Seema Shah
Biographic Data
| ID | 3807012 |
|---|---|
| NAME | Seema Shah |
| GIVEN NAMES | Seema |
| FAMILY NAME | Shah |
| SIGNATURE | SHAH S |
| AFFILIATIONS | Northwestern University |
| ORCID | 0000-0001-7726-1186 |
| VERIFIED | Yes |
| TOTAL WORKS | 31 |
| TOTAL CITATIONS | 46 |
| WORKS AS AUTHOR | 31 |
| WORKS AS EDITOR | 0 |
| FIRST PUBLICATION YEAR | 2003 |
| LATEST PUBLICATION YEAR | 2025 |
| H-INDEX | 3 |
An African Model of Democracy? Evidence from Treaties and Frameworks, Constitutional Preambles, and Public Opinion
Possibly more so than ever before, postcolonial states in Africa are pushing back against the hegemony of the liberal democratic model. Such arguments have explained how liberal democracy does not centre socioeconomic rights and group rights enough or in ways that align with many African communities’ priorities. Others have faulted weak institutions, adopted wholesale from colonial rulers who designed them for purposes of extraction and exclusion…
Women as Environmental Protectors
Environmental protection has become a global concern, requiring collective action and innovative solutions. Women are increasingly recognized for their contributions to environmental sustainability. A qualitative research design was implemented, focusing on a family unit as the case study. A total of 16 participants, eight from the younger generation and eight from the elder generation, were involved in in-depth interviews using a purposive sampl…
Racism Undermines High-Performance Democracies
Racism is a chronic problem for fifteen of the world’s top scoring democracies (Denmark serves as a case study). This evidence—which we draw from academic research, government and non-government body reports, journalistic reports, and polling data published between 2013 and 2023—troubles doctrines of representative, liberal, electoral, and participatory theories of democracy. In this article, we apply an aspect of Graefrath and Jahn’s ontological…
No public restroom
Ethical preparedness of data monitoring committees (DMCs) to oversee international clinical trials
INTRODUCTION: A data monitoring committee (DMC) is an independent group of experts who assess the ongoing scientific and ethical integrity of a study through periodic analyses of study data. The objective of this study was to explore the extent to which the structure, membership and deliberations of DMCs enable them to address ethical issues. METHODS: We conducted qualitative individual interviews (n=22) with DMC members from countries across Afr…
Virtue ethics and the unsettled ethical questions in controlled human infection studies
Controlled human infection studies (CHIs) involve the intentional infection of human subjects for a scientific aim. Though some past challenge trials have involved serious ethical abuses, in the last few decades, CHIs have had a strong track record of safety. Despite increased attention to the ethics of CHIs during the COVID‐19 pandemic, CHIs remain controversial, and there has been no in‐depth treatment of CHIs through the lens of virtue ethics.…
Pediatric Intensive Care Provider Attitudes About Children with Medical Complexity and Neurologic Impairment
(1) Background: Children with medical complexity (CMC) and neurologic impairment (NI) are a growing population in pediatric intensive care units (PICUs). (2) Objective: Our aim was to explore and describe the experiences and beliefs of PICU providers caring for CMC with NI. (3) Methods: A qualitative interview-based study was conducted. Participants were 20 providers (12 attendings and 8 nurse practitioners) who met inclusion criteria of being a …
‘I feel that I should decide on my own….’
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: We conducted focus group discussions (FGDs) and in-depth interviews (IDIs) with ALHs (aged 14-24 yea…
Lessons learned about publication of results of community surveys when regulatory oversight has not occurred
We conducted a survey in an online forum without prior IRB approval which yielded information we wanted to share with the medical community. We sought approaches to ethically publish the survey's results. Address the ethical issues raised by considering publication of community forum perspectives without prior regulatory oversight or written informed consent. A research ethics consultation identified two approaches: 1) assessing community perspec…
Demonstrating ‘respect for persons’ in clinical research
The ethical principle of ‘respect for persons’ in clinical research has traditionally focused on protecting individuals’ autonomy rights, but respect for participants also includes broader, although less well understood, ethical obligations to regard individuals’ rights, needs, interests and feelings. However, there is little empirical evidence about how to effectively convey respect to potential and current participants. To fill this gap, we con…
Ethically incentivising healthy behaviours
BACKGROUND: To assess ethical concerns associated with participation in a financial incentive (FI) programme to help adolescents with type 1 diabetes improve diabetes self-management. METHODS: Focus groups with 46 adolescents with type 1 diabetes ages 12-17 and 38 of their parents were conducted in the Seattle, Washington metropolitan area. Semistructured focus group guides addressed ethical concerns related to the use of FI to promote change in …
Informed consent for controlled human infection studies in low‐ and middle‐income countries
In controlled human infection studies (CHIs), participants are deliberately exposed to infectious agents in order to better understand the mechanism of infection or disease and test therapies or vaccines. While most CHIs have been conducted in high‐income countries, CHIs have recently been expanding into low‐ and middle‐income countries (LMICs). One potential ethical concern about this expansion is the challenge of obtaining the voluntary informe…
