Bangladesh Climate Research: The Role of IRBs

THE EFFECTS OF CONFLICTS OF INTEREST on the conduct of human research have been roundly debated, but less attention has been paid to the role of Institutional Review Boards (IRBs) in their identification and management. Government and private policy recommendations disagree about IRBs' responsibility in this area. A survey focusing on respondents' attitudes and behaviors regarding consideration of investigator and institutional financial relationships with industry when reviewing research protocols was mailed to a random sample of 893 IRB members and 316 IRB chairs at 115 academic institutions (response rates of 67% and 72%, respectively). More than half of IRB members and chairs felt that industry relationships posed a moderate or big problem for research integrity nationally, and about one-third thought such relationships were a problem at their own institution. Approximately two-thirds felt that investigator-industry relationships should be considered when reviewing protocols regardless of whether they are deemed to be conflicts of interest. While more than 90% of IRB members and chairs believed that investigators' relationships should be disclosed to research participants, 61% of members and chairs reported that these relationships were not always disclosed to participants. While more than 80% believed that institutional relationships should be disclosed to research participants, only 39% of members and chairs said this happened all the time. Some beliefs of IRB members and chairs are at odds with recommendations to limit the role of IRBs in the management of potential investigator conflicts. Lack of unambiguous guidelines has led to inconsistent practices among IRBs.

Background, The regulation of research involving human subjects through the creation of Institutional Review Boards (IRBs) aims to consolidate a culture of respect for human rights, mainly of research subjects. Method, This study discusses the regulations for the development of research involving human subjects and the role of IRBs in Brazil. Results, More than half of the IRBs are located in the South and Southeast, where IRBs are being consolidated. Progress is being made in Brazil as a result of Resolutions 196/96 and 466/12, however, challenges continue. In response to deficits in researchers’ and research institutions’ appreciation of, and lack of commitment to, ethical research practice IRBs have an important educative role. IRBs need to make their work transparent for the entire community and demonstrate the ability to enhance the organizational climate of institutions. Conclusions, Some deficits exist in the scientific community’s understanding of the importance and role of IRBs, as well as in the excessive bureaucratization of the relationship between researchers and IRB members. In a country with so many regional differences, despite national regulations, IRB members should recognize and effectively deal with local particularities to guarantee respect for research subjects’ dignity.

BackgroundBiomedical research is overseen by numerous Institutional Review Boards (IRBs) in Singapore but there has been no research that examines how the research review process is perceived by the local research community nor is there any systematic data on perceptions regarding the review process or other research ethics processes and IRB characteristics. The aim of this study was to ascertain general views regarding the overall perceived value of ethics review processes; to measure perceptions about local IRB functions and characteristics; to identify IRB functions and characteristics viewed as important; and to compare these views with those of other international studies.MethodsAn online survey was used with the main component being the IRB-Researcher Assessment Tool (IRB-RAT), a validated tool, to evaluate perceptions of ideal and actual IRB functions and characteristics held by Singaporean researchers and research support staff. Data were analysed descriptively first, with mean and SD of each item of IRB-RAT questionnaire reported, excluding the respondents whose answers were unknown or not applicable. The Wilcoxon Sign Rank test was used to compare the ideal and actual ratings of each IRB-RAT item, while the Mann-Whitney U test was used to compare the ratings of each IRB-RAT item between respondents with different characteristics. The Z-test was used to compare the mean ratings of our cohort with the mean ratings reported in the literature. The correlation between our mean ideal scores and those of two international studies also employing the IRB-RAT was examined.ResultsSeventy-one respondents completed the survey. This cohort generally held positive views of the impact of the ethics review process on: the quality of research; establishing and maintaining public trust in research; the protection of research participants; and on the scientific validity of research. The most important ideal IRB characteristics were timeliness, upholding participants’ rights while also facilitating research, working with investigators to find solutions when there are disagreements, and not allowing biases to affect reviews. For almost all 45 IRB-RAT statements, the rating of the importance of the characteristic was higher than the rating of how much that characteristic was descriptive of IRBs the respondents were familiar with. There was a significant strong correlation between our study’s scores on the ideal IRB characteristics and those of the first and largest published study that employed the IRB-RAT, the US National Validation (USNV) sample in Keith-Spiegel et al. [19].ConclusionsAn understanding of the perceptions held by Singaporean researchers and research support staff on the value that the ethics review process adds, their perceptions of actual IRB functions and characteristics as well as what they view as central to high functioning IRBs is the first step to considering the aspects of the review process that might benefit from improvements. This study provides insight into how our cohort compares to others internationally and highlights strengths and areas for improvement of Singapore IRBs as perceived by a small sample of the local research community. Such insights provide a springboard for additional research and may assist in further enhancing good relations so that both are working towards the same end.

