Informed consent for research on stored blood and tissue samples: a survey of institutional review board practices

Numerous position papers have outlined informed consent recommendations for the collection, storage, and future use of biological samples; however, there currently is no consensus regarding what kinds of information should be included in consent forms. This study aimed to determine whether institutional review boards (IRBs) vary in their informed consent requirements for research on stored biological samples, and whether any variation observed could be correlated to factors such as volume of work, IRB members' familiarity with ethical issues in genetic research, and IRBs' use of either of two policy guidelines as resources. A brief survey was mailed to all IRB chairpersons on a mailing list obtained from the Office for Human Research Protections. Survey questions included whether consent forms for the collection of biological samples for future use address each of six provisions recommended in current guidelines and position statements, and whether IRBs used the Office for Protection from Research Risks' 1993 Protecting Human Research Subjects: Institutional Review Board Guidebook, chapter 5 (hereinafter IRB Guidebook) or the National Bioethics Advisory Commission's 1999 Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, Volume I (hereinafter Report) in their deliberations. Despite a low response rate (22%, 427 respondents), results indicate that IRB practices vary substantially. The degree to which the provisions were included in consent forms was found to correlate positively with IRBs that review a greater volume of protocols annually, those that use the National Bioethics Advisory Commission Report in their deliberations, and those that draw on both the Report and the IRB Guidebook.     

Informed consent of very sick subjects in Nigeria

This article highlights a number of ethical challenges I face in obtaining informed consent from very sick subjects with suspected pulmonary tuberculosis (TB). Some of the subjects with TB have an associated human immunodeficiency virus (HIV) infection. From my experience in administering informed consent and health surveys, I found the subjects to be generally mentally stable but physically exhausted. Many of the very sick subjects cough excessively and cannot tolerate a 45-minute conversation with the study staff in order for them to administer consent and conduct a survey after the routine clinical evaluation. In this situation, the administration of a qualitative consent that preserves the subject's right and autonomy becomes a challenge.     

The expanding purview: institutional review boards and the review of human subjects research

The implications of the institutional review board (IRB) system's growing purview are examined. Among the issues discussed are whether IRBs are censoring research and whether the IRB review process fundamentally alters the research that is being conducted. The intersection between IRB review and free speech is also explored. In general, it is argued that the review system for human subjects research (HSR) should be modified in order to limit the scope of IRB review.     

Informed consent comprehension among vulnerable populations in Ecuador: video-delivered vs. in-person standard method

The informed consent comprehension process is key to engaging potential research subject participation. The aim of this study is to compare informed consent comprehension between two methods: standard and video-delivered. We compared the in-person and video-delivered informed consent process in the Familias Unidas intervention. We evaluated comprehension using a 7-item true/false questionnaire. There were a total of 152 participants in the control group and 87 in the experimental. General characteristics were similar between both groups (p > 0.05). First-attempt informed consent comprehension was higher in the intervention group but was not statistically significant (80% and 78% respectively p = 0.44). A video-delivered informed consent process did not differ from the standard method of informed consent in a low educational and socioeconomic environment.     

The therapeutic misconception: a threat to valid parental consent for pediatric neuroimaging research

Neuroimaging research has brought major advances to child health and wellbeing. However, because of the vulnerabilities associated with neurological and developmental conditions, the parental need for hope, and the expectation of parents that new medical advances can benefit their child, pediatric neuroimaging research presents significant challenges to the general problem of consent in the context of research involving children. A particular challenge in this domain is created by the presence of therapeutic misconception on the part of parents and other key research stakeholders. This article revierws the concept of therapeutic misconception and its role in pediatric neuroimaging research. It argues that this misconception can compromise consent given by parents for the involvement of their children in research as healthy controls or as persons with neurological and developmental conditions. The article further contends that therapeutic misconception can undermine the research ethics review process for proposed and ongoing neuroimaging studies. Against this backdrop, the article concludes with recommendations for mitigating the effects of therapeutic misconception in pediatric neuroimaging research.     

The ethical review of medical research: a social movement to protect the interests of research subjects

This paper is based upon observations made in the United States regarding the operation of the Institutional Review Boards. Institutional Review Boards are an essential part of the American system for the ethical review of human subjects research and it is argued that their importance is due in part to the American approach to the protection of minority groups. It is important to evaluate the effectiveness of the Institutional Review Boards since a similar model is being proposed by the National Health & Medical Research Council as part of the ethical review of medical research projects conducted in Australia.     

Challenges in recruiting parents to participate in child welfare research: implications for study design and research practice

Although research with hard‐to‐reach populations is necessary to deepen the social work knowledge base and improve services to these groups, recruiting members of hard‐to‐reach populations for research projects is often a challenging process. Frequently, non‐probability sampling is used to obtain participants. However, the difficulties and limitations associated with this process in quantitative research are rarely discussed in depth in the literature. Sampling issues can significantly impact a research project, delaying it, extending it or even causing the premature termination of a project. Challenges to recruitment can limit the type of research that is completed, impact the knowledge base or introduce threats to validity through sampling bias. Using a preliminary quantitative study on parental engagement with child protective services as an illustration for the discussion, the challenges of non‐probability sampling with a hard‐to‐reach population and the implications for research practice are explored and discussed. Implications for future research practice are considered.     

