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1.
Title: Counsellors are human [letter]
Author: Anand V
Source: Indian Journal of Medical Ethics. 2009 Jul-Sep;6(3):169-70.
Abstract: This letter touches on the subject of the medical knowledge of physicians in India. It first discusses male circumcision and then moves on to India not having an established system for sharing medical information and updates. It asks that better systems of regularly updating the medical knowledge of Indian physicians be developed.
Language: English

Keywords:
INDIA | CRITIQUE | PROVIDERS WITH CLIENTS | MALE CIRCUMCISION | KNOWLEDGE | INFORMED CONSENT | FEES | INFORMATION DISTRIBUTION | Asia, Southern | Asia | Developing Countries | Health Services | Delivery of Health Care | Health | Medical Procedures | Medicine | Sociocultural Factors | Financial Activities | Economic Factors | Communication
Document Number: 342876  

2.
Title: HIV: time for the medical community to move forward [editorial]
Author: Chua AC
Source: Annals of the Academy of Medicine, Singapore. 2009 Feb;38(2):97-8.
Abstract: As we encourage more people to undergo HIV testing, it is important to understand the implications of an HIV diagnosis and to respect confidentiality and the voluntary consent process. Regarding HIV testing, 50% believe that it should be voluntary and 62.5% believe that mandatory HIV tests should be conducted on men who have sex with men (unpublished data -data available upon request from author). How do we begin to address these issues in our medical profession? We need sound policies and to challenge traditional medical education. (excerpt)
Language: English

Keywords:
SINGAPORE | SUMMARY REPORT | SCREENING | PERSONS LIVING WITH HIV/AIDS | CLIENTS | HIV TESTING | HIV PREVENTION | TREATMENT | HEALTH SERVICES | DELIVERY OF HEALTH CARE | HEALTH POLICY | INFORMED CONSENT | Asia, Southeastern | Asia | Developed Countries | Examinations and Diagnoses | Medical Procedures | Medicine | Health | HIV Infections | Viral Diseases | Diseases | Program Activities | Programs | Organization and Administration | Laboratory Examinations and Diagnoses | Policy | Political Factors | Sociocultural Factors
Document Number: 341548  

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Title: Access to medications and medical care after participation in HIV clinical trials: a systematic review of trial protocols and informed consent documents.
Author: Ciaranello AL; Walensky RP; Sax PE; Chang Y; Freedberg KA; Weissman JS
Source: HIV Clinical Trials. 2009 Jan-Feb;10(1):13-24.
Abstract: BACKGROUND: Expectations regarding receipt of medications and medical care after clinical trials conclude may inform decisions about trial participation. We describe the frequency with which these posttrial services are described in the protocols and informed consent forms (ICFs) of antiretroviral drug (ARV) trials. METHOD: We systematically reviewed protocols and ICFs from Phase 3 and 4 antiretroviral trials in adults (> or = 12 years) from 1987 to 2006. Pharmaceutical industry-sponsored trials were selected from US Food and Drug Administration (FDA) documentation and Clinicaltrials.gov. Trials administered by the AIDS Clinical Trials Group (ACTG) were selected from the ACTG online registry. ACTG- and industry-provided protocols and ICFs were reviewed in full. The primary outcome was any mention of posttrial services, defined as any text regarding posttrial medications or medical care. RESULTS: Complete trial documents were available for 31 (48%) of 65 trials meeting inclusion criteria. Documents from 14 trials (45%) mentioned any posttrial service: 12 (39%) mentioned medications, and 5 (16%) mentioned medical care. Payment for trial participation (74%) and for care for trial-related injury (94%) were mentioned more often than were posttrial services. CONCLUSIONS: Posttrial medications or medical care was mentioned in the trial documents of <50% of reviewed antiretroviral trials. Improved efforts are needed to clearly describe posttrial services in clinical trial protocols and ICFs.
Language: English

Keywords:
GLOBAL | RESEARCH REPORT | CLINICAL TRIALS | ADULTS | HUMAN VOLUNTEERS | ANTIRETROVIRAL DRUGS | INFORMED CONSENT | PARTICIPATION | ETHICS | ANTIRETROVIRAL THERAPY | PROGRAM ACCESSIBILITY | Clinical Research | Research Methodology | Age Factors | Population Characteristics | Demographic Factors | Population | Treatment | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Social Behavior | Behavior | Sociocultural Factors | HIV | HIV Infections | Viral Diseases | Diseases | Program Evaluation | Programs | Organization and Administration
Document Number: 341817  

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Peer Reviewed

Title: Ethical Considerations in HIV/AIDS Biobehavioral Surveys That Use Respondent-Driven Sampling: Illustrations From Lebanon.
Author: Dejong J; Mahfoud Z; Khoury D; Barbir F; Afifi RA
Source: American Journal of Public Health. 2009 Jul 16;
Abstract: Respondent-driven sampling is especially useful for reaching hidden populations and is increasingly used internationally in public health research, particularly on HIV. Respondent-driven sampling involves peer recruitment and has a dual-incentive structure: both recruiters and their peer recruits are paid. Recent literature focusing on the ethical dimensions of this method in the US context has identified integral safeguards that protect against ethical violations. We analyzed a study of 3 groups in Lebanon who are at risk for HIV (injection drug users, men who have sex with men, female sex workers) and the ethical issues that arose. More explicit attention should be given to ethical issues involved in research implementing respondent-driven sampling of at-risk populations in developing countries, where ethical review mechanisms may be weak.
Language: English

Keywords:
LEBANON | SUMMARY REPORT | RECRUITMENT ACTIVITIES | RESPONDENTS | IV DRUG USERS | MEN HAVING SEX WITH MEN | SEX WORKERS | PUBLIC HEALTH | HIV INFECTIONS | AIDS | ETHICS | INFORMED CONSENT | Middle East | Developing Countries | Program Activities | Programs | Organization and Administration | Surveys | Sampling Studies | Studies | Research Methodology | Drug Use and Abuse | Behavior | Sex Behavior | Health | Viral Diseases | Diseases | Sociocultural Factors | Health Services | Delivery of Health Care
Document Number: 342038  

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Title: Women, contraception, and consent to research participation [editorial]
Author: Ding EL; Nagda SR
Source: Journal of Women's Health. 2009 Apr;18(4):439-41.
Abstract: This editorial piece explores women's Willingness To Participate (WTP) in clinical research. The sufficient inclusion of women in clinical research remains a challenge due to research participation conflicting with women's contraceptive behaviors and is further complicated by the potential risk of harm to a fetus.
Language: English

Keywords:
UNITED STATES OF AMERICA | METHODOLOGICAL STUDIES | CRITIQUE | RECOMMENDATIONS | STUDY DESIGN | PILOT PROJECTS | WOMEN | INFORMED CONSENT | SEX FACTORS | GENDER ISSUES | CONTRACEPTION RESEARCH | PARTICIPATION | CONTRACEPTIVE METHODS CHOSEN | PERCEPTION | COST EFFECTIVENESS | Developed Countries | North America | Americas | Studies | Research Methodology | Demographic Factors | Population | Health Services | Delivery of Health Care | Health | Population Characteristics | Sociocultural Factors | Contraception | Family Planning | Social Behavior | Behavior | Contraceptive Usage | Psychological Factors | Evaluation Indexes | Quantitative Evaluation | Evaluation
Document Number: 330976  

