Tag: aptitude

Bioethics Blogs

Oxford Uehiro Prize in Practical Ethics: The Ethical Dilemma of Youth Politics, written by Andreas Masvie

 This essay was the runner up in the undergraduate category of the Oxford Uehiro Prize in Practical Ethics 2017

Written by University of Oxford Student, Andreas Masvie

 

The West in general, and perhaps Europe in particular, tend to celebrate youth politics as a vital force of democracy. This is reflected in the current literature on youth politics, which appears to be almost exclusively descriptive (e.g. ‘What is the level of youth politics in country X?’) or positively normative (e.g. ‘How can country X heighten engagement in youth politics?’). Various youth councils and parliaments are encouraged and empowered by government as well as civil society, both at local and national level. This is also the case internationally. The UN, for instance, demands that youth politics be stimulated: “[Such] engagement and participation is central to achieving sustainable human development.”[1] I will approach the rationale of this collective celebration as a syllogism, defining ‘youth politics’ as organized political engagement of people aged 13–25:

P1        Youth politics increases the level of political engagement;

P2        Political engagement promotes democratic vitality and sustainability; thus

C1        Youth politics promotes democratic vitality and sustainability.

In this paper I am interested in challenging P2. Does the increased political engagement due to youth politics promote democratic vitality and sustainability? For the sake of argument, I will posit the trueness of P1. When it comes to P2: it would be difficult to argue that all forms of political engagement promote democratic vitality and sustainability (e.g. authoritarian neo-Nazism or revolutionary Communism). Hence, I shall take it for granted that P2 is constrained to activities and policies compatible with democracy.

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

A social scientist’s guide to the Final Rule

On 18 January 2017, sixteen federal agencies announced revisions to the Federal Policy for the Protection of Human Subjects. As I noted earlier, this marks a huge victory for historians, who have spent the last 20 years working to end the inappropriate interference of IRBs with oral history research.

In addition, the final rule includes several provisions of note to scholars in the humanities and social sciences. Here are some of them; I don’t claim it is a complete list.

No biospecimens overhaul; less controversy

The final rule “does not adopt the proposal to require that research involving nonidentified biospecimens be subject to the Common Rule, and that consent would need to be obtained in order to conduct such research.” This was the target of the greatest criticism from groups like the National Academies of Sciences, Engineering, and Medicine and SACHRP. So while this change has little direct bearing on the work of social scientists and scholars in the humanities, it will likely reduce the controversy surrounding the regulatory reform as a whole.

The abandonment of the biospecimens proposal could also reduce opposition to reform by conservatives. The House Freedom Caucus opposed a new Common Rule on the grounds that it would cost $13.334 billion over 10 years. This figure seems to have been drawn from the NPRM’s quantified costs of $13.342 billion (using a 3 percent discount rate), and ignored the NPRM’s quantified benefits of $2.6 billion. If all the Freedom Caucus cares about is money, it may like the final rule a lot more.

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

New Common Rule Regs Mean New Training for IRB Members

by Craig Klugman, Ph.D.

Yesterday, the Department of Health & Human Services released the long-awaited, and debated, new Common Rule. Many of the proposals that were released in earlier versions for public comment did not make their way into the rule. All IRB members will also need to undergo training to incorporate the new rules into their reviews. Most of the changes have a deadline of 1 year (January 2018) for enactment.

Though many experts in research ethics will be writing on this in great detail, I offer a brief synopsis of the changes here. However, keep in mind that the incoming administration has suggested they may rollback all executive orders made by the Obama administration in its last few months, if not during the entire Obama presidency. Thus, it is possible that these rule changes are rolled back very quickly.

Who is covered?

The new rules maintain that only federally funded clinical trials must be reviewed by an IRB.

New Definitions

For the first time, the rules adopt a definition of Clinical Trial as “a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.” The new rules also offer separate definitions of “identifiable biospecimen” and “identifiable private information,” whereas previously, both were defined together.

Some definitions were tweaked (e.g. “private information”) and others remain unchanged (e.g. “human subject”).

