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Journal articles on the topic 'Prior Informed Consent'

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Published: 4 June 2021

Last updated: 13 February 2022

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Rose, Gregory. "Prior Informed Consent: Hazardous Chemicals." Review of European Community and International Environmental Law 1, no. 1 (1992): 64–68. http://dx.doi.org/10.1111/j.1467-9388.1992.tb00016.x.

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Aveyard, Helen. "Informed Consent Prior to Nursing Care Procedures." Nursing Ethics 12, no. 1 (2005): 19–29. http://dx.doi.org/10.1191/0969733005ne755oa.

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It is largely undisputed that nurses should obtain consent prior to nursing care procedures. This article reports on a qualitative study examining the way in which nurses obtain such informed consent. Data were collected through focus group discussion and by using a critical incident technique in order to explore the way in which nurses approach consent prior to nursing care procedures. Qualified nurses in two teaching hospitals in England participated in the study. An analysis of the data provides evidence that consent was often not obtained by those who participated in the study and that refusals of care were often ignored. In addition, participants were often uncertain how to proceed with care when the patient was unable to consent. Consent prior to nursing care procedures is an essential but undeveloped concept, for which a new ethos is required.

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Burns, Paul, Ivan Keogh, and Conrad Timon. "Informed consent: a patients’ perspective." Journal of Laryngology & Otology 119, no. 1 (2005): 19–22. http://dx.doi.org/10.1258/0022215053222860.

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The medico-legal issues surrounding informed consent are highly topical and contentious. Current attitudes to consent emphasize the high level of ’good medical practice’ expected by a ’reasonable patient/parent’. The authors’ objectives were to assess the levels of knowledge and information expected by patients and parents, prior to signing consent forms for a surgical procedure. Each patient or parent was asked a series of questions prior to signing a consent form. Answers were recorded on a standard questionnaire. More than 80 per cent of respondents were happy with the information provided in out-patients, however, over half of these could not list even one complication of their operation. Two-thirds of those surveyed sought information elsewhere, while over half expected to be informed of all known complications, even if the rate of complications was less than one per cent. In conclusion, the information provided by surgeons might not meet the expectations of today’s informed patients.

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Desch, Karl, Jun Z. Li, Scott Kim, Naomi Laventhal, David Siemieniak, and David Ginsburg. "How Informed Is Informed Consent?" Blood 116, no. 21 (2010): 2556. http://dx.doi.org/10.1182/blood.v116.21.2556.2556.

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Abstract Abstract 2556 The informed consent process is a critical component of human subject protection in biomedical research, with the goals of informing participants of the purpose of the study, as well as the likely risks, benefits and alternatives. The signed informed consent document (ICD) is a required legal disclosure which documents that the informed consent process has taken place and provides research subjects with comprehensive information about their role in a study. Despite efforts to optimize the ICD, only limited data are available regarding the utilization of these documents by participants in biomedical research. We measured the time taken by participants, in a genetic study of hematologic traits, to review a 2833 word online ICD prior to indicating consent. ICDs were generated utilizing standard templates provided by the University of Michigan IRB with the addition of a hyperlink at word 2254 of the ICD that read “If you are reading this form, please click on this sentence”. Identification of the hyperlink, as a proxy for thorough reading of the ICD, was recorded. The study was approved by the University of Michigan IRB (IRBMED# 2005-0080.) A total of 1209 subjects were recruited from the University of Michigan, Ann Arbor student population from 2/12/08 to 1/30/09. Age ranged from 14 to 35 years with a mean of 21. Standard reading speeds predicted a range of 567 to 850 seconds to read the full ICD text. The distribution of consent times was heterogeneous, heavily weighted toward times that would suggest little to no reading of the ICD. Twenty-eight percent of participants consented within ten seconds. Only 78 participants (6.4%) took longer than the minimum estimated reading time (566 seconds) to indicate consent. The hyperlink was identified by 2.2% of participants with a median reading time of 621 seconds, significantly longer than those who did not (52 seconds, p<3×10−11). Additionally, significant differences in consent time were noted for sex, age, and downloading of the ICD PDF file. Our results demonstrate that the majority of participants in this study (93.6%) provided consent without spending sufficient time to thoroughly read and comprehend the ICD. The 6.4% of participants with consent times greater than the minimum predicted ICD reading times is likely a significant overestimate of ICD comprehension since the consent interval recorded could also include time spent on other distracting activities. In conclusion, these observations imply that the consent by subjects to participate in this and many other low-risk studies is unlikely to have been as truly informed as originally intended by the investigators and the IRB. This lack of truly informed consent is also likely to extend beyond research studies, to include ICDs used for treatment in the routine clinical care setting. These data suggest that current ICDs, particularly for low-risk studies, may no longer serve the intended informed consent purpose and that ICD length and complexity should be reassessed. Disclosures: No relevant conflicts of interest to declare.

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Perry, Courtney, and Terrence Barrett. "3412 Informed Consent: Refining the Process." Journal of Clinical and Translational Science 3, s1 (2019): 123. http://dx.doi.org/10.1017/cts.2019.280.

