Tag: consent

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.

Source: Ampersand, the blog of PRIM&R.

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

Not Just About Consent: The Ethical Dimensions of Research Methodology Knowledge in IRBs

Guest Post: Sarah Wieten

The recent article, “Some Social Scientists Are Tired of Asking for Permission” in the New York Times inspired a great deal of debate about the role of institutional research ethics board (IRB) oversight in social science, which some argue is in most cases unlikely to involve significant harm to participants.

While the role IRBs play in sociological research is being re-examined, the importance of IRB oversight for medical research was not similarly called into question. But what exactly does IRB oversight in medical research involve? Should these groups be content with assuring that patients and participants in medical research have provided informed consent? Or do they have wider duties? What is the relationship between methodologically rigorous science and ethical science?

The approval of research projects by IRBs is an integral part of the conduct of research in universities. IRBs ensure that all research follows key ethical guidelines and is pursued for good reason, and in doing so, they aim to keep patients and participants out of harm’s way. IRBs are important gatekeepers of institutional research, and serve as a check on the work of scientists, physicians, and others who are pursuing new knowledge.

We would assume then, that people serving on IRBs have a clear understanding of relevant research design. That way, they can check the research for ethical issues stemming from the methodology. They can also make sure that methodologically poor studies do not proceed, as this would be an unethical waste of resources (and would put participants at risk without a reasonable prospect of gaining reliable knowledge in exchange).

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

Access to Physicians’ Prescription Habits

Jean-Christophe Bélisle-Pipon calls attention to issues of accessibility and transparency related to the collection and sale of physician prescribing data by data solution companies.

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QuintilesIMS is a data solution company that provides services to the pharmaceutical industry. In 2002, the company was authorized by the Commission d’accès à l’information du Québec to receive and make use of personal information held by Québec pharmacies about physician prescribing practices, provided that: 1) specific professional acts were not linked to specific professionals; 2) physicians could refuse to have their information used; and 3) use of the information was restricted to reaching out, informing and training physicians. Data related to physician prescribing practices is sold by Québec pharmacies to QuintilesIMS. In turn, QuintilesIMS collects, collates this data and sells it to pharmaceutical companies for marketing purposes.

Recently, information related to QuintilesIMS business practices were leaked to the media.

Allegations have been made suggesting that data detailing the prescribing practices of 7,000 Québec physicians (including identifying information) have been disclosed to pharmaceutical companies. If proven true, this would represent an unauthorized practice, that contravenes the Act respecting the protection of personal information in the private sector. The issue at stake in the allegations is not the disclosure to companies, but rather, the disclosure of identifying information.

Physician prescribing data must be clustered in groups of 30 that have similar prescribing profiles. Thus, it is impossible in Canada (contrary to the US) to have access to individual physician prescribing profiles. In Québec, physicians can opt out of this data collection, and those who allow their information to be used, freely have access to their own prescribing profile.

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

Advance Care Planning and End of Life (ACPEL) Conference

The program for the 2017 Advance Care Planning and End of Life (ACPEL) Conference in Banff is now available.


Pre-Conference Sessions (Part 1)
Session 1: CRIO 
1. How do people with disabilities perceive advance care planning – Robin Gray, University of Calgary


2. Differences in survey methodology of two Advance Care Planning survey polls conducted in Alberta, Canada – Sunita Ghosh, Alberta Health Services-CancerControl


3. Efficacy of Advance Care Planning and Goals of Care Designations Discussions: A Randomized Controlled Trial and Video Intervention – Maureen Douglas, University of Alberta
  
4. Identification of indicators to monitor successful implementation of Advance Care Planning policies: a modified Delphi study – Patricia Biondo, University of Calgary

5. The economics of advance care planning, Konrad Fassbender, University of Alberta; Covenant Health

Session 2: Health Care Consent, Advance Care Planning, and Goals of Care: The Challenge to Get It Right in Ontario

