Jeffrey R Botkin
Datos Biográficos
| ID | 227183 |
|---|---|
| NOMBRE | Jeffrey R Botkin |
| NOMBRES | Jeffrey R |
| APELLIDO | Botkin |
| FIRMA | BOTKIN J R |
| AFILIACIONES | University of Utah |
| ORCID | 0000-0002-7897-5153 |
| VERIFICADO | Sí |
| TOTAL DE OBRAS | 22 |
| TOTAL DE CITAS | 64 |
| TOTAL COMO AUTOR | 22 |
| TOTAL COMO EDITOR | 0 |
| PRIMER AÑO DE PUBLICACIÓN | 1995 |
| AÑO MÁS RECIENTE DE PUBLICACIÓN | 2021 |
| ÍNDICE H | 3 |
What Should Physician-Researchers Tell Patient-Subjects About Their Relationships With Industry
An investigator's personal financial interest in technology under investigation or in the company sponsoring the research is a clear conflict of interest (COI). Such financial relationships are common, and ethical questions rightly emerge about COIs' capacity to compromise an investigator's approaches to research. This commentary on a case suggests that COI disclosure is appropriate during the process of facilitating patient-subjects' informed co…
Comparison of Video, App, and Standard Consent Processes on Decision-Making for Biospecimen Research
Obtaining informed consent for bloodspot research from newborn screening is particularly challenging due to the hectic environment of the postnatal period and the relatively abstract nature of future, unspecified research on the biospecimens. A randomized controlled trial was conducted in three Michigan hospitals to compare two different consent processes (video and interactive tablet "app") with standard brochure-based consent in the Michigan Bi…
Education for fathers about newborn screening and leftover dried blood spots
An Assessment of a Shortened Consent Form for the Storage and Research Use of Residual Newborn Screening Blood Spots
As state newborn screening programs develop approaches to parental permission for the storage and use of residual dried newborn screening samples, it is important to understand how the public comprehends the consent elements. Focus groups in Utah, California, and Michigan ( n = 7 groups, 69 participants) were conducted to evaluate the language on a shortened consent form. Outcomes from the analysis included barriers to conceptualizing biospecimen…
Evaluating Harms in the Assessment of Net Benefit
Deliberative Discussion Focus Groups
This article discusses a new approach for the conduct of focus groups in health research. Identifying ways to educate and inform participants about the topic of interest prior to the focus group discussion can promote more quality data from informed opinions. Data on this deliberative discussion approach are provided from research within three federally funded studies. As healthcare continues to improve from scientific and technological advanceme…
The Influence of Education on Public Trust and Consent Preferences With Residual Newborn Screening Dried Blood spots
The objectives of this study were to evaluate the impact of educational interventions during prenatal care on public trust for newborn screening and consent preferences for the retention and use of leftover newborn screening dried blood spots. Women who were 30 to 36 weeks pregnant were recruited, and outcomes were measured by telephone survey 2 to 4 weeks postpartum (n = 901). Approximately 40% of the sample chose the opt-out approach but those …
Waving Goodbye to Waivers of Consent
The Common Rule governs research on human subjects and attempts to balance respect for individual decision-making with efficiency when research risks are low. The regulations allow research to be conducted without consent if the data or biospecimens collected in a study are deidentified, and consent can be waived for identifiable data and biospecimens if the risks of the research are minimal and consent is deemed impracticable. These approaches h…
Public attitudes regarding the use of electronic health information and residual clinical tissues for research
Investigator Experiences and Attitudes About Research With Biospecimens
To advance scientific knowledge about human diseases and effective therapeutic treatments, investigators need access to human biospecimens and associated data. However, regulatory and procedural requirements may impede investigators' efforts to share biospecimens and data within and across institutions. Although a number of studies have explored experiences and attitudes of study participants and others about biospecimen and data sharing, less is…
The Irregular Terrain of Human Subjects Research Regulations
The overlap and differences between the parallel regulatory systems for research create ample room for confusion and missteps, as discussed by Barbara Bierer and Mark Barnes in their report in this supplement. In practice, beyond the inherent differences in the two systems of regulations themselves, there are many issues that further complicate the application of these regulations. These include the variation in size of the institutions receiving…
An Analysis of Information Technology Adoption by IRBs of Large Academic Medical Centers in the United States
The clinical research landscape has changed dramatically in recent years in terms of both volume and complexity. This poses new challenges for Institutional Review Boards' (IRBs) review efficiency and quality, especially at large academic medical centers. This article discusses the technical facets of IRB modernization. We analyzed the information technology used by IRBs in large academic institutions across the United States. We found that large…
