David Wendler
Biographic Data
| ID | 5972304 |
|---|---|
| NAME | David Wendler |
| GIVEN NAMES | David |
| FAMILY NAME | Wendler |
| SIGNATURE | WENDLER D |
| AFFILIATIONS | National Institutes of Health |
| ORCID | 0000-0002-9359-4439 |
| VERIFIED | Yes |
| TOTAL WORKS | 34 |
| TOTAL CITATIONS | 9 |
| AUTHOR COUNT | 34 |
| EDITOR COUNT | 0 |
| FIRST PUBLICATION YEAR | 1989 |
| LATEST PUBLICATION YEAR | 2025 |
| H-INDEX | 2 |
Respecting formerly autonomous persons
Degrees of Moral Status
The Normative Power of Consent and Limits on Research Risks
Research regulations around the world do not impose any limits on the risks to which consenting adults may be exposed. Nonetheless, most review committees regard some risks as too high, even for consenting adults. To justify this practice, commentators have appealed to a range of considerations which are external to informed consent and the risks themselves. Most prominently, some argue that exposing consenting adults to very high risks has the p…
Response to commentaries
The authors respond to four JME commentaries on their Feature Article, ‘Autonomy-based criticisms of the patient preference predictor’
Distinguishing appropriate from inappropriate conditions on research participation
Individuals do not have a right to participate in clinical trials. But, they do have a right against being denied participation for inappropriate reasons. Despite the widespread endorsement of these two claims, there has been little discussion regarding which conditions for participation in clinical trials are appropriate and which are inappropriate. The present manuscript attempts to address this gap in the literature. We first describe and then…
Setting Risk Limits and Ensuring Fairness in Learning Health Care
Historical abuses resulted in the segregation of clinical research and clinical care. While this approach has protected participants, it is extremely inefficient, leading commentators to propose (re)integrating research and care into learning health care systems. Previous commentators have argued that, in these systems, it could be appropriate to condition care on patients’ consent to participation in research, but only when the added research ri…
Autonomy-based criticisms of the patient preference predictor
The patient preference predictor (PPP) is a proposed computer-based algorithm that would predict the treatment preferences of decisionally incapacitated patients. Incorporation of a PPP into the decision-making process has the potential to improve implementation of the substituted judgement standard by providing more accurate predictions of patients’ treatment preferences than reliance on surrogates alone. Yet, critics argue that methods for maki…
Locating the Source(s) of the Social Value Requirement(s)
In this issue of the Hastings Center Report, Danielle Wenner looks at a few prominent analyses of the social value requirement for clinical research, claiming that they are all based on what she calls a transactional model of research ethics. She argues that the transactional model fails to provide a secure foundation for the social value requirement, and then, appealing to John Rawls, she argues that a more secure foundation lies in the principl…
The Ethics of Net‐Risk Pediatric Research
Net‐risk pediatric research encompasses interventions and studies that pose risks and do not offer a compensating potential for clinical benefit. These interventions and studies are central to efforts to improve pediatric clinical care. Yet critics argue that it is unethical to expose children to research risks for the benefit of unrelated others. While a number of ethical justifications have been proposed, none have received widespread acceptanc…
Broad Consent for Research on Biospecimens
Commentators are concerned that broad consent may not provide biospecimen donors with sufficient information regarding possible future research uses of their tissue. We surveyed with interviews 302 cancer patients who had recently provided broad consent at four diverse academic medical centers. The majority of donors believed that the consent form provided them with sufficient information regarding future possible uses of their biospecimens. Dono…
The Theory and Practice of Surrogate Decision‐Making
When a patient lacks decision‐making capacity and has not left a clear advance directive, there is now widespread agreement that patient‐designated and next‐of‐kin surrogates should implement substituted judgment within a process of shared decision‐making. Specifically, after discussing the “best scientific evidence available, as well as the patient's values, goals, and preferences” with the patient's clinicians, the patient‐designated or next‐of…
Should All Research Subjects Be Treated the Same
One of the founding principles of research ethics is that subjects should be treated equally. In the words of the Belmont Report, “equals ought to be treated equally.” This principle does not imply that all subjects should be treated exactly the same. Rather, subjects who are similar in relevant respects should receive similar treatment. Clinical status is clearly relevant to determining how subjects should be treated. Greater resources should be…
Making Treatment Decisions for Oneself
