General Consent Research Articles

A patient perspective: Talking about the Swiss General Consent

To get an understanding of the patient perspective on the General Consent (GC), RA Watch Editor Séverine Méance met with Philipp do Canto from the Swiss Multiple Sclerosis Association (MSA).

Developing innovative procedures for obtaining informed consent: Three solutions underway

The Swiss Personalized Health Network (SPHN), a national initiative funded by the State Secretariat for Education, Research and Innovation (SERI), was designed to promote the development of personalised medicine and personalised health in Switzerland. The SPHN aims to develop infrastructure projects that will make health-related data interoperable and shareable at the national level. Accordingly, certain projects related to informed consent (IC) were funded and are described in this article: the Electronic General Consent (e-GC), the Citizen Centered Consent: Shared, Transparent and Dynamic (the so-called C3-STuDY), and the proactive management tool of consent for research (in French so-called “Gestion Proactive des Consentements de Recherche”, GPCR).

Considerations When Writing and Presenting Consent Forms for Clients

Abstract While the writing and presentation of most general consent forms can be accomplished using a checklist of what to include and say, different nuances and considerations enter the process when the participants of a research study involve present or past clients who retain their legal rights. This process is even more challenging for student music therapists conducting research as part of a school-related project. While the Belmont Report1 and the American Music Therapy Association’s (AMTA) Code of Ethics (https://www.musictherapy.org/about/ethics/) provide some insights and direction for many ethical research decisions, music therapy researchers also must be aware of their values, morals, and integrity, as well as various ethical considerations. Based on an example scenario, six ethical questions related to writing and presenting a consent form for a past client are discussed along with references to the Belmont Report and AMTA’s Code of Ethics.

Correction: Unicondylar Tibiofemoral Arthroplasty – Opinions of the Members of the German Knee Society (DKG) and the German Professional Association of Orthopaedic and Trauma Specialists (BVOU)

Background The number of implanted unicondylar tibiofemoral knee arthroplasties (UKA) is despite the potential advantages in comparison to total knee arthroplasties (TKA) in Germany relatively low. Goal of this survey, initiated by the Small Implants Group of the German Knee Society, was to gather opinions and put them into context of the current literature. Methods Based on the Delphi method and the AWMF rules and standards, 19 statements were developed, which were presented to the members of the DKG and BVOU in an anonymous online survey using “SurveyMonkey”. Overall, 410 colleagues participated. Results The biggest detected controversies were the determination of indications with respect to the body mass index and the existence of a patellofemoral arthrosis. A general consent was determined that a contralateral tibiofemoral arthrosis grade III – IV and meniscal deficiency in the contralateral compartment are an absolute contraindication. There was a consent that age is not a limitation for the implantation of an UKA. If a personal minimum volume of 15 implantations/year should be implemented was seen controversial. Conclusion The personal opinion, eventually built by personal experiences, appears to be in conflict with the knowledge of scientific literature in many instances. Intensive training and education appears necessary.

Decisional authority of gamete donors over embryos created with their gametes

In the ongoing discussion on the rights and obligations of gamete donors, scant attention has been paid to the decisional authority of gamete donors over the disposition of the embryos created with their gametes. This paper analyses four different positions: three cases relate to the disposition options for surplus or unused embryos by the first recipients, and one case relates to the use of the embryos stored by the first recipients for procreation.We conclude that the gamete donor causally contributes to the creation of the embryos and thus becomes indirectly responsible. To avoid that donors would become accomplices to an activity to which they morally object, a qualified generic consent mentioning types of research should be obtained. No consent from the donor is required for the destruction of the embryos.The cancellation of the agreement by anonymous or identifiable gamete donors should not be possible for embryos in storage for reproduction by the recipients. The interests in not becoming a genetic parent against one's wishes do not outweigh the damage done to recipients who would no longer be able to use their embryos. Known donors, on the contrary, should be able to withdraw their consent up to the moment of transfer of the embryos based on the greater harm caused to them as a consequence of attributional parenthood. They should also be able to veto transfer of the embryos to other people than the original recipients.

