AJOB primary research最新文献_第9页

Exploring the Obligation to Inform: Disclosing the Purpose and Benefits of Research in an Increasingly Commercial Research Environment 探索告知的义务:在日益商业化的研究环境中披露研究的目的和利益

AJOB primary research Pub Date : 2011-01-01 DOI: 10.1080/21507716.2011.565492

A. Cook, H. Hoas

{"title":"Exploring the Obligation to Inform: Disclosing the Purpose and Benefits of Research in an Increasingly Commercial Research Environment","authors":"A. Cook, H. Hoas","doi":"10.1080/21507716.2011.565492","DOIUrl":"https://doi.org/10.1080/21507716.2011.565492","url":null,"abstract":"This article draws on a subset of data from an empirical study supported by the National Science Foundation. The study explored how institutional review boards (IRBs) fulfill their obligations to oversee research that involves human subjects. The subset of data is used to discuss two themes that shed light on how IRBs approach issues that may have a bearing on protection of human subjects but that are not well covered by federal regulatory guidance. The authors conducted 40 semistructured, key informant interviews, over a 1-year period, with members of various types of IRBs, including independent, academic/university, hospital, medical school, and community/tribal IRBs. Among the 40 participants, there were 16 chairs (president, administrator) and 24 members, and 17 males and 23 females; most had served as IRB members for more than 5 years. The data from this study indicate that fulfillment of the IRBs’ oversight responsibilities may be undermined by a lack of regulatory guidance as to how much information should be disclosed to the IRB and to research participants about: (a) the purpose of a study including commercial purposes and (b) researcher/institutional compensation. The data suggest that without adequate regulatory guidance, IRBs may be meeting the letter but not the spirit of the federal regulations. The lack of regulatory guidance with respect to these two issues limits the extent to which IRBs can assess the adequacy of the consent process, the effectiveness of the IRB in performing oversight responsibilities, and optimal protection of human subjects.","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"38 1","pages":"34 - 41"},"PeriodicalIF":0.0,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82267339","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 10

Moving Forward With Research Involving Pregnant Women: A Critical Role for Wisdom From the Field 推进涉及孕妇的研究:来自该领域的智慧的关键作用

AJOB primary research Pub Date : 2011-01-01 DOI: 10.1080/21507716.2011.562476

M. Little, A. Lyerly, R. Faden

{"title":"Moving Forward With Research Involving Pregnant Women: A Critical Role for Wisdom From the Field","authors":"M. Little, A. Lyerly, R. Faden","doi":"10.1080/21507716.2011.562476","DOIUrl":"https://doi.org/10.1080/21507716.2011.562476","url":null,"abstract":"Each year, hundreds of thousands of women in the United States confront significant medical illness while pregnant: Hypertension, diabetes, serious psychiatric illnesses, autoimmune diseases such as arthritis and lupus, and even cancers complicate pregnancies. Yet we face a critical dearth of information about how to treat them. Little is known about how drugs work in their bodies, whether those drugs are safe for the fetus, and the extent to which treatment or nontreatment affects maternal and child health (Chambers, Polifka, and Friedman 2008; Fisk and Atun 2008). Recently, a groundswell of attention has begun to highlight the urgent need to garner adequate evidence for the treatment of pregnant women who face illness (Lyerly, Little, and Faden 2008, 2009; Baylis 2010; Macklin 2010). The National Institutes of Health Office of Research on Women’s Health convened a research forum on enrolling pregnant women in research on October 18, 2010 that emphasized both the imperative for and early work on such research1; the Obstetric-Fetal Pharmacology Research Unit (OPRU) Networkand the Microbicide Trials Network have begun to pioneer innovative models for research involving pregnant women.2 The Second Wave Initiative—so named because it calls for a","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"14 1","pages":"15 - 17"},"PeriodicalIF":0.0,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90973694","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The FDA Perspective on the Ethical Barriers of Conducting Research in Pregnant Women FDA对孕妇进行研究的伦理障碍的看法

