Tag: research subjects

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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.

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Patients in Research: What the Professionals Don’t Get

Guest Post by Rebecca Dresser When scientists and doctors get together to talk about accelerating medical advances, someone inevitably brings up the need for more research subjects.  Not enough patients are participating in clinical trials, experts complain.  If more patients … Continue reading

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.

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Big Data researchers call for IRB review, based on shaky premises

Jacob Metcalf of the Data & Society Research Institute and Kate Crawford of Microsoft Research, MIT Center for Civic Media, and New York University Information Law Institute (I think those are three different things) want to subject Big Data research to IRB review, at least in universities. Their argument rests on shaky premises.

[Jacob Metcalf and Kate Crawford, “Where Are Human Subjects in Big Data Research? The Emerging Ethics Divide,” Big Data & Society 3, no. 1 (January–June 2016): 1–14, doi:10.1177/2053951716650211.]

Assumptions about assumptions

Metcalf and Crawford understand that the current Common Rule does not require IRB review of publicly available datasets. Claiming to be “historicizing extant research ethics norms and regulations” and drawing lessons “from the history and implementation of human-subjects research protections,” they proceed to invent a history of the relevant provisions.

They write,

US research regulations (both the current rules and proposed revisions) exempt projects that make use of already existing, publicly available datasets on the assumption that they pose only minimal risks to the human subjects they document. (1)

And

The Common Rule assumes that data which is already publicly available cannot cause any further harm to an individual. (3)

And

The criteria for human-subjects protections depend on an unstated assumption that we argue is fundamentally problematic: that the risk to research subjects depends on what kind of data is obtained and how it is obtained, not what is done with the data after it is obtained. This assumption is based on the idea that data which is public poses no new risks for human subjects, and this claim is threaded throughout the NPRM.

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.

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Big Data researchers call for IRB review, based on on shaky premises

Jacob Metcalf of the Data & Society Research Institute and Kate Crawford of Microsoft Research, MIT Center for Civic Media, and New York University Information Law Institute (I think those are three different things) want to subject Big Data research to IRB review, at least in universities. Their argument rests on shaky premises.

[Jacob Metcalf and Kate Crawford, “Where Are Human Subjects in Big Data Research? The Emerging Ethics Divide,” Big Data & Society 3, no. 1 (January–June 2016): 1–14, doi:10.1177/2053951716650211.]

Assumptions about assumptions

Metcalf and Crawford understand that the current Common Rule does not require IRB review of publicly available datasets. Claiming to be “historicizing extant research ethics norms and regulations” and drawing lessons “from the history and implementation of human-subjects research protections,” they proceed to invent a history of the relevant provisions.

They write,

US research regulations (both the current rules and proposed revisions) exempt projects that make use of already existing, publicly available datasets on the assumption that they pose only minimal risks to the human subjects they document. (1)

And

The Common Rule assumes that data which is already publicly available cannot cause any further harm to an individual. (3)

And

The criteria for human-subjects protections depend on an unstated assumption that we argue is fundamentally problematic: that the risk to research subjects depends on what kind of data is obtained and how it is obtained, not what is done with the data after it is obtained. This assumption is based on the idea that data which is public poses no new risks for human subjects, and this claim is threaded throughout the NPRM.

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.

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Special Issue! Resisting Power, Retooling Justice: Promises of Feminist Postcolonial Technosciences by Anna Zogas

In advance of our regular In the Journals post, I want to highlight a Special Issue. Anne Pollock and Banu Subramaniam have guest edited “Resisting Power, Retooling Justice: Promises of Feminist Postcolonial Technosciences,” in Science, Technology & Human Values. Here are the abstracts!

Resisting Power, Retooling Justice: Promises of Feminist Postcolonial Technosciences
Anne Pollock, Banu Subramaniam

This special issue explores intersections of feminism, postcolonialism, and technoscience. The papers emerged out of a 2014 research seminar on Feminist Postcolonial Science and Technology Studies (STS) at the Institute for Research on Women and Gender, University of Michigan. Through innovative engagement with rich empirical cases and theoretical trends in postcolonial theory, feminist theory, and STS, the papers trace local and global circulations of technoscience. They illuminate ways in which science and technology are imbricated in circuits of state power and global inequality and in social movements resisting the state and neocolonial orders. The collection foregrounds the importance of feminist postcolonial STS to our understandings of technoscience, especially how power matters for epistemology and justice.

Informed Refusal: Toward a Justice-based Bioethics
Ruha Benjamin

“Informed consent” implicitly links the transmission of information to the granting of permission on the part of patients, tissue donors, and research subjects. But what of the corollary, informed refusal? Drawing together insights from three moments of refusal, this article explores the rights and obligations of biological citizenship from the vantage point of biodefectors—those who attempt to resist technoscientific conscription. Taken together, the cases expose the limits of individual autonomy as one of the bedrocks of bioethics and suggest the need for a justice-oriented approach to science, medicine, and technology that reclaims the epistemological and political value of refusal.

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.

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Obama Administration Still Wants to Release New Common Rule

November 30, 2016

(Bloomberg) – A major revision of the regulations designed to protect research subjects is still on track for release before the Obama administration exits the White House Jan. 20.  “It is the goal of this administration to come out with a final rule,” Jerry Menikoff, director of the Health and Human Services Office for Human Research Protections, said Nov. 14.

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.

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A Hot Take on a Cold Body

It’s good to see Nils’ post about the recent UK cryonics ruling getting shared around quite a bit – so it should.  I thought I’d throw in my own voice, too.