Моральная универсальность в этике Генри Сиджвика

The article analyzes the idea of moral universality in the Henry Sidgwick’s Methods of Ethics. It is shown that this idea is the leitmotif of this work. The following implications of moral universality are highlighted: (1) the impartiality of moral philosopher’s position in his research (excluding sermon or edifying); (2) the position of every thinking person while making judgments and decisions: this position is set by the self-evident principles of justice (equality), or an impartial attitude to different people in similar situations, as well as the impartial application of general rules to them; prudence, or an impartial attitude of persons to their own good throughout life; benevolence, or an impartial attitude to the good of different people. (3) the special feature of the self-evident principles themselves, which manifests itself either in the general consent of experts or all people regarding these rules (general acceptance), or in the absence of disagreement. The article concludes that the idea of universality as an objective characteristic of substantial moral principles as their general acceptance is rather vulnerable: none of Sidgwick’s principles meets his criterion of general acceptance. However, the interpretation of universality as impartiality in making decisions and judgments seems quite reliable. The peculiarity of Sidgwick’s position in comparison with Kant's was that he applied a utilitarian approach to the analysis of universality as im­partiality and filled it with substantial points.

Characteristics of emergency department presentations requiring consultation of the national Poisons Information Centre.

To describe the characteristics of cases presenting at the emergency department due to (suspected) poisoning for which consultation on patient management with the national Poisons Information Centre was required. Retrospective study at the emergency department of Bern University Hospital, Switzerland, from May 2012 to December 2017. Cases were identified in the electronic patient database using appropriate full-text search terms. Cases were excluded if the contact with the National Poisons Information Centre was through an external hospital or directly by the patient. Cases in which the poison centre was not contacted and cases without the patient’s general consent to use their medical data for research purposes were also excluded. Overall, 667 cases from the study period were included. The median age was 32 years (range 16–94); 405 patients (61%) were female and 262 (39%) male. In most cases, the poisoning was acute (n = 631, 95%) and intentional (n = 505, 76%). The most common route of exposure was ingestion (n = 587, 88%) and the most commonly involved substances were sedatives (n = 185, 28%), antidepressants (n = 162, 24%) and non-opioid analgesics (n = 161, 24%). Impaired consciousness was documented in 299 cases (45%). Approximately half of the cases (n = 359, 54%) were of minor severity as assessed using the Poisoning Severity Score, 142 (21%) were of moderate severity, 110 (16%) were asymptomatic and 56 (8%) were severe. There were no fatalities. In most cases (n = 599, 90%), immediate therapeutic or diagnostic measures were undertaken prior to contact with the poison centre. Decontamination measures and specific antidotes undertaken or administered only after contacting the poison centre included whole bowel irrigation, haemodialysis, fomepizole, biperiden, silibinin, deferoxamine, leucovorin, dimercaptopropanesulfonic acid and hydroxocobalamin. Administration of a specific antidote/therapeutic agent was recommended in 87 cases (13%). In 70 of these 87 cases (80%), the specific agents were administered as recommended by the poison centre. In 17 cases (20%), the specific antidotes were not administered as recommended because of either clinical improvement (n = 11), termination of therapy based on laboratory results (n = 3), therapy refused by the patient (n = 2), or identification of a mushroom as non-poisonous (n = 1). In 109 cases (16%), there was no change in patient management after contacting the poison centre. For patients presenting at the emergency department with severe poisoning, contact with the poison information centre can help to implement specific treatment and avoid fatalities. In less severe cases involving more common agents (e.g. paracetamol, benzodiazepines), contact can help to avoid unnecessary treatment and serve as a source of information and/or confirmation.

Pre-induction checklists and discomfort in patients. An observational study.

