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Background

Estimating the seroprevalence of HIV in a low risk population such as pregnant women provides essential information for an effective implementation of AIDS control programmes, and also for the monitoring of HIV spread within a country. Very few studies are available from north India showing the current trend in HIV prevalence in the antenatal population;which led us to carry outthis study at a tertiary care hospital in north India

Methods

Blood samples from pregnant women attending antenatal clinics at the All India Institute of Medical Sciences, New Delhi were collected after informed consent and pre-test counseling. The samples were tested for HIV antibodies as per the WHO guidelines, over a period of four years from January 2003 to December 2006.

Results

Of the 3529 pregnant women tested in four years, 0.88% (CI 0.5 – 1.24) women were found to be HIV seroreactive. Majority of the seroreactive pregnant women (41.9%) were in the age group of 20–24 years followed by the 30–34 yrs (25.8%) and 25–29 years (22.6%) age group. The mean age of the HIV positive women was 24.9 years (SD ± 1.49 yrs). The HIV seroprevalence rates showed an increasing trend from 0.7% (CI 0.14 – 2.04) in 2003–2004 to 0.9% (CI 0.49 – 1.5) in 2005–2006. This prevalence rate indicates concern, as Delhi and its adjoining states are otherwise considered as 'low prevalence states'.

Conclusion

Seroprevalence of HIV infection was found to be increasing in the last four years amongst pregnant women of North India. These findings are in contrast to the national projections.

Background

Much attention has been devoted to ethical issues related to randomized controlled trials for HIV treatment and prevention. However, there has been less discussion of ethical issues surrounding families involved in observational studies of HIV transmission. This paper describes the process of ethical deliberation about how best to obtain informed consent from sex partners of injection drug users (IDUs) tested for HIV, within a recent HIV study in Eastern Europe. The study aimed to assess the amount of HIV serodiscordance among IDUs and their sexual partners, identify barriers to harm reduction, and explore ways to optimize intervention programs. Including IDUs, either HIV-positive or at high risk for HIV, and their sexual partners would help to gain a more complete understanding of barriers to and opportunities for intervention.

Discussion

This paper focuses on the ethical dilemma regarding informed recruitment: whether researchers should disclose to sexual partners of IDUs that they were recruited because their partner injects drugs (i.e., their heightened risk for HIV). Disclosing risks to partners upholds the ethical value of respect for persons through informed consent. However, disclosure compromises the IDU's confidentiality, and potentially, the scientific validity of the research. Following a brief literature review, we summarize the researchers' systematic evaluation of this issue from ethical, scientific, and logistical perspectives. While the cultural context may be somewhat unique to Eastern Europe and Central Asia, the issues raised and solutions proposed here inform epidemiological research designs and their underlying ethical tensions.

Summary

We present ethical arguments in favor of disclosure, discuss how cultural context shapes the ethical issues, and recommend refinement of guidance for couples research of communicable diseases to assist investigators encountering these ethical issues in the future.

Background

The HIV/AIDS epidemic in Kenya is a major public-health problem. Estimating the prevalence of HIV in pregnant women provides essential information for an effective implementation of HIV/AIDS control measures and monitoring of HIV spread within a country. The objective of this study was to determine the prevalence of HIV infection, risk factors for HIV/AIDS and immunologic (lymphocyte profile) characteristics among pregnant women attending antenatal clinics in three district hospitals in North-Rift, Kenya.

Methods

Blood samples were collected from pregnant women attending antenatal clinics in three district hospitals (Kitale, Kapsabet and Nandi Hills) after informed consent and pre-test counseling. The samples were tested for HIV antibodies as per the guidelines laid down by Ministry of Health, Kenya. A structured pretested questionnaire was used to obtain demographic data. Lymphocyte subset counts were quantified by standard flow cytometry.

Results

Of the 4638 pregnant women tested, 309 (6.7%) were HIV seropositive. The majority (85.1%) of the antenatal attendees did not know their HIV status prior to visiting the clinic for antenatal care. The highest proportion of HIV infected women was in the age group 21–25 years (35.5%). The 31–35 age group had the highest (8.5%) HIV prevalence, while women aged more than 35 years had the lowest (2.5%).

Women in a polygamous relationship were significantly more likely to be HIV infected as compared to those in a monogamous relationship (p = 0.000). The highest HIV prevalence (6.3%) was recorded among antenatal attendees who had attended secondary schools followed by those with primary and tertiary level of education (6% and 5% respectively). However, there was no significant relationship between HIV seropositivity and the level of education (p = 0.653 and p = 0.469 for secondary and tertiary respectively). The mean CD4 count was 466 cells/mm3 (9–2000 cells/mm3). Those that had less than 200 cells/mm3 accounted for 14% and only nine were on antiretroviral therapy.

