Medicine and Health Sciences Commons^™

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Katharine Van Tassel

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Hip Fracture Evaluation With Alternatives Of Total Hip Arthroplasty Versus Hemiarthroplasty (Health): Protocol For A Multicentre Randomised Trial, Mohit Bhandari, P. J. Devereaux, Thomas A. Einhorn, Lehana Thabane, Emil H. Schemitsch, Kenneth J. Koval, Frede Frihagen, Rudolf W. Poolman, Kevin Tetsworth, Ernesto Guerra-Farfán, Kim Madden, Sheila Sprague, Gordon Guyatt, Ali Oliasharazi, Franklin D. Shuler, Jonathon Salva, James Day, Tigran Garabekyan, Felix Cheung, Linda Morgan, Timothy Wilson-Byrne Md, Mary Beth Cordle

Linda Morgan

Introduction: Hip fractures are a leading cause of mortality and disability worldwide, and the number of hip fractures is expected to rise to over 6 million per year by 2050. The optimal approach for the surgical management of displaced femoral neck fractures remains unknown. Current evidence suggests the use of arthroplasty; however, there is lack of evidence regarding whether patients with displaced femoral neck fractures experience better outcomes with total hip arthroplasty (THA) or hemiarthroplasty (HA). The HEALTH trial compares outcomes following THA versus HA in patients 50 years of age or older with displaced femoral neck fractures.

Methods and …

Hip Fracture Evaluation With Alternatives Of Total Hip Arthroplasty Versus Hemiarthroplasty (Health): Protocol For A Multicentre Randomised Trial, Mohit Bhandari, P. J. Devereaux, Thomas A. Einhorn, Lehana Thabane, Emil H. Schemitsch, Kenneth J. Koval, Frede Frihagen, Rudolf W. Poolman, Kevin Tetsworth, Ernesto Guerra-Farfán, Kim Madden, Sheila Sprague, Gordon Guyatt, Ali Oliasharazi, Franklin D. Shuler, Jonathon Salva, James Day, Tigran Garabekyan, Felix Cheung, Linda Morgan, Timothy Wilson-Byrne Md, Mary Beth Cordle

MaryBeth Cordle

Introduction: Hip fractures are a leading cause of mortality and disability worldwide, and the number of hip fractures is expected to rise to over 6 million per year by 2050. The optimal approach for the surgical management of displaced femoral neck fractures remains unknown. Current evidence suggests the use of arthroplasty; however, there is lack of evidence regarding whether patients with displaced femoral neck fractures experience better outcomes with total hip arthroplasty (THA) or hemiarthroplasty (HA). The HEALTH trial compares outcomes following THA versus HA in patients 50 years of age or older with displaced femoral neck fractures.

Methods and …

Hip Fracture Evaluation With Alternatives Of Total Hip Arthroplasty Versus Hemiarthroplasty (Health): Protocol For A Multicentre Randomised Trial, Mohit Bhandari, P. J. Devereaux, Thomas A. Einhorn, Lehana Thabane, Emil H. Schemitsch, Kenneth J. Koval, Frede Frihagen, Rudolf W. Poolman, Kevin Tetsworth, Ernesto Guerra-Farfán, Kim Madden, Sheila Sprague, Gordon Guyatt, Ali Oliasharazi, Franklin D. Shuler, Jonathon Salva, James Day, Tigran Garabekyan, Felix Cheung, Linda Morgan, Timothy Wilson-Byrne Md, Mary Beth Cordle

Felix Cheung

Introduction: Hip fractures are a leading cause of mortality and disability worldwide, and the number of hip fractures is expected to rise to over 6 million per year by 2050. The optimal approach for the surgical management of displaced femoral neck fractures remains unknown. Current evidence suggests the use of arthroplasty; however, there is lack of evidence regarding whether patients with displaced femoral neck fractures experience better outcomes with total hip arthroplasty (THA) or hemiarthroplasty (HA). The HEALTH trial compares outcomes following THA versus HA in patients 50 years of age or older with displaced femoral neck fractures.