Since the WHO release of the Safe Surgery Saves Lives Program in 2008, peri-operative checklists minimise errors and improve patient safety worldwide. Anaesthesia professionals are often reluctant to use these checklists in front of patients because they fear causing patients' discomfort before anaesthesia and surgery. To assess and compare the subjective level of patient discomfort caused by the use of pre-induction checklists with the patient discomfort estimated by anaesthesia providers. Prospective observational study. The current single-centre trial included 110 anaesthesia providers and 125 nonpremedicated ear, nose and throat or maxillofacial surgery patients in Switzerland from June to August 2016. Inclusion criterion: signed general research consent. received premedication, less than 18 years old, day-care patients, dementia or other mental illnesses. Anaesthesia healthcare providers and patients before surgery and on the first postoperative day were asked to rate three statements: MAIN OUTCOME MEASURES: All statements were rated on a 100-mm visual analogue scale, where 0 meant no agreement and 100 meant total agreement. Patients overwhelmingly agreed that anaesthesia providers should use checklists in front of them. Anaesthesia providers rated the patient discomfort much higher than actually perceived by patients. Both, patients and anaesthesia providers rated the possibility of reducing the risk of errors high. Patients experience far less discomfort observing the use of pre-induction checklists than anaesthesia providers expect. Patients value the potential safety benefit significantly higher than anaesthesia providers. These results further support the implementation of peri-operative checklists in the operating room environment. The current observational study had no intervention, therefore, was not registered.

Unicondylar Tibiofemoral Arthroplasty - Opinions of the Members of the German Knee Society (DKG) and the German Professional Association of Orthopaedic and Trauma Specialists (BVOU).

The number of implanted unicondylar tibiofemoral knee arthroplasties (UKA) is despite the potential advantages in comparison to total knee arthroplasties (TKA) in Germany relatively low. Goal of this survey, initiated by the Small Implants Group of the German Knee Society, was to gather opinions and put them into context of the current literature. Based on the Delphi method and the AWMF rules and standards, 19 statements were developed, which were presented to the members of the DKG and BVOU in an anonymous online survey using "SurveyMonkey". Overall, 410 colleagues participated. The biggest detected controversies were the determination of indications with respect to the body mass index and the existence of a patellofemoral arthrosis. A general consent was determined that a contralateral tibiofemoral arthrosis grade III - IV and meniscal deficiency in the contralateral compartment are an absolute contraindication. There was a consent that age is not a limitation for the implantation of an UKA. If a personal minimum volume of 15 implantations/year should be implemented was seen controversial. The personal opinion, eventually built by personal experiences, appears to be in conflict with the knowledge of scientific literature in many instances. Intensive training and education appears necessary.

117.2: Organ donation organization preparation for facial transplantation: The Transplant Québec experience.

Background: Globally, there have been 43 face transplants performed since the first one in France, 2005. The preparation required to proceed towards vascularized composite allotransplant donation is dynamic and complex. Three years of collaborative, multi-disciplinary planning were required prior to the completion of the first facial transplantation in Canada and the Commonwealth. Methods: Transplant Québec worked in a coordinating role with multiple teams and agencies, including the transplant team, Hôpital Maisonneuve-Rosemont (located in Montréal), Health Canada, and the Ministry of Health of Québec. While developing a standard operating procedure (SOP), Transplant Québec looked to other jurisdictions which had already successfully performed this highly sophisticated procedure including the University of Maryland in Baltimore, Maryland, and New York University. Using these existing SOPs as a model, a specific SOP, tools and manuals were created and adapted to educate the Transplant Québec clinical staff regarding donor eligibility evaluation and the, logistics of procurement procedure. Concurrently, the ethics committee of Transplant Québec and the hospital research ethics board reviewed the research protocol, to ensure that the donor families were aware that images from the transplant recipient will presented to the media, and to ensure that no lifesaving organs were put at risk during the procurement. Results: Transplant Québec deployed the SOP for facial donation in February 2018. The protocol was executed by the donor coordinators who displayed interest in the project and who helped outline throughout the 3-year process. In accordance with ethics recommendations and the new SOP, facial transplantation was successfully performed in May 2018 during a 30 hours operation. Thoracic and abdominal organs were also successfully recovered and transplanted from the same donor. Coordinators approached the family in two distinct steps: first general consent was obtained for organ donation from a patient determined brain death, then separate consent was obtained for facial recovery and transplantation. The transplant surgeon was then called to the bedside to perform a bone, tooth and skin tone evaluation. The donor family was given guidance and support regarding media exposure. Conclusions: Successful facial transplantation requires focused and strong collaboration of all shareholders. While the medical, ethical and logistic issues were difficult to overcome, the result for the donor family, the recipient and the interest generated in the donation and transplantation system will generate benefits for years to come.

