A Scoping Review Of The Literature Of Research Ethics Committees And Ethics Review Framework In Pakistan: What We Know And What We Still Need To Learn.

OBJECTIVE: To map literature on research ethics committees, institutional review boards and ethics review framework in Pakistan to identify key insights during public health emergencies and normal times. Method: The systematic scoping review was conducted in April 2022, and comprised literature search on PubMed, World Health Organisation Global Index Medicus and Summons databases for articles published between January 2005 and February 2022. Information extracted included authors' names, year of publication, title, study methodology, and key insights under the heads of challenges and solutions. Due to data heterogeneity, key themes were identified and analysed. RESULTS: Of the 2,190 studies initially identified, 21(0.95%) were subjected to full-text review, and, from among them, 9(45%) were analysed in detail. There were 4 key insights identified: research ethics committees and institutional review boards in Pakistan remain unregulated as they are currently not registered or accredited by a competent national-level authority; most members of such committees are not formally trained to implement the mandate; internal and external pressures hinder independent decision-making of such committees; and other issues hindering the functionality and performance of research ethics committees and institutional review boards. CONCLUSIONS: Despite existing publications calling for urgent policy and regulatory reforms, there is a dearth of literature and minimal policy actions underlying the fact that ethics review remains a neglected area in Pakistan.

Informed consent for controlled human infection studies in low- and middle-income countries: Ethical challenges and proposed solutions.

In controlled human infection studies (CHIs), participants are deliberately exposed to infectious agents in order to better understand the mechanism of infection or disease and test therapies or vaccines. While most CHIs have been conducted in high-income countries, CHIs have recently been expanding into low- and middle-income countries (LMICs). One potential ethical concern about this expansion is the challenge of obtaining the voluntary informed consent of participants, especially those who may not be literate or have limited education. In some CHIs in LMICs, researchers have attempted to address this potential concern by limiting access to literate or educated populations. In this paper, we argue that this practice is unjustified, as it does not increase the chances of obtaining valid informed consent and therefore unfairly excludes illiterate populations and populations with lower education. Instead, we recommend that investigators improve the informed consent process by drawing on existing data on obtaining informed consent in these populations and interventions aimed at improving their understanding. Based on a literature review, we provide concrete suggestions for how to follow this recommendation and ensure that populations with lower literacy or education are given a fair opportunity to protect their rights and interests in the informed consent process.

Perceptions of people living with HIV/AIDS regarding access to health care.

Although the health care is replete with technology in the present day, it is not freely accessible in a developing country. The situation could be even more compromised in the case of people living with HIV/AIDS, with the added dimension of stigma and discrimination. What are the factors that act as barriers to health care? This study was conducted to look into perceptions of people living with HIV/AIDS with regard to access to health care. The study looked into accessibility of general health vis-à-vis access to antiretroviral therapy. Demographic variables like age, gender, income were studied in relation to factors such as counseling, confidentiality, stigma and discrimination, which are known to influence access to health care. People living with HIV/AIDS perceive general health care as more accessible than care for HIV treatment. Discrimination by health care workers causes a barrier to accessibility.

Corpse identification in mass disasters and other violence: the ethical challenges of a humanitarian approach.

In October 2022, the Centre for Ethics of Yenepoya University hosted a national workshop entitled: "Respect for human dignity of the unidentified dead from mass disasters and other violence: strategies for the ethical management of biological samples and personal data". The aim was to explore and share experience and ethical considerations regarding the management and identification of human remains in the event of disasters, with the purpose to arrive at a general consensus about what constitutes the ethical foundation of the management of unidentified human remains in forensic practice and, in particular, contextualizing this in India. The main ethical consideration that emerged was tracing the missing and identifying the dead are crucial to maintaining or restoring basic human rights and responsible relief activities. Identification is not only an organizational and scientific achievement but, regardless of circumstances, also necessarily and always an activity with significant political, epistemic, and philosophical relevance and consequence. In India, it could be important to consider new legal provisions for the management of human samples so that this would provide a starting point for the treatment of human remains managed for forensic purposes with uniformity in the country. Another important step in which governments should take part regards the involvement and education of the general public to develop their interest in this important goal. In the field of forensic anthropology, artificial intelligence can support, through the use of algorithms, the decision-making process that leads to the identification of the victim or its remains. Furthermore, they can be used to extract new knowledge from huge databases and shorten identification through computer automation of data binding activities. Applying artificial intelligence tools in forensic sciences to collect new information from massive datasets to enhance knowledge, and reduce human subjectivity and errors, provides a greater scientific basis that could improve the strength of the evidence and support the admissibility of expert evidence. In light of the general lack of national/international guidance about ethical oversight for identification and care of human remains, the fact that regulations are frequently not adequate to govern ethical aspects, we hope that an internationally recognized body should develop such guidance in collaboration with relevant organizations.

