Situation analysis of research ethics governance in Pakistan.

Background: Mapping of ethical governance structures is very useful in identifying strengths and weaknesses in order to uphold integrity and ensure standardization. However, reliable countrywide data about ethical review committees (ERCs) is unavailable in Pakistan. Aims: To evaluate the research ethics governance mechanisms at national level and at key healthcare institutions in Pakistan. Methods: This pilot mapping exercise used a mixed-methods approach, involving a cross-sectional survey of 19 key healthcare research institutions, and structured in-depth interviews with the chairs of the National Bioethics Committee and the Drug Regulatory Authority of Pakistan. Results: Eighteen institutions responded to the ethics mapping survey. Twelve public sector ERCs had a permanent structure and 17 had formal terms of reference. Seven ERCs claimed accreditation, although no central accreditation agency exists in Pakistan. Eight ERCs were chaired by the heads of the institutions. There was no fixed tenure for the heads in 13 committees, and 14 committees allowed multiple terms. Six ERCs had follow-up mechanisms for ethical approvals, and 6 took punitive actions in response to any deviation from an approved protocol, or to a scientific misconduct. Two respondents recalled situations where applicants pressured committee members for favourable approvals. Survey respondents mentioned the lack of central research ethics guidelines as a weakness of the national governance system. Structured interviews revealed the need for formal training of committee members and capacity strengthening, particularly for administrative staff. Conclusion: There is a need to develop guidelines for local ethics governance in Pakistan, and ensure accreditation of ERCs through the National Bioethics Committee to uphold the integrity of the ethics governance structure.

Fighting the COVID-19 pandemic: A socio-cultural insight into Pakistan.

During the COVID-19 pandemic, healthcare professionals around the world were driven by universal values of solidarity and duty to provide care. However, local societal norms and existing healthcare systems influenced interactions among physicians, and with patients and their families. An exploratory qualitative study design using in-depth interviews was undertaken with physicians working at two public sector hospitals in Karachi, Pakistan. Using the constant comparison method of data analysis, several key themes were identified highlighting norms of kinship and interdependencies characteristic of collectivistic societies that influenced professional interactions. The role of seniors in the hierarchical society of Pakistan played a major role in provision of care. Physicians reported numerous challenges in dealing with patients and their families amidst public denial fueled due to ill-formed government policies. This included interruption of funeral rites which undermined public trust. The study provides insights into the local moral world of two healthcare institutions in Pakistan.

COVID-19 vaccine hesitancy among health service providers: A single centre experience from Karachi, Pakistan.

OBJECTIVE: To assess the views of health service providers towards coronavirus disease 2019 vaccination with Cansino, Sinovac and Sinopharm vaccines. METHODS: The analytical cross-sectional study was conducted at the Sindh Institute of Urology and Transplantation, Karachi, in May and June 2021, and comprised doctors, nurses, technical staff, and medical social officers. Data was collected using a questionnaire, in Urdu and English languages, assessing determinants of hesitancy. Data was analysed using SPSS 19. RESULTS: Of the 331 subjects, 156(47%) were males and 175(53%) were females. Overall, 183(55%) subjects were aged <30 years, and 7(2%) were aged >60 years. Among the responders, 274(83%) were vaccinated, 49(15%) wanted to delay, and 8(2.4%) were outright refusers. Among the hesitant, 43(80%) were women, and 56(98%) were aged <40 years. Age, gender, occupational group and personal experience with the disease had significant correlations with vaccination status (p<0.05). Personal safety 202(74%) followed by the perception of official requirement 162(59%) were the prime reasons for getting vaccinated. No respondent cited religious inhibitions or social media as the reason behind vaccine refusal. CONCLUSIONS: A lack of trust in the safety and efficacy data of the available Chinese vaccines appeared as a factor inducing hesitancy. The resistance of younger respondents, especially trainee physicians, was a finding of concern since they form the backbone of the health system in the country.

Adapting the ethical review process for COVID-19 research: reviewers' perspectives from Pakistan.

BACKGROUND: Research ethics committees (RECs) globally have adapted their responses to provide timely reviews of research proposals in the wake of the COVID-19 pandemic. The REC of the National Bioethics Committee (NBC) of Pakistan has followed suit. AIMS: To explore perceptions of NBC-REC reviewers who reviewed COVID-19 research proposals while describing the newly instituted Rapid Turnaround Review (RTR) system. METHODS: This cross-sectional study used 3 methods of data collection: a demographic questionnaire filled in by permanent members and co-opted reviewers; qualitative in-depth interviews conducted with both groups; and document review related to COVID-19 research proposals. RESULTS: Eight permanent members and 3 co-opted members participated. Under the RTR system, the time for review was established as 72 hours after receipt of the proposal. The Committee reviewed 55 projects over 10 months. Participants described numerous strengths of the new system, including introduction of online discussions via Zoom as well as presence of co-opted members leading to learning opportunities, particularly for junior members. The RTR system also allowed NBC-REC to gain recognition it had not enjoyed previously. Challenges identified by respondents included initial difficulty in initiating the system and tighter deadlines that may have compromised review quality. Poor scientific quality of proposals, compounded by external pressures to provide rapid approval, added to reviewers' frustrations. While fruitful, the RTR system was considered unsustainable beyond a public health emergency. CONCLUSION: Adaptation of ethical review processes is essential in emergencies, however, existing guidelines have to be modified to suit contextual needs.

