Assessment of factors that motivate participants to take part in a COVID-19 vaccine study [email protected] Authors: Nithya J Gogtay, Dhruve Soni*, Palvi Kudyar, Saee Hinglaspukar, Ishita Lanjewar Institution: Dept of Clinical Pharmacology, King Edward Memorial Hospital, Mumbai, India Introduction: Mitigation of the COVID-19 pandemic involves meticulous clinical research with drugs and use of vaccines. Both of these depend on the successful recruitment and retention of participants in the clinical trials. Factors driving participation in such studies could be manifold and could potentially include – understanding the importance of these trials, motivation to help the country , societal benefit, anticipated personal or family benefits and the level of trust in the study site and investigators’ team. The present study is aimed at identify specific motivating factors that inspired participants to volunteer for two separate COVID-19 vaccine trials (one of which is ongoing) at our institute. Objectives: The primary objective is to identify factors that motivated healthy volunteers to participate in two phase II/III COVID-19 vaccine trials conducted at the department. The secondary objective is to identify the sociodemographic and socioeconomic profile of participants in these two studies. Methods: Participants of two COVID-19 vaccine trials will be approched telephonically for the participation in the study and verbal consent taken. They will be asked to state the primary and secondary reason for the participation. The stated reasons will be recorded in the case record form as verbatim followed by content analysis of the interview transcripts. Anticipated results: The study will help in understanding the factors that motivate individuals to volunteer for COVID-19 vaccine research studies. Understanding these factors, can help in better recruitment and retention for future studies and also help investigators, ethics committees and policy makers understand determinants and drivers in a pandemic.
Evaluation of satisfaction and motivating reasons for participation in a COVID-19 Vaccine Clinical Trial: Single Centre Observational Study [email protected] Authors: Nithya J Gogtay, Palvi Kudyar*, Dhruve Soni, Priyanka Pehekar Institution: Dept of Clinical Pharmacology, Seth GSMC & KEM Hospital, Mumbai, India Introduction In May 2020, the 73rd World Health Assembly issued a resolution recognizing the role of extensive immunization for preventing, containing and stopping transmission of SARS-CoV-2. Up till 21st October, 2021, a total of 23 vaccines have got approval world-wide and 432 clinical trials for 153 vaccine candidates are ongoing. The conduct of these vaccine studies relies upon the enrolment and retention of participants who are invested in, understand and trust the clinical research process. Assessment of participant factors like motivation and satisfaction are important in this regard to gain a perspective and to ensure successful completion of these studies. Objectives The primary objective of this study is to evaluate the satisfaction and motivating factors for participants in a COVID-19 vaccine study. Materials & Methods :- We anticipate ethics committee approval for the study shortly. The study will include participants who have completed both doses of vaccine. All participants will be contacted telephonically and verbal consent will be taken. A validated questionnaire with fifteen questions divided into domains of ‘participant satisfaction’, ‘motivation factors’ and ‘motivation for future participation’ will be administered. Categorical responses [yes/no] will be documented. In addition, information on variables like age, gender, education and employment status will be collected. Descriptive statistics will be applied to the data and content analysis will be done. Association of independent variables with the participant responses will be analysed using the Chi-square test at 5% significance. Anticipated Results This assessment will give us an insight into drivers for participation in a COVID-19 vaccine study and provide useful insights to investigators, ethicists, ethics committee members and policy makers.
A literature review of consent declines and consent withdrawals in published Randomized Controlled Trials (RCTs) during the COVID-19 pandemic Gogtay NJ, Sheth HJ, Maurya MR, Behlekar MN, Thatte UM Department of Clinical Pharmacology, KEM Hospital, Mumbai, India Presenting author – Gogtay NJ Objectives: We evaluated the extent of consent declines and consent withdrawals during the COVID-19 pandemic as seen in published Randomized Controlled Trials (RCTs) and compared it with Non-COVID19 RCTs published at the same time and two historical controls. Methods: PubMed/Medline only was searched using key-word “COVID-19” and “RCTs” separately, and filtered for COVID-19 RCTs and Non-COVID-19 RCTs respectively, published during a nine-month period (1 Feb - 1 Nov 2020). Exclusions were study protocols, observational studies, interim analysis of RCT data and RCTs with missing data. Primary outcome measures were the proportion of consent declines and consent withdrawals as percentage of total participants screened and randomized respectively in COVID-19 RCTs. We compared consent declines and consent withdrawals of COVID-19 RCTs with Non-COVID19 RCTs and two earlier studies on the same topic that served as historical controls (non-pandemic setting). Results: The search yielded a total of N=111 COVID-19 RCTs and N=49 Non-COVID19 RCTs. Of these, n=39/111 (35.13%) COVID-19 RCTs and n=11/49 (22.45%) Non-COVID19 RCTs were finally analysed. A total of 770/17759 (4.3%) consent declines and 100/7607 (1.31%) consent withdrawals were seen in 39 COVID-19 RCTs. A significant difference was observed in consent declines between COVID-19 vs Non-COVID19 RCTs [4.3% vs 11.9%, p<0.0001] and between COVID-19 RCTs vs two historical controls [(4.3% vs 8.6%, p<0.0001) and (4.3% vs 21.1%, p<0.0001) respectively]. Conclusion: RCTs conducted during the COVID-19 pandemic appear to have significantly lower consent declines relative to Non-COVID19 RCTs during pandemic and RCTs conducted in non-pandemic settings.