Post-approval process: A challenge for ethics committees.

Context: Ethics committees (ECs) work toward upholding rights, dignity, safety, and well-being of research participants. They are also tasked with conducting oversight pre- and post-approval. ECs face various challenges in their functioning. Post-approval oversight is one of the major challenges, and various studies have stressed the importance of post-approval oversight. Aims: The aim of this study was to explore the challenges in the post-approval processes that are faced by the ECs and to suggest solutions to the most common challenges. Methods: We conducted a quantitative study contacting member secretaries of different ECs using an online Google Forms questionnaire. The questionnaire consisted of three domains and included questions about the description of the EC, conduct of post-approval activities, and challenges encountered during the post-approval process. Results and Conclusion: We received responses from 61 member secretaries. We were able to identify challenges faced by the EC members in the post-approval process in the areas of site monitoring visit, review of post-approval submission (nonsubmission/incomplete submission/late submission of documents by PI, long time taken by reviewers, nonavailability of reviewers, nonadherence to timeline and too much paperwork), review of serious adverse events, and review of protocol deviations. Our study also noted the difference between accredited/assessed (National Accreditation Board for Hospitals and Healthcare Providers/Forum for Ethical Review Committees in the Asian and Western Pacific Region) ECs versus registered (Central Drugs Standard Control Organisation/Department of Health Research only) ECs by comparing the challenges.

Evaluation and comparison of linear and diagonal odontometry of first molars as a tool for gender discrimination; assessed in a population from Maharashtra.

Background: Linear odontometry is customarily used in gender determination which can pose difficulties in cases of tooth decay, attrition since they mainly involve the proximal surfaces. Objectives: The present cross-sectional observation study, estimated the efficacy of alternative measurements, that is, diagonal measurements and cervical measurements in gender determination in comparison to routine odontometry. Material and Methods: A total of 200 dental cast models (upper and lower) of 100 individuals (50 male and 50 female) from Maharashtra state were included. Results: Univariate discriminant function analysis showed that, in maxillary molars, MD width gave the highest gender dimorphism of 64%, followed by BL with 62%. In the mandibular teeth, MD gave an accuracy of 75% followed by MB-DL with 73%. Multivariate logistic regression analysis showed that overall diagonal and linear measurements gave the highest dimorphism of 81% with 80% correctly identified as females and 82% as males. The mandibular MD, BL and MB-DL gave an accuracy of 79% with 78% corrected identified as females and 80% correctly identified as males. Mandibular ML-DB and Cervical DB-CML together gave an accuracy of 77% and mandibular MD with75%. Conclusion: Thus, the study proves that diagonal measurements give almost equivalent or better results than linear measurements in gender determination.

Perceptions about controlled human infection model (CHIM) studies among members of ethics committees of Indian medical institutions: A qualitative exploration.

Introduction: Controlled Human Infection Model (CHIM) studies provide a unique platform for studying the pathophysiology of infectious diseases and accelerated testing of vaccines and drugs in controlled settings. However, ethical issues shroud them as the disease-causing pathogen is intentionally inoculated into healthy consenting volunteers, and effective treatment may or may not be available. We explored the perceptions of the members of institutional ethics committees (IECs) in India about CHIM studies. Methods: This qualitative exploratory study, conducted across seven sites in India, included 11 focused group discussions (FGD) and 31 in-depth interviews (IDI). A flexible approach was used with the aid of a topic guide. The data were thematically analyzed using grounded theory and an inductive approach. Emerging themes and sub-themes were analyzed, and major emergent themes were elucidated. Results: Seventy-two IEC members participated in the study including 21 basic medical scientists, 29 clinicians, 9 lay people, 6 legal experts and 7 social scientists. Three major themes emerged from this analysis-apprehensions about conduct of CHIM studies in India, a perceived need for CHIM studies in India and risk mitigation measures needed to protect research participants and minimize the associated risks. Conclusion: Development of a specific regulatory and ethical framework, training of research staff and ethics committee members, and ensuring specialized research infrastructure along with adequate community sensitization were considered essential before initiation of CHIM studies in India.

Reliability of palatal rugae patterns in individual identification.

