Informed Consent in Clinical and Research Settings: What Do Patients and Families Need to Make Informed Decisions?

2015 ◽  
Vol 24 (4) ◽  
pp. 130-139 ◽  
Author(s):  
Helen M. Sharp
Keyword(s):  
Informed Consent ◽  
Family Members ◽  
Cognitive Disorders ◽  
Informed Consent Process ◽  
Consent Process ◽  
Clinical Settings ◽  
Risks And Benefits ◽  
Suboptimal Outcome ◽  
Research Environments ◽  
The Impact

Informed consent requires that patients in clinical settings and participants in research voluntarily agree to a proposed plan based on their understanding of a clear and thorough explanation of purpose, risks, benefits, and alternatives. Although the need to obtain informed consent is well understood in clinical and research environments, the evidence suggests that patients, family members, and participants in research are often unclear about options, risks, and benefits even after providing “informed” consent. Individuals with communication or cognitive disorders are at particular risk for a suboptimal outcome of the informed consent process. There are many barriers to achieving true informed consent, but the use of appropriate strategies can minimize the impact of these barriers and allow clinicians and researchers to improve the process of achieving true informed consent.

Survey of risks and benefits communication strategies by research nurses

2017 ◽  
Vol 26 (3) ◽  
pp. 937-950 ◽  
Author(s):  
Lika Nusbaum ◽  
Brenda Douglas ◽  
Neenah Estrella-Luna ◽  
Michael Paasche-Orlow ◽  
Karla Damus
Keyword(s):  
Informed Consent ◽  
Research Question ◽  
Role Playing ◽  
Informed Consent Process ◽  
Consent Process ◽  
Attitudes And Practices ◽  
Work Related ◽  
Risks And Benefits ◽  
Research Nurses ◽  
And Training

Background: An ethical, informed consent process requires that potential participants understand the study, their rights, and the risks and benefits. Yet, despite strategies to improve communication, many participants still lack understanding of potential risks and benefits. Investigating attitudes and practices of research nurses can identify ways to improve the informed consent process. Research question: What are the attitudes, practices, and preparedness of nurses involved in the informed consent process regarding communication of risks and benefits? Research design: A survey was developed and administered online to a national purposive sample of 107 research nurses with experience obtaining informed consent for clinical trials. Survey responses stratified by selected work-related characteristics were analyzed. Ethical considerations: Participants were instructed they need not answer each question and could stop at any time. They consented by clicking “accept” on the email which linked to the survey. The study was approved by the Northeastern University Institutional Review Board, Boston, Massachusetts (NU-IRB Protocol #: 13-06-17). Findings: Most research nurses (87%) used a teach-back method to assess participant comprehension, while 72% relied on their intuition. About one-third did not feel prepared to communicate related statistics. About 20% did not feel prepared to tailor information, and half did not feel competent using supplemental materials to enhance risks and benefits comprehension. Only 70% had received training in the informed consent process which included in-person training (84%), case studies (69%), online courses (57%), feedback during practice sessions (54%), and simulation, such as role playing (49%) and viewing videos (45%). Perceived preparedness was significantly associated with greater informed consent experience and training. Conclusion: Research nurses may have inadequate training to encourage, support, and reinforce communication of risks and benefits during the informed consent process. Relevant purposeful education and training should help to improve and standardize the ethical informed consent process.

Ethics and ego dissolution: the case of psilocybin

2020 ◽  
pp. medethics-2020-106070 ◽  
Author(s):  
William R Smith ◽  
Dominic Sisti
Keyword(s):  
Substance Use ◽  
Informed Consent ◽  
Symptom Relief ◽  
Informed Consent Process ◽  
Consent Process ◽  
Ethical Considerations ◽  
Medical Treatments ◽  
Early Phase Trials ◽  
Research Environments ◽  
Key Issues

Despite the fact that psychedelics were proscribed from medical research half a century ago, recent, early-phase trials on psychedelics have suggested that they bring novel benefits to patients in the treatment of several mental and substance use disorders. When beneficial, the psychedelic experience is characterized by features unlike those of other psychiatric and medical treatments. These include senses of losing self-importance, ineffable knowledge, feelings of unity and connection with others and encountering ‘deep’ reality or God. In addition to symptom relief, psychedelic experiences often lead to significant changes in a patient’s personality and worldview. Focusing on the case of psilocybin, we argue that the peculiar features of psychedelics pose certain novel risks, which warrant an enhanced informed consent process–one that is more comprehensive than what may be typical for other psychiatric medications. We highlight key issues that should be focused on during the consent process and suggest discussion prompts for enhanced consent in psychedelic psychiatry. Finally, we respond to potential objections before concluding with a discussion of ethical considerations that will arise as psychedelics proceed from highly controlled research environments into mainstream clinical psychiatry.