Improving comprehension, recall and attention using multimedia informed assent among pediatric oncology patients: a comparative randomized controlled trial Piya Rujkijyanont1, Passara Wongthai2, Apichat Photia1, Chanchai Traivaree1 [email protected] 1Division of Hematology-Oncology, Department of Pediatrics, Phramongkutklao Hospital and Phramongkutklao College of Medicine, Bangkok, Thailand. 2Department of Pediatrics, Phramongkutklao Hospital and Phramongkutklao College of Medicine, Bangkok, Thailand. Background: When children are involved in research, the assent should be obtained in keeping with their level of maturity. However, traditional assent forms contain too much information and are difficult to read. Since mere failure to object should not, absent affirmative agreement, be construed as assent (45 CFR 46.402(b)), the study aimed to identify an effective tool to enhance children’s comprehension during the informed assent process and focused on those with cancer who are likely more engaged in research involving greater than minimal risk. Methods: In all, 116 children diagnosed with cancer were randomized to receive either a paper- based assent document in traditional narrative paper format or a multimedia-based assent document using a short video clip. Open-ended and multiple-choice questions were used to assess comprehension and recall. Time spent on the documents and children’s behavior during the assent process were recorded to determine their attention and satisfaction. Results: Children randomized to a multimedia-based assent document achieved significant higher comprehension and recall assessment scores with P-values <.001. The high score achievement was significantly correlated with the child’s age with adjusted OR of 1.94 (P- value <.001; 95% CI, 1.37-2.74) for comprehension assessment and 1.87 (P-value <.001; 95% CI, 1.33-2.64) for recall assessment. In addition, those children randomized to a multimedia- based assent document had significant longer time spent on the document (P-value =.001) with less numbers of inattention (P-value <.001). Besides, they also expressed more signs of enjoyment during the assent process determined by significant higher numbers of smiling and laughing with P-values <.001. Conclusion: Multimedia-based assent document successfully enhanced comprehension, recall and attention with more satisfaction compared with a traditional paper-based document among children diagnosed with cancer. This approach may be considered as an alternative assent format for children engaging in research involving greater than minimal risk. Keywords: assent, multimedia, comprehension, recall, children, cancer IRBRTA reference number: IRBRTA 256/2563 Thai Clinical Trials Registry (TCTR) number: TCTR20201020006
An audit of questions asked by participants during the informed consent process for a phase 2/3 COVID-19 vaccine regulatory study at a tertiary referral centre Godbole CJ, Chaudhari VL, Bendkhale SR, Desai NN, Gogtay NJ, Thatte UM Department of Clinical Pharmacology Seth GS Medical College and KEM Hospital, Mumbai, India [email protected] Objective: To evaluate the questions asked during the informed consent process by adult participants in a COVID-19 vaccine regulatory study conducted at our centre in 2020. Methods: After approval by the IEC, informed consent documents and consent narratives were evaluated. We collated the total number and nature of questions. Subsequently, we looked at the association between education, gender, socio-economic status, employment status, language of consent and number of questions. Between group comparison (female vs male, unemployed vs employed, primary school vs secondary school vs graduates vs post-graduates, upper vs upper middle vs middle vs lower middle vs lower) for the number of questions asked was done using univariate analysis followed by a multivariate regression analysis with post hoc Tukey test. Independent variables were - gender, employment status, education and socioeconomic status and dependent variable was number of questions asked by the participant. All analyses were done at 5% significance. Content analysis was done in addition by creating categories after evaluation and coding them. Results: A total of N=129 consent narratives from N=129 participants were evaluated. A total of N=127/129 participants asked at least one question. Sixty seven percent participants asked questions related to study procedure, followed by 44.9% participants who asked questions related to safety of vaccine or placebo. A total of N=295 questions were asked by the 127 participants. In content analysis, 149/295 (50.5%) questions were on study related procedures followed by one quarter 76/295 (25.8%) based on safety associated with IP. Very few participants 2.4% were asked about post-trial access. None of the variables found to be associated with the number of questions. Conclusion: Majority of the questions asked by the participants process were about study related procedures and vaccine safety. No association was found between any of the independent variables and the number of questions asked. However, there were differences in the demographics of the trial participants between pandemic and pre-pandemic era. Keywords: Compensation, Content analysis, Narrative, Safety
Obtaining Consent in Covid-19 Pandemics Dr Alvin B. Marcelo St Luke’s Medical Center [email protected] The mandatory social distancing enforced by the pandemic constrained healthcare providers to investigate different methods for obtaining consent for healthcare and/or research. This paper presents various methods that were developed in a tertiary care facility that offered telemedicine services. Within the Data Privacy Act framework, hospital executives brainstormed various options that can meet the compliance requirements of obtaining consent before offering telehealth services, while maintaining the health encounter confidential. A thorough assessment of the external environment and focus group discussions with key internal stakeholders were crucial in identifying options that allowed the hospital meet the urgent demands of patients and doctors to communicate. The solutions found ranged from paper-based manual systems delivered via courier to cloud-based solutions. One lesson learned was that most healthcare professionals and organizations are not aware of existing technologies that allow the recording of consent. And for those who are aware, they grapple with the protocols required to make these technologies work.
New methods for obtaining consent during pandemics Alvin B. Marcelo, MD University of the Philippines Manila The mandatory social distancing enforced by the pandemic constrained healthcare providers to investigate different methods for obtaining consent for healthcare and/or research. This paper presents various methods that were developed in a tertiary care facility that offered telemedicine services. Within the Data Privacy Act framework, hospital executives brainstormed various options that were available to meet the compliance requirements of obtaining consent before offering telehealth services while at the same time keeping the health encounter confidential. A thorough assessment of the external environment and focus group discussions with key internal stakeholders opened up options that allowed the hospital the emerging demands of patients and doctors. The solutions range from paper-based manual systems to cloud-based solutions. Lessons learned are that while technologies exist that will allow the recording of consent, many practitioners do not realize its importance and even if they do, know how to use existing technology.