Biobanking specimens and information

One of the most controversial proposed changes was that of having to gain subject consent for use of banked specimens.

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

Cell therapy clinics questioned.Technical and ethical aptitude of clincs in North America

Today in the United States there are 350 cell therapy centres offering stem cell-based treatments for autism, cystic fibrosis, multiple sclerosis and other diseases.Cell therapy clinics questioned because the vast majority lack not only approval by the United States medicines agency (FDA), but even a modest clinical trial that would allow them to begin to be used with assurance. As stem cells are not exactly a “medicinal product”, the companies — or their lawyers — claim that they can market their treatments without having approval from the FDA. This argument might be solid from a legal point of view (see HERE), but it is undoubtedly outside the most elementary ethical standards.

La entrada Cell therapy clinics questioned.Technical and ethical aptitude of clincs in North America aparece primero en Observatorio de Bioética, UCV.

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

Political Scientists Complain about Lost Exemption

Political scientists and law professors are protesting the proposed elimination of the current exemption for research about public officials and candidates for office. The drafters may have eliminated the exemption by mistake, thinking that such research was exempted by other provisions of the proposed rule, which turns out not to be the case.

OHRP can’t explain why it cut the exemption

Since 1981, 45 CFR 46.101(b)(3)(i) has exempted “research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office.” I was never able to nail down the exact origin of this exemption, but my best guess is that it was a response to the criticism leveled by political scientist Ithiel de Sola Pool, one of the leaders of the 1978–1981 social science campaign against IRB regulation.

The 2011 ANPRM proposed that “The existing six exemption categories would be retained as part of the new Excused category.” (76 FR 44518). Since the ANPRM did not warn anyone that they might lose the public-official exemption, none of the 2011 ANPRM comments seems to have commented on its value.

The 2015 NPRM’s proposed rule, however, does not include the exemption. As the NPRM states, “The rationale for this change in the proposed NPRM is that it does not seem appropriate to single out this category of subjects for different treatment in this way.” (80 FR 53951) In other words, the drafters eliminated the exemption because they wanted to eliminate the exemption.

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

My NPRM Comments

Perhaps 2016 will be the year when OHRP makes good on its 2007 promise to “give more guidance on how to make the decision on what is research and what is not,” in the form of a promulgated revision to the Common Rule. If so, Happy New Year, OHRP!

Wth these hopes, I have submitted my own comments on the NPRM. I have posted a copy of the PDF I submitted, and below is a web version with links.

Zachary M. Schrag. Comments on Notice of Proposed Rulemaking: 
Federal Policy for the Protection of Human Subjects. 1 January 2016

The proposed rule is designed “to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.” So far as research in the social sciences and humanities is concerned, several of its provisions are likely to achieve these goals, so I applaud this effort and look forward to the final rule. However, I wish to draw attention to some of the limits of the proposals, particularly in the areas of due process protections, empirical research, and revision in light of experience.

The Common Rule should adhere to statutory law

  • HHS and other regulatory agencies lack the authority to regulate research in the humanities and social sciences

The NPRM cites as its statutory authority 42 U.S.C. 289, which applies to “biomedical or behavioral research involving human subjects,” and does not mention social science or research in the humanities. As the NPRM acknowledges, “some of the commenters [on the ANPRM] recommended that the definition of research be focused more explicitly by being limited to ‘biomedical and behavioral research,’ in accordance with the statutory provision underlying the Common Rule.”

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

PRIM&R and SACHRP Attack Social Science Exclusion

In their comments on the NPRM, SACHRP and PRIM&R oppose the proposed exclusion of “Research, not including interventions, that involves the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) uninfluenced by the investigators” (§ ll.101(b)(2)(i)); they want such research to be moved from the excluded to the exempt category. But they differ in what they think the consequences of such a move would be; SACHRP thinks that researchers would face low barriers, while PRIM&R sees a chance for its members to continue to exert more control than is authorized by regulations. Both groups fail to represent the researchers most likely to conduct these kinds of studies.

