Distinctive aspects of consent in pilot and feasibility studies
Original Paper
Julius Sim
Journal of Evaluation in Clinical Practice, 24 February 2021
Open Access
Abstract
Prior to a main randomized clinical trial, investigators often carry out a pilot or feasibility study in order to test certain trial processes or estimate key statistical parameters, so as to optimize the design of the main trial and/or determine whether it can feasibly be run. Pilot studies reflect the design of the intended main trial, whereas feasibility studies may not do so, and may not involve allocation to different treatments. Testing relative clinical effectiveness is not considered an appropriate aim of pilot or feasibility studies. However, consent is no less important than in a main trial as a means of morally legitimizing the investigator’s actions. Two misperceptions are central to consent in clinical studies—therapeutic misconception (a tendency to conflate research and therapy) and therapeutic misestimation (a tendency to overestimate possible benefits and/or underestimate possible harms associated with participation). These phenomena may take a distinctive form in pilot and feasibility studies, owing to potential participants’ likely prior unfamiliarity with the nature and purposes of such studies. Thus, participants may confuse the aims of a pilot or feasibility study (developing or optimizing trial design and processes) with those of a main trial (testing treatment effectiveness) and base consent on this misconstrual. Similarly, a misunderstanding of the ability of pilot and feasibility studies to provide information that will inform clinical care, or the underdeveloped nature of interventions included in such studies, may lead to inaccurate assessments of the objective possibility of benefit, and weaken the epistemic basis of consent accordingly. Equipoise may also be particularly challenging to grasp in the context of a pilot study. The consent process in pilot and feasibility studies requires a particular focus, and careful communication, if it is to carry the appropriate moral weight. There are corresponding implications for the process of ethical approval.
Model Operational Procedures for the Implementation and Review of NIH Sponsored Multicenter Clinical Trials with Exception from Informed Consent (EFIC) for Emergency Research
Model Operational Procedures for the Implementation and Review of NIH Sponsored Multicenter Clinical Trials with Exception from Informed Consent (EFIC) for Emergency Research
SIREN Clinical Coordinating Center
Version 1, January 2021
Open Access
Introduction
The purpose of this document is to provide a model process and procedures that can be used as starting point for implementation of clinical trials using Exception from Informed Consent for Emergency Research (EFIC) in NIH funded multicenter clinical trials. The process and procedures described can and must be adapted to the specific needs and details of any future trials. The materials provided were developed and informed by both thorough review of the accumulated scholarship related to EFIC, and other lessons learned through practical shared experiences of prior NIH funded emergency care researchers.
This document is intended to be a useful, practical, and tested peer-to-peer tool for future investigators in this field. It is not intended to be a definitive guideline for application of the EFIC regulations, and should NOT be interpreted as any form of regulatory guidance. Regulatory guidance is available from FDA. This document does not represent the only way to implement Exception from Informed Consent, and may not be applicable or optimal for EFIC studies that differ from those for which this document was created. This document is intended to be open access, and shared through a Creative Commons Attribution-NonCommercial (CC BY-NC) license that lets others adapt, and build upon the work non-commercially. New works must acknowledge the source materials and the NIH and be non-commercial. The derivative works do not have be licensed on the same terms.
Nano-drug Clinical Trials: Informed Consent and Risk Management Through Blockchain
Nano-drug Clinical Trials: Informed Consent and Risk Management Through Blockchain
Yousef Haik, Ilias Bantekas
Pittsburgh Journal of Technology Law & Policy, 2021
Open Access
Abstract
Drug bearing nano-shells that can be utilized for targeted drug delivery have been shown to enhance the therapeutic index by increasing the drug concentration in diseased tissue and reducing the toxicity in normal tissue. The controllability of the drug bearing shell size provides predictability measure for the amount of drug payload per shell which improves the administration of the therapeutic dose. The FDA approved different formulations for clinical use in metastatic and recurrent breast cancer, among other diseases. At the moment, some of these formulations are the subject of international clinical trials. Informed consent is legally mandated in administering drug bearing nano-shells. The risks of the new formulations, as with all new technologies, are not well known and continue to be a subject of intensive research, thus exacerbating the existing informed consent legal issues, thus exacerbating the existing informed consent legal issues. This short essay focuses on proposing a framework to mitigate liabilities administering a new formulation on nano-enabled drug carriers particularly when uncertainties of the benefits and damages are not fully known.
