Informed Consent: A Monthly Review
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June 2022

This digest aggregates and distills key content addressing informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.

Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:

Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_June 2022

Information Provision for Informed Consent Procedures in Psychological Research under the GDPR: A Practical Guide

Information Provision for Informed Consent Procedures in Psychological Research under the GDPR: A Practical Guide
Dara Hallinan, Franziska Boehm, Annika Külpmann, Malte Elson
The Society for the Improvement of Psychological Science; GDPR and Consent Forms in Psychological Research, 18 May 2022
Open Access
Abstract
Psychological research often involves the collection and processing of personal data from human research participants, and there is a norm that informed consent should be obtained before such research can go ahead. The European General Data Protection Regulation (GDPR) applies, in principle, to psychological research. It elaborates a range of conditions concerning the forms of information which should be communicated to research participants whenever personal data are collected from them, in order that they might be considered to be ‘informed’. There is reason to believe, however, that the information required by the GDPR may not always be provided in consent materials. This may – at least in part – be due to the fact that psychological researchers are not aware of the exact requirements. This tutorial thus aims to provide general practical guidance to psychological researchers allowing them to understand which forms of information must be provided to research subjects in consent materials according to the GDPR.

Without their Consent: Handling Legacy Collections and Anatomy Teaching Specimens Acquired without Informed Consent

Without their Consent: Handling Legacy Collections and Anatomy Teaching Specimens Acquired without Informed Consent
Pamela L. Geller
Federation of American Societies for Experimental Biology, 13 May 2022; 36(1)
Open Access
Abstract
Legacy collections have proven invaluable for teaching students about anatomy and standard methods. It is safe to presume, however, that ancient and historic decedents never consented to their inclusion in collections or use as pedagogical tools. A utilitarian position—that the use of these human remains serves a higher scientific purpose—becomes even harder to justify when educators acknowledge the historic necropolitical projects and suffering that underpinned the formation of legacy collections. How then to proceed scholastically with such affective and politically charged human remains?

As a complex case study, I consider the Samuel G. Morton Crania Collection. To instruct the medical students who populated his anatomy classes, the Philadelphia physician amassed over 900 crania from 1830 to 1851. After Morton’s death, the Academy of Natural Sciences purchased the collection, where it was all but forgotten. Almost a century later, in 1966, it came under the stewardship of the Penn Museum, its pedagogical purpose resurrected. While Stephen Jay Gould drew attention to the scientific racism of Morton’s research, it was not until the passage of the Native American Graves Protection and Repatriation Act of 1990 that ethical deliberations began in earnest. Here I continue these trains of thought with a discussion of the Afro-Cuban crania in the Morton Collection.

Morton acquired these decedents from his Cuban colleague Dr. José Rodriguez Cisneros in 1840. The latter designated them “negros bozales,” an indicator of their enslaved status and African origins; additional information about tribe and country was not provided. In summer 2020, in the wake of the murder of George Floyd and the racial justice protests his death catalyzed, these skulls erupted into the public consciousness. There were calls to “Return Them All.” I regard this response as well intentioned but also reactionary and unnuanced. To determine if sustained use is viable where consent is inadequate, for this case and more generally, I bring to the fore two concepts: the agentive corpse and ontological insecurity. Both concepts require educators and researchers to culturally contextualize human remains, as well as attend to the dynamic meanings attached to them—by past communities and their living descendants. With this knowledge in hand, I make some tentative recommendations about the fate of these controversial and highly sensitive human remains.

‘If we don’t have consent, we need to have beneficence’: Requiring beneficence in nonconsensual neurocorrection

‘If we don’t have consent, we need to have beneficence’: Requiring beneficence in nonconsensual neurocorrection
Emma Dore-Horgan
Bioethics, 8 April 2022
Abstract
Neurointerventions—interventions that cause direct physical, chemical or biological effects on the brain—are sometimes administered to criminal offenders for the purpose of reducing their recidivism risk and promoting their rehabilitation more generally. Ethical debate on this practice (henceforth called ‘neurocorrection’) has focused on the issue of consent, with some authors defending a consent requirement in neurocorrection and others rejecting this. In this paper, I align with the view that consent might not always be necessary for permissible neurocorrective use, but introduce a qualification I argue ought to inform our ethical and legal analysis of neurocorrection if we are to administer neurocorrectives nonconsensually. I maintain our use of nonconsensual  neurocorrection should be constrained by a beneficence requirement—that it should be limited to neurocorrectives that can be expected to benefit those required to undergo them; and my argument is that a beneficence requirement is necessary in order to safeguard against offender abuse. I highlight how we afford a heightened protective role to beneficence in other instances of biomedical intervention where consent is absent or in doubt; and I argue a beneficence requirement is also necessary in the correctional context because alternative candidate protections would provide insufficiently strong safeguards on their own. I then consider whether requiring beneficence in nonconsensual neurocorrection would (a) be incompatible with penal theory, (b) be objectionably paternalistic, or (c) foreclose many fruitful avenues of crime control. I argue in each case that it would not.