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OBJECTIVES/SPECIFIC AIMS: -This study aims to evaluate our retention rate into our prospective clinical trial. We will be comparing the rate of withdrawal both before and after our revamped informed consent process. -We aim to assess patient satisfaction with our study and u METHODS/STUDY POPULATION: -The informed consent process for an observational prospective study at our institution has been modified to lengthen the recruitment and consenting process. -In brief, the research protocol for this observational prospective aims to evaluate the role of steroids on ulcer healing in patients with ulcerative colitis. This study involves an initial standard of care colonoscopy with biopsies and photos. The areas biopsied are marked with a tattoo. The patients are started on steroids for management of their Ulcerative Colitis, and must return for two research colonoscopies at one week post- initial diagnostic visit, and at one month. Additional study biopsies are obtained at the one week visit and photo documentation is obtained. At the one month visit, only photos are obtained to document healing. -In addition to patients with active ulcerative colitis, this study recruits control groups of patients with UC in remission, as well as two groups of normal control patients (one group on steroids for non-IBD reasons, and one group not on steroids. -Prior to our informed consent intervention, patients were screened for eligibility on the day of their standard of care endoscopy. The study was explained to the patient prior to their endoscopy, often in the “pre-op” endoscopy suite. -Our intervention seeks to draw out the consent and recruitment process. All patients scheduled for upcoming endoscopies will be mailed a generic flyer announcing research studies occurring in the endoscopy suite. Patients will be pre-screened at least a week prior to endoscopy with the aid of the endoscopy scheduler. Patients interested in hearing about research will be contacted via phone by study personnel, and a copy of the consent as well as a brief summary will be mailed to the patient. -Patients potentially interested in study participation will be asked to arrive 30 minutes earlier than they typically would for their procedure, and they will be consented in a quiet and private consultation room. They will be given ample time to ask clarifying questions regarding the study. -At the conclusion of their participation, patients will receive an anonymous post-participation survey that seeks to assess their feelings regarding the study and their understanding of the research process. RESULTS/ANTICIPATED RESULTS: DISCUSSION/SIGNIFICANCE OF IMPACT: This study adds to the ongoing body of evidence suggesting that the informed consent process is more than the three key elements initially described by the Belmont Report 40 years ago. Several factors can impact patient’s willingness to participate in research, and the amount of time it takes for patients to achieve all three elements of consent can vary from person to person. The traditional method of consent just prior to study entrance is one that needs to be revisited, and we propose that prolonging the consenting process will positively impact not only patients, but also the overall research process by ensuring that those who decide to participate remain adherent to study protocols.

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Aveyard, Helen. "The requirement for informed consent prior to nursing care procedures." Journal of Advanced Nursing 37, no. 3 (2002): 243–49. http://dx.doi.org/10.1046/j.1365-2648.2002.02084.x.

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Thomson, I. G., D. Schache, B. Miller, P. Gourlas, and J. Cohen. "CR11 PATIENT RECALL OF INFORMED CONSENT INFORMATION PRIOR TO COLONOSCOPY." ANZ Journal of Surgery 77, s1 (2007): A17. http://dx.doi.org/10.1111/j.1445-2197.2007.04116_11.x.

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Shrinkhal, Rashwet. "“Free Prior Informed Consent” as a Right of Indigenous Peoples." Journal of National Law University Delhi 2, no. 1 (2014): 54–65. http://dx.doi.org/10.1177/2277401720140103.

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Kovac, JasonR, and LarryI Lipshultz. "Factors to consider for informed consent prior to vasectomy reversal." Asian Journal of Andrology 18, no. 3 (2016): 372. http://dx.doi.org/10.4103/1008-682x.179156.

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Alharbi, A., M. Alkindi, and Y. Alali. "Patient's informed consent prior to extraction of impacted third molars." International Journal of Oral and Maxillofacial Surgery 42, no. 10 (2013): 1238. http://dx.doi.org/10.1016/j.ijom.2013.07.233.

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Harap, Inensa Khoirul. "Informed Consent Position in Doctor and Patient Relationship." Journal La Sociale 2, no. 1 (2021): 31–39. http://dx.doi.org/10.37899/journal-la-sociale.v2i1.304.

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Awareness of risks may be interpreted as a patient's approval in the context of submitting the doctor's schedule with the necessary details for making an appointment or an informed refuse. Prior to signing the consent document, the agreement, the prospective student already confirmed that she understood the terms and conditions. to let the patient understand anything before doing it, and when making the judgment, the patient should make the most of any of an exhaustive information (informed decision). The kinds of studies found in this paper are what lawyers refer to as "normative" studies. The nature of this analysis is informative, and is research that outlines, discusses, illustrates, and analyzes legal rules pertaining to the role of consent in the doctor and patient's relationship. Patients are given the right to know regarding the medical activities, outlined in Regulation Minister of Health (Per) No. 290 on Approval of Medical Actions, prior to accessing treatment. As seen from the standpoint of the idea of unauthorized consent (considered given), the patient-doctor partnership becomes complicated. This issue revolves around the concept of informed consent, which is essentially an assumption that the patient has already agreed to carry out medical procedures with the doctor prior to seeking medical treatment.

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George, Dalton R., Todd Kuiken, and Jason A. Delborne. "Articulating ‘free, prior and informed consent’ (FPIC) for engineered gene drives." Proceedings of the Royal Society B: Biological Sciences 286, no. 1917 (2019): 20191484. http://dx.doi.org/10.1098/rspb.2019.1484.

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Recent statements by United Nations bodies point to free, prior and informed consent (FPIC) as a potential requirement in the development of engineered gene drive applications. As a concept developed in the context of protecting Indigenous rights to self-determination in land development scenarios, FPIC would need to be extended to apply to the context of ecological editing. Without an explicit framework of application, FPIC could be interpreted as a narrowly framed process of community consultation focused on the social implications of technology, and award little formal or advisory power in decision-making to Indigenous peoples and local communities. In this paper, we argue for an articulation of FPIC that attends to issues of transparency, iterative community-scale consent, and shared power through co-development among Indigenous peoples, local communities, researchers and technology developers. In realizing a comprehensive FPIC process, researchers and developers have an opportunity to incorporate enhanced participation and social guidance mechanisms into the design, development and implementation of engineered gene drive applications.

