AJOB primary research最新文献

{"title":"Physician-Researchers' Experiences of the Consent Process in the Sociocultural Context of a Developing Country.","authors":"Aisha Y Malik","doi":"10.1080/21507716.2011.616183","DOIUrl":"10.1080/21507716.2011.616183","url":null,"abstract":"<p><p>Background: International guidelines for medical research involving human subjects maintain the primacy of informed consent while recognizing cultural diversity. Methods: This article draws on empirical data obtained from interviews with physician-researchers in teaching hospitals of Lahore, Pakistan, to identify social and cultural factors that affect the consent process for participants in research. Results: This article presents variable findings with regards to communication, comprehension, and decision making. While some physicians consider that social factors such as lack of education, a patriarchal family system, and skepticism about research can make patients dependent on either the physician-researcher or the family, others believe that patients do make independent decisions. Conclusions: In light of the findings, the article ends with a recommendation for communication and decision making that is sensitive to the local sociocultural environment while at the same time meeting the ethical imperative of respect for persons.</p>","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"2 3","pages":"38-46"},"PeriodicalIF":0.0,"publicationDate":"2011-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3396358/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30777422","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}

{"title":"An Attempt to Ground the Expressivist Objection in Actual Practice Flounders","authors":"S. Edwards","doi":"10.1080/21507716.2011.602380","DOIUrl":"https://doi.org/10.1080/21507716.2011.602380","url":null,"abstract":"Klein claims that current practice in the context of fetal selection and screening (FSS) falls well short of acceptable standards in very many instances. He refers to “FSS practices [that] are too often derivative of inaccurate and disparaging models of disability and disability experience . . . and sustained ignorance of disability issues [which is] evident in medical attitudes, practice, education, and research” (Klein 2011, 8). Moreover, the complaint is based upon a considerable degree of empirical evidence that is cited and discussed in the paper. For example, we learn that health care professionals (HCPs) are much more likely than lay people to favor termination of pregnancy when disabling traits are diagnosed in the fetus, and that these negative attitudes insidiously ‘pollute’ the decisions of people in the context of FSS, making them more likely to opt for termination of pregnancy. Worse, disturbing reports of women feeling pressured to opt for amniocentesis are also described. The paper also draws attention to more general problems in the responses of HCPs to the health problems of people with disabilities, which stem from stereotyping and prejudice. Obviously, one would not wish to defend such practices, and one can only endorse the claims in the paper for radical change in the education of health care professionals in relation to disability. Yet there is a tendency in the paper to overstate the negative aspects of care. For example, Klein states that “a large minority of [women] did feel pressured to consent to amniocentesis” (8)—so presumably the majority did not feel similarly pressured. We learn that “13% of physicians would emphasize the negative aspects of sickle cell anaemia, cystic fibrosis, and Down syndrome” (8), so presumably the rest would not. There are other similar examples in the paper in which Klein opts to interpret the data negatively as opposed to positively. The significance of this is that, given the statistics cited in the paper, it does not look promising to claim that there is a campaign, consciously or unconsciously orchestrated, against disabled people, nor does it look promising to claim that there is an institutionalized prejudice against disabled people in the health care professions. The statistics are definitely a cause for concern and as the author recommends, certain measures—perhaps","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"22 1","pages":"21 - 23"},"PeriodicalIF":0.0,"publicationDate":"2011-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75138813","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}