Ethics review during a pandemic in a resource limited setting: Lessons from Sri Lanka Suraweera C1, Wanigatunge C2 1Secretary, Ethics Review Committee, Sri Lanka Medical Association 2Chairperson, Ethics Review Committee, Sri Lanka Medical Association [email protected] Globally, no one was prepared for the COVID-19 pandemic. Neither were the ethics review committees in Sri Lanka when the first case of COVID-19 was reported in the country in March 2020. With the increasing demand for new information on COVID-19, there was a substantial increase in COVID-19 related protocols submitted for ethics review. The Ethics Review Committee (ERC) of the Sri Lanka Medical Association (SLMA) was one of the few ERCs to function during the quarantine curfew in Sri Lanka. The ERC implemented several new steps to ensure that COVID-19 related protocols were reviewed as quickly as possible while appreciating that most of the members are busy clinicians involved in provision of clinical care. Eleven out of 36 proposals reviewed in the year 2020 and twelve out of 25 received until October 2021 were on COVID-19. Five extra meetings were conducted to discuss proposals for accelerated review. A complete online submission process was introduced with all meetings conducted online. The ERC carried out accelerated full board review process for COVID-19 related protocols, with the decision conveyed to the research team within a week. This was in addition to carrying out the routine review processes of the ERC. There were several obstacles we faced when processing and reviewing protocols. The administrative tasks needed to be carried out immediately by the committee members themselves as the ERC office was non-functional. The investigators were informed of the availability of ERC services via SLMA website, and the ERC members were given training on the online system for review and meetings. Lack of expertise in certain areas was a major problem the ERC faced, particularly when reviewing protocols of traditional and complementary medicine Assistance of external experts was obtained when reviewing protocols related to some sub-specialties like immunology and virology. The members had to update themselves with ethical issues specific to pandemic situations and randomized clinical trials consistently. Changing evidence, protocols and guidelines was another issue that needed to be considered when reviewing protocols. Several trials were undertaken in the same setting with the same investigators which needed special consideration as the chances of same study population undergoing several interventions needed to be minimized. Although accelerated reviews were undertaken, we observed several poorly written protocols perhaps due to busy schedules and lack of understanding of the investigators on ethics review process. Although there were many obstacles, the ERC managed to overcome the problems and make the best of the worst pandemic of the century to ensure that research is conducted in an ethical manner.
Impact of covid pandemic on institutional ethics committee functioning: a comparison study Shetty YC*,Thatte U$, Katkar J# * Faculty working in Department of Pharmacology & Therapeutics, $ Faculty working in Department of Clinical Pharmacology, #Administrative manager , Institutional Ethics Committee Seth GS Medical College & KEM Hospital, Parel, Mumbai, India Introduction: During the COVID19 pandemic, due to the humanitarian crisis and complete lockdown, everything was out of place worldwide. Just as the entire research network got affected so also the functioning of ethics committee. Objectives The main objective of our study was a) To assess the impact of the COVID pandemic (P) on the structure, review process, outcomes and administration of our IEC-1 (March 2020 to Feb 2021) and b) To compare the structure, review process, outcomes and administration of our IEC-1 with the functioning pre-pandemic (PP)- between March 2019 – Feb 2020. Methodology : This was a retrospective audit. The study was exempted from ethics review The following documents were used as source data from the IEC office situated in the institution campus : standard operating procedures , project registers, project files (whichever were needed) and minutes of meetings. Confidentiality of all documents and stakeholders was maintained strictly. The data was analysed using descriptive statistics and inferential statistics considering p<0.05 as significant Results : The study compared pre pandemic (PP) versus pandemic (P) outcomes. A total of 40 PP/56 P studies were reviewed. Meetings held were 8 PP/16 P. The number of training to all the IEC members was PP 5/P 6.The administrative, scientific and regulatory queries were more and statistically significantly during the pandemic than pre pandemic period (Mann Whitney test). However, number of ethical queries were similar in both periods. The median approval time (time from submission to first letter from EC) was 40 days PP [IQR 10-70 days ]/26 days P [IQR 1-45 days]. But the final approval was later in 30 days PP [IQR 15-90 days]/50 days [IQR 1-150] P. The recruitment as per the continuation review seen during those period was 26 PP/12 P. Turnover time for completion of the study in PP was 800 days and 380 days during the pandemic. Studies terminated were 6 PP/7 P, Deviations submitted were PP 37/P 22. SAE subcommittee meeting held was 31 PP/29 P, but SAE reviewed were 13 PP/23 P, but SAE related to study related injury and compensation paid was the same during both the periods. Monitoring of studies done were the same, 12 each during prepandemic and pandemic period. There were changes in the SOP, membership in pandemic and expenses actually decreased due to online meeting and less of paper work . Conclusion: IECs in India faced a lot of challenges while functioning in covid times, and our study shows the impact of the COVID pandemic on the structure, review process, outcomes and administration although overall a lot of paper and money was saved.
