Articulating ‘free, prior and informed consent’ (FPIC) for engineered gene drives

Articulating ‘free, prior and informed consent’ (FPIC) for engineered gene drives
Research Articles
Dalton R. George, Todd Kuiken and Jason A. Delborne
Proceedings of the Royal Society B, 11 December 2019; 286 (1917)
Abstract
Recent statements by United Nations bodies point to free, prior and informed consent (FPIC) as a potential requirement in the development of engineered gene drive applications. As a concept developed in the context of protecting Indigenous rights to self-determination in land development scenarios, FPIC would need to be extended to apply to the context of ecological editing. Without an explicit framework of application, FPIC could be interpreted as a narrowly framed process of community consultation focused on the social implications of technology, and award little formal or advisory power in decision-making to Indigenous peoples and local communities. In this paper, we argue for an articulation of FPIC that attends to issues of transparency, iterative community-scale consent, and shared power through co-development among Indigenous peoples, local communities, researchers and technology developers. In realizing a comprehensive FPIC process, researchers and developers have an opportunity to incorporate enhanced participation and social guidance mechanisms into the design, development and implementation of engineered gene drive applications.

Knowledge, attitude, and practices regarding informed consent for research purposes among postgraduate resident doctors

Knowledge, attitude, and practices regarding informed consent for research purposes among postgraduate resident doctors
Original Research
Noopur Vyas, Pradeep Jadhav, Rohit Sane.
National Journal of Physiology Pharmacy and Pharmacology. 2020; 10(1): 54-58
[country of publication: India]
Open Access
Abstract
Background
Informed consent is an ethical and legal requirement for research involving human participants. Postgraduate (PG) residents are budding doctors who are in their interim phase of education and are engaged in thesis/research work, which mandates adequate knowledge of informed consent and regulatory guidelines. There exists paucity of data in literature on the informed consent process with regard to PG residents; therefore, this study was conducted to assess the knowledge, attitude, and practices (KAP) of informed consent among PG residents.
Aims and Objectives
The aim of the study was to assess the level of knowledge and attitude about the informed consent process and assess practices adopted by PG residents for research purposes.
Materials and Methods
It was a cross-sectional, observational and questionnaire-based study conducted from January 2018 to March 2018 at a tertiary care teaching hospital, Navi Mumbai. The study included PG residents of either sex pursuing specialty MD/MS courses. A validated KAP questionnaire was used to assess KAP of the informed consent process. Responses from the eligible participants were obtained and analyzed.
Results
A total of 100 PG residents participated; 39% of males and 61% of females. Overall, the knowledge score was high and attitude toward informed consent was average. However, 34% participants felt that witness is not necessary, 20% felt that once the patient participates, they should not be allowed to withdraw and few felt that on voluntary withdrawal, participants are not liable for further standard care and compensation. In practice, few participants failed to explain consent in the local language and neglected to take the signature of an impartial witness.
Conclusions
Overall, the KAP of informed consent among PG residents were adequate. Structured continuing medical education/workshops are necessary to advance informed consent practices.

Jordanians’ Perspectives On Open Consent In Biomedical Research

Jordanians’ Perspectives On Open Consent In Biomedical Research
Original Research
Nasr Alrabadi, Hanin Makhlouf, Omar F Khabour, Karem H Alzoubi
Risk Management and Healthcare Policy, 2 December 2019; 2019(12) pp 265—273
Introduction
The informed consent process is an integral step in biomedical research. However, the emergence of biobanks and the need for open consent (also called “broad” or “blanket” consent) create challenges to this process.
Aims and methodology
A survey was used to examine Jordanians’ perspectives on open consent and reuse of stored samples in future research.
Results
The majority of participants had positive perceptions of informed consent and its importance. In addition, they appreciated the challenges that are associated with multiple uses of their biospecimens. About 55% agreed to provide open consent for reuse of their donated biospecimens. Participants (75–80%) also agreed that issues such as the possibility of sharing samples with international research centers, storage duration, and use of biospecimens after their death should be clarified as part of open consent. The inconvenience of the re-contact process, trust in the research team, and the importance of biobanks were all associated with participants’ willingness to provide open consent (P<0.05). On the other hand, privacy and confidentiality, doubt about future use of samples, unknown storage period, and the possibility of cross-border sample sharing were significantly associated with participants’ reluctance to provide open consent.
Conclusion
The majority of Jordanians accept the idea of open consent. Clarification of issues such as international sample sharing, duration of storage, domains of intended research, confidentiality, and privacy can provide more support for the use of open consent.

