Tag: confidentiality

Bioethics Blogs

The 2017 Common Rule and the Clinical Ethics of Prolixity

Some bioethicists link the beginnings of our field to the Nazi Medical experiments and the Nuremberg Trial (Annas). Whether this is the beginning of bioethics is debatable, but without a doubt, research ethics has been a central topic in the field. In fact, the very first federal bioethics commission laid out the principles of research ethics in the Belmont Report. Later, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research recommended to the President and Congress that a uniform framework and set of regulations should govern human subjects research.  This effort reached fruition under The Federal Policy for the Protection of Human Subjects or the “Common Rule” that was issued in 1991.  Since then, there have been no major changes to the regulations – until now.  After a five-year process and thousands of comments, the new “final rule” was released on January 19th, 2017.  The July 2017 issue of the American Journal of Bioethics addresses these changes.  In addition to our usual open peer commentaries, we are posting a number of blog posts written in response to the AJOB target article.

The following is a re-post of Steven Mile’s original February 2017 post.


by Steven H. Miles, MD

The new Common Rule to protect human subjects has an extraordinarily large and diverse audience.[i] The new Rules defines the obligations of an enormous number of personnel at the National Institutes of Health as well as virtually any other government agency engaged in research with human subjects. The Rules define the requisite knowledge, training, and work of staff who oversee and conduct clinical research in the United States.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Introducing Common Rule Webinar Series Blog Squad Member Dawn Leusner

Among scientists in the field of education, there are many who believe that all educational research, regardless of purpose, should be exempt from IRB processes and procedures. While the government did not approve education as a new category of excused research under the new proposed Common Rule that is currently slated to take effect in January 2018, there remain many areas of consideration that might be affected, including confidentiality, authentication of online participants, consent and assent, and questions around what constitutes research when conducting data collection activities in school settings.

The post Introducing Common Rule Webinar Series Blog Squad Member Dawn Leusner appeared first on Ampersand.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Responsibility in the age of precision genomics

by Alexa Woodward

Alexa is a fellow in the Precision Medicine: Ethics, Policy, and Culture project through Columbia University’s Center for the Study of Social Difference. The following is her reflection on the ongoing discussion around the Precision Medicine Initiative that has been the subject of recent political, social, and popular media attention. A recent presentation by Sandra Soo-Jin Lee, PhD, from the Center for Biomedical Ethics at Stanford University spurred our multi-disciplinary discussion of some of the following themes.

What is normal, anyway?

Genetically speaking, that’s precisely the question that the Obama administration’s Precision Medicine Initiative (PMI) seeks to answer. In recruiting and collecting comprehensive genetic, medical, behavioral, and lifestyle data from one million Americans, the scientific and medical communities will be better able to understand what constitutes normal genetic variation within the population, and in turn, what amount of variation causes or contributes to disease or disease risk.[1] Using this data, researchers could potentially create tailored approaches for intervention and treatment of an incredible range of diseases.

The PMI has a secondary aim: to increase the representation of previously underrepresented populations in research – primarily African Americans and Hispanics/Latinos. Inclusion of these groups in research has been a challenge for decades, with lack of access, distrust in the medical and research systems, and institutionalized racism all playing exclusionary roles. More broadly, outside of the government initiative, the promise of precision medicine ultimately seeks to alleviate disparities by finding and addressing supposed genetic differences, and empowering people with information to take responsibility for their health.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Trump Opioid Task Force Considers HIPAA Exception for Overdoses

by Craig Klugman, Ph.D.

Confidentiality is one of the sacrosanct principles of medicine. By keeping the secrets that patients share with health care providers, the patient trusts the provider and the provider has the information necessary to diagnose and treat. The Hippocratic Oath, American Medical Association commentaries, 1974 Federal Privacy Act and 1996 Health Insurance Portability and Accountability Act place confidentiality front and center in ethics and law.

Although we place confidentiality on a high pedestal, it does have many exceptions—some which are acceptable and some of which are required. For example, under the Tarasoff rule a provider in most states must report a specific and explicit threat to a third party. Reporting is required for concerns of public health such as abuse or infectious disease. Information must be shared if law enforcement shows a subpoena. A physician may consult colleagues about a case. Administrative assessment and quality improvement review can access patient information without specific patient consent.  In some states, a physician may inform a spouse of certain infectious diseases even when the partner does not want him/her to know. Exceptions are not made lightly since the lack of protecting secrets can decrease patient trust and thus the ability for health care providers to help patients. When exceptions are carved out they are generally because maintaining secrecy would substantially harm the patient or a third party.