Design and Implementation of an online IRB system with Google Workspace; A case study of Naresuan University Institutional Review Board Author: Patcharaporn Sudchada*, Sansanee Chamnikhetkit, Siriwan Kaewsukruang, Thanakorn Teerawuttichaikit, Sirikan Muyjunta, Thananya Sroemchutham. *Corresponding author: Asso.Prof.Dr.Patcharaporn Sudchada, Department of Pharmacy Practice, Faculty of Pharmaceutical Sciecnes, Naresuan University, Phitsanulok Thailand, 65000 E-mail: [email protected] Tel: Abstract (499 Words) 66816883843 Introduction The COVID-19 pandemic has caused limited efficiency on research protocol reviews of NU-IRB. Therefore, we made a prompt decision to transform the NU-IRB system from paper to an online system in April 2020 with one month of preparation to improve the productivity of reviews. Method The authors had explained the conceptual framework, design, implementation, and assessment plan of the NU-IRB online system. Results Google workspace for education, which is free and easy to use, was selected as a platform to develop our NU-IRB online system. The system is designed based on GCP Regulations and Guidance 21 CFR Part 1. Using Google applications facilitate connecting office databases, review, and submission systems seamlessly, including G-drive, Docs, Sheets, Forms, G-mail, Chat, and Sites. The investigators share the protocol files stored in their own G-drive with the NU-IRB account. Then, they can submit the link of the files via the online submission using Google forms. Office staff make a copy and upload it to the NU-IRB G-drive to further process. All Electronic files can be real-time tracked and are stored securely in G-drive under the Google Workspace of the institution. The G-drive of Main NU-IRB account is connected with G-drive of all 3 NU-IRB panels via folder shared. Each year folder contains protocol documents separated by the NU- IRB number of each protocol. Each protocol folder contains two main folders that are the initial submission and the post-approval folders. The initial submission folder is composed of each version of the files. There are 4 four sub-folders; the administrative folder, the investigator folder, reviewer folders, and notification folders, in every version of the files. The protocol indeks created by the Google Sheets app links all documents stored in google drive of each panel. The spreadsheet composes of NU-IRB protocol number, protocol title, academic position, and the name of the investigator, department, or faculty, a type of review, type of study, protocol documents of each submission, assignment form, submission progress, comments of reviewers, approval documents, and post-approval submission folders. Each cell of documents has hyperlinked to related files or folders stored in the G-drive of each panel. For the review system, \"space\" for each reviewer in the Google chat application under the
NU-IRB account of each panel is created. The office staff will generate task(s) in the \"space\" in the G-mail application. Upon the reviewer marked completed, the alert sends back to the email and \"space\" of each NU-IRB panel as well. Electronic time-stamped and changes of the comment forms by reviewers using Google Docs are automatically recorded and can track accessibility. We create the NU-IRB google site to support the workflow of our online system. All databases using Google Sheets have embedded to be easier to locate, process, and update related documents as all in one place. Conclusion We successfully designed and implemented the NU-IRB online system using Google workspace and allows us to evaluate the efficiency of real-time records for each action of every process of all personnel involving investigators, reviewers, and office staff.
Lessons Learned in the Ethics Review and Monitoring of COVID-19 Vaccine Clinical Trials in the Philippines Mr. Pio Justin V. Asuncion, MPH, MOHRE, RN; Ms. Xcyllea Jasmine E. Abanilla, RMT; Ms. Jamie Denisse C. Alcantara; Dr. Cristina E. Torres; and, Ms. Barbara Michelle de Guzman, MSN, RN Background: As the designated central ethics committee by the Vaccine Experts Panel (VEP) for review of COVID-19 Vaccine Clinical Trials (VCTS), the Single Joint Research Ethics Board (SJREB) of the Department of Health has been facilitating the joint ethics review of CVT protocols since 2020. To date, the Board has reviewed a total of 15 clinical vaccine clinical trials: four (4) in 2020 and eleven (11) in 2021. The volume of vaccine clinical trials protocols submitted for review, increased awareness of people about participation in COVID- 19 clinical trials, the ongoing national COVID-19 vaccination plan, and a recent guideline by the Philippine Health Research Ethics Board (PHREB) regarding the use of placebo for CVTs have led to a number of complex issues especially in the implementation aspect of the trials down the site. Objectives: The aim of this paper is to identify the ethical issues and emerging implementation challenges encountered by SJREB in the assessment and monitoring of COVID-19 vaccine trial protocols in the country. It also highlights practical recommendations to address these issues in view of recent guidelines issued by the Philippine Health Research Ethics Board in the conduct of trials that use placebo. Methodology: SJREB analyzed reports from the Primary investigators (PIs), clinical trial sites and Research Ethics Committees (RECs), and issues raised during meetings with stakeholders regarding PHREB guidelines on the use of placebo for CVTs. The issues were categorized according to investigator, clinical trial site, recruitment and implementation issues. Results: The discussions among the SJREB members and representatives from the various participating sites revealed unique implementation challenges at the community level. PI issues: 1. Principal Investigators (PIs), especially seasoned vaccine trialists, are taking on multiple CVTs at the same time which raises questions on potential conflict of interest and competition of recruitment across different sites. Site issues: 1. Recruitment for CVTs are happening at the same sites maintained by the PIs which opens the possibility of “trial shopping”. 2. Local Government Units lament not being informed about CVTs being implemented among their constituents, which possibly points to a lack of community preparation. Recruitment issues: 1. Metro Manila and other main metropolitan areas have already vaccinated more than 85% of its population from the National COVID-19 Vaccination Plan (NCVP), limiting the number of prospective participants.