Can a \u2018consent to contact\u2019 community help research teams overcome barriers to recruitment? The development and impact of the \u2018Research for the Future\u2019 community

BackgroundRecruitment to health research remains a major challenge. Innovation is required to meet policy commitments to help patients take part in health research. One innovation that may help meet those policy goals is the development of ‘consent to contact’ systems, where people give generic consent to be contacted about research opportunities. Despite their potential, there are few empirical assessments of different ways of recruiting patients to such communities, or of the value of such communities to local research teams.Main textWe describe the development of the ‘Research for the Future‘consent to contact community, outline the recruitment of patients to the community, and present data on their participation in research.DiscussionOver 5000 people have been registered across 3 clinical areas. A range of recruitment strategies have been used, including direct recruitment by clinicians, postal invitations from primary care, and social media. In a 1 year period (2016–2017), the community provided over 1500 participants for a variety of research projects. Feedback from research teams has generally been positive.SummaryThe ‘Research for the Future‘consent to contact community has proven feasible and useful for local research teams. Further evaluation is needed to assess the cost-effectiveness of different recruitment strategies, explore patient and researcher experience of its advantages and disadvantages, and explore how the community can be more reflective of the wider population.

Ethical considerations about informed consent in physiotherapy in Romania.

Background and aimPhysiotherapy has a distinct feature in terms of patient relationship, regarding the level of communication, especially how physical therapy sessions take place throughout the rehabilitation process. One of the particularities encountered in Romanian physiotherapy practice is related to obtaining informed consent (IC), considering that the initial contact of the patient is with a rehabilitation doctor when general consent is obtained. The aim of this study was to investigate Romanian physiotherapists aspects related to the frequency and use of IC at physiotherapy onset.MethodA cross-sectional study was conducted among Romanian physiotherapists using a survey with 2 open and 37 closed items, including nine demographics items, developed after a systematic literature review. The closed items were Likert type scales, measuring frequency or agreement on scale from 1 to 5. The questionnaire was distributed online from November 2017 until May 2018 and data was gathered from 148 physiotherapists. The statistical analysis targeted descriptive analysis and multiple regression.ResultsThe results suggested that only 40.82 % of physiotherapists are always seeking to obtain IC at physiotherapy onset, while 16.3 % never apply this legal demand in their professional activity, confidence intervals were set to 95% with 3.34 lower bound and 3.82 upper bound. Through multiple regression, we have identified factors which correlates with an increased frequency of IC obtaining at physiotherapy onset. Professional skills, ethical knowledge and ethical reasoning are factors with a positive influence towards obtaining IC with an increased frequency.ConclusionsEthical knowledge, moral reasoning and consideration for patient are elements which have a positive influence regarding the awareness of IC. The process of demanding and obtaining IC within Romanian physiotherapists must be improved despite the particularities of medical practice. Further research is needed to identify the methods by which Romanian physiotherapists awareness toward IC can be increased.

Physicians' perceptions of shared decision-making for implantable cardioverter-defibrillators: Results of a physician survey.

