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1

Moody, Harry R. "From Informed Consent to Negotiated Consent1." Gerontologist 28, Suppl (June 1, 1988): 64–70. http://dx.doi.org/10.1093/geront/28.suppl.64.

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2

White, Alfred C. "Consent or no consent." Psychiatric Bulletin 18, no. 8 (August 1994): 507. http://dx.doi.org/10.1192/pb.18.8.507-a.

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3

Rowbotham, Michael C., John Astin, Kaitlin Greene, and Steven R. Cummings. "Interactive Informed Consent: Randomized Comparison with Paper Consents." PLoS ONE 8, no. 3 (March 6, 2013): e58603. http://dx.doi.org/10.1371/journal.pone.0058603.

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4

YU, Ho-Jong. "Doctors Duty of Informed Consent and Patient Informed Consent Form." Korean Journal of Medical Ethics 5, no. 1 (June 2002): 27–41. http://dx.doi.org/10.35301/ksme.2002.5.1.27.

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1. When a patient goes to a hospital, he is expected to give consent to the treatment his/her doctor may provide. The initial consent, however, does not include all the consents to the following treatment a patient is going to receive. For further treatments, especially for concrete treatments, the doctor must seek for additional consents. 2. A doctor must offer sufficient informations to his patient when getting a consent. While doing this a pre-written patient informed consent form can be convenient as well as effective. The doctor can explain systematically without leaving out any important point, and the patient can understand much better what the doctor is explaining by reading the paper repeatedly. Furthermore this same form can be useful later on when any legitimate question arise. 3. I reviewed many patient informed consent forms previously made by many academies of medical science in specific medical fields. I find the papers lacking in sufficient informations especially on alternative treatment measures. Even if there are, they are described negatively, which make the forms suspicious of giving biased informations. Above all the terms used are too difficult for the patients to understand. I, therefore, propose a patient informed consent form, which I believe might be ideal.
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5

Hadden, Kristie B., Latrina Y. Prince, Tina D. Moore, Laura P. James, Jennifer R. Holland, and Christopher R. Trudeau. "Improving readability of informed consents for research at an academic medical institution." Journal of Clinical and Translational Science 1, no. 6 (December 2017): 361–65. http://dx.doi.org/10.1017/cts.2017.312.

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IntroductionThe final rule for the protection of human subjects requires that informed consent be “in language understandable to the subject” and mandates that “the informed consent must be organized in such a way that facilitates comprehension.” This study assessed the readability of Institutional Review Board-approved informed consent forms at our institution, implemented an intervention to improve the readability of consent forms, and measured the first year impact of the intervention.MethodsReadability assessment was conducted on a sample of 217 Institutional Review Board-approved informed consents from 2013 to 2015. A plain language informed consent template was developed and implemented and readability was assessed again after 1 year.ResultsThe mean readability of the baseline sample was 10th grade. The mean readability of the post-intervention sample (n=82) was seventh grade.ConclusionsProviding investigators with a plain language informed consent template and training can promote improved readability of informed consents for research.
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6

Sheehan, M. "Broad consent is informed consent." BMJ 343, no. 01 3 (November 1, 2011): d6900. http://dx.doi.org/10.1136/bmj.d6900.

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7

MANSON, NEIL C. "Normative Consent Is Not Consent." Cambridge Quarterly of Healthcare Ethics 22, no. 1 (December 4, 2012): 33–44. http://dx.doi.org/10.1017/s0963180112000369.

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8

Gerver, Mollie. "Consent for Data on Consent." Ethical Theory and Moral Practice 18, no. 4 (December 28, 2014): 799–816. http://dx.doi.org/10.1007/s10677-014-9553-5.

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9

Erlen, Judith A. "Informed Consent: The Consent Component." Orthopaedic Nursing 13, no. 4 (July 1994): 65–67. http://dx.doi.org/10.1097/00006416-199407000-00011.

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10

&NA;. "CONSENT ISSUE APPLYING IMPLIED CONSENT." Nursing 23, no. 6 (June 1993): 66–67. http://dx.doi.org/10.1097/00152193-199306000-00024.

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11

Gerver, Mollie. "Inferring Consent without Communication." Social Theory and Practice 46, no. 1 (2020): 27–53. http://dx.doi.org/10.5840/soctheorpract202021478.