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Title: CULTURE AND GENETIC SCREENING IN AFRICA.
Author: Jegede AS
Source: Developing World Bioethics. 2009 Aug 3;
Abstract: Africa is a continent in transition amidst a revival of cultural practices. Over previous years the continent was robbed of the benefits of medical advances by unfounded cultural practices surrounding its cultural heritage. In a fast moving field like genetic screening, discussions of social and policy aspects frequently need to take place at an early stage to avoid the dilemma encountered by Western medicine. This paper, examines the potential challenges to genetic screening in Africa. It discusses how cultural practices may affect genetic screening. It views genomics science as a culture which is trying to diffuse into another one. It argues that understanding the existing culture will help the diffusion process. The paper emphasizes the importance of genetic screening for Africa, by assessing the current level of burden of diseases in the continent and shows its role in reducing disease prevalence. The paper identifies and discusses the cultural challenges that are likely to confront genetic screening on the continent, such as the worldview, rituals and taboos, polygyny, culture of son preference and so on. It also discusses cultural practices that may promote the science such as inheritance practices, spouse selection practices and naming patterns. Factors driving the cultural challenges are identified and discussed, such as socialization process, patriarchy, gender, belief system and so on. Finally, the paper discusses the way forward and highlights the ethical considerations of doing genetic screening on the continent. However, the paper also recognizes that African culture is not monolithic and therefore makes a case for exceptions.
Language: English

Keywords:
AFRICA | RESEARCH REPORT | ETHICS | GENETICS | INFORMED CONSENT | RESEARCH AND DEVELOPMENT | Developing Countries | Sociocultural Factors | Biology | Health Services | Delivery of Health Care | Health | Technology | Economic Factors
Document Number: 342535  

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Title: Adolescent and youth reproductive health care and confidentiality FIGO Committee for the Ethical Aspects of Human Reproduction and Women's Health.
Author: Milliez J
Source: International Journal of Gynaecology and Obstetrics. 2009 Apr 25;
Abstract: This report provides background and specific recommendations on issues surrounding adolescent and youth reproductive health care and confidentiality.
Language: English

Keywords:
GLOBAL | RECOMMENDATIONS | EVALUATION | ADOLESCENTS | HEALTH PERSONNEL | CONFIDENTIAL INFORMATION | ADOLESCENT PREGNANCY | ADOLESCENT HEALTH | INFORMED CONSENT | SEX EDUCATION | REPRODUCTIVE HEALTH | HUMAN RIGHTS | ETHICS | REPRODUCTIVE RIGHTS | LEGISLATION | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Delivery of Health Care | Health | Sociocultural Factors | Reproductive Behavior | Fertility | Population Dynamics | Health Services | Education | Political Factors
Document Number: 341503  

8.
Title: Is there coercion or undue inducement to participate in health research in developing countries? An example from Rakai, Uganda.
Author: Nalugoda F; Wagman J; Kiddugavu M; Kiwanuka N; Garrett E; Gray RH; Serwadda D; Wawer MJ; Emanuel EJ
Source: Journal of Clinical Ethics. 2009 Summer;20(2):141-9.
Abstract: This study looks at the question, "Is there coercion and undue inducement to participate in health research in developing countries?" The study in Uganda found that there is little data to support the claim that coercion and undue inducement are difficult to avoid when conducting research studies in poor, developing countries and many Ugandan people were able to decline participation and decline biological samples in a study of STDs and HIV in the Rakai district.
Language: English

Keywords:
UGANDA | RURAL AREAS | RESEARCH REPORT | RESEARCH ACTIVITIES | LOW INCOME POPULATION | HUMAN VOLUNTEERS | INFORMED CONSENT | ETHICS | EDUCATIONAL STATUS | SOCIOECONOMIC STATUS | PARTICIPATION | SEXUALLY TRANSMITTED DISEASES | HIV PREVENTION | Africa, Eastern | Africa, Sub Saharan | Africa | Developing Countries | Geographic Factors | Population | Research Methodology | Social Class | Socioeconomic Factors | Economic Factors | Clinical Research | Health Services | Delivery of Health Care | Health | Sociocultural Factors | Social Behavior | Behavior | Reproductive Tract Infections | Infections | Diseases | HIV Infections | Viral Diseases
Document Number: 342151  

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Peer Reviewed

Title: Ethical and social issues facing obstetricians in low-income countries.
Author: Ogwuegbu CC; Eze OH
Source: Clinical Obstetrics and Gynecology. 2009 Jun;52(2):237-49.
Abstract: A review of publications on ethical and social issues from low-income countries was done with the aim of highlighting the major ethical and social issues facing obstetricians in these countries. Low-income countries were identified using the World Health Organization income group classification of member nations. Obstetricians in low-income countries face a wide range of special social and ethical issues that reflect the peculiarities of their practice environment characterized by poverty, low education, deep attachment to tradition and culture, low social status of women, and high levels of physician's paternalism.
Language: English

Keywords:
DEVELOPING COUNTRIES | CRITIQUE | LITERATURE REVIEW | PHYSICIANS | OBSTETRICS | ETHICS | POVERTY | SOCIOCULTURAL FACTORS | WOMEN'S STATUS | MATERNAL HEALTH SERVICES | UTILIZATION OF HEALTH CARE | DECISION MAKING | INFORMED CONSENT | EDUCATIONAL STATUS | HARMFUL TRADITIONAL PRACTICES | Health Personnel | Delivery of Health Care | Health | Medicine | Health Services | Socioeconomic Factors | Economic Factors | Maternal-Child Health Services | Primary Health Care | Behavior | Socioeconomic Status | Traditional Health Practices | Culture
Document Number: 342174  

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Peer Reviewed

Title: Confronting the legal risks of prescribing the contraceptive patch with ongoing litigation.
Author: Phelps JY; Kelver ME
Source: Obstetrics and Gynecology. 2009 Mar;113(3):712-6.
Abstract: Recent changes in U.S. Food and Drug Administration (FDA) labeling and news reports of lawsuits resulting in million-dollar settlements understandably may deter gynecologists from prescribing the transdermal contraceptive patch Ortho Evra (Ortho-McNeil Pharmaceutical, Inc., Titusville, NJ). Gynecologists who, with all good intentions, prescribe an FDA-approved drug such as the contraceptive patch potentially could find themselves liable for an adverse drug reaction. Although much of the current focus by plaintiff attorneys and the news media is on the contraceptive patch, no prescription contraceptive method is without medical risks to the patient or legal risks to the prescribing gynecologist. The purpose of this commentary is to provide an overview of the medical-legal controversies and pitfalls in prescribing the contraceptive patch as well as to outline how gynecologists can avert legal liability by providing proper informed consent. Despite FDA labeling changes and ongoing litigation, with proper informed consent, the contraceptive patch still may be the best choice for many patients who prefer the convenience of a weekly patch over a daily oral contraceptive. Also, regardless of the contraceptive option chosen, the principles of providing and documenting proper informed consent in medical records are applicable not only to providing quality care to patients, but also to protecting the legal interests of the prescribing gynecologist. By documenting proper informed consent in medical records, gynecologists should feel more at ease in prescribing the contraceptive method that best fits their individual patients' needs, even in the presence of ongoing litigation.
Language: English