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Hofbauer, Jane A. "Foreign Investments Meet Free, Prior and Informed Consent (FPIC) – Whose Sovereignty?" Austrian Review of International and European Law Online 18, no. 1 (2016): 71–98. http://dx.doi.org/10.1163/15736512-90000004b.

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Papillon, Martin, Jean Leclair, and Dominique Leydet. "Free, Prior and Informed Consent: Between Legal Ambiguity and Political Agency." International Journal on Minority and Group Rights 27, no. 2 (2020): 223–32. http://dx.doi.org/10.1163/15718115-02702015.

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Dawson, Angus J. "Methodological reasons for not gaining prior informed consent are sometimes justified." BMJ 329, no. 7457 (2004): 87.1. http://dx.doi.org/10.1136/bmj.38112.692211.f7.

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Saad, Toni C., Bruce Philip Blackshaw, and Daniel Rodger. "Hormone replacement therapy: informed consent without assessment?" Journal of Medical Ethics 45, no. 12 (2019): 824–25. http://dx.doi.org/10.1136/medethics-2019-105611.

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Florence Ashley has argued that requiring patients with gender dysphoria to undergo an assessment and referral from a mental health professional before undergoing hormone replacement therapy (HRT) is unethical and may represent an unconscious hostility towards transgender people. We respond, first, by showing that Ashley has conflated the self-reporting of symptoms with self-diagnosis, and that this is not consistent with the standard model of informed consent to medical treatment. Second, we note that the model of informed consent involved in cosmetic surgery resembles the model Ashley defends, and that psychological assessment and referral is recognised as an important aspect of such a model. Third, we suggest that the increased prevalence of psychiatric morbidity in the transgender population arguably supports the requirement of assessment and referral from a mental health professional prior to undergoing HRT.

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Kinkorová, Judita, Ondřej Topolčan, and Radek Kučera. "Informed Consent in the Newly Established Biobank." International Journal of Environmental Research and Public Health 16, no. 20 (2019): 3943. http://dx.doi.org/10.3390/ijerph16203943.

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Informed consent is an important document for every existing biobank or repository to obtain, store and use human biospecimens and associated data and information for current and future research. Biobanks have undergone great progress worldwide during the last three decades and have become an integral part of personalized medicine and health care systems and due to new scientific and social questions to be solved. Ethical, legal and social issues (ELSI) guarantee safe sample and data management, and informed consent is one of the key ELSI documents. The form and the consent given in biobank informed consent forms differs between biobank-related institutions, national biobanks, between EU states, and to find the optimal informed consent requires one to fulfil national and international laws and regulations. The Biobank in Pilsen, Czech Republic was officially opened on April the 20th 2017 as a hospital-integrated biobank, and the informed consent was one of the essential documents that had to be ready prior the opening. The process of formulating informed consent corresponding with institutional, national, and international rules and laws to share the experience, to present the challenges, and to demonstrate the national dissimilarity are tasks of the article.

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Bogolub, Ellen B. "The Acquisition of Informed Consent for Foster Children's Research Participation." Families in Society: The Journal of Contemporary Social Services 86, no. 4 (2005): 511–19. http://dx.doi.org/10.1606/1044-3894.3456.

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In a public child welfare agency, 6 respondents were recruited for a pilot study about foster children's transitions from birth homes to out-of-home care. During recruitment, knowledge was gained about the acquisition of informed consent for foster children's research participation, a topic about which there is remarkably little prior literature. In addition to being a necessity for research enactment, consent acquisition is a multifaceted process involving complex relationships with colleagues, potential respondents, and their birth and foster parents. Four detailed vignettes each illustrate a consent issue. With reference to each vignette, suggestions are made for researchers' sensitive, ethical, planful consent acquisition. Implications for agency-based professionals are offered, as are ideas for future study of consent acquisition.

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Sherpa, Pasang D., and Tunga B. Rai. "Experience of Nepali Indigenous Peoples on Free, Prior and Informed Consent (FPIC)." Journal of Forest and Livelihood 11, no. 2 (2013): 82–86. http://dx.doi.org/10.3126/jfl.v11i2.8626.

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Woodrow, Susannah R., and Anthony P. Jenkins. "How Thorough Is the Process of Informed Consent prior to Outpatient Gastroscopy?" Digestion 73, no. 2-3 (2006): 189–97. http://dx.doi.org/10.1159/000094528.

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Southalan, John, and Joe Fardin. "Free, prior and informed consent: how and from whom? An Australian analogue." Journal of Energy & Natural Resources Law 37, no. 4 (2018): 365–88. http://dx.doi.org/10.1080/02646811.2018.1524436.

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Kummer, Katharina. "Prior Informed Consent for Chemicals In International Trade: The 1998 Rotterdam Convention." Review of European Community & International Environmental Law 8, no. 3 (1999): 323–29. http://dx.doi.org/10.1111/1467-9388.00216.

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Rodhouse, Toyah, and Frank Vanclay. "Is free, prior and informed consent a form of corporate social responsibility?" Journal of Cleaner Production 131 (September 2016): 785–94. http://dx.doi.org/10.1016/j.jclepro.2016.04.075.

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NAGAR, Anirudha. "The Juukan Gorge Incident: Key Lessons on Free, Prior and Informed Consent." Business and Human Rights Journal 6, no. 2 (2021): 377–83. http://dx.doi.org/10.1017/bhj.2021.18.

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On 24 May 2020, Rio Tinto detonated an area of the Juukan Gorge in the Pilbara in Western Australia as part of its iron ore mining operations, damaging two ancient rock shelters with profound cultural significance to the Puutu Kunti Kurrama and Pinikura (PKKP) People.1 The incident has brought international attention to the importance of Indigenous cultural heritage within broader environmental, social and governance (ESG) considerations.

