Seema K Shah

• JD
• National Institutes of Health

Background Many adolescents and young adults (AYA, 10-24 years old) are excluded from HIV research due to social, ethical, and legal challenges with informed consent, resulting in limited AYA-focused data. We use a participatory approach to identify strategies for improving AYA consent processes in HIV research in low- and middle-income countries (...

Introduction: Efforts to improve health outcomes among adolescents and young adults living with HIV (ALHs) are hampered by limited adolescent engagement in HIV-related research. We sought to understand the views of adolescents, caregivers and healthcare workers (HCWs) about who should make decisions regarding ALHs’ research participation. Methods:...

Introduction Loss to follow-up (LTFU) among adolescents and young adults living with HIV (AYALWH) is a barrier to optimal health and HIV services. We developed and validated a clinical prediction tool to identify AYALWH at risk of LTFU. Methods We used electronic medical records (EMR) of AYALWH ages 10 to 24 in HIV care at 6 facilities in Kenya an...

Introduction: Engaging adolescents in HIV care and research promotes the development of interventions tailored to their unique needs. Guidelines generally require parental permission for adolescents to receive HIV care/testing or participate in research, with exceptions. Nevertheless, parental permission requirements can restrict adolescent involv...

Introduction: Adolescents and youth living with HIV (AYLHIV) have lower retention in care, adherence to treatment, and viral suppression compared with adults. Stepped care is a process by which clients are assigned to increasingly intensive services or 'steps' according to level of need. Differentiated care, in which stable clients access less fre...

Adolescent participation in research is critical to inform interventions that improve outcomes for this group. Adolescents and young adults living with HIV often present to care without caregivers, yet caregiver permission is typically required for those younger than 18 years. We evaluated whether understanding of key consent information differed b...

Adolescents in low and middle-income countries (LMICs) have a high prevalence of HIV, therefore, it is important that they are included in HIV research. However, ethical challenges regarding consent can hinder adolescent research participation. We examined examples from the Prevention and Treatment Through a Comprehensive Care Continuum for HIV-aff...

There is wide agreement that communities in lower-income countries should benefit when they participate in multinational research. Debate now focuses on how and to what extent these communities should benefit. This debate has identified compelling reasons to reject the claim that whatever benefits a community agrees to accept are necessarily fair....

Children younger than 18 years account for a substantial proportion of patients with tuberculosis worldwide. Available treatments for paediatric drug-susceptible and drug-resistant tuberculosis, albeit generally effective, are hampered by high pill burden, long duration of treatment, coexistent toxic effects, and an overall scarcity of suitable chi...

The recent Ebola outbreak in West Africa began in the spring of 2014 and has since caused the deaths of over 6,000 people. Since there are no approved treatments or prevention modalities specifically targeted at Ebola Virus Disease (EVD), debate has focused on whether unproven interventions should be offered to Ebola patients outside of clinical tr...

In 2013, researchers announced that a newborn child from Mississippi, USA might have been functionally cured of HIV by being given combination antiretroviral therapy within hours of birth. Public and media attention has since been captured by the possibility of finding a cure for HIV transmitted from mother to child. Research into the strategy used...

Vital organ transplantation is premised on 'the dead donor rule': donors must be declared dead according to medical and legal criteria prior to donation. However, it is controversial whether individuals diagnosed as 'brain dead' are really dead in accordance with the established biological conception of death-the irreversible cessation of the funct...

Globally, there are 5 million young people aged 15–24 years living with HIV, and many more millions are at risk for HIV acquisition. Compelling research questions exist that require the involvement of young people and other vulnerable populations in HIV-related research in diverse settings around the world. Despite this, there remains a reluctance...

Imagine a study in which HIV-infected pregnant women are given antiretroviral treatment (ART) to determine how effectively it will prevent HIV transmission during childbirth. Each mother’s involvement in this study ends with the birth of her child, at which time her access to antiretrovirals provided by the study also ceases. At the outset of the s...

The Declaration of Helsinki and the Council of the International Organization of Medical Sciences provide guidance on standards of care and prevention in clinical trials. In the current and increasingly challenging research environment, the ethical status of a trial design depends not only on protection of participants, but also on social value, fe...