The practice of obtaining informed consent for elective surgery and anesthesia from patients’ perspective: An institutional based cross-sectional study

2021 ◽  
pp. 147775092199428
Author(s):  
Tadese Tamire ◽  
Aragaw Tesfaw
Keyword(s):  
Informed Consent ◽  
Elective Surgery ◽  
Healthcare Providers ◽  
Cross Sectional Study ◽  
Informed Consent Process ◽  
Consent Process ◽  
Sectional Study ◽  
Cross Sectional ◽  
Risks And Benefits ◽  
To Receive

Introduction Informed consent is a body of shared decision-making process and voluntary authorization of patients to receive medical or surgical intervention. There are limited studies conducted so far to examine the practice of informed consent in Ethiopia. This study aimed to assess the practice of informed consent process for surgery and Anesthesia. Method A cross-sectional study was conducted from March to May 2019. The data were collected using interviewer-administered structured questionnaire and analyzed in SPSS version 23. Results A total of 139 patients were interviewed in this study. Most 42(30.2%) of patients were in the age group of 29–38 years. Nearly half 68 (48.9%) of the patients were informed the benefits of the surgical procedure and 78(56.1%) of the patients were informed on the type of anesthesia to be administered while 65 (46.8%) were not informed on any complication related to the anesthesia. About 66 (47.5%) of patients were informed on alternatives to the surgery. Of these patients, 39(59%) were not informed of any benefits and possible risks associated with the alternative modes of treatment. About half (54%) of the patients were reported as they were understood the information provided during the pre-operative informed consent process. Conclusion This research revealed that patients were inadequately informed on the complications of proposed procedure, alternative forms of treatment, risks and benefits of the proposed procedure. Therefore, healthcare providers should provide adequate information regarding the proposed procedure and make sure whether patients understood the risks and benefits before the consent.

The Impact of the Informed Consent Process on the Anxiety Levels of Patients Undergoing Rhinoplasty

2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Abdulhalim Aysel ◽  
Uzdan Uz ◽  
Berrak Karatan ◽  
Enes Aydin ◽  
Esin Erdoğan ◽  
...  
Keyword(s):  
Informed Consent ◽  
Informed Consent Process ◽  
Consent Process ◽  
Anxiety Levels ◽  
The Impact

scholarly journals Communicating Risks and Benefits in Informed Consent for Research: A Qualitative Study

2017 ◽  
Vol 4 ◽  
pp. 233339361773201 ◽  
Author(s):  
Lika Nusbaum ◽  
Brenda Douglas ◽  
Karla Damus ◽  
Michael Paasche-Orlow ◽  
Neenah Estrella-Luna
Keyword(s):  
Informed Consent ◽  
Informed Consent Process ◽  
Consent Process ◽  
Research Staff ◽  
Research Participants ◽  
Risks And Benefits ◽  
Successful Communication ◽  
Communication Practices ◽  
And Training

Multiple studies have documented major limitations in the informed consent process for the recruitment of clinical research participants. One challenging aspect of this process is successful communication of risks and benefits to potential research participants. This study explored the opinions and attitudes of informed consent experts about conveying risks and benefits to inform the development of a survey about the perspectives of research nurses who are responsible for obtaining informed consent for clinical trials. The major themes identified were strategies for risks and benefits communication, ensuring comprehension, and preparation for the role of the consent administrator. From the experts’ perspective, inadequate education and training of the research staff responsible for informed consent process contribute to deficiencies in the informed consent process and risks and benefits communication. Inconsistencies in experts’ opinions and critique of certain widely used communication practices require further consideration and additional research.

scholarly journals An evaluation of the process of informed consent: views from research participants and staff

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lydia O’ Sullivan ◽  
Laura Feeney ◽  
Rachel K. Crowley ◽  
Prasanth Sukumar ◽  
Eilish McAuliffe ◽  
...  
Keyword(s):  
Informed Consent ◽  
Research Study ◽  
Contextual Factors ◽  
Informed Consent Process ◽  
Small Sample ◽  
Consent Process ◽  
Online Research ◽  
Research Staff ◽  
Research Participants ◽  
The Impact

