Informed Consent

A Social Work Primer to Confidentiality and Informed Consent

by Derek Chechak

Informed consent as waiver: the doctrine rethought?

by Emma Bullock

Neil Manson and Onora O’Neill have recently defended an original theory of informed consent in their book Rethinking... more Neil Manson and Onora O’Neill have recently defended an original theory of informed consent in their book Rethinking Informed Consent in Bioethics (2007). The development of their ‘waiver’ model is premised on the failings of the theory of informed consent as disclosure, which is rejected on two counts: firstly, the disclosure model’s implicit reliance upon a ‘conduit-container’ model of communication means that the regulatory requirements of informed consent can rarely be achieved; secondly, the model’s purported ethical justification via a principle of respect for patient autonomy is presented as being vacuous.

Despite having laudable motivations for rethinking informed consent, I argue that their theory of informed consent as waiver can be criticised on similar grounds. In order to support this thesis I object that Manson and O’Neill’s developed theory of agential communication is too intricate to easily meet the demands of informed consent as waiver. Secondly, I show that the model appears to be implicitly reliant upon a principle of respect for patient autonomy.

Hence, despite improving upon the doctrine of informed consent, the waiver model needs further elucidation in order to avoid the problems mounted against the disclosure model.

Reconsidering Consent and Biobanking

by Emma Bullock

Co-authored with Heather Widdows

The acquisition of fully informed consent presents a central ethical problem for the procurement and storage of human... more The acquisition of fully informed consent presents a central ethical problem for the procurement and storage of human tissue in biobanks. The tension lies between the apparent necessity of obtaining informed consent from potential research subjects and the projected future use of the tissue. Specifically, under the doctrine of informed consent medical researchers are required to inform their potential research subjects about the relevant risks and purposes of the proposed research. However, because human tissue – when stored in biobanks – can be put to multifarious uses, the information that medical researchers are expected to divulge to their subjects is epistemologically inaccessible. Biobank researchers are thus thought to be unable to obtain informed consent from their subjects, making the practice ethically suspicious. We propose that such suspicions of ethical failure should be reconsidered by presenting two possible solutions. Firstly we argue that the epistemological difficulty might be partially solved by adopting the “waiver model” of informed consent. Secondly, we put forward an argument that individual consent can be supplemented by group ethical models. We thus conclude that while informed consent is problematic for biobank researchers, alternative ethical solutions are available.

Competency of Gaining Consent: a Foundation Trainee’s Perspective in the North Western Deanery

by IOMC Conference

Hiew K.1, Eyres G.1, Chauhan S.2, Ekta P.3, Haddock C.4, Heath R.5, Jawaheer L.6, Looi E.7, Rai. C.8, Thampy A.9, and Baker P.10
(1) Blackpool Teaching Hospitals NHS Foundation Trust, (2) Salford Royal NHS Foundation Trust, (3) Pennine Acute Hospitals NHS Trust, (4) East Lancashire Hospitals NHS Foundation Trust, (5) University Hospitals of South Manchester NHS Foundation Trust, (6) Bolton NHS Foundation Trust, (7) Wrightington, Wigan, and Leigh NHS Foundation Trust, (8) Stockport NHS Foundation Trust, (9) University Hospitals of Morecombe Bay NHS Foundation Trust, (10) North Western Deanery
genesisken@doctors.org.uk

Tacitly Opting Out of Organ Donation: Too Presumptuous After All?

by Jurgen De Wispelaere

Published in Journal of Medical Ethics 38(2), 2012.

Outil d'aide à la réflexion sur des problèmes éthiques liés à l'obtention du consentement au dépistage du VIH

by Michel Desy

In Optimiser le dépistage et le diagnostic de l'infection par le virus de l'immunodéficience humaine. INSPQ, Québec, 2011

The Other Human-Subject Experiments

by Chris Herrera

Journal of Medicine and Philosophy (1997) 22 (2)

Although deceptive psychology experiments receive less attention than some forms of medical research, they pose... more Although deceptive psychology experiments receive less attention than some forms of medical research, they pose similar moral challenges. These challenges mainly concern the use of human subjects and intentional deception. Psychologists provide an argument to justify this deception. But what is an essentially utilitarian argument too often includes faulty comparisons and dubious accounts of risks and benefits. Commentators in other areas of humansubject research might examine this argument and the assumptions behind it. Bioethics commentators seem especially well-positioned for this task.