Keywords:
UNITED STATES OF AMERICA | CRITIQUE | RECOMMENDATIONS | EVALUATION | PHYSICIANS | LITIGATION | RISK ASSESSMENT | PRESCRIPTIONS | CONTRACEPTIVE AGENTS, FEMALE | ADMINISTRATION AND DOSAGE | USFDA | SIDE EFFECTS | INFORMED CONSENT | RECORDS | Developed Countries | North America | Americas | Health Personnel | Delivery of Health Care | Health | Political Factors | Sociocultural Factors | Distributional Activities | Program Activities | Programs | Organization and Administration | Contraceptive Agents | Contraception | Family Planning | Drugs | Treatment | Medical Procedures | Medicine | Health Services | USPHS | Government Agencies | Organizations | Information Processing | Information
Document Number: 330700  

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Peer Reviewed

Title: Confronting the legal risks of prescribing the contraceptive patch with ongoing litigation.
Author: Phelps JY; Kelver ME
Source: Obstetrics and Gynecology. 2009 Jun;113(6):1367-8.
Abstract: As former Senior Medical Officer in the Division at the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA), which handled the original approval for Ortho Evra (norelgestromin/ethinyl estradiol [E2], Ortho Women's Health & Urology, Raritan, NJ), Dr. Patsner's insider perspective is informative and a worthwhile contribution. However, we respectfully disagree with his comments that "physicians should be aware that even the best informed consent likely will provide little or no shield if they are sued in a medical malpractice action for prescribing the patch . . ." and that ". . . ob-gyns should steer clear of the product." We stand firm that providing proper informed consent is critical not only to providing quality patient care but also to deterring potential lawsuits against physicians prescribing the contraceptive patch. Additionally, despite litigation, we believe that the contraceptive patch should remain an option for many patients. The two primary causes of action that plaintiff attorneys may pursue against physicians prescribing the contraceptive patch are 1) medical negligence for breaching the standard of care by prescribing the contraceptive patch and 2) failure to provide informed consent by not warning patients of the risks of the contraceptive patch. As long as the contraceptive patch remains U.S. Food and Drug Administration-approved, it will be difficult for plaintiff attorneys to prevail in arguing that a physician breached the standard of care by prescribing the contraceptive patch, unless it was prescribed to a patient with a known contraindication to the contraceptive patch. The vast majority of patients seeking birth control do not have known medical contraindications to the contraceptive patch. The best way to negate the other potential cause of action-failure to provide informed consent-is to provide and document informed consent in the medical records. Once informed consent is documented in the medical records, there is the legal presumption in favor of the physician that the medical records are accurate and that the patient was provided proper informed consent. However, this is a rebuttable presumption, and an injured patient will be given the opportunity to dispute that she was not properly informed of the risks and that she would not have chosen the contraceptive patch as a means of contraception if she had been properly informed of the risks. Nevertheless, the legal presumption remains that the information documented in the medical records is accurate. By documenting proper informed consent in the medical records, physicians should be more comfortable in prescribing the contraceptive method they believe best fits the needs of their patients, regardless of ongoing litigation and controversies surrounding a contraceptive product. (full-text)
Language: English

Keywords:
UNITED STATES OF AMERICA | TEXAS | CRITIQUE | USFDA | PHYSICIANS | PRESCRIPTIONS | CONTRACEPTION | PRODUCT APPROVAL | INFORMED CONSENT | Developed Countries | North America | Americas | USPHS | Government Agencies | Organizations | Political Factors | Sociocultural Factors | Health Personnel | Delivery of Health Care | Health | Distributional Activities | Program Activities | Programs | Organization and Administration | Family Planning | Legislation | Health Services
Document Number: 341195  

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Peer Reviewed

Title: Implications of the HIV testing protocol for refusal bias in seroprevalence surveys.
Author: Reniers G; Araya T; Berhane Y; Davey G; Sanders EJ
Source: BMC Public Health. 2009 May 28;9(1):163.
Abstract: ABSTRACT: BACKGROUND: HIV serosurveys have become important sources of HIV prevalence estimates, but these estimates may be biased because of refusals and other forms of non-response. We investigate the effect of the post-test counseling study protocol on bias due to the refusal to be tested. METHODS: Data come from a nine-month prospective study of hospital admissions in Addis Ababa during which patients were approached for an HIV test. Patients had the choice between three consent levels: testing and post-test counseling (including the return of HIV test results), testing without post-test counseling, and total refusal. For all patients, information was collected on basic sociodemographic background characteristics as well as admission diagnosis. The three consent levels are used to mimic refusal bias in serosurveys with different post-test counseling study protocols. We first investigate the covariates of consent for testing. Second, we quantify refusal bias in HIV prevalence estimates using Heckman regression models that account for sample selection. RESULTS: Refusal to be tested positively correlates with admission diagnosis (and thus HIV status), but the magnitude of refusal bias in HIV prevalence surveys depends on the study protocol. Bias is larger when post-test counseling and the return of HIV test results is a prerequisite of study participation (compared to a protocol where test results are not returned to study participants, or, where there is an explicit provision for respondents to forego post-test counseling). We also find that consent for testing increased following the introduction of antiretroviral therapy in Ethiopia. Other covariates of refusal are age (non-linear effect), gender (higher refusal rates in men), marital status (lowest refusal rates in singles), educational status (refusal rate increases with educational attainment), and counselor. CONCLUSIONS: The protocol for post-test counseling and the return of HIV test results to study participants is an important consideration in HIV prevalence surveys that wish to minimize refusal bias. The availability of ART is likely to reduce refusal rates.
Language: English

Keywords:
ETHIOPIA | METHODOLOGICAL STUDIES | EPIDEMIOLOGIC METHODS | CLINICAL RESEARCH | ESTIMATION TECHNIQUES | PROSPECTIVE STUDIES | PERSONS LIVING WITH HIV/AIDS | PREVALENCE | HIV INFECTIONS | HIV TESTING | BIAS | COUNSELING | VOLUNTARY COUNSELING AND TESTING | INFORMED CONSENT | ANTIRETROVIRAL THERAPY | Africa, Eastern | Africa, Sub Saharan | Africa | Developing Countries | Studies | Research Methodology | Viral Diseases | Diseases | Measurement | Laboratory Examinations and Diagnoses | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Error Sources | Clinic Activities | Program Activities | Programs | Organization and Administration | HIV
Document Number: 341483  