Fears of interview trauma

Since the exclusion would only apply to research with a low risk of privacy breach, either because the subjects could not be identified or because the information they share is not sensitive, PRIM&R and SACHRP attack it on the grounds that risks other than privacy are at stake.

PRIM&R’s draft comments explicitly worry that interviews are traumatic:

Comprehensive ethics review of the sort envisioned in the Belmont Report requires thoughtful and experienced individuals to weigh the benefits and harms of each research project in terms of beneficence, justice, and respect for persons. Consider, for instance, a study in which college-aged victims of sexual trauma suffering from post-traumatic stress disorder are interviewed about their experience. Under the proposal at §__.101(b)(2)(i), this study may not be subject to the regulatory requirements of the Common Rule if the data are not recorded in an identifiable manner or if the researcher determines that disclosure of “responses outside the research would not reasonably place the subject at risk of criminal liability or be damaging to the subject’s financial standing, employability, reputation, educational advancement, or reputation” [§__.101(b)(2)(i)].

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, June 2015 – Part I by Elizabeth Lewis

Journal of the Royal Anthropological Institute

Deaf Bodies and Corporate Bodies: New Regimes of Value in Bangalore’s Business Process Outsourcing Sector
Michele Friedner

This article ethnographically analyses how groups (and not just individuals) are produced in business process outsourcing (BPO) workplaces. In order to mitigate an unstable labour pool, corporations hire deaf workers to perform identical BPO work regardless of their qualifications and backgrounds. These hiring practices serve to cement existing relationships and produce deaf workers as a group marked only by deafness. This article explores how engaging in the same work articulates with deaf young adults’ ‘sameness work’ to produce ambivalent deaf groups. It also analyses the everyday practices of deaf employees, their relationships with their normal co-workers who ‘love’ them, and the ways that value is reconfigured in the workplace through the existence of disabled workers. This article argues that in contrast to dominant representations of disabled people as unemployable, the (re)inscription of deafness as a source of multiple forms of value begs for a broader analysis of the role of disability in late capitalism.

Bodily Rights and Collective Claims: The Work of Legal Activists in Interpreting Reproductive and Maternal Rights in India
Carolyn Heitmeyer and Maya Unnithan

This article engages with anthropological approaches to the study of global human rights discourses around reproductive and maternal health in India. Whether couched in the language of human rights or of other social justice frameworks, different forms of claims-making in India exist in tandem and correspond to particular traditions of activism and struggle. Universal reproductive rights language remains a discourse aimed at the state in India, where the primary purpose is to demand greater accountability in the domain of policy and governance.

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

Wisdom Does Come with Age

Reminders of our finitude always lurk close by, like Ezekiel Emanuel’s article in last month’s Atlantic, “Why I Hope to Die at 75.” The head of the Clinical Bioethics Department at the National Institutes of Health gives reasons for not living beyond 75: inevitable decline, disability, incapacity, and diminishment of “creativity, originality, and productivity.” According to Emanuel, we wish to be remembered for our good years, prior to decline.

There are grains of truth here. Many of us “die” well before we are officially declared dead. I’ve seen patients kept alive for far too long in permanent vegetative states, while family dynamics, emotions, finances and scarce medical resources are depleted. We pay a high price for medical “progress.” I also know thriving, vibrant elderly, themselves significantly disabled and incapacitated.

Emanuel’s posture represents a deep-rooted cultural symptom — our fixation on productivity. “I produce, therefore I am of value.” From early on, we are conditioned to focus on performance, “making something of ourselves.” Even our leisure time is instrumental, a re-energizing in order to produce. And via our devices, work invades our leisure.

Retired SUNY Social Welfare Professor Edmund Sherman wisely writes of this in “Contemplative Aging,” particularly the quandary of retirement when people persistently ask, “So, what will you do?”

Now for the symptom’s underlying cause: We lack a cohesive, coherent, integrated philosophy of life-stages so that growing old beyond retirement years plays no meaningful role. It’s a stage we ignore, downplay, fear, or resist — a phantom stage, an anticipated accident waiting to happen.

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.