2. Hired professional recruiters were reported to have been cross-recruiting from communities outside of the planned recruitment sites. 3. Hired recruiters have been engaging in undue inducement when recruiting participants for CVTs. Implementation Issues: 1. As the Philippines aims to vaccinate 1.5 Million of its population daily, CVT participants in the placebo group may already be eligible to receive a COVID-19 vaccine from the NCVP. Recommendations: 1. Protocol and consent review: a. Protocol provisions about safety of participants in the intervention and placebo arms b. Comprehensive information in the informed consent form about safeguards related to placebo use c. Provisions for re-consent and unblinding procedures of participants when they become eligible for COVID-19 vaccines that are part of the national roll-out 2. Other requirements: a. Prescribed COI declaration template which includes current CVTs and other CTs being implemented by the PIs, clinical trial sites, target sample size, stage of implementation, and percentage of time allotted by the PI per CVT. b. Training of the trial team about community recruitment for CVTs, especially of the recruiters and community organizers. c. Submission of local government units (LGU) consent or permission at least from the Municipal Health Office (MHO) prior to the commencement of the trial. d. Submission of progress report every 6 months from the date of approval. Keywords: COVID-19 vaccine clinical trials, Common ethical issues
Institutional Bioethics Committee Evaluation and Accreditation System of the Republic of Korea Yeong Hee Cho, MPH Deputy Director General Unit office for evaluation and accreditation of Institutional Bioethics Committee Korea National Institute For Bioethical Policy Background: Korea’s National Institutional Bioethics Committee evaluation and accreditation is operated based on Article 14 (1) of the Bioethics and Safety Act : “The Minister of Health and Welfare may evaluate and accredit the organization, operation performance, etc. of each IRB on a regular basis”. Korea National Institute for Bioethics Policy (KoNIBP) has been designated by the Ministry of Health and Welfare for the evaluation and accreditation of IRB, thereby formed the IRB evaluation and accreditation office under KoNIBP to operate the national evaluation and accreditation system. Pursuant to “IRB Quality Management Plan, which specifies the evaluation and accreditation into ‘Step 1 Pilot Evaluation (2013-2015) → Step 2 Mandatory Evaluation (2016-2019) → Step 3 Accreditation Implementation (2021~)’, in the 「Measures to Establish International Standard of Bioethics」 approved by National Bioethics Committee, KoNIBP conducts evaluation and accreditation by steps. Objective: The Institutional Bioethics Committee Evaluation and Accreditation aims to protect human subjects and create an ethical research environment by strengthening and supporting the role of the IRB as an autonomous ethical body within the institution, creating an international bioethical environment and enhancing credibility. Evaluation & Accreditation Standards: A total of 40 standards were established in accordance with the evaluation and certification standards of Article 10 (1) of the Enforcement Decree of the Bioethics and Safety Act. The standards are divided into two domains: (1) Institutions, and (2) IRB. In detail, there are standards for Establishment and Independence of IRB (4 standards), Institutional Support (5 standards), Composition (5 standards), Operation (11 standards), and Roles and Functions (14 standards). Current status of evaluation and Accreditation Operation: As of 2021, 53 institutions are being evaluated for accreditation. Evaluation and accreditation are planned to be implemented for 99 institutions in 2022 and 159 institutions by 2023.
Biobank Research Regulations And Guidelines In Low-And Middle-Income Countries In Southeast Asia: A Scoping Review Kuen Yei Chin1*, Mohammad Firdaus Bin Abdul Aziz2 , Kee Seong Ng3 1. Master of Health Research Ethics (MOHRE), Faculty of Medicine, University of Malaya 2. Faculty of Law, University of Malaya. 3. Faculty of Medicine, University of Malaya Introduction: Biobank is a collection of human biological materials and data generated by specimen analysis. They are crucial resources for biomedical research. Recent years have seen a surge in efforts by low-and middle-income countries (LMICs) involved in biobank research, and this includes countries in Southeast Asia (SEA). There have been active global collaborative biobank research projects, which involve sharing of human biological material (HBM) and data. Future and secondary uses of collected biological materials raise ethical concerns with respect to informed consent, privacy, and international HBM and data sharing. Therefore, it is important to address these ethical concerns with proper guidelines and regulations. Methods: This study is a scoping review using the six-stage framework by Arksey and O'Malley, to examine the extent, range and nature of research activity and to identify research gaps in the existing documents. To increase methodological transparency and uptake of research findings, the PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-analyses extension for scoping reviews) checklist is used to report the review results. Results: Among the SEA countries, only Malaysia, Thailand, and the Philippines are selected due to the absence of human biobank research in Cambodia, Myanmar, and Laos and the limitation in documents in the English language for Vietnam and Indonesia. In total, 26 documents were identified for final analysis. For informed consent, the guideline in Malaysia recommends blanket consent and multi-layered consent, Thailand employs blanket consent even though the terms is not stated specifically, and the Philippines recommends specific consent. The Philippines follows the recommendation by the Declaration of Taipei by the World Medical Association and the CIOMS Guidelines i.e., broad and specific consent. In terms of privacy and security mechanism, all the jurisdictions recommend the process of coding and anonymisation before sharing the HBM and data for secondary uses. For sharing of HBM and data, the data protection laws applied but the Malaysian data protection law does not apply to the public sector. Material Transfer Agreement is also required in Thailand and the Philippines although this position is not clear in Malaysia. Conclusion: The most significant finding is the heterogeneity of the informed consent models for biobank research suggested in the guidelines in Malaysia, Thailand, and the Philippines. The Malaysian and Thailand position for blanket consent conflicts with international guidelines whereas the Philippines follows the recommended specific consent. The positions adopted for privacy and security mechanism and sharing of HBM and data are rather homogenous and follow most of the standards in the international guidelines. The policymakers should ensure that the regulations are reviewed periodically to accommodate changes and provide guidance that is certain, unambiguous, and up to date for novice
researchers in biobank research and ethics committee members. Given the “regulatory patchwork” pattern, Malaysia and Thailand could adopt the national research law such as the Philippines whereby all relevant policymakers in different ministries would be involved to review the regulatory periodically.