Proceduralisation, choice, and parental reflections on decisions to accept newborn bloodspot screening

by Stuart Nicholls

Forthcoming in Journal of Medical Ethics: doi:10.1136/medethics-2011-100040

Newborn screening is the program through which newborn babies are screened for a variety of conditions shortly after... more Newborn screening is the program through which newborn babies are screened for a variety of conditions shortly after birth. Programs such as this are individually oriented but resemble traditional public health programs because (a) they are targeted at large groups of the population and (b) they are offered as preventive interventions to a population considered healthy. As such an ethical tension exists between the goals of promoting high uptake of supposedly ‘effective’ population oriented programs and the goal of promoting genuinely informed decision-making. There is, however, a lack of understanding with regard to how parents experience the tension between promoting uptake and facilitating informed choice. In this paper I address this issue and present data to show how aspects of the timing, presentation of information and procedural routinisation of newborn screening serves to impact on the decisions made by parents.

An Ethical Argument Against Leaving Psychologists to Their Statistical Devices

by Chris Herrera

The Journal of Psychology, Volume 130, Issue 2, 1996

The frequent critiques of the statistical tools used by experimental psychologists, especially the null-hypothesis... more The frequent critiques of the statistical tools used by experimental psychologists, especially the null-hypothesis test, cast substantial doubt on the scientific integrity of experiments associated with them. This doubt leaves psychologists with weak grounds for promising results or benefits from their experiments. In addition to the methodological problems raised, the shortcomings of null-hypothesis testing and associated experiments suggest an ethical problem in which deception of the participants is involved. Psychologists who use deception claim that the scientific and educational gains from their experiments balance the ethical costs. But given a dubious prospect of scientifically respectable results, there are good reasons to wonder whether there can be anything to offset the deception. Null-hypothesis testing therefore undermines not only experimental rigor but a significant part of the ethical justification for deceptive methods as well.

Taking Refuge in the Branches of a Guava Tree: The Difficulty of Retaining Consenting and Nonconsenting Participants’ Confidentiality as an Indigenous Researcher

by Dawn Mannay

Published in Qualitative Inquiry 2011 17 (10)

Issues of anonymity of place, participants, and visual images are well documented in social science research (Wiles et... more Issues of anonymity of place, participants, and visual images are well documented in social science research (Wiles et al., 2008). However, in this article, I move beyond issues of the immediate concerns of anonymity to a wider application that encompasses the position of research participants, the researcher, and that of individuals who are unaware that they are a focus of research. The research study focused on the experiences of mothers and daughters residing in a marginalized housing area in urbanized South Wales, United Kingdom. The article draws specifically on data that present the darker side of family life and explores the affective landscapes of trust, confidentiality, silence, and the unintended consequences that encroach upon, and beyond, research relationships in indigenous qualitative inquiry.

What Does “Informed Consent” Mean in the Internet Age?: Publishing Sign Language Corpora as Open Content

by Onno Crasborn

Ongoing processes of managing consent: the empirical ethics of using video-recording in clinical practice and research

by Michelle O'Reilly

with Nicola Parker and Ian Hutcbhy  - in press with Clinical Ethics

Using video to facilitate data collection has become increasingly common in health research. Using video in research,... more Using video to facilitate data collection has become increasingly common in health research. Using video in research, however, does raise additional ethical concerns. In this paper we utilise family therapy data to provide empirical evidence of how recording equipment is treated. We show that families made a distinction between what was observed through the video by the reflecting team and what was being recorded onto videotape. We show that all parties actively negotiated what should and should not go ‘on the record’ with particular attention to sensitive topics and the responsibility of the therapist. Our findings have important implications for both clinical professionals and researchers using video data.  We maintain that informed consent should be an ongoing process and with this in mind we present some arguments pertaining to the current debates in this field of health care practice.

From Actors to Authors: A First Account About the Involvement of Patients in the Informed Consent Governance of a Major Italian Translational Research Hospital

by Paolo Monti

published in «Journal of Ambulatory Care Management», 33 (3), 2010, con S. Casati, F. Bonino, pp. 231-240.

