Consent and Inclusion of People Living with Dementia (PLWD) in Research: Establishing a Canadian Agenda for Inclusive Rights-Based Practices

Consent and Inclusion of People Living with Dementia (PLWD) in Research: Establishing a Canadian Agenda for Inclusive Rights-Based Practices
Amanda Grenier, Deborah O’Connor, Krista James, Daphne Imahori, Daniella Minchopoulos, Nicole Velev, Laura Tamblyn-Watts, Jim Mann
Canadian Journal on Aging, 20 May 2024
Abstract
Background
People living with dementia (PLWD) may want to participate in research, but the guidelines and processes enacted across various contexts may prohibit this from happening.
Objective
Understanding the experiences of people with lived experiences of dementia requires meaningful inclusion in research, as is consistent with rights-based perspectives. Currently, the inclusion of PLWD in Canadian research is complex, and guidelines and conceptual frameworks have not been fully developed.
Methods
This research note outlines a three-year proof-of-concept grant on the inclusion and consent of PLWD in research.
Findings
It presents a brief report on some of the contradictions and challenges that exist in legislation, research guidelines, and research practices and raises a series of questions as part of an agenda on rights and inclusion of PLWD in research.
Discussion
It suggests conceptual, legal, and policy issues that need to be addressed and invites Canadian researchers to re-envision research practices and to advocate for law and policy reform that enables dementia research to align and respect the rights and personhood of PLWD.

Framework to elicit consent from lightly sedated mechanically ventilated intensive care patients in nursing practice

Framework to elicit consent from lightly sedated mechanically ventilated intensive care patients in nursing practice
Yoko Onishi, Yoshiko Murai, Emiko Nakajima
Japan Journal Of Nursing Science, 2 May 2024
Abstract
Aim
The study aimed to ascertain a framework of nursing practices to elicit consent from lightly sedated ventilated patients.
Methods
Study participants were nurses working in intensive care and critical care wards, whose observations and semi-structured interviews were assessed using a modified grounded theory approach.
Results
A total of 15 concepts were generated, from which three categories and three subcategories were generated. Category 1: Nurses taking the lead in providing assistance by sharing signs of change while continuing the invasive treatment, working to maintain the patient’s life, alleviation of pain, promotion of awareness of the current situation, and acclimating them to the treatment environment as the basis for building a relationship between patients and nurses. Category 2: Searching for points of agreement and reaching a compromise involves the nurse drawing out the patient’s thoughts, hopes, and expectations, and transforming the relationship into a patient-centered one by sharing goals with the patient in order to achieve them. Category 3: Organizing collaboration within care supported the patient’s ability to move safely while maintaining the patient’s pace to achieve shared goals, and guided the patient’s independent actions.
Conclusions
Even when patients recover from an acute life-threatening situation, their physical sensations remain vague and their functional decline continues. Rather than simply eliciting consent from patients, the structure of nursing practice to elicit such response from patients involves drawing out the patient’s thoughts, hopes, and expectations, as well as guiding the patient toward goals that they have created together with the nurse and utilizing the patient’s strengths to achieve these goals.

Exploring the consent process among pregnant and breastfeeding women taking part in a maternal vaccine clinical trial in Kampala, Uganda: a qualitative study

Exploring the consent process among pregnant and breastfeeding women taking part in a maternal vaccine clinical trial in Kampala, Uganda: a qualitative study
Research
Agnes Ssali, Rita Namugumya, Phiona Nalubega, Mary Kyohere, Janet Seeley, Kirsty Le Doare
BMC Medical Ethics, 16 May 2024
Open access
Abstract
Background
The involvement of pregnant women in vaccine clinical trials presents unique challenges for the informed consent process. We explored the expectations and experiences of the pregnant women, spouses/partners, health workers and stakeholders of the consent process during a Group B Streptococcus maternal vaccine trial.
Methods
We interviewed 56 participants including pregnant women taking part in the trial, women not in the trial, health workers handling the trial procedures, spouses, and community stakeholders. We conducted 13 in-depth interviews and focus group discussions with 23 women in the trial, in-depth interviews with 5 spouses, and 5 women not in the trial, key informant interviews with 5 health workers and 5 other stakeholders were undertaken.
Results
Decision-making by a pregnant woman to join a trial was done in consultation with spouse, parents, siblings, or trusted health workers. Written study information was appreciated by all but they suggested the use of audio and visual presentation to enhance understanding. Women stressed the need to ensure that their male partners received study information before their pregnant partners joined a clinical trial. Confidentiality in research was emphasised differently by individual participants; while some emphasised it for self, others were keen to protect their family members from being exposed, for allowing them to be involved in research. However, others wanted their community participation to be acknowledged.
Conclusion
We found that pregnant women make decisions to join a clinical trial after consulting with close family. Our findings suggest the need for an information strategy which informs not only the pregnant woman, but also her family about the research she is invited to engage in.