Competent adults should be permitted to determine the course of their own lives. We may try to influence them. We may ask them, perhaps even implore them, to change their minds. But in the end, they are in charge of their lives. They get to choose their careers, whether and whom to marry, whether to exercise, and whether to have surgery . This emphasis on respect for patients’ autonomy may seem to imply that allowing patients to make their own de…
Contrasting Views of Risk Perception and Influence of Financial Compensation Between Adolescent Research Participants and Their Parents
U.S. regulations governing pediatric research do not specify the assent process. To identify best practices, it is important to examine parents' and adolescents' views. The present study focuses on parents' and adolescents' views regarding possible research risks and the influence of financial compensation on their willingness to accept research procedures. Interviews were conducted with 177 adolescents participating in clinical research for a me…
Making the Transition to a Learning Health Care System
The authors of the two main articles in this supplement recognize the enormous potential of learning health care systems. Their first article argues that the development of these systems calls into question existing guidelines and practices that treat clinical care and clinical research as distinct activities. Their second article proposes to replace this traditional approach with a new framework, one intended to promote two important goals: supp…
Broad versus Blanket Consent for Research with Human Biological Samples
The first of two commentaries on “Respecting Donors to Biobank Research,” from the January-February 2013 issue
Using Data to Improve Surrogate Consent for Clinical Research with Incapacitated Adults
Current practice relies on surrogates to enroll incapacitated adults in research. Yet, it is unclear to what extent this practice protects adults who have lost the ability to consent for themselves. To address this question, we conducted two literature searches to identify articles which report empirical data on three issues central to protecting adults who have lost the ability to consent: (1) adults' willingness to participate in research shoul…
Benefits and Burdens of Participation in a Longitudinal Clinical Trial
SYSTEMATIC DATA ON THE IMPACT THAT longitudinal clinical trials have on patient participants are needed to ensure that all the risks and potential benefits of participating in clinical research are properly evaluated and disclosed. Recognizing the lack of systematic data on this topic, we surveyed 582 individuals from Argentina, Brazil, and Thailand who were participating in the ESPRIT study, a Phase III randomized trial of interleukin-2 in HIV d…
The Accuracy of Surrogate Decision Makers
BACKGROUND: Clinicians currently rely on patient-designated and next-of-kin surrogates to make end-of-life treatment decisions for incapacitated patients. Surrogates are instructed to use the substituted judgment standard, which directs them to make the treatment decision that the patient would have made if he or she were capacitated. However, commentators have questioned the accuracy with which surrogates predict patients' treatment preferences.…
Are Racial and Ethnic Minorities Less Willing to Participate in Health Research?
BACKGROUND: It is widely claimed that racial and ethnic minorities, especially in the US, are less willing than non-minority individuals to participate in health research. Yet, there is a paucity of empirical data to substantiate this claim. METHODS AND FINDINGS: We performed a comprehensive literature search to identify all published health research studies that report consent rates by race or ethnicity. We found 20 health research studies that …
Protecting Subjects Who Cannot Give Consent
Placebo Research and the Spirit of Informed Consent
Department of Clinical Bioethics; National Institutes of Health; Bethesda, Maryland The opinions expressed are the views of the authors and do not necessarily reflect the policy of the National Institutes of Health, the Public Health Service, or the US Department of Health and Human Services
Research on Stored Biological Samples
David Wendler, Christine Pace, Ambrose O. Talisuna, Faustine Maiso, Christine Grady, Ezekiel Emanuel, Research on Stored Biological Samples: The Views of Ugandans, IRB: Ethics & Human Research, Vol. 27, No. 2 (Mar. - Apr., 2005), pp. 1-5
The Quality of Informed Consent in a Clinical Research Study in Thailand
Christine Pace, Ezekiel J. Emanuel, Theshinee Chuenyam, Chris Duncombe, Judith D. Bebchuk, David Wendler, Jorge A. Tavel, Laura A. McNay, Praphan Phanuphak, Heidi P. Forster, Christine Grady, The Quality of Informed Consent in a Clinical Research Study in Thailand, IRB: Ethics & Human Research, Vol. 27, No. 1 (Jan. - Feb., 2005), pp. 9-17
Informed Consent
Lindsay Sabik, Christine A. Pace, Heidi P. Forster-Gertner, David Wendler, Judith D. Bebchuk, Jorge A. Tavel, Laura A. McNay, Jack Killen, Ezekiel J. Emanuel, Christine Grady, Informed Consent: Practices and Views of Investigators in a Multinational Clinical Trial, IRB: Ethics & Human Research, Vol. 27, No. 5 (Sep. - Oct., 2005), pp. 13-18
Benefits and Burdens of Participation in a Longitudinal Clinical Trial
SYSTEMATIC DATA ON THE IMPACT THAT longitudinal clinical trials have on patient participants are needed to ensure that all the risks and potential benefits of participating in clinical research are properly evaluated and disclosed. Recognizing the lack of systematic data on this topic, we surveyed 582 individuals from Argentina, Brazil, and Thailand who were participating in the ESPRIT study, a Phase III randomized trial of interleukin-2 in HIV d…