Ethical dilemmas in clinical care during COVID-19 pandemic.

In a short span of a few weeks, the COVID-19 pandemic has affected the entire world like no other event in modern history. Healthcare institutions and providers have been at the forefront of containing the ravages of this disease, and are experiencing unprecedented challenges. Medical decision making has become all the more complex because of the moral weight of difficult decisions that need to be made. This paper discusses three areas where ethical decision making is extremely important: dealing with those patients with COVID-19 who no longer have access to their doctors; following ethical criteria for assigning risky duties to healthcare professionals; and in making life and death decisions while allocating scarce resources. This paper describes a national level guidance document for the COVID-19 pandemic that is designed to facilitate ethical decision-making.

Realigning Pakistan's Bioethics Center during Covid-19.

The arrival of the Covid-19 pandemic in Pakistan necessitated that the Centre of Biomedical Ethics and Culture in Karachi realign its activities to changing realities in the country. As Pakistan's only bioethics center, and with no guidelines available for allocation of scarce medical resources, CBEC developed "Guidelines for Ethical Healthcare Decision-Making in Pakistan" with input from medical and civil society stakeholders. The CBEC blog connected to the center's bioethics programs for students from Pakistan and Kenya shifted to Covid-related issues specific to the context of existing social and political realities within these countries. As part of its outreach activities, CBEC initiated a popular Facebook series, #HumansofCovid, as an experience-sharing platform for health care professionals and members of the public. Narratives received vary from those by frustrated physicians under quarantine to those concerning street vendors left jobless and a transsexual person in whose opinion "social distancing" is not a new phenomenon for their communities.

The meaninglessness of doing bioethics: Reality check from a conflict zone.

Running bioethics workshops one after the other can become a mundane affair, primarily because of the similarity of their content and discourse. However, conducting a workshop for participants from conflict zones such as Palestine provided an entirely new perspective for this author. While the bioethics discourse may translate into useful and actionable guidelines in the free world to help uphold human dignity, to those living in occupied territories and conflict zones, in the face of their lived lives, it appears little more than a self-serving academic exercise by "parachute bioethicists".

Demystifying the practice of khafd in the Dawoodi Bohra community: A commentary on the WeSpeakOut report from India.

In this commentary, we critique a recent report on female genital cutting (FGC) in the Indian Dawoodi Bohra community titled "The Clitoral hood a contested site: Khafd or female genital mutilation/cutting (FGM/C) in India." Published against the backdrop of possible legislation against FGC in India, the report makes good recommendations and is a useful addition to global literature on FGC. We critique specific sections of the document using relevant literature and informal conversations with the Bohra community in Pakistan, thereby highlighting both its strengths and weaknesses. We also attempt to show that criminalising khafd by conflating it with more drastic forms of cutting may be counterproductive. In conclusion, education and activism from within the community may be more fruitful than the imposition of a law banning khafd.

Biobanking in the subcontinent: exploring concerns.

Biobanking is an important tool for biomedical research. However, it raises a variety of ethical issues, which are compounded in the developing world. This paper is based on data from three sources on the ethical issues associated with biobanking, including a mixed method pilot study conducted with students in Karachi, Pakistan, a workshop in Karachi, and another workshop held in Bengaluru, India. Findings from these sources reveal a unanimous lack of clarity about what constitutes a biobank. While informed consent was deemed necessary for storage of materials, participants were unsure of how this could be achieved for samples stored indefinitely for future research. Although study participants showed limited understanding of genetic research, concerns were raised in the Karachi workshop. A majority of survey participants found it acceptable to transfer biospecimens across borders, but possibility of misuse was highlighted in both workshops. This paper reveals ambiguities with respect to ethical challenges of biobanking, indicating the need for further discourse.

Pakistan's experience with kidney transplantation and trade: a call for international solidarity.

Pakistan has taken a long and tortuous road towards curbing the trade in organs within its borders. Yet, despite the phenomenal gains, several challenges remain in this area. For example, robust and sustainable deceased donor programmes must be established to meet the needs of a country which has a high prevalence of kidney disease and failure. Further, it is necessary to offer an alternative source of organs for transplantation to desperate patients who resort to buying these from the "market". Cultural factors and religious beliefs about the sanctity and inviolability of the corpse, as well as the lack of public and professional education regarding the procurement of organs from the deceased, pose considerable barriers that must be surmounted. We believe it is equally important that transplant professionals and the governments of affluent countries consider measures to discourage, if not prevent, their citizens from travelling to impoverished countries such as Pakistan to buy organs. Without a commitment, ethical and legal, to international solidarity in this matter, the goals that are already difficult for developing countries to achieve, ie, establishing deceased donor programmes and bringing an end to organ trafficking, will be even harder to achieve.