Abstract Background The process of informed consent for enrolment to a clinical research study can be complex for both participants and research staff. Challenges include respecting the potential participant’s autonomy and information needs while simultaneously providing adequate information to enable an informed decision. Qualitative research with small sample sizes has added to our understanding of these challenges. However, there is value in garnering the perspectives of research participants and staff across larger samples to explore the impact of contextual factors (time spent, the timing of the discussion and the setting), on the informed consent process. Methods Research staff and research participants from Ireland and the UK were invited to complete an anonymous survey by post or online (research participants) and online (research staff). The surveys aimed to quantify the perceptions of research participants and staff regarding some contextual factors about the process of informed consent. The survey, which contained 14 and 16 multiple choice questions for research participants and staff respectively, was analysed using descriptive statistics. Both surveys included one optional, open-ended question, which were analysed thematically. Results Research participants (169) and research staff (115) completed the survey. Research participants were predominantly positive about the informed consent process but highlighted the importance of having sufficient time and the value of providing follow-up once the study concludes, e.g. providing results to participants. Most staff (74.4%) staff reported that they felt very confident or confident facilitating informed consent discussions, but 63% felt information leaflets were too long and/or complicated, 56% were concerned about whether participants had understood complex information and 40% felt that time constraints were a barrier. A dominant theme from the open-ended responses to the staff survey was the importance of adequate time and resources. Conclusions Research participants in this study were overwhelmingly positive about their experience of the informed consent process. However, research staff expressed concern about how much participants have understood and studies of patient comprehension of research study information would seem to confirm these fears. This study highlights the importance of allocating adequate time to informed consent discussions, and research staff could consider using Teach Back techniques. Trial Registration Not applicable

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.

The impact of disease severity on the informed consent process in clinical research

1996 ◽  
Vol 100 (3) ◽  
pp. 261-268 ◽  
Author(s):  
Monica H. Schaeffer ◽  
David S. Krantz ◽  
Alison Wichman ◽  
Henry Masur ◽  
Eddie Reed ◽  
...  
Keyword(s):  
Informed Consent ◽  
Clinical Research ◽  
Disease Severity ◽  
Informed Consent Process ◽  
Consent Process ◽  
The Impact

scholarly journals PO 8194 OPTIMISED INFORMED CONSENT FOR PARTICIPANTS IN A RANDOMISED CONTROLLED TRIAL IN RURAL UGANDA: A COMPARATIVE PROSPECTIVE COHORT STUDY

2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A22.1-A22
Author(s):  
James Ditai ◽  
Jesca Kanyago ◽  
Rachael Nambozo ◽  
Nathan Kanyago ◽  
Julian Abeso ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Informed Consent ◽  
Controlled Trial ◽  
Informed Consent Process ◽  
African Women ◽  
Consent Process ◽  
Research Information ◽  
Slide Show ◽  
Randomised Controlled ◽  
The Impact

BackgroundPoor participant understanding of research information can be a problem in community interventional studies in rural African women where levels of illiteracy, dependency and compliance are high. We assessed the impact of alternative consent models on participants’ understanding of the clinical trial information and its contribution to the informed consent process in rural Uganda.MethodsThis was a prospective comparative cohort, nested within a pilot study of community distribution of alcohol-based hand rub to prevent neonatal sepsis (BabyGel). As part of the informed consent process, information about the trial was presented using one of three consent methods: standard researcher-read information; a ‘slide show’ using illustrated text on a flip chart; and a video showing the patient information sheet (PIS) being read as if by a newsreader in either English or the local language. In addition, all women received a written PIS in their preferred language. Each information method was used for 1 week of recruitment. Two days after recruitment, women’s understanding of the clinical trial was evaluated.ResultsA total of 30 pregnant women from 13 villages in Mbale participated in this study. Majority 90% (27/30) were assessed for recall of trial information within planned 48 hours. The slide-show was the most popular, with a mean score not less than 4.2 highest [mean (sd) range: 4.8 (0.6) [4–5]] by women who had been recruited using any of the three models. The slide show was preferred by 63% of the women (19/30), compared with 17% (5/30) and 20% (6/30) who preferred the standard and video show message, respectively. Reasons given included the benefits of having pictures to aid understanding, and the logical progression of the information.ConclusionOur results suggest that a slide-show message is an effective and popular alternative way of presenting trial information to women in rural Uganda, many of whom had little or no literacy.

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