 

Promoting informed consent in a children’s hospital in Tabriz, Iran: a best practice implementation project

Promoting informed consent in a children’s hospital in Tabriz, Iran: a best practice implementation project
Neda Kabiri, Sakineh Hajebrahimi, Gisoo Alizadeh, Solmaz Azimzadeh, Nayyereh Farajzadeh, Amin Talebpour
JBI Database of Systematic Reviews and Implementation Reports, December 2019; 17(12) pp 2570–2577
Abstract
Introduction 
Informed consent is a continuous and dynamic process. It is a crucial part of healthcare procedures that becomes more complex in a pediatric clinical practice, where parents must make decisions for their children.
Objectives
The aim of this implementation project was to evaluate the current practice and implement the best practice related to obtaining informed consent in a children’s hospital in Tabriz, Iran.
Methods
A clinical audit was undertaken using the JBI Practical Application of Clinical Evidence System (JBI PACES) tool. Five audit criteria representing the best-practice recommendations for informed consent were used. A baseline audit was conducted, followed by the implementation of multiple strategies. The project was finalized with a follow-up audit to determine change in practice.
Results
The compliance rate of all criteria improved from baseline to follow-up audit. Criteria 1 (obtaining informed consent prior to all nursing procedures) and 5 (provision of information related to the necessity of the treatment) reached 97% compliance in the follow-up cycle. Criterion 4 (provision of information related to the nature and effect of the treatment) achieved 74% compliance. Both criteria 2 and 3 (provision of information related to alternative treatments and consequences of refusing treatment) reached 57% in the follow-up cycle. To improve compliance, meetings were organized with the heads of departments, nurses and residents regarding informed consent. Also, staff were encouraged to report cases where informed consent was not obtained.
Conclusion
The audit results indicated an improvement in obtaining informed consent in the included departments. The interventions that were employed can facilitate the implementation of evidence into clinical practice.

The factors associated with maternal consent to human papillomavirus vaccination among adolescents in Israel

The factors associated with maternal consent to human papillomavirus vaccination among adolescents in Israel
Research Paper
Rana Shibli, Shmuel Rishpon
Human Vaccines & Immunotherapeutics, 24 Jul 2019
Abstract
Purpose
To evaluate the knowledge and attitudes toward the human papillomavirus (HPV) vaccine among mothers of 8th graders in Israel, and to determine the factors associated with maternal consent to the HPV vaccine.
Methods
We conducted a cross-sectional study among mothers of 8th grade students in 27 schools in Haifa and Northern districts of Israel during the 2016–17 school year. Data were collected using a structured telephone questionnaire.
Results
313 mothers answered the questionnaire (response rate = 91.8%). The mean knowledge level score was low (3.96 points [out of 10] ±2.68). Knowledge level was positively associated with Jewish nationality, being secular in religious practice and higher education. The attitude mean score was low-moderate (11.22 points [out of 18] ± 5.01). Attitude score was positively associated with Arab nationality. No significant association was found between knowledge level and attitudes. According to multivariate analysis, mothers’ consent to the HPV vaccine was associated with the knowledge level score (OR = 0.82; 95%CI 0.68–0.98), the attitude score (OR = 1.76; 95%CI 1.53–2.02) and nationality (OR = 27.86, 95%CI 3.41–227.56).
Conclusions
The knowledge level and attitudes toward the HPV vaccine were found to be unsatisfactory with racial disparities between Arabs and Jews. Jewish mothers compared with Arab mothers, mothers with a higher knowledge level or less positive attitudes were less likely to consent to the vaccine. These findings could contribute toward adapting programs to the different Israeli sectors in order to improve the rates of HPV vaccine receipt among adolescents.