{"title":"Examining the Quest to Eliminate Discrepancies in IRB Decisions","authors":"D. Diekema","doi":"10.1080/21507716.2011.600750","DOIUrl":"https://doi.org/10.1080/21507716.2011.600750","url":null,"abstract":"Beginning in 1990, investigators at Arizona State University (ASU) collected more than 200 blood samples from members of the Havasupai Indian tribe in an effort to describe genetic variants that might be contributing to the increased incidence of diabetes among tribe members. Over the course of the next 10 years, those blood samples were also used to examine DNA variants linked to schizophrenia, alcoholism, metabolic disorders, and the geographic and anthropologic origins of the Havasupai people. This work resulted in more than 20 academic papers, including several that might be considered stigmatizing for members of the tribe and others that were disruptive to beliefs concerning the tribe’s origins (Mello and Wolf 2010). The Havasupai people became aware of the research using their blood samples only after a tribal member attended a research presentation at ASU and asked whether permission had been obtained to use the blood samples for purposes other than diabetes research. Ultimately, a lawsuit was filed against the university. The case was eventually settled and included monetary compensation, an apology, and the return of blood samples so that they could be properly buried (Harmon 2010). The Havasupai research presents an interesting case study within which to consider the issues raised by Klitzman’s article in this issue. On its surface, the original Havasupai diabetes study appears to be minimal risk, and I suspect most institutional review boards (IRBs) would have agreed with that assessment. Yet it’s doubtful that members of the Havasupai Tribe would agree. Likewise, the decision to allow the use of blood samples for purposes beyond those intended by the original research would have been handled differently by different IRBs. Some would have considered the original consent form adequate to cover the new activities, others would have granted waivers of informed consent for the use of the existing specimens, and a few might have considered the new uses to be exempt from the federal regulations if the samples could be de-identified. Of course, the tribe would argue that even with individual deidentification, the community could not be de-identified. While most would agree that IRBs should consider these","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"26 1","pages":"34 - 36"},"PeriodicalIF":0.0,"publicationDate":"2011-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84624587","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}

{"title":"Medical Disparagement of the Disability Experience: Empirical Evidence for the “Expressivist Objection”","authors":"D. Klein","doi":"10.1080/21507716.2011.594484","DOIUrl":"https://doi.org/10.1080/21507716.2011.594484","url":null,"abstract":"Fetal screening and selection (FSS) services offered in the context of prenatal care have been criticized for decades. One important objection has charged that the utilization of FSS expresses disparagement toward the lives, value, and experiences of people with disabilities. Critiques of this expressivist objection to FSS attempt to challenge the interpretability of FSS decisions, or emphasize the importance of autonomy in defending FSS services against concerns about social injustice. The following discussion of sociomedical research demonstrates that FSS practices are too often derivative of inaccurate and disparaging models of disability and disability experience. A disregard for the disability experience and sustained ignorance of disability issues are evident in medical attitudes, practice, education, and research. Thus, critiques of the expressivist objection do not hold up when examined in the context of actual practices.","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"4 1","pages":"20 - 8"},"PeriodicalIF":0.0,"publicationDate":"2011-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82075900","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}

{"title":"Orthodox Ashkenazi Young Adults’ Knowledge, Experiences, Attitudes, and Beliefs About Genetic Carrier Testing","authors":"A. Kalfoglou, Melissa Broder","doi":"10.1080/21507716.2011.600749","DOIUrl":"https://doi.org/10.1080/21507716.2011.600749","url":null,"abstract":"Background: The Orthodox Ashkenazi Jewish community promotes carrier testing of young adults prior to dating in order to prevent the birth of children affected with genetic diseases. It is unclear how much this young consumer group understands about carrier testing and the testing options available to them, particularly around the inclusion or exclusion of Gaucher disease carrier screening on testing panels. Additionally, little is known about their attitudes toward the use of reproductive technologies to avoid having affected children. Methods: We conducted eight focus groups with 49 Orthodox Ashkenazi young adults. Participants were assigned to groups based on gender and whether or not they had received carrier testing. Audiotapes were transcribed and transcripts analyzed for themes.Results: Most participants expressed trust in Dor Yeshorim's anonymous testing process, but many were unaware of other testing options. Most women were tested through Dor Yeshorim at their Jewish high schools between the ages of 17 and 18 years. Men were tested either through Dor Yeshorim or a university-based laboratory after high school, usually while they attended yeshiva. Those who had not yet been tested either had not been presented with the opportunity or planned to wait until they were in a serious relationship. The untested were less likely to participate in arranged marriages, more likely to want to know their test results, and more open to using reproductive technology. Participants had mixed attitudes about whether Gaucher disease ought to be on the Dor Yeshorim Jewish panel. In vitro fertilization (IVF) with preimplantation genetic diagnosis (PGD) was the only assisted reproductive technology acceptable to most participants.Conclusions: There is an opportunity to educate Orthodox Ashkenazi young adults about their testing options, about the pros and cons of testing for Gaucher disease, and about the reproductive options for couples who are both carriers of the same genetic disease. Rabbis may be uniquely situated to provide referrals to culturally sensitive genetic counselors and web-based educational materials.","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"103 1","pages":"1 - 7"},"PeriodicalIF":0.0,"publicationDate":"2011-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79420150","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}

