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Open consent, biobanking and data protection law: can open consent be ‘informed’ under the forthcoming data protection regulation? (Papers: Dara Hallinan & Michael Friedewald | 2015)0

Posted by Admin in on August 22, 2019
 

Abstract
This article focuses on whether a certain form of consent used by biobanks – open consent – is compatible with the Proposed Data Protection Regulation. In an open consent procedure, the biobank requests consent once from the data subject for all future research uses of genetic material and data. However, as biobanks process personal data, they must comply with data protection law. Data protection law is currently undergoing reform. The Proposed Data Protection Regulation is the culmination of this reform and, if voted into law, will constitute a new legal framework for biobanking. The Regulation puts strict conditions on consent – in particular relating to information which must be given to the data subject. It seems clear that open consent cannot meet these requirements. 4 categories of information cannot be provided with adequate specificity: purpose, recipient, possible third country transfers, data collected. However, whilst open consent cannot meet the formal requirements laid out by the Regulation, this is not to say that these requirements are substantially undebateable. Two arguments could be put forward suggesting the applicable consent requirements should be rethought. First, from policy documents regarding the drafting process, it seems that the informational requirements in the Regulation are so strict in order to protect the data subject from risks inherent in the use of the consent mechanism in a certain context – exemplified by the online context. There are substantial differences between this context and the biobanking context. Arguably, a consent transaction in the biobanking does not present the same type of risk to the data subject. If the risks are different, then perhaps there are also grounds for a reconsideration of consent requirements? Second, an argument can be made that the legislator drafted the Regulation based on certain assumptions as to the nature of ‘data’. The authors argue that these assumptions are difficult to apply to genetic data and accordingly a different approach to consent might be preferable. Such an approach might be more open consent friendly.

Hallinan, D. and M. Friedewald (2015). “Open consent, biobanking and data protection law: can open consent be ‘informed’ under the forthcoming data protection regulation?” Life Sciences, Society and Policy 11(1): 1.
Publisher (Open Access): https://lsspjournal.biomedcentral.com/articles/10.1186/s40504-014-0020-9

International Association for the Study of Forced Migration (IASFM) Code of ethics: Critical reflections on research ethics in situations of forced migration0

Posted by Admin in on August 18, 2019
 

Context:
Research with people in situations of forced migration poses particular ethical challenges because of unequal power relations, legal precariousness, extreme poverty, violence, the criminalization of migration, politicized research contexts, the policy relevance of our research and/or dependence on government and non-governmental services and funding. However, Research Ethics Boards (REBs) are not always aware of these particular ethical issues; some countries and institutions do not have REBs; and some kinds of research are not subject to REB approval. In this context of heightened risks of research, and uneven institutional accountability for research ethics, the International Association for the Study of Forced Migration (IASFM) hereby proposes this code of ethics for research with people in situations of forced migration. Similarly to how Indigenous research methodologies incorporate a broad, engaged and critical notion of ethics that recognizes power differentiations and the agency of the participants within exploitive research histories, this document sets forth principles that are starting points for respectful research.1 It is intended to reflect the broad diversity of our membership, including those involved in gathering information – whether in an academic or community setting – as well as those who are asked to take part in research. That being said, we acknowledge that this is not a comprehensive nor exhaustive document, but rather a starting point for active, critical engagement with ethical issues.

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How to organize a conference that’s open to everyone – Nature (Nic Fleming | July 2019)0

Posted by Admin in on August 17, 2019
 

Thinking about the needs of all participants is key to a successful event.

Having enjoyed their meal in a neo-Gothic, wood-panelled grand hall, most delegates were on their way to the afternoon sessions. Meanwhile, Caroline Miles had just spent 20 minutes sitting in her wheelchair looking at the back of the delivery van blocking her path to both the talk and the lunch.

The simple strategies described in this piece speak not only to respect and justice in our endeavours, failing to be inclusive can significantly limit the relevance and impact of our work.  Gary has been compiling anecdotes from the field that would make you cry with laughter, or just cry.

Miles, a solicitor turned independent-researcher specializing in legal issues relating to social care, describes her attendance at the Socio-Legal Studies Association (SLSA) annual meeting at the University of Bristol, UK, last March as “demeaning and embarrassing and just horrible”. The talks took place across two buildings, and the lifts were frequently filled with participants who could have used nearby stairs. Her access was blocked by delivery vehicles on two occasions. When this made her late, sessions had to be interrupted as tables and chairs were rearranged to fit her in. Miles was provided with a dedicated support worker by the university, but says that networking took place in standing spaces that had no chairs at her level, and that access to disabled toilets was blocked by participants having refreshments.
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As Miles waited for someone to find the driver of the delivery vehicle blocking her way into the main meeting venue for the second time, she finally gave up. “I burst into tears and said, ‘That’s it, I’m going home’.”
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Using ASCO’s Clinical Database for Commercial Research Raises Questions, Ethicists Say – Medscape (Ellie Kincaid | May 2019)0

Posted by Admin in on August 8, 2019
 

Eleven abstracts of the thousands accepted for publication at this year’s annual meeting of the American Society of Clinical Oncology (ASCO), one of the largest cancer research conferences in the world, draw upon data collected through a nonprofit subsidiary of ASCO that in 4 years has brought together the electronic health records (EHRs) of 1.2 million patients.

The ASCO subsidiary — CancerLinQ — will have its own 1200 square foot booth in prime real estate at the entrance to the meeting’s exhibit hall. It has received data from 48 healthcare institutions to help them improve care for patients and has compiled a treasure trove of data for researchers studying how expensive cancer drugs work for patients in the real world. But ethicists are concerned that CancerLinQ is allowing companies to sell access to the data after they have been stripped of patient identifiers, without asking for patients’ permission.

“I think that the ethics of profiting off of someone else’s information is dicey and at the very least the patient should go in with their eyes open, and that requires informing them,” said Robert Field, PhD, MPH, JD, a professor of law and public health at Drexel University, Philadelphia, Pennsylvania.

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