Conclusion

Seroprevalence of HIV was found to be consistent with the reports from the national HIV sentinel surveys. Enumeration of T-lymphocyte (CD4/8) should be carried out routinely in the antenatal clinics for proper timing of initiation of antiretroviral therapy among HIV infected pregnant women.

Background

Clinical trials involving children previously considered unethical are now considered essential because of the inherent physiological differences between children and adults. An integral part of research ethics is the informed consent, which for children is obtained by proxy from a consenting parent or guardian. The informed consent process is governed by international ethical codes that are interpreted in accordance with local laws and procedures raising the importance of contextualizing their implementation.

Findings

In Zimbabwe the parental informed consent document for children participating in clinical research is modeled along western laws of ethics and requires that the parent or legally authorized representative provide consent on behalf of a minor. This article highlights the experiences and lessons learnt by Zimbabwean researchers in obtaining informed consent from guardians of orphaned children participating in a collaborative HIV clinical trial involving the Medical Research Council, United Kingdom and four centers, three of which are in Uganda. Researchers were faced with a situation where caregivers of orphaned children were not permitted to provide informed consent for trial participation. The situation contrasted with general clinical practice where consent for procedures on orphans is obtained from their caregivers who are not legal guardians.

Conclusion

The challenges faced in obtaining informed consent for orphans in this clinical trial underscores the need for the Zimbabwe ethics committee to develop an ethical and legal framework for pediatric research that is based on international guidelines while taking into account the cultural context. The Medical Research Council of Zimbabwe has since started the process that is expected to involve critical stakeholders namely the community including children, ethicists, the legal fraternity and researchers.

Background

Testing pregnant women for HIV at the time of labor and delivery is the last opportunity for prevention of mother-to-child HIV transmission (PMTCT) measures, particularly in settings where women do not receive adequate antenatal care. However, HIV testing and counseling of pregnant women in labor is a challenge, especially in resource-constrained settings. In India, many rural women present for delivery without any prior antenatal care. Those who do get antenatal care are not always tested for HIV, because of deficiencies in the provision of HIV testing and counseling services. In this context, we investigated the impact of introducing round-the-clock, rapid, point-of-care HIV testing and counseling in a busy labor ward at a tertiary care hospital in rural India.

Methods and Findings

After they provided written informed consent, women admitted to the labor ward of a rural teaching hospital in India were offered two rapid tests on oral fluid and finger-stick specimens (OraQuick Rapid HIV-1/HIV-2 tests, OraSure Technologies). Simultaneously, venous blood was drawn for conventional HIV ELISA testing. Western blot tests were performed for confirmatory testing if women were positive by both rapid tests and dual ELISA, or where test results were discordant. Round-the-clock (24 h, 7 d/wk) abbreviated prepartum and extended postpartum counseling sessions were offered as part of the testing strategy. HIV-positive women were administered PMTCT interventions. Of 1,252 eligible women (age range 18 y to 38 y) approached for consent over a 9 mo period in 2006, 1,222 (98%) accepted HIV testing in the labor ward. Of these, 1,003 (82%) women presented with either no reports or incomplete reports of prior HIV testing results at the time of admission to the labor ward. Of 1,222 women, 15 were diagnosed as HIV-positive (on the basis of two rapid tests, dual ELISA and Western blot), yielding a seroprevalence of 1.23% (95% confidence interval [CI] 0.61%–1.8%). Of the 15 HIV test–positive women, four (27%) had presented with reported HIV status, and 11 (73%) new cases of HIV infection were detected due to rapid testing in the labor room. Thus, 11 HIV-positive women received PMTCT interventions on account of round-the-clock rapid HIV testing and counseling in the labor room. While both OraQuick tests (oral and finger-stick) were 100% specific, one false-negative result was documented (with both oral fluid and finger-stick specimens). Of the 15 HIV-infected women who delivered, 13 infants were HIV seronegative at birth and at 1 and 4 mo after delivery; two HIV-positive infants died within a month of delivery.

Conclusions

In a busy rural labor ward setting in India, we demonstrated that it is feasible to introduce a program of round-the-clock rapid HIV testing, including prepartum and extended postpartum counseling sessions. Our data suggest that the availability of round-the-clock rapid HIV testing resulted in successful documentation of HIV serostatus in a large proportion (82%) of rural women who were unaware of their HIV status when admitted to the labor room. In addition, 11 (73%) of a total of 15 HIV-positive women received PMTCT interventions because of round-the-clock rapid testing in the labor ward. These findings are relevant for PMTCT programs in developing countries.