{"title":"We Have Met the Enemy and He Is Us","authors":"Mark S. Schreiner, Barbara C. Engel","doi":"10.1080/21507716.2011.605420","DOIUrl":"https://doi.org/10.1080/21507716.2011.605420","url":null,"abstract":"Numerous authors have demonstrated that when multiple institutional review boards (IRBs) review the same protocol, the results are quite variable (Dilts et al. 2009; Dziak et al. 2005; Green et al. 2006; Greene et al. 2006; Helfand et al. 2009; Kimberly et al. 2006; Mansbach et al. 2007; McWilliams et al. 2003; Silverman et al. 2001; Stair et al. 2001; Stark et al. 2010). However, the federal regulations governing the conduct of human subjects research are gray, by either design or accident, and it is therefore to be expected that reasonable people with differing interpretations will reach disparate conclusions about whether or not a given study meets the criteria for approval (Sayers 2007). Klitzman (2011) provides anecdotal evidence that lends credence to another aspect of IRB variability long known to clinical investigators, namely, that there are differences between the IRBs within institutions. The Klitzman paper is fundamentally based on anecdotes. There is no reason why clinical research into IRB decision making shouldn’t be held to the same standards as those for other types of clinical research. As Halpern (2005) advocated recently, there is a need for evidence-based bioethics to inform decisions. From an epidemiologist’s perspective, large randomized clinical trials rank highest in strength of evidence, followed by smaller clinical trials, cohort studies, case-control studies, and then anecdotal evidence at the bottom. Depending on one’s perspective, meta-analyses combining the results of several trials would be at or near the top of the hierarchy of evidence. Even when a study has a high degree of internal validity, the results from a study may not be generalizable to one’s own situation, patient population, and institution. Given the low position within the hierarchy of evidence occupied by this current report, the results and conclusions reported by Klitzman should be viewed with caution and skepticism. If cause and effect are beyond the realm of the anecdotal study design, then why bother with this type of research? Not all research needs to involve confirmatory designs with formal hypothesis testing. Other exploratory designs are valuable when aimed at generating hypotheses and directions for future research. The power of this paper, then, is not in the amalgamation of the results into a","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"6 1","pages":"39 - 41"},"PeriodicalIF":0.0,"publicationDate":"2011-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75982109","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}

{"title":"IRB Inconsistency: Be Careful What You Wish For","authors":"N. Fost","doi":"10.1080/21507716.2011.605419","DOIUrl":"https://doi.org/10.1080/21507716.2011.605419","url":null,"abstract":"Robert Klitzman’s report (2011) of his study of discrepancies among institutional review boards (IRBs) reminds me of the joke about two rabbis who met in the desert. After extensive arguing, unable to agree on anything, they decided they not only had to build separate temples, but a third temple that neither would set foot in. Differences and inconsistency are inherent in human activity (and canine, feline, etc.). We should not be surprised when two humans differ in how they apply a regulation to a particular case, whether it be as simple as a traffic light rule, as complex as the tax code, or the federal rules on human subjects research. Similarly, disagreement among groups of individuals, such as IRBs, whether within one institution or across multiple institutions, should be expected. Even an individual member may take inconsistent positions on the same issue arising in different protocols. As Klitzman notes, these disagreements among IRBs are due to numerous factors, including varying knowledge about scientific issues, personal biases, political factors, personalities, small-group dynamics, leadership styles, community values, and so on. His study suggests that differences in community values may not be the most important or common reason for these intergroup differences. As one of Klitzman’s respondents noted, this is not different from clinical medicine, where equally qualified physicians commonly have widely different views of diagnosis, prognosis, and treatment of the same patient. In one study, not only did a group of experienced, qualified radiologists disagree about the findings in a group of chest x-rays; when the same group was asked to read the same x-rays a year later, there was no correlation within each individual’s interpretations from one year to the next.","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"1 1","pages":"37 - 38"},"PeriodicalIF":0.0,"publicationDate":"2011-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84087216","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}

