Tag: data sharing

Bioethics Blogs

Response to the Common Rule Special Issue: Attention to Health Disparities

by Nicolle K. Strand, JD, MBioethics, and Nora Jones, PhD

The article and commentaries on recent revisions to the Common Rule published in the July 2017 issue of AJOB are missing, we believe, a key perspective. The target articles and open peer commentaries suggested strategies for revising or overhauling the Common Rule to best address subject protections in light of the new and unique features of our contemporary research landscape, including the move from prospective research to research using existing data and biospecimens, personalized medicine, the increase in international collaboration, and the uptick in data sharing across institutions.…

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

Rethinking the Belmont Report? Yes!

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.


by Emily Caldes, MA, CIP and Jennifer B McCormick, Ph.D., MPP

As noted by Friesen, Kearns, Redman and Caplan in their review of the Belmont Report, the Belmont Commission tackled the difficult task of distinguishing research from practice. The report defines research activities as those intended to develop or contribute to generalizable knowledge, and it defines practice as activities intended to enhance the well-being of particular individuals or groups of individuals.

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

Research Ethics Roundup: New USDA Numbers on Animals in Research Labs, Improving Diversity in Research, Collins to Stay at NIH, ICMJE’s New Policy on Data Sharing

This week’s Research Ethics Roundup looks at the latest US Department of Agriculture (USDA) numbers on animals living in research labs, how researchers are working to better engage diverse populations, President Trump’s decision to keep Dr. Francis Collins as director of the National Institutes of Health (NIH), and the International Committee of Medical Journal Editors (ICMJE)’s final policy on data sharing statements for clinical trials.

The post Research Ethics Roundup: New USDA Numbers on Animals in Research Labs, Improving Diversity in Research, Collins to Stay at NIH, ICMJE’s New Policy on Data Sharing 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

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

Research Ethics Roundup: New Data Authorship System Proposed, San People’s New Code of Research Ethics, More Details on Proposed NIH Cuts, and Revisiting Handling of Lab Mice

This week’s Research Ethics Roundup reviews how experts think data sharing can be accelerated with data authorship attribution, how southern Africa’s San people are combatting exploitative research, the President’s plan for National Institutes of Health (NIH) grants, and a better way to transport laboratory mice.

The post Research Ethics Roundup: New Data Authorship System Proposed, San People’s New Code of Research Ethics, More Details on Proposed NIH Cuts, and Revisiting Handling of Lab Mice 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

Moving Toward Answers in ME/CFS

Thinkstock/Katarzyna Bialasiewicz

Imagine going to work or school every day, working out at the gym, spending time with family and friends—basically, living your life in a full and vigorous way. Then one day, you wake up, feeling sick. A bad cold maybe, or perhaps the flu. A few days pass, and you think it should be over—but it’s not, you still feel achy and exhausted. Now imagine that you never get better— plagued by unrelenting fatigue not relieved by sleep. Any exertion just makes you worse. You are forced to leave your job or school and are unable to participate in any of your favorite activities; some days you can’t even get out of bed. The worst part is that your doctors don’t know what is wrong and nothing seems to help.

Unfortunately, this is not fiction, but reality for at least a million Americans—who suffer from a condition that carries the unwieldy name of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), a perplexing disease that biomedical research desperately needs to unravel [1]. Very little is currently known about what causes ME/CFS or its biological basis [2]. Among the many possibilities that need to be explored are problems in cellular metabolism and changes in the immune system.

A number of studies suggest that abnormalities in cellular metabolism, a complex biological process that the body uses to create energy [3][4][5], may underlie ME/CFS. A recent study of metabolite pathways in blood samples from people with ME/CFS reported a signature suggestive of a hypometabolic condition, similar to a phenomenon biologists have studied in other organisms and refer to by the term “dauer” (a hibernation-like state) [5].

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

User Beware: Privacy Settings just a Facade

Image via

By Brenda Curtis, Ph.D.

Social media platforms continue to improve and refine their privacy settings as the demand for advanced user protections increases. Although enabling catered privacy settings to online profiles allows users to indicate who they would like share personal information with, it does not necessarily protect them from the platforms – i.e. websites and apps – themselves. Since social media accounts provide users with a sense of control over personal data, users assume that their information is safe. However, no matter what settings or privacy protections are applied to personal profiles, users do not generally have control over the online platform itself. What this means is the website or app being used usually shares information from accounts with third parties like advertising agencies or other databases. This data sharing is widespread throughout the industry, but it is not generally known by the public. This is partly because the disclosure of this sharing is done in the social media platform’s “Terms and Conditions” Which are often skimmed over or ignored.