Is true informed consent achievable?

Is true informed consent achievable?
Miya Matz
MacEwan University Student eJournal, 6 May 2022; 6(1)
Abstract
Imagine you have just found out that a loved one, such as a parent, sibling, or close friend, suffers from a rare and deadly genetic disorder. There are currently no successful mainstream treatments for this disorder. However, the doctor mentions a highly experimental treatment that would involve removing bone marrow from a healthy donor once a month for a full year and could potentially cause permanent damage to them. It turns out that you are a match. How would you make your decision regarding treatment? Most individuals would suggest leaving it to the doctor’s discretion, but because it is your body, it is ultimately your choice. You attempt to do further research on the internet but end up confused and frustrated. How will you ultimately decide as to whether you should give informed consent for the procedure?

Informed Consent: A Monthly Review
_________________

May 2022

This digest aggregates and distills key content addressing informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.

Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:

Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
PDF Version: GE2P2 Global_Informed Consent – A Monthly Review_May 2022

Will obtaining digital consent from patients in advance of undergoing procedures improve the quality of the consent process?

Will obtaining digital consent from patients in advance of undergoing procedures improve the quality of the consent process?
Opinion
Tessa Richards
BMJ, 26 April 2022; 377
Open Access
Excerpt
…During my patient journey I have always (as here) been “consented” for procedures on the day. While I have read up about—and mentally committed to—the interventions in advance, pre-operative anxiety has meant I have been quite unable to take in information, let alone pose questions, as my doctors have sped through the standard spiel on potential risks and harms…

Surgeons, Hernia Surgery and Informed Consent in the Seventeenth Century Ottoman Istanbul

Surgeons, Hernia Surgery and Informed Consent in the Seventeenth Century Ottoman Istanbul
Surgical History
Mahmut Said Degerli
World Journal of Surgery, 10 April 2022
Abstract
Background
In the seventeenth century Ottoman Istanbul, especially Greek surgeons specialized in hernia surgery. Both Muslim and non-Muslim patients had signed contracts with surgeons in sharia courts before undergoing a surgery. In this study, we analyze these documents, which serve as informed consent in the Ottoman period, in detail.
Methods
We used Istanbul Sharia Court Registers (Istanbul Sicils) as the primary information source. We scanned a total of twenty nine registers dating back to the seventeenth century. In six of these registers, we determined a total of twenty one informed consents (known as rıza senedi in Turkish literature) regarding hernia surgery and surgeons. Based on these data, we examined the surgeons and hernia surgeries, the fees received by surgeons, and the informed consent documents of the seventeenth-century Istanbul.
Results
In the scanned informed consents, we identified five male surgeons and twenty one patients. While four of the surgeons were Greek, one of them was Muslim. The contracts show that the patients were informed about possible complications before operations, and their permissions were obtained accordingly. The contracts also clearly state that a blood-money from the surgeons would not be requested if a patient dies during or after an operation. The cost of operations ranged between 500 and 2100 aḳče.
Conclusions
The patient-physician relationship in Ottomans was seen as a business relationship. Medical processes were recorded in courts before treatment fees were paid. These court records had been a practice that protected the patients and the physicians in terms of criminal liability.

Consent, Interaction, and the Value of Shared Understanding

Consent, Interaction, and the Value of Shared Understanding
Research Article
Richard Healey
Legal Theory, 28 March 2022; 28(1) pp 35 – 58
Abstract
Recent years have seen a proliferation of philosophical work on consent. Within this body of work, philosophers often appeal to an account of the interests, values, or functions that underpin the power of consent. By far the most commonly cited value realized by the power of consent is the promotion and protection of the power-holder’s autonomy. This focus on autonomy yields what I call the Gate Opener Model of consent, according to which the central valuable function of consent is to give the power-holder control over whether other people can act in certain ways. In this article, I argue that the Gate Opener Model of consent is inadequate. I then defend an alternative Relational Model of consent, according to which a central valuable function of consent is to enable a non-instrumentally valuable form of interaction between people.

Informed Consent: A Monthly Review
___________________________

April 2022

This digest aggregates and distills key content addressing informed consent from a broad spectrum of peer-reviewed journals and grey literature, and from various practice domains and organization types including international agencies, INGOs, governments, academic and research institutions, consortiums and collaborations, foundations, and commercial organizations. We acknowledge that this scope yields an indicative and not an exhaustive digest product.

Informed Consent: A Monthly Review is a service of the Center for Informed Consent Integrity, a program of the GE2P2 Global Foundation. The Foundation is solely responsible for its content. Comments and suggestions should be directed to:

Editor
Paige Fitzsimmons, MA
Associate Director, Center for Informed Consent Integrity
GE2P2 Global Foundation
paige.fitzsimmons@ge2p2global.org
PDF Version:  GE2P2 Global_Informed Consent – A Monthly Review_April 2022