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1.  Informed recruitment in partner studies of HIV transmission: an ethical issue in couples research 
BMC Medical Ethics  2009;10:14.
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.
doi:10.1186/1472-6939-10-14
PMCID: PMC2751767  PMID: 19709442
2.  Seroprevalence of HIV in pregnant women in North India: a tertiary care hospital based study 
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.
doi:10.1186/1471-2334-7-133
PMCID: PMC2198915  PMID: 18005436
3.  Ethical and legal constraints to children’s participation in research in Zimbabwe: experiences from the multicenter pediatric HIV ARROW trial 
BMC Medical Ethics  2012;13:17.
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.
doi:10.1186/1472-6939-13-17
PMCID: PMC3521203  PMID: 22818109
4.  Cancer patient perceptions on the ethical and legal issues related to biobanking 
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.
doi:10.1186/1755-8794-6-8
PMCID: PMC3599691  PMID: 23497701
Biobank; Tissue repository; Cancer patient perspectives; Consent; Withdrawal; Anonymity; Incidental findings; Return of results; Ownership; Trust
5.  Ethical and Legal Issues in Biobanking for Genomic Research in Nigeria 
The pursuit of genomic research and biobanking has raised concerns and discussions about the ethical and legal implications. Given the specific challenges that surround such enterprise in low and middle income countries, it is pertinent to examine them in the light of the advent of Biobanking and Genomic research in Nigeria. In this paper I discuss the issues and suggest model solutions derived from advanced jurisdictions. These ethical and legal issues are discussed within the context of the legal system of a typical African country whose jurisprudence derives from that of its erstwhile colonial master, the United Kingdom. This includes issues relating to law and human rights, informed consent, native and customary law.
PMCID: PMC3863711  PMID: 24353984
Biobanking; Genomic; Research; Nigeria; Law
6.  Improving Participant Understanding of Informed Consent in an HIV-Prevention Clinical Trial: A Comparison of Methods 
AIDS and behavior  2012;16(2):412-421.
Empirical research on informed consent has shown that study participants often do not fully understand consent information. This study assessed participant understanding of three mock consent approaches describing an HIV-prevention clinical trial in Lilongwe, Malawi prior to trial implementation. Pregnant women (n = 297) were systematically selected from antenatal-care waiting lines and sequentially allocated to receive an enhanced standard consent form (group 1), a context-specific consent form (group 2), or context-specific counseling cards (group 3). Understanding of research concepts and study procedures was assessed immediately postintervention and at 1-week follow-up. At postintervention, participants in groups 2 and 3 understood more about research concepts and study procedures compared with group 1. Group 3 participants also understood more about study procedures compared with group 2. At follow-up, participants in groups 2 and 3 continued to understand more about research concepts and study procedures. Context-specific approaches improved understanding of consent information in this study.
doi:10.1007/s10461-011-9977-z
PMCID: PMC3923514  PMID: 21656146
Informed consent; Evaluation; Comprehension; Africa
7.  Survey on prevalence and risk factors on HIV-1 among pregnant women in North-Rift, Kenya: a hospital based cross-sectional study conducted between 2005 and 2006 
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.
doi:10.1186/1472-698X-9-10
PMCID: PMC2683791  PMID: 19405971
8.  Incidental findings found in “healthy” volunteers during imaging performed for research: current legal and ethical implications 
The British Journal of Radiology  2010;83(990):456-465.
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.
doi:10.1259/bjr/15877332
PMCID: PMC3473586  PMID: 20335427
9.  Informed Consent: Corner Stone in Ethical Medical and Dental Practice 
Progress in health care technologies has enabled patients to be better informed about all aspects of health care. Patients' informed consent is a legal regulation and a moral principle which represents patients' rights to take part in the clinical decisions concerning their treatment. With increasing awareness among the patients, the concept of informed consent is also evolving in developing countries like India. It is important for the medical and dental practitioners to have a written and signed informed consent from their patients before performing any invasive or irreversible procedures. Informed consent is also needed when providing medical care to children, foreign patients, and incorporating images of the patients while conducting medical and dental research. The present review addresses some of the vital issues regarding informed consent when providing medical and dental care with current review of the literature.
doi:10.4103/2249-4863.130284
PMCID: PMC4005206  PMID: 24791241
Children; dentistry; informed consent; medicine; risks; smart consent
10.  Notifying patients exposed to blood products associated with Creutzfeldt-Jakob disease: integrating science, legal duties and ethical mandates 
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.
