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South African Medical Journal =... Aug 2022South African fertility clinics often include a provision in their consent forms that deals with the disposition of reproductive material (gametes and embryos) after a...
South African fertility clinics often include a provision in their consent forms that deals with the disposition of reproductive material (gametes and embryos) after a fertility patient's death. This practice is problematic as such a provision is not legally valid. If the clinic acts in pursuance of such a provision upon a fertility patient's death, the fertility clinic may be committing a civil wrong and a crime. Accordingly, consent forms should not include any provision that deals with the disposition of reproductive material after a fertility patient's death. Instead, to address the practical concern of keeping reproductive material cryopreserved without receiving payment, fertility clinics' storage agreements should use non-payment by fertility patients (or their successors in title) as the trigger event for the disposition of reproductive material. The importance of dealing with reproductive material in both its property rights dimension and its personality rights dimension is highlighted.
Topics: Consent Forms; Cryopreservation; Humans; South Africa
PubMed: 36214040
DOI: 10.7196/SAMJ.2022.v112i9.16610 -
Annals of the Royal College of Surgeons... Nov 2017Introduction The aim of this study was to objectively ascertain the level of readability of standardised consent forms for orthopaedic procedures. Methods Standardised...
Introduction The aim of this study was to objectively ascertain the level of readability of standardised consent forms for orthopaedic procedures. Methods Standardised consent forms (both in summary and detailed formats) endorsed by the British Orthopaedic Association (BOA) were retrieved from orthoconsent.com and assessed for readability. This involved using an online tool to calculate the validated Flesch reading ease score (FRES). This was compared with the FRES for the National Health Service (NHS) Consent Form 1. Data were analysed and interpreted according to the FRES grading table. Results The FRES for Consent Form 1 was 55.6, relating to the literacy expected of an A level student. The mean FRES for the BOA summary consent forms (n=27) was 63.6 (95% confidence interval [CI]: 61.2-66.0) while for the detailed consent forms (n=32), it was 68.9 (95% CI: 67.7-70.0). All BOA detailed forms scored >60, correlating to the literacy expected of a 13-15-year-old. The detailed forms had a higher FRES than the summary forms (p<0.001). Conclusions This study demonstrates that the BOA endorsed standardised consent forms are much easier to read and understand than the NHS Consent Form 1, with the detailed BOA forms being the easiest to read. Despite this, owing to varying literacy levels, a significant proportion of patients may struggle to give informed consent based on the written information provided to them.
Topics: Comprehension; Consent Forms; Humans; Informed Consent; Literacy; Orthopedic Procedures
PubMed: 29046092
DOI: 10.1308/rcsann.2017.0188 -
Bulletin of the World Health... Oct 2004Although a relatively recent phenomenon, the role of informed consent in human research is central to its ethical regulation and conduct. However, guidelines often... (Review)
Review
Although a relatively recent phenomenon, the role of informed consent in human research is central to its ethical regulation and conduct. However, guidelines often recommend procedures for obtaining informed consent (usually written consent) that are difficult to implement in developing countries. This paper reviews the guidelines for obtaining informed consent and also discusses prevailing views on current controversies, ambiguities and problems with these guidelines and suggests potential solutions. The emphasis in most externally sponsored research projects in developing countries is on laborious documentation of several mechanical aspects of the research process rather than on assuring true comprehension and voluntary participation. The onus for the oversight of this process is often left to overworked and ill-equipped local ethics review committees. Current guidelines and processes for obtaining informed consent should be reviewed with the specific aim of developing culturally appropriate methods of sharing information about the research project and obtaining and documenting consent that is truly informed. Further research is needed to examine the validity and user friendliness of innovations in information sharing procedures for obtaining consent in different cultural settings.