Reexamining the categorical exclusion of pediatric participants from controlled human infection trials
Controlled human infection (CHI) models have been developed for numerous pathogens in order to better understand disease processes and accelerate drug and vaccine testing. In the past, some researchers conducted highly controversial CHIs with vulnerable populations, including children. Ethical frameworks for CHIs now recommend vulnerable populations be excluded because they cannot consent to high risk research. In this paper we argue that CHI stu…
Ethics of controlled human infection studies
The role of community engagement in addressing bystander risks in research
There is limited guidance on how to assess the ethical acceptability of research risks that extend beyond research participants to third parties (or “research bystanders”). Community or stakeholder engagement has been proposed as one way to address potential harms to community members, including bystanders. Despite widespread agreement on the importance of community engagement in biomedical research, this umbrella term includes many different goa…
Rethinking Brain Death as a Legal Fiction
Brain death, or the determination of death by neurological criteria, has been described as a legal fiction. Legal fictions are devices by which the law treats two analogous things (in this case, biological death and brain death) in the same way so that the law developed for one can also cover the other. Some scholars argue that brain death should be understood as a fiction for two reasons: the way brain death is determined does not actually satis…
Cricket Island Foundation
In 2015, the Cricket Island Foundation conducted a multimethod assessment of its grantmaking portfolio to examine its impact and inform future decision-making and strategy. The foundation, which supports youth-led social change using a cohort-based model, focuses on emerging and medium-sized organizations and provides capacity-building supports to help organizations achieve greater organizational sustainability. The assessment focused on two of t…
Full Issue
The Foundation
Executive Summary
Funders can play a proactive role in helping to fill the gap between funders' expectations and nonprofits' ability to evaluate grant results. Using a partner-centered design, Johnson & Johnson piloted an evaluation capacity-building initiative that supported eight grantees in strengthening their ability
When does evidence from clinical trials influence health policy? A qualitative study of officials in nine African countries of the factors behind the HIV policy decision to adopt Option B
Introduction The appropriate role of evidence in health policy decision making is controversial and requires more data on how decisions are actually made. Option B+ is a strategy to prevent mother to child transmission (PMTCT) of HIV that involves starting pregnant, HIV-positive women on triple drug antiretroviral therapy (ART) and continuing for life. It was rapidly adopted by sub-Saharan African countries with limited scientific evidence for it…
Exploring Ethical Concerns About Human Challenge Studies
Controlled human malaria infection (CHMI) studies deliberately infect healthy participants with malaria to test interventions faster and more efficiently. Some argue the study design and high payments offered raise ethical concerns about participants' understanding of risks and undue inducement. We conducted baseline and exit interviews with 16 CHMI study participants to explore these concerns. Participants described themes including decision-mak…
Free and fair? Citizens’ assessments of the 2013 general election in Kenya
Kenya's peaceful 2013 election came as a relief to domestic and international observers, who feared a repeat of the brutal 2007––2008 post-election violence. Many observers conflated this relative peace with electoral credibility, but analysis of a post-election national opinion poll reveals a more complex picture. Most Kenyans did feel that the 2013 election was free and fair, but their conception of free and fair is rooted more in the historica…
Ethical Tradeoffs in Trial Design
The D eclaration of H elsinki and the C ouncil of the I nternational O rganization of M edical S ciences 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, feasibility, and scientific validity. Using the example of a study assessing efficacy of a vacc…
Aggressive and Prosocial Behavior
We use longitudinal multilevel modeling to test how exposure to community violence and cognitive and behavioral factors contribute to the development of aggressive and prosocial behaviors. Specifically, we examine predictors of self‐, peer‐, and teacher‐reported aggressive and prosocial behavior among 266 urban, African American early adolescents. We examine lagged, within‐person, between‐person, and protective effects across 2 years. In general,…
Shah and Grady Respond
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 in developing countries, including those in the studies cited, understandably feel that antiretrovira…
A Social Ecological Approach to Investigating Relationships Between Housing and Adaptive Functioning for Persons with Serious Mental Illness
This paper seeks to advance mental health—housing research regarding which factors of housing and neighborhood environments are critical for adaptive functioning, health, and recovery for persons with serious mental illness (SMI). Housing and neighborhood environments are particularly important for persons with SMI because of the prevalence of poor housing conditions among this population. Most mental health—housing research has been limited by a…
Aggressive and Prosocial Behavior
We use longitudinal multilevel modeling to test how exposure to community violence and cognitive and behavioral factors contribute to the development of aggressive and prosocial behaviors. Specifically, we examine predictors of self‐, peer‐, and teacher‐reported aggressive and prosocial behavior among 266 urban, African American early adolescents. We examine lagged, within‐person, between‐person, and protective effects across 2 years. In general,…
