The Journal of Law, Medicine and Ethics This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Pediatric Cancer Genetics Research and an Evolving Preventive Ethics Approach for Return of Results after Death of the Subject
The return of genetic research results after death in the pediatric setting comes with unique complexities. Researchers must determine which results and through which processes results are returned. This paper discusses the experience over 15 years in pediatric cancer genetics research of returning research results after the death of a child and proposes a preventive ethics approach to protocol development in order to improve the quality of return of results in pediatric genomic settings. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - October 19, 2015 Category: Medical Law Authors: Sarah Scollon, Katie Bergstrom, Laurence B. McCullough, Amy L. McGuire, Stephanie Gutierrez, Robin Kerstein, D. Williams Parsons, Sharon E. Plon Tags: Symposium Articles Source Type: research

Returning a Research Participant's Genomic Results to Relatives: Perspectives from Managers of Two Distinct Research Biobanks
Research biobanks are heterogeneous and exist to manage diverse biosample types with the goal of facilitating and serving biomedical discovery. The perspectives of biobank managers are reviewed, and the perspectives of two biobank directors, one with experience in institutional biobanks and the other with national cooperative group banks, are presented. Most research biobanks are not designed, nor do they have the resources, to return research results and incidental findings to participants or their families. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - October 19, 2015 Category: Medical Law Authors: Gloria M. Petersen, Brian Van Ness Tags: Symposium Articles Source Type: research

Canadian Research Ethics Board Leadership Attitudes to the Return of Genetic Research Results to Individuals and Their Families
Genomic research may uncover results that have direct actionable benefit to the individual. An emerging debate is the degree to which researchers may have responsibility to offer results to the biological relatives of the research participant. In a companion study to one carried out in the United States, we describe the attitudes of Canadian Research Ethics Board (REB) chairs to this issue and their opinions as to the role of the REB in developing related policy. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - October 19, 2015 Category: Medical Law Authors: Conrad V. Fernandez, P. Pearl O'Rourke, Laura M. Beskow Tags: Symposium Articles Source Type: research

Return of Genetic Research Results to Participants and Families: IRB Perspectives and Roles
We surveyed IRB chairs' perspectives on offering individual genetic research results to participants and families, including family members of deceased participants, and the IRB's role in addressing these issues. Given a particular hypothetical scenario, respondents favored offering results to participants but not family members, giving choices at the time of initial consent, and honoring elicited choices. They felt IRBs should have authority regarding the process issues, but a more limited role in medical and scientific issues. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - October 19, 2015 Category: Medical Law Authors: Laura M. Beskow, P. Pearl O'Rourke Tags: Symposium Articles Source Type: research

Mapping the Ethics of Translational Genomics: Situating Return of Results and Navigating the Research‐Clinical Divide
Both bioethics and law have governed human genomics by distinguishing research from clinical practice. Yet the rise of translational genomics now makes this traditional dichotomy inadequate. This paper pioneers a new approach to the ethics of translational genomics. It maps the full range of ethical approaches needed, proposes a “layered” approach to determining the ethics framework for projects combining research and clinical care, and clarifies the key role that return of results can play in advancing translation. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - October 19, 2015 Category: Medical Law Authors: Susan M. Wolf, Wylie Burke, Barbara A. Koenig Tags: Symposium Articles Source Type: research

Patients' Choices for Return of Exome Sequencing Results to Relatives in the Event of Their Death
The informed consent process for genetic testing does not commonly address preferences regarding disclosure of results in the event of the patient's death. Adults being tested for familial colorectal cancer were asked whether they want their exome sequencing results disclosed to another person in the event of their death prior to receiving the results. Of 78 participants, 92% designated an individual and 8% declined to. Further research will help refine practices for informed consent. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - October 19, 2015 Category: Medical Law Authors: Laura M. Amendola, Martha Horike‐Pyne, Susan B. Trinidad, Stephanie M. Fullerton, Barbara J. Evans, Wylie Burke, Gail P. Jarvik Tags: Symposium Articles Source Type: research

Preferences Regarding Return of Genomic Results to Relatives of Research Participants, Including after Participant Death: Empirical Results from a Cancer Biobank
Data are lacking with regard to participants' perspectives on return of genetic research results to relatives, including after the participant's death. This paper reports descriptive results from 3,630 survey respondents: 464 participants in a pancreatic cancer biobank, 1,439 family registry participants, and 1,727 healthy individuals. Our findings indicate that most participants would feel obligated to share their results with blood relatives while alive and would want results to be shared with relatives after their death. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - October 19, 2015 Category: Medical Law Authors: Carmen Radecki Breitkopf, Gloria M. Petersen, Susan M. Wolf, Kari G. Chaffee, Marguerite E. Robinson, Deborah R. Gordon, Noralane M. Lindor, Barbara A. Koenig Tags: Symposium Articles Source Type: research