Aside from social media websites, there are several other websites and apps that access your personal information via this information sharing to create a single database for everyone in the country. This is generally called data aggregation. One such site that has been in the news recently is FamilyTreeNow.  FamilyTreeNow is explicitly a genealogy site, and compiles information from various legal online sources to create a database full of personal information for genealogical research. This site pairs information from public records such as police records and court documents with the information collected from social media and address databases to create a sometimes way too revealing 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 News

Informed Consent and Data Sharing in a Mobile World

John Wilbanks, Chief Commons Officer of Sage Bionetworks, spoke at the last Seminar event of the year.

 

Mobile technologies have the potential to revolutionize both the way in which individuals monitor their health as well as the way researchers are able to collect frequent, yet sparse data on participants in clinical studies. In order for data from these devices to have maximal impact in a research setting however, the development of systems to collect, manage, and broadly share these data is essential. Possibly more important are the social constructs on which these systems need to be built to allow maximal utility to come from these data while minimizing adverse impact on individual participants. More specifically, the union of these systems and constructs must be an ecosystem build upon trust. We will present one such ecosystem focused on putting the participant at the center of the data collection: specifically by acknowledging possible risks to both individual participants as well as sub-populations of participants, providing opt-in settings for broad data sharing, and the development of an open research ecosystem built upon a social contract between researchers and research participants. A case study of one such mHealth study, leveraging Apple’s ResearchKit framework, will be presented and discussed.

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

Dissenting from care.data: an analysis of opt out forms

Guest Post: Paraskevas Vezyridis

Article: Dissenting from Care.data: An Analysis of Opt-out Forms

In our article, which is part of a wider project examining the technical, social and ethical challenges of big data in primary care, we simply wanted to explore how varied opt out forms can be when there is no standardised form available. We took as our case study opt out forms from care.data; the highly controversial (scrapped in July 2016) programme of work by NHS England and the Health and Social Care Information Centre (HSCIC) to extract and link (in one central database) healthcare information from GP practices and other NHS and social care services for all sorts of administrative and research purposes. This was an important research question for us since wordings, available options and even design layouts could influence the decision of patients whether to allow the sharing of their GP record for the care.data programme.

While it relies on the individual’s inertia (and often lack of awareness) an opt out is usually considered a more practical and valid approach to consent when compared to an opt in, particularly for low risk, population level studies where highly representative samples are required. For care.data, two types of opt outs were possible: data would either not be extracted from GP records and/or shared outside of the HSCIC in any identifiable form. However, there was no standardised opt out form released, like with the Summary Care Records (SCR). GPs had to come up with their own forms to register patients’ dissent.

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

Clinical Trials: Sharing of Data and Living Up to Our End of the Bargain

Thinkstock

Today we took a huge step forward in our efforts to make sure that data from biomedical research is shared widely and rapidly. The NIH, in collaboration with our fine colleagues at the U.S. Food and Drug Administration (FDA), and with the valuable input from scientists, patients and other members of the public, has announced the HHS regulation and NIH policy to ensure that information about clinical trials is widely shared. In this blog I want to talk about what this will mean for patients, providers, and researchers. I also want to reflect a bit on how the new regulation and policy fit into our overall efforts to improve clinical trials and data sharing.

Clinical trials are essential for the translation of research advances to new approaches to prevention and treatment. Volunteers who take part in clinical trials often do so with no assurance of personal benefit, but with the expectation that their involvement will add to the growing body of knowledge about health and disease, and thus may help others someday. For that to be realized, all trial results information needs to be publicly reported in a timely fashion—and yet we know that doesn’t always happen. Today’s announcements aim to change that. The HHS regulation issued today, called a “final rule”, describes requirements for registering certain clinical trials and submitting summary results information from these trials to ClinicalTrials.gov, a database managed by NIH’s National Library of Medicine (NLM).

The rule implements the statutory requirements established by Congress for ClinicalTrials.gov to serve as a public source for information about clinical trials.

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.