The Standard of Care Debate
To avoid exploitaiton of host communities, many commentators argue that subjects must receive the best methods available worldwide. Others worry that this requirement may block important research intended to improve health care, especially in developing countries. To resolve this dilemma, we propose a framework for the conditions under which it is acceptable to provide subjects with less than the best methods. Specifically, institutional review b…
Quality of Parental Consent in a Ugandan Malaria Study
Objectives. We surveyed Ugandan parents who enrolled their children in a randomized pediatric malaria treatment trial to evaluate the parents’ levels of understanding about the treatment trial and the quality of the parents’ consents to allow their children to participate in the study. Methods. We conducted 347 interviews immediately following enrollment at 4 Ugandan sites. Results. A majority (78%) of the parents, most of whom where mothers (86%…
Comprehension Instruction of Award-Winning Teachers, Teachers with Master's Degrees, and Other Teachers
Informed Consent and Respecting Autonomy
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
What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research
In recent years, there has been substantial debate about the ethics of research in developing countries [1–5]. In general, the controversies have centered on 3 issues: first, the standard of care that should be used in research in developing countries[6–13]; second, the “reasonable availability” of interventions that are proven to be useful during the course of research trials [14–19]; and third, the quality of informed consent. The persistence o…
Moral Standards for Research in Developing Countries from "Reasonable Availability" to "Fair Benefits"
Maged El Setouhy, Tsiri Agbenyega, Francis Anto, Christine Alexandra Clerk, Kwadwo A. Koram, Michael English, Rashid Juma, Catherine Molyneux, Norbert Peshu, Newton Kumwenda, Joseph Mfutso-Bengu, Malcolm Molyneux, Terrie Taylor, Doumbia Aissata Diarra, , Mamadou Sylla, Dione Youssouf, Catherine Olufunke Falade, Segun Gbadegesin, Reidar Lie, Ferdinand Mugusi, David Ngassapa, Julius Ecuru, Ambrose Talisuna, Ezekiel Emanuel, Christine Grady, Elizabe…
Assessing the Ethics of Ethics Research
The Standard of Care Debate
To avoid exploitaiton of host communities, many commentators argue that subjects must receive the best methods available worldwide. Others worry that this requirement may block important research intended to improve health care, especially in developing countries. To resolve this dilemma, we propose a framework for the conditions under which it is acceptable to provide subjects with less than the best methods. Specifically, institutional review b…
Wendler Et Al. Respond
We proposed conditions under which health investigators may provide research participants with less than the worldwide-best methods. Hyder poses a number of questions for this framework, and we consider his points in turn. First, as Hyder points out, current data suggest that social factors have a significant impact on health. Our claim that inequalities in health care have contributed to inequalities in health was not meant to deny the importanc…
Are Racial and Ethnic Minorities Less Willing to Participate in Health Research?
BACKGROUND: It is widely claimed that racial and ethnic minorities, especially in the US, are less willing than non-minority individuals to participate in health research. Yet, there is a paucity of empirical data to substantiate this claim. METHODS AND FINDINGS: We performed a comprehensive literature search to identify all published health research studies that report consent rates by race or ethnicity. We found 20 health research studies that …
Protecting Subjects Who Cannot Give Consent
Placebo Research and the Spirit of Informed Consent
Department of Clinical Bioethics; National Institutes of Health; Bethesda, Maryland The opinions expressed are the views of the authors and do not necessarily reflect the policy of the National Institutes of Health, the Public Health Service, or the US Department of Health and Human Services
Research on Stored Biological Samples
David Wendler, Christine Pace, Ambrose O. Talisuna, Faustine Maiso, Christine Grady, Ezekiel Emanuel, Research on Stored Biological Samples: The Views of Ugandans, IRB: Ethics & Human Research, Vol. 27, No. 2 (Mar. - Apr., 2005), pp. 1-5
The Quality of Informed Consent in a Clinical Research Study in Thailand
Christine Pace, Ezekiel J. Emanuel, Theshinee Chuenyam, Chris Duncombe, Judith D. Bebchuk, David Wendler, Jorge A. Tavel, Laura A. McNay, Praphan Phanuphak, Heidi P. Forster, Christine Grady, The Quality of Informed Consent in a Clinical Research Study in Thailand, IRB: Ethics & Human Research, Vol. 27, No. 1 (Jan. - Feb., 2005), pp. 9-17
Informed Consent
Lindsay Sabik, Christine A. Pace, Heidi P. Forster-Gertner, David Wendler, Judith D. Bebchuk, Jorge A. Tavel, Laura A. McNay, Jack Killen, Ezekiel J. Emanuel, Christine Grady, Informed Consent: Practices and Views of Investigators in a Multinational Clinical Trial, IRB: Ethics & Human Research, Vol. 27, No. 5 (Sep. - Oct., 2005), pp. 13-18
Quality of Parental Consent in a Ugandan Malaria Study
