scholarly journals A qualitative exploration of the informed consent process in hematopoietic cell transplantation clinical research and opportunities for improvement

2016 ◽  
Vol 52 (2) ◽  
pp. 292-298 ◽  
Author(s):  
M Raj ◽  
S W Choi ◽  
J Platt
Keyword(s):  
Informed Consent ◽  
Clinical Research ◽  
Cell Transplantation ◽  
Hematopoietic Cell Transplantation ◽  
Informed Consent Process ◽  
Hematopoietic Cell ◽  
Consent Process ◽  
Qualitative Exploration

Obtaining Patient Informed Consent (IC) for Hematopoietic Cell Transplantation. How Much Information Is Enough?.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 2189-2189
Author(s):  
Ariadni Hotidou ◽  
Charalambos Kartsios ◽  
Ioanna Sakellari ◽  
Panagiotis Kaloyiannidis ◽  
Athanasios Fassas ◽  
...  
Keyword(s):  
Informed Consent ◽  
Side Effects ◽  
Cell Transplantation ◽  
Hematopoietic Cell Transplantation ◽  
Hematopoietic Cell ◽  
Consent Process ◽  
Individual Autonomy ◽  
Risks And Benefits ◽  
Numeric Data ◽  
The Impact

Abstract Introduction: Importance of the IC process emerges from the respect of individual autonomy and the right to self-determination. Beyond being informed, consent involves evaluating, making and signifying a decision. Hematopoietic cell transplantation (HCT) is a complex therapeutic option of “last resort” requiring patients’ full understanding and approval. Candidates shall sign detailed documents describing potentially lethal complications and percentages of survival and cure, before HCT. Objectives-Methods: One hundred twenty post-HCT patients were studied after giving IC. They answered a questionnaire and participated in semi-structured interviews focusing on their experience of consent process. Our aim was to evaluate: a) patients’ comprehension, perception and impact of the IC process, b) the degree to which they assimilated purposes, risks and benefits of transplantation, c) factors influencing patients’ decision to proceed with HCT, d) patient’s psychological status at the time of giving IC. Results: IC was considered as an important medico-legal aspect of HCT by 82% of the population. The transition from informal verbal agreement to a formal written contract implied an important psychological impact for the patient. Significant distress occurred by detailed descriptions of potential side effects and mortality. The awareness of only hope of cure centered patient’s attention negatively on numeric data regarding death risks and survival. Discordance was showed between pre-HCT expectations and actual outcomes. Consent process failed to prepare patients for the post-HCT difficulties of recovery. Patients indicated insufficient provision of information regarding the impact of HCT in their quality of life. Patients made the decision to undergo HCT prior to possessing any substantial knowledge of risks and benefits of the procedure. Decision was largely based on positive outcome expectation. HCT was valued as a cure and therefore this belief determined their decision. Degree of comprehension depended on age, emotional resources, educational level, familial relationships and physician’s personality. Conclusions: Despite patients’ claim to understand important information regarding HCT (treatment risks, side effects, outcome probabilities) IC resulted in confusion and anxiety. Considerable distress occurred by detailed descriptions of potential side effects and mortality. Numeric data was proven useless and seriously altered the physician-patient interaction. Providing details of risks and benefits during the IC process may have little impact on the patients’ decision-making. Patient’s life-threatening illness and limitations on treatment options alter the voluntary nature of their decision. IC has little significance to the patient in terms of his autonomous decision to proceed with treatment. Patient’s continuing education is critical and can help HCT candidates to accept what to expect at different stages of treatment. Comprehensiveness of HCT information is a cognitive, emotional and relational procedure demanding appropriate approach to be successful. Providing information is required at every stage of the HCT procedure and has great importance for the development of a trusting relationship with doctors. Accurate counseling empowers patients to make informed decisions. The findings of the present study give implications for clinical practice and for further research.

scholarly journals Regulatory developments in the conduct of clinical trials in India

2016 ◽  
Vol 1 ◽  
Author(s):  
R. Roy Chaudhury ◽  
D. Mehta
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Clinical Research ◽  
Supreme Court ◽  
Large Scale ◽  
Ethics Committees ◽  
Informed Consent Process ◽  
Consent Process ◽  
Regulatory Institutions ◽  
Indian Supreme Court

There has been a drop in clinical research in India following stringent conditions put in place by the Indian Supreme Court in 2013. The Court's orders came in the wake of irregularities highlighted in the conduct of clinical trials in the country. This paper highlights the steps taken by the Indian regulator, the Central Drugs Standard Control Organisation to comply with these directions. These are of three kinds: strengthening regulatory institutions, protecting participant safety and creating regulatory certainty for sponsors and investigators. Examples include the large-scale training of Ethics Committees, framing detailed guidelines on compensation and audiovisual recording of the informed consent process, as well as reducing the time taken to process applications. It is expected that these measures will inspire confidence for the much-needed resumption of clinical research.