A new required exception may be added to this list if New Jersey Governor Chris Christie has his way. He is asking the federal government to carve out a HIPAA exception to allow reporting to a family if a loved one has an opioid overdose.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

In the Journals – May 2017 by Livia Garofalo

Please enjoy the article round-up for the month of May! This post was put together in collaboration with Ann Marie Thornburg.

American Ethnologist

Plant matters: Buddhist medicine and economies of attention in postsocialist Siberia

Tatiana Chudakova

Buddhist medicine (sowa rigpa) in Siberia frames the natural world as overflowing with therapeutic potencies: “There is nothing in the world that isn’t a medicine,” goes a common refrain. An exploration of sowa rigpa practitioners’ committed relations with the plants they make into medicines challenges human-centric notions of efficacy in anthropological discussions of healing. Their work of making things medicinal—or pharmacopoiesis—centers on plants’ vital materialities and requires attention to the entanglements among vegetal and human communities and bodies. Potency is thus not the fixed property of substances in a closed therapeutic encounter but the result of a socially and ecologically distributed practice of guided transformations, a practice that is managed through the attentive labor of multiple actors, human and otherwise. In Siberia, pharmacopoiesis makes explicit the layered relations among postsocialist deindustrialization, Buddhist cosmologies, ailing human bodies, and botanical life.

Annals of Anthropological Practice

Special Issue: Continuity and Change in the Applied Anthropology of Risk, Hazards, and Disasters

Disaster vulnerability in anthropological perspective 

A.J. Faas

In the study of disasters, the concept of vulnerability has been primarily employed as a cumulative indicator of the unequal distributions of certain populations in proximity to environmental and technological hazards and an individual or group ability to “anticipate, cope with, resist and recover” from disaster (Wisner et al. 2004). This concept has influenced disaster research as a means to question how natural, temporary, and random disasters are and focused analysis on the human-environmental processes that produce disasters and subject some populations more than others to risk and hazards.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

The Unusual Case of Ian Paterson and Criminally Harmful Surgery

Guest post by Alex Mullock, University of Manchester

On 28th April 2017 in the case of breast surgeon, Ian Paterson, the jury in Nottingham Crown Court agreed that in carrying out unnecessary and mutilating surgery the defendant had done what no reasonable surgeon would do.  Paterson was convicted of seventeen counts of wounding with intent to cause grievous bodily harm (GBH) and three counts of unlawful wounding (under, respectively, sections 18 and 20 of the Offences Against the Person Act 1861) against nine women and one man. These ten victims, however, have been reported to represent a tiny proportion of all Paterson’s alleged victims, a group that might amount to hundreds from his many years of practice in the NHS and private sector.

The “obscure motives” that compelled Paterson may forever remain a mystery but it is interesting that the charges against him relate only to patients he treated in his private practice.  This enabled the prosecution to create a narrative that suggested that financial gain could have been the motivating factor for Paterson’s crimes.  Without greed as a possible motive his actions are baffling, and the prosecution’s case, in alleging that surgery which Paterson argued was performed in the patient’s best interests actually constituted GBH or unlawful wounding, would be more challenging because of the medical context of the allegations.  Importantly, the medical exception to the criminal law – the principle that consensual surgery carried out by qualified professionals is legitimate (“proper medical treatment”) – means that there is an assumption that harm caused by surgery is not a matter for the criminal law because it is a risk that we accept in order to enjoy the benefits of surgical medicine.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

E-H-ARRGH: The Frustrating Costs and Benefits of the Electronic Health Record

April 28, 2017

by Jami Starr, MD, Clarkson University Bioethics Policy Certificate 2017

E-H-ARRGH: The Frustrating Costs and Benefits of the Electronic Health Record

 The concept of electronic medical recordkeeping was first introduced in the late 1960’s but it did not really become established until this century. Electronic Health Records (EHRs) are expected to provide a number of benefits, including: ability to track data over time, monitoring use of interventions (i.e. vaccinations), and identifying patients in need of preventive screening. Data are forthcoming as to how effectively EHRs meet these goals. What is clear, however, is that it is third party payers profit from EHRs as a result of improvements in claims processing.

The use of EHRs carries implicit hazards with respect to confidentiality. It seems no cyber security system today is impenetrable.  We have witnessed multiple breaches in the past few years involving government agencies, major retail chains, and financial institutions. If a hospital database were hacked, not only would pertinent demographics be exposed (social security numbers, insurance policies, etc.) but also personal information about diagnoses, socioeconomic circumstances, and the like.  While this is a risk with paper medical records as well, the rapid and potentially widespread dissemination of information though a computer data system is far more menacing in scope.  In most clinical settings where EHRs are employed, paper charts have been eliminated and patients do not have an option as to how personal data are maintained.  Vulnerability has been increased de facto by reliance upon this new medium.