Centers for Medicare and Medicaid Services has mandated the use of shared decision-making (SDM) for implantable cardioverter-defibrillator (ICD) implantation. SDM tools help facilitate quality SDM by presenting patients with balanced evidence-based facts related to risk and benefits. Perceptions of ICD implantation may differ based on patients' sex and race. To determine if and how physicians are incorporating SDM in counseling patients about ICD and if they are aware of sex- and race-based differences in patients' perception of ICDs. This was a pilot study involving an online survey targeting attending physicians who implant ICDs. Physicians were randomly selected by a computer-based program; 350 surveys were sent. Of the 124 (35%) respondents to the survey, 102 (84%) met the inclusion criteria, and of those, 99 (97%) were adult electrophysiologists. Most physicians (90, 88%) stated they engaged in SDM during the general consent process. Sixty-three (62%) physicians discuss end of life issues while obtaining general consent. Forty-four (43%) physicians said they use an existing SDM tool with the Colorado SDM tool being the most common (39, 89%). The majority of physicians were unaware of sex- and race-based differences in perceptions related to ICD implantation (sex 64, 63% and race 63, 62%). A vast majority of physicians are engaging in SDM; however less than half are using a formal SDM tool, and a minority of physicians were aware of sex- and race-based differences in patients' perception of ICD implantation. Sex- and race-based tools might help address this gap.

Utilization of a Parental Approach to Informed Consent in Intravenous Tissue Plasminogen Activator Administration Decision-Making: Patient Preference and Ethical Considerations.

Objective While administration of intravenous tissue plasminogen activator (IV-tPA) is the standard of care in acute ischemic stroke and has been shown to have statistically significant benefit, there can also be potentially life-threatening complications; however, there is no standard informed consent approach. The purpose of this study was to present a parental, technical, and general model of informed consent for IV-TPA and to determine which approach was preferred. Methods Survey respondents were asked to hypothetically decide whether or not to provide consent for their family member to receive IV-tPA. Respondents were presented with 3 informed consent models: one emphasizing parental qualities, one emphasizing statistical data, and one representing a general consent statement. After being presented each model, the respondents had to select their preferred consent model, as well as rate their level of agreeability toward their family member receiving the medication following each approach. Results The results of 184 surveys showed respondents were equally as likely to give consent for their family member to receive IV-TPA following all three approaches; however, respondents were significantly more likely to prefer the parental approach compared to a technical or general approach. Conclusion Our results indicate that while paternalism is generally discouraged in the medical community, some degree of parental language may be preferred by patients in tough decision-making situations toward consent to receive medical interventions.

Contacting gamete donors to facilitate diagnostic genetic testing for the donor-conceived child: what are the rights and obligations of gamete donors in these cases? A response to Horton et al

In their paper Horton et al argue that it is acceptable to contact an anonymous egg-donor to facilitate diagnostic genetic testing for the donor conceived child, despite the donor, ‘indicating...

Current Situation and Problems of General Consent in Clinical Trials

Current Situation and Problems of General Consent in Clinical Trials

COMPARISON OF PROFESSIONAL TRAINING OF PUBLIC SERVANTS IN SERBIA AND SELECTED COUNTRIES

The paper presents the experiences of Serbia and selected European Union countries in the field of professional development of civil servants as one of the most important factors in the reform processes of professionalisation and depolitization of the public sector. The performed comparison showed that the professional development of public servants in the observed countries has certain similarities, but also differences.Similarities relate firstly to the already established general consent to the treatment of this area as an important development factor for each state, then in the organization of management of professional development, as well as the technology of that performance with the accompanying evaluations. It was noted that the professional development of civil servants in the Republic of Serbia is still not being given the necessary attention in higher education, while significant improvements have been made in terms of improving the form of professional development through training and seminars.As for the technology of the observed professional development, it is in Serbia in the stage of constitution, and the expectations are that the latest amendments to the laws will improve this area. The significance of this contribution should be achieved through the work of the National Academy of Public Administration, as newly established centralized institutions entrusted with all expert and related executive and other state administration tasks related to the preparation, organization, monitoring and evaluation of the program of professional development of employees in public administration.

Organ donor registration in the UK: The need for informed consent for ante-mortem interventions to facilitate organ donation

A generic consent model for the organ donation process currently permeates organ donation policy in the United Kingdom. The National Health Service Blood and Transplant’s (NHSBT’s) strategy for increasing organ donation rates in the United Kingdom includes interpreting a person’s registration on the Organ Donor Register (ODR) as justifying changes to the end-of-life care of the ODR registrant once incapacitated. However, individuals registering on the ODR are not currently provided with specific information regarding any ante-mortem procedures that may be carried out to facilitate organ donation. In this article, I argue that a specific consent model for ante-mortem donor optimisation procedures is needed not only to facilitate the achievement of the best interests of ODR registrants once incapacitated but also to fulfil NHSBT’s obligations to ODR registrants under the law on informed consent. I argue that NHSBT owes a duty of care to ODR registrants and that the implications of this duty of care include incorporating informed consent standards into the process of ODR registration.