Returning a Research Participant's Genomic Results to Relatives: Analysis and Recommendations
Genomic research results and incidental findings with health implications for a research participant are of potential interest not only to the participant, but also to the participant's family. Yet investigators lack guidance on return of results to relatives, including after the participant's death. In this paper, a national working group offers consensus analysis and recommendations, including an ethical framework to guide investigators in managing this challenging issue, before and after the participant's death. (Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - October 19, 2015 Category: Medical Law Authors: Susan M. Wolf, Rebecca Branum, Barbara A. Koenig, Gloria M. Petersen, Susan A. Berry, Laura M. Beskow, Mary B. Daly, Conrad V. Fernandez, Robert C. Green, Bonnie S. LeRoy, Noralane M. Lindor, P. Pearl O'Rourke, Carmen Radecki Breitkopf, Mark A. Rothstein, Tags: Symposium Articles Source Type: research

INTRODUCTION: Return of Research Results: What About the Family?
(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - September 1, 2015 Category: Medical Law Authors: Susan M. Wolf Tags: Symposium Articles Source Type: research

Calendar of Events
(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - August 4, 2015 Category: Medical Law Tags: Calendar of Events Source Type: research

Ethical Issues in Big Data Health Research: Currents in Contemporary Bioethics
(Source: The Journal of Law, Medicine and Ethics)
Source: The Journal of Law, Medicine and Ethics - August 4, 2015 Category: Medical Law Authors: Mark A. Rothstein Tags: Columns Source Type: research

Conflicts of Interest and Effective Oversight of Assisted Reproduction Using Donated Oocytes
Oocyte donation raises conflicts of interest and commitment for physicians but little attention has been paid to how to reduce these conflicts in practice. Yet the growing popularity of assisted reproduction has increased the stakes of maintaining an adequate oocyte supply and (where appropriate) minimizing conflicts. A growing body of professional guidelines, legal challenges to professional self‐regulation, and empirical research on the practice of oocyte donation all call for renewed attention to the issue. As empirical findings better inform existing conflicts and their potential harms, we can better attempt to reduc...
Source: The Journal of Law, Medicine and Ethics - August 4, 2015 Category: Medical Law Authors: Valarie K. Blake, Michelle L. McGowan, Aaron D. Levine Tags: Independents Source Type: research

Stakeholders' Views of Alternatives to Prospective Informed Consent for Minimal‐Risk Pragmatic Comparative Effectiveness Trials
The objective was to elicit participants' views of the acceptability of four different disclosure and authorization models for low‐risk pragmatic comparative effectiveness trials of widely‐used therapies. Results suggest that although participants valued autonomous choice, many also believed that it was acceptable to streamline information disclosure and to use an opt‐out process for eligible individuals who would prefer not to participate. This provides some preliminary evidence that relevant stakeholders find alternatives to traditional informed consent acceptable for low‐risk pragmatic comparative effectiveness ...
Source: The Journal of Law, Medicine and Ethics - August 4, 2015 Category: Medical Law Authors: Danielle Whicher, Nancy Kass, Ruth Faden Tags: Independents Source Type: research

Institutional Oversight of Faculty‐Industry Consulting Relationships in U.S. Medical Schools: A Delphi Study
The conflicts of interest that may arise in relationships between academic researchers and industry continue to prompt controversy. The bulk of attention has focused on financial aspects of these relationships, but conflicts may also arise in the legal obligations that faculty acquire through consulting contracts. However, oversight of faculty members' consulting agreements is far less vigorous than for financial conflicts, creating the potential for faculty to knowingly or unwittingly contract away important rights and freedoms. Increased regulation could prevent this, but it is unclear what forms of oversight universitie...
Source: The Journal of Law, Medicine and Ethics - August 4, 2015 Category: Medical Law Authors: Stephanie R. Morain, Steven Joffe, Eric G. Campbell, Michelle M. Mello Tags: Independents Source Type: research

Organ Donation, Brain Death and the Family: Valid Informed Consent
I argue that valid informed consent is ethically required for organ donation from individuals declared dead using neurological criteria. Current policies in the U.S. do not require this and, not surprisingly, current practices inhibit the possibility of informed consent. Relevant information is withheld, opportunities to ensure understanding and appreciation are extremely limited, and the ability to make and communicate a free and voluntary decision is hindered by incomplete disclosure and other practices. Current practices should be revised to facilitate valid informed consent for organ donation. (Source: The Journal of L...
Source: The Journal of Law, Medicine and Ethics - August 4, 2015 Category: Medical Law Authors: Ana S. Iltis Tags: Independents Source Type: research