Nitika Pant Pai and colleagues report the results of offering a round-the-clock rapid HIV testing program in a rural labor ward setting in India.

Editors' Summary

Background.

Since the first reported case of AIDS (acquired immunodeficiency syndrome) in 1981, the number of people infected with the human immunodeficiency virus (HIV), which causes AIDS, has risen steadily. Now, more than 33 million people are infected, almost half of them women. HIV is most often spread through unprotected sex with an infected partner, but mother-to-child transmission (MTCT) of HIV is also an important transmission route. HIV-positive women often pass the virus to their babies during pregnancy, labor and delivery, and breastfeeding, if nothing is done to prevent viral transmission. In developed countries, interventions such as voluntary testing and counseling, safe delivery practices (for example, offering cesarean delivery to HIV-positive women), and antiretroviral treatment of the mother during pregnancy and labor and of her newborn baby have minimized the risk of MTCT. In developing countries, the prevention of MTCT (PMTCT) is much less effective, in part because pregnant women often do not know their HIV status. Consequently, in 2007, nearly half a million children became infected with HIV mainly through MTCT.

Why Was This Study Done?

In many developing countries, women do not receive adequate antenatal care. In India, for example, nearly half the women living in rural areas do not receive any antenatal care until they are in labor. This gives health care providers very little time in which to counsel women about HIV infection, test them for the virus, and start interventions to prevent MTCT. Furthermore, testing pregnant women in labor for HIV and counseling them is a challenge, particularly where resources are limited. In this study, therefore, the researchers investigate the feasibility and impact of introducing round-the-clock, rapid HIV testing and counseling in a busy labor ward in a rural teaching hospital in Sevagram, India.

What Did the Researchers Do and Find?

Women admitted to the labor ward between January and September 2006 were offered two rapid HIV tests—one that used a saliva sample and the other that used blood taken from a finger prick. Blood was also taken from a vein for conventional HIV testing. All the women were given a 15-minute counseling session about how HIV is transmitted, the importance of HIV testing, and information on PMTCT before their child was born (prepartum counseling), and a longer postpartum counseling session. HIV-positive women were given a cesarean delivery where possible and antiretroviral drug treatment to reduce MTCT. 1,222 women admitted to the labor ward during the study period (1,003 of whom did not know their HIV status) accepted HIV testing. Of 15 study participants who were HIV positive, 11 learnt of their HIV status in the labor room. Two babies born to these HIV-positive women were HIV positive and died within a month of delivery; the other 13 babies were HIV negative at birth and at 1 and 4 months after delivery. Finally, the rapid HIV tests missed only one HIV-positive woman (no false-positive results were given), and the time from enrolling a woman into the study through referring her for PMTCT intervention where necessary averaged 40–60 minutes.

What Do These Findings Mean?

These findings show the feasibility and positive impact of the introduction of round-the-clock pre- and postpartum HIV counseling and rapid HIV testing into a busy rural Indian labor ward. Few of the women entering this ward knew their HIV status previously but the introduction of these facilities in this setting successfully informed these women of their HIV status. In addition, the round-the-clock counseling and testing led to 11 women and their babies receiving PMTCT interventions who would otherwise have been missed. These findings need to be confirmed in other settings and the cost-effectiveness and sustainability of this approach for the improvement of PMTCT in developing countries needs to be investigated. Nevertheless, these findings suggest that round-the-clock rapid HIV testing might be an effective and acceptable way to reduce MTCT of HIV in many developing countries.

Additional Information.

Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050092.

Read a related PLoS Medicine Perspective article

Information is available from the US National Institute of Allergy and Infectious Diseases on HIV infection and AIDS and on HIV infection in women

HIV InSite has comprehensive information on all aspects of HIV/AIDS

Women, Children, and HIV provides extensive information on the prevention of mother-to-child transmission of HIV in developing countries

Information is available from Avert, an international AIDS charity, on HIV and AIDS in India, on women, HIV, and AIDS, and on HIV and AIDS prevention, including the prevention of mother-to-child transmission

AIDSinfo, a service of the US Department of Health and Human Services provides health information for HIV-positive pregnant women (in English and Spanish)

Background

Understanding the perception of patients on research ethics issues related to biobanking is important to enrich ethical discourse and help inform policy.

Methods

We examined the views of leukemia patients undergoing treatment in clinics located in the Princess Margaret Hospital in Toronto, Ontario, Canada. An initial written survey was provided to 100 patients (64.1% response rate) followed by a follow-up survey (62.5% response rate) covering the topics of informed consent, withdrawal, anonymity, incidental findings and the return of results, ownership, and trust.