Objectives. We surveyed Ugandan parents who enrolled their children in a randomized pediatric malaria treatment trial to evaluate the parents’ levels of understanding about the treatment trial and the quality of the parents’ consents to allow their children to participate in the study. Methods. We conducted 347 interviews immediately following enrollment at 4 Ugandan sites. Results. A majority (78%) of the parents, most of whom where mothers (86%…
The Accuracy of Surrogate Decision Makers
BACKGROUND: Clinicians currently rely on patient-designated and next-of-kin surrogates to make end-of-life treatment decisions for incapacitated patients. Surrogates are instructed to use the substituted judgment standard, which directs them to make the treatment decision that the patient would have made if he or she were capacitated. However, commentators have questioned the accuracy with which surrogates predict patients' treatment preferences.…
Benefits and Burdens of Participation in a Longitudinal Clinical Trial
SYSTEMATIC DATA ON THE IMPACT THAT longitudinal clinical trials have on patient participants are needed to ensure that all the risks and potential benefits of participating in clinical research are properly evaluated and disclosed. Recognizing the lack of systematic data on this topic, we surveyed 582 individuals from Argentina, Brazil, and Thailand who were participating in the ESPRIT study, a Phase III randomized trial of interleukin-2 in HIV d…
Using Data to Improve Surrogate Consent for Clinical Research with Incapacitated Adults
Current practice relies on surrogates to enroll incapacitated adults in research. Yet, it is unclear to what extent this practice protects adults who have lost the ability to consent for themselves. To address this question, we conducted two literature searches to identify articles which report empirical data on three issues central to protecting adults who have lost the ability to consent: (1) adults' willingness to participate in research shoul…
Making the Transition to a Learning Health Care System
The authors of the two main articles in this supplement recognize the enormous potential of learning health care systems. Their first article argues that the development of these systems calls into question existing guidelines and practices that treat clinical care and clinical research as distinct activities. Their second article proposes to replace this traditional approach with a new framework, one intended to promote two important goals: supp…
Broad versus Blanket Consent for Research with Human Biological Samples
The first of two commentaries on “Respecting Donors to Biobank Research,” from the January-February 2013 issue
Making Treatment Decisions for Oneself
Competent adults should be permitted to determine the course of their own lives. We may try to influence them. We may ask them, perhaps even implore them, to change their minds. But in the end, they are in charge of their lives. They get to choose their careers, whether and whom to marry, whether to exercise, and whether to have surgery . This emphasis on respect for patients’ autonomy may seem to imply that allowing patients to make their own de…
Contrasting Views of Risk Perception and Influence of Financial Compensation Between Adolescent Research Participants and Their Parents
U.S. regulations governing pediatric research do not specify the assent process. To identify best practices, it is important to examine parents' and adolescents' views. The present study focuses on parents' and adolescents' views regarding possible research risks and the influence of financial compensation on their willingness to accept research procedures. Interviews were conducted with 177 adolescents participating in clinical research for a me…
Should All Research Subjects Be Treated the Same
One of the founding principles of research ethics is that subjects should be treated equally. In the words of the Belmont Report, “equals ought to be treated equally.” This principle does not imply that all subjects should be treated exactly the same. Rather, subjects who are similar in relevant respects should receive similar treatment. Clinical status is clearly relevant to determining how subjects should be treated. Greater resources should be…
The Theory and Practice of Surrogate Decision‐Making
When a patient lacks decision‐making capacity and has not left a clear advance directive, there is now widespread agreement that patient‐designated and next‐of‐kin surrogates should implement substituted judgment within a process of shared decision‐making. Specifically, after discussing the “best scientific evidence available, as well as the patient's values, goals, and preferences” with the patient's clinicians, the patient‐designated or next‐of…
Locating the Source(s) of the Social Value Requirement(s)
In this issue of the Hastings Center Report, Danielle Wenner looks at a few prominent analyses of the social value requirement for clinical research, claiming that they are all based on what she calls a transactional model of research ethics. She argues that the transactional model fails to provide a secure foundation for the social value requirement, and then, appealing to John Rawls, she argues that a more secure foundation lies in the principl…
Psychology (27 works) · Medicine (23 works) · Ethics in Clinical Research (21 works) · Political science (20 works) · Law (17 works) · Biomedical Ethics and Regulation (13 works) · Informed consent (13 works) · Alternative medicine (12 works) · Ethics in medical practice (11 works) · Family medicine (9 works)