AJOB primary research Pub Date : 2011-01-01 DOI: 10.1080/21507716.2011.562275

L. Sahin

{"title":"The FDA Perspective on the Ethical Barriers of Conducting Research in Pregnant Women","authors":"L. Sahin","doi":"10.1080/21507716.2011.562275","DOIUrl":"https://doi.org/10.1080/21507716.2011.562275","url":null,"abstract":"The need for data related to medication use in pregnancy, especially for psychiatric medications, is undeniable. Onethird of pregnant women are exposed to medication for psychiatric conditions (American College of Obstetricians and Gynecologists 2008). Untreated psychiatric illness during pregnancy may be associated with preterm birth, low birth weight, increased social withdrawal, and reliance on alcohol and drugs. Pregnant women are an understudied population due to the ethical and medical–legal considerations of harming the fetus. Ironically, it is this fear of harming the fetus that often results in lack of data collection in pregnant women and uninformed prescribing without true knowledge of safety or efficacy. Although randomized controlled trials (RCTs) are the gold standard for safety and efficacy prior to approving new drug applications, these types of studies are not appropriate for pregnant women in most situations due to the ethical consideration of exposing a fetus to the risks of an investigational drug where efficacy has not been clearly demonstrated. In the premarketing setting, reproductive and developmental toxicity data are usually the only data available to inform risk in pregnant women. If there are no other treatment options available for a serious or life-threatening condition, it may be appropriate to study an investigational drug that may benefit the woman or the fetus. In the postmarketing setting, it may be ethically appropriate to include pregnant women in RCTs if there is an established safety database and the drug is already being used by pregnant women. However, in addition to RCTs, other study methods to collect data in pregnant women can provide valuable information without any additional studyrelated risks. Similar to the pediatric population, some estimates of efficacy can often be extrapolated from adult, female populations through pharmacokinetic studies. Safety data can be collected through prospective observational co-","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"16 1","pages":"13 - 14"},"PeriodicalIF":0.0,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89333793","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

Content Analysis of Major Textbooks and Online Resources Used in Responsible Conduct of Research Instruction. 负责任研究性教学主要教材及网络资源的内容分析

AJOB primary research Pub Date : 2011-01-01 DOI: 10.1080/21507716.2011.564263

Alexander A Kon, Debie A Schilling, Elizabeth Heitman, Nicholas H Steneck, James M Dubois

{"title":"Content Analysis of Major Textbooks and Online Resources Used in Responsible Conduct of Research Instruction.","authors":"Alexander A Kon, Debie A Schilling, Elizabeth Heitman, Nicholas H Steneck, James M Dubois","doi":"10.1080/21507716.2011.564263","DOIUrl":"10.1080/21507716.2011.564263","url":null,"abstract":"Instruction in the responsible conduct of research (RCR) is required for all trainees funded by the National Institues of Health (NIH) or National Science Foundation (NSF). A recent Delphi study identified 53 key topics in 7 core areas that RCR education experts felt should be included in this instruction, which is required of many trainees in clinical and translational research. We performed a content analysis of major textbooks and online resources used in RCR instruction to determine the extent to which the 53 key topics identified in the Delphi study are covered by these resources. Textbooks and online resources used in RCR education at Clinical and Translational Science Award institutions were identified via survey. These resources were subjected to a content analysis. The 53 key topics identified in the Delphi study formed the basis of these analyses. We identified 10 textbooks and 1 online resource currently in use. Of the 53 key topics, only 4 were included in all 11 resources, and another 12 were included in 10. Twenty-three topics were covered in fewer than 65% of the resources, and two topics were absent from nearly all. Educators in clinical and translational research should be aware of key topics that are not covered in the RCR textbooks and online resources they may use and should consider augmenting discussion of such topics with other materials.","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"2 1","pages":"42-46"},"PeriodicalIF":0.0,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3135017/pdf/nihms297882.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30012694","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Animal Origins of Surfactant: A Survey of Neonatologists’ Perceptions and Practices Regarding Parent Information Sharing 表面活性剂的动物起源:新生儿科医生对父母信息共享的认知和实践的调查