Please refer to the editor’s note regarding ‘Relational, Culturally-Conditioned, Decolonized Consent’ here.

The ethics of research informed consent from the Kyrgyz perspective: A qualitative study

The ethics of research informed consent from the Kyrgyz perspective: A qualitative study
Tamara Kudaibergenova
Developing World Bioethics, 14 May 2024
Abstract
To ensure informed consent is tailored to ethnic Asian communities, it is necessary to establish an ethical foundation that is relevant to the specific populations. We hypothesized that certain communitarian factors unique to traditional Kyrgyz culture may influence an individual’s decision to participate in research. Guided by Seedhouse’s (2005) Rational Field Theory, we conducted qualitative, in-depth interviews with cultural experts in Kyrgyzstan to identify the ethical foundations of decision-making for informed consent in Kyrgyz culture. The results indicate that Kyrgyz people have a distinctive decision-making style influenced by their nomadic culture and history, which values and prioritizes family integrity and reputation. These findings indicate that a multidimensional approach based on socio-cultural sensitivities is necessary to assess the appropriateness of consent procedures. We believe our results may have implications for revising the guidelines of local and regional research ethics committees in Kyrgyzstan and other Central Asian countries.

Please refer to the editors note regarding ‘Relational, Culturally-Conditioned, Decolonized Consent’ here.

Incorporating religious and cultural background: Patient informed consent in the era of acellular dermal matrix breast reconstruction

Incorporating religious and cultural background: Patient informed consent in the era of acellular dermal matrix breast reconstruction
J.A. Foppiani, E. Kim, K. Beltran, A. Hernandez Alvarez, I. Taritsa, M.J. Escobar-Domingo, D. Lee, K.A. Schuster, S. Terkonda, S.J. Lin, O. Ho
ESMO Open, May 2024; Volume 9, Supplement 4
Open Access
Background
Acellular Dermal Matrices (ADMs) have become an integral part of breast reconstruction. An additional level of informed consent may hinge on personal and cultural beliefs, especially concerning the source matrix. This study seeks to evaluate socio-cultural factors influencing patient decisions on ADM use, with the end goal of enhancing practice through better-informed consent and comprehension of patient values.
Methods
A survey of adult women in the U.S. and India was conducted via Amazon Mechanical Turk. Chi-squared tests were used to compare preferences across dietary and religious groups.
Results
645 complete responses were analyzed, with 12.2% from India and 87.8% from the USA. Predominantly, respondents were White (68.2%) or Asian (26.2%), with major religious affiliations being Christianity (68.4%) and Hinduism (23.7%). The most common dietary preferences were Vegetarian (36.2%), Omnivorous (27.9%), and Vegan (21.3%). Upon disclosing the composition of ADMs, 49 (6.5%) individuals changed their answers and opted against Human Cadaveric ADM; 82 (10.8%) against Bovine-derived ADM; 101 (13.3%) against Porcine-derived ADM; and 73 (9.6%) against Ovine-derived ADM. Both religion and diet type significantly impacted individuals’ decisions to forgo ADM usage upon understanding its composition (P <0.001), and also notably influenced their choices of ADM types (P = 0.024).
Conclusions
Disclosing ADM’s origin significantly impacted patient choices, and in some cases, shifted the patient’s opinion of potential choice. Thorough counseling of surgical preferences is a crucial component of patient care. The findings advocate for the importance of culturally sensitive discussions in improving healthcare equity in our diverse society.