Results

The majority (59.6%) preferred one-time consent, 30.3% desired a tiered consent approach that provides multiple options, and 10.1% preferred re-consent for future research. When asked different questions on re-consent, most (58%) reported that re-consent was a waste of time and money, but 51.7% indicated they would feel respected and involved if asked to re-consent. The majority of patients (62.2%) stated they had a right to withdraw their consent, but many changed their mind in the follow-up survey explaining that they should not have the right to withdraw consent. Nearly all of the patients (98%) desired being informed of incidental health findings and explained that the information was useful. Of these, 67.3% of patients preferred that researchers inform them and their doctors of the results. The majority of patients (62.2%) stated that the research institution owns the samples whereas 19.4% stated that the participants owned their samples. Patients had a great deal of trust in doctors, hospitals and government-funded university researchers, moderate levels of trust for provincial governments and industry-funded university researchers, and low levels of trust towards industry and insurance companies.

Conclusions

Many cancer patients surveyed preferred a one-time consent although others desired some form of control. The majority of participants wanted a continuing right to withdraw consent and nearly all wanted to be informed of incidental findings related to their health. Patients had a great deal of trust in their medical professionals and publically-funded researchers as opposed to profit-based industries and insurance companies.

Incidental findings found in “healthy” volunteers during research imaging are common and have important implications for study design and performance, particularly in the areas of informed consent, subjects' rights, clinical image analysis and disclosure. In this study, we aimed to determine current practice and regulations concerning information that should be given to research subjects when obtaining consent, reporting of research images, who should be informed about any incidental findings and the method of disclosure. We reviewed all UK, European and international humanitarian, legal and ethical agencies' guidance. We found that the guidance on what constitutes incidental pathology, how to recognise it and what to do about it is inconsistent between agencies, difficult to find and less complete in the UK than elsewhere. Where given, guidance states that volunteers should be informed during the consent process about how research images will be managed, whether a mechanism exists for identifying incidental findings, arrangements for their disclosure, the potential benefit or harm and therapeutic options. The effects of incidentally discovered pathology on the individual can be complex and far-reaching. Radiologist involvement in analysis of research images varies widely; many incidental findings might therefore go unrecognised. In conclusion, guidance on the management of research imaging is inconsistent, limited and does not address the interests of volunteers. Improved standards to guide management of research images and incidental findings are urgently required.

The issue of notifying people who have been exposed to blood products that have been associated with Creutzfeldt-Jakob disease (CJD) has arisen at a time when the Canadian blood system is under intense scrutiny. As a result, the Canadian Red Cross Society issued a recommendation to health care institutions that recipients of CJD-associated blood products be identified, notified and counselled. Although Canadian jurisprudence in the realm of informed consent may support a policy of individual notification, a review of the scientific evidence and the applicable ethical principles arguably favours a policy of a more general public notification. Indeed, situations such as this require a unique approach to the formation of legal and ethical duties, one that effectively integrates all relevant factors. As such, the authors argue that individual notification is currently not justified. Nevertheless, if a system of general notification is implemented (e.g., through a series of public health announcements), it should provide, for people who wish to know, the opportunity to find out whether they were given CJD-associated products.

Seroprevalence monitoring of HIV in pregnant women by anonymised unlinked testing has been widely adopted in the UK and other countries. The scientific rationale is to eliminate participation and selection bias. The ethical justification is that the public good outweighs any harm to individuals. The assumption has been that individuals have had their autonomy respected by the offer of informed consent. In the light of new scientific evidence, it is doubtful that the public good is best served by the continuation of anonymously testing women receiving antenatal care. It is submitted that it is no longer ethical for health professionals to refrain from informing pregnant women of the benefits of voluntary named testing, or to request their consent to anonymised testing. The legal and moral concept of duty of care is examined, and the abrogation of this duty through anonymisation is explained.

Key Words: Anonymisation • HIV • antenatal testing • informed consent • duty of care

The legal requirements and justifications for collecting patient‐identifiable data without patient consent were examined. The impetus for this arose from legal and ethical issues raised during the development of a population‐based disease register. Numerous commentaries and case studies have been discussing the impact of the Data Protection Act 1998 (DPA1998) and Caldicott principles of good practice on the uses of personal data. But uncertainty still remains about the legal requirements for processing patient‐identifiable data without patient consent for research purposes. This is largely owing to ignorance, or misunderstandings of the implications of the common law duty of confidentiality and section 60 of the Health and Social Care Act 2001. The common law duty of confidentiality states that patient‐identifiable data should not be provided to third parties, regardless of compliance with the DPA1998. It is an obligation derived from case law, and is open to interpretation. Compliance with section 60 ensures that collection of patient‐identifiable data without patient consent is lawful despite the duty of confidentiality. Fears regarding the duty of confidentiality have resulted in a common misconception that section 60 must be complied with. Although this is not the case, section 60 support does provide the most secure basis in law for collecting such data. Using our own experience in developing a disease register as a backdrop, this article will clarify the procedures, risks and potential costs of applying for section 60 support.