Methods and …

Hip Fracture Evaluation With Alternatives Of Total Hip Arthroplasty Versus Hemiarthroplasty (Health): Protocol For A Multicentre Randomised Trial, Mohit Bhandari, P. J. Devereaux, Thomas A. Einhorn, Lehana Thabane, Emil H. Schemitsch, Kenneth J. Koval, Frede Frihagen, Rudolf W. Poolman, Kevin Tetsworth, Ernesto Guerra-Farfán, Kim Madden, Sheila Sprague, Gordon Guyatt, Ali Oliasharazi, Franklin D. Shuler, Jonathon Salva, James Day, Tigran Garabekyan, Felix Cheung, Linda Morgan, Timothy Wilson-Byrne Md, Mary Beth Cordle

James Day

Introduction: Hip fractures are a leading cause of mortality and disability worldwide, and the number of hip fractures is expected to rise to over 6 million per year by 2050. The optimal approach for the surgical management of displaced femoral neck fractures remains unknown. Current evidence suggests the use of arthroplasty; however, there is lack of evidence regarding whether patients with displaced femoral neck fractures experience better outcomes with total hip arthroplasty (THA) or hemiarthroplasty (HA). The HEALTH trial compares outcomes following THA versus HA in patients 50 years of age or older with displaced femoral neck fractures.

Methods and …

Hip Fracture Evaluation With Alternatives Of Total Hip Arthroplasty Versus Hemiarthroplasty (Health): Protocol For A Multicentre Randomised Trial, Mohit Bhandari, P. J. Devereaux, Thomas A. Einhorn, Lehana Thabane, Emil H. Schemitsch, Kenneth J. Koval, Frede Frihagen, Rudolf W. Poolman, Kevin Tetsworth, Ernesto Guerra-Farfán, Kim Madden, Sheila Sprague, Gordon Guyatt, Ali Oliasharazi, Franklin D. Shuler, Jonathon Salva, James Day, Tigran Garabekyan, Felix Cheung, Linda Morgan, Timothy Wilson-Byrne Md, Mary Beth Cordle

Timothy Wilson-Byrne MD

Introduction: Hip fractures are a leading cause of mortality and disability worldwide, and the number of hip fractures is expected to rise to over 6 million per year by 2050. The optimal approach for the surgical management of displaced femoral neck fractures remains unknown. Current evidence suggests the use of arthroplasty; however, there is lack of evidence regarding whether patients with displaced femoral neck fractures experience better outcomes with total hip arthroplasty (THA) or hemiarthroplasty (HA). The HEALTH trial compares outcomes following THA versus HA in patients 50 years of age or older with displaced femoral neck fractures. Methods and …

Hip Fracture Evaluation With Alternatives Of Total Hip Arthroplasty Versus Hemiarthroplasty (Health): Protocol For A Multicentre Randomised Trial, Mohit Bhandari, P. J. Devereaux, Thomas A. Einhorn, Lehana Thabane, Emil H. Schemitsch, Kenneth J. Koval, Frede Frihagen, Rudolf W. Poolman, Kevin Tetsworth, Ernesto Guerra-Farfán, Kim Madden, Sheila Sprague, Gordon Guyatt, Ali Oliasharazi, Franklin D. Shuler, Jonathon Salva, James Day, Tigran Garabekyan, Felix Cheung, Linda Morgan, Timothy Wilson-Byrne Md, Mary Beth Cordle

Ali Oliashirazi

Introduction: Hip fractures are a leading cause of mortality and disability worldwide, and the number of hip fractures is expected to rise to over 6 million per year by 2050. The optimal approach for the surgical management of displaced femoral neck fractures remains unknown. Current evidence suggests the use of arthroplasty; however, there is lack of evidence regarding whether patients with displaced femoral neck fractures experience better outcomes with total hip arthroplasty (THA) or hemiarthroplasty (HA). The HEALTH trial compares outcomes following THA versus HA in patients 50 years of age or older with displaced femoral neck fractures. Methods and …