Assessment of Use, Specificity, and Readability of Written Clinical Informed Consent Forms for Patients With Cancer Undergoing Radiotherapy

Appropriate informed consent processes are crucial to preservation of patient autonomy and shared decision making. Although half of patients with cancer receive radiotherapy, it is unknown whether current consent practices are comprehensible for patients. To characterize use, specificity, and readability of clinical informed consent forms for radiotherapy, hypothesizing that forms would be higher than the recommended sixth- to eighth-grade readability level. This nationwide cross-sectional survey study and readability analysis was conducted from 2016 to 2018 and included 89 academic radiation oncology departments that were part of the 2016 Electronic Residency Application Service. Department leaders (clinical directors, chairs, and personal contacts of study authors) at academic radiation oncology departments were contacted via email. Readability levels were measured by 7 validated readability indices, including the Ford, Caylor, Sticht (FORCAST) index for nonnarrative texts. Difficult words were identified using The Living Word Vocabulary, which describes the readability grade levels of 40 000 common words. Of 89 departments, 67 (75%) responded to questions and 57 (64%) provided 113 forms for analysis. Departments providing forms did not differ substantially from others in terms of region, residency size, research output, rural vs urban location, or public vs private institution status. All departments obtained patient written informed consent before radiotherapy; 38 (57%) used body site-specific forms. Using the most conservative (low-score) estimate, mean form readability ranged from grade level 10.6 to 14.2. By 7 distinct indices, only 9 (8%) of 113 forms met the recommended eighth-grade readability level, and 4 (4%) forms met a sixth-grade level. Not a single form met either recommendation based on the FORCAST index. Forms used an average of 7.2 difficult words. Body site-specific forms had considerably better readability than general consent forms. This nationwide study of informed consent practices for cancer treatment with radiotherapy demonstrates that while all US academic radiotherapy departments use written consent forms, it is rare for templates to meet the recommended readability levels for patient materials. These data suggest the need for reevaluation and modification of the approach to radiotherapy consent, ideally with guidance and templates designed by national professional organizations.

Inner Retinal Layer and Outer Retinal Layer Findings after Macular Hole Surgery Assessed by means of Optical Coherence Tomography.

Aim To summarize the spectrum of optical coherence tomography (OCT) and OCT angiography (OCTA) features after full-thickness macular hole (MH) repair surgery. Methods A PubMed engine search was carried out using the terms “Macular Hole,” “Optical Coherence Tomography,” and “Optical Coherence Tomography Angiography.” All reports published in English up to October 2018, irrespective of their publication status, were included. Tomographic signs analyzed were divided according to the involved portion of the retina in “inner retinal layers” and “external retinal layers.” Despite predominantly involving the inner retinal layers, cystoid macular edema (CME) has been treated as a separate entity. Finally, report on vessel density (VD) changes and the foveal avascular zone (FAZ) area modifications have been included. Results Different clinical findings can be observed on OCT of patients who underwent MH repair surgery. There is general consent that retinal thinning involving primarily the retinal nerve fiber layer and the ganglion cell layer takes place after surgery. In the postoperative period, the outermost retinal layers get progressively restored. Persistent defects in the ellipsoid zone or in the external limiting membrane correlate with worse postoperative visual outcome. OCTA has globally demonstrated that eyes after MH closure show a reduction in macular and paramacular VD and smaller FAZ areas, compared with control or fellow eyes. Conclusion Clinicians should be aware of the most common tomographic findings to properly manage each condition. In addition, significant advantages for the postoperative application of OCT and OCTA include noninvasiveness, rapid and simple execution, repeatability, and precise measurements.