Editor’s note: ESMO Open is published by the European Society for Medical Oncology.

Please refer to the editors note regarding ‘Relational, Culturally-Conditioned, Decolonized Consent’ here.

Relational, Culturally-Conditioned, Decolonized Consent 

Editor’s Note:

We recognize a growing literature which argues [in whole or in part] that norms requiring the individual, prior, free, express and informed consent of persons to be involved in research must accommodate notions which integrate terms such as ‘community-driven’, ‘decolonized’, or ‘culturally-appropriate’ and which insist that consent processes “prioritize local/indigenous values and protocols.” As an editorial policy, we have decided to group such literature together in this section of the digest.

More broadly, we recognize that this literature raises critically important issues around consent integrity. Our Center for Informed Consent Integrity is actively developing a position on this matter, mindful of core guidance in research involving human participants overall, and selected instruments such as the Universal Declaration on Bioethics and Human Rights [2005]which notes:

Article 12.  Respect for cultural diversity and pluralism
The importance of cultural diversity and pluralism should be given due regard. However, such considerations are not to be invoked to infringe upon human dignity, human rights and fundamental freedoms, nor upon the principles set out in this Declaration, nor to limit their scope.

We will keep readers advised of our progress. If you have an interest in participating in our working group, please contact Paige Fitzsimmons [paige.fitzsimmons@ge2p2global.org].

Knowledge, and Practice of Nurses regarding informed consent at Friendship Hospital in Sudan

Knowledge, and Practice of Nurses regarding informed consent at Friendship Hospital in Sudan
Zeinab Taha Ali Omer
Egyptian Journal of Health Care, June 2024
Abstract
Aim
To assess the knowledge and practice of nurses about informed consent at Friendship Hospital in Sudan.
Methods
A descriptive cross-sectional hospital-based methodology was used. A hundred nurses enrolled in a study as total coverage, and data were gathered using an interview questionnaire. SPSS version 22 was used to analyze the data.
Results
The study had A hundred participants, 69%Female making up most of the sample. The majority of participants age range between 35-39years. A large number of participants had 7-10 years of experience. Regarding the informed consent process, half of the participants (50%) reported that they had enough information about the informed consent process. Also, forty percent of participants informed the patients about the risks and complications of their planned treatment.
Conclusion
In conclusion, the study found that half of the participants knew the process of consent. Majority of participants were aware that mental status was an important indicator of the ability to consent.
Recommendations
The findings manifest the need for an efficient education program that concentrates on learning nurses about consent.

Readability and Comprehension of Anesthesia Informed Consent Forms in a Spanish County Hospital: An Observational Study

Readability and Comprehension of Anesthesia Informed Consent Forms in a Spanish County Hospital: An Observational Study
José Manuel García-Álvarez, Alfonso García-Sánchez
Nursing Reports, 24 May 2024; 14(2) pp 1338-1352
Abstract
Background
The wording of informed consent forms could hinder their comprehension and hinder patients’ autonomous choice. The objective of this study was to analyze the readability and comprehension of anesthesia informed consent forms in a Spanish county hospital.
Methods
Descriptive and cross-sectional study carried out on patients who were going to undergo anesthetic techniques. The readability of the forms was analyzed using the INFLESZ tool and their subjective comprehension using an ad hoc questionnaire.
Results
The analyzed forms presented a “somewhat difficult” legibility. A total of 44.2% of the patients decided not to read the form, mainly because they had previously undergone surgery with the same anesthetic technique. The language used in the forms was considered inadequate by 49.5% of the patients and 53.3% did not comprehend it in its entirety. A statistically significant negative correlation of age and INFLESZ readability score with the overall questionnaire score was found. A statistically significant association was observed as a function of age and educational level with the different criteria of the questionnaire.
Conclusions
The anesthesia informed consent forms presented low readability with limited comprehension. It would be necessary to improve their wording to favor comprehension and to guarantee patients’ freedom of choice.

