Tag: empirical research

Bioethics Blogs

Ethics & Society 2015 Year in Review

Starting with a national discussion on vaccinations, public health and autonomy, and ending with widespread reflection on yet another mass shooting, 2015 had no shortage of ethics-related news and events.

Here are a few highlights of the work of Fordham University Center for Ethics Education faculty, staff, and students from 2015:

Dr. Celia B. Fisher Contributes to National Discussion on Ethical Review & Oversight Issues in Standard of Care Research

Common clinical practices might lack a robust evidence base if there have not been empirical interventional research studies to compare an array of available routine or standard treatment options. Fordham University Center for Ethics Education Director Dr. Celia B. Fisher, an internationally renowned expert on empirical research on research ethics, recently traveled to Washington, D.C. to participate in an Institute of Medicine (IOM) workshop aimed to inform practice and policy of regulated research studies involving standard of care interventions. Read more here.

 

Fordham Professor, Coast Guard Pioneer and Civil Rights Activist Dr. Olivia J. Hooker to Receive Recognition following her 100th Birthday

Photo by White House photographer Pete Souza

Nationally recognized pioneer in the rights of minority students and retired Fordham University Professor of Psychology Dr. Olivia J. Hooker is a lifelong civil rights activist and the first African American woman to enlist in the Coast Guard. To celebrate her life and 100th birthday, the Coast Guard will name a building on Staten Island in her honor on March 12th. Read more here.

Modern Family: Dr. Celia B. Fisher Discusses Ethics, Biological Parenthood & Sofia Vergara’s Frozen Embryos

Fordham University Center for Ethics Education Director Dr. Celia B. Fisher

Fordham University Center for Ethics Education Director Dr.

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

My NPRM Response. Draft 1.

Though the deadline for commenting on the NPRM has been extended until January 6, I post here a draft of my comments in the hopes that they may help others craft theirs and send me feedback on mine.

Jerry Menikoff, M.D., J.D.

Office for Human Research Protections (OHRP)

Department of Health and Human Services

Dear Dr. Menikoff:

Thank you for the opportunity to comment on the September 8 notice of proposed rulemaking: Federal Policy for the Protection of Human Subjects, docket ID number HHS–OPHS–2015–0008.

I write these comments as the author of “How Talking Became Human Subjects Research: The Federal Regulation of the Social Sciences, 1965–1991,” Journal of Policy History 21 (2009): 3- 37, and Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965–2009 (Baltimore: Johns Hopkins University Press, 2010), and as the editor of the Institutional Review Blog, http://www.institutionalreviewblog.com, all of which were graciously cited in the NPRM.

Most recently, in November 2015, I participated as a panelist in the Chicago round of the workshops on “Revising and Expanding the Scope of the Common Rule,” sponsored by the CTSA Consortium Coordinating Center (C4). I also offered assistance to the drafters of the comments on the NPRM submitted by the National Coalition for History, and I endorse those comments.

In addition, I wish to offer the attached observations, which reflect only my views and may not represent those of historians’ organizations, George Mason University, or any other institution.

Comments on Notice of Proposed Rulemaking: Federal Policy for the Protection of Human Subjects

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.”

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

Fordham RETI Fellows Present at PRIM&R Annual Meeting

Dr. Erin Bonar, Dr. Faith Fletcher, and Dr. Celia B. Fisher at the PRIM&R Annual Meeting 2015. Photo courtesy Dr. Sue Fish

The Fordham HIV and Drug Abuse Prevention Research Ethics Training Institute (RETI) was well-represented at the Public Responsibility in Medicine and Research (PRIM&R) Annual Meeting in Boston, November 12-15, with faculty and fellows presenting on their institute-funded research.

RETI Director Dr. Celia B. Fisher and Cohort 4 fellows Dr. Erin Bonar and Dr. Faith Fletcher presented a session entitled, “Enhancing the Responsible Conduct of Adolescent and Young Adult Health Research through Empirical Studies on Research Ethics.”

This session featured presentations describing empirical studies on research ethics issues that can help IRBs evaluate human subjects protections for health research involving adolescents and young adults. The research described draws on the perspectives of adolescents and parents to illuminate opportunities and barriers to the responsible conduct of HIV, drug use, and mental health research.