A Randomized Controlled Trial of an Electronic Informed Consent Process
A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and …
Public attitudes regarding the use of electronic health information and residual clinical tissues for research
Informed Consent for Biobank-Dependent Research
Research is often conducted without the knowledge or consent of those whose tissues are banked and poses possible harms to social groups if information about a few members is unscientifically applied to all
Assessing public attitudes on the retention and use of residual newborn screening blood samples
Concerns of Newborn Blood Screening Advisory Committee Members Regarding Storage and Use of Residual Newborn Screening Blood Spots
Objectives. We assessed attitudes and opinions of members of newborn blood screening (NBS) advisory committees regarding the storage and secondary research use of residual specimens from NBS. Methods. We conducted focus groups in 2008 and 2009 with NBS advisory committees (4 focus groups; n = 39 participants) in the Mountain States region (i.e., AZ, CO, MT, NM, NV, TX, UT, and WY). Results. Participants identified several challenges to implementi…
Nine Key Functions for a Human Subjects Protection Program for Community-Engaged Research
The ethical conduct of Community-Engaged Research (CEnR), of which the Community-Based Participatory Research (CBPR) model is the partnership model most widely discussed in the CEnR literature and is the primary model we draw upon in this discussion, requires an integrated and comprehensive human subjects protection (HSP) program that addresses the additional concerns salient to CEnR where members of a community are both research partners and par…
Human Subjects Protections in Community-Engaged Research
In the 30 years since the Belmont Report, the role of the community in research has evolved and has taken on greater moral significance. Today, more and more translational research is being performed with the active engagement of individuals and communities rather than merely upon them. This engagement requires a critical examination of the range of risks that may arise when communities become partners in research. In attempting to provide such a…
The Challenges of Collaboration for Academic and Community Partners in a Research Partnership
The philosophical underpinning of Community-Engaged Research (CEnR) entails a collaborative partnership between academic researchers and the community. The Community-Based Participatory Research (CBPR) model is the partnership model most widely discussed in the CEnR literature and is the primary model we draw upon in this discussion of the collaboration between academic researchers and the community. In CPBR, the goal is for community partners to…
Are there Characteristics of Infectious Diseases that Raise Special Ethical Issues? 1
This paper examines the characteristics of infectious diseases that raise special medical and social ethical issues, and explores ways of integrating both current bioethical and classical public health ethics concerns. Many of the ethical issues raised by infectious diseases are related to these diseases’ powerful ability to engender fear in individuals and panic in populations. We address the association of some infectious diseases with high mor…
Fetal Privacy and Confidentiality
With the advent of new and better contraceptive methods and the ability to facilitate and manipulate fertilization and gestation, couples will gain greater control over their fertility. Once a pregnancy has been established or an in vitro embryo created, the ability to evaluate the embryo and fetus will increase dramatically with progress in human genetic research. Preconception and preimplantation genetic testing and screening are now possible, …
The Challenges of Collaboration for Academic and Community Partners in a Research Partnership
The philosophical underpinning of Community-Engaged Research (CEnR) entails a collaborative partnership between academic researchers and the community. The Community-Based Participatory Research (CBPR) model is the partnership model most widely discussed in the CEnR literature and is the primary model we draw upon in this discussion of the collaboration between academic researchers and the community. In CPBR, the goal is for community partners to…
Human Subjects Protections in Community-Engaged Research
In the 30 years since the Belmont Report, the role of the community in research has evolved and has taken on greater moral significance. Today, more and more translational research is being performed with the active engagement of individuals and communities rather than merely upon them. This engagement requires a critical examination of the range of risks that may arise when communities become partners in research. In attempting to provide such a…
Nine Key Functions for a Human Subjects Protection Program for Community-Engaged Research