Prevalence of different variations of non-consented care during the childbirth process in Mexico by geographical regions: comparing ENDIREH survey data from 2016 to 2021

Prevalence of different variations of non-consented care during the childbirth process in Mexico by geographical regions: comparing ENDIREH survey data from 2016 to 2021
Research
Marian Marian, Kathryn M. Barker, Elizabeth Reed, Amanda C. McClain, Rebecka Lundgren, Samantha Hurst, Ramona L. Pérez
BMC Pregnancy and Childbirth, 13 May 2024
Open Access
Abstract
Introduction
Non-consented care, a form of obstetric violence involving the lack of informed consent for procedures, is a common but little-understood phenomenon in the global public health arena. The aim of this secondary analysis was to measure the prevalence and assess change over time of non-consented care during childbirth in Mexico in 2016 and 2021, as well as to examine the association of sociodemographic, pregnancy-, and childbirth-factors with this type of violence.
Methods
We measured the prevalence of non-consented care and three of its variations, forced sterilization or contraception, forced cesarean section, and forced consent on paperwork, during childbirth in Mexico for 2016 (N = 24,036) and 2021 (N = 19,322) using data from Mexico’s cross-sectional National Survey on the Dynamics of Household Relationships (ENDIREH). Weighted data were stratified by geographical regions. We performed adjusted logistic regression analyses to explore associations.
Results
The national prevalence of non-consented care and one of its variations, pressure to get a contraceptive method, increased from 2016 to 2021. A decrease in the prevalence was observed for forced contraception or sterilization without knowledge, forcing women to sign paperwork, and non-consented cesarean sections nationally and in most regions. Women between the ages of 26 and 35 years, married, cohabiting with partner, living in urban settings, who do not identify as Indigenous, and who received prenatal services or gave birth at the Mexican Institute of Social Security (IMSS) facilities experienced a higher prevalence of non-consented care. Being 26 years of age and older, living in a rural setting, experiencing stillbirths in the last five years, having a vaginal delivery, receiving prenatal services at IMSS, or delivering at a private facility were significantly associated with higher odds of reporting non-consented care.
Conclusion
While a decrease in most of the variations of non-consented care was found, the overall prevalence of non-consented care and, in one of its variations, pressure to get contraceptives, increased at a national and regional level. Our findings suggest the need to enforce current laws and strengthen health systems, paying special attention to the geographical regions and populations that have experienced higher reported cases of this structural problem.

Informed Consent in Clinical Studies in the Republic of Srpska

Informed Consent in Clinical Studies in the Republic of Srpska
Snežana Pantović, Dijana Zrnić
Review of European and Comparative Law, 6 May 2024
Abstract
As human medicine is developing at a galloping pace, continuously offering new medical products, diagnostic methods and preventive programmes, there is almost no time gap between their creation and application in medical practice. All these biomedical achievements are primarily intended to improve public health and the patient’s quality of life and health. Hence, it is important to define potential risks, side effects, and unwanted outcomes when applying a medical product/treatment before integrating it into healthcare. Unlike any other product/treatment intended for human use, medical products/treatments require prior clinical testing on human subjects (sick or sound). The authors of this paper have restricted their scientific interest to the participant (human subject) of a clinical study as one of the core elements of a clinical investigation, representing at the same time its means and its aim. By analyzing relevant international as well as national legal rules and ethical principles of the Republic of Srpska related to the participation of humans in clinical studies, it will be concluded that the participants’ safety and right to self-determination, integrity, and autonomy manifested through their independent right to either consent or refuse to participate in a clinical study supersedes the interests of science or society. However, clinical trial-related statistical data obtained from randomly chosen healthcare institutions in the Republic of Srpska will show certain derogations from prescribed ethical policies. Considering this fact, the authors have paid special attention to thematising the ethicality of recruiting participants for a clinical study based on partial or no information related to the purpose, methods, potential risks and side effects of the investigation in the name of the greater good for humanity. Such practice has accentuated the discretionary powers of ethical review committees on the one side and the uncertainty of the right to informed consent on the other.

Editor’s note: The Republic of Sprska is one of the two entities of Bosnia and Herzegovina.