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Zatarain, Lauren Azure, Jessica Ashford, and David Bivens. "Improving the quality of the consenting and education process for patients starting on oral oncology medications." Journal of Clinical Oncology 34, no. 7_suppl (2016): 82. http://dx.doi.org/10.1200/jco.2016.34.7_suppl.82.

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82 Background: Oral oncology medication prescribing is on the rise nationwide. Given that these medications are self-administered, drug compliance is a concern. Appropriate patient education directly impacts drug adherence. Prior to the process improvement initiative in our community based medical oncology clinic, implied consent was obtained while educating patients on side effects and written informed consent was documented 0% of the time. This creates a patient safety and risk management problem. Methods: Our clinic implemented a new process for consenting and educating patients starting on new oral oncology medications from April – October 2015. The plan/do/study/act performance improvement technique was utilized. A new consent form was created for oral oncology medications meeting ASCO/ONS safety standards. The consent and education packets were placed centrally in the office and coincided with an initiative to improve consenting for IV chemotherapy. Providers were in-serviced to contact the nurse prior to patients exiting clinic to initiate the new prescription and begin the patient education process. Reminder checklists were placed in exam rooms to trigger the provider to communicate with nursing staff. Outcome measures included data on the percent of patients with written informed consent in health record and percent of patients with patient education handouts in health record prior to drug start. Data on percent of patients for whom the provider notified nurse prior to end of clinic visit were collected as a balance measure. Results: Over a 6 month period, 101 consecutive patients initiated on oral oncology drugs were included in the data analysis. The baseline mean improved from 0% to 75% for obtaining written informed consent (p chart, 3 sigma). The baseline mean improved from 37% to 80% for documenting patient education in health record prior to oral oncology medication start (p chart, 3 sigma). Conclusions: There was significant improvement in obtaining written informed consent and providing patient education prior to oral oncology drug start after implementation of new clinic processes.

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Zethof, Siem, Wouter Bakker, Felix Nansongole, Kelvin Kilowe, Jos van Roosmalen, and Thomas van den Akker. "Pre-post implementation survey of a multicomponent intervention to improve informed consent for caesarean section in Southern Malawi." BMJ Open 10, no. 1 (2020): e030665. http://dx.doi.org/10.1136/bmjopen-2019-030665.

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ObjectiveSurgical informed consent is essential prior to caesarean section, but potentially compromised by insufficient communication. We assessed the association between a multicomponent intervention and women’s recollection of information pertaining to informed consent for caesarean section in a low-resource setting, thereby contributing to respectful maternity care.DesignPre-post implementation survey, conducted from January to June 2018, surveying women prior to discharge.SettingRural 150-bed mission hospital in Southern Malawi.ParticipantsA total of 160 postoperative women were included: 80 preimplementation and 80 postimplementation.InterventionBased on observed deficiencies and input from local stakeholders, a multicomponent intervention was developed, consisting of a standardised checklist, wall poster with a six-step guide and on-the-job communication training for health workers.Primary and secondary outcome measuresIndividual components of informed consent were: indication, explanation of procedure, common complications, implications for future pregnancies and verbal enquiry of consent, which were compared preintervention and postintervention using χ2test. Generalised linear models were used to analyse incompleteness scores and recollection of the informed consent process.ResultsThe proportion of women who recollected being informed about procedure-related risks increased from 25/80 to 47/80 (OR 3.13 (95% CI 1.64 to 6.00)). Recollection of an explanation of the procedure changed from 44/80 to 55/80 (OR 1.80 (0.94 to 3.44)), implications for future pregnancy from 25/80 to 47/80 (1.69 (0.89 to 3.20)) and of consent enquiry from 67/80 to 73/80 (OR 2.02 (0.73 to 5.37)). After controlling for other variables, incompleteness scores postintervention were 26% lower (Exp(β)=0.74; 95% CI 0.57 to 0.96). Recollection of common complications increased with 0.25 complications (β=0.25; 95% CI 0.01 to 0.49). Recollection of the correct indication did not differ significantly.ConclusionRecollection of informed consent for caesarean section changed significantly in the postintervention group. Obtaining informed consent for caesarean section is one of the essential components of respectful maternity care.

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Mylnikova, IS. "Informed consent in Russia: misuse and abuse." Медицинская этика, no. 2021(1) (March 31, 2021): 44–48. http://dx.doi.org/10.24075/medet.2021.007.

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Even T. Beauchamp and J. Childress, the founders of ethical principlism, noted that in practice the principles of bioethics, which they might have formulated, may conflict, and adherence to one principle may violate the other. To date, the conflict between the principle of autonomy and the doctrine of informed consent, and the principle of vulnerability formulated ten years later (one of the principles introduced by P. Kemp) and the necessity to take care of the patient is one of the major irreconcilable conflicts. This conflict is especially severe in Russia, where the informed consent was immediately enshrined as a statutory provision without prior discussion with the medical and non-medical communities, which gave rise to numerous opportunities for misuse and abuse, and stepped up the bureaucratic pressure both on patients, who became more vulnerable, and the physicians, who started using the informed consent to their advantage, sometimes being openly market-oriented. The growth of mutual mistrust, sometimes reaching the level of aggression, forces one to find a remedy for this situation. In the author's view, this requires revision of the patient’s autonomy concept and the concept of informed consent considering the acceptance of the patient’s intense vulnerability and the patient’s need for the healthcare specialists’ (physicians and nurses) personal involvement and care. It may be helpful to consult the writings of the ethics of care, feminist ethics and other ethical trends representation, as well as the results of field research aimed to combine principles of freedom and patient care in a given situation.