During this session, Bonar reviewed how mixed-method research (surveys and interviews) can illuminate best practices for assessing risks and benefits and protecting confidentiality in mobile health-based research on drug use and sexual risk among emerging adults. In addition, Fletcher described how empirical data on African American mothers’ and daughters’ attitudes toward adolescent participation in HIV biomedical prevention trials can inform IRB evaluations of research vulnerability. Finally, Fisher outline how to evaluate ethical justifications for requests to waive guardian permission using data from an innovative, web-based, asynchronous focus group methodology that examined ethical barriers and facilitators to lesbian, gay, bisexual and transgender (LGBT) youth participation in HIV prevention medication adherence 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.

Bioethics Blogs

Fordham’s Dr. Celia B. Fisher on Charlie Sheen’s HIV disclosures: ‘Sex workers may not have the economic or social power to say no’

 

While there has been no shortage of coverage of actor Charlie Sheen’s announcement last week that he is HIV positive, one aspect of the story has been noticeably missing: the complex power dynamic when an HIV-positive individual solicits a sex worker. For many sex workers, negotiating terms or leaving the situation may not be an option.

Dr. Celia B. Fisher, director of the Fordham University Center for Ethics Education and HIV and Drug Abuse Prevention Research Ethics Training Institute (RETI) weighed in on the issue in an article in The Washington Post:

“For Charlie Sheen to think that simply disclosing his HIV status to someone allows that person to protect themselves in the best way possible – that’s not always the case. They may not have either the economic or social power to say no.”

In the same Washington Post article, Lindsay Roth, executive director of Philadelphia-based Project SAFE and former board president of the Sex Workers Outreach Program explained that it is difficult to hear someone with Charlie Sheen’s power and resources claim that he was victimized by being blackmailed by sex workers who threatened to go public with his HIV status.

“The reality is, when it comes to a sex worker, they’re laboring in a job where they have no legal or human rights,” Roth said.

In recent years, both the Centers for Disease Control and World Health Organization have identified sex workers as a population at increased risk for contracting HIV, and a significant public health concern.

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 Tribute to James Fowler

James Fowler, former Professor of Theology and Human Development at Emory University, and director for many years of both the Center for Ethics and the Center for Research on Faith and Moral Development died on October 15, 2015.  A Minister in the Methodist Church and a faculty member at Emory’s Candler School of Theology, Dr. Fowler was world renowned for his work arguing that there are stages of faith development akin to Piaget’s stages of cognitive development.

 

Fowler articulated his theory in his most famous work, Stages of Faith: The Psychology of Human Development and the Quest for Meaning, which was published in 1981.  The book, which virtually founded a field of inquiry, suggested that as the human beings develops, cognitive structures favor six phases of encounters with faith, from “Intuitive-Projective faith between 3-7 (characterized by fluidity in faith thinking) through the final phase, “universalizing”, where parochialism gives way to an acceptance of individual beliefs and respect of different faith approaches. Stages of Faith spawned significant empirical research and is still widely studied in the academy and read in seminaries of many different faiths across the world.  Fowler also wrote or edited 11 books and numerous articles and book chapters.

 

In addition to his scholarly work, Fowler was the director of the Emory Center for Ethics from 1994 until a familial form of Alzheimer’s forced his retirement in 2005.  Under his leadership the Center grew and flourished, and perhaps more importantly, developed a familial, mutually supportive culture between faculty and staff that continues to this day.

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

Publishing Research Ideas

The newest science journal on the block with several unique twists is Research Ideas and Outcomes (RIO) (http://riojournal.com/). RIO aims to publish a variety of outputs in the research cycle, not only the results of research. The journal will publish papers on ideas, proposals, methods, research results, and software. They also publish review articles, opinion pieces, data papers, software descriptions, workflows, data management plans, conference abstracts, single figure publications, project reports and much more. Their aim is to better use the efforts scientists spend on writing and evaluating research proposals and other products within the research cycle. RIO does have limits; they will not accept teaching lectures or materials, clinical trials, patient or other data that may be considered unethical, homeopathy, nuclear or bioweapons research, creationist or religiously motivated research, cryptozoology, and pseudoscience. The journal also has many other interesting aspects. While they are an open access journal, unlike others, they do not charge the typical high costs of thousands of dollars. The journal charges between 50 to a few hundred euros for most types of publications. Peer review is also optional and RIO relies on public scrutiny to promote transparent and public peer review. Expert driven peer review, typically done in most medical and science journals, however, can be done upon the author’s request. The typical review process for papers submitted to RIO includes several technical checks and an external pre-submission review from a colleague.