AJOB primary research Pub Date : 2011-01-01 DOI: 10.1080/21507716.2011.566597

Sean M. Bailey, K. Hendricks-Muñoz, P. Mally

{"title":"Animal Origins of Surfactant: A Survey of Neonatologists’ Perceptions and Practices Regarding Parent Information Sharing","authors":"Sean M. Bailey, K. Hendricks-Muñoz, P. Mally","doi":"10.1080/21507716.2011.566597","DOIUrl":"https://doi.org/10.1080/21507716.2011.566597","url":null,"abstract":"Exogenous surfactants commonly used to treat a variety of neonatal respiratory diseases are derived from either bovine or porcine sources. The extent to which parents are aware of this fact is currently unclear, as is the impact that this may have on familial cultural or religious belief systems. Our primary aims were to assess U.S. neonatologists’ utilization of bovine and porcine surfactant preparations, their views on parent disclosure pertaining to the particular animal origins of exogenous surfactant therapy, and their willingness to provide alternative surfactant preparations based on parental religious preferences. An anonymous Web-based survey was provided to 2,137 neonatologists. There was a 46.9% response rate. We found that 63.4% of respondents used only bovine-derived surfactants, 14.9% exclusively used porcine-based surfactants, and 21.7% used combinations. While 74.3% of neonatologists discussed surfactant use with parents, only 2.2% always discussed its animal origins. When asked, 47.9% of neonatologists believed parental preference for religious reasons would not impact their surfactant choice, 19.4% reported it would affect their choice, and 32.7% said it maybe would. Access to only one surfactant was a major barrier to communication. Results showed that many neonatologists may be open to being inclusive of parents regarding surfactant therapy. Carrying different surfactant types on hospital pharmacy formularies and encouraging physician–parent communication may achieve a more family-centered approach to neonatal care.","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"155 1","pages":"26 - 33"},"PeriodicalIF":0.0,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81725979","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 4

Physician Opinions Regarding Informed Consent for a “Cutting-Edge” Intervention for Critically Ill Neonates 医生对危重新生儿“前沿”干预的知情同意意见

AJOB primary research Pub Date : 2011-01-01 DOI: 10.1080/21507716.2011.567368

C. Wusthoff, C. Feudtner

{"title":"Physician Opinions Regarding Informed Consent for a “Cutting-Edge” Intervention for Critically Ill Neonates","authors":"C. Wusthoff, C. Feudtner","doi":"10.1080/21507716.2011.567368","DOIUrl":"https://doi.org/10.1080/21507716.2011.567368","url":null,"abstract":"New “cutting-edge” medical interventions generally transition from research to the clinical realm after initial studies resolve short-term equipoise, demonstrating greater benefit than harm. During this transition, new interventions’ potential long-term consequences remain uncertain, which is problematic for physicians attempting to obtain appropriately informed consent. In this study, physicians were interviewed regarding their perspectives on the informed consent process for a particular intervention (neonatal therapeutic hypothermia) at a particular historical moment after short-term equipoise had been resolved but before a definitive understanding of this therapy's long-term consequences existed. Thirty neonatologists and pediatric neurologists at the Children's Hospital of Philadelphia were interviewed using a structured tool that quantified agreement with general statements regarding neonatal therapeutic hypothermia and perceptions of different consent processes. Of these, 33% of physicians agreed that neonatal therapeutic hypothermia should only be initiated after obtaining signed informed consent, whereas 37% felt that hypothermia should be initiated as standard emergent treatment. Preference for a more stringent consent process did not correlate with concerns regarding the strength of evidence supporting the intervention, but rather with placing a high value on parental counseling and with believing that children who receive the intervention may be less likely to die but more likely to survive in a severely disabled state. Thus, physicians conceptualized how to obtain consent for a transitional intervention with uncertain long-term consequences based less on strength of evidence and more on concerns regarding their duty to counsel and the potential for long-term disability. We discuss possible solutions for clinicians approaching these challenges.","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"146 1","pages":"18 - 25"},"PeriodicalIF":0.0,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86086052","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

Ethics in Psychiatric Research: A Review of 25 Years of NIH-funded Empirical Research Projects. 精神病学研究中的伦理问题：美国国立卫生研究院（NIH）资助的实证研究项目 25 年回顾》（A Review of 25 Years of NIH-funded Empirical Research Projects）。

