Browsing by Subject "Informed Consent"
Now showing 1 - 6 of 6
- Results Per Page
- Sort Options
Item Addressing privacy challenges in healthcare through the lens of contextual integrity(2023-02-14) Nissenbaum, Helen[Note: The slide presentation is not available from this event.] In healthcare, as in other social spheres, digital technology has posed dire challenges to entrenched approaches to privacy. Yet, as a fundamental cornerstone of ethical healthcare, privacy cannot be allowed to erode. The theory of contextual integrity (CI), which defines privacy as appropriate flow of personal information answers the need for a meaningful concept of privacy that, simultaneously explains its value to individuals and to societies. CI requires that we bend away from one-dimensional ideas, which for decades have gripped the privacy domain, namely, control over information about ourselves, stoppage of flow, or fetishization of specific, "sensitive" attributes (e.g., identity, health). This lecture will review key ideas behind CI, contrast it with alternative accounts, and apply these ideas to the domain of intensive health care and health research domains, distinctive not only for their societal importance but for their ages-long attentiveness to privacy.Item The challenge of precision medicine: ethical, legal & clinical issues in genomic medicine (The Daniel W. Foster, M.D., Visiting Lectureship in Medical Ethics)(2015-11-03) Wolf, Susan M.Genomics is advancing at a tremendous rate, bringing powerful new capabilities but also big challenges to clinical practice and research. With the federal government launching the Precision Medicine Initiative, the time to face those challenges is now. Genomic medicine raises fundamental issues including the role of patient choice, the development of quality standards, the privacy of sequence data, return of results and incidental findings, protection of patient privacy, and responsibilities to share information with the family. This lecture will analyze those challenges and suggest a way forward in biomedical research as well as clinical care.Item Conceptual controversies in death determination(2017-04-11) Bernat, James L.There is an intractable disagreement over whether the organ donor after the circulatory determination of death (DCDD) is dead at the time death is ordinarily declared. A rigorous analysis of death determination illuminates the cause of the controversy. Death determination can be conceptualized in two distinct ways: the biological approach in which cessation of vital functions must be irreversible and the medical approach in which cessation of vital functions must be permanent. The two noncongruent standards lead to determining death at different times and explain the current controversy over death determination in the DCDD donor. By the biological standard, the organ donor is not dead but by the medical standard, the organ donor is dead.Item The ethics police?: the struggle to make human research safe(2016-01-12) Klitzman, RobertExperiments on human beings have saved countless lives, but sometimes harmed participants. Critical questions thus emerge: how much government should regulate science, and how. Nazi experiments and the Tuskegee syphilis study led the US, in 1974, to establish Research Ethics Committees (or Institutional Review Boards -- IRBs) to oversee human research. But these committees have increasingly been criticized for blocking important studies, while ethical violations continue. Crucial dilemmas thus emerge: whether this system should be changed, and if so, how. In September 2015 President Obama's administration recommended several reforms. Yet we must first understand this system to know how to improve it. Unfortunately, these committees operate behind closed doors, and have received relatively little in-depth investigation. This talk, based on interviews with dozens of IRB leaders, explores how they make decisions, wrestling with conflicts and complexities assessing possible risks and benefits of studies, and deciding how much to trust researchers -- key questions that ultimately affect us all.Item Surrogate decision making in the internet age(2018-02-13) Berg, Jessica W.[Note: The slides are not available from this event.] The technology revolution has had an enormous effect on all aspects of the practice of medicine, from record-keeping to scheduling to billing to treatments to research. But although there have been efforts to create online decision-aids to facilitate informed consent, little thought has been given to the role of social media in surrogate decision making. Many people have been using various outlets for years, and left significant electronic documentation of their preferences. As social media users age, questions of how and whether to use social media to assist surrogate decision making will become more prevalent. This presentation considers the ethical and legal issues involved in the use of social media -- such as Facebook and Twitter -- in determining medical treatment preferences for surrogate decision making.Item What makes research ethical?(2014-02-11) Wendler, DavidMany believe that informed consent makes clinical research ethical. However, informed consent is neither necessary nor sufficient for ethical clinical research. Drawing on the basic philosophies underlying major codes, declarations, and other documents relevant to research with human subjects, this presentation proposes seven requirements that systematically elucidate a coherent framework for evaluating the ethics of clinical research studies: (1) value; (2) scientific validity; (3) fair subject selection; (4) favorable risk-benefit ratio; (5) independent review; (6) informed consent; and (7) respect for enrolled subjects. These requirements are universal, although they must be adapted to the health, economic, cultural, and technological conditions in which clinical research is conducted.