Why should psychiatrists and psychologists of Sri Lanka should agree soon Tina Solomons, Clinical Psychologist/ Senior Lecturer - General Sir John Kotelawala Defence University (KDU), Sri Lanka [email protected] At present psychologists have not been incorporated into the government health service of Sri Lanka. National Mental health policy developed for 2005- 2015 has stated the requirement to have at least two clinical psychologists per district. (Ministry of Health Sri Lanka, n.d.) The author was an undergraduate when this said policy document was forwarded. Even when the policy document was done, discussions were being carried out in the ministry of health regarding incorporating clinical psychologists into the health ministry cadre. Despite, continued discussions and frictions, psychologists and psychiatrists of Sri Lanka have been unable to agree on how best to incorporate psychologists into the health ministry cadres. The need for mental health services remains high in the country as evidenced by high suicide rates. (Senavirathna & Sanjeewani, n.d.) Therefore in the recent past, there has been a proliferation of psychological professionals such as counsellors, therapists, and psychologists and educational and training programs aimed at producing such professionals. Yet, there is no professional body to govern the practice of these professionals or the training programs that produce them. Therefore, there is no legally binding code of ethics to make sanctions when unethical practices are reported. Only clinical psychologists are provided registration by the Sri Lanka Medical Council (SLMC) and therefore, other titles such as psychologist, counsellor, etc are being freely used by individuals who are not sufficiently trained. In addition to this, there are no continued professional development opportunities for these practitioners. Most registered clinical psychologists practice in renowned private hospitals of Colombo and the majority of Sri Lankans cannot afford to obtain their services. There are set guidelines for the practice of psychological professionals in the world.(Australian Counselling Association, 2013; “Ethical principles of psychologists and code of conduct.,” 2002) The current evidence base provides sufficient evidence for the importance of psychological services in mental health. If psychologists are successfully integrated into the current health system of Sri Lanka, they can take the lead in providing professional standards for other psychological professionals such as counsellors. Therefore, it is of paramount importance that psychiatrists and psychologists reach an agreement on integrating each other’s services. By lack of such agreement, it is the patients who require mental health services who would not receive appropriate psychotherapeutic treatments. As patients’ best interest is practitioner ethical responsibility, reaching an agreement to work together, may also be seen as an ethical responsibility. References Australian Counselling Association. (2013). Australian Counselling Association - Code Of Ethics and Practice. Australian Counselling Association - Code of Ethics and Practice, April, 1–16. www.theaca.net.au Ethical principles of psychologists and code of conduct. (2002). The American Psychologist,
57(12), 1060–1073. https://doi.org/10.1037/0003-066X.57.12.1060 Ministry of health Sri Lanka. (n.d.). Policy Repository-Ministry of Health-Sri Lanka The Mental Health Policy of Sri Lanka Preamble. Senavirathna, H. A. C. D., & Sanjeewani, R. M. S. (n.d.). Demographic characteristics of suicides in Sri Lanka from 2006 to 2018.
ADHERENCE AND AWARENESS ABOUT INDIAN NATIONAL ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTS AMONG HEALTH MULTIDISCIPLINARY FACULTY FROM SOUTHERN INDIA: A CROSS-SECTIONAL SURVEY AND SUBGROUP ANALYSIS [email protected] Madhavrao C1, Mythili Bai K2 1Associate Professor, Dept. of Pharmacology, All India Institute of Medical Sciences [AIIMS], Mangalagiri, India (Institution of National Importance, Under Ministry of Health & Family Welfare [MoHFW], Govt. of India), 2Associate Professor, Dept. of Physiology, Dr. Pinnamaneni Siddhartha Institute of Medical Sciences & Research Foundation [PSIMS], Chinaoutpalli, Andhra Pradesh, India AIM AND OBJECTIVES: To study the adherence and awareness about Indian national ethical guidelines for biomedical research on human participants among health multidisciplinary faculty from a teaching tertiary care centre from southern part of India MATERIALS AND METHODS: The research proposal was approved by the Institutional Review Board (IRB). After due approval, the written informed consent was obtained from the eligible study participants for enrollment into the study. The study was done in a southern teaching tertiary care centre and hospital involving medical, dental and nursing faculty as target population (n=112). A prevalidated structured questionnaire was used to get the relevant data as per the aims and objectives of the study. The collected data was then entered into the ‘Microsoft office excel 2007’ and was represented as frequency and percentage(s) and appropriate statistical tests (One Way ANOVA/ Kruskal-Wallis) were performed for statistical significance with (P<0.05). RESULTS: The study showed that, majority of the study participants were able to define and mark the correct response(s) for questions related to the various components (Informed Consent Process, Ethics in Clinical Trials, Genomic Research, Organ Transplantation etc) as highlighted in the Indian Council of Medical Research (ICMR) of ‘National Ethical Guidelines for Biomedical Research on Human Participants’. The awareness and knowledge was more among medical faculty when compared to the dental and nursing faculty (P<0.05). The adherence to ICMR ethical guidelines in research varied among multidisciplinary health faculty and it was statistically significant among dental faculty when compared to the medical/nursing faculty (P <0.01) and there was no significant difference (P>0.05) was found among medical and nursing faculty. It was also revealed that, more than 90% of the study participants opined to undergo further training as well as update on biomedical research ethics principles through CME, workshops, symposia or conferences etc. Meanwhile, the practical adherence of biomedical research ethics principles among study participants was found to be less than as expected. This study also revealed that, only less than 25% study participants had undergone training in either Good