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Humphrey Beebe, Lora, and Kathlene Smith. "Informed consent to research in persons with schizophrenia spectrum disorders." Nursing Ethics 17, no. 4 (2010): 425–34. http://dx.doi.org/10.1177/0969733010364581.

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This manuscript describes the responses and correlates of outpatients with schizophrenia spectrum disorders to a tool designed to measure comprehension before obtaining informed consent for research participation. We used the Evaluation to Sign Consent form to document comprehension in 100 outpatients as part of their consent to participate in an ongoing study of an exercise intervention. The findings suggest that using this form is a feasible and acceptable approach to documenting comprehension of research procedures prior to obtaining informed consent. Age 49 years and older and the receipt of intramuscular antipsychotic medication predicted the need for additional assistance to complete the Evaluation to Sign Consent form successfully (χ2 = 8.29, P = 0.016). Nurse researchers should consider documenting comprehension with this tool owing to its availability, time efficiency and utility.

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Stohl, Hindi E. "When Consent Does Not Help." American Journal of Law & Medicine 43, no. 4 (2017): 388–425. http://dx.doi.org/10.1177/0098858817753405.

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Pregnant women with a prior cesarean delivery face challenges in accessing a vaginal birth due to both hospital and provider preferences and practices. Although the doctrine of informed consent secures women's reproductive rights, it is not a viable legal remedy. Instead, women should champion increased maternity-related education and transparency as well as medical malpractice reform to increase the desired access.

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Brear, Michelle. "Ethical Research Practice or Undue Influence? Symbolic Power in Community- and Individual-Level Informed Consent Processes in Community-Based Participatory Research in Swaziland." Journal of Empirical Research on Human Research Ethics 13, no. 4 (2018): 311–22. http://dx.doi.org/10.1177/1556264618761268.

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In community-based participatory research (CBPR), community-level consent is assumed to enhance ethical rigor, when obtained prior to individual informed consent. However, community leaders’ permission to conduct research may influence individuals’ agency to decline participation. This article presents findings of a Bourdieusian analysis of ethnographic data documenting CBPR in rural Swaziland. The findings reveal that the “symbolic power” of leaders who provide community-level consent constrains individual agency and reproduces existing relations of power, if individual informed consent is simply a procedure. However, when informed consent is a process that introduces notions of autonomy and rights, it can disrupt power relations. Implications for ethical CBPR practice, and ethnography’s value for developing theory from real-world research ethics practice, are discussed.

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O’Hare, Fleur, Zachary Flanagan, Mark Nelson, et al. "Comparing two methods for delivering clinical trial informed consent information to older adults: singular versus stepped approach." Clinical Trials 15, no. 6 (2018): 610–15. http://dx.doi.org/10.1177/1740774518793377.

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Background Adapting the informed consent process to the needs of older adults may enhance engagement and willingness to participate in a clinical trial. A key aspect of the process is being provided with written clinical trial information and consent documents and having an opportunity to discuss the information with the researcher. However, there are no guidelines on the most appropriate method for delivering this information to older adults and it is not known whether the delivery method is a facilitator or barrier towards clinical trial participation. Aims To compare two delivery methods of informed consent on recruitment, refusal to continue and randomisation rates in a general practice-based clinical trial involving older adults. Methods In a matched cohort sub-study as part of the STAtins in Reducing Events in the Elderly clinical trial, 520 participants were allocated into two groups by age, gender and attending general practice location, to receive the trial information and consent form in the mail (Method 1) prior to the first baseline visit or in person (Method 2) at the visit where a comprehensive informed consent process took place. Results Compared with Method 1, potential participants assigned to Method 2 were more likely to agree to attend the first baseline screening visit (refusal rate 20% vs 13.5%, respectively, p = 0.05). However, there was no significant difference in the proportion of participants recruited into the trial by providing written informed consent at the first baseline screening visit. For each informed consent delivery method, similar proportions of participants refused to take part in the trial by the end of the screening phase. Randomisation rates in the two groups were also similar. Time to conduct the informed consent procedure took significantly longer with Method 2 compared with Method 1 (median time 20 vs 15 min, respectively, p < 0.01). Interest in the research trial topic was the main reason cited (33.4%) for considering trial participation. Conclusion Later delivery of informed consent documents to potential participants in this trial was associated with a small increase in attendance at the first, in person, screening visit. However, the randomisation rate of participants into the trial was not affected by the method and timing of delivery of informed consent information. Similar randomisation rates occurred whether potential participants were mailed informed consent documents prior to the first in person screening visit or were given the information at the screening visit.

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Healey, Richard. "From Individual to Collective Consent: The Case of Indigenous Peoples and undrip." International Journal on Minority and Group Rights 27, no. 2 (2019): 251–69. http://dx.doi.org/10.1163/15718115-02702006.

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Much of the debate around requirements for the free, prior, and informed consent of indigenous peoples has focused on enabling indigenous communities to participate in various forms of democratic decision-making alongside the state and other actors. Against this backdrop, this article sets out to defend three claims. The first two of these claims are conceptual in nature: (i) Giving (collective) consent and participating in the making of (collective) decisions are distinct activities; (ii) Despite some scepticism, there is a coherent conception of collective consent available to us, continuous with the notion of individual consent familiar from discussions in medical and sexual ethics. The third claim is normative: (iii) Participants in debates about free, prior, and informed consent must keep this distinction in view. That is because a group’s ability to give or withhold consent, and not only participate in making decisions, will play an important role in realising that collectives’ right to self-determination.