What do patients want? Surgical informed‐consent and patient‐centered care – An augmented model of information disclosure

What do patients want? Surgical informed‐consent and patient‐centered care – An augmented model of information disclosure
Original Article
Gillie Gabay, Yaarit Bokek‐Cohen
Bioethics, 2 December 2019 
Abstract
The ideal moral standard for surgical informed‐consent calls upon surgeons to carry out a disclosure dialogue with patients so they have as full as possible an understanding of the procedure before they sign the informed‐consent form. This study is the first to empirically explore patient preferences regarding disclosure dialogue. Twelve Israelis who underwent life‐saving surgeries participated in a narrative study. Three themes emerged from the analysis: objectification of patients, anxiety provoking processes and information, and lack of information that was essential for patients. Findings contribute to existing debates among surgeons regarding the scope and importance of some disclosure components. Analysis led to our formulation of an augmented subjective model of information disclosure that participants prefer, which extends beyond the immediate present of the surgery to the period after discharge, and until return to routine. Surgeons should be aware of patient preferences in disclosure, and gaps between perceptions of surgeons, and preferences and needs of patients.

Perception and confidence of medical students in informed consent: A core EPA

Perception and confidence of medical students in informed consent: A core EPA
Tiffany N. Anderson, Lauren R. Aalami, Edmund W. Lee, Sylvia Bereknyei Merrell, Michael D. Sgroi, Dana T. Lin, James N. Lau
Surgery, 24 December 2019
Abstract
Background
Informed consent discussions have been identified as a core entrustable professional activity for medical students by the Association of American Medical Colleges. Medical students, however, rarely receive formal instruction on how to appropriately conduct informed consent discussions before residency, resulting in inconsistent levels of experience and deficiencies in performance. This study explores medical students’ understanding of the elements of informed consent discussions and their readiness to perform a comprehensive informed consent discussion.
Methods
Using expert consensus, cognitive interviews, and piloting, we iteratively developed a 15-item survey aligned with entrustable professional activity guidelines concerning informed consent discussions consisting of multiple choice, free text, and 5-point Likert-type questions. The instrument covered domains of experience, confidence, medical-legal knowledge, and recall of informed consent discussion elements. The full survey was distributed anonymously to undergraduate medical students at our institution. An abbreviated survey was administered to postgraduate students who were new interns at our institution. Responses were analyzed quantitatively using descriptive statistics. The free text data were coded for inclusion in this analysis.
Results
A total of 75 undergraduate medical students across all years responded (response rate [RR] = 86%), and 34 (RR = 77%) of the postgraduate students who were new interns participated. A total of 45 (75%) undergraduate medical students reported no training on informed consent discussions, and 9 (15%) undergraduate medical students had never witnessed an informed consent discussion. The undergraduate medical students agreed that informed consent discussions could be legally performed by residents and advance practice providers but were unsure whether the same applied to medical students. On a 5-point scale (anchored to “Not at all,” “Somewhat,” and “Extremely”), they were “somewhat confident” in their ability to perform an informed consent discussion. When asked to list the 7 elements of an informed consent discussion, 2 undergraduate medical students (3%) were able to identify all the elements. Although 3 undergraduate medical students (9%) had experience leading an informed consent discussion and 11 (32%) reported formal instruction in informed consent, the ability (3.7 ± 0.9 standard deviation [SD]) of the postgraduate students who were new interns to recall the 7 elements was similar to that of the undergraduate medical students (3.4 ± 1.2 SD); P = .31.
Conclusion
These findings suggest that undergraduate medical students and postgraduate students who are new interns are not confident or competent in their ability to perform an appropriate informed consent discussion. Our study findings support the creation of a needs-based, entrustable professional activity–aligned informed consent discussion teaching program and the need for an ongoing evaluation of the success of such a program.

Legal and Ethical Considerations for Radiology Procedural Consent [CHAPTER]

Legal and Ethical Considerations for Radiology Procedural Consent [CHAPTER]
Adrienne N. Dixon, Meghan Stepanek
Advanced Practice and Leadership in Radiology Nursing
Springer, 17 December 2019; pp 225-234
Abstract
This chapter will introduce readers to the legal and ethical principles of patient autonomy as well as the consenting process in the context of scenarios such as types of consents, capacity determination, communication, and liability risks.