AJOB primary research Pub Date : 2011-01-01 Epub Date: 2011-12-06 DOI: 10.1080/21507716.2011.631514

James Dubois, Holly Bante, Whitney B Hadley

{"title":"Ethics in Psychiatric Research: A Review of 25 Years of NIH-funded Empirical Research Projects.","authors":"James Dubois, Holly Bante, Whitney B Hadley","doi":"10.1080/21507716.2011.631514","DOIUrl":"10.1080/21507716.2011.631514","url":null,"abstract":"BACKGROUND: This paper reviews the past 25 years of empirical research funded by the National Institutes of Health (NIH) on matters of ethics in psychiatric research. METHODS: Using the NIH RePORTER and Medline databases, we identified 43 grants and 77 publications that involved the empirical study of a matter of ethics in research involving mental health service users. RESULTS: These articles provide original and useful information on important topics, most especially the capacity to consent and the voluntariness of consent. For example, participants who share a diagnosis vary widely in levels of cognitive impairment that correlate with decisional capacity, and capacity to consent can be enhanced easily using iterative consent processes. Few articles address matters of justice or benefits in research, particularly from the perspectives of participants. No articles address matters of privacy, confidentiality, or researcher professionalism. CONCLUSIONS: Despite the usefulness of data from the studies conducted to date, current research on research ethics in psychiatry does not adequately address the concerns of service users as expressed in recent publications.","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"2 4","pages":"5-17"},"PeriodicalIF":0.0,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3524581/pdf/nihms411837.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31140479","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

International Guidelines and Ethical Context 国际准则和道德背景

AJOB primary research Pub Date : 2010-11-10 DOI: 10.1080/21507716.2010.538035

Benjamin Chan, D. Wendler

{"title":"International Guidelines and Ethical Context","authors":"Benjamin Chan, D. Wendler","doi":"10.1080/21507716.2010.538035","DOIUrl":"https://doi.org/10.1080/21507716.2010.538035","url":null,"abstract":"Clinical practice and clinical research are subject to numerous ethical principles and guidelines, both formal and informal. Protect and promote patients’ and subjects’ clinical interests. Respect autonomy. Avoid exploitation. Yet what is required to follow these principles depends on the context. Which principles and guidelines are relevant, and how they should be specified and applied, all depend to varying degrees on the context in question. This sensitivity to context influences both how individuals ought to act and how their actions ought to be evaluated. In this way, the interpretive challenge posed by empirical research—what ethical conclusions can be drawn from the data?—is heightened when the results are obtained in unfamiliar contexts. Failure to recognize the relevance of context can lead one to see appropriate behavior as involving an inappropriate ethical double standard. This happened in the evaluation of the Rotashield vaccine for rotavirus. The withdrawal of Rotashield from the U.S. market due to a risk of intussusception lead to the cancellation of trials of the vaccine in developing countries (Melton 2000; Shaw 2006). However, given the much greater risk that rotavirus disease poses in developing countries, it was incorrect to assume that conducting Rotashield trials in those contexts was unacceptable simply because it would have been unacceptable to do so in the United States. From the perspective of an outsider, evaluating three empirical studies in this volume—the ethics of Iranian surgical practice, Portuguese neonatal care, and Brazilian human subjects protection—while being sensitive to context is a daunting challenge. There is much that might be ethically relevant in the respective social/cultural/historical/political/economic settings of those practices and places. At the same time, as outsiders, our ignorance of the respective contexts is vast. How could researchers hope to provide us with the context needed to grasp the ethical significance of their data?","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"34 1","pages":"28 - 30"},"PeriodicalIF":0.0,"publicationDate":"2010-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81478907","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Factors Associated with Quality of Informed Consent in Patients Admitted for Surgery: An Iranian Study 与手术患者知情同意质量相关的因素:一项伊朗研究