Formative Research on Perceptions of Biobanking: What Community Members Think

by Francisco Alejandro Montiel Ishino

John S. Luque, Gwendolyn P. Quinn, Francisco A. Montel-Ishino, Mariana Arevalo, Shalanda A. Bynum, Shalewa Noel-Thomas, Kristen J. Wells, Clement K. Gwede, Cathy D. Meade, Tampa Bay Community Cancer Network Partners

Journal of Cancer Education

Preparing healthy community members with timely communications prior to engaging them in a request to donate... more Preparing healthy community members with timely communications prior to engaging them in a request to donate biospecimens promises to improve the experience of biobanking participation. To this end, a qualitative study was conducted to assess community member knowledge, attitudes, beliefs, and informational needs about cancer-related biospecimen collection in a large metropolitan area in southwest Florida. The study utilized purposive sampling techniques to recruit a total of 95 participants to participate in 12 focus groups, segmented by race/ethnicity and language preference (mixed race, African American only, and Spanish speaking) and age (18–29, 30–54, and 55 and older). Focus group interviews were analyzed using content analysis to identify emergent themes. Overall, participants in the 30 years and older groups were favorable toward participating in biobanking if their concerns were addressed, such as confidentiality and consent issues, in contrast to participants aged 18–29 who were more skeptical. For all participants, the desire to participate in research that seeks new cancer treatments outweighed mistrust. Moreover, many cited the potential scientific benefit for future generations as a primary motivator. Finally, in some groups a therapeutic misconception was expressed, where participants expressed a willingness to forego confidentiality of their health status in exchange for therapeutic benefit. This study contributes to the literature on community perceptions of the benefits and barriers of biobanking and adds to the development of meaningful education communication priming tools to advance understandings about biobanking.

O Consentimento Informado

by Daniel Torres Gonçalves

Paper apresentado na Conferência “Responsabilidade por actos médicos”, em 27 de Março de 2009, no Porto.

Usualmente, quando se pensa na responsabilização do médico, tem-se em mente a imperícia ou desmazelo do cirurgião ou... more Usualmente, quando se pensa na responsabilização do médico, tem-se em mente a imperícia ou desmazelo do cirurgião ou do médico ao fazer um diagnóstico. Tende-se a associar essa responsabilização com a denominada “negligência médica”. Porém, de forma diversa, poderá vir um médico a ser responsabilizado, mesmo depois de cumprir todos os requisitos técnicos e até de ter curado o paciente. Falaremos do Consentimento Informado.

Impact of informed-choice invitations on diabetes screening knowledge, attitude and intentions: an analogue study

by Ian Kellar

Background
Despite concerns that facilitating informed choice would decrease diabetes screening uptake, 'informed... more Background
Despite concerns that facilitating informed choice would decrease diabetes screening uptake, 'informed choice' invitations that increased knowledge did not affect attendance (the DICISION trial). We explored possible reasons using data from an experimental analogue study undertaken to develop the invitations. We tested a model of the impact on knowledge, attitude and intentions of a diabetes screening invitation designed to facilitate informed choices.

Methods
417 men and women aged 40-69 recruited from town centres in the UK were randomised to receive either an invitation for diabetes screening designed to facilitate informed choice or a standard type of invitation. Knowledge of the invitation, attitude towards diabetes screening, and intention to attend for diabetes screening were assessed two weeks later.

Results
Attitude was a strong predictor of screening intentions (β = .64, p = .001). Knowledge added to the model but was a weak predictor of intentions (β = .13, p = .005). However, invitation type did not predict attitudes towards screening but did predict knowledge (β = -.45, p = .001), which mediated a small effect of invitation type on intention (indirect β = -.06, p = .017).

Conclusions
These findings may explain why information about the benefits and harms of screening did not reduce diabetes screening attendance in the DICISION trial.

Impact of an informed choice invitation on uptake of screening for diabetes in primary care (DICISION): trial protocol

by Ian Kellar

Screening invitations have traditionally been brief, providing information only about population benefits. Presenting... more Screening invitations have traditionally been brief, providing information only about population benefits. Presenting information about the limited individual benefits and potential harms of screening to inform choice may reduce attendance, particularly in the more socially deprived. At the same time, amongst those who attend, it might increase motivation to change behavior to reduce risks. This trial assesses the impact on attendance and motivation to change behavior of an invitation that facilitates informed choices about participating in diabetes screening in general practice. Three hypotheses are tested: 1. Attendance at screening for diabetes is lower following an informed choice compared with a standard invitation. 2. There is an interaction between the type of invitation and social deprivation: attendance following an informed choice compared with a standard invitation is lower in those who are more rather than less socially deprived. 3. Amongst those who attend for screening, intentions to change behavior to reduce risks of complications in those subsequently diagnosed with diabetes are stronger following an informed choice invitation compared with a standard invitation.