Association Between the Communication Skills of Physicians and the Signing of Do-Not-Resuscitate Consent for Terminally Ill Patients in Emergency Rooms (Cross-Sectional Study)          

Association Between the Communication Skills of Physicians and the Signing of Do-Not-Resuscitate Consent for Terminally Ill Patients in Emergency Rooms (Cross-Sectional Study)          
Original Research
Chih-Hung Chen, Ya-Hui Cheng, Fen-Ju Chen, Eng-Yen Huang, Po-Ming Liu, Chia-Te Kung, Chao-Hui Su, Shu-Hwa Chen, Peng-Chen Chien, Ching-Hua Hsieh
Risk Management and Healthcare Policy, 11 December 2019; 12 pp 307—315
Abstract
Background

The signing of do-not-resuscitate (DNR) consent is mandatory in providing a palliative approach in the end-of-life care for the terminally ill patients and requires an effective communication between the physician and the patients or their family members. This study aimed to investigate the association between the communication skills of physicians who participated in the SHARE (supportive environment, how to deliver the bad news, additional information, reassurance, and emotional support) model course on the patient notification and the signing of do-not-resuscitate (DNR) consent by the terminally ill patients at emergency rooms.
Methods
Between May 1, 2017 and April 30, 2018, a total of 109 terminally ill patients were enrolled in this study, of which 70 had signed a DNR and 39 had not. Data regarding the patients’ medical records, a questionnaire survey completed by family members, and patient observation forms were used for the assessment of physicians’ communication skills during patient notification. The observation form was designed based on the SHARE model. A multivariate logistic regression model was applied to identify the independent significant factors of the patient and family member variables as well as the four main components of the observation form.
Results
The results revealed that knowing how to convey bad news and providing reassurance and emotional support were significantly correlated with a higher rate of signing DNR consent. Additionally, physician-initiated discussion with family members and a predicted limited life expectancy were negative independent significant factors for signing DNR consent.
Conclusion
This study revealed that good communication skills help to increase the signing of DNR consent. The learning of such skills from attendance of the SHARE model course is encouraged for the physicians in the palliative care of terminally ill patients in an emergency room.

Informed consent for anaesthesia: Presential or non-presential information?

Informed consent for anaesthesia: Presential or non-presential information?
Faura A, Izquierdo E, Escriche L, Nogué G, Videla S
Journal of Healthcare Quality Research, 21 Nov 2019
Abstract
Introduction
The anaesthesia informed consent (AIC) is a process of communication between a clinician and a patient that results in the patient agreeing to undergo a specific anaesthetic procedure after understanding all the information needed to make a free, voluntary and conscious decision. This information is traditionally given during a face-to-face pre-operative visit.
Objective
To evaluate patient perceptions when they receive the information about AIC, face-to-face or by phone.
Patients and Methods
A single centre, randomised, double-blind, parallel-group pilot clinical trial was conducted on patients > 18 years of age undergoing major ambulatory surgery procedures with a surgical complexity that did not require a face-to-face pre-operative visit. Patients were randomly assigned to be informed by telephone (experimental group) or in a face-to-face visit (control group). Fifteen days after the surgery a questionnaire was used to gather patient perceptions in understanding the anaesthetic procedure and risks, autonomy (to ask for explanations), as well as and satisfaction.
Results
Of the 160 patients that gave their consent, 142 were interviewed: 70 from the experimental group and 72 from the control group. Both groups were comparable in age, gender, anaesthetic risk, and surgical complexity. The percentage of patients that understood the information provided on the anaesthetic technique was 71% and 81%, respectively (P=.429); on its risks: 67% and 69% (P=.951); autonomy: 56% and 74% (P=.036) and satisfaction rate: 46% and 46% (P=.835).
Conclusion
There is no difference between the groups in the level of understanding of the information that the patient perceives and the level of satisfaction. Nevertheless, almost half of them did not remember to have been given the possibility to clear-up doubts.