A degree in bioethics: an "introspective" analysis from Pakistan.

The success of degree-level bioethics programmes, a recent development across the world, is generally evaluated on the basis of their quantifiable impact; for instance, the number of publications graduates produce. The author conducted a study of Pakistani graduates who had pursued a higher qualification in bioethics, and on the basis of the respondents' written and verbal narratives, this paper presents an analysis of their perceptions of the internal impact of bioethics degree programmes. Using these narratives, the paper also analyses the reactions of their colleagues to their new qualification.The respondents reported significant changes in their thinking and actions following their education in bioethics. They exhibited more empathy towards their patients and research subjects, and became better "listeners~ They also reported changes in practices,the most significant being the discontinuation of the linkages they had established with pharmaceutical firms to seek support,because of concerns related to conflict of interest. Although some respondents believed that their new qualification was generally welcomed by their colleagues, who considered them aesthetics resources, others reported that their colleagues harboured unreasonable and impractical expectations from them, and that these were impossible to fulfil. They also got the feeling of being ostracized and regarded as "ethics watchdogs~ Whereas the internalisation of bioethics is an encouraging finding in this cohort, the mixed reception that bioethics and those involved in it received indicates a Jack of understanding of the field and is a source of concern.

To donate a kidney: public perspectives from Pakistan.

Despite the majority opinion of Muslim jurists that organ donation is permitted in Sharia, surveys indicate continuing resistance by lay Muslims, especially to donating organs following death. Pakistan, a country with 165 million Muslims, currently reliant on live donors, is considering steps to establish deceased donor programs which will require public acceptance and support. This article analyzes the results of in-depth interviews with 105 members of the public focusing on opinions and knowledge about juristic rulings regarding kidney donations, donor-family dynamics in deceased donation decisions, and attitudes towards buying kidneys. The objective was to determine the influence if any of cultural and religious values, and norms of traditional family structures and kinships, on decisions to donate. Study participants view donation of kidneys, particularly from the deceased, through a different lens from that used by jurists and physicians, one that also does not conform to familiar paradigms defining ethical organ donation. A socially modulated understanding of Islam passed down the generations, and longstanding family-centric norms, shape the moral worldview of many rather than academic juristic rulings or non-contextual concepts of autonomy and rights. The results of this study also highlight that medical science may be universal but its application occurs within particularities of cultural and religious values, social constructs of the self and its relationship with others, and different ways in which humans comprehend illness, suffering, and death. These findings are of relevance both to transplant related professionals and bioethicists involved with this field.

Ethical review in Pakistan: the credibility gap.

The concept of mandatory ethical review of research involving human participants is gradually taking root in Pakistani institutions. Based on the opinions of Institutional Review Board (IRB) members from institutions across the country, the process faces several challenges which threaten its integrity. The lack of registration or accreditation for IRBs has resulted in a wide variation in the calibre and working of such Boards. Despite the recent growth in numbers of people with formal bioethics degrees in the country, a majority of membership remains without any formal training for the work expected from them in ethical review. External pressures to influence deliberations, conflict of interest issues within board leadership and inconsistent application of review requirements all contribute in undermining the reliability of the process. Some of the most significant threats to independent and uninfluenced functioning of such boards arise from institutional leadership itself. In the opinions of IRB members, the review process has to be uniform, consistent and trustworthy if it is to gain the respect of researchers, and IRB need to be given the autonomous space to make independent decisions. Otherwise there is a real danger of IRBs being relegated to being no more than rubber stamping committees.

Plagiarism and the medical fraternity: a study of knowledge and attitudes.

OBJECTIVE: To assess knowledge and perceptions of plagiarism in medical students and faculty of private and public medical colleges in Karachi. METHODS: A questionnaire based study was conducted on groups of 4th year medical students and medical faculty members. Group A consisted of medical students while group B comprised faculty members. The questionnaire contained 19 questions that assessed knowledge and attitudes of the respondents regarding various aspects of plagiarism. RESULTS: The total number of medical students (Group A) studied was 114 while the faculty number (Group B) was 82. Nineteen percent Group A and 22% of Group B displayed the correct knowledge about referencing materials from the internet or other sources. Seventeen percent of respondents in Group A and 16% in Group B had correct information about the use of quotation marks when incorporating verbatim phrases from external sources. Regarding Power Point presentations, 53% of respondents from Group A and 57% from Group B knew the appropriate requirements. There was a statistically significant difference among the two groups regarding the issue of self plagiarism, with 63% of respondents in Group A and 88% in Group B demonstrating correct understanding. Both groups showed a general lack of understanding regarding copyright rules and 18% of Group A and 23% of respondents in Group B knew the correct responses. Eighteen percent of respondents in Group A and 27% in Group B claimed to have never indulged in this practice. CONCLUSION: There is a general lack of information regarding plagiarism among medical students and faculty members.