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Some claim that consent requires common knowledge. For a doctor to obtain consent, a doctor must know that her patient has given her permission to perform surgery, and her patient must know the doctor knows that he has given this permission. Some claim that such common knowledge requires communication, and so consent requires communication: the patient must tell the doctor he consents for both to know consent took place, and for both to know the other knows consent took place. I first defend the claim that consent requires common knowledge, responding to recent objections. I then argue that, though consent requires common knowledge, it does not always require communication. It does not require communication when the agent obtaining consent can infer common knowledge based on non-behavioral facts about the world.
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12

Walsh, Peter. "Consent." Clinical Risk 22, no. 1-2 (March 2016): 4–5. http://dx.doi.org/10.1177/1356262216664247.

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13

Fong, Y., P. Lewis, and MH Lewis. "Consent." Annals of The Royal College of Surgeons of England 89, no. 1 (January 2007): 87–88. http://dx.doi.org/10.1308/003588407x155626.

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14

Hope, Tony. "Consent." Medicine 28, no. 10 (2000): 5–10. http://dx.doi.org/10.1383/medc.28.10.5.27971.

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Hope, Tony. "Consent." Medicine 33, no. 2 (February 2005): 3–7. http://dx.doi.org/10.1383/medc.33.2.3.58378.

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16

Constant, Chris. "Consent." Surgery (Oxford) 23, no. 12 (December 2005): 439–40. http://dx.doi.org/10.1383/surg.2005.23.12.439.

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17

Worlock, Peter H. "Consent." Bone & Joint 360 5, no. 3 (June 2016): 38–40. http://dx.doi.org/10.1302/2048-0105.53.360434.

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18

Hope, Tony. "Consent." Foundation Years 2, no. 5 (October 2006): 194–98. http://dx.doi.org/10.1053/j.mpfou.2006.06.005.

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19

Markus, P. M. "Consent." Viszeralchirurgie 40, no. 4 (2005): 288–90. http://dx.doi.org/10.1055/s-2005-836755.

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20

Hain, Richard. "Consent." Medicine 44, no. 10 (October 2016): 593–95. http://dx.doi.org/10.1016/j.mpmed.2016.07.009.

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21

White, Stuart M., and Mark Ashley. "Consent." Anaesthesia & Intensive Care Medicine 13, no. 4 (April 2012): 141–44. http://dx.doi.org/10.1016/j.mpaic.2012.01.005.

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White, Stuart M., and Mark Ashley. "Consent." Anaesthesia & Intensive Care Medicine 16, no. 4 (April 2015): 151–54. http://dx.doi.org/10.1016/j.mpaic.2015.01.009.

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23

Love, Christopher, and Nick Pace. "Consent." Anaesthesia & Intensive Care Medicine 19, no. 5 (May 2018): 263–66. http://dx.doi.org/10.1016/j.mpaic.2018.02.009.

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24

Kaye, Andrew. "Consent." Journal of Clinical Neuroscience 1, no. 2 (April 1994): 77. http://dx.doi.org/10.1016/0967-5868(94)90079-5.

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25

Srivastava, CP. "Consent." Journal of Universal College of Medical Sciences 1, no. 4 (January 12, 2014): 69–70. http://dx.doi.org/10.3126/jucms.v1i4.9581.

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26

Bogod, David. "Consent." Annals of The Royal College of Surgeons of England 93, no. 4 (May 2011): 265–67. http://dx.doi.org/10.1308/147870811x571127.

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27

Wheeler, R. "Consent." Annals of The Royal College of Surgeons of England 93, no. 7 (October 2011): 562–63. http://dx.doi.org/10.1308/147870811x598560.

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28

Shepard, Karen. "Consent." Ploughshares 46, no. 2 (2020): 133–45. http://dx.doi.org/10.1353/plo.2020.0115.

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29

Gillon, R. "Consent." BMJ 291, no. 6510 (December 14, 1985): 1700–1701. http://dx.doi.org/10.1136/bmj.291.6510.1700.

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30

Moreno, María, and Paco Brito Núñez. "Consent." Critical Times 5, no. 2 (August 1, 2022): 434–43. http://dx.doi.org/10.1215/26410478-9799752.