It is essential that anyone involved in research involving human subjects be familiar with the purpose and role of institutional review boards. Institutional review boards are designed, first and foremost, to protect human research subjects by overseeing the implementation of federal regulations regarding protection of human subjects. The federal government requires institutional review board approval for any human subject research that receives federal funding, and many scholarly journals require proof of institutional review board approval of the research before publication. In this article, the answers to 10 frequently asked questions about the role of institutional review boards highlight the important contributions made by institutional review boards to the conduct of ethically sound research. The aim is to generate a working knowledge of the institutional review board's function that can be used by every researcher contemplating working with human research subjects. This is the first in a series of 3 articles examining common issues in research ethics.

It is essential that anyone involved in research involving human subjects be familiar with the purpose and role of institutional review boards. Institutional review boards are designed, first and foremost, to protect human research subjects by overseeing the implementation of federal regulations regarding protection of human subjects. The federal government requires institutional review board approval for any human subject research that receives federal funding, and many scholarly journals require proof of institutional review board approval of the research before publication. In this article, the answers to 10 frequently asked questions about the role of institutional review boards highlight the important contributions made by institutional review boards to the conduct of ethically sound research. The aim is to generate a working knowledge of the institutional review board's function that can be used by every researcher contemplating working with human research subjects. This is the first in a series of 3 articles examining common issues in research ethics.

ABSTRACTBackground: Institutional review boards (IRBs) have been criticized for inconsistency, delay, and bias, suggesting an opportunity for quality improvement. To aid such quality improvement, this study aimed at determining IRB members’ and investigators’ priorities regarding IRB review at 10 Veterans Affairs (VA) IRBs. Methods: Six hundred and eighty anonymous Internet surveys were sent to 252 IRB members and staff, and to 428 principal investigators and project coordinators at 9 VA Medical Centers and the VA Central IRB. Surveys included 27 statements adapted from Koocher and Kieth-Spiegel's IRB-RAT describing IRB activities or functions (e.g., “An IRB that is open to reversing its earlier decisions”). Respondents indicated how each statement described both their “ideal” and “actual” IRBs. The difference between the ratings of the actual and ideal IRBs was calculated for each item, along with estimated 95% confidence intervals. Ratings outside those intervals indicated activities or functions with relatively good or poor performance compared to the ideal IRB. Results: Three hundred and ninety (57.4%) responses from 165 IRB members and staff (65.5%) and 225 investigators and project coordinators (52.6%) demonstrated that these IRBs were closest to the ideal when protecting human subjects, treating investigators with respect, and taking appropriate action for alleged scientific misconduct. The IRBs were furthest from the ideal regarding duplicative forms, timeliness of review, and provision of complete rationales for decisions. Although IRB members reported near-ideal willingness to reverse earlier decisions, investigators rated this capacity far from ideal. Investigators rated IRB members’ knowledge about procedures and policy as nearly ideal, but IRB members themselves rated this aspect far from ideal. Noteworthy site-level differences in the ratings of IRB functions and activities were also identified. Conclusions: Although these VA IRBs perform well in some areas, these data support the need for ongoing quality improvement. The described method of administering and analyzing the IRB-RAT may help identify and monitor site- and activity-specific initiatives for quality improvement.