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Prashar, Akash, Saqib Butt, Davide Giuseppe Castiglione, and Nadeem Shaida. "Informed consent in interventional radiology – are we doing enough?" British Journal of Radiology 94, no. 1122 (2021): 20201368. http://dx.doi.org/10.1259/bjr.20201368.

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Objectives: Obtaining informed consent is a mandatory part of modern clinical practice. The aim of this study was to identify how often complications relating to Interventional Radiology (IR) procedures were discussed with the patient prior to the procedure. Methods: A retrospective analysis of 100 patients who experienced a complication related to an IR procedure was performed. The patient’s procedure consent form was examined to identify whether the complication they experienced had been discussed as a possible risk. Other parts of the consent form relating to need for blood transfusion and the need for further procedures were also examined. Results: 39% of patients who experienced a complication did not have the complication documented as a potential risk on the consent form. 14% of patients required a blood transfusion but were not consented for this. 42% of patients required a further procedure or operation but were not warned of this. Conclusion: The model of gaining informed consent on the day of procedure is no longer valid. Better education and the use of clinics, patient information sheets and other resources is essential. Advances in knowledge: The paper highlights the inadequacies of the current model in gaining consent for IR procedures. A more comprehensive consent process making use of all available resources is essential.

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Vaishnav, Neil, and Winston Chiong. "Informed Consent for the Human Research Subject with a Neurologic Disorder." Seminars in Neurology 38, no. 05 (2018): 539–47. http://dx.doi.org/10.1055/s-0038-1668077.

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AbstractThe doctrine of informed consent sits at the intersection of law, ethics, and neuroscience, posing unique challenges for human subject research involving neurological patients. These challenges are compounded by the variegated nature of both neurological injury and the law governing research consent. This article provides a framework for investigators likely to encounter subjects with some degree of neurological impairment, whose capacity to consent requires scrupulous assessment prior to enrollment in research trials. We consider several researches and disease contexts—from emergency epilepsy research to long-term dementia research—and clarify the ethical and legal principles governing consent for participation in each. We additionally explore empirical research on consent capacity and survey several areas of emerging ethical import that will require the attention of investigators in decades to come.

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Rice, Roberta. "The Politics of Free, Prior and Informed Consent: Indigenous Rights and Resource Governance in Ecuador and Yukon, Canada." International Journal on Minority and Group Rights 27, no. 2 (2020): 336–56. http://dx.doi.org/10.1163/15718115-02702007.

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What are the institutional arrangements required to implement a genuine process of free, prior and informed consent (fpic)? This article provides a comparative perspective on the politics of consent in the context of relations between Indigenous peoples, states and extractive industries in Canada and Latin America. The case of Ecuador is presented as an emblematic example of a hybrid regime in which Indigenous communities have the right to free, prior and informed consultation, not consent, concerning planned measures affecting them, such as mineral, oil and gas exploitation. In the case of Yukon, Canada, the settlement of a comprehensive land claim with sub-surface mineral rights has provided the institutional basis for the implementation of a genuine fpic process, one that includes participatory decision-making power over natural resource development projects. The article concludes with a discussion on the necessary conditions for moving governments from a consultation to a consent regime.

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Schwaegermann, Marie-Kristin, Melanie Schranz, Markus Moehler, et al. "Any progress in informed consenting for cancer treatment? Results from a cross sectional analysis at a comprehensive cancer center." Journal of Cancer Research and Clinical Oncology 147, no. 7 (2021): 2117–26. http://dx.doi.org/10.1007/s00432-020-03495-1.

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Abstract Purpose Informed consent is required prior to any medical procedure. In the context of cancer treatment, special efforts are needed to inform cancer patients properly about treatment, potential sequelae and alternative therapies. Little is known about the effectiveness of current informed consent strategies and patients’ individual satisfaction. Given the heterogeneity in terms of age, education, sex and other factors, detailed understanding of patients’ comprehension and perception is the basis for further optimization of the informed consent process, which was the aim of the current investigation. Methods Patients with a new cancer diagnosis and recent informed consent were asked to complete a questionnaire about satisfaction, comprehension, time management, physician–patient relationship and other items of the informed consent process. Patients were followed for 6 months and invited to complete a follow-up questionnaire. Results In total, 89 patients completed the first questionnaire and 52 the follow-up questionnaire. Subjective understanding was assumed high, however, this did not correlate with objective understanding. Age and education were identified as influencing factors for comprehension. 85% of the patients were satisfied with the information provided. A major gap was the information on alternative therapies. Moreover, not all patients perceived the consent dialog as such, and particularly the individual treatment intention partially remained unclear for some patients. Conclusions To ensure that informed consent is based on solid understanding, informed consenting must be patient-centered and consider the individual expectations, needs and abilities of cancer patients. Further studies are required to develop tailored informed consent strategies.

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Shafiq, Nusrat, and Samir Malhotra. "Clinical Research: Comprehension of the Patient Information Leaflet and the Consent Form." Journal of Postgraduate Medicine, Education and Research 46, no. 3 (2012): 122–25. http://dx.doi.org/10.5005/jp-journals-10028-1028.

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ABSTRACT Informed consent process is an integral component of conducting clinical research ethically. Prior to giving an informed consent to participate in clinical research, it is important that the participant has fully understood all the components of a patient information leaflet and the consent form. The issue of comprehension of informed consent form and patient information leaflet has acquired particular importance in view of research being carried out in developing countries and in vulnerable population. The present review addresss this issue by discussing the need for addressing comprehension of research process by the participant, the tools for assessing the same and various ways in which these tools have been used. How to cite this article Shafiq N, Malhotra S. Clinical Research: Comprehension of the Patient Information Leaflet and the Consent Form. J Postgrad Med Edu Res 2012;46(3):122-125.