Free and fair? Citizens’ assessments of the 2013 general election in Kenya
Kenya's peaceful 2013 election came as a relief to domestic and international observers, who feared a repeat of the brutal 2007––2008 post-election violence. Many observers conflated this relative peace with electoral credibility, but analysis of a post-election national opinion poll reveals a more complex picture. Most Kenyans did feel that the 2013 election was free and fair, but their conception of free and fair is rooted more in the historica…
Racism Undermines High-Performance Democracies
Racism is a chronic problem for fifteen of the world’s top scoring democracies (Denmark serves as a case study). This evidence—which we draw from academic research, government and non-government body reports, journalistic reports, and polling data published between 2013 and 2023—troubles doctrines of representative, liberal, electoral, and participatory theories of democracy. In this article, we apply an aspect of Graefrath and Jahn’s ontological…
Planning for Posttrial Access to Antiretroviral Treatment for Research Participants in Developing Countries
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 studies we identified had posttrial access plans for trial participants. More than 70% had specific mech…
Nonbeneficial Research with Individuals Who Cannot Consent
David Wendler, Seema Shah, Amy Whittle, Benjamin S. Wilfond, Nonbeneficial Research with Individuals Who Cannot Consent: Is It Ethically Better to Enroll Healthy or Affected Individuals?, IRB: Ethics & Human Research, Vol. 25, No. 4 (Jul. - Aug., 2003), pp. 1-4
A Study of Awareness Among Adolescent Girls Regarding Child Care Practices Belonging to Different Socio-Economic Status
The present study was conducted to examine the extent of awareness among adolescent girls regarding childcare practices. The present study was conducted to examine the extent of awarness among adolescent girls regarding child care practices.The first five years of child is very crucial and its quite evident that the well being of the child and his future is totally dependent upon the knowledge the mother has about child care.But half of the popul…
Psychological Distress for African-American Adolescent Males
Perceptions of the Use of Compulsory Detention in Treatment of People with Eating Disorders
To examine the perceived acceptability of compulsory detention in treatment of an individual with severe anorexia nervosa amongst a sample of members of the general population, 151 participants read vignettes describing the compulsory detention of a female patient with a Body Mass Index of 12.4. The vignettes systematically varied along three dimensions: patients' reaction, immediate outcome (psychological state), and long-term outcome (attendanc…
A Social Ecological Approach to Investigating Relationships Between Housing and Adaptive Functioning for Persons with Serious Mental Illness
This paper seeks to advance mental health—housing research regarding which factors of housing and neighborhood environments are critical for adaptive functioning, health, and recovery for persons with serious mental illness (SMI). Housing and neighborhood environments are particularly important for persons with SMI because of the prevalence of poor housing conditions among this population. Most mental health—housing research has been limited by a…
Planning for Posttrial Access to Antiretroviral Treatment for Research Participants in Developing Countries
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 studies we identified had posttrial access plans for trial participants. More than 70% had specific mech…
Shah and Grady Respond
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 in developing countries, including those in the studies cited, understandably feel that antiretrovira…
Ethical Tradeoffs in Trial Design
The D eclaration of H elsinki and the C ouncil of the I nternational O rganization of M edical S ciences 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, feasibility, and scientific validity. Using the example of a study assessing efficacy of a vacc…
Aggressive and Prosocial Behavior
We use longitudinal multilevel modeling to test how exposure to community violence and cognitive and behavioral factors contribute to the development of aggressive and prosocial behaviors. Specifically, we examine predictors of self‐, peer‐, and teacher‐reported aggressive and prosocial behavior among 266 urban, African American early adolescents. We examine lagged, within‐person, between‐person, and protective effects across 2 years. In general,…
Free and fair? Citizens’ assessments of the 2013 general election in Kenya
Kenya's peaceful 2013 election came as a relief to domestic and international observers, who feared a repeat of the brutal 2007––2008 post-election violence. Many observers conflated this relative peace with electoral credibility, but analysis of a post-election national opinion poll reveals a more complex picture. Most Kenyans did feel that the 2013 election was free and fair, but their conception of free and fair is rooted more in the historica…
Rethinking Brain Death as a Legal Fiction
Brain death, or the determination of death by neurological criteria, has been described as a legal fiction. Legal fictions are devices by which the law treats two analogous things (in this case, biological death and brain death) in the same way so that the law developed for one can also cover the other. Some scholars argue that brain death should be understood as a fiction for two reasons: the way brain death is determined does not actually satis…
Cricket Island Foundation