About 18 months ago, Imogen Jones and I wrote a paper musing on some of the ethical and legal dimensions of Christopher Priest’s The Prestige.  One dimension of this was a look at the legal status of the bodies produced as a result of the “magic” trick – in particular, the haziness of whether they were alive or dead; the law doesn’t have any space for a third state.  The paper was something of a jeu d’esprit, written to serve a particular function in a Festschrift for Margot Brazier.  If I say so myself, I think it’s a pretty good paper – but it’s also meant to be fun, and is clearly rather less serious than most ethico-legal scholarship (or anything else in the book, for that matter).

Not quite “Cold Lazarus”, but close enough…

So it’s a bit of a surprise to see relevantly similar themes popping up in the news.  If we’re freezing people in the hope of curing terminal illness in the future, what’s the status of the bodies in the meantime (especially if the death certificate has been signed)?  There’s a load of questions that we might want to ask before we get too carried away with embracing cryonics.

Right from the start, there’s a question about plausibility.  For the sake of what follows, I’m going to treat “freezing” as including the process of defrosting people successfully as well, unless the context makes it clear that I mean something else.

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.

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The ‘P’ Word: Hospital Ethics Committees and Palestinian National Identity by Guy Shalev

Anthropologists like to tell their stories of ‘entering the field,’ whether they are left alone on a tropical beach as their dinghy sails away (Malinowski 1922) or run away from the police into a local’s courtyard (Geertz 1973). These stories are often told to show us, their readers, the distance anthropologists must travel from their own worlds into those of their research subjects. If stories traditionally fall within the thriller or adventure genres, my own is rather more Kafkaesque. And much like the stories from The Trial and The Castle, it is more about the system in which my interlocutors and I live than our own personal stories.

It took me more than six months to get my research with Palestinian physicians approved in two large Israeli hospitals. In a third hospital my access was denied. My ‘entry story’ is thus about my repeated attempts to obtain the approval of three Helsinki Committees (HCs, Israeli hospitals’ research ethics committees) to conduct ethnographic research with Palestinian physicians in Israeli public hospitals. While my research was eventually approved in two of these institutions, correspondence with HC representatives, as well as evidence of their informal moves with institutions’ management, reflect their perceptions of the risk my study posed.

I had already passed the University of North Carolina’s meticulous ethical approval process, and so the very different response of Israeli committees left me bewildered. Had the UNC’s committee overlooked important risks? In fact, the discrepancies between these committees calls into question the very idea of a universal ethical code of research conduct, as the 1964 Declaration of Helsinki aimed to establish.

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.

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Final Rule: HHS and NIH’s New Information Requirements for Clinical Trials: Is More Information Beneficial and For Whom?

By Jorge Luis Rivera-Agosto

On September 16, 2016, the U.S. Department of Health and Human Services (HHS) presented a final rule, in conjunction with a complementary policy of the National Institutes of Health (NIH), amending Tile 42, Chapter 1 of the Code of Federal Regulations[1]. This final rule will bring about a new era for the different stakeholders in the health care industry: patients, providers, researchers and our government[2]. It represents a big step toward increased access to information about certain clinical trials, a topic that affects subjects’ informed consent directly. The regulation’s aim is to specify “how data that were collected and analyzed in accordance with a clinical trial’s protocol are submitted to ClinicalTrials.gov”. As such, it does not create new requirements on data, design, or conduct of clinical trials[3].

All stakeholders in the field of research ethics have engaged in continuous debate regarding the need for “increased access to information about clinical trials”[4]. The lack of publications[5] (researchers that don’t publish their findings for a variety of reasons such as that their data won’t be of benefit to the whole community) of clinical trials and biased literature[6],[7] (when researchers publish positive rather than negative findings) concerning clinical trials outcomes are major concerns. The problems previously mentioned are what this regulation tackles.

First, Section 11.22 of the final rule explains which clinical trials must be registered in the webpage. It states that all clinical trials initiated after September 27, 2007, or any clinical trial initiated before or continued after such date, must figure in ClinicalTrials.gov

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.

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Secrecy, Security, & Science

In 1994, before the Berman Institute of Bioethics at Johns Hopkins was established, Ruth Faden was asked to consult the US Department of Energy (DOE) on reports of government-sponsored radiation-related medical research on citizens without their knowledge. At the time, Faden was a professor at the Johns Hopkins School of Hygiene and Public Health, teaching medical ethics. Shocked by the accounts of widespread radiation experiments on unknowing, unconsenting citizens, Faden suggested that the DOE needed an independent investigation, and it should not be limited to that department alone.  Secretary of Energy Hazel O’Leary and President Bill Clinton agreed, and asked Faden to lead the investigation as chair of the White House Advisory Committee on Human Radiation Experiments (ACHRE).  Faden assembled her ideal interdisciplinary staff of historians, clinicians, philosophers, lawyers, and scientists who went on to work together the committee named by Pres. Clinton for 18 months before issuing its report on October 3, 1995.

 

On October 5, 2016, Johns Hopkins will host a day-long symposium to consider the committee’s work and its impact in the 20 years since the release of its report. Members of the ACHRE committee and staff will reflect on the seminal report, its impact since 1995 and into the future on topics including the regulation of human-subject research, considerations around remedies for past wrongs, and the use of historical information to make moral judgments about the past.

 

According to a New York Times story published in 1994 shortly after President Clinton established ACHRE, Faden said the most difficult task for the committee would be deciding what standard of ethics to measure the experiments against.

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.