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Gerancher, J. C., S. C. Grice, D. M. Dewan, and J. Eisenach. "An evaluation of informed consent prior to epidural analgesia for labor and delivery." International Journal of Obstetric Anesthesia 9, no. 3 (2000): 168–73. http://dx.doi.org/10.1054/ijoa.1999.0371.

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Krueger, Jonathan. "Prior Informed Consent and the Basel Convention: The Hazards of What Isn't Known." Journal of Environment & Development 7, no. 2 (1998): 115–37. http://dx.doi.org/10.1177/107049659800700203.

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Hanna, Philippe, and Frank Vanclay. "Human rights, Indigenous peoples and the concept of Free, Prior and Informed Consent." Impact Assessment and Project Appraisal 31, no. 2 (2013): 146–57. http://dx.doi.org/10.1080/14615517.2013.780373.

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Eggers, Carsten, Rainer Obliers, Armin Koerfer, et al. "A Multimedia Tool for the Informed Consent of Patients prior to Gastric Banding**." Obesity 15, no. 11 (2007): 2866–73. http://dx.doi.org/10.1038/oby.2007.340.

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Furyk, Jeremy, Kristin McBain-Rigg, Kerrianne Watt, et al. "Qualitative evaluation of a deferred consent process in paediatric emergency research: a PREDICT study." BMJ Open 7, no. 11 (2017): e018562. http://dx.doi.org/10.1136/bmjopen-2017-018562.

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BackgroundA challenge of conducting research in critically ill children is that the therapeutic window for the intervention may be too short to seek informed consent prior to enrolment. In specific circumstances, most international ethical guidelines allow for children to be enrolled in research with informed consent obtained later, termed deferred consent (DC) or retrospective consent. There is a paucity of data on the attitudes of parents to this method of enrolment in paediatric emergency research.ObjectivesTo explore the attitudes of parents to the concept of DC and to expand the knowledge of the limitations to informed consent and DC in these situations.MethodChildren presenting with uncomplicated febrile seizures or bronchiolitis were identified from three separate hospital emergency department databases. Parents were invited to participate in a semistructured telephone interview exploring themes of limitations of prospective informed consent, acceptability of the DC process and the most appropriate time to seek DC. Transcripts underwent inductive thematic analysis with intercoder agreement, using Nvivo 11 software.ResultsA total of 39 interviews were conducted. Participants comprehended the limitations of informed consent under emergency circumstances and were generally supportive of DC. However, they frequently confused concepts of clinical care and research, and support for participation was commonly linked to their belief of personal benefit.ConclusionParticipants acknowledged the requirement for alternatives to prospective informed consent in emergency research, and were supportive of the concept of DC. Our results suggest that current research practice seems to align with community expectations.

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Parshin, Pavel. "Indigenous Peoples’ Interaction with External World: The Principle of Free, Prior and Informed Consent." Journal of International Analytics, no. 1-2 (March 28, 2019): 114–28. http://dx.doi.org/10.46272/2587-8476-2019-0-1-2-114-128.

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Indigenous peoples are inheritors of earlier population of their present day territories of modern states, committed to their land and traditional way of life. The world community for many decades proceeds along the path of recognition the rights of indigenous peoples, the main of which, in the author’s opinion, is the right to choose the degree and form of their integration in the modern society. Historically, the attitude towards indigenous peoples’ rights developed from recognition of their right “to be as other peoples are” to the consent to their right to be different an original. One of the main tenet ensuring the realization of their right to originality, which has important practical implications, is the principle of free, prior and informed consent (FPIC) of indigenous peoples to affecting them economic and cultural activities of their dominant neighbors, as well as to more particular (including special) rights and implementation procedures resulting from them. In economic terms, it primarily concerns nature management and, especially, extraction of natural fossil and usage of biological resources, military activities, and waste disposal. The article analyzes the history of ideas about the of indigenous peoples’ rights and their legal fixation, as well as problems of interpretation of the principle of free, prior and informed consent and its implementation in various regions of the world and spheres of activity.

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Mahafzah, Rania, Karem H. Alzoubi, and Omar F. Khabour. "The Attitudes of Relatives of ICU Patients toward Informed Consent for Clinical Research." Critical Care Research and Practice 2020 (October 9, 2020): 1–6. http://dx.doi.org/10.1155/2020/2760168.

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Background. Informed consent is a key ethical requirement for biomedical research that is implemented to ensure autonomy and voluntary participation. However, patients in the intensive care unit (ICU) may be unconscious or severely ill and thus lack the capacity for decisions about research participation. Thus, relatives or guardians are usually asked to provide informed consent prior to the inclusion of ICU patients in research. Aims. This study aimed to assess the attitudes and preferences of relatives of ICU patients toward informed consent in biomedical research in Jordan. Subjects and Methods. A sample of 184 relatives with a critically ill next of kin in the ICU was anonymously surveyed regarding their attitudes and preferences toward giving informed consent for biomedical research on behalf of their patients. Results. The study showed that the majority of relatives had a positive attitude toward the informed consent process on behalf of their patients in the ICU (72.3%). The perception that participation in research would be directly beneficial to their patient was the most significant reason to provide informed consent among relatives. The degree of relatedness to the patient was significantly associated with the decision to provide informed consent on behalf of the patients in the ICU. Additionally, more than 70% of the relatives strongly agreed to take part in clinical research if they were to be unconscious patients in the ICU. Moreover, the majority of the respondents agreed that their first-degree relatives would give consent on their behalf. Conclusion. Relatives with a critically ill next of kin in the ICU had positive attitudes toward providing informed consent on behalf of their patients. This was motivated by the direct benefit from the research to their patient.