Research with human subjects is essential for most clinical and social science research. As such, the ethical treatment of subjects, including the role of Institutional Review Boards (IRBs), is of paramount concern. The prevailing system of IRBs in the United States reflects an integrated approach in which research organizations have their own local IRB. Recent regulatory changes and a few high-profile problems have prompted proposals for greater investments in IRBs. We conducted regression analyses, looking at how IRB size was associated with IRB costs (economies of scale). We studied data from a cross-sectional survey. We studied IRBs at Veterans Affairs (VA) and VA-affiliated medical centers (n = 109); 81 (73%) IRB administrators completed the survey. Fourteen of the administrators had missing data and were excluded from final analysis, leaving a sample of 67. The primary dependent variable was IRB costs in 2001, which we estimated from the survey. Independent variables included IRB size measured as the number of actions (ie, number of initial reviews, amendments, continuing/annual reviews, and harms/adverse event reports) reviewed by the IRB in the last year. The results indicate that very large economies of scale exist, especially for IRBs that handle fewer than 150 actions per year. A discussion of the costs of benefits of having 3000 to 5000 local IRBs in the United States is warranted because other organizational arrangements could be economically and socially advantageous.

Most countries, including Botswana, have established Institutional Review Boards (IRBs) to provide oversight of research involving human beings. Although much has been published on the structure and function of IRBs around the world, there is less literature that empirically describes the perspectives of stakeholders in low- and middle-income country (LMIC) settings regarding IRB processes. In this study, we employed primarily quantitative methods to examine the perceptions of researchers at the University of Botswana (UB) about the review of research protocols by local IRBs. Data were collected using a web-based survey (SurveyMonkey1). This was a preliminary effort to document some of the emerging experiences of researchers with ethics review in a context where both research and research oversight are relatively new. Findings from 85 researchers indicate that researchers recognized the need for an IRB to review all human research protocols, expressed the need for research ethics training, experienced high rates of approval at government ministries and UB, and generally believed that ethics review processes can help researchers themselves better understand and appreciate research ethics in general. Though only about one-quarter of respondents reported a more positive view of research ethics after interacting with the UB IRB, 56.5 percent reported no change. In contexts where IRBs have recently been established, it can be particularly important to document the perspectives of researchers in order to align expectations with capabilities, and identify areas where IRBs can improve operations. Future efforts to advance research ethics and ethical review in Botswana should include establishing research ethics training requirements and courses for researchers, increasing investment in IRBs and their training, further developing institutional and national research ethics policies, and formalizing agreements between IRBs and others involved in research oversight in the country to support coordinated review.

Institutional review boards (IRBs) are integral to the U.S. system of protection of human research participants. Evaluation of IRBs, although difficult, is essential. To date, no systematic review of IRB studies has been published. We conducted a systematic review of empirical studies of U.S. IRBs to determine what is known about the function of IRBs and to identify gaps in knowledge. A structured search in PubMed identified forty-three empirical studies evaluating U.S. IRBs. Studies were included if they reported an empirical investigation of the structure, process, outcomes, effectiveness, or variation of U.S. IRBs. The authors reviewed each study to extract information about study objectives, sample and methods, study results, and conclusions. Empirical evidence collected in forty-three published studies shows that for review of a wide range of types of research, U.S. IRBs differ in their application of the federal regulations, in the time they take to review studies, and in the decisions made. Existing studies show evidence of variation in multicenter review, inconsistent or ambiguous interpretation of the federal regulations, and inefficiencies in review. Despite recognition of a need to evaluate effectiveness of IRB review, no identified published study included an evaluation of IRB effectiveness. Multiple studies evaluating the structure, process, and outcome of IRB review in the United States have documented inconsistencies and inefficiencies. Efforts should be made to address these concerns. Additional research is needed to understand how IRBs accomplish their objectives, what issues they find important, what quality IRB review is, and how effective IRBs are at protecting human research participants.