Summary

Purpose

Emerging genetic information and the availability of genetic testing has the potential to increase understanding of the disease and improve clinical management of some types of epilepsy. However, genetic testing is also likely to raise significant ethical, legal, and social issues for people with epilepsy, their family members, and their health care providers. We review the genetic and social dimensions of epilepsy relevant to understanding the complex questions raised by epilepsy genetics.

Methods

We reviewed two literatures: (a) research on the genetics of epilepsy, and (b) social science research on the social experience and social consequences of epilepsy. For each, we note key empiric findings and discuss their implications with regard to the consequences of emerging genetic information about epilepsy. We also briefly review available principles and guidelines from professional and advocacy groups that might help to direct efforts to ascertain and address the ethical, legal, and social dimensions of genetic testing for epilepsy.

Results

Genetic information about epilepsy may pose significant challenges for people with epilepsy and their family members. Although some general resources are available for navigating this complex new terrain, no guidelines specific to epilepsy have yet been developed to assist people with epilepsy, their family members, or their health care providers.

Conclusions

Research is needed on the ethical, legal, and social concerns raised by genetic research on epilepsy and the advent of genetic testing. This research should include the perspectives of people with epilepsy and their family members, as well as those of health care professionals, policymakers, and bioethicists.

This article considers some of the ethical and legal issues relating to the ownership and use – including for commercial purposes – of biological material and products derived from humans. The discussion is divided into three parts: after first examining the general notion of ownership, it moves to the particular case of possible commercial use, and finally reflects on the case in point in the light of the preceding considerations. Units of cord blood donated altruistically for transplantation and which are found unsuitable for storage and transplantation, or which become unsuitable while stored in biobanks, are taken as an example. These cord-blood units can be discarded together with other biological waste, or they can be used for research or the development of blood-derived products such as platelet gel. Several ethical questions (eg, informed consent, property, distribution of profits, and others) arise from these circumstances. In this regard, some criteria and limits to use are proposed.

Three recent Canadian legal cases have dealt with the proposed blood transfusion of adolescent members of Jehovah’s Witness (JW) families. In each case, the court permitted transfusions if medically necessary. Much critical analysis of the issue of forced treatment of decisionally competent adolescents focuses exclusively on competence and questions why mature minors may not decide for themselves. The authors argue that a focus on decision-making competence alone is too narrow. Before one may legally give or refuse consent to medical treatment, three conditions must be met: competence, adequate information and lack of coercion. In striving to find agreement on medical treatment, physicians, patients and JW family members seek and, in fact, often achieve mutual understanding and cooperation. Coercion by actual or threatened shunning and excommunication can occur, and these factors may affect adolescent decision-making. In this context, a court order authorizing medical treatment can, therefore, be seen as enhancing patient freedom. The authors suggest that, in addition to fulfilling existing statutory duties to report a child in need of protection, health care professionals caring for acute patients of JW families should actively look for evidence that the patient has accurate medical information and is acting without coercion. The authors also explore suggestions on how to deal with the unusual complexities of such cases.

Background

An 'opt-out' policy of routine HIV counseling and testing (HCT) is being implemented across sub-Saharan Africa to expand prevention of mother-to-child transmission (PMTCT). Although the underlying assumption is that pregnant women in rural Africa are able to voluntarily consent to HIV testing, little is known about the reality and whether 'opt-out' HCT leads to higher completion rates of PMTCT. Factors associated with consent to HIV testing under the 'opt-out' approach were investigated through a large cross-sectional study in Kenya.

Methods

Observations during HIV pre-test information sessions were followed by a cross-sectional survey of 900 pregnant women in three public district hospitals carrying out PMTCT in the Busia district. Women on their first antenatal care (ANC) visit during the current pregnancy were interviewed after giving blood for HIV testing but before learning their test results. Descriptive statistics and multivariate regression analysis were performed.

