Pre-post implementation survey of a multicomponent intervention to improve informed consent for caesarean section in Southern Malawi
Original Research
Siem Zethof, Wouter Bakker, Felix Nansongole, Kelvin Kilowe, Jos van Roosmalen, Thomas van den Akker
BMJ Open, 6 January 2020
Open Access
Abstract
Objective Surgical informed consent is essential prior to caesarean section, but potentially compromised by insufficient communication. We assessed the association between a multicomponent intervention and women’s recollection of information pertaining to informed consent for caesarean section in a low-resource setting, thereby contributing to respectful maternity care.
Design
Pre-post implementation survey, conducted from January to June 2018, surveying women prior to discharge.
Setting
Rural 150-bed mission hospital in Southern Malawi.
Participants
A total of 160 postoperative women were included: 80 preimplementation and 80 postimplementation.
Intervention
Based on observed deficiencies and input from local stakeholders, a multicomponent intervention was developed, consisting of a standardised checklist, wall poster with a six-step guide and on-the-job communication training for health workers.
Primary and secondary outcome measures
Individual components of informed consent were: indication, explanation of procedure, common complications, implications for future pregnancies and verbal enquiry of consent, which were compared preintervention and postintervention using χ2 test. Generalised linear models were used to analyse incompleteness scores and recollection of the informed consent process.
Results
The proportion of women who recollected being informed about procedure-related risks increased from 25/80 to 47/80 (OR 3.13 (95% CI 1.64 to 6.00)). Recollection of an explanation of the procedure changed from 44/80 to 55/80 (OR 1.80 (0.94 to 3.44)), implications for future pregnancy from 25/80 to 47/80 (1.69 (0.89 to 3.20)) and of consent enquiry from 67/80 to 73/80 (OR 2.02 (0.73 to 5.37)). After controlling for other variables, incompleteness scores postintervention were 26% lower (Exp(β)=0.74; 95% CI 0.57 to 0.96). Recollection of common complications increased with 0.25 complications (β=0.25; 95% CI 0.01 to 0.49). Recollection of the correct indication did not differ significantly.
Conclusion
Recollection of informed consent for caesarean section changed significantly in the postintervention group. Obtaining informed consent for caesarean section is one of the essential components of respectful maternity care.

Assent and consent in adolescent research: teachers’ perspectives from a developing country
Research Article
Mahmoud A. Alomari, Nihaya A. Al-sheyab, Omar F. Khabour, Karem H. Alzoubi
Heliyon, January 2020; 6(1)
Open Access
Abstract
Teachers play a vital role in facilitating research in schools. However, teachers’ views of informed consent/assent for children participation in research in the Middle East have not been investigated. In this study, focus group interviews were conducted to understand high-school teachers’ perspectives toward adolescent assents and consents. The teachers indicated that parent consent is important and should be coupled with sufficient information about the research study. The teachers added that assent is most important for children above 13 years old. Conversely, the teachers believed that parent approval is only important for invasive (such as research involves blood withdrawal) but not simple procedures. Most importantly, for procedures that are considered simple, part of the teachers do not acknowledge the significance of parental approval, such as body weight, or beneficial, such as new treatment. The results indicate that some of the teachers’ views were consistent with proper conduction of pediatric research. However, other views were worrisome and might warrant further studies and actions. Risks related need to be assessed and policies needs to be developed in order to ensure the proper conduction of pediatric research.

Medical Informed Consent in India: Blind Leading the Blind
Review article
Sareen R
Journal of Community Medicine and Health Research, 4 December 2019; 1(3)
Open Access
Abstract
This work is an endeavor to enable health care workers to understand the significance of ‘consent in medical treatment in India’. There have been increased litigations in recent years in health care therefore it is prudent to respect patient autonomy and refrain from too harsh medical paternalistic attitude. The Bolam test has been the yard stick for determining Medical negligence and it is also relevant in terms of consent for medical treatment. The landmark judgment by apex court in India emphasized on role of consent, absence of which shall be considered as deficiency of medical services actionable under tort. As the developed nations move towards ‘Informed consent’ we in India have a long way to go with rampant illiteracy, poor socioeconomic strata and limited resources it is like a dream. The review focuses on hurdles in the informed consenting process as well as the mandatory bare minimum requirements in Indian Law.

The Landscape of the Legal Aspects of Informed Consent for Medical Treatment in Papua New Guinea
Alfred P. Minei, Rachelyn Ann S. Araña, Ronald R. Roldan Jr., Sam O. Kaipu
Journal of Health Science, 2019; 7
Open Access
Abstract
The major challenges militating against the proper practice of informed consent identified in our desk top review are related to cultural issues of the people. Many patients continue to value strongly their kinship ties with the past and believe in the traditional methods of healing sickness. The patients must be given some information about what the doctor proposes to do. The underlying spirit of informed consent is new in PNG, and it strives against the traditional attitudes of doctors that they know it best for the patients and the strong culture in customs and patients’ misconceptions that affect their perceptions in making important health care decisions. Majority of the patients have some notion of informed consent, however not many people understand what it is. They still hang onto their traditional customs, beliefs and opinions that affect their health care decisions; they often look to their village elders, family and parents for advice in times of sickness or death in the family but where the law implies consent it is not often obtained. Summarization of current laws, reports of legal cases, and personal experiences were examined. Special requirements must be prescribed when patients are subjected to medical treatment. Documentation of a well-defined process, not only on paper, may not only protect the medical doctor from exposure to liability but increases the patient’s autonomy in decisions concerning health and encourages compliance with treatment; and advances the interests of both patient and doctor. Lack of informed consent can reinforce a claim of medical malpractice, and could well undermine relevant health care policy to protect patient autonomy.

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.

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
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 is needed to obtain informed consent and monitor capacity for a successful study involving People with Mild Dementia? Our experience in a multi-centre study
Jennifer NW Lim, Rosa Almeida, Vjera Holthoff-Detto, Geke DS Ludden, Tina Smith, Kristina Niedderer
International Mind Conference, 19-20 September 2019; Dresden Germany
Open Access
Abstract
Strategies on informed consent process and capacity monitoring for mild dementia research are at developing state. We reflected on our experience and found that the successful collection of informed consent and full participation of PwD required the involvement of familiar healthcare professionals/care workers/staff at the recruitment and data collection stages and this needs to occur in an active support environment. Time is another important factor affecting the success of the study.