“Why didn’t we do it”? Reproductive loss and the problem of post-mortem consent
“Why didn’t we do it”? Reproductive loss and the problem of post-mortem consent
Kate Reed, Maria Teresa Ferazzoli, Elspeth Whitby
Social Science & Medicine, 12 March 2021
Abstract
Informed consent has been a much debated topic within the social sciences. It often forms a central feature of discussions on research in medical settings and in social research methods more broadly. While sympathetic to its’ underlying principles of autonomy and choice, social scientists have tended to argue that these are seldom enacted in research or clinical practice. Rather, such principles are often circumscribed by wider social structures and by a culture of medical dominance. Drawing on data from a qualitative study on perinatal post-mortem, this paper explores informed consent in the emotionally charged clinical arena of perinatal pathology. Our in-depth analysis will provide fresh insight into post-mortem decision-making in the sensitive arena of baby loss. Our findings show how parents often found it difficult to give consent for post-mortem, and also for professionals to take consent from parents. It was also not uncommon for parents to experience regret over non-consent later on. One of our key findings, however, related to the sense of emotional and diagnostic closure often afforded by post-mortem when consent had been given. We conclude by arguing that, although we cannot resolve the tension between the principles of consent and their enactment in practice, we can develop a reflexive approach with which to navigate the process. In doing so, the paper contributes to wider sociological discussions on the meaning and use of informed consent in various settings beyond medical contexts.
Mainstreaming informed consent for genomic sequencing: A call for action
Mainstreaming informed consent for genomic sequencing: A call for action
Current Perspective
Eline M. Bunnik, Wybo J. Dondorp, Annelien L. Bredenoord, Guido de Wert, Martina C. Corneld
European Journal of Cancer, May 2021; 148 pp 405-410
Abstract
The wider availability of genomic sequencing, notably gene panels, in cancer care allows for personalised medicine or the tailoring of clinical management to the genetic characteristics of tumours. While the primary aim of mainstream genomic sequencing of cancer patients is therapy-focussed, genomic testing may yield three types of results beyond the answer to the clinical question: suspected germline mutations, variants of uncertain significance (VUS), and unsolicited findings pertaining to other conditions. Ideally, patients should be prepared beforehand for the clinical and psychosocial consequences of such findings, for themselves and for their family members, and be given the opportunity to autonomously decide whether or not to receive such unsolicited genomic information. When genomic tests are mainstreamed into cancer care, so should accompanying informed consent practices. This paper outlines what mainstream oncologists may learn from the ethical tradition of informed consent for genomic sequencing, as developed within clinical genetics. It argues that mainstream informed consent practices should focus on preparing patients for three types of unsolicited outcomes, briefly and effectively. Also, it argues that when the chance of unsolicited findings is very low, opt-out options need not be actively offered. The use of a layered approach – integrated in information systems – should render informed consent feasible for non-geneticist clinicians in mainstream settings. (Inter) national guidelines for mainstreaming informed consent for genomic sequencing must be developed.
The use of personal health information outside the circle of care: consent preferences of patients from an academic health care institution
The use of personal health information outside the circle of care: consent preferences of patients from an academic health care institution
Research Article
Sarah Tosoni, Indu Voruganti, Katherine Lajkosz, Flavio Habal, Patricia Murphy, Rebecca K. S. Wong, Donald Willison, Carl Virtanen, Ann Heesters, Fei-Fei Liu
BMC Medical Ethics, 24 March 2011; 22(29)
Open Access
Abstract
Background
Immense volumes of personal health information (PHI) are required to realize the anticipated benefits of artificial intelligence in clinical medicine. To maintain public trust in medical research, consent policies must evolve to reflect contemporary patient preferences.
Methods
Patients were invited to complete a 27-item survey focusing on: (a) broad versus specific consent; (b) opt-in versus opt-out approaches; (c) comfort level sharing with different recipients; (d) attitudes towards commercialization; and (e) options to track PHI use and study results.
Results
222 participants were included in the analysis; 83% were comfortable sharing PHI with researchers at their own hospital, although younger patients (≤ 49 years) were more uncomfortable than older patients (50 + years; 13% versus 2% uncomfortable, p < 0.05). While 56% of patients preferred broad consent, 38% preferred specific consent; 6% preferred not sharing at all. The majority of patients (63%) preferred to be asked for permission before entry into a contact pool. Again, this trend was more pronounced for younger patients (≤ 49 years: 76%). Approximately half of patients were uncomfortable sharing PHI with commercial enterprises (51% uncomfortable, 27% comfortable, 22% neutral). Most patients preferred to track PHI usage (61%), with the highest proportion once again reported by the youngest patients (≤ 49 years: 71%). A majority of patients also wished to be notified regarding study results (70%).
Conclusions
While most patients were willing to share their PHI with researchers within their own institution, many preferred a transparent and reciprocal consent process. These data also suggest a generational shift, wherein younger patients preferred more specific consent options. Modernizing consent policies to reflect increased autonomy is crucial in fostering sustained public engagement with medical research.