Results

Of the 900 women participating, 97% tested for HIV. Lack of testing kits was the only reason for women not being tested, i.e. nobody declined HIV testing. Despite the fact that 96% had more than four earlier pregnancies and 37% had been tested for HIV at ANC previously, only 17% of the women surveyed knew that testing was optional. Only 20% of those surveyed felt they could make an informed decision to decline HIV testing. Making an informed decision to decline HIV testing was associated with knowing that testing was optional (OR = 5.44, 95%CI 3.44-8.59), not having a stable relationship with the child's father (OR = 1.76, 95%CI 1.02-3.03), and not having discussed HIV testing with a partner before the ANC visit (OR = 2.64 95%CI 1.79-3.86).

Conclusion

High coverage of HIV testing appears to be achieved at the cost of pregnant women not understanding that testing is optional. Good quality HIV pre-test information is central to ensure that pregnant women understand and accept the reasons for testing and will thus come back to collect their test results, an important prerequisite for completing PMTCT for those who test HIV-positive.

Background

Informed consent is considered the most important step in clinical interventions. The aims of this study were (1) to assess the quality of informed consent for invasive procedures with regard to consent process and information given about risks and alternative treatments, and (2) to determine patients’ attitude toward informed consent at King Abdulaziz Medical City, Riyadh, Saudi Arabia.

Methods

A cross-sectional study was conducted of 162 adult patients in different wards after undergoing surgery or invasive procedures within 1–2 days of signing the informed consent, using a previously validated interview questionnaire. Data on patients’ characteristics, type of invasive procedure, and some informed consent-related issues were collected. Multiple linear regression analysis was used to identify the predictors of the percentage mean score of quality of informed consent, and significance was considered at P ≤ 0.05.

Results

The quality of informed consent was generally poor (% mean score = 50.98 ± 17.49). About two-thirds of patients were told during the informed consent process that they have to sign merely as routine, 48% thought that if they refused the treatment plan they would lose the interest of the treating physician to help them, 42% thought that by saying no they would lose the good relationship with their physician, and 42.6% were not interested in having a copy of the informed consent document. Significantly higher quality was predicted when the physicians were the ones who explained the informed consent (t = 4.15, P < 0.001) and when informed consent was explained to younger patients (t = 2.754, P = 0.007). The overall attitude of the patients toward the process of informed consent was satisfactory (% mean score = 76.31 ± 7.63).

Conclusion

The results suggest either that patients are not aware of their rights or that physician paternalism is practiced in Saudi Arabia. Cultural barriers should not be an argument to diminish the role of informed consent. Further studies should focus on how the value of autonomy can be appreciated in the Saudi culture.

Informed consent has historically been a cornerstone to ensuring autonomy during HIV testing. However, recent changes to global guidance on HIV testing have led to substantial debate on what policy provisions are necessary to ensure that consent remains meaningful in the context of testing. Despite disproportionate rates of testing during pregnancy, pregnant women's perspectives on the HIV testing process are underrepresented in the testing discourse. This study explores women's experiences with HIV testing and the consent process in a public antenatal clinic in South Africa. Qualitative interviews with 25 women were conducted at the clinic at either an antenatal visit or an infant immunization visit that followed HIV testing. Interviews were transcribed, translated, and coded for analysis. Women were categorized into one of the three groups based on their perceptions of choice in consenting for an HIV test. Matrices were used to allow for cross-category and cross-case comparison. Half of the women described having a clear choice in their decision to test. Others were less clear about their choice. Some women felt they had no choice in testing for HIV. None of the women stated that they were tested without having signed a consent form. We found that half of the women's narratives illustrated direct and indirect ways in which providers coerced them into taking an HIV test while receiving antenatal care. As the new guidance on HIV testing is implemented in different settings, it is critical to monitor women's testing experiences to ensure that a woman's right to make an informed, voluntary choice is not violated. Furthermore, models of testing that allow us to meet broader public health goals while simultaneously respecting women's autonomy are needed.

Background

Legislation demands the establishment of client councils in Dutch nursing homes and residential care facilities. The members of those councils are residents or their representatives. Client councils have the right to participate in the strategic management of long-term care facilities. More specifically, they need to be consulted regarding organisational issues and a right to consent on issues regarding daily living of residents, including CQ-index research. CQ-index research concerns a method that measures, analyses and report clients' experiences about the quality of care. Research questions were: 'Do client councils exercise their rights to be consulted and to give their consent?' and 'What is the role of client councils in the process of measuring clients' experiences with the CQ-index and what is their opinion about the CQ-index?'

Methods

Postal questionnaires were sent to members of 1,540 client councils of Dutch nursing homes and residential care facilities. The questionnaire focussed on background information and client councils' involvement in decision-making and strategic management.