Clinical Practice (GCP)/ Ethical principles in biomedical research involving human participants. CONCLUSION: This study concluded that, there was a statistically significant adherence to the ICMR ethical guidelines among dental faculty when compared to the medical and nursing faculty; with better awareness among medical fraternity with positive attitude towards the training in ethical principles for biomedical research on human participants among all multidisciplinary faculty in a teaching tertiary care centre and hospital from southern part of India. KEY WORDS: Ethics, ICMR Guidelines, Medical/Dental/Nursing Faculty, Adherence, GCP
Assessment of Ethics and Professionalism among the Medical Undergraduate Students in a Tertiary Care Teaching Hospital in India: A Questionnaire Based Cross-sectional Survey [email protected] Background: Awareness about how to act appropriately in challenging situations that require integration of clinical judgement, ethical reasoning and careful communication in clinical practice is must for every doctor. Medical Council in India provides a code of conduct for practicing doctors, however, formal training of undergraduate medical students with respect to professionalism and ethics related to patient care is lacking. New competency-based curriculum which has been implemented from 2019 -2020 will address this need for the future doctors. The study was conducted in 2018 prior to implementation of new curriculum with an objective to assess knowledge of undergraduate (UG) medical students regarding ethics and professionalism. Material & Methods: In a Cross-sectional questionnaire-based survey, students of second, third MBBS and interns of 2018-19 year were enrolled after taking informed consent and institutional ethics committee permission. A questionnaire was developed and validated by investigators (Content Validity Ratio= 0.83), It was a composite questionnaire with two domains – A & B. Domain A had 11 MCQs pertaining to knowledge on ethics (6) and professionalism (5) while Domain B had 21 Likert scale questions for the assessment of attitude towards professionalism, developed by medical university of South Carolina (used with permission). Ethical and moral standards, humanistic values, accountability, self-reflection and subordinate self-interests were the elements for assessment in the Domain B. The data obtained was analysed by descriptive statistics. Domain A & B scores were compared using Kruskal Wallis and Chi-square test respectively. Analysis was done using Graphpad Instat software. The level of significance was set at 0.05. Results: Total 192 students and interns were enrolled in the study (Second year = 95, third year = 67 and interns = 30). In Domain A, composite mean score for all students together was less than 50% and among the groups, there was an increasing trend in the mean score over the years, however the change was not statistically significant. In Domain B, Desirable responses were ranging from 56%-86%, with Humanistic Value having highest positive responses. There was no significant difference among the groups. Conclusion: The study showed that the awareness of students regarding ethics and professionalism was less than 50% and there was marginal increase in the awareness with the increase in professional experience. Attitude for professionalism although is positive, there is no difference among junior and senior students and interns indicating that there is scope for improvement with intensive training in the new curriculum.
DESCRIPTION KNOWLEDGE LEVEL COMMUNITY PREVENTION COVID-19 IN RT 005 RW 003 BINONG VILLAGE, TANGERANG REGENCY Maria Imakulata1, Monika Selfi Epriani2, Natasha O. Yulianto3, Ballsy C. A. Pangkey4, Sumiaty Aiba5 1 Universitas Pelita Harapan, Faculty Of Nursing, Lippo Karawaci Tangerang 2Universitas Pelita Harapan, Faculty Of Nursing, Lippo Karawaci Tangerang 3Universitas Pelita Harapan, Faculty Of Nursing, Lippo Karawaci Tangerang 4Universitas Pelita Harapan, Faculty Of Nursing, Lippo Karawaci Tangerang 5Universitas Pelita Harapan, Faculty Of Nursing, Lippo Karawaci Tangerang Correspondence: Sumiaty Aiba Gd. FK-UPH Lt. 2 Jl. Boulevard Jendral. Sudirman (Samping Rs. Siloam), Lippo Karawaci, Tangerang, Telp.(021) 54210130-54210131, Hp (+62) 85256385535, Fax. (021) 54210133, email:[email protected] Abstract Background: Coronavirus Disease 2019 (covid 19) is an infectious disease originating from SARS-CoV-2. The World Health Organization officially declared COVID-19 as a pandemic that causing global health problems. The knowledge level community of the prevention still lacking covid 19 in Indonesia reviewed of the rate case covid 19 the more day increasing. the prevention in question is such as taking steps to wash hands properly, using masks correctly, and limiting distance physical or physical distancing correctly. Research objectives: to determine the level of public knowledge of prevention covid 19 in sub-district Binong, Tangerang. Research methods: uses quantitative research with descriptive design. The sample in this study amounted to 67 respondents. The data analysis technique used is univariate analysis. This research will be conducted on January-April 2020. The result: the level of public knowledge regarding the prevention of covid 19 (3M) in RT 005 RW 003 Binong, Tangerang Regency are good with the knowledge level as many as 87 people (90,6%), the level of knowledge in the understanding of 62 people (64,6%), and the level of knowledge in the application as many as 60 people (62,5%). Conclusion: people in RT 005 RW 003 Binong, Tangerang Regency have a good level of knowledge and application, so it is hoped that it can become one of the basic efforts to break the covid 19 chain. Keywords: Knowledge, Prevention, Covid-19
Experiences of a researcher with diverse stakeholders during the COVID -19 pandemic at a tertiary referral center’ [email protected] Chaudhari VL, Godbole CJ, Konwar M, Bose D, Gogtay NJ Department of Clinical Pharmacology Seth GS Medical College and KEM Hospital, Mumbai, India Abstract: The onset of the COVID-19 pandemic brought to fore investigators doing clinical research all over the world. At our institute which is a tertiary referral center, we are involved in multiple research studies [both academic and regulatory] throughout the year primarily in the area of vaccines and infectious diseases. Early on in the pandemic we were approached by the pharmaceutical industry for studies with repurposed drugs while a few months into the pandemic, we were also approached for regulatory vaccine studies. This resulted in us interacting with the regulator, ethics committees, pharmaceutical industry, study participants and stakeholders within the institution. This paper highlights the myriad challenges that we faced and how we addressed each one of them in the best possible way and ethical lessons learnt which may resonate with investigators worldwide and also bring learnings which can continue beyond the pandemic.