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Peer Reviewed

Title: Planning for Posttrial Access to Antiretroviral Treatment for Research Participants in Developing Countries.
Author: Shah S; Elmer S; Grady C
Source: American Journal of Public Health. 2009 Jul 16;
Abstract: Despite recognition of the importance of posttrial access to antiretroviral therapy (ART), the implementation process has not been studied. We examined whether National Institutes of Health (NIH) guidance was being implemented in NIH-funded ART trials conducted in developing countries between July 2005 and June 2007. All of the 18 studies we identified had posttrial access plans for trial participants. More than 70% had specific mechanisms for posttrial access, but none guaranteed long-term sponsor funding after the trials. The plans reflected variation in local contexts and the uncertainty of predicting local conditions in the long term. The strength of the NIH guidance may be that it encourages investigators to formulate plans in advance and to work with other stakeholders to provide access to ART.
Language: English

Keywords:
DEVELOPING COUNTRIES | RESEARCH REPORT | STUDIES | CLINIC ACTIVITIES | ANTIRETROVIRAL THERAPY | PARTICIPATION | ETHICS | INFORMED CONSENT | TREATMENT | FUNDS | INTERNATIONAL COOPERATION | PROGRAM ACCESSIBILITY | Research Methodology | Program Activities | Programs | Organization and Administration | HIV | HIV Infections | Viral Diseases | Diseases | Social Behavior | Behavior | Sociocultural Factors | Health Services | Delivery of Health Care | Health | Medical Procedures | Medicine | Financial Activities | Economic Factors | Political Factors | Program Evaluation
Document Number: 342040  

14.    Full text document

Title: South African national HIV prevalence, incidence, behaviour and communication survey 2008: a turning tide among teenagers?
Author: Shisana O; Rehle T; Simbayi LC; Zuma K; Jooste S
Source: Cape Town, South Africa, HSRC Press, 2009. [116] p.
Abstract: This report is the third in a series of population-based HIV seroprevalence surveys that started in 2002 and were repeated in 2005 and again in 2008. The survey found that South Africa's HIV epidemic has leveled off at a prevalence of 10.9 percent for people aged two years and older, with 5.2 million people estimated to be living with HIV in 2008. HIV prevalence has also declined among children aged 2-14, from 5.6 percent in 2002 to 2.5 percent in 2008, and a decline in new infections has also been noted among teenagers aged 15-19. But the survey warns that the overall situation remains "dire" since South Africa has the world's largest HIV-positive population.
Language: English

Keywords:
SOUTH AFRICA | SUMMARY REPORT | RESEARCH METHODOLOGY | INCIDENCE | ADOLESCENTS | SEX BEHAVIOR | RISK BEHAVIOR | HIV TESTING | ANTIRETROVIRAL DRUGS | TREATMENT | ETHICS | INFORMED CONSENT | LABORATORY PROCEDURES | PROGRAM ACTIVITIES | Developing Countries | Africa, Southern | Africa, Sub Saharan | Africa | Measurement | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Behavior | Laboratory Examinations and Diagnoses | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Sociocultural Factors | Programs | Organization and Administration
Document Number: 342037  

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Title: Informed consent for IUD fitting [letter]
Author: Stillwell S; Searle S
Source: Journal of Family Planning and Reproductive Health Care. 2009 Apr;35(2):132-3.
Abstract: Perforation of the uterus is a rare complication of intrauterine device (IUD) fitting. It is quoted as occurring in up to 2 in 1000 IUD fittings. Risk factors for perforation include previous caesarean section and postpartum insertion up to 6 months after delivery. Perforation may occur during the sounding of the uterus or the device itself may perforate the uterus. This can lead to the device being free in the abdominal cavity, necessitating removal by laparoscopy or laparotomy. Faculty Guidance tells IUD fitters that they should explain the risk of perforation to women considering an IUD and document this discussion in the clinical record. This fits with General Medical Council (GMC) guidance on informed consent. I dealt with a complaint from a woman who had a perforation of the uterus following an IUD change; this lady required laparoscopy to remove a missing IUD. The perforation was diagnosed at her IUD check, when the threads were found to be missing. Despite a clinical record showing "perf" followed by a tick this lady alleged that she had not been made aware of the risk of perforation and that if she had been aware she would not have had an IUD fitted. Dealing with this complaint led me to review my own clinical practice and to seek the opinions of other IUD fitters. Using a questionnaire, 15 instructing doctors were asked about the manner in which they (1) explain perforation risk to women and their confidence doing this and (2) assess their patients' understanding of the risk of perforation. These doctors all explained the risk of perforation to all women on their first IUD fitting but only 80% did on subsequent fittings. They commonly used an explanation along the lines of: "There is a small chance -1 in a 1000 -of perforation. This means making a hole in the wall of the womb. This is not serious but if the IUD goes into the tummy outside the womb it has to be removed with keyhole surgery". An explanation such as this would meet GMC consent guidance (i.e. you must tell patients if an investigation or treatment might result in a serious adverse outcome, even if the likelihood is very small). Although 50% of doctors found perforation easy to explain only 20% felt that their patients had understood the risk of perforation. If this is the case then this would not meet guidance that "you should check that a patient understands the terms that you use, particularly when describing the seriousness, frequency and likelihood of an adverse outcome". No doctor felt that patients were deterred from having an IUD fitted by the risk of perforation. More than 50% of the doctors felt that they would like further training in the discussion of risk of perforation of the uterus and of explanation of risk in general. It sometimes takes a review of everyday practice to identify a learning need. In this case it was prompted by a complaint from a woman who unfortunately did experience uterine perforation following an IUD change. All the doctors questioned did discuss the risk of perforation at a first IUD fitting but not all did at a subsequent IUD change. We should not assume that a woman will remember the potential complications of IUD fitting from a previous consultation. The management of this particular complaint and the results of this survey have changed the way in which I discuss perforation risk with women, and I now incorporate this into a fuller explanation of how the device is introduced and why a problem might occur potentially leading to perforation. (full-text)
Language: English

Keywords:
UNITED KINGDOM | SUMMARY REPORT | CASE HISTORIES | INFORMED CONSENT | IUD COMPLICATIONS | INSERTION | UTERINE PERFORATION | PHYSICIAN-PATIENT RELATIONS | Developed Countries | Europe, Western | Europe | Data Collection | Research Methodology | Health Services | Delivery of Health Care | Health | IUD | Contraceptive Methods | Contraception | Family Planning | Treatment | Medical Procedures | Medicine | Perforations | Diseases | Interpersonal Relations | Behavior
Document Number: 341646  