Topics: Codes of Ethics; Consent Forms; Culture; Developing Countries; Disclosure; Documentation; Ethics Committees, Research; Guidelines as Topic; Health Knowledge, Attitudes, Practice; Human Experimentation; Humans; Informed Consent; Mental Competency; Patient Selection
PubMed: 15643799
DOI: No ID Found -
JACC. Cardiovascular Imaging Jun 2012
Topics: Cardiology; Comprehension; Consent Forms; Diagnostic Imaging; Humans; Informed Consent; Patient Selection; Practice Guidelines as Topic; Predictive Value of Tests; Risk Assessment; Risk Factors
PubMed: 22698541
DOI: 10.1016/j.jcmg.2012.05.001 -
BMJ Open Quality Jun 2022The COVID-19 pandemic has brought a series of new challenges to the management of surgical patients. The consent process relies on a foundation of open and non-coerced... (Review)
Review
INTRODUCTION
The COVID-19 pandemic has brought a series of new challenges to the management of surgical patients. The consent process relies on a foundation of open and non-coerced discussion between clinician and patient, which includes all the potential risks of surgery. This must be updated to incorporate the additional risks of surgery during the pandemic including infection with the SARS-CoV-2 and increased risks of complications with the potential requirement for intensive care support.
AIM
The aim of this multi-cycle quality improvement project was to ensure all patients were fully informed of the risks of developing COVID-19 and the possible need for intensive care unit (ICU) support.
METHODS
We investigated the quality of the consent process for patients undergoing surgery for trauma at our major trauma centre. Our baseline data collection included a review of all orthopaedic trauma consent forms over a 4-week period in March 2020. We subsequently undertook three further Plan-Do-Study-Act (PDSA) cycles over separate 4-week periods. First, in June 2020, after education measures and presentation of baseline data, second in July 2020 after further education and regular digital reminders were sent to staff, and third in September 2021 after the implementation of an electronic consent form.
RESULTS
At baseline, only 2.6% of consent forms mentioned the risk of COVID-19 and none mentioned the risk of requiring ITU support. Through three PDSA cycles this increased to 97% of cases where consent forms displayed the additional risks of COVID-19 and the potential need for ITU admission.
CONCLUSION
Our quality improvement project improved the informed consent procedure at our trust. By incorporating these additional risks into the template of an electronic consent form, we hope to achieve sustained improvement in practice.
Topics: COVID-19; Humans; Informed Consent; Orthopedics; Pandemics; SARS-CoV-2
PubMed: 35772834
DOI: 10.1136/bmjoq-2021-001778 -
AJNR. American Journal of Neuroradiology Dec 2013
Topics: Consent Forms; Humans; Informed Consent; Patient Access to Records; Patient Participation; Physician's Role; United States
PubMed: 23449652
DOI: 10.3174/ajnr.A3426 -
BMC Medical Ethics Nov 2022The research shows a growing trend in using an electronic platform to supplement or replace traditional paper-based informed consent processes. Instead of the... (Review)
Review
BACKGROUND
The research shows a growing trend in using an electronic platform to supplement or replace traditional paper-based informed consent processes. Instead of the traditionally written informed consent document, electronic informed consent (eConsent) may be used to assess the research subject's comprehension of the information presented. By doing so, respect for persons as one of the research ethical principles can be upheld. Furthermore, these electronic methods may reduce potential airborne infection exposures, particularly during the pandemic, thereby adhering to the beneficence and nonmaleficence principle. This scoping review aims to identify the ethics related criteria that have been included in electronic informed consent processes and to synthesize and map these criteria to research ethics principles, in order to identify the gaps, if any, in current electronic informed consent processes.
METHODS
The search was performed based on internet search and three main databases: PubMed, SCOPUS and EBSCO. PRISMA Extension for Scoping Reviews (PRISMA-ScR): Checklist and Explanation guideline was used to report this work.
RESULTS
Of 34 studies that met the inclusion criteria, 242 essential original constructs were collated, and 7 concepts were derived. Digital content showed the highest percentage of collated original constructs (27%, n = 65) followed by accessibility (24%, n = 56), comprehension engagement (18%, n = 43), autonomy (14%, n = 34), confidentiality (11%, n = 25), language (5%, n = 13), and parental consent (1%, n = 2). Twenty-five new items were synthesized for eConsent criteria which may provide guidance for ethical review of research involving eConsent.
CONCLUSION
The current study adds significant value to the corpus of knowledge in research ethics by providing ethical criteria on electronic informed consent based on evidence-based data. The new synthesized items in the criteria can be readily used as an initial guide by the IRB/REC members during a review process on electronic informed consent and useful to the future preparation of a checklist.