{"title":"Ethical Barriers to Perinatal Mental Health Research and Evidence-Based Treatment: An Empirical Study","authors":"A. Brandon","doi":"10.1080/21507716.2011.561517","DOIUrl":"https://doi.org/10.1080/21507716.2011.561517","url":null,"abstract":"Although more than 500,000 women annually experience a psychiatric illness during pregnancy, and approximately 30% will be prescribed medication, no psychotropic medications are approved by the Food and Drug Administration (FDA) for use during pregnancy. In the absence of an evidence base, investigators, clinicians, and patients are concerned that we are “operating in a vast sea of ignorance.” International pregnancy registries and observational studies exist, but there are few randomized controlled trials (RCTs), the gold standard of evidence-based medicine, due to the fear of fetal harm, even in non-pharmacological research. Current research guidelines reflect the ambivalence of regulatory agencies regarding pregnant research participants and use ambiguous language unhelpful to institutional review boards (IRBs), leaving perinatal women the last “therapeutic orphans.” This is a review of the issues as identified by perinatal investigators and a proposal to draft new collaborative guidelines to facilitate perinatal mental health research necessary for empirically-based treatment.","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"3 1","pages":"12 - 2"},"PeriodicalIF":0.0,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81062032","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}

{"title":"An Empirical Ethics Agenda for Psychiatric Research Involving Prisoners.","authors":"Paul P Christopher, Philip J Candilis, Josiah D Rich, Charles W Lidz","doi":"10.1080/21507716.2011.627082","DOIUrl":"10.1080/21507716.2011.627082","url":null,"abstract":"<p><p>In the past 30 years, the incarcerated population in the United States has more than quadrupled to 2.3 million adults. With an alarmingly high prevalence of mental illness, substance use, and other serious health conditions compounding their curtailed autonomy, prisoners constitute perhaps the nation's most disadvantaged group. Scientifically rigorous research involving prisoners holds the potential to inform and enlighten correctional policy and to improve their treatment. At the same time, prisoner research presents significant ethical challenges to investigators and institutional review boards (IRBs) alike, by subjecting participants to conditions that potentially undermine the validity of their informed consent. In 2006, the Institute of Medicine Committee on Ethical Considerations for Revisions to the Department of Health and Human Services (DHHS) Regulations for Protection of Prisoners Involved in Research recommended both further protections and a more permissive approach to research review that would allow inmates greater access to potentially beneficial research. These recommendations have sparked renewed debate about the ethical trade-offs inherent to prisoner research. In this article, the authors review the major justifications for research with prisoner subjects and the associated ethical concerns, and argue that the field of empirical ethics has much to offer to the debate. They then propose a framework for prioritizing future empirical ethics inquiry on this understudied topic.</p>","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"2 4","pages":"18-25"},"PeriodicalIF":0.0,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21507716.2011.627082","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32742249","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}

{"title":"The Myth of Community Differences as the Cause of Variations Among IRBs.","authors":"Robert Klitzman","doi":"10.1080/21507716.2011.601284","DOIUrl":"https://doi.org/10.1080/21507716.2011.601284","url":null,"abstract":"<p><strong>Background: </strong>Although variations among institutional review boards (IRBs) have been documented for 30 years, they continue, raising crucial questions as to why they persist as well as how IRBs view and respond to these variations.</p><p><strong>Methods: </strong>In-depth, 2-hour interviews were conducted with 46 IRB chairs, administrators, and members. The leadership of 60 U.S. IRBs were contacted (every fourth one in the list of the top 240 institutions by NIH funding). IRB leaders from 34 of these institutions were interviewed (response rate = 55%).</p><p><strong>Results: </strong>The interviewees suggest that differences often persist because IRBs think these are legitimate, and regulations permit variations due to differing \"community values.\" Yet, these variations frequently appear to stem more from differences in institutional and subjective personality factors, and from \"more eyes\" examining protocols, trying to foresee all potential future logistical problems, than from the values of the communities from which research participants are drawn. However, IRBs generally appear to defend these variations as reflecting underlying differences in community norms.</p><p><strong>Conclusions: </strong>These data pose critical questions for policy and practice. Attitudinal changes and education among IRBs, principal investigators (PIs), policymakers, and others and research concerning these issues are needed.</p>","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"2 2","pages":"24-33"},"PeriodicalIF":0.0,"publicationDate":"2011-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21507716.2011.601284","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"32722847","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}