Guinea Pigs on the payroll: The ethics of paying research subjects

Regulatory bodies and scholars have traditionally conceptualized biomedical research on healthy subjects in the same way as research on patients. Guidelines and regulations have portrayed payment to a healthy subject as a potential constraint, or “undue influence,”; on the subject's free consent. In this essay we suggest an alternative way of conceptualizing research on healthy subjects, which sees the basic issue not as one of undue influence but as one of justice. Healthy subjects generally enroll in research protocols not for humanitarian reasons but for the money they will receive. Many of these protocols are conducted by profit‐driven corporations. Yet current guidelines and regulations prohibit subjects from negotiating for fair payment for the risks, discomforts and inconveniences they undergo, and IRBs are not staffed adequately to monitor the subject's safety. We propose to remedy the situation by regulating payment to healthy subjects as a labor relation.     

The issue of consent in research that administers drugs of addiction to addicted persons

In addiction, impaired control over drug use raises questions about the capacity of addicted persons to consent to participate in research studies in which they are given their drug of addiction. We review the case for doing such research, and the arguments that addiction does, and does not, prevent addicted persons from consenting to such research. We argue for a more nuanced view that acknowledges that while in some situations addiction impairs decision-making capacity, it does not eliminate such capacity. We conclude with some suggestions for recruiting addicted subjects and designing experiments in ways to obtain free and informed consent.     

Informed parental consent for cochlear implantation of young deaf children: social and other considerations in the use of the 'bionic ear'

This paper examines the social parameters surrounding the management of informed consent procedures for the parents of young deaf children for the surgical fitting of a cochlear implant ('bionic ear') to their child. Although most observers of this remarkable and well publicised medical development only see benefits in its use, the authors examine the nature of the conflict which has emerged between medical and media portrayals of the 'miracle' device and contrasting social, cultural and linguistic views of many Deaf people. The paper analyses the components of parental consent procedures for surgical implantation of their child, covering the risk-benefit analysis and, in particular, the information base that is provided for parents about the social construction of a 'Deaf life' by many Deaf people.     

Bad news about bad news: the disclosure of risks to insurability in research consent processes

One of the phenomena associated with research is "incidental findings," that is, unexpected findings made during the research, and outside the scope of the research, which have potential health importance. One underappreciated risk of incidental findings is the potential loss of the research subject's insurability; or if a research subject fails to disclose incidental findings when applying for insurance, the insurance contract may be voidable by the insurer. In this article, we seek to explain the insurability risks associated with incidental findings and to make recommendations for how researchers and research ethics committees should address the issue of disclosure of these risks.     

Group benefit and protection of pediatric research subjects: Grimes v. Kennedy Krieger and the Lead Abatement Study

The Maryland Court of Appeals in Grimes v. Kennedy Krieger Institute was sharply critical of the lead abatement study conducted by this Institute, an affiliate of Johns Hopkins University. Grimes ruled that investigators might, given the facts of the case, have a special relationship with subjects, thereby creating a duty of care that could, if breached, give rise to an action in negligence. This ruling has implications for pediatric research practices and long-standing disputes among informed people of good will about what pediatric studies should be permitted.     

The contested terrain of environmental justice research: community as unit of analysis

Social scientists have entered the debate over the environmental inequities facing the poor in general, and communities of color in particular. Crucial to their empirical studies is the operational definition of “community” as a unit of analysis. Different operationalizations of community exist, leading to divergent conclusions about the extent of the problem. Earlier research concluded that inequities were national in scope, while later studies found little evidence to support the previous research. This paper examines three general ways in which community has been framed as a geographical unit of analysis in environmental justice research: (1) as a neighborhood (a place of cultural identity); (2) as part of a political jurisdiction (county, city, etc.); and (3) as approximated by data constructs (like zip code areas and census tracts). The paper discusses several theoretical and methodological issues involved in operationally defining an appropriate unit, or units, of analysis for research on environmental inequity.     

Financial development,institutional improvement,poverty reduction: The multiple challenges in West Africa

Poverty continues to be one of the biggest difficulties confronting humanity today, and eradicating poverty has become one of the most difficult tasks facing developing countries in their drive for long-term development. Accordingly, this study assesses the moderating role of institutional quality (measured by rule of law, regulation quality, control of corruption, government effectiveness, political stability, and voice and accountability) in the finance-poverty nexus for a sample of 16 West African countries spanning 2002–2019. The findings show that finance (represented by domestic credit, and money supply) reduces poverty; however, the weak institutional quality reduces the positive effect of finance on poverty reduction. The study establishes that the institutional quality thresholds at which domestic credit could reduce poverty are: rule of law (0.6), regulation quality (0.1), control of corruption (1.6), government effectiveness (0.1), and political stability (0.3) on the scale of ?2.5–2.5. Finally, the institutional quality thresholds at which money supply could reduce poverty are: rule of law (2.5), regulation quality (0.3), control of corruption (2.0), government effectiveness (1.5), and political stability (1.4) on the scale of ?2.5–2.5, whilst the interaction effect of domestic credit, money supply, and voice and accountability were insignificant. The study concludes that policymakers must enhance the institutional environment in West Africa to boost financial development to reduce poverty.     

Young people act as consultants in child‐directed research: an action research study in Iceland

This paper evaluates an action research study, conducted in Iceland, which involved young service users as consultants to the research. We used participatory group work methods to activate the young people's knowledge and guide social workers in developing their practice. The young people's advice influenced the data generation and analysis, guided the action intervention and contributed to the evaluation. Their emphasis on the quality of relationships and attention to children's concerns was crucial in developing the concept of child‐directed practice.