Hip Fracture Evaluation With Alternatives Of Total Hip Arthroplasty Versus Hemiarthroplasty (Health): Protocol For A Multicentre Randomised Trial, Mohit Bhandari, P. J. Devereaux, Thomas A. Einhorn, Lehana Thabane, Emil H. Schemitsch, Kenneth J. Koval, Frede Frihagen, Rudolf W. Poolman, Kevin Tetsworth, Ernesto Guerra-Farfán, Kim Madden, Sheila Sprague, Gordon Guyatt, Ali Oliasharazi, Franklin D. Shuler, Jonathon Salva, James Day, Tigran Garabekyan, Felix Cheung, Linda Morgan, Timothy Wilson-Byrne Md, Mary Beth Cordle

Franklin D. Shuler

Introduction: Hip fractures are a leading cause of mortality and disability worldwide, and the number of hip fractures is expected to rise to over 6 million per year by 2050. The optimal approach for the surgical management of displaced femoral neck fractures remains unknown. Current evidence suggests the use of arthroplasty; however, there is lack of evidence regarding whether patients with displaced femoral neck fractures experience better outcomes with total hip arthroplasty (THA) or hemiarthroplasty (HA). The HEALTH trial compares outcomes following THA versus HA in patients 50 years of age or older with displaced femoral neck fractures. Methods and …

Recruitment & Enrollment Of Older Adults Into Mobile Phone Text Message Clinical Trials, Sandra Spoelstra

Sandra L. Spoelstra, PhD, RN, FGSA, FAAN

Researchers’ Perceptions Of Ethical Challenges In Cluster Randomized Trials: A Qualitative Analysis, Andrew Mcrae, Carol Bennett, Judith Belle Brown, Charles Weijer, Robert Boruch, Jamie Brehaut, Shazia Chaudhry, Allan Donner, Martin Eccles, Jeremy Grimshaw, Merrick Zwarenstein, Monica Taljaard

Charles Weijer

Background

Cluster randomized trials (CRTs) pose ethical challenges for investigators and ethics committees. This study describes the views and experiences of CRT researchers with respect to: (1) ethical challenges in CRTs; (2) the ethics review process for CRTs; and (3) the need for comprehensive ethics guidelines for CRTs.

Methods

Descriptive qualitative analysis of interviews conducted with a purposive sample of 20 experienced CRT researchers.

Results

Informants expressed concern over the potential for bias that may result from requirements to obtain informed consent from research participants in CRTs. Informants suggested that the need for informed consent ought to be related to …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Frank A. Pasquale

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Katharine Van Tassel

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Yaniv Heled

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …

Ethical Considerations In The Conduct Of Vaccine Trials In Developing Countries, Charles Weijer, C. Lanata, C. Plowe

Charles Weijer

No abstract provided.

Decision-Making By Adolescents And Parents Of Children With Cancer Regarding Health Research Participation, Kate Read, Conrad Fernandez, Jun Gao, Caron Strahlendorf, Albert Moghrabi, Rebecca Pentz, Raymond Barfield, Justin Baker, Darcy Santor, Charles Weijer, Eric Kodish

Charles Weijer

Background: Low rates of participation of adolescents and young adults (AYAs) in clinical oncology trials may contribute to poorer outcomes. Factors that influence the decision of AYAs to participate in health research and whether these factors are different from those that affect the participation of parents of children with cancer.

Methods: This is a secondary analysis of data from validated questionnaires provided to adolescents (>12 years old) diagnosed with cancer and parents of children with cancer at 3 sites in Canada (Halifax, Vancouver, and Montreal) and 2 in the United States (Atlanta, GA, and Memphis, TN). Respondents reported their …

Evidence, Belief, And Action: The Failure Of Equipoise To Resolve The Ethical Tension In The Randomized Clinical Trial, Deborah Hellman

Deborah Hellman

No abstract provided.

