not the brain.

In the journal Lancet, David Shaw argues that Institutional Review Boards “should never reject a study because it poses too high a risk to participants.” Institutional Review Boards are the mechanisms that review research protocols designed to be conducted with human subjects. Among the charges to Institutional Review Boards is to evaluate the balance between the potential benefits and potential risks of a proposed research project. When assessing protocols of prospective therapies they need to identify that there is adequate reason, both theoretical and experimental, to think the therapy might work. They should also assure that the risks of the proposed study do not endanger the participants out of proportion to the potential benefits. These dangers were excessive in the well known Tuskegee syphilis studies and similar studies in Guatemala as well as the supposed research in the Nazi atrocities. This horrendous history drove many of the protections we now use to safeguard human research participants.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

SEARCH BIOETHICS TODAY
SUBSCRIBE TO BIOETHICS TODAY
ABOUT BIOETHICS TODAY
BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.
TOPICS