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Abstract María Moreno begins by examining the limits of our common legal and psychological understandings of consent. She examines how the self who gives consent fluctuates in a way occluded by the liberal notion of the contract and proceeds to consider consent in the broadest sociopolitical context, as a minor part or element of a greater instrument of control: rape itself. Through a consideration of a series of violations committed in Argentina, some by civilians, others by agents of the state during the country's last civico-military dictatorship, Moreno illustrates how the contradictions inherent in the current legal category of consent obscure how rape functions, not only as a major crime on par with murder but also as a weapon in the preservation of the patriarchal symbolic economy and as a key element in the arsenal of war. The author asks whether it's time to seek to think rape politically, and not just morally. She concludes with a powerful reflection on nonconsent and the kind of sovereignty it can afford to victims and their victimizers who are both oppressed by a system that subsumes them.
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31

Chuchalin, Alexandr G. "Consent. Modern interpretation: "Voluntary Informed Consent"." Terapevticheskii arkhiv 93, no. 5 (May 15, 2021): 640–44. http://dx.doi.org/10.26442/00403660.2021.05.200797.

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The article is devoted to voluntary informed consent. It considers the historical issues of the formation of this concept in modern health care and medical science. The article highlights a historical role of the Nuremberg Code which was taken as the basis for the Universal Declaration of Human Rights, the World Medical Association (WMA) Code of Ethics, the Declaration on Bioethics and Human Rights, i.e. documents that defined the world order after the end of World War II.
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32

Hendershot, Marcus E. "From Consent to Advice and Consent." Political Research Quarterly 63, no. 2 (December 24, 2008): 328–42. http://dx.doi.org/10.1177/1065912908329354.

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33

Sheehan, M. "Can Broad Consent be Informed Consent?" Public Health Ethics 4, no. 3 (August 3, 2011): 226–35. http://dx.doi.org/10.1093/phe/phr020.

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34

Boers, Sarah N., Johannes J. M. van Delden, and Annelien L. Bredenoord. "Broad Consent Is Consent for Governance." American Journal of Bioethics 15, no. 9 (August 25, 2015): 53–55. http://dx.doi.org/10.1080/15265161.2015.1062165.

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35

Wendler, David, and Alan Wertheimer. "Why is Coerced Consent Worse Than No Consent and Deceived Consent?" Journal of Medicine and Philosophy: A Forum for Bioethics and Philosophy of Medicine 42, no. 2 (February 13, 2017): 114–31. http://dx.doi.org/10.1093/jmp/jhw064.

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36

Mhaske, Sunil, Vineetranjan Gupta, Ramesh Kothari, and Ninza Rawal. "Consent in Paediatrics." Pediatric Education and Research 5, no. 3 (2017): 233–35. http://dx.doi.org/10.21088/per.2321.1644.5317.12.

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37

Rangaramanujam, ATM. "Liberalizing consent - Supreme Court′s preference for ′real consent′ over ′informed consent′." Indian Journal of Radiology and Imaging 18, no. 03 (July 2008): 195–97. http://dx.doi.org/10.1055/s-0041-1734428.

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38

Lie, Rico, and Loes Witteveen. "Visual informed consent: informed consent without forms." International Journal of Social Research Methodology 20, no. 1 (December 11, 2015): 63–75. http://dx.doi.org/10.1080/13645579.2015.1116835.

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39

Souhami, R. L., and J. S. Tobias. "Informed consent Consent requires a flexible approach." BMJ 308, no. 6923 (January 22, 1994): 271. http://dx.doi.org/10.1136/bmj.308.6923.271a.

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40

Aitkenhead, A. "Anaesthetists need consent, but not written consent." BMJ 319, no. 7217 (October 23, 1999): 1135. http://dx.doi.org/10.1136/bmj.319.7217.1135.

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41

Merz, Jon F., and Baruch Fischhoff. "Informed consent does not mean rational consent." Journal of Legal Medicine 11, no. 3 (September 1990): 321–50. http://dx.doi.org/10.1080/01947649009510831.

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42

Finch, John. "Consent conundrums: patient consent in neuroscience nursing." British Journal of Neuroscience Nursing 16, no. 1 (February 2, 2020): 48–52. http://dx.doi.org/10.12968/bjnn.2020.16.1.48.