Background: Dental identification plays a major role in mass disaster identification of human remains. Palatal rugae can be used as a substitute for a comparative method of identification. Materials and Methods: The present cross-sectional study was done with 137 pre- and post-orthodontically treated casts of patients, which were divided into 50 cases each of extraction and nonextraction and 37 cases of palatal expansion involving both extraction and nonextraction. Hydrocolloid (alginate) impression of the upper jaw of the patient was taken and then cast in the dental plaster of Paris material. Palatal rugae pattern was classified according to Lysellm, and Thomas and Kotze classification. Two Observers recorded the data, mean of two were taken for analysis. Results: On the right side, there was no significant difference between the extraction and nonextraction groups; however, there was a rise in length in the nonextraction and palatal expansion groups. On the left side, there was little change between the nonextraction and palatal expansion groups, but the extraction group had a modest increase in length. Mean lengths compared within three groups revealed insignificant difference. Conclusion: Palatal rugae pattern can be used in establishing identity in forensic medicine provided antemortem data are available. Orthodontic treatment has an impact on stability of palatal rugae. Most reliable and stable points being third rugae, they could be used as reference points to evaluate tooth movements.

Diversity in approach to teaching and assessing ethics education for medical undergraduates: A scoping review.

There are diverse methods to teach medical ethics, and there is no single accepted approach towards its learning and assessment. The authors aim to explore the various strategies practised to teach undergraduate medical students the fundamentals of medical ethics and their evaluation. The authors reviewed the articles published from January 2014 to September 2019. The authors searched PubMed for the relevant publications and extracted the information using a data extraction sheet. Twenty-nine articles were included for the review, which fulfilled the inclusion criteria. Case-based discussions were a widely accepted strategy to learn ethics. The studies highlighted a mixed teaching approach using multiple teaching tools. A qualitative approach was preferred for the assessment through reflections, simulated patient interactions, and development of portfolios. However, there are gaps in the existing literature on the assessment strategies for ethics education. Heterogeneity still exists in the planning of the curricula, teaching, and assessment methods. These curricula suit the cultural and religious set up of that particular country. Case-based discussion is a popular teaching strategy, and there exist numerous innovative and cost-effective active teaching strategies. There is a need for studies that are more rigorous to address the evaluation of the ethics curricula. This review would help educators to choose their preferred approach based on their teaching environment.

Ethics-related guidelines for authors and article retractions: How do Indian biomedical journals measure up?

BACKGROUND: There has been an increase in research output from India, which in turn has led to an increase in the number of Indian journals facilitating biomedical research. The instructions to authors in the websites of these journals should clearly display ethics-related guidelines for the ethical publication process. The present study did an objective assessment of instructions to authors on the websites of Indian biomedical journals in PubMed and IndMED and retractions in these journals from January 2012 to October 2017. METHODS: A 14-point checklist based on previous studies and review of literature was used. A total of 110 journals were included in the study and their websites assessed. RESULTS: A dedicated section on ethics was found in 56 (50.9%) journal websites, 42 (38.2%) did not mention any specific bioethics guidelines, animal ethics was mentioned in 65 (59%) of the journals, and an ethics committee approval was required by 65 (59%) of the journals. Sixty-four (58.2%) journals mentioned mandatory informed consent and 19 (17.3%) required assent. There were 22 (20%) journals that required neither Clinical Trial Registry of India (CTRI) registration nor Consolidated Standards of Reporting Trials (CONSORT) guidelines for reporting of clinical trials. There were 38 (34.5%) journals that actively looked for plagiarism. Most common reason for retraction was duplicate publication (23, 38.4%) followed by plagiarism (17,28.3%). CONCLUSION: The lacunae found in this survey indicate a need for strengthening of author instructions. The number of retractions in the last five years suggests that there are valid reasons to strengthen ethics in the publication process in India.

Evaluation of canine sexual dimorphism in deciduous and permanent dentition.