Health Care Consent, Advance Care Planning, and Goals of Care: The Challenge to Get It Right in Ontario – Tara Walton, Ontario Palliative Care Network Secretariat

Session 3: How to Invite Clinicians to Initiate ACP

1. How to Invite Clinicians to Initiate ACP to Residents, Patients, and Family Carers? – Luc Deliens  
  
2. Development of a complex intervention to support the initiation of advance care planning by general practitioners in patients at risk of deteriorating or dying: a phase 0-1 study – Aline De Vleminck, Free University of Brussels & Ghent University

Pre-Conference Sessions (Part 2)

Session 1: Faith Based Workshop

Inviting the voice of Spirituality within the conversation of Advanced Care Planning – Thomas Butler, Bon Secours Health System Inc.

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

2nd International Conference on End-of-Life Law, Ethics, Policy, and Practice

Check out this remarkable collection of concurrent sessions coming up at the 2nd International Conference on End-of-Life Law, Ethics,
Policy, and Practice (ICEL) in Halifax.



The Ethics of POLST
Lloyd Steffen


The Perils of POLST
Jean Abbott


Advanced Directives and Advanced Care Planning
Peter Saul


“Rock, Paper, Scissors” – Ideologies of End of Life Care for Older People in Hospital
Laura Green


The Cultural Construction of End of Life Issues in Biomedicing: Anthropological Perspectives
Betty Wolder Levin


Caregiver Perspectives of Palliative and End of Life Care for Individuals at End-Stage Dementia in Newfoundland and Labrador: A Qualitative 
Phenomenological Perspective
Barbara Mason


End of Life Regulation and Recent Evolutions in France
Veronique Fournier


To Live and Let Die. Withholding and Withdrawing Life Sustaining Treatment in Argentina: From Therapeutic to Judicial Obstinacy
Maria Ciruzzi


When and How I Shan’t Live: Refusing Life-Prolonging Medical Treatment and Article 8 ECHR
Isra Black


Divorcing Mercy Killing from Euthanasia
Bryanna Moore


The Shift Away from Suicide Talk: Incorporating Voices of Experience
Phoebe Friesen


Elderly Who are Ready to Give Up on Life and the Right to Autonomy
Michelle Habets


Dutch GP’s Views on Good Dying and Euthanasia
Katja ten Cate


Medical Aid in Dying in New York State: Physician Attitudes and Impact of Framing Bias
Brendan Parent


Physicians’ Perceptions of Aid in Dying in Vermont
Ari Kirshenbaum


A New American Threat to Open Discussion of End-of-Life Issues
Robert Rivas


Demedicalised Assistance in Suicide
Martijn Hagens


The Human Rights Implications of the Blanket Ban on Assisted Suicide in England and Wales
Stevie Martin


A Year in Review: The Who, When, Why and How of Requests for Medical Aid in Dying in Quebec
Lori Seller and Veronique Fraser


Medical Aid in Dying: An Update from Québec
Michelle Giroux


Regulating MAiD: The Medical Regulatory Perspective
Andréa Foti


Patients with Parkinson’s Disease, Caregivers’, and Healthcare Providers’ Perspectives on Advance Care Planning on End-of-Life Care
Kim Jameson


‘You’re Going to Die.

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

Helping or hacking? Engineers and ethicists must work together on brain-computer interface technology

A subject plays a computer game as part of a neural security experiment at the University of Washington. Patrick Bennett, Author provided

In the 1995 film “Batman Forever,” the Riddler used 3-D television to secretly access viewers’ most personal thoughts in his hunt for Batman’s true identity. By 2011, the metrics company Nielsen had acquired Neurofocus and had created a “consumer neuroscience” division that uses integrated conscious and unconscious data to track customer decision-making habits. What was once a nefarious scheme in a Hollywood blockbuster seems poised to become a reality.