16.
Peer Reviewed

Title: Surgeons and HIV: South African attitudes.
Author: Szabo CP; Dhai A; Veller M; Kleinsmidt A
Source: South African Medical Journal. 2009 Feb;99(2):110-3.
Abstract: OBJECTIVES: The HIV status of surgeons, in the context of the informed consent obtained from their patients, is a contentious matter. We surveyed the views of practising surgeons in South Africa regarding aspects of HIV and its impact on surgeons. DESIGN: A cross-sectional survey of surgeons who were members of the Association of Surgeons of South Africa, regarding their attitudes to the preceding issues. RESULTS: The salient findings included the view that a patient-centered approach requiring HIV status disclosure to patients would be discriminatory to surgeons and provide no clear benefit to patients, and that HIV-positive surgeons should determine their own scope of practice. CONCLUSION: Patient-centered approaches and restrictive policies, related to this issue, do not accord with clinician sentiment. In the absence of comparable local or international data, this study provides clinicians' views with implications for the development of locally relevant policies and guidelines.
Language: English

Keywords:
SOUTH AFRICA | SUMMARY REPORT | CROSS SECTIONAL ANALYSIS | PHYSICIANS | SURGERY | PERSONS LIVING WITH HIV/AIDS | CLIENTS | ATTITUDES | INFORMED CONSENT | Developing Countries | Africa, Southern | Africa, Sub Saharan | Africa | Research Methodology | Health Personnel | Delivery of Health Care | Health | Treatment | Medical Procedures | Medicine | Health Services | HIV Infections | Viral Diseases | Diseases | Program Activities | Programs | Organization and Administration | Psychological Factors | Behavior
Document Number: 341325  

17.    Full text document

Title: Technical report: Behavioral and social science support to CONRAD Phase III clinical trial of cellulose sulfate 6% gel.
Author: Family Health International [FHI]
Source: Research Triangle Park, North Carolina, FHI, 2008 Jun. [96] p. (USAID Cooperative Agreement No. HRN-A-00-98-000200-00)
Abstract: The successful implementation of Phase III clinical trials requires careful planning and management. In order to plan and monitor the CONRAD multi-site Phase III clinical trial of the topical microbicide cellulose sulfate 6% (Ushercell) in preventing transmission of HIV, behavioral and social science (BSS) research was applied. This report documents the process, findings, and recommendations from the BSS activities.
Language: English

Keywords:
AFRICA | TECHNICAL REPORT | DATA COLLECTION | INFORMED CONSENT | RESPONDENTS | PERSONS LIVING WITH HIV/AIDS | HIV TESTING | SEX BEHAVIOR | VAGINAL GEL | ATTITUDES | KNOWLEDGE | MOTIVATION | Developing Countries | Research Methodology | Health Services | Delivery of Health Care | Health | Surveys | Sampling Studies | Studies | HIV Infections | Viral Diseases | Diseases | Laboratory Examinations and Diagnoses | Examinations and Diagnoses | Medical Procedures | Medicine | Behavior | Vaginal Spermicides | Contraceptive Methods | Contraception | Family Planning | Psychological Factors | Sociocultural Factors
Document Number: 331500  

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Title: Process for obtaining informed consent: women's opinions.
Author: Bento SF; Hardy E; Osis MJ
Source: Developing World Bioethics. 2008 Dec;8(3):197-206.
Abstract: In Brazil, every study involving human beings is required to produce an informed consent form that must be signed by study participants: this is stated in Resolution 196/96.(1) Consent must be obtained through a specific structured process. OBJECTIVE: To present the opinions of women regarding how the process of obtaining informed consent should be conducted when women are invited to participate in studies on contraceptive methods. SUBJECTS AND METHODS: Eight focus groups were conducted, involving a total of 51 women living in the metropolitan region of Campinas. The women involved in the study were either participating in a clinical trial in the area of women's health or had participated in such a trial in the previous 12 months. A thematic guide was used to conduct the focus group discussions; the discussions were recorded, transcribed and a thematic analysis performed. RESULTS: In general, the person who invites a woman to participate in a study should be a member of the research team but not the principal investigator. Information relating to the study should be given orally and in writing, both individually and in the group setting. Study volunteers should be informed about, among other things, the risks, possible side effects and discomforts, including long-term effects. The use of audiovisual aids to provide information was suggested. CONCLUSION: The process for obtaining informed consent was seen as a means of establishing a relationship between the volunteers and the investigator/research team. The information that the study participants expected to be given coincides with the requirements established under Resolution 196/96. The use of audiovisual aids would improve understanding of the information provided.
Language: English

Keywords:
BRAZIL | RESEARCH REPORT | FOCUS GROUPS | WOMEN | PARTICIPATION | INFORMED CONSENT | CONTRACEPTIVE METHODS | ETHICS | INFORMATION | DECISION MAKING | RESEARCH AND DEVELOPMENT | Developing Countries | South America, Eastern | South America | Latin America | Americas | Data Collection | Research Methodology | Demographic Factors | Population | Social Behavior | Behavior | Health Services | Delivery of Health Care | Health | Contraception | Family Planning | Sociocultural Factors | Technology | Economic Factors
Document Number: 329598  

19.
Peer Reviewed

Title: Demographic and health surveillance: longitudinal ethical considerations.
Author: Carrel M; Rennie S
Source: Bulletin of the World Health Organization. 2008 Aug;86(8):612-6.
Abstract: Longitudinal data gathered from health surveillance, when combined with detailed demographic information, can provide invaluable insight into disease outcomes. Many such surveillance sites exist in the developing world, particularly in Asia and sub-Saharan Africa, and focus on diseases such as HIV/AIDS, cholera, malaria and tuberculosis. The indistinct positions of such surveillance systems, often inhabiting an area between research, treatment and population health monitoring, means that the necessity of and responsibility for ethical oversight is unclear. This regulatory vacuum is further compounded by a lack of attention to longitudinal surveillance systems in ethics literature. In this paper, we explore some key ethical questions that arise during demographic and health surveillance in relation to ethical principles of beneficence, respect for persons and justice: health-care provision, informed consent and study sustainability.
Language: English

Keywords:
DEVELOPING COUNTRIES | METHODOLOGICAL STUDIES | CRITIQUE | RECOMMENDATIONS | DEMOGRAPHIC SURVEYS | HEALTH SURVEYS | LONGITUDINAL STUDIES | EPIDEMIOLOGIC METHODS | POLICYMAKERS | ETHICS | DEMOGRAPHY | EPIDEMIOLOGY | HEALTH POLICY | INFORMED CONSENT | PROGRAM SUSTAINABILITY | Population Dynamics | Demographic Factors | Population | Health | Studies | Research Methodology | Administrative Personnel | Organization and Administration | Sociocultural Factors | Social Sciences | Science | Public Health | Policy | Political Factors | Health Services | Delivery of Health Care | Programs
Document Number: 329104  