INTRODUCTION: Teeth are an excellent material in living and nonliving populations for anthropological, genetic, odontologic and forensic investigations. Among the various calcified structures in the human body, teeth have gained lot of popularity in estimating the sex of an individual as they are highly resistant to destruction and decomposition. The present study aims to assess the importance of canines in sexual dimorphism in both primary and permanent dentition as well as to describe the dimensional characteristics of canines among the population of Bagalkot district of Karnataka, India. MATERIALS AND METHODS: One hundred and fifty participants belonging to Bagalkot district of Karnataka population, 100 adults (50 males and 50 females) in the age group of 17-30 years and 50 children (25 boys and 25 girls) in the age group of 3-6 years were included in the study. Impressions were made using alginate and study models were prepared using dental stone. Clinical crown height (CCH), maximum mesiodistal diameter (MMD) and maximum buccolingual width (MBL) of maxillary and mandibular canines of both dentitions were measured using digital vernier caliper. RESULTS: In deciduous dentition, significant differences were noted between maxillary and mandibular deciduous canines in male and female children using three dimensions, except mandibular canine, i.e., CCH did not show a significant difference. In permanent dentition, CCH and MMD showed significant differences except mandibular canines not showing significant differences in MBL (P < 0.05). CONCLUSION: Thus, canines can act as a valuable tool in gender determination as there is significant sexual dimorphism in maxillary and mandibular deciduous and permanent dentition.

Knowledge and awareness of informed consent among orthodontists and patients: A pilot study.

AIM: Despite fixed professional opinion of what might constitute optimal treatment, patients must be informed of the various treatment options available in orthodontics to manage their clinical problem. The purpose of this study was to compare and evaluate the knowledge and awareness among practicing orthodontists and patients with regard to informed consent in clinical practice and research. MATERIALS AND METHODS: Twenty-five orthodontists and 25 patients were enrolled in a questionnaire study which was descriptive and cross-sectional in the nature. The questionnaire focused on the following aspects; contents of informed consent, at what age and who can give consent. RESULTS: The study showed a majority of orthodontists (79.14%) were aware of knowledge regarding informed consent when compared to patients(35.14%). CONCLUSION: The overall result showed the huge gap that exists between orthodontists and patients and thus making it categorical for patients to be more involved in the decision-making process.

Identification of four differently injured victims of the Mangalore air crash disaster.

On the 22nd of May 2010, a Boeing 737-800 aircraft crashed at the Mangalore International Airport killing all but 8 of the 166 people on board. One of the most important roles of the forensic investigation is to identify the victims of the crash. This task was made even more difficult because of the fact that most of the bodies were charred beyond recognition. Four bodies were transported to a mortuary to undergo a postmortem examination, whereas the rest of the victims were examined elsewhere. There is a wide range of methods to identify victims of mass disasters ranging from simple facial recognition to highly complex DNA comparisons. This paper highlights the experience and methods used to describe various types of injuries associated with a plane crash and the methods and techniques used to successfully identify the four victims of the crash. Implications for forensic nurses are discussed.

Self-reported tobacco smoking practices among medical students and their perceptions towards training about tobacco smoking in medical curricula: A cross-sectional, questionnaire survey in Malaysia, India, Pakistan, Nepal, and Bangladesh.

BACKGROUND: Tobacco smoking issues in developing countries are usually taught non-systematically as and when the topic arose. The World Health Organisation and Global Health Professional Student Survey (GHPSS) have suggested introducing a separate integrated tobacco module into medical school curricula. Our aim was to assess medical students' tobacco smoking habits, their practices towards patients' smoking habits and attitude towards teaching about smoking in medical schools. METHODS: A cross-sectional questionnaire survey was carried out among final year undergraduate medical students in Malaysia, India, Nepal, Pakistan, and Bangladesh. An anonymous, self-administered questionnaire included items on demographic information, students' current practices about patients' tobacco smoking habits, their perception towards tobacco education in medical schools on a five point Likert scale. Questions about tobacco smoking habits were adapted from GHPSS questionnaire. An 'ever smoker' was defined as one who had smoked during lifetime, even if had tried a few puffs once or twice. 'Current smoker' was defined as those who had smoked tobacco product on one or more days in the preceding month of the survey. Descriptive statistics were calculated. RESULTS: Overall response rate was 81.6% (922/1130). Median age was 22 years while 50.7% were males and 48.2% were females. The overall prevalence of 'ever smokers' and 'current smokers' was 31.7% and 13.1% respectively. A majority (> 80%) of students asked the patients about their smoking habits during clinical postings/clerkships. Only a third of them did counselling, and assessed the patients' willingness to quit. Majority of the students agreed about doctors' role in tobacco control as being role models, competence in smoking cessation methods, counseling, and the need for training about tobacco cessation in medical schools. About 50% agreed that current curriculum teaches about tobacco smoking but not systematically and should be included as a separate module. Majority of the students indicated that topics about health effects, nicotine addiction and its treatment, counselling, prevention of relapse were important or very important in training about tobacco smoking. CONCLUSION: Medical educators should consider revising medical curricula to improve training about tobacco smoking cessation in medical schools. Our results should be supported by surveys from other medical schools in developing countries of Asia.