Among the first tasks in a collaboration between Tufts University and community organizations in Somerville, MA, was designing an interview instrument to assess occupational health needs among immigrant workers. Human subjects protections was a critical issue, but community partners were not well informed about the need for such protections or the role of the institutional review board (IRB). During research meetings, members of the team from Tufts trained community collaborators to work with research participants and organized a presentation by a key university IRB administrator. We present findings from the process evaluation of this project and suggest ways to (1) assess community partners' understanding about working with research volunteers, (2) train collaborators, and (3) involve IRBs.

Guidelines for Institutional Review Boards (IRBs) or research ethics committees exist at national and international levels. These guidelines are based on ethical principles and establish an internationally acceptable standard for the review and conduct of medical research. Having attained a multinational consensus about what these fundamental guidelines should be, IRBs are left to interpret the guidelines and devise their own means of implementing them. Individual and community values bear on the interpretation of the guidelines so different IRBs attain different levels of effectiveness. In the Caribbean and Pan American regions there are few IRBs. Obstacles to the establishment and function of IRBs are exacerbated in developing regions like these by differences in language, literacy, and local value systems; education, administrative expertise, facilities, and access to information are also limited. A regional IRB network might facilitate more uniform ethical review in developing countries, and simplify IRB procedures.

Tensions between researchers and ethics committees have been reported in several institutions. Some reports suggest researchers lack confidence in the quality of institutional review board (IRB) reviews, and that emphasis on strict procedural compliance and ethical issues raised by the IRB might unintentionally lead to delays in correspondence between researchers and ethics committees, and/or even encourage prevarication/equivocation, if researchers perceive committee concerns and criticisms unjust. This study systematically analyzed the efficiency of different IRB functions, and the relationship between efficiency and perceived quality of the decision-making process. The major purposes of this study were thus (1) to use the IRB Metrics developed by the Faculty of Tropical Medicine, Mahidol University, Thailand (FTM-EC) to assess the operational efficiency and perceived effectiveness of its ethics committees, and (2) to determine ethical issues that may cause the duration of approval process to be above the target limit of 60 days. Based on a literature review of definitions and methods used and proposed for use, in assessing aspects of IRB quality, an “IRB Metrics” was developed to assess IRB processes using a structure-process-outcome measurement model. To observe trends in the indicators evaluated, data related to all protocols submitted to the two panels of the FTM-EC (clinical and non-clinical), between January 2010–September 2013, were extracted and analyzed. Quantitative information based on IRB Metrics structure-process-outcome illuminates different areas for internal-process improvement. Ethical issues raised with researchers by the IRB, which were associated with the duration of the approval process in protocol review, could be considered root causes of tensions between the parties. The assessment of IRB structure-process-outcome thus provides a valuable opportunity to strengthen relationships and reduce conflicts between IRBs and researchers, with positive outcomes for all parties involved in the conduct of human-subject research.

Background and importanceIt is the responsibility of institutional review boards (IRBs) and hospital pharmacists, as members of these boards, to review a research proposal and ensure that adequate informed consent...

Alignment of municipal climate change and urban forestry policies: A Canadian perspective

This article examines Malaysia's response to the challenges of climate change after a decade of implementation of the National Climate Change Policy. The evaluation of the effectiveness of Malaysia's Climate Change Policy is still lacking in identifying the shortcomings of a policy to serve as a reference for the formulation of new policies, especially those related to climate change policies in Malaysia. Through the analysis of secondary data from government reports, scholarly publications, and international data sources, the study aims to assess Malaysia's success in reducing greenhouse gas emissions, raising public awareness, and adapting to climate change. By using a document analysis approach, the study found that there has been an increase in emissions from several sectors, but there has been significant progress in reducing emissions through renewable energy initiatives and energy efficiency policies. The results of this study show that Malaysia's Climate Change Policy has strengthened the country's ability to adapt to climate change. However, there is still room for improvement in integrating more effective mitigation and adaptation strategies. The implications of this study are important for the development of knowledge and the formulation of public policies that are more responsive to global and local climate change challenges. The study recommends that Malaysia continue to scale up mitigation and adaptation efforts, with a focus on improving the efficiency of resource use and the application of environmentally friendly technologies to support sustainable and low-carbon development.