scholarly journals Easy-to-Read Informed Consent Forms for Hematopoietic Cell Transplantation Clinical Trials

2012 ◽  
Vol 18 (2) ◽  
pp. 183-189 ◽  
Author(s):  
Ellen M. Denzen ◽  
Martha E. Burton Santibáñez ◽  
Heather Moore ◽  
Amy Foley ◽  
Iris D. Gersten ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Cell Transplantation ◽  
Hematopoietic Cell Transplantation ◽  
Hematopoietic Cell ◽  
Consent Forms

scholarly journals Facilitating The Informed Consent Process Using Teleconsent: A Study Protocol (Preprint)

2018 ◽  
Author(s):  
Saif Khairat ◽  
Paige Ottmar ◽  
Christina Smith ◽  
Betsy Sleath ◽  
Brandon Welch ◽  
...  
Keyword(s):  
Clinical Trials ◽  
South Carolina ◽  
Informed Consent ◽  
Rural Communities ◽  
Clinical Research ◽  
Phase 1 ◽  
Informed Consent Process ◽  
Consent Process ◽  
University Of South Carolina ◽  
Novel Approach

BACKGROUND Informed consent is among the biggest challenges in recruiting participants for clinical research studies. Researchers face many challenges in conducting clinical trials, some of which include budgetary restrictions, lack of trained personnel, and difficulty recruiting study participants--particularly minorities and participants from rural communities. OBJECTIVE The objective of this study is to utilize telemedicine to improve the informed consent process for the clinical trials and studies. METHODS This study will be conducted separately yet concurrently at two institutions, the Medical University of South Carolina (MUSC) and the University of North Carolina at Chapel Hill (UNC), in order to compare results both within and across institutions. RESULTS Enrollment for Phase 1 began in March of 2018 and concluded in May 2018. Data transcription and analysis will be conducted through June and September of 2018. CONCLUSIONS In this paper, we present a novel approach to conducting the informed consent using a new telemedicine modality namely, teleconsent. Teleconsent presents the ability to conduct a live interaction among clinical research coordinators and potential participants while synchronously presenting the consent form on the screen and obtaining participant’s signature through doxy.me, the teleconsent system. The aim of this research is to assess the feasibility and efficacy of the teleconsent intervention among residents in urban and rural settings. Teleconsent provides potential to improve obtaining informed consent from potential clinical trial participants.

scholarly journals Digital tools in the Informed Consent process: a systematic review

2021 ◽  
Author(s):  
Gesualdo Francesco ◽  
Margherita Daverio ◽  
Laura Palazzani ◽  
Dimitris Dimitriou ◽  
Javier Diez Domingo ◽  
...  
Keyword(s):  
Systematic Review ◽  
Informed Consent ◽  
Clinical Research ◽  
Surgical Procedures ◽  
Interactive Multimedia ◽  
Digital Technologies ◽  
Informed Consent Process ◽  
Digital Tools ◽  
Consent Process ◽  
Positive Effect

Abstract Background: Providing understandable information to patients is necessary to achieve the aims of the Informed Consent process: respecting and promoting patients’ autonomy and protecting patients from harm. In recent decades, new, primarily digital, technologies have been used to apply and test innovative formats of Informed Consent. We conducted a systematic review to explore the impact of using digital tools for Informed Consent in both clinical research and in clinical practice.. Understanding, satisfaction and participation were compared for digital tools versus the non-digital Informed Consent process.Methods: We searched for studies on available electronic databases, including Pubmed, EMBASE, and Cochrane. Studies were identified using specific Mesh-terms/keywords. We included studies, published from January 2012 to October 2020, that focused on the use of digital Informed Consent tools for clinical research, or clinical procedures. Digital interventions were defined as interventions that used multimedia or audio-video to provide information to patients. We classified the interventions into 3 different categories: video only, non-interactive multimedia, and interactive multimedia.Results: Our search yielded 19,579 publications. After title and abstract screening 100 studies were retained for full-text analysis, of which 73 publications were included. Studies examined interactive multimedia (29/73), non-interactive multimedia (13/73), and videos (31/73), and most (34/38) studies were conducted on adults. Innovations in consent were tested for clinical/surgical procedures (26/38) and clinical research (12/38). For research IC, 21 outcomes were explored, with a positive effect on at least one of the studied outcomes being observed in 8/12 studies. For clinical/surgical procedures 49 outcomes were explored, and 21/26 studies reported a positive effect on at least one of the studied outcomes. Conclusions: Digital technologies for informed consent were not found to negatively affect any of the outcomes, and overall, multimedia tools seem desirable. Multimedia tools indicated a higher impact than videos only. Presence of a researcher may potentially enhance efficacy of different outcomes in research IC processes. Studies were heterogeneous in design, making evaluation of impact challenging. Robust study design including standardization is needed to conclusively assess impact. Trial registration: NA

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