Results

The response rate was 34% (n = 524). Most councils consisted of seven members (range: 5 to 12 members). One out of four members participating in the client councils were clients themselves. Although councils have a legal right to be consulted for organisational issues like finance, vision, annual report, and accommodation, less than half the councils (31-46%) reported that they exercised this right. The legal right to consent was perceived by 18 to 36% of the councils regarding client care issues like food and drink, complaints registration, respectful treatment, and activities. For CQ-index research, only 18% of the client councils perceived a right to consent. Their rights to choose an approved contractor -who performs CQ-index research- and indicating improvement priorities, were hardly used.

Conclusions

Client councils play a rather passive role in determining the policy on quality of long-term care. Therefore, specific attention and actions are needed to create a more proactive attitude in councils towards exercising their rights, which are already supported by legislation.

BACKGROUND

Little is known about patient characteristics associated with comprehension of consent information, and whether modifications to the consent process can promote understanding.

OBJECTIVE

To describe a modified research consent process, and determine whether literacy and demographic characteristics are associated with understanding consent information.

DESIGN

Descriptive study of a modified consent process: consent form (written at a sixth-grade level) read to participants, combined with 7 comprehension questions and targeted education, repeated until comprehension achieved (teach-to-goal).

PARTICIPANTS

Two hundred and four ethnically diverse subjects, aged ≥50, consenting for a trial to improve the forms used for advance directives.

MEASUREMENTS

Number of passes through the consent process required to achieve complete comprehension. Literacy assessed in English and Spanish with the Short Form Test of Functional Health Literacy in Adults (scores 0 to 36).

RESULTS

Participants had a mean age of 61 years and 40% had limited literacy (s-TOHFLA<23). Only 28% of subjects answered all comprehension questions correctly on the first pass. After adjustment, lower literacy (P=.04) and being black (P=.03) were associated with requiring more passes through the consent process. Not speaking English as a primary language was associated with requiring more passes through the consent process in bivariate analyses (P<.01), but not in multivariable analyses (P>.05). After the second pass, most subjects (80%) answered all questions correctly. With a teach-to-goal strategy, 98% of participants who engaged in the consent process achieved complete comprehension.

CONCLUSIONS

Lower literacy and minority status are important determinants of understanding consent information. Using a modified consent process, little additional education was required to achieve complete comprehension, regardless of literacy or language barriers.

Informed consent is a vital document while performing all surgical and aesthetic procedures, particularly in the current day practice. Proper documentation and counseling of patients is important in any informed consent.

The study examined the influence of socio cultural factors, perception of risk and exposure to violence on consent to HIV testing among at risk women in an urban slum. Married women chosen via a multistage probability sampling in a section of Bangalore, India, between 18 and 44 years, sexually active and considered to be at risk because of their husband’s hazardous drinking were recruited for the study. Written informed consent was obtained and measures of risk behavior and violence were administered. Pretest HIV counseling was then conducted and consent for HIV testing was sought. Factors influencing refusal of and consent to HIV testing were documented. Data collected on 100 participants indicated that over half the sample (58%) refused consent for HIV testing. There were no significant differences between the groups who consented and those who refused on perception of risk and exposure to violence. Reasons women refused testing include the following: spouse/family would not allow it (40%), believed that they were not at risk or would test negative (29%) and underwent HIV testing during an earlier pregnancy (21%). Among those who consented for HIV testing, 79% did so because the testing site was easily accessible, 67% consented because testing was free and because the importance of HIV testing was understood. The findings highlight the role of social, logistic and awareness related factors in utilizing voluntary counseling and testing services by women in the slum community. They have important implications for HIV testing, particularly among at risk monogamous women.

Background

Universities in Cameroon are playing an active part in HIV/AIDS research and much of this research is carried out by students, usually for the purpose of a dissertation/thesis. Student theses/dissertations present research findings in a much more comprehensive manner and have been described as the stepping-stone of a budding scientist’s potential in becoming an independent researcher. It is therefore important to verify how students handle issues of research ethics.

Method

Theses/dissertations on HIV/AIDS that described research studies involving the use of human research participants were screened to verify if research ethics approval and informed consent were obtained and documented. The contents of the consent forms were also qualitatively analyzed.

Results

Of 174 theses/dissertations on HIV, ethics approval was documented in 17 (9.77%) and informed consent in 77 (47.83%). Research ethics approval was first mentioned at all in 2002 and highly reported in the year 2007. Evidence of ethics approval was found for the first time in 2005 and informed consent first observed and evidenced in 1997. Ethics approval was mostly reported by students studying for an MD (14.01%) and was not reported in any Bachelors’ degree dissertation. Informed consent was also highly reported in MD theses (64.58%) followed by undergraduate theses (31.58%). Voluntary participation and potential benefits of the study were some of the common aspects dealt with in most of the consent forms. The right to discontinue participation in the study and management of residual samples were scarcely ever mentioned.