Even as research with children has increasingly been recognized as urgently needed for generating effective treatments for childhood diseases, drug formulations for infants and young children, and dosages appropriate for children, it has remained controversial. Scholars have engaged in heated debates over whether non-beneficial research with childr...

In rapidly evolving medical fields where the standard of care or prevention changes frequently, guidelines are increasingly likely to conflict with what participants receive in research. Although guidelines typically set the standard of care, there are some cases in which research can justifiably deviate from guidelines. When guidelines conflict wi...

ABSTRACT: Increasing numbers of multinational clinical trials have generated new ethical obligations of research sponsors and their DSMBs. Although sponsors and DSMBs clearly have ethical obligations to protect subjects in their trials, future patients, and the integrity of their trial, the obligations they have to protect subjects in other trials...

Advances in life-saving technologies in the past few decades have challenged our traditional understandings of death. Traditionally, death was understood to occur when a person stops breathing, their heart stops beating and they are cold to the touch. Today, physicians determine death by relying on a diagnosis of 'total brain failure' or by waiting...

Many guidelines for international research require that studies be responsive to host community health needs or health priorities. Although responsiveness possesses great intuitive and rhetorical appeal, existing conceptions are confusing and difficult to apply. Not only are there few examples of what research the responsiveness requirement permits...

This article outlines the concerns and dangers associated with evaluating HIV vaccine research on adolescents in South Africa using relative standard of minimal risk. It finds that the main problem with this evaluation is that a relative minimal risk standard might put extra and unfair burdens on those who are already burdened. It concludes that al...

Although there has been considerable attention to the plight of terminally ill patients with highly sympathetic constitutional and contractual claims that they should be permitted access to unapproved drugs, courts have been appropriately reluctant to grant such claims. Congress and administrative agencies have the requisite institutional competenc...

Advances in life-saving technologies in the past few decades have challenged our traditional understandings of death. People can be maintained on life-support even after permanently losing the ability to breathe spontaneously and remaining unconscious and unable to interact meaningfully with others. In part because this group of people could help f...

Onyeabor's letter highlighted some of the ethical complexities inherent in posttrial access. Although we agree that ethically, individuals benefiting from antiretroviral therapy should continue to receive it, the challenge for all of us involved in the ethical conduct of research is to be clear about how this should occur. Many study participants i...

Clinical research with children generates special ethical concern, raising the need for additional protections beyond those for research with competent adults. Most guidelines permit research with children when it offers a prospect of direct benefit, or poses minimal risk. Unlike many other guidelines, the U.S. federal regulations also allow instit...

For this reason, the UK’s Nuffi eld Council 1 suggests research on Burkitt’s lymphoma is unresponsive to local health priorities and, therefore, unethical without further justifi cation. Responsiveness to a community’s health needs or health priorities is endorsed widely as an ethical requirement for clinical research in developing countries. 2,3 A...

Despite recognition of the importance of posttrial access to antiretroviral therapy (ART), the implementation process has not been studied. We examined whether the National Institutes of Health (NIH) guidance document was being implemented in NIH-funded ART trials conducted in developing countries between July 2005 and June 2007. All of the 18 stud...

This essay exposes how recent attempts at lethal injection reform have involved unethical and illegal research on prisoners. States are varying the doses and types of drugs used, developing methods designed for non-medical professionals to administer medical procedures, and gathering data or making provisions for the gathering of data to learn from...

To assess how Institutional Review Boards (IRBs) implement the assent requirement for research with children. Telephone interviews were conducted with 188 chairpersons of IRBs from a range of institutions nationwide. Respondents were queried on 4 topics: 1) which children are considered capable of assent, 2) which information investigators must pro...

Federal regulations allow children in the United States to be enrolled in clinical research only when the institutional review board (IRB) determines that the risks are minimal or a minor increase over minimal, or that the research offers a prospect of direct benefit. Despite this reliance on IRBs, no data exist on how IRBs apply the risk and benef...

The U.S. federal regulations require investigators conducting nonbeneficial research to obtain the assent of children who are capable of providing it. Unfortunately, there has been no analysis of which children are capable of assent or even what abilities ground the capacity to give assent. Why should investigators be required to obtain the positiv...