Trade-offs in COVID-19 vaccine characteristics– a discrete choice experiment study in Indian adults Jeffrey Pradeep Raj1, Sukant Pandit1, Dhruve Soni1, Charuta Godbole1, Sheetal S. Kudtarkar1, Malavika Babu2, Melvin Joy2, Jeyaseelan L2, Milind Y. Nadkar1, Nithya J. Gogtay 1Seth GS Medical College & King Edward Memorial Hospital, Mumbai, India 2Christian Medical College, Vellore, India [email protected] Introduction: Currently, India has three COVID-19 vaccines approved for use in adults and many more in the pipeline. Several of their attributes such as duration of protection, long term efficacy, need for a booster dose are yet unknown and not ideal. Against this background, trade- offs are inevitable, - for example the choice of efficacy over safety leading to ethical dilemmas. The present study aimed to identify trade-offs that were deemed acceptable by the Indian adult population while choosing one COVID-19 vaccine over the other. Methods: The study post IEC approval is yet ongoing. All consenting adults of any gender and over the age of 18 years, and Indian citizens are being included. An online link is being circulated in various digital platforms and the study questionnaire comprises of three sections namely: (1) Socio-demographic characteristics, (2) Medical and COVID related history and, (3) Discrete choice experiment with six pairs of hypothetical vaccines. An example of a hypothetical vaccine pair is appended at the end of the abstract. Each COVID vaccine is described by a fixed set of attributes such as effectiveness, side effects, cost, number of doses, duration of protection, place of origin and risk of death. Each attribute has multiple pre-defined levels within them. For example, the levels within the efficacy attribute will be 50%, 70% and 90%. Thus, each vaccine in a pair will be described by all the attributes but with different levels within each attribute. This will enable us to identify the attributes that the Indian adults are willing to trade off. Incompletely filled survey forms or those forms that fails to clear the internal quality standards decided apriori will be excluded from analysis. Anticipated Results: We aim to obtain responses from at least 10,000 participants. As on date, 3000 plus responses have been received. This study will help identify the preferences/ acceptable trade-offs of various COVID-19 vaccine attributes in India which will in turn inform policy makers and vaccine manufacturers about predictors for the country’s vaccination and its success [or lack thereof].
Annexure – 1: A hypothetical vaccine pair Attributes Vaccine A Vaccine B Effectiveness 90% 70% Duration of protection 1 year 5 years Number of Injections Three doses One dose Common Side effects No common side effects Fever and body ache 1- anticipated 2 days Risk of severe/ serious One in one lakh One in one lakh side effects Vaccine origin Imported India Cost per injection Rs.500 Rs.2000 Which among the above vaccines would you prefer? Vaccine A Vaccine B Neither vaccine
Animal Research in COVID-19 Vaccine: The Ethical Concerns and Implication to Future Animal Research Lui Sze Chiang1,2*, Sharifah Zamiah Binti Syed Abdul Kadir3, Mohammed Abdullah Mahdi Alshawsh3 1. Faculty of Medicine, University of Malaya (UM), Kuala Lumpur, Malaysia. 2. Clinical Research Centre (CRC), Hospital Tunku Azizah, Kuala Lumpur, Malaysia. 3. Department of Pharmacology, Faculty of Medicine, University of Malaya (UM), Kuala Lumpur, Malaysia. Introduction: Since the dawn of the Coronavirus disease (COVID-19) pandemic, the global healthcare system has focused on finding the cure, including developing a vaccine as a public health measure. International collaborations were expedited to establish the appropriate animal models for COVID-19, including the use of rodents, ferrets, pigs, and primates to understand the pathophysiology of the disease and accelerate vaccine testing. This overview focuses on the ethical concerns with animal research during the pre-clinical stage of COVID-19 vaccine development and its implication for future animal research. Methodology: A literature search on animal research of traditional vaccine development and during fasttrack COVID-19 vaccine development and related ethical issues was performed from June to September 2021. PubMed and Google Scholar databases were searched using keywords such as COVID-19 vaccine, animal studies, and ethical issues or concerns. Results: The pandemic has caused tremendous pressure on scientists worldwide to produce a reliable and effective vaccine with the least side effects in the shortest time. This has led to a shorter time frame for pre-clinical testing, which reduced from 6-24 months to 4-8 months. Several processes were being exempted compared to the regular practices in traditional vaccine development. Only three types of animal testing: immunogenicity, challenge study, and toxicity testing, were done; even so, it was concurrently done on rodents and non-human primates(NHP). Testing on NHP also was conducted concurrently with first-in-human trials before NHP studies were concluded. There was a point in time where there was a severe shortage of NHP even though NHP might not be the best animal model for COVID-19. Bypassing certain animal studies undoubtedly saves time, effort, and money; this might bring risk to human participants in clinical trials without knowing the complete safety profile of the vaccines. Vaccine manufacture started concurrently with pre-clinical testing, which is not common in traditional vaccine development, and this diminishes the importance of animal testing for human safety. It is crucial to properly monitor animal research, especially during a pandemic where the focus is shifted to discover the cure due to the disease burden. Escaping certain toxicity testing in animals such as genotoxicity, teratogenicity, reproductive toxicity, and repeated dose toxicity will impact human safety. However, every animal used in pre-clinical trials
should be justified with solid scientific reasons, and to reduce the number of animals used, scientists worldwide should develop a centralized database to share the latest data. Besides focusing on human research, regulators such as the World Health Organization (WHO) and Organisation for Economic Co-operation and Development (OECD) should also act as a centralized regulatory agency for animal research. Conclusion: Animal welfare should be given extra attention, particularly during a pandemic, as they become more vulnerable to be sacrificed in the name of science for the benefit of humankind. Therefore, researchers should strictly adhere to the 3Rs principles (replacement, reduction, and refinement) to ensure that humane animal work is purported at all times. We should apply the lessons learned in this pandemic and solve the possible ethical issues before the next pandemic.
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