Topics: Humans; Beneficence; Consent Forms; Electronics; Ethics, Research; Informed Consent
PubMed: 36414962
DOI: 10.1186/s12910-022-00849-x -
Ochsner Journal 2020The Federal Policy for the Protection of Human Subjects-the Common Rule-was revised in 2017 to reduce administrative burdens for low-risk research while enhancing... (Review)
Review
The Federal Policy for the Protection of Human Subjects-the Common Rule-was revised in 2017 to reduce administrative burdens for low-risk research while enhancing protections for human subjects enrolled in greater-than-minimal-risk trials. These enhanced protections involve changes to the consent process. We review the general requirements applicable to the consent process, as well as the additional elements of consent mandated by the revisions to the Common Rule. The regulations apply to federally funded studies and are optional for non-federally funded studies. Two new general requirements for the consent process, one basic required element for the consent form, and three optional additional elements for the consent form were added in an effort to improve potential subjects' understanding of research studies and to facilitate the exchange of information between the research staff and potential subjects. Important information about the study should be extracted into a concise key information section to help potential subjects make informed decisions regarding participation. The revisions to the Common Rule are intended to enhance human subject protection by providing more information in an understandable form during the consent process. The new consent elements aim to increase transparency and help improve clarity.
PubMed: 32284685
DOI: 10.31486/toj.19.0055 -
Medicina Oral, Patologia Oral Y Cirugia... May 2022The healthcare practice of dentistry, as well as medicine, is framed within a legal environment. Patients have the right to know all the information related to any...
BACKGROUND
The healthcare practice of dentistry, as well as medicine, is framed within a legal environment. Patients have the right to know all the information related to any action performed on them and dental or medical doctors are obliged to obtain their patient's prior written informed consent (IC) before undertaking any healthcare procedures.
MATERIAL AND METHODS
Here we reviewed the legality and jurisprudence in Spain regarding IC. We also used INFLESZ text readability analysis software to analyse a sample of official Spanish informed consent documents (ICDs) from different surgical and interventional procedures related to dentistry and oral cavity interventions.
RESULTS
It is a mistake to confound IC with ICDs. This error prevents physicians from considering the former as a care process in which the patient's authorisation signature is the last link in a chain formed, almost in its entirety, by the informative process and deliberation alongside the patient. Multiple factors can influence communication between practitioners and their patients. Importantly, treatment adherence is greater when patients feel involved and autonomous in shared decision-making and when the circumstances of their lives are adequately considered. We concluded that although the ICDs we analysed conformed to the requirements set out in international law, they were somewhat difficult to read according to the reading habits of the general Spanish population.
CONCLUSIONS
Knowledge about the legality of IC helps professionals to understand the problems that may arise from their non-compliance. This is because the omission or defective fulfilment of IC obligations is the origin of legal responsibility for medical practitioners. In this sense, to date, there have been more convictions for defective ICs than for malpractice. The information provided in ICs should include the risks, benefits, and treatment alternatives and must be tailored to the needs and capabilities of the patient to enable autonomous decision-making.
Topics: Comprehension; Consent Forms; Dentistry; Humans; Informed Consent; Spain
PubMed: 35368004
DOI: 10.4317/medoral.25265 -
Journal of Empirical Research on Human... Oct 2016Ethical principles in conducting technology-based research require effective and efficient methods of ensuring adequate informed consent. This study examined how well... (Comparative Study)
Comparative Study Randomized Controlled Trial
Ethical principles in conducting technology-based research require effective and efficient methods of ensuring adequate informed consent. This study examined how well participants understood the informed consent form for an online postpartum depression trial. Pregnant women ( N = 1,179) who consented to the trial demonstrated an understanding of the purpose (86.1%) and procedures of the study (75.8%), and the minimal risks associated with answering sensitive questions online (79%). Almost all (99.6%) understood that psychological treatment was not offered. Participants with current depression incorrectly indicated that participation would replace current psychological treatment relative to participants with a lifetime or no depression history (19.6% vs. 13.5 % vs. 10.4%, respectively) and that there were no associated risks with participation (29.6% vs.17.6% vs. 16.7%, respectively). Findings provide initial evidence that most individuals who seek online psychological resources are informed consumers.
Topics: Adult; Comprehension; Consent Forms; Depression; Depression, Postpartum; Ethics, Research; Female; Health Knowledge, Attitudes, Practice; Health Services Research; Humans; Informed Consent; Internet; Pregnancy; Risk; Therapeutic Misconception; Young Adult
PubMed: 27630213
DOI: 10.1177/1556264616668974