PMCID: PMC1228467  PMID: 9371070
11.  Impact of Round-the-Clock, Rapid Oral Fluid HIV Testing of Women in Labor in Rural India 
PLoS Medicine  2008;5(5):e92.
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)
doi:10.1371/journal.pmed.0050092
PMCID: PMC2365974  PMID: 18462011
12.  Legal and ethical considerations in processing patient‐identifiable data without patient consent: lessons learnt from developing a disease register 
Journal of Medical Ethics  2007;33(5):302-307.
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.
doi:10.1136/jme.2006.016907
PMCID: PMC2598125  PMID: 17470509
13.  Doing research on the ethics of doing research 
Critical Care  2007;11(1):111.
In the previous issue of Critical Care Chenaud and colleagues found that most intensive care unit patients who had given informed consent for their participation in a clinical trial could not recall either the purpose of the trial or its related risks several days later. These findings should remind us that informed consent is a process, not an event, but they should not be interpreted to mean that recall is, of itself, a useful criterion for evaluating either the validity or the quality of the informed consent process. On an entirely separate note, the decision of the authors not to obtain informed consent for this study itself raises interesting questions about the ethics of doing research on the ethics of doing research.
doi:10.1186/cc5684
PMCID: PMC2151858  PMID: 17316465
14.  Ethical, Legal, and Social Dimensions of Epilepsy Genetics 
Epilepsia  2006;47(10):1595-1602.
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.
doi:10.1111/j.1528-1167.2006.00632.x
PMCID: PMC1802101  PMID: 17054679
Epilepsy; Genetics; Genetic testing; Stigma; Discrimination
15.  Medical emergencies in children of orthodox Jehovah’s Witness families: Three recent legal cases, ethical issues and proposals for management 
Paediatrics & Child Health  2006;11(10):655-658.
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.
PMCID: PMC2528596  PMID: 19030248
Blood; Children; Emergency; Ethical issues; Jehovah’s Witness; Management
16.  Ethical and legal considerations regarding the ownership and commercial use of human biological materials and their derivatives 
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.
doi:10.2147/JBM.S36134
PMCID: PMC3440234  PMID: 22977316
bioethics; biological specimen banks; cord-blood stem cell transplantation; ethics; informed consent; legislation
17.  Taking ethical photos of children for medical and research purposes in low-resource settings: an exploratory qualitative study 
BMC Medical Ethics  2013;14:27.
Background
Photographs are commonly taken of children in medical and research contexts. With the increased availability of photographs through the internet, it is increasingly important to consider their potential for negative consequences and the nature of any consent obtained. In this research we explore the issues around photography in low-resource settings, in particular concentrating on the challenges in gaining informed consent.
Methods
Exploratory qualitative study using focus group discussions involving medical doctors and researchers who are currently working or have recently worked in low-resource settings with children.
Results
Photographs are a valuable resource but photographers need to be mindful of how they are taken and used. Informed consent is needed when taking photographs but there were a number of problems in doing this, such as different concepts of consent, language and literacy barriers and the ability to understand the information. There was no consensus as to the form that the consent should take. Participants thought that while written consent was preferable, the mode of consent should depend on the situation.