The Limits Of Consent: A Socio-Ethical Approach To Human Subject Research In Medicine, Oonagh Corrigan, John Mcmillan, Kathleen Liddell, Martin Richards, Charles Weijer

Charles Weijer

Since its inception as an international requirement to protect patients and healthy volunteers taking part in medical research, informed consent has become the primary consideration in research ethics. Despite the ubiquity of consent, however, scholars have begun to question its adequacy for contemporary biomedical research. This book explores this issue, reviewing the application of consent to genetic research, clinical trials, and research involving vulnerable populations. For example, in genetic research, information obtained from an autonomous research participant may have significant bearing on the interests of family members who have not consented to the study. This casts doubt on the adequacy …

Revisiting Equipoise: A Response To Gifford, Paul Miller, Charles Weijer

Charles Weijer

The authors respond to objections Fred Gifford has raised against their paper "Rehabilitating Equipoise." They situate this exchange in the wider context of recent debate over equipoise, highlighting substantial points of agreement between themselves and Gifford. The authors offer a brief restatement of "Rehabilitating Equipoise" in which they amplify some of its core arguments. They then assess Gifford's objections. Finding each to be unfounded, they argue that there is no justification for "pulling the plug" on clinical equipoise.

Clinical Trials, Jane Gervasio

Jane M. Gervasio

No abstract provided.

Clinical Trials, Jane Gervasio

Jane M. Gervasio

No abstract provided.

Clinical Trials, Charles Weijer

Charles Weijer

No abstract provided.

Continuing Review Of Clinical Research Canadian-Style, Charles Weijer

Charles Weijer

No abstract provided.

Informed Consent And Patients' Rights In Japan: 2001 Epilogue, Robert B. Leflar

Robert B Leflar

Japan is on a steeper trajectory toward the incorporation of informed consent principles into medical practice than the “gradual transformation” observed in a 1996 article, Informed Consent and Patients’ Rights in Japan. Among the most significant recent developments from 1996 to 2001 have been these seven: (1) the 1997 enactment of the Organ Transplantation Law permitting the use of brain death criteria in limited circumstances in which informed consent is present; (2) the strengthening of patients’ rights in clinical drug trials; (3) the continued trend toward increasing disclosure to patients of cancer diagnoses; (4) initiatives by the health ministry toward …

Ethical Challenges Of The Randomized Controlled Trial, Charles Weijer

Charles Weijer

No abstract provided.

Consensus-Seeking Roundtable On Placebos In Clinical Research, Charles Weijer

Charles Weijer

No abstract provided.

Reb Review Of Research Proposals Involving Placebo Controls, Charles Weijer

Charles Weijer

No abstract provided.

Down With Placebolatry, Charles Weijer, Carl Elliott

Charles Weijer

No abstract provided.

Do The Right Thing, Charles Weijer

Charles Weijer

McGill ethicists help ensure that medical research conforms to the highest scientific and ethical standards.

Characterizing The Population In Clinical Trials: Barriers, Comparability, And Implications For Review, Charles Weijer

Charles Weijer

The definition of the study population for a clinical trial via the criteria for trial eligibility has implications for the validity of the study and its applicability to clinical practice. Though issues of equity regarding the selection of subjects for research have long been a concern of ethicists, issues regarding the impact of subject selection on a trial's generalizability have only recently attracted ethical scrutiny. After a review of the history of the ethics of subject selection, I focus on three empirical questions regarding the generalizability of clinical trials. (1) What proportion of diseased populations are studied in clinical trials? …

The Revolution In Clinical Trials: From Burden To Benefit And Back Again, Charles Weijer

Charles Weijer

No abstract provided.