{"title":"巴基斯坦科研伦理治理现状分析。","authors":"Aamir Jafarey, Sualeha Shekhani, Faiz Raza, Sumera Naz","doi":"10.26719/emhj.23.069","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Aims: </strong>To evaluate the research ethics governance mechanisms at national level and at key healthcare institutions in Pakistan.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":11411,"journal":{"name":"Eastern Mediterranean Health Journal","volume":"29 7","pages":"500-507"},"PeriodicalIF":1.7000,"publicationDate":"2023-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Situation analysis of research ethics governance in Pakistan.\",\"authors\":\"Aamir Jafarey, Sualeha Shekhani, Faiz Raza, Sumera Naz\",\"doi\":\"10.26719/emhj.23.069\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Aims: </strong>To evaluate the research ethics governance mechanisms at national level and at key healthcare institutions in Pakistan.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>\",\"PeriodicalId\":11411,\"journal\":{\"name\":\"Eastern Mediterranean Health Journal\",\"volume\":\"29 7\",\"pages\":\"500-507\"},\"PeriodicalIF\":1.7000,\"publicationDate\":\"2023-07-31\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Eastern Mediterranean Health Journal\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.26719/emhj.23.069\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"HEALTH CARE SCIENCES & SERVICES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Eastern Mediterranean Health Journal","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.26719/emhj.23.069","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
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.
期刊介绍:
The Eastern Mediterranean Health Journal, established in 1995, is the flagship health periodical of the World Health Organization Regional Office for the Eastern Mediterranean.
The mission of the Journal is to contribute to improving health in the Eastern Mediterranean Region by publishing and publicising quality health research and information with emphasis on public health and the strategic health priorities of the Region. It aims to: further public health knowledge, policy, practice and education; support health policy-makers, researchers and practitioners; and enable health professionals to remain informed of developments in public health.
The EMHJ:
-publishes original peer-reviewed research and reviews in all areas of public health of relevance to the Eastern Mediterranean Region
-encourages, in particular, research related to the regional health priorities, namely: health systems strengthening; emergency preparedness and response; communicable diseases; noncommunicable diseases and mental health; reproductive, maternal, child health and nutrition
-provides up-to-date information on public health developments with special reference to the Region.
The Journal addresses all members of the health profession, health educational institutes, as well as governmental and nongovernmental organizations in the area of public health within and outside the Region.