The ethical conduct of Community-Engaged Research (CEnR), of which the Community-Based Participatory Research (CBPR) model is the partnership model most widely discussed in the CEnR literature and is the primary model we draw upon in this discussion, requires an integrated and comprehensive human subjects protection (HSP) program that addresses the additional concerns salient to CEnR where members of a community are both research partners and par…
Assessing public attitudes on the retention and use of residual newborn screening blood samples
An Assessment of a Shortened Consent Form for the Storage and Research Use of Residual Newborn Screening Blood Spots
As state newborn screening programs develop approaches to parental permission for the storage and use of residual dried newborn screening samples, it is important to understand how the public comprehends the consent elements. Focus groups in Utah, California, and Michigan ( n = 7 groups, 69 participants) were conducted to evaluate the language on a shortened consent form. Outcomes from the analysis included barriers to conceptualizing biospecimen…
A Randomized Controlled Trial of an Electronic Informed Consent Process
A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and …
Fetal Privacy and Confidentiality
With the advent of new and better contraceptive methods and the ability to facilitate and manipulate fertilization and gestation, couples will gain greater control over their fertility. Once a pregnancy has been established or an in vitro embryo created, the ability to evaluate the embryo and fetus will increase dramatically with progress in human genetic research. Preconception and preimplantation genetic testing and screening are now possible, …
Are there Characteristics of Infectious Diseases that Raise Special Ethical Issues? 1
This paper examines the characteristics of infectious diseases that raise special medical and social ethical issues, and explores ways of integrating both current bioethical and classical public health ethics concerns. Many of the ethical issues raised by infectious diseases are related to these diseases’ powerful ability to engender fear in individuals and panic in populations. We address the association of some infectious diseases with high mor…
Nine Key Functions for a Human Subjects Protection Program for Community-Engaged Research
The ethical conduct of Community-Engaged Research (CEnR), of which the Community-Based Participatory Research (CBPR) model is the partnership model most widely discussed in the CEnR literature and is the primary model we draw upon in this discussion, requires an integrated and comprehensive human subjects protection (HSP) program that addresses the additional concerns salient to CEnR where members of a community are both research partners and par…
Human Subjects Protections in Community-Engaged Research
In the 30 years since the Belmont Report, the role of the community in research has evolved and has taken on greater moral significance. Today, more and more translational research is being performed with the active engagement of individuals and communities rather than merely upon them. This engagement requires a critical examination of the range of risks that may arise when communities become partners in research. In attempting to provide such a…
The Challenges of Collaboration for Academic and Community Partners in a Research Partnership
The philosophical underpinning of Community-Engaged Research (CEnR) entails a collaborative partnership between academic researchers and the community. The Community-Based Participatory Research (CBPR) model is the partnership model most widely discussed in the CEnR literature and is the primary model we draw upon in this discussion of the collaboration between academic researchers and the community. In CPBR, the goal is for community partners to…
Concerns of Newborn Blood Screening Advisory Committee Members Regarding Storage and Use of Residual Newborn Screening Blood Spots
Objectives. We assessed attitudes and opinions of members of newborn blood screening (NBS) advisory committees regarding the storage and secondary research use of residual specimens from NBS. Methods. We conducted focus groups in 2008 and 2009 with NBS advisory committees (4 focus groups; n = 39 participants) in the Mountain States region (i.e., AZ, CO, MT, NM, NV, TX, UT, and WY). Results. Participants identified several challenges to implementi…
Informed Consent for Biobank-Dependent Research
Research is often conducted without the knowledge or consent of those whose tissues are banked and poses possible harms to social groups if information about a few members is unscientifically applied to all
Assessing public attitudes on the retention and use of residual newborn screening blood samples
Public attitudes regarding the use of electronic health information and residual clinical tissues for research
The Irregular Terrain of Human Subjects Research Regulations
The overlap and differences between the parallel regulatory systems for research create ample room for confusion and missteps, as discussed by Barbara Bierer and Mark Barnes in their report in this supplement. In practice, beyond the inherent differences in the two systems of regulations themselves, there are many issues that further complicate the application of these regulations. These include the variation in size of the institutions receiving…