Aside from the issues related to cyber security, there are start-up costs related to productivity, burnout and physician-patient relationships.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

CHALLENGING TIMES FOR LONG-TERM CARE STAFF

Mary Jo Bernard and Jodie Penwarden call for a review of practices and policies that contribute to hostile working and living conditions in long-term care facilities.

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Violence is on the rise in long-term care facilities. This is due to both an increase in ‘challenging behaviours’ on the part of residents and an increase in the number of front-line staff working alone due to staff shortages. Often, when workers are ill or injured (sometimes as a direct result of rushing through physical labour all day long), their shifts are not covered.

When there are not enough trained staff on the floor, the residents suffer. They sit in soiled clothing with their call bells ringing, they are rushed through unpleasant meal times, and they are pushed in a commode to their shower through common space in nothing but a towel. Meanwhile, staff become demoralized and the environment risks becoming hostile.

A case from O’Leary, Prince Edward Island, first reported in the spring of 2015, demonstrates how a culture of hostility in long-term care facilities can result in poor quality care.

During the summer of 2016, a resident care worker at a government-funded long-term care facility was fired by Health P.E.I after sharing a photo (which is described as a ‘head shot’) of a deceased resident via Snapchat. Health P.E.I. launched an investigation into the incident and learned a number of disturbing facts. The photo that was shared included an inappropriate caption and was forwarded to someone outside of the workplace. As well, over a period of months, the employee in question had shared numerous other photos of vulnerable residents while they were eating, sleeping, or receiving care after a bowel movement.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Memories Shouldn’t Last a Megabyte

By: Shari Esquenazi

Imagine a world where you can take a picture of anything you desire with just your eyes. You can keep these images stored forever on a wireless device, immediately and infinitely retrievable.  Sounds great, right?

Recent scientific advancements have made contact lenses that are embedded with small cameras a reality. Such forthcoming technologies tend to bring an abundance of ethical considerations with them. 

Google’s “Glass” was the first step toward eyewear that can record photos and video. The tech giant applied for a patent for a contact lens camera in 2014.  Last year, Sony filed a similar patent for a contact lens-embedded camera. While these contacts have a variety of practical uses which both benefit individuals and the overall society, they are not without their faults.

This technology would be undeniably valuable in innumerable situations. A witness to a crime could take a photo that defends the word of a victim, trimming down court cases and protecting innocent citizens in society. A surgeon who finds herself in a problematic operation could live stream the images to another specialist for advice on how to quickly and safely remedy the situation and save a life. 

While the technology has unparalleled benefits, there are ethical concerns that need to be deeply weighed before a person opts for such a capacity in day-to-day life. A brief bioethical analysis illustrates these concerns. 

The existential and ethical theory of transhumanism is the belief that the human race can evolve beyond its current physical and mental limitations, particularly by means of science and technology.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

The National Academy of Sciences Expands its Approval for Gene Editing

by Keisha Ray, Ph.D.

This week the National Academy of Sciences (NAS) released a report giving their support for altering heritable genes when previously the NAS only supported altering uninheritable genes. Although it gave very special conditions in which altering human eggs, sperm, and embryos would be acceptable, giving their seal of approval to any alteration of the human germline is a revolutionary move for the current and future status of genetic engineering for a few reasons:

  1. Expanding Clinical Research

Genetic engineering is already practiced for non-heritable genes. Genes that are known to cause chronic and debilitating diseases are the subject of clinical trials all across the world. However, with the advancement of affordable gene editing technology like CRISPR, some bioethicists, physicians, and scientists have changed their stance on what was once seen as an unethical use of genetic engineering—altering genes that could be passed down to offspring. Now the NAS endorses extending the benefits of gene editing to preventing, curing, and treating chronic, deadly, and heritable diseases, when there is no alternative intervention. Changing their ethical stance on gene editing will expand clinical research and change how research funds are allocated. It will give laboratories new avenues in which to pursue cures for diseases that were once thought incurable. Inevitably, there will be also be an increase in lively debate among bioethicists about what the NAS’s new report means for the relationship between science, ethics, and patient care.

  1. Research Arms-Race

The release of this report, for better or for worse, puts the United States on the same playing field as other countries who have already begun to use gene editing tools to alter the germline, particularly in embryos.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.