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Peer Reviewed

Title: Ethical approaches to adolescent participation in sexual health research.
Author: Flicker S; Guta A
Source: Journal of Adolescent Health. 2008 Jan;42(1):3-10.
Abstract: In this paper we make the case for the importance of adolescent sexual health research, and argue that requiring parental consent for adolescent participation may (a) be unwarranted, (b) be inconsistent with the principles of justice and inclusiveness, (c) be confusing, and (d) serve to silence young people who most need to have a voice in sexual health research. Through a case study of the Toronto Teen Survey, we offer concrete suggestions and alternatives for protecting adolescent health research participants in community-based settings and promoting ethical research approaches. Strategies suggested include: (1) adopting a community-based participatory research approach, (2) careful attention to youth-friendly protocols and consent procedures, (3) proper training of all research staff and peer researchers, (4) partnering with experienced community based youth-serving agencies, (5) paying maximum attention to issues of confidentiality and anonymity, and (6) valuing participation appropriately. Institutional review boards and researchers should be encouraged to adopt localized context-dependent strategies that attend to the unique vulnerabilities of their particular study populations. Attention to flexibility, vulnerability, and community-specific needs is necessary to ensure appropriate ethical research practices that attend to the health and well-being of young people. (author's)
Language: English

Keywords:
CANADA | RESEARCH REPORT | CASE STUDIES | COMMUNITY SURVEYS | ADOLESCENTS | ADOLESCENT HEALTH | REPRODUCTIVE HEALTH | RESEARCH ACTIVITIES | ETHICS | PARENTAL CONSENT | INFORMED CONSENT | CONFIDENTIAL INFORMATION | North America, Northern | Americas | Developed Countries | Studies | Research Methodology | Surveys | Sampling Studies | Youth | Age Factors | Population Characteristics | Demographic Factors | Population | Health | Sociocultural Factors | Political Factors | Health Services | Delivery of Health Care
Document Number: 325014  

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Peer Reviewed

Title: Male circumcision as an HIV prevention strategy in sub-Saharan Africa: sociolegal barriers [editorial]
Author: Gostin LO; Hankins CA
Source: JAMA. Journal of the American Medical Association. 2008 Dec 3;300(21):2539-41.
Abstract: The Joint United Nations Programme on HIV/AIDS (UNAIDS) and the World Health Organization (WHO) recommend safe, voluntary male circumcision as an additional, important strategy for the prevention of heterosexually acquired human immunodeficiency virus (HIV) infection in men in areas with high HIV prevalence and low levels of male circumcision. Comprehensive male circumcision services should include HIV testing and counseling, partner reduction, and male and female condom use. However, male circumcision can have deep symbolic meaning that could pose barriers to implementation. In some parts of the world, male circumcision is a traditional practice with religious or cultural significance; in others, it is a common hygiene intervention; and in yet others, it is unfamiliar or foreign. Consequently, the proportion of men who are circumcised varies by country from less than 5% to more than 80%, with an estimated 30% to 40% of adult men circumcised worldwide. Confirming a number of observational studies, 3 randomized controlled trials in Africa have shown that circumcision reduces the likelihood of female-to-male HIV transmission by 50% to 60%, leading the WHO and UNAIDS to conclude that the evidence is "compelling." There is no comparable evidence demonstrating that male circumcision protects against male-to-female transmission or male-to-male HIV transmission. Male circumcision is a relatively simple, inexpensive 1-time surgical procedure that is cost-effective, but raises a host of ethical, legal, and human rights challenges. (excerpt)
Language: English

Keywords:
AFRICA, SUB SAHARAN | SUMMARY REPORT | MALE CIRCUMCISION | HIV PREVENTION | IMPLEMENTATION | CULTURE | RELIGION | HETEROSEXUALS | PROGRAM ACCEPTABILITY | QUALITY OF HEALTH CARE | HIV TESTING | COUNSELING | SEX EDUCATION | HUMAN RIGHTS | INFORMED CONSENT | SOCIAL CHANGE | Africa | Developing Countries | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | HIV Infections | Viral Diseases | Diseases | Programs | Organization and Administration | Sociocultural Factors | Sex Behavior | Behavior | Program Evaluation | Health Services Evaluation | Laboratory Examinations and Diagnoses | Examinations and Diagnoses | Clinic Activities | Program Activities | Education | Political Factors
Document Number: 329775  

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Peer Reviewed

Title: Recruiting patients for postgraduate medical training in a community family planning clinic: How do patients want to be asked?
Author: Heathcote J
Source: Journal of Family Planning and Reproductive Health Care. 2008;34(1):43-46.
Abstract: The objectives were to look at patients' views about the way in which they are recruited to assist with postgraduate medical training (i.e. Who is the best person to ask patients to participate? When is the best time for patients to be asked?) and to compare these with clinical practice. Questionnaire surveys of 103 female family planning clinic (FPC) patients and 40 Diploma of the Faculty of Family Planning (DFFP) instructing doctors. Patients were recruited from the waiting room of a community FPC, and DFFP instructing doctors from the North West of England were recruited at an updating meeting. Patients preferred to be recruited by non-medical staff (i.e. receptionist and nurses). Few patients wanted to be asked by the training doctor. Only 9% would find it difficult to refuse a receptionist, 47% would find it difficult to refuse the instructing doctor and 65% would find it difficult to refuse the training doctor. In practice, the commonest person to recruit patients is the instructing doctor. Patients wanted to be given some time to consider the request; this was not always given. Patients may feel coerced into seeing training doctors because they find it difficult to refuse requests, particularly when they are being recruited by doctors. Non-medical staff may be more appropriate for the initial recruitment of patients. Patients need time to consider their involvement. The provision of written information may be useful. Further research is indicated to empower patients' decision-making and reduce the likelihood of coercion. (author's)
Language: English

Keywords:
UNITED KINGDOM | RESEARCH REPORT | QUESTIONNAIRES | WOMEN | CLIENTS | MEDICAL STUDENTS | FAMILY PLANNING CENTERS | RECRUITMENT ACTIVITIES | TRAINING ACTIVITIES | INFORMED CONSENT | Developed Countries | Europe, Western | Europe | Demographic Factors | Population | Program Activities | Programs | Organization and Administration | Students | Education | Health Facilities | Delivery of Health Care | Health | Training Programs | Health Services
Document Number: 323391  

23.    Full text document

Peer Reviewed

Title: Patients with severe mental illness: a new approach to testing for HIV.
Author: Joska JA; Kaliski SZ; Benatar SR
Source: South African Medical Journal. 2008 Mar;98(3):213-217.
Abstract: Background. The prevalence of HIV infection in South Africa is approaching 20% of young adults. In severely mentally ill people it is probably higher. Testing for infection is subject to stringent ethical principles. Undiagnosed HIV infection in people with severe mental illness increases costs and morbidity. Since effective treatments are available, it is imperative to diagnose HIV infection early in this high-risk population. Methods. A literature review established the prevalence of HIV infection in inpatient populations with HIV infection. The pattern of testing for HIV over 3 years at a major psychiatric hospital was investigated. We surveyed public sector psychiatrists in the Western Cape to establish their attitudes to HIV in their patients. Results. The reported HIV seroprevalence in psychiatric inpatients ranges from 0 to 59.3%, with a mean of 10%. Data show a clear trend towards an increase in prevalence: before 1996 the mean HIV seroprevalence was 7.4%, while after 1996 the mean was 15%. State psychiatrists in the Western Cape do not test routinely for HIV infection, mainly owing to ethical constraints: 14.6% of patients at Lentegeur Hospital were tested in 2006. Conclusions. The high prevalence of HIV infection in South Africa, which is probably higher in patients with severe mental illness (most of whom are not competent to provide informed consent), and the availability of effective treatment require debate and a clear policy regarding testing for HIV infection to be implemented. We recommend a new approach to HIV testing in these patients.
Language: English