While all this sounds pretty good thus far, one of the major questions is whether scientists are willing to share good research ideas (Rabesandratana, 2015).

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

TCPS Envy, Continued

Writing in the Journal of Academic Freedom, law student James Nichols presents Canada’s TCPS2 as a model of balance “that promotes intuitive and promising research without sacrificing human integrity and protection.” However, his conclusion is largely speculative, since we still lack studies of how the document is working in practice.

[James Nichols, “The Canadian Model: A Potential Solution to Institutional Review Board Overreach,” Journal of Academic Freedom 6 (2015)]

Nichols points up several attractive features of TCPS2, including its:

  • status as “a living document that is constantly evolving with the help of scholars”
  • embrace of academic freedom as a guiding principle
  • detailed guidance about specific issues, including a whole chapter on qualitative research
  • heightened requirement for REB expertise
  • requirement of an appeals process.

All of this makes TCPS2 look great on paper, and the object of envy to American scholars like me, as well as some in New Zealand.

On the other hand, Kirsten Bell, a medical anthropologist working in Canada was skeptical of TCPS2 at the 2012 Ethics Summit, and her skepticism remains in her chapter in the forthcoming conference volume, Ethics Rupture.

Neither side offers empirical research on how REB practice has or has not changed in the nearly five years since the release of TCPS2. If anyone knows of such a study, I hope they will alert me.

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, September 2015 (Part 1) by Anna Zogas

Here is the first round of “In the Journals” for September. Happy autumn reading!

American Anthropologist

Commitments of Debt: Temporality and the Meanings of Aid Work in a Japanese NGO in Myanmar
Chika Watanabe

The rise of debt as a mechanism of development troubles many scholars and aid practitioners. Contrary to these concerns, however, ethnographic research at a Japanese NGO in Myanmar showed that Japanese and Burmese aid workers found value in moral and monetary debt relations. In this article, I argue that these aid workers viewed indebtedness as a precondition for the making of voluntary actors, willing and committed to aid work. What they problematized was not indebtedness but, rather, competing understandings of the appropriate temporality of a debt’s repayment. The fault lines did not appear along cultural or moral-monetary boundaries; they existed in the ways that people conceptualized voluntary actors as emerging from either long-term forms of indebted gratitude or sequences of short-term contractual agreements. While the entrapment of the poor in cycles of debt remains an increasing concern in the world, I here ask how we might understand local aid workers’ professional commitments when they do not question indebtedness as a moral framework.

Rich Sentiments and the Cultural Politics of Emotion in Postreform Ho Chi Minh City, Vietnam
Allen L. Tran

Linking socioeconomic and personal transformations, recent scholarship on neoliberalism in East and Southeast Asia has examined the role of various emotional experiences in reconfiguring selfhood toward values of personal responsibility and self-care. However, studies rarely focus on how such experiences come to be understood as specifically emotional themselves.

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

Less cooperation, please

Written by Joao Fabiano

Since the idea of enhancing human morality was proposed – and perhaps long before then – there has been a great deal of scientific research directly or indirectly inspired by the goal of improving human moral dispositions. Manipulations which result in increased levels of cooperation, prosociality or altruism are often seen as promising discoveries towards the path of developing moral enhancement technologies. The fact that increasing cooperation between individuals would be going in the wrong direction seems to be ignored. The problem moral enhancement proposes to fix is large-scale cooperation – cooperation between groups of individuals – not between individuals inside a group. Issues like global warming and nuclear disarmament arise primarily in the interaction between large groups of individuals, not in the interaction of individuals within the same group.

In actuality, humans already cooperate well inside small groups. We have evolved many emotional and cognitive mechanisms which enable us to function quite satisfactorily in the context of small cooperative groups such as the ones more frequently studied in empirical research. Many have proposed local economies as the ideal design for producing sustainable management of common resources[1]. There is not that much room for improvement there.

On the other hand, when it comes to interactions between groups of different religions, nationalities and morals we can fail spectacularly. What’s more, our ability to cooperate well inside groups seems to be directly correlated with our inability for cooperation between groups. Let me cite a few empirical results to substantiate this last claim.

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.