Conclusions

Overall, and given the current state of the art of research ethics around the world, student-scientists in Cameroon would seem to be merely kidding with research ethics. It is thus essential that training in health research ethics (HRE) be incorporated in the curriculum of universities in Cameroon in order that the next generation of scientists may be better equipped with thorough knowledge and practice of HRE. This, we believe, would be one way of fighting the occurrence of research scandals, which have not yet abated significantly, especially those arising from negligence or inexcusable ignorance.

The conduct of biomedical research involving the participation of human beings implicates a variety of ethical concerns pertaining to such values as dignity, bodily integrity, autonomy, and privacy. These ethical concerns have been translated into a complex regulatory apparatus in the USA, containing specific legal provisions concerning such matters as participant safety, informed consent, and confidentiality. A topic of particular interest for pathologists is the handling of human tissue specimens that may be used for present, or stored for future, research purposes. This article examines the ethical and legal ramifications of obtaining and storing tissue samples for research purposes, with special attention to the issues of informed consent and confidentiality.

Background: Increasing collaboration between industrialised and developing countries in human research studies has led to concerns regarding the potential exploitation of resource deprived countries. This study, commissioned by the former National Bioethics Advisory Commission of the United States, surveyed developing country researchers about their concerns and opinions regarding ethical review processes and the performance of developing country and US international review boards (IRBs).

Methods: Contact lists from four international organisations were used to identify and survey 670 health researchers in developing countries. A questionnaire with 169 questions explored issues of IRB review, informed consent, and recommendations.

Results: The majority of the developing country researchers were middle aged males who were physicians and were employed by educational institutions, carrying out research on part time basis. Forty four percent of the respondents reported that their studies were not reviewed by a developing country IRB or Ministry of Health and one third of these studies were funded by the US. During the review process issues such as the need for local language consent forms and letters for approval, and confidentiality protection of participants were raised by US IRBs in significantly higher proportions than by host country IRBs.

Conclusion: This survey indicates the need for the ethical review of collaborative research in both US and host countries. It also reflects a desire for focused capacity development in supporting ethical review of research.

The element of consent is one of the critical issues in medical treatment. The patient has a legal right to autonomy and self determination enshrined within Article 21 of the Indian Constitution. He can refuse treatment except in an emergency situation where the doctor need not get consent for treatment. The consent obtained should be legally valid. A doctor who treats without valid consent will be liable under the tort and criminal laws. The law presumes the doctor to be in a dominating position, hence the consent should be obtained after providing all the necessary information.

Background

Human Immunodeficiency virus (HIV) transmission is widespread across the globe. Millions of pregnant women are affected due to the high risk behaviour of their partners. Mother-to-child vertical transmission, has increased the burden of paediatric HIV population.

Method

A retrospective analysis of data on the utilisation of Integrated Counselling and Training Centre (ICTC) services by pregnant women at a tertiary care hospital in Ahmednagar district of Maharashtra, India from 1 January 2003 to 31 December, 2009. Pre-test counselling, HIV testing and post-test counselling was done by the trained staff of an ICTC centre as per National AIDS Control Organisation (NACO) guidelines. Anti-retroviral prophylaxis in the form of single dose oral Nevirapine (200mg) was given to seropositive women during active labour. Nevirapine syrup was administered to newborn babies. Analysis of the demographic profile of seropositive women was done.

Results

Out of 12,719 pregnant women attending the antenatal clinic, 10,491 (82.48%) accepted pre-test counselling and HIV testing. One hundred and forty-five women were found to be seropositive with a seroprevalence rate of 1.38%; 11% did not come for collection of the laboratory report and missed the post-test counselling. Most of the seropositive women belonged to rural areas (81.37%), had lowsocioeconomic status (77.93%), were illiterate, and were unaware of their serostatus and their husband’s risk behaviour. Less than 30% of women were using contraceptives. After registration, the majority of seropositive women (89.65%) attended the antenatal clinic regularly; 11% opted for pregnancy termination; 76% delivered vaginally and 12% underwent Caesarean section. A further 86% of women and 80% of newborns received Nevirapine prophylaxis. Postnatal follow-up of babies was very limited.

Conclusion

HIV seroprevalence among the pregnant population is declining steadily. More and more women are availing the facilities of ICTC centres. Integration of PPTCT (Prevention of Parent To Child Transmission) and RNTCP (Revised National Tuberculosis Control Programme) has improved the uptake of services. Free Anti-Retroviral Treatment (ART) for seropositives will help in controlling the disease progression and will reduce the vertical transmission.