An Analysis of Information Technology Adoption by IRBs of Large Academic Medical Centers in the United States
The clinical research landscape has changed dramatically in recent years in terms of both volume and complexity. This poses new challenges for Institutional Review Boards' (IRBs) review efficiency and quality, especially at large academic medical centers. This article discusses the technical facets of IRB modernization. We analyzed the information technology used by IRBs in large academic institutions across the United States. We found that large…
A Randomized Controlled Trial of an Electronic Informed Consent Process
A pilot study assessed an electronic informed consent model within a randomized controlled trial (RCT). Participants who were recruited for the parent RCT project were randomly selected and randomized to either an electronic consent group (n = 32) or a simplified paper-based consent group (n = 30). Results from the electronic consent group reported significantly higher understanding of the purpose of the study, alternatives to participation, and …
Waving Goodbye to Waivers of Consent
The Common Rule governs research on human subjects and attempts to balance respect for individual decision-making with efficiency when research risks are low. The regulations allow research to be conducted without consent if the data or biospecimens collected in a study are deidentified, and consent can be waived for identifiable data and biospecimens if the risks of the research are minimal and consent is deemed impracticable. These approaches h…
Public attitudes regarding the use of electronic health information and residual clinical tissues for research
Investigator Experiences and Attitudes About Research With Biospecimens
To advance scientific knowledge about human diseases and effective therapeutic treatments, investigators need access to human biospecimens and associated data. However, regulatory and procedural requirements may impede investigators' efforts to share biospecimens and data within and across institutions. Although a number of studies have explored experiences and attitudes of study participants and others about biospecimen and data sharing, less is…
Evaluating Harms in the Assessment of Net Benefit
Deliberative Discussion Focus Groups
This article discusses a new approach for the conduct of focus groups in health research. Identifying ways to educate and inform participants about the topic of interest prior to the focus group discussion can promote more quality data from informed opinions. Data on this deliberative discussion approach are provided from research within three federally funded studies. As healthcare continues to improve from scientific and technological advanceme…
The Influence of Education on Public Trust and Consent Preferences With Residual Newborn Screening Dried Blood spots
The objectives of this study were to evaluate the impact of educational interventions during prenatal care on public trust for newborn screening and consent preferences for the retention and use of leftover newborn screening dried blood spots. Women who were 30 to 36 weeks pregnant were recruited, and outcomes were measured by telephone survey 2 to 4 weeks postpartum (n = 901). Approximately 40% of the sample chose the opt-out approach but those …
Education for fathers about newborn screening and leftover dried blood spots
An Assessment of a Shortened Consent Form for the Storage and Research Use of Residual Newborn Screening Blood Spots
As state newborn screening programs develop approaches to parental permission for the storage and use of residual dried newborn screening samples, it is important to understand how the public comprehends the consent elements. Focus groups in Utah, California, and Michigan ( n = 7 groups, 69 participants) were conducted to evaluate the language on a shortened consent form. Outcomes from the analysis included barriers to conceptualizing biospecimen…
Comparison of Video, App, and Standard Consent Processes on Decision-Making for Biospecimen Research
Obtaining informed consent for bloodspot research from newborn screening is particularly challenging due to the hectic environment of the postnatal period and the relatively abstract nature of future, unspecified research on the biospecimens. A randomized controlled trial was conducted in three Michigan hospitals to compare two different consent processes (video and interactive tablet "app") with standard brochure-based consent in the Michigan Bi…
What Should Physician-Researchers Tell Patient-Subjects About Their Relationships With Industry
An investigator's personal financial interest in technology under investigation or in the company sponsoring the research is a clear conflict of interest (COI). Such financial relationships are common, and ethical questions rightly emerge about COIs' capacity to compromise an investigator's approaches to research. This commentary on a case suggests that COI disclosure is appropriate during the process of facilitating patient-subjects' informed co…
Medicine (19 obras) · Ethics in Clinical Research (17 obras) · Political science (14 obras) · Psychology (13 obras) · Informed consent (12 obras) · Alternative medicine (11 obras) · Pathology (11 obras) · Family medicine (10 obras) · Business (8 obras) · Engineering ethics (8 obras)