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Zimmermann, Agnieszka, Anna Pilarska, Aleksandra Gaworska-Krzemińska, Jerzy Jankau, and Marsha N. Cohen. "Written Informed Consent—Translating into Plain Language. A Pilot Study." Healthcare 9, no. 2 (2021): 232. http://dx.doi.org/10.3390/healthcare9020232.

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Background: Informed consent is important in clinical practice, as a person’s written consent is required prior to many medical interventions. Many informed consent forms fail to communicate simply and clearly. The aim of our study was to create an easy-to-understand form. Methods: Our assessment of a Polish-language plastic surgery informed consent form used the Polish-language comprehension analysis program (jasnopis.pl, SWPS University) to assess the readability of texts written for people of various education levels; and this enabled us to modify the form by shortening sentences and simplifying words. The form was re-assessed with the same software and subsequently given to 160 adult volunteers to assess the revised form’s degree of difficulty or readability. Results: The first software analysis found the language was suitable for people with a university degree or higher education, and after revision and re-assessment became suitable for persons with 4–6 years of primary school education and above. Most study participants also assessed the form as completely comprehensible. Conclusions: There are significant benefits possible for patients and practitioners by improving the comprehensibility of written informed consent forms.

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Carlisle, Jeffrey, and Ann T. Neulicht. "The Necessity of Professional Disclosure and Informed Consent for Rehabilitation Counselors." Journal of Applied Rehabilitation Counseling 41, no. 2 (2010): 25–31. http://dx.doi.org/10.1891/0047-2220.41.2.25.

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Within the rehabilitation counseling arena, professional disclosure and informed consent are critical concepts for the rehabilitation counselor to understand. Once understood, they become key components of a rehabilitation counselor's daily practice. Counselors need to provide sufficient prior information about their evaluation and services to respect the individual's right to make an informed choice about participating in the activities. This is one of the most important steps for the counselor to make at the outset of the relationship and thereafter. Yet, inconsistency abounds among rehabilitation counselors when it comes to providing a full and adequate disclosure, thereby ensuring the individual's right to informed consent. This article addresses the history of these issues, the manner by which earlier versions of the Code of Professional Ethics for Rehabilitation Counselors addressed them, and the changes regarding disclosure and informed consent within the revised 2010 code. Because the code now requires written disclosure, this article provides guidance to rehabilitation counselors for incorporating proper professional disclosure and informed consent protocols into their daily professional activities.

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Mukisa, P. K., D. M. Tumusiime, C. Webersik, E. T. Liwenga, and J. R. S. Tabuti. "Dissenting voices in a consenting village: lessons from implementation of free, prior and informed consent at a REDD+ pilot in Tanzania." International Forestry Review 22, no. 1 (2020): 120–31. http://dx.doi.org/10.1505/146554820828671508.

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Free, prior and informed consent (FPIC) is a key institutional tool in meeting social safeguards. Its implementation ensures respect of the local people's rights in an intervention. This paper presents a case of FPIC implementation at a REDD+ pilot site. Data were obtained through key informant interviews and focus group discussions with proponents and village members of the Lindi REDD+ project. Findings indicate that the inclusive approach to FPIC by taking the consultations to the hamlet level did not deliver a flawless process. The consent decision was reached by a majority vote, not consensus. There was some dissent, prompting the early establishment of project implementation committees. Consent was obtained, though it was not absolutely free, prior and informed. Future REDD+ projects should consider having FPIC as an independent and earlier process, separate from the main implementation of the project in order to uphold local peoples' rights in a less anxious process.

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Yucel, A., O. Gecici, M. Emul, et al. "Effect of informed consent for intravascular contrast material on the level of anxiety: how much information should be given?" Acta Radiologica 46, no. 7 (2005): 701–7. http://dx.doi.org/10.1080/02841850500215816.

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Purpose: To compare the effect of two different informed consent forms on patients' anxiety level prior to intravenous contrast material (IVCM) injection. Material and Methods: Two different informed consent forms were randomly given to 265 consecutive patients referred for either intravenous pyelography or computed tomography requiring IVCM injections. Form 1 had brief information, including only the common risks and risk factors associated with IVCM, while Form 2 had more comprehensive information. Before being presented with the two different informed consent forms, 191 of the 265 patients filled out two other forms evaluating: 1: How they felt in that particular situation/moment (STAI-T); and 2: How they felt independently of the situation or condition at that moment (STAI-S). After the patients were informed, the STAI-T (measuring how they felt in that particular situation) was filled out once more to see if the anxiety level had changed. Results: The anxiety level for 88 patients receiving Form 1 decreased after they were given the informed consent ( P = 0.033). However, among the 103 patients receiving Form 2, the anxiety level showed a significant increase ( P = 0.001) compared to the values obtained before Form 2 was given. Conclusion: These results indicate that informed consent, including brief information about the risk factors and potential adverse reactions of IVCM, reduces anxiety level, while detailed information before the procedure increases the anxiety level.

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Martin, Emily M. W. "Free, Prior, and Informed Consent (FPIC) in the Yukon: Established Practice or Untravelled Path?" Northern Review 47 (August 1, 2018): 113–34. http://dx.doi.org/10.22584/nr47.2018.006.

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Yin, Bob, Laura Goldsmith, and Ralph Gambardella. "Web-Based Education Prior to Knee Arthroscopy Enhances Informed Consent and Patient Knowledge Recall." Journal of Bone and Joint Surgery-American Volume 97, no. 12 (2015): 964–71. http://dx.doi.org/10.2106/jbjs.n.01174.

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