Design and Implementation of an Informed Consent Process before Liver Transplantation

2008 ◽  
Vol 18 (4) ◽  
pp. 273-283 ◽  
Author(s):  
Lori Rosenthal
Keyword(s):  
Informed Consent ◽  
Medical Center ◽  
Informed Consent Process ◽  
Educational Process ◽  
Consent Form ◽  
Consent Process ◽  
Columbia University ◽  
Department Of Health ◽  
Informed Consent Form ◽  
National Model

In the past, the content of patient education was designed at the discretion of each individual transplant center and could vary greatly from center to center. Since the 2007 implementation of the guidelines from the Department of Health and Human Services, Centers for Medicare and Medicaid Services, transplant centers have had to standardize the educational material they give to patients while generating an informed consent form to incorporate this required information. This article describes the development and use of an informed consent form and the educational process for potential liver transplant recipients at Columbia University Medical Center in adherence with the new regulations. This informed consent process can be used as a national model.

scholarly journals Satisfaction of Surgical Informed Consent and Associated Factors Among Women Undergone Obstetric and Gynecologic Surgery at Jimma Medical Center, Jimma, Oromia Region, Ethiopia 2020.

2020 ◽  
Author(s):  
Tsegaw Biyazin Tesfa ◽  
AYANOS TAYE ◽  
YESHITILA BELAY
Keyword(s):  
Health Care ◽  
Patient Satisfaction ◽  
Informed Consent ◽  
Associated Factors ◽  
Medical Center ◽  
Multivariate Logistic Regression Analysis ◽  
Informed Consent Process ◽  
Consent Process ◽  
Outcome Variable ◽  
Gynecologic Surgery

Abstract Background: Informed consent is a process in which a healthcare provider obtains permission from an individual before delivering a certain health intervention. Patient satisfaction towards informed consent process is one main indicator of patient experience on health care services and mirror image of quality health care. The objective of this study was to assess the level of women satisfaction towards surgical informed consent and its associated factors at Jimma Medical Center, Ethiopia, 2020.Method: Facility based cross-sectional study was conducted from April 1 to May30, 2020 at Jimma Medical Center. A total of 372 surgical patients were selected using a systematic random sampling method. The collected data was coded, entered into Epi data version 3.1 and analyzed using SPSS version 25. Bivariate and multivariate regression was carrying out to determine the association between outcome variable and independent variable. Result: A total of 372 study participants were interviewed and giving a response rate of 97.8 %. Of this majority respondents were 167(44.9%) between 28-37 years old, married 310(83.3%), Urban residence 242 (65.1%) and housewife 168 (45%). Patients’ satisfaction towards surgical informed consent was 43%. Multivariate logistic regression analysis showed that residence (AOR: 2.279, 95% CI: 1.257-4.131), current referred history (AOR: 1.856, 95% CI: 1.033-3.337), language of the written consent form (AOR: 2.076, 95% CI: 1.143-3.773), time taken for informed consent provision (AOR: 5.227, 95% CI: 2.499-10.936) and patient to health provider relationship (AOR: 5.419, 95% CI: 3.103-9.464) were positively associated with patient satisfaction.Conclusion: In this study, the level of patient satisfaction towards surgical informed consent process was relatively low compared with previous studies. Health care professionals need to give emphasize on way of delivering informed consent, patients’ need and obey a standard informed consent process with evidence based practice to improve patient satisfaction.

A risk-specific anesthesia consent form may hinder the informed consent process

1991 ◽  
Vol 3 (6) ◽  
pp. 481 ◽  
Author(s):  
Scott K. Clark ◽  
Barbara L. Leighton ◽  
Joseph L. Seltzer
Keyword(s):  
Informed Consent ◽  
Informed Consent Process ◽  
Consent Form ◽  
Consent Process

A risk-specific anesthesia consent form may hinder the informed consent process

1991 ◽  
Vol 3 (1) ◽  
pp. 11-13 ◽  
Author(s):  
Scott K. Clark ◽  
Barbara L. Leighton ◽  
Joseph L. Seltzer
Keyword(s):  
Informed Consent ◽  
Informed Consent Process ◽  
Consent Form ◽  
Consent Process

Randomized comparison of two interventions to enhance understanding during the informed consent process for research

2021 ◽  
pp. 174077452110095
Author(s):  
Holly A Taylor ◽  
Daphne Washington ◽  
Nae-Yuh Wang ◽  
Hiten Patel ◽  
Daniel Ford ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Randomized Study ◽  
Informed Consent Process ◽  
Consent Form ◽  
Consent Process ◽  
P Value ◽  
Fact Sheet ◽  
Significant Difference ◽  
Participant Understanding

Background/Aims: Many investigators have tested interventions to improve research participant understanding of information shared during the informed consent process, using a variety of methods and with mixed results. A valid criticism of most consent research is that studies are often conducted in simulated research settings rather than ongoing clinical studies. The present study rigorously tested two simple and easily adoptable strategies for presenting key consent information to participants eligible to enroll in six actual clinical trials (i.e. six parent studies). Methods: In collaboration with the study team from each parent study, we developed two consent interventions: a fact sheet and an interview-style video. The content of each of the intervention was based on the information shared in the consent form approved for each parent study. Participants were randomized to the standard consent process, or to one of the two interventions. Once exposed to the assigned consent mode, participants were asked to complete an assessment of understanding. The study was powered to determine whether those exposed to the fact sheet or video performed better on the consent assessment compared to those exposed to the standard consent. We also assessed participant satisfaction with the consent process. Results: A total of 284 participants were randomized to one of the three consent arms. Assessments of understanding were completed with a total of 273 participants from July 2017 to April 2019. Participants exposed to the video had better understanding scores compared to those exposed to the standard consent form process ( p value = 0.020). Participants were more satisfied with the video when compared to the standard consent. Participants who received the fact sheet did not achieve higher overall understanding or satisfaction scores when compared to the standard consent process. Conclusion: This randomized study of two novel consent interventions across six different clinical trials demonstrated a statistically significant difference in participant understanding based on overall scores among those exposed to the video intervention compared to those exposed to the standard consent.