AJOB primary research Pub Date : 2010-11-10 DOI: 10.1080/21507716.2010.528507

A. Sheikhtaheri, M. Farzandipour

{"title":"Factors Associated with Quality of Informed Consent in Patients Admitted for Surgery: An Iranian Study","authors":"A. Sheikhtaheri, M. Farzandipour","doi":"10.1080/21507716.2010.528507","DOIUrl":"https://doi.org/10.1080/21507716.2010.528507","url":null,"abstract":"Informed consent is regarded as a pillar of medical ethics. The purpose of this study was to evaluate perceptions of the informed consent process prior to surgery. Three hundred elective surgery patients were randomly selected from three teaching hospitals in Kashan, Iran, and asked to complete a questionnaire about four key aspects of the informed consent process: information disclosure, voluntariness, comprehension, and their relationship with physicians. Data were scored and analyzed using univariate and multivariate methods. Based on the responses, the perceived quality of information disclosure (7.96 ± 4.9 out of 18 points), comprehension of the consent form (0.55 ± 1.1 out of 4 points), and voluntariness (1.73 ± 2.1 out of 8 points) were considered to be unacceptable and the perceived quality of the physician–patient relationships (10.6 ± 4.1 out of 14 points) acceptable. Most of the participants (88.7%) reported that they had requested to be informed about the complications of the surgical procedures, including severe complications such as death, but most of them did not receive this information. The most important factors associated with the perceived quality of informed consent were the patient's level of education and type of surgery. In conclusion, practices consistent with the principles of informed consent have not been adequately implemented in the surgical departments of these hospitals in Kashan. To improve current practices, patients should receive more information about the risks and benefits of surgery as well as any available alternatives. Information about the expected length of hospital stay, post-discharge follow-up, and the cost of surgery should also be provided to patients. To improve the perceived quality of the informed consent process, more emphasis should be placed on ensuring that patients receive the requested information in a manner they can comprehend. Redesigning consent forms may be an important step in improving the patients’ experience of the informed consent process.","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"10 1","pages":"16 - 9"},"PeriodicalIF":0.0,"publicationDate":"2010-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80995462","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 14

Twelve Years of the Brazilian Initiative to Create a Network of IRBs for the Ethical Evaluation of Research Studies Involving Human Subjects 为涉及人类受试者的研究的伦理评价建立irb网络的巴西倡议的十二年

AJOB primary research Pub Date : 2010-11-10 DOI: 10.1080/21507716.2010.528506

E. Hardy, S. F. Bento, E. M. Hebling, A. Faúndes, M. Osis, M. H. Sousa

{"title":"Twelve Years of the Brazilian Initiative to Create a Network of IRBs for the Ethical Evaluation of Research Studies Involving Human Subjects","authors":"E. Hardy, S. F. Bento, E. M. Hebling, A. Faúndes, M. Osis, M. H. Sousa","doi":"10.1080/21507716.2010.528506","DOIUrl":"https://doi.org/10.1080/21507716.2010.528506","url":null,"abstract":"In Brazil, Resolution 196/96 on research involving human subjects created the National Council of Ethics in Research (CONEP) with a mandate to stimulate the creation of institutional review boards (IRBs) throughout the country, provide guidelines, and regulate their structure and operation. A descriptive study was carried out in 2007. The coordinators of all 508 IRBs registered in CONEP in 2006 were invited to participate; 502 accepted (response rate = 99%) and responded to a structured questionnaire conducted via telephone. Prior to the publication of Resolution 196/96, IRBs were created at an average rate of 1.7 per year. In contrast, an average of 47.3 IRBs per year were created between 1997 and 2006. The percentage of IRBs with their own physical space and telecommunication equipment was higher among older IRBs compared to more recently established IRBs. A significantly greater proportion of IRBs created prior to the year 2000 provided services for other institutions, offered courses, and produced texts on bioethics compared to the more recently established IRBs. Thus, in a period of only 12 years, Brazil progressed from having a small number of functioning IRBs to the current number of 508, reflecting the capacity of the federal government to mobilize teaching and research institutions and investigators. Nevertheless, while research institutions are adhering to the requirement for the social control of ethics in research, they are not yet willing to provide the resources these committees need to function properly. Despite these limitations, the colossal effort to promote implementation of appropriate ethical standards in research studies involving human subjects in Brazil has been successful.","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"62 1","pages":"19 - 27"},"PeriodicalIF":0.0,"publicationDate":"2010-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87937549","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1