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In BJNN 15(4) and BJNN 15(5), John Finch looked in detail at the role of the Mental Capacity Act 2005 and its accompanying Code in the practice of neuroscience nurses. He concluded, as have others, that the guidance offered by the Act and the Code falls short of what neuroscience nurses need in their practice. In this article, he turns his attention to the treatment of patients who can and do consent to proposed treatment. The law relating to such patients in this matter offers neither an act nor a code. The law is to be found in court decisions. It might, at first sight, appear that a practice situation in which a patient with undoubted mental capacity or, at least, sufficient mental capacity to understand and accept what is proposed, presents no legal problem. But a closer examination of mental processes encountered in patients who may be in pain, distress and pressing need reveals that communication between the treater and the treated may be subtle and complex, and that the meeting of minds required in law to ensure that a patient has genuinely agreed to a detailed proposal is anything but simple.
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43

Topolovec-Vranic, Jane, Marlene Santos, Andrew J. Baker, Orla M. Smith, and Karen EA Burns. "Deferred Consent in a Minimal-Risk Study Involving Critically Ill Subarachnoid Hemorrhage Patients." Canadian Respiratory Journal 21, no. 5 (2014): 293–96. http://dx.doi.org/10.1155/2014/719270.

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INTRODUCTION: Alterations from first-party and surrogate decision-maker consent can enhance the feasibility of research involving critically ill patients.OBJECTIVE: To describe the use of a deferred-consent model to enable participation of critically ill patients in a minimal-risk biomarker study.METHODS: A prospective observational study was conducted in which serum biomarker samples were collected three times daily over the first 14 days following aneurysmal subarachnoid hemorrhage. Sample collection was initiated on intensive care unit admission and consent was obtained when research personnel could approach the patient or the patient’s surrogate decision maker.RESULTS: Twenty-seven patients were eligible for the study, of whom only five were capable of providing informed consent. Full consent was obtained for 21 (78%) patients through self- (n=4) and surrogate (n=17) consent. Partial consent or refusal (only permitting the collection of blood samples as a part of routine care or use of data) occurred in three patients. Among the 22 consents sought from surrogates, three (11%) refused participation. The refusals included the sickest patients in the cohort. Once consent was provided, no patient or surrogate withdrew consent before study completion.DISCUSSION: Use of a deferred consent model enabled participation of critically ill patients in a minimal-risk biomarker study with no withdrawals.CONCLUSIONS: Further research and enhanced awareness of the potential utility of hybrid models, including deferred consent in addition to patient or surrogate consent, in the conduct of low-risk and minimally interventional time-sensitive studies of critically ill patients are required.
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44

Sibold, Hannah Claire, Gavin Paul Campbell, John Bourgeois, Margie D. Dixon, R. Donald Harvey, and Rebecca D. Pentz. "Improving consent forms for first-in-human trials through participant feedback." Journal of Clinical Oncology 39, no. 15_suppl (May 20, 2021): e13563-e13563. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.e13563.

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e13563 Background: Risks and benefits of investigational agents that have not been tested in humans are, at best, incompletely characterized in nonclinical investigations. Despite the growing emphasis to include patient voices in clinical trial design, no published research has explored patient preferences on how best to convey the information that the agent has not been tested in humans. This study established that First in Human (FIH) consent forms present this information in different locations and queried participants for their input on the preferable FIH consent form structure. Methods: Consent forms for FIH oncology trials open to accrual at Winship Cancer Institute in 2019-2020 were analyzed for (1) the location of the mention that the study drug has not been used in humans before (FIH information), (2) the location of animal and other nonclinical data, and (3) placement of the risks section. Patients offered enrollment in a FIH trial were eligible for this study. Participants were interviewed during a clinic visit after consent was obtained. An ethics researcher asked questions about the participant’s opinions on the wording and placement of the FIH, nonclinical, and risk information in the specific trial consent form. All interviews were audio-recorded and double coded by two independent coders. The location of FIH and nonclinical data in the consent forms was compared to the patient’s suggested location for this information. Results: Saturation of themes was reached after interviewing 17 (17/19, 89% accrual) participants who were enrolled in 9 different FIH trials. Twenty FIH consents were qualitatively analyzed. Preferred placement compared to actual consent placement is listed in the table. 82% (14/17) of participants thought that nonclinical data on risks and efficacy was important to mention. 95% (19/20) of consents listed nonclinical data and most participants thought the placement in the consent was appropriate but 18% (3/17) of participants wanted the information earlier in the consent. No consent forms that were analyzed had the risks section before the study schedule; however, 47% (8/17) of participants wanted to move the risks sections before the study schedule. Conclusions: There is considerable variation in the layout of FIH consent forms that does not align with patient preferences. Standardization of FIH consent forms to better reflect patient input is essential in order to promote understandability of these important yet sometimes misunderstood clinical trials and to ensure ethical informed consent.[Table: see text]
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45