A survey on the current status and future perspective of informed consent management in the MIRACUM consortium of the German Medical Informatics Initiative
A survey on the current status and future perspective of informed consent management in the MIRACUM consortium of the German Medical Informatics Initiative
Research
Christopher Hampf, Martin Bialke, Lars Geidel, Albert Vass, Thomas Bahls, Romina Blasini, Arne Blumentritt, Martin Boeker, Christian Bruns, Burkhard Jandrig, Maximilian Fünfgeld, Philipp Heinrich, Torsten Leddig, Achim Michel-Backofen, Anna Pirkl, Michael Rautenberg, Fabian Simons, Dana Stahl, Hans-Ulrich Prokosch, Wolfgang Hoffmann
Translational Medicine Communications, 8 March 2021; 6(7)
Open Access
Abstract
Background
The consent management is an essential component for supporting the implementation of consents and withdrawals and thus, the realisation of patient’s rights. In MIRACUM, one of the four consortia of the Medical Informatics Initiative (MII), ten university hospitals intend to integrate the generic Informed Consent Service® (gICS) in their Data Integration Center (DIC). To provide a tool that supports the local workflows of the MIRACUM sites, the gICS should be improved.
Methods
We used three standardised questionnaires with 46 questions to elicit requirements from the ten sites. Each site answered the questions from the current and the desired future perspective. This made it possible to understand the individual processes at each site and it was possible to identify features and improvements that were generally necessary.
Results
The results of the survey were classified according to their impact on the gICS. Feature requests of new functionalities, improvements of already implemented functionalities and conceptual support for implementing processes were identified. This is the basis for an improved gICS release to support the ten sites’ individual consent management processes.
Conclusions
A release plan for the feature requests and improvements was coordinated with all sites. All sites have confirmed that the implementation of these features and enhancements will support their software-based consent management processes.
Assessing Patient Satisfaction and Confidence After Use of Educational Video to Augment Surgical Consent for Thyroid Surgery
Assessing Patient Satisfaction and Confidence After Use of Educational Video to Augment Surgical Consent for Thyroid Surgery
Michelle Schafer, Katie Holland, Alexander Duffy, Kelley Yuan, Marisa Wu, Raphael Banoub, Elizabeth Cottrill
Translational Medical Research Commons, February 2021
Abstract
Introduction
Informed consent is a crucial aspect of ethical patient care, yet the increase in surgical complexity presents a challenge in achieve this properly. This study explores the use of an educational video to help standardize the consent process, increase patient retention of information, and promote patient understanding by allowing patients to replay the information remotely as often as needed.
Methods
This is a prospective, survey-based study of adult patients undergoing thyroid surgery. A novel video detailing thyroid surgery containing the standard contents of informed consent was shown to patients after traditional informed consent followed by a survey on their level of comfort of the information before and after the video. Data on patient age, education level, previous surgical experience was collected.
Results
Preliminary data shows that there is an increase in confidence, benefits, and knowledge of risk of the patients’ operation. We expect to find that with the addition of an educational video to the thyroid surgery consent process, patients will report a higher level of satisfaction as well as confidence in regards to their surgery.
Discussion
The process of informed consent has not evolved with the complexity of procedures. The use of multimedia has been demonstrated as a valuable teaching tool in addition to traditional informed. Our study reinforces that there is a place for multimedia, specifically educational videos in informed consent for thyroid surgery as it may help patients better understand their procedure. Future aims of this study include evaluating patient comprehension with the addition of an educational video to informed consent, as well as the creation of more educational videos for head and neck surgery consent.
Competence and informed consent
Competence and informed consent
Adam Doležal, Tomáš Doležal
Vnitr̆ní lékar̆ství, Winter 2021; 67(1) pp 49-55
Abstract
The issue of a patient´s competence is often solved in practice without a major theoretical concept. Such an approach, focused only on the basis of intuitions and experiences of physicians, however, may lead in some cases to an inadequate assessment of competence of a particular patient. Ultimately, it can happen that the decision of an incompetent person will be respected or that the decision of the competent person will be disrespected. Both possibilities can have ethical as well as legal consequences. This article addresses both theoretical and practical issues of competence in adult patients.
Editor’s note: Internal Medicine is the official journal of the Czech Internal Medicine Society.
Psychological, ethical and legal aspects of neurosurgical procedures in conscious patients with judgment consent
Psychological, ethical and legal aspects of neurosurgical procedures in conscious patients with judgment consent
Zygmunt Siedlecki, Agnieszka Gutkowska, Karol Nowak, Sheeba Shaik, Maciej Śniegocki
Psychology and Education, 2021; 58(2) pp 7179-7183
Open Access
Abstract
Neurosurgical procedures are often performed on patients with brain diseases, making them mentally dysfunctional. These patients may be unconscious, and the surgery is emergency and life-saving then. Its execution from a legal point of view is performed with implied consent. Another problem, both ethically and legally, are the conscious patients who, however, has mental limitations and disturbed criticism, are fully conscious and who do not agree to pronounced treatment. Judgment approval is necessary in these cases. A certain dilemma is the implementation of treatment during the consistently emphasized refusal of treatment. It is difficult for physician, especially since he has contact with this patient every day. We present our own experience in the treatment of such patients. We share our comments and observations. We describe cases of patients treated for brain tumors, hydrocephalus and chronic subdural hematomas. We present the daily ethical, legal and organizational aspects of treating such patients. We suggest that empathy and conversation with such patients is of key importance.
Center for Informed Consent Integrity 