Evaluation of an informed choice invitation for type 2 diabetes screening

by Ian Kellar

Objective
To evaluate an innovative invitation designed to facilitate informed choices for undergoing screening... more Objective
To evaluate an innovative invitation designed to facilitate informed choices for undergoing screening for type 2 diabetes.
Methods
Four hundred and seventeen people aged 40–69 years (sex: F 53%/M 47%), without known diabetes, recruited from street locations. Participants were randomised to receive one of two hypothetical invitations for screening for type 2 diabetes; one based on General Medical Council guidelines and combined with a decisional balance sheet, the other a brief traditional invitation. Informed choice was assessed immediately after the invitation and 3 weeks later using measures of knowledge, attitudes and intentions.
Results
Two weeks after receipt of the invitation, the proportion of informed choices was significantly higher among participants who received the informed choice invitation compared with those who received the traditional invitation (42.9% versus 11.2%; difference = 31.7%, 95% CI: 22.5–40.5%; p < 0.001). Mean knowledge scores were significantly higher after the receipt of the invitation designed to facilitate informed choices than after the traditional invitation (5.49 versus 3.90; t(405) = 10.106, p < 0.001). Intentions to participate in screening were unaffected by receipt of the informed choice invitation.
Conclusion
Compared with a traditional invitation, receipt of the invitation designed to facilitate informed choices increased the proportion of informed choices about type 2 diabetes screening attendance.
Practice implications
: Although the new invitation was associated with better knowledge of screening it had no differential effect on intention and its effect on attendance still requires evaluation.

Confounders in Voluntary Consent about Living Parental Liver Donation: No Choice and Emotions

by mare knibbe

Medicine Health Care and Philosophy, 2007, vol. 10, afl. 4, pp. 433-440. Mare Knibbe, Els Maeckelberghe & Marian Verkerk

Parents’ perception of having no choice and strong emotions like fear about the prospect of living liver donation can... more Parents’ perception of having no choice and strong emotions like fear about the prospect of living liver donation can lead professionals to question the voluntariness of their decision. We discuss the relation of these experiences (no choice and emotions), as they are communicated by parents in our study, to the requirement of voluntariness. The perceived lack of choice, and emotions are two themes we found in the interviews conducted within the “Living Related Donation; a Qualitative-Ethical Study” research program. As a framework for the interpretation of these themes we discuss views of moral agency. We adopt a view in which relations are seen as constitutive of moral agency. Judging from this view, the perceived lack of choice can best be understood as a sign of commitment. We argue in this article that neither seeing no choice, nor emotions in themselves should be seen as compromises of a voluntary consent. However both experiences draw attention to aspects that are important to come to an evaluation of consent to donation. We discuss the story of one mother as an exemplary case to show how both themes can intertwine.

Can user testing of a clinical trial patient information sheet make it fit-for-purpose? - a randomised controlled trial

by Theo Raynor

BMC Medicine 2011, 9:89doi:10.1186/1741-7015-9-89

Peter Knapp, David K Raynor, Jonathan Silcock and Brian Parkinson

Background

The participant information sheet (PIS) provided to potential trial participants is a critical... more Background

The participant information sheet (PIS) provided to potential trial participants is a critical part of the process of valid consent. However, there is long-standing concern that these lengthy and complex documents are not fit-for-purpose. This has been supported recently through the application of a performance-based approach to testing and improving readability called user testing. This method is now widely used to improve patient medicine leaflets - determining whether people can find and understand key facts. This study applied for the first time a controlled design to determine whether a PIS developed through user testing had improved readability over the original, using a sheet from a UK trial in acute myeloid leukemia (AML16).

Methods

In the first phase the performance of the original PIS was tested on people in the target group for the trial. There were three rounds of testing including 50 people in total - with the information revised according to its performance after each of the first 2 rounds. In the second phase, the revised PIS was compared with the original in a parallel groups randomised controlled trial (RCT) A total of 123 participants were recruited and randomly allocated to read one version of the PIS to find and show understanding of 21 key facts.

Results

The first, developmental phase produced a revised PIS significantly altered in its wording and layout. In the second, trial phase 66% of participants who read the revised PIS were able to show understanding of all aspects of the trial, compared with 15% of those reading the original version (Odds Ratio 11.2; Chi-square = 31.5 p<.001). When asked to state a preference,
87.1% participants chose the revised PIS (Sign test p<.001).

Conclusions

The original PIS for the AML16 trial may not have enabled valid consent. Combining performance-based user testing with expertise in writing for patients and information design led to a significantly improved and preferred information sheet. User testing is an efficient method for indicating strengths and weaknesses in trial information, and Research Ethics Committees and Institutional Review Boards should consider requesting such testing, to ensure that PIS are fit-for-purpose.