Ulum, Miftachul. "PENERAPAN KOMUNIKASI EFEKTIF DI UNIT PUSAT ADMINSTRASI TERPADU RSUD KANJURUHAN KABUPATEN MALANG." JRMIK 3, no. 2 (June 10, 2022): 56–62. http://dx.doi.org/10.58535/jrmik.v3i2.19.

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ABSTRAK Komunikasi efektif merupakan sebuah komunikasi yang mampu menghasilkan perubahansikap (attitude change)pada orang yang terlibat komunikasi. General Consent atau lembar persetujuan umum merupakan lembar persetujuan yang diberikan kepada pasien atau keluarga setelah mendapat penjelesan secara lengkap dari petugas pendaftaran. Tujuan penelitian ini untuk mengetahui apakah para petugas di bagian PAT telah menerapakan komunikasi efektif dalam menjelaskan isi dan maksud dari General Consent kepada pasien. Pada penelitian kali ini, peniliti menggunakan kuisioner yang dibagikan kepada 62 pasien dan 5 petugas PAT RSUD Kanjuruhan Kabupaten Malang. Penelitian ini menggunakan metode deskriptif kualitatif. Dari hasil pembagian kuisioner kepada 62 pasien, terdapat hasil bahwasanya 65% pasien mengerti apakah itu General Consent. Akan tetapi walaupun merak mengetahui apa itu General Consent meraka belum paham benar apakah maksud dan isi dari General Consnet. Terbukti hanya 23% pasien yang menjawab “YA” atau mereka mengetahui apakah maksud dan tujuan dari General Consent. Sedangkan identifikasi petugas ditemukan hasil bahwasanya dari kelima petugas hanya 2 orang yang mengerti SPO tentang penjelasan General Consent. Dan hanya 2 orang yang menjawab telah menerapkan komunikasi efektif dalam pengisian General Consent.
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46

Abdul Rauf, Umm-E.-Habiba, Mujeeb Rehman Malik, Faisal Ghani Siddiqui, Omema Saleem, and Summaya Saeed. "Informed Consent in Surgical Patients Current Issues and Future Perspective." Pakistan Journal of Medical and Health Sciences 17, no. 2 (March 5, 2023): 408–10. http://dx.doi.org/10.53350/pjmhs2023172408.

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Objective: Informed consent is an essential and standard procedure in medical practice. The objective of the study was to evaluate the informed consent practices of surgeons at a university teaching hospital. Materials and Methods: A prospective cross sectional study was performed between the time duration of February 2022 till June 2022 at surgical and allied units of Dow University Hospital, DUHS Karachi, Pakistan Results: A total of 196 patients were interviewed on their first post-operative day at their bed side. . Patients were selected randomly from all surgical and allied departments of Dow university hospital, including Gynecology(36.22%), General surgery(34.18%), orthopedics(16.33%), ENT (6.12%), urology (2.55%), eye (2.55%), neurosurgery(1.53%) and maxillofacial(0.51%). 39.8% patients gave consent themselves while rest 55.1% and 5.1% consents were given by family members and parents. Only 23.47% patients or the representative who signed the consent, read the consent form before signing it Conclusions: To improve the quality of communication with the informed consent, a structured conversation helps physicians establish relationships with the patients, regarding the adequacy of the information provided. Keywords: Surgical Patients, informed consent, communication
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47

Law, Zhe Kang, Jason P. Appleton, Polly Scutt, Ian Roberts, Rustam Al-Shahi Salman, Timothy J. England, David J. Werring, et al. "Brief Consent Methods Enable Rapid Enrollment in Acute Stroke Trial: Results From the TICH-2 Randomized Controlled Trial." Stroke 53, no. 4 (April 2022): 1141–48. http://dx.doi.org/10.1161/strokeaha.121.035191.