Conclusions
Photographs are a valuable but potentially harmful resource, thus informed consent is required but its form may vary by context. We suggest applying a hierarchy of dissemination to gauge how detailed the informed consent should be. Care should be taken not to cause harm, with the rights of the child being the paramount consideration.
doi:10.1186/1472-6939-14-27
PMCID: PMC3750443  PMID: 23835013
Photography; Ethics; Informed consent; Teleconference
18.  Quality of informed consent for invasive procedures in central Saudi Arabia 
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.
doi:10.2147/IJGM.S29599
PMCID: PMC3325015  PMID: 22505825
informed consent; quality; invasive procedure; Saudi Arabia
19.  Legal rights of client councils and their role in policy of long-term care organisations in the Netherlands 
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.
doi:10.1186/1472-6963-11-215
PMCID: PMC3181203  PMID: 21910899
Consumer participation; empowerment; patients' rights; long-term care
20.  Use of a Modified Informed Consent Process among Vulnerable Patients: A Descriptive Study 
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.
doi:10.1111/j.1525-1497.2006.00535.x
PMCID: PMC1831581  PMID: 16881949
informed consent; health literacy; communication; vulnerable populations; ethics
21.  Patient information leaflets (PILs) for UK randomised controlled trials: a feasibility study exploring whether they contain information to support decision making about trial participation 
Trials  2014;15:62.
Background
Informed consent is regarded as a cornerstone of ethical healthcare research and is a requirement for most clinical research studies. Guidelines suggest that prospective randomised controlled trial (RCT) participants should understand a basic amount of key information about the RCTs they are being asked to enrol in in order to provide valid informed consent. This information is usually provided to potential participants in a patient information leaflet (PIL). There is evidence that some trial participants fail to understand key components of trial processes or rationale. As such, the existing approach to information provision for potential RCT participants may not be optimal. Decision aids have been used for a variety of treatment and screening decisions to improve knowledge, but focus more on overall decision quality, and may be helpful to those making decisions about participating in an RCT. We investigated the feasibility of using a tool to identify which items recommended for good quality decision making are present in UK PILs.
Methods
PILs were sampled from UK registered Clinical Trials Unit websites across a range of clinical areas. The evaluation tool, which is based on standards for supporting decision making, was applied to 20 PILs. Two researchers independently rated each PIL using the tool. In addition, word count and readability were assessed.
Results
PILs scored poorly on the evaluation tool with the majority of leaflets scoring less than 50%. Specifically, presenting probabilities, clarifying and expressing values and structured guidance in deliberation and communication sub-sections scored consistently poorly. Tool score was associated with word count (r = 0.802, P <0.01); there was no association between score and readability (r = -0.372, P = 0.106).
Conclusions
The tool was feasible to use to evaluate PILs for UK RCTs. PILs did not meet current standards of information to support good quality decision making. Writers of information leaflets could use the evaluation tool as a framework during PIL development to help ensure that items are included which promote and support more informed decisions about trial participation. Further research is required to evaluate the inclusion of such information.
doi:10.1186/1745-6215-15-62
PMCID: PMC3936815  PMID: 24548781
Patient information leaflets; Informed consent; Randomised controlled trials; Decision support
22.  Informed Consent: An Ethical Obligation or Legal Compulsion? 
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.
doi:10.4103/0974-2077.41159
PMCID: PMC2840885  PMID: 20300341
Informed consent; Ethical obligation; Legal complusion
23.  FACTORS INFLUENCING CONSENT TO HIV TESTING AMONG WIVES OF HEAVY DRINKERS IN AN URBAN SLUM IN INDIA 
AIDS care  2009;21(5):615-621.
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.
doi:10.1080/09540120802385603
PMCID: PMC2886200  PMID: 19444670
HIV testing; Community Based Prevention; Consent; India; Women
24.  Are students kidding with health research ethics? The case of HIV/AIDS research in Cameroon 
BMC Medical Ethics  2012;13:12.
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.
doi:10.1186/1472-6939-13-12
PMCID: PMC3470971  PMID: 22686445
25.  Ethical review of health research: a perspective from developing country researchers 
Journal of Medical Ethics  2004;30(1):68-72.
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.
doi:10.1136/jme.2002.001933
PMCID: PMC1757137  PMID: 14872079

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