Tag: research ethics committees

Bioethics News

Available for download: The Research Ethics Committee Assessment Toolkit (RECAT) is designed to facilitate evaluation of the operational needs of Research Ethics Committees (RECs) globally to inform local quality assurance and quality improvement efforts

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

Research Ethics Committee Assessment Toolkit (RECAT)

Available for download: The Research Ethics Committee Assessment Toolkit (RECAT) is designed to facilitate evaluation of the operational needs of Research Ethics Committees (RECs) globally to inform local quality assurance and quality improvement efforts

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

Exclusion of Mothers-To-Be From Clinical Studies Unfair and Potentially Harmful

July 18, 2017

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In fact, pregnant women’s vulnerability boils down to the lack of research carried out in this group, and it’s a dilemma that can only be overcome by including mums-to-be in clinical studies, they say.

“Our study once and for all demonstrates that there is no indication that pregnant women are vulnerable because of informed consent, susceptibility to coercion, or vulnerability of the fetus,” they write.

“The only reason why pregnant women are potentially vulnerable in clinical research is to the extent that they are increasingly exposed to higher risks due to a lack of scientific knowledge which might render them vulnerable as research subjects,” they continue.

“Only a joint effort to promote fair inclusion by funding agencies, authorities, researchers, methodologists, pharmacologists, guideline committees and [research ethics committees] can successfully reduce pregnant women’s vulnerability,” they conclude.

In a linked Commentary, Drs Carleigh Krubiner and Ruth Faden, of the Berman Institute for Bioethics at Johns Hopkins University, Baltimore, argue that the designation of pregnant women as ‘vulnerable’ “is inappropriate and disrespectful.”

And rather than protecting them, it has had the opposite effect, and created a great deal of uncertainty and anxiety.

… Read More

Vulnerability of pregnant women in clinical research, Journal of Medical Ethics (2017). DOI: 10.1136/medethics-2016-103955

Commentary: Pregnant women should not be categorised as a ‘vulnerable population’ in biomedical research studies: ending a vicious cycle of ‘vulnerability’ Journal of Medical Ethics (2017). DOI: 10.1136/medethics-2017-104446

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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

HIV Cure Research and The Dual Aims of the Informed Consent Process

Guest Post: Danielle Bromwich and Joseph Millum

Paper: Informed Consent to HIV Research 

Special Issue: The benefit/risk ratio challenge in clinical research, and the case of HIV cure

A cure for HIV would be tremendously valuable. Approximately 37 million people worldwide are HIV-positive and 15 million are currently on antiretroviral therapy. Until recently it was assumed that this therapy would be the extent of HIV treatment and that those with access to it would need to take their drugs for life. But what once seemed impossible is now in early phase clinical trials: interventions designed to completely eradicate HIV from the immune system.

Excitement surrounding these “HIV cure” studies is tempered by ethical concern. They require participants to come off their antiretroviral therapy and undergo highly risky interventions using gene transfers or stem cell therapy. These are currently proof of concept studies—no one expects the participants to be cured. Their purpose is to provide essential information about safety and pharmacokinetics, but in doing so they expose participants to high risks with little prospect of direct benefit.

If we could be confident that participants understood their trials’ true risk-benefit ratio, these high risks might be less troubling. But such confidence would be misplaced. Decades of data show poor comprehension of risk among participants in clinical trials. The fact that HIV is still a stigmatized condition amplifies this concern. Potential participants may be desperate to be rid of their disease and so downplay the risks and exaggerate the potential benefits. Understandably, HIV cure researchers and research ethics committees are worried.

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

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.

Bioethics Blogs

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.

Bioethics Blogs

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.

Bioethics News

Strengthening ‘Ethics’ in Health Systems Research

By Bridget Pratt, Coordinator for the HSG Ethics of Health Systems Research TWG, and Joseph Ali

 

Crossposted from hsg: health systems global blog

 

Funders, researchers, institutions, and research ethics committees (RECs) worldwide are struggling to interpret and apply ethical principles to the increasing number of health systems research (HSR) studies being performed globally. Available research ethics guidelines, while relevant to HSR, focus predominantly on traditional forms of health research, including biomedical, social science, and epidemiological research.

 

But currently, no comprehensive HSR-specific guidelines exist that lay out the relevant ethical issues to consider when conducting HSR projects and provide guidance on how to address them. That HSR-specific guidelines are needed has been recognised by bioethicists and bodies such as the Alliance for Health Policy and Systems Research. Without such guidelines, key ethical issues in HSR studies are likely to be overlooked and (as a result) not addressed, or addressed inappropriately.

 

A first step to develop HSR-specific ethics guidance

 

We were recently part of a team funded by the Alliance for Health Policy and Systems Research to perform a scoping review of the HSR ethics literature. We set out to identify a number of factors: the key ethics issues that arise when conducting HSR, with a focus (though not exclusive) on low- and middle-income (LMIC) settings; existing guidance on these ethical issues; and any gaps in the available guidance.

 

What emerged from the review were a number of ethical issues and a limited amount of guidance within various categories: 1) justice, 2) identifying and balancing risks and benefits, and 3) upholding autonomy.

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

Brazil calls for "equitable representation from the Social Sciences and Humanities"

Brazil is revising its research ethics standards in ways that will help tailor them to research in the social sciences and the humanities. The standards provide for greater representation by scholars in those fields when policies and decisions are made, and they decenter some of the medical assumptions that had previously governed all research. But they do not go as far as the Canadian TCPS2 in recognizing the legitimacy of critical inquiry.

[Iara Coelho Zito Guerriero, “Approval of the Resolution Governing the Ethics of Research in Social Sciences, the Humanities, and Other Disciplines That Use Methodologies Characteristic of These Areas: Challenges and Achievements,” Ciência & Saúde Coletiva 21, no. 8 (August 2016): 2619–29, doi:10.1590/1413–81232015218.17212016.]

In Brazil, a National Research Ethics Committee (Comissão Nacional de Ética em Pesquisa, or CONEP) oversees each local Research Ethics Committee (Comitê de Ética em Pesquisa, or CEP). As in other countries, medical researchers and health officials have dominated the crafting of policy, resulting in restrictions that make little sense for research in the social sciences and humanities (SSH).

Since 2013, public health researcher Iara Guerriero and other members of a Working Group in Social Sciences and Humanities have labored to improve this situation, and in April 2016 they won National Board of Health approval for their resolution. In her article, Guerriero publishes the resolution and notes four major advances:

  1. Equitable composition of CONEP and involvement of SSH members in reviewing the protocols for these areas.
  2. Recognition that scientific merit must be assessed by competent areas.
  3. Discrimination between the process of obtaining and registering consent.

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

A New Edition of Research Ethics is Now Available

July 29, 2016

Research Ethics (vol. 12, no. 3, 2016) is available online by subscription only.

Articles include:

  • “The Contribution and Attitudes of Research Ethics Committees to Complete Registration and Non-Selective Reporting of Clinical Trials: A European Survey” by Daniel Strech, Jasper Littmann, and on behalf of the OPEN consortium

  • “Could Providing Financial Incentives to Research Participants be Ultimately Self-Defeating?” by TL Zutlevics

  • “Opportunities, Challenges and Ethical Issues Associated With Conducting Community-Based Participatory Research in a Hospital Setting” by C Strike, A Guta, K. de Prinse, S Switzer, and S Chan Carusone

  • “Prevalence and Commonalities of Informed Consent Templates for Biomedical Research” by Jhia LN Jackson and Elaine Larson

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.