In 2015, the Cricket Island Foundation conducted a multimethod assessment of its grantmaking portfolio to examine its impact and inform future decision-making and strategy. The foundation, which supports youth-led social change using a cohort-based model, focuses on emerging and medium-sized organizations and provides capacity-building supports to help organizations achieve greater organizational sustainability. The assessment focused on two of t…
Full Issue
The Foundation
Executive Summary
Funders can play a proactive role in helping to fill the gap between funders' expectations and nonprofits' ability to evaluate grant results. Using a partner-centered design, Johnson & Johnson piloted an evaluation capacity-building initiative that supported eight grantees in strengthening their ability
When does evidence from clinical trials influence health policy? A qualitative study of officials in nine African countries of the factors behind the HIV policy decision to adopt Option B
Introduction The appropriate role of evidence in health policy decision making is controversial and requires more data on how decisions are actually made. Option B+ is a strategy to prevent mother to child transmission (PMTCT) of HIV that involves starting pregnant, HIV-positive women on triple drug antiretroviral therapy (ART) and continuing for life. It was rapidly adopted by sub-Saharan African countries with limited scientific evidence for it…
Exploring Ethical Concerns About Human Challenge Studies
Controlled human malaria infection (CHMI) studies deliberately infect healthy participants with malaria to test interventions faster and more efficiently. Some argue the study design and high payments offered raise ethical concerns about participants' understanding of risks and undue inducement. We conducted baseline and exit interviews with 16 CHMI study participants to explore these concerns. Participants described themes including decision-mak…
Informed consent for controlled human infection studies in low‐ and middle‐income countries
In controlled human infection studies (CHIs), participants are deliberately exposed to infectious agents in order to better understand the mechanism of infection or disease and test therapies or vaccines. While most CHIs have been conducted in high‐income countries, CHIs have recently been expanding into low‐ and middle‐income countries (LMICs). One potential ethical concern about this expansion is the challenge of obtaining the voluntary informe…
Reexamining the categorical exclusion of pediatric participants from controlled human infection trials
Controlled human infection (CHI) models have been developed for numerous pathogens in order to better understand disease processes and accelerate drug and vaccine testing. In the past, some researchers conducted highly controversial CHIs with vulnerable populations, including children. Ethical frameworks for CHIs now recommend vulnerable populations be excluded because they cannot consent to high risk research. In this paper we argue that CHI stu…
Ethics of controlled human infection studies
The role of community engagement in addressing bystander risks in research
There is limited guidance on how to assess the ethical acceptability of research risks that extend beyond research participants to third parties (or “research bystanders”). Community or stakeholder engagement has been proposed as one way to address potential harms to community members, including bystanders. Despite widespread agreement on the importance of community engagement in biomedical research, this umbrella term includes many different goa…
Demonstrating ‘respect for persons’ in clinical research
The ethical principle of ‘respect for persons’ in clinical research has traditionally focused on protecting individuals’ autonomy rights, but respect for participants also includes broader, although less well understood, ethical obligations to regard individuals’ rights, needs, interests and feelings. However, there is little empirical evidence about how to effectively convey respect to potential and current participants. To fill this gap, we con…
Ethically incentivising healthy behaviours
BACKGROUND: To assess ethical concerns associated with participation in a financial incentive (FI) programme to help adolescents with type 1 diabetes improve diabetes self-management. METHODS: Focus groups with 46 adolescents with type 1 diabetes ages 12-17 and 38 of their parents were conducted in the Seattle, Washington metropolitan area. Semistructured focus group guides addressed ethical concerns related to the use of FI to promote change in …
Lessons learned about publication of results of community surveys when regulatory oversight has not occurred
We conducted a survey in an online forum without prior IRB approval which yielded information we wanted to share with the medical community. We sought approaches to ethically publish the survey's results. Address the ethical issues raised by considering publication of community forum perspectives without prior regulatory oversight or written informed consent. A research ethics consultation identified two approaches: 1) assessing community perspec…
‘I feel that I should decide on my own….’
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: We conducted focus group discussions (FGDs) and in-depth interviews (IDIs) with ALHs (aged 14-24 yea…
Ethical preparedness of data monitoring committees (DMCs) to oversee international clinical trials
INTRODUCTION: A data monitoring committee (DMC) is an independent group of experts who assess the ongoing scientific and ethical integrity of a study through periodic analyses of study data. The objective of this study was to explore the extent to which the structure, membership and deliberations of DMCs enable them to address ethical issues. METHODS: We conducted qualitative individual interviews (n=22) with DMC members from countries across Afr…
Medicine (21 works) · Psychology (21 works) · Political science (16 works) · Ethics in Clinical Research (11 works) · Sociology (10 works) · Law (9 works) · Alternative medicine (8 works) · Qualitative research (8 works) · Social Psychology (8 works) · Family medicine (7 works)