scholarly journals Clinical Research: Comprehension of the Patient Information Leaflet and the Consent Form

2012 ◽  
Vol 46 (3) ◽  
pp. 122-125
Author(s):  
Nusrat Shafiq ◽  
Samir Malhotra
Keyword(s):  
Developing Countries ◽  
Informed Consent ◽  
Clinical Research ◽  
Patient Information ◽  
Research Process ◽  
Informed Consent Process ◽  
Patient Information Leaflet ◽  
Consent Form ◽  
Information Leaflet ◽  
Informed Consent Form

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.

Evaluating nurse understanding and participation in the informed consent process

2017 ◽  
Vol 26 (4) ◽  
pp. 1050-1061 ◽  
Author(s):  
Sydney A Axson ◽  
Nicholas A Giordano ◽  
Robin M Hermann ◽  
Connie M Ulrich
Keyword(s):  
Informed Consent ◽  
Medical Center ◽  
Academic Medical Center ◽  
The United States ◽  
Structured Interview ◽  
Informed Consent Process ◽  
Consent Process ◽  
Minimal Risk ◽  
Structured Interviews ◽  
Patient Comprehension

Background: Informed consent is fundamental to the autonomous decision-making of patients, yet much is still unknown about the process in the clinical setting. In an evolving healthcare landscape, nurses must be prepared to address patient understanding and participate in the informed consent process to better fulfill their well-established role as patient advocates. Research objective: This study examines hospital-based nurses’ experiences and understandings of the informed consent process. Research design: This qualitative descriptive study utilized a semi-structured interview approach identifying thematic concerns, experiences, and knowledge of informed consent across a selected population of clinically practicing nurses. Participants and research context: In all, 20 baccalaureate prepared registered nurses practicing in various clinical settings (i.e. critical care, oncology, medical/surgical) at a large northeastern academic medical center in the United States completed semi-structured interviews and a demographic survey. The mean age of participants was 36.6 years old, with a mean of 12.2 years of clinical experience. Ethical considerations: Participation in this study involved minimal risk and no invasive measures. This study received Institutional Review Board approval from the University of Pennsylvania. All participants voluntarily consented. Findings: The majority of participants (N = 19) believe patient safety is directly linked to patient comprehension of the informed consent process. However, when asked if nurses have a defined role in the informed consent process, nearly half did not agree (N = 9). Through this qualitative approach, three major nursing roles emerged: the nurse as a communicator, the nurse as an advocate, and the clerical role of the nurse. Discussion and conclusion: This investigation contributes to the foundation of ethical research that will better prepare nurses for patient engagement, advance current understanding of informed consent, and allow for future development of solutions. Nurses are at the forefront of patient–provider interactions and they are often presented opportunities to learn about and engage in the informed consent process.

Psychometric evaluation of the Informed Consent Process Scale in Chinese

2019 ◽  
Vol 26 (7-8) ◽  
pp. 2456-2466
Author(s):  
Shu Yu Chen ◽  
Shu-Chen Susan Chang ◽  
Chiu-Chu Lin ◽  
Qingqing Lou ◽  
Robert M Anderson
Keyword(s):  
Informed Consent ◽  
Clinical Research ◽  
Informed Consent Process ◽  
Chinese Version ◽  
Consent Process ◽  
Institutional Review Boards ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Informed Consent Form ◽  
Process Scale

Background: Informed consent is essential for the ethical conduct of clinical research and is a culturally sensitive issue. But, a measurable Chinese version of the scale to evaluate the informed consent process has not yet been explored in the existing literature. Research objectives: This study aimed to develop and psychometrically test the Chinese version of the Informed Consent Process Scale. Research design: Back-translation was conducted to develop the Chinese version of the questionnaire. A cross-sectional survey was administered, after which an exploratory factor analysis was conducted. Participants: We recruited a total of 375 participants who had experience in signing an informed consent form within the previous 3 years in Taiwan. Ethical considerations: This study was approved by two Institutional Review Boards and the autonomy of the participants was respected. Findings: The Chinese version of the Informed Consent Process Scale is composed of three factors with 23 items showing evidence of acceptable reliability and validity. Three major factors were extracted and labeled: Factor 1 – ‘Understanding of the research’, Factor 2 – ‘Trust and confidence’ and Factor 3 – ‘Doubt and uncertainty’. The three factors accounted for is 52.954 of the total variance with Cronbach’s α of .917. Discussion and conclusion: The finding corroborates previous studies showing that participants had too little understanding on the informed consent forms they signed and implied the need to clarify the critical points in clinical research. The psychometric results indicated good internal consistency and validity for this newly constructed instrument, and it was found worthy of conducting further testing and application.

Sign in / Sign up

Export Citation Format

Share Document