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Background: Seeking consent rapidly in acute stroke trials is crucial as interventions are time sensitive. We explored the association between consent pathways and time to enrollment in the TICH-2 (Tranexamic Acid in Intracerebral Haemorrhage-2) randomized controlled trial. Methods: Consent was provided by patients or by a relative or an independent doctor in incapacitated patients, using a 1-stage (full written consent) or 2-stage (initial brief consent followed by full written consent post-randomization) approach. The computed tomography-to-randomization time according to consent pathways was compared using the Kruskal-Wallis test. Multivariable logistic regression was performed to identify variables associated with onset-to-randomization time of ≤3 hours. Results: Of 2325 patients, 817 (35%) gave self-consent using 1-stage (557; 68%) or 2-stage consent (260; 32%). For 1507 (65%), consent was provided by a relative (1 stage, 996 [66%]; 2 stage, 323 [21%]) or a doctor (all 2-stage, 188 [12%]). One patient did not record prerandomization consent, with written consent obtained subsequently. The median (interquartile range) computed tomography-to-randomization time was 55 (38–93) minutes for doctor consent, 55 (37–95) minutes for 2-stage patient, 69 (43–110) minutes for 2-stage relative, 75 (48–124) minutes for 1-stage patient, and 90 (56–155) minutes for 1-stage relative consents ( P <0.001). Two-stage consent was associated with onset-to-randomization time of ≤3 hours compared with 1-stage consent (adjusted odds ratio, 1.9 [95% CI, 1.5–2.4]). Doctor consent increased the odds (adjusted odds ratio, 2.3 [1.5–3.5]) while relative consent reduced the odds of randomization ≤3 hours (adjusted odds ratio, 0.10 [0.03–0.34]) compared with patient consent. Only 2 of 771 patients (0.3%) in the 2-stage pathways withdrew consent when full consent was sought later. Two-stage consent process did not result in higher withdrawal rates or loss to follow-up. Conclusions: The use of initial brief consent was associated with shorter times to enrollment, while maintaining good participant retention. Seeking written consent from relatives was associated with significant delays. Registration: URL: https://www.isrctn.com ; Unique identifier: ISRCTN93732214.
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48

Jacob, Marie-Andrée. "Form-Made Persons: Consent Forms as Consent's Blind Spot." PoLAR: Political and Legal Anthropology Review 30, no. 2 (November 2007): 249–68. http://dx.doi.org/10.1525/pol.2007.30.2.249.

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49

Director, Samuel. "Consent’s dominion: Dementia and prior consent to sexual relations." Bioethics 33, no. 9 (August 28, 2019): 1065–71. http://dx.doi.org/10.1111/bioe.12652.

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50

Mushtaq, Muhammad, Zoya Imran, Imran Jawaad, Urva Maryum, and Humaira Mukhtar. "Medicolegal Aspect of Consent." Pakistan Journal of Medical and Health Sciences 16, no. 12 (December 31, 2022): 681–83. http://dx.doi.org/10.53350/pjmhs20221612681.

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Introduction: Consent is a legal requirement for all medical procedures whether surgical or non-surgical. Different types of consents are discussed in books, all fulfill legal requirements which totally depends upon the nature and type of case under process. Objective: Main objective of the study is to determine the awareness of public about consent and its legal value. Material and Method: It is a cross sectional observational study conducted at orthopedic department of Services Hospital Lahore, from 1st January 2019 to 29th December, 2019. A total of 125 patients were selected for this study. Study design: It is a cross sectional observational study. Setting: Study was conducted in the orthopedic department of Services Hospital Lahore. Duration: Study was conducted from 1st January 2019 to 29th December 2019. Data Collection: Data was collected through a questionnaire which was modified after pilot study. Results: Majority 60% of the patients believe that consent is a formality for any medical procedure. 76% of the patients have a feeling that consent is a medical document and has no legal value. 40% of the patients believe that by signing consent they forgive their right for any compensation. 48% of patient’s view consent as protection of their rights whereas 36% of them are unaware about this fact. Conclusion: This study concludes the ignorance of the people about the legal value of consent. A vast gap exists between the informed consent and the knowledge of the people signing this document. In the current situation inform consent need to be modified so that public should be aware about its importance. Keywords: Consent
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