Keywords:
SOUTH AFRICA | RESEARCH REPORT | CLINICAL RESEARCH | EPIDEMIOLOGIC METHODS | DISABLED PERSONS AND DISABILITIES | PHYSICIANS | MENTAL DISORDERS | HIV TESTING | ETHICS | PREVALENCE | HIV INFECTIONS | INFORMED CONSENT | Developing Countries | Africa, Southern | Africa, Sub Saharan | Africa | Research Methodology | Population Characteristics | Demographic Factors | Population | Health Personnel | Delivery of Health Care | Health | Diseases | Laboratory Examinations and Diagnoses | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Sociocultural Factors | Measurement | Viral Diseases
Document Number: 330620  

24.
Title: The federal government and academic texts as barriers to informed consent.
Author: Lanfranchi A
Source: Issues In Law and Medicine. 2008 Summer;24(1):61-9.
Abstract: Informed patient consent for medical treatment is required by both law and medical ethics. Yet, both federal agencies and academicians are participating in the suppression of information about the heightened risk of breast cancer posed by oral contraceptives and induced abortion. There is historical precedent in the long-delayed acknowledgement of the smoking/lung cancer link. By law, a patient has the right to be fully informed of the nature of her medical condition and any proposed course of therapy. It is assumed that a patient will be given the complete and true scientific basis of her diagnosis and treatment, to ensure that her well-being and her autonomy in decision-making are protected. Informed consent is the process by which a patient can participate in choices about medical treatment. It originates from the legal and ethical right of the patient to direct what is done to her body, and from the ethical duty of the physician to involve the patient in her medical care. Our federal government has become a barrier to informed consent concerning oral contraceptive drugs and induced abortion.
Language: English

Keywords:
UNITED STATES OF AMERICA | NEW JERSEY | ETHICS | CLIENTS | INFORMED CONSENT | EXAMINATIONS AND DIAGNOSES | DECISION MAKING | TREATMENT | ORAL CONTRACEPTIVES | DRUGS | ABORTION | GOVERNMENT AGENCIES | Developed Countries | North America | Americas | Sociocultural Factors | Program Activities | Programs | Organization and Administration | Health Services | Delivery of Health Care | Health | Medical Procedures | Medicine | Behavior | Contraceptive Methods | Contraception | Family Planning | Fertility Control, Postconception | Organizations | Political Factors
Document Number: 329036   Notification

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Title: "Even if you're positive, you still have rights because you are a person": Human rights and the reproductive choice of HIV-positive persons.
Author: London L; Orner PJ; Myer L
Source: Developing World Bioethics. 2008;8(1):11-22.
Abstract: Global debates in approaches to HIV/AIDS control have recently moved away from a uniformly strong human rights-based focus. Public health utilitarianism has become increasingly important in shaping national and international policies. However, potentially contradictory imperatives may require reconciliation of individual reproductive and other human rights with public health objectives. Current reproductive health guidelines remain largely nonprescriptive on the advisability of pregnancy amongst HIV-positive couples, mainly relying on effective counselling to enable autonomous decision-making by clients. Yet, health care provider values and attitudes may substantially impact on the effectiveness of nonprescriptive guidelines, particularly where social norms and stereotypes regarding childbearing are powerful, and where providers are subjected to dual loyalty pressures, with potentially adverse impacts on rights of service users. Data from a study of user experiences and perceptions of reproductiveand HIV/AIDS services are used to illustrate a rights analysis of how reproductive health policy should integrate a rights perspective into the way services engage with HIV-positive persons and their reproductive choices. The analysis draws on recognised tools developed to evaluate health policies for their human rights impacts and on a model developed for health equity research in South Africa to argue for greater recognition of agency on the part of persons affected by HIV/AIDS in the development and content of policies on reproductive choices. We conclude by proposing strategies that are based upon a synergy between human rights and public health approaches to policy on reproductive health choices for persons with HIV/AIDS. (author's)
Language: English

Keywords:
SOUTH AFRICA | RESEARCH REPORT | KAP SURVEYS | PERSONS LIVING WITH HIV/AIDS | PROVIDERS WITH CLIENTS | HUMAN RIGHTS | REPRODUCTIVE BEHAVIOR | GENDER ISSUES | INFORMED CONSENT | PUBLIC HEALTH | COUNSELING | VALUE ORIENTATION | Africa, Southern | Africa, Sub Saharan | Africa | Developing Countries | Surveys | Sampling Studies | Studies | Research Methodology | Persons Living With HIV/AIDS | HIV Infections | Viral Diseases | Diseases | Health Services | Delivery of Health Care | Health | Political Factors | Sociocultural Factors | Fertility | Population Dynamics | Demographic Factors | Population | Clinic Activities | Program Activities | Programs | Organization and Administration | Psychological Factors | Behavior
Document Number: 325100  

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Peer Reviewed

Title: Voluntary counselling and testing uptake and HIV prevalence among tuberculosis patients in Jogjakarta, Indonesia.
Author: Mahendradhata Y; Ahmad RA; Kusuma TA; Boelaert M; Van der Werf MJ
Source: Transactions of the Royal Society of Tropical Medicine and Hygiene. 2008 Oct;102(10):1003-1010.
Abstract: We aimed to establish HIV prevalence and uptake of unlinked anonymous testing and voluntary counselling and testing (VCT) among tuberculosis (TB) patients in Jogjakarta, Indonesia. We introduced unlinked anonymous HIV testing for TB patients attending directly observed treatment, short-course services between April and December 2006. Patients were additionally offered VCT services. Of 1269 TB patients who were offered unlinked anonymous testing, 989 (77.9%; 95% CI 75.6-80.1%) accepted. HIV prevalence was 1.9% (95% CI 1.6-2.2%). HIV infections were less frequently diagnosed among TB patients who attended a public health centre [odds ratio (OR) 0.15; 95% CI 0.03-0.70] rather than public hospital. They were more frequent in TB patients with a university education background (OR 5.16; 95% CI 1.01-26.63) or a history of HIV testing (OR 57.87; 95% CI 9.42-355.62). Of the 989 patients who accepted unlinked anonymous testing, only 133 (13.4%; 95% CI 11.5-15.7%) expressed interest in VCT. Of these, 52 (39.1%; 95% CI 31.2-47.6%) attended VCT, but interest was higher among students and those offered VCT by public health centres. The HIV prevalence in Jogjakarta is higher than expected and needs to be monitored cautiously. Unlinked anonymous HIV testing is well accepted and can be implemented with modest additional efforts. (author's)
Language: English