Recent announcements by Elon Musk and Facebook about brain-computer interface (BCI) technology are just the latest headlines in an ongoing science-fiction-becomes-reality story.

BCIs use brain signals to control objects in the outside world. They’re a potentially world-changing innovation – imagine being paralyzed but able to “reach” for something with a prosthetic arm just by thinking about it. But the revolutionary technology also raises concerns. Here at the University of Washington’s Center for Sensorimotor Neural Engineering (CSNE) we and our colleagues are researching BCI technology – and a crucial part of that includes working on issues such as neuroethics and neural security. Ethicists and engineers are working together to understand and quantify risks and develop ways to protect the public now.

Picking up on P300 signals

All BCI technology relies on being able to collect information from a brain that a device can then use or act on in some way. There are numerous places from which signals can be recorded, as well as infinite ways the data can be analyzed, so there are many possibilities for how a BCI can be used.

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

From the Director: Informed Consent in the Revised Common Rule

Over the coming months, I’m going to look more closely at a few areas of the revised rule. I won’t be giving tips on implementation, just pointing out some of what I find interesting in a few specific areas. In this post, I’m going to take a deeper dive into the changes around informed consent, an area that, as I mentioned in my preliminary reflections on the rule, I am pretty excited about.

The post From the Director: Informed Consent in the Revised Common Rule appeared first on Ampersand.

Source: Ampersand, the blog of PRIM&R.

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

Vanderbilt Children’s Hospital Removes Life Support over Parents’ Objections

Steffen Rivenburg Jr. was born in October 2016 with a congenital heart defect. In February 2017, because his parents had missed several medical appointments, the Tennessee Department of Child Services took custody.  But during that time, Steffen became quite ill.


Steffen was admitted to Vanderbilt Children’s Hospital where he had several heart surgeries and was placed on ECMO.  He needed a heart transplant, but was too sick to be eligible. Determining it was in Steffen’s best interest, Vanderbilt planned to withdraw life-sustaining treatment.


On May 30, Steffen’s parents obtained a court injunction mandating Vanderbilt to continue treatment until June 6.  The Montgomery County, Tennessee Juvenile Court later denied the parents’ request for an extension.  Vanderbilt discontinued life-sustaining treatment on June 8.


In some states, like Ohio, temporary guardians may not consent to withdrawing life-sustaining treatment unless there has been a termination of parental rights.  In other states, like Delaware, temporary guardians may consent to withdrawing life-sustaining treatment if that is in the child’s best interest.  

Source: bioethics.net, a blog maintained by the editorial staff of The American Journal of Bioethics.

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

Human Milk Banking in Guatemala City: All for All

Martha Paynter compares human milk banking practices in Guatemala City and Atlantic Canada.

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Last month, non-profit human milk banking staff and researchers from across the continent met in Dallas for the Human Milk Banking of North America 2017 Symposium to share best practices and new developments. The use of human donor milk is growing and non-profit banks must compete with for-profit enterprises and private milk markets. Human donor milk health and safety standards in North America continue to evolve in response to scientific evidence, epidemiological developments such as Zika, and funding changes including the recent Medicaid coverage for banked milk in New York State. While we adapt processes and goals for milk banking in North America, it is worth examining alternative models of milk bank operations.

In Atlantic Canada, for example, three level-3 Neonatal Intensive Care Units (NICU) provide human donor milk to infants under 1500 grams who are unable to receive sufficient milk from their own mothers. The milk is purchased at approximately $5/ounce, including shipping, from the Northern Star Mothers Milk Bank in Calgary. Northern Star is a private, community-based non-profit business. Milk is collected from healthy volunteer lactating women across Canada who meet donor criteria. Donors may take some medications, but not pharmaceuticals or herbs to promote lactation. Donors ship the frozen milk by courier to Northern Star, where it is pasteurized and distributed to NICUs, inpatients and outpatients across the country according to need and availability. Since opening in 2012, Northern Star has distributed over 500,000 ounces of milk.

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.