Keywords:
INDONESIA | RESEARCH REPORT | TUBERCULOSIS | VOLUNTARY COUNSELING AND TESTING | HIV TESTING | DIRECTLY OBSERVED THERAPY SHORT-COURSE (DOTS) | BLOOD | LABORATORY EXAMINATIONS AND DIAGNOSES | INFORMED CONSENT | Asia, Southeastern | Asia | Developing Countries | Infections | Diseases | Examinations and Diagnoses | Medical Procedures | Medicine | Health Services | Delivery of Health Care | Health | Treatment | Hemic System | Physiology | Biology
Document Number: 328172  

27.
Title: [Menstrual cycle perception and psychological distress in a sample of Mexican women] Percepcion del ciclo menstrual y malestar psicologico en una muestra de mujeres
Author: Morales-Carmona F; Pimentel-Nieto D; Bustos-Lopez H
Source: Revista De Investigacion Clinica; Organo Del Hospital De Enfermedades De La Nutricion. 2008 Nov-Dec;60(6):478-85.
Abstract: OBJECTIVE: To evaluate the association between psychological distress and menstrual bleeding perception, in order to design a psychological intervention for women in reproductive age. MATERIAL AND METHODS: Ex post facto and retrospective study in a random sample of women living in Mexico City with ages between 15 to 35 years. The following instruments were administered after reading the informed consent form: demographic and social questionnaire, gyneco-obstetric clinical history, menstrual bleeding diagnostic scale, menstrual bleeding analogical scale and the Goldberg's General Health Questionnaire. RESULTS: 909 women were interviewed and 776 completed the study. A significant statistic association existed between the presence of menorrhagia and the symptoms of psychological distress. CONCLUSIONS: Our results suggest a temporary interaction between physiological and psychological symptoms that produce an intense sense of distress in the women.
Language: Spanish

Keywords:
MEXICO | RESEARCH REPORT | RETROSPECTIVE STUDIES | WOMEN | BLEEDING | MENSTRUATION | INFORMED CONSENT | MENORRHAGIA | PSYCHOLOGICAL FACTORS | STRESS | SIGNS AND SYMPTOMS | North America | Americas | Developing Countries | Studies | Research Methodology | Demographic Factors | Population | Diseases | Reproduction | Health Services | Delivery of Health Care | Health | Menstruation Disorders | Behavior
Document Number: 341188  

28.    Subscription may be needed for full text     
Title: Data-protection standards and confidentiality of HIV/AIDS status in the workplace -- a South African case study.
Author: Muskat-Gorska Z
Source: African Journal of AIDS Research. 2008 Nov;7(3):311-322.
Abstract: The article contextualises an emerging new regime for information privacy in South Africa (i.e. the draft Protection of Personal Information Bill). Subsequently, it discusses the possibility of successful implementation of international data-protection standards in an environment where there is an urgent need to balance HIV/AIDS confidentiality rights with public health requirements. Also, the article presents a preliminary assessment of the possible impact of professionalisation (and outsourcing) of workplace HIV/AIDS management on workplace data-protection practices, and it identifies some spaces for social dialogue on HIV/AIDS-data treatment in South Africa. The study methods comprise an analysis of legal documents (concerning international data-protection standards and the development of law governing data protection and HIV/AIDS confidentiality in South Africa) and interviews conducted with workplace health managers and trade union representatives, in Johannesburg, in 2007.
Language: English

Keywords:
SOUTH AFRICA | RESEARCH REPORT | CASE STUDIES | LABOR UNIONS | HIV INFECTIONS | AIDS | CONFIDENTIAL INFORMATION | DATA STORAGE AND RETRIEVAL | LEGISLATION | INFORMED CONSENT | STANDARDS | WORKPLACE | Developing Countries | Africa, Southern | Africa, Sub Saharan | Africa | Studies | Research Methodology | Organizations | Political Factors | Sociocultural Factors | Viral Diseases | Diseases | Ethics | Information Processing | Information | Health Services | Delivery of Health Care | Health | Employment | Macroeconomic Factors | Economic Factors
Document Number: 341275  

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Peer Reviewed

Title: Ethical dilemmas of social science research on AIDS and orphanhood in Western Kenya.
Author: Nyambedha EO
Source: Social Science and Medicine. 2008 Sep;67(5):771-9.
Abstract: This paper is based on the experiences drawn from a long-term social science research programme on the impact of the AIDS pandemic on orphanhood in western Kenya. It discusses the ethical dilemma of maintaining a delicate balance between research ethics, the expectations of the study population and negotiating the community's vested interests in a health related research project in a low-income society. I argue that informed consent and the intended benefits of the study to the participants continue to be major challenges facing the justification of social research with people affected by or living with AIDS in low-income societies. The paper underscores the importance of community feedback sessions as a way of enhancing chances of acceptability of research efforts and obtaining informed consent. It further shows how community feedback sessions contribute to local knowledge of the problem being studied, creating opportunities for advocacy. This discussion adds to the existing ethical debate on the wider contexts within which research on vulnerable people affected by AIDS is conducted by arguing that research practice is inseparable from epistemological concerns of knowledge production. I suggest that ethnographers should enhance efforts to innovatively design action research projects to serve the twin purposes of data collection and deal with ethical challenges that are experienced when doing long-term research on vulnerable groups.
Language: English

Keywords:
KENYA | RESEARCH REPORT | ORPHANS AND VULNERABLE CHILDREN | SOCIAL SCIENCES | INFORMED CONSENT | ETHICS | AIDS | RESEARCH AND DEVELOPMENT | Africa, Eastern | Africa, Sub Saharan | Africa | Developing Countries | Family and Household | Sociocultural Factors | Science | Health Services | Delivery of Health Care | Health | HIV Infections | Viral Diseases | Diseases | Technology | Economic Factors
Document Number: 330569  

30.
Title: [To bleed or not--a new dogma or a real choice in contraception?] Les regles n'ont plus la cote: une question de contraception ou de choix?
Author: Renteria SC
Source: Revue Medicale Suisse. 2008 Oct 22;4(176):2246-50, 2252.
Abstract: Let's talk about it Suppression of menstruation, by extending the duration of contraceptives containing estro-progestins (oral contraception, patch or vaginal ring) to long cycles, is a new approach in the field of contraception. These extended cycles aim at obtaining prolonged amenorrhea, interrupted periodically by a free interval of 7 days without hormone intake and thus causing breakthrough bleeding. Pathologies, which are supposed to get some benefit from the suppression of menstruation and of hormone level variations related to ovarian activity, are widely recognized as an indication. Some interest is also coming up for so called life style indications. Treatment issues, advantages and disadvantages are examined in the light of women's expectations and right to access to informed consent and independent choice.
Language: French

Keywords:
RESEARCH REPORT | CONTRACEPTION | ORAL CONTRACEPTIVES | MENSTRUATION | BLEEDING | LIFE STYLE | INFORMED CONSENT | Family Planning | Contraceptive Methods | Reproduction | Signs and Symptoms | Diseases | Behavior | Health Services | Delivery of Health Care | Health
Document Number: 329814  
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