Risks, Benefits, and Conflicts of Interest in Human Research: Ethical Evolution in the Changing World of Science

2000 ◽  
Vol 28 (4) ◽  
pp. 330-331 ◽  
Author(s):  
Greg Koski
Keyword(s):  
Conflicts Of Interest ◽  
Human Subjects ◽  
Scientific Discovery ◽  
Ethical Conduct ◽  
Technological Advancement ◽  
Research Environment ◽  
Human Research ◽  
National System ◽  
New Challenges ◽  
Protection Of Human Subjects

A generation ago, we adopted a national system for the protection of human subjects in research. Today, that system is facing new challenges. Many argue that the system has failed to evolve in concert with dramatic changes in the research environment. Accordingly, efforts are underway to reform the existing process to make it both more efficient and more effective. At the same time, many are also reexamining the system in more fundamental ways — going well beyond considerations of policies and compliance and raising questions that go to the very foundations of what constitutes an ethical conduct of human research.Experimentation involving human subjects is a necessary step in the process of translating scientific discovery and technological advancement into procedures and products that offer the prospect of better lives for all of us. It helps us to better understand why we do the things we do and believe what we believe.

Justice, Fairness, and Membership in a Class: Conceptual Confusions and Moral Puzzles in the Regulation of Human Subjects Research

2011 ◽  
Vol 39 (3) ◽  
pp. 488-501 ◽  
Author(s):  
Ana S. Iltis
Keyword(s):  
United States ◽  
Human Subjects ◽  
United States Public Health ◽  
The United States ◽  
National Commission ◽  
Human Research ◽  
Common Rule ◽  
Department Of Health ◽  
The Common ◽  
Protection Of Human Subjects

Much of the human research conducted in the United States or by U.S. researchers is regulated by the Common Rule. The Common Rule reflects the decision of 17 federal agencies, including the Department of Health and Human Services (whose regulations appear at 45CFR46), to require that investigators follow the same rules for conducting human research. (The Food and Drug Administration [FDA] has its own rules (at 21CFR50 and 21CFR56), though there is significant overlap with the Common Rule.) Many of the obligations delineated in the Common Rule can be traced back to the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (hereafter the National Commission). The National Commission was appointed in 1974 as part of the National Research Act (P.L. 93-348) in response to revelations about serious abuses involving human subjects, most notably the Tuskegee/United States Public Health Service Syphilis Study.

Financial Conflicts of Interest in Human Subjects Research: The Problem of Institutional Conflicts

2002 ◽  
Vol 30 (3) ◽  
pp. 390-402 ◽  
Author(s):  
Mark Barnes ◽  
Patrik S. Florencio
Keyword(s):  
Conflicts Of Interest ◽  
Medical Center ◽  
Human Subjects ◽  
The United States ◽  
Human Subjects Research ◽  
Human Research ◽  
University Of Oklahoma ◽  
Financial Conflicts Of Interest ◽  
Oklahoma Health ◽  
The University

In both academic literature and the media, financial conflicts of interest in human subjects research have come center-stage. The cover of a recent edition of Time magazine features a research subject in a cage with the caption human guinea pigs, signifying perhaps that human research subjects are no more protected from research abuses than are laboratory animals. That magazine issue highlights three well-publicized cases of human subjects research violations that occurred at the University of Oklahoma, the University of Pennsylvania, and Johns Hopkins University.At St. John Medical Center in Tulsa, Oklahoma, a study that was co-sponsored by the University of Oklahoma Health Sciences Center investigated an experimental vaccine for malignant melanoma. In that case, the chair of the university's institutional review board (IRB) — the committee within each medical institution charged with ethics review of human research projects undertaken at that institution — and the dean of the University's College of Medicine allegedly concealed from both the IRB and the United States Food and Drug Administration (FDA) a report by an outside consulting firm that had found severe deficiencies with the melanoma vaccine study being conducted at the medical center.

Involving Parents and Children in Community-Engaged Research

2018 ◽  
pp. 206-226
Author(s):  
Erin Talati Paquette ◽  
Lainie Friedman Ross
Keyword(s):  
Stakeholder Engagement ◽  
Moral Agency ◽  
Conflicts Of Interest ◽  
Human Subjects ◽  
Research Process ◽  
Privacy Concerns ◽  
Community Engaged Research ◽  
Parents And Children ◽  
Patient Groups ◽  
Protection Of Human Subjects

Stakeholder engagement in research is increasingly relied upon for its potential to increase the relevance of research, improve transparency of the research process, and translate evidence into practice. Engaging communities in research provides research teams with unique views into the needs, interests, and skills of public stakeholders including healthy volunteers, advocacy groups, patient groups, and their families and/or caregivers. This chapter considers key ethical considerations for researchers contemplating community-engaged research, including how to think about protection of human subjects and privacy, concerns regarding conflicts of interest and group harms, and compensation in community-engaged research. These concerns are heightened and further complicated in community-engaged pediatric research because of the additional vulnerabilities of children. In the pediatric setting, the scope of child participation, consent, and compensation deserve special attention, with respect to and for the evolving but not yet fully developed moral agency of children.

Doubtful use of placebo following placebo in recent controlled trials of lasmiditan and ubrogepant for the treatment of migraine attacks

Cephalalgia ◽  
2021 ◽  
pp. 033310242110299
Author(s):  
Peer Tfelt-Hansen ◽  
Karsten Jørgensen ◽  
Hans-Christoph Diener
Keyword(s):  
Clinical Research ◽  
Migraine Attack ◽  
Human Subjects ◽  
Second Step ◽  
Controlled Trials ◽  
Scientific Rigor ◽  
Protection Of Human Subjects

Purpose In four large controlled trials with lasmiditan and ubrogepant placebo was administered in the first step to demonstrate an effect on migraine attack. In the same trials the investigators also asked the question: is a second dose of the drug effective in non-responders to the first dose? In this phase patients who received placebo in the first phase of the trial again after 2 hours received another dose of placebo. Conclusion To be ethical, clinical research requires balancing rigorous science with the protection of human subjects; and it is, in our view, questionable whether placebo was used with “scientific rigor” in the second step of these trials, and this design is not recommended.

scholarly journals Medical Student Selection

2019 ◽  
Author(s):  
Leila E Harrison ◽  
Radha Nandagopal
Keyword(s):  
Conflicts Of Interest ◽  
Human Subjects ◽  
Medical Schools ◽  
Candidate Selection ◽  
Student Selection ◽  
Community Members ◽  
Medical Student Selection ◽  
Holistic Review ◽  
Regional Campus ◽  
Admissions Process

This is included in the attached word document   Many medical schools rely solely on their Admissions Committee members or core faculty for all aspects of the admissions process. In a distributed campus model, involving stakeholders from different contexts and campuses, can help medical schools diversify the participants in each step of the admissions process, from recruitment, to screening, to interviewing, to selection. Using the regional campus structure poses an advantage to embed multiple constituents, including faculty, staff, and community members, into the entire process supporting collective input in training future physicians for those communities and provides the opportunity for more people to become aware of institutional missions and to become invested in the holistic review framework used for candidate selection. The authors declare no conflicts of interest. This work does require human subjects review.

Research Ethics as Social Policy. Some Lessons from Experiences in Canada and in the United States

2003 ◽  
Vol 24 (2) ◽  
pp. 61-85
Author(s):  
Michael McDonald ◽  
Eric Meslin
Keyword(s):  
United States ◽  
Human Subjects ◽  
Ethics Committees ◽  
The United States ◽  
Prior Review ◽  
Emerging Trends ◽  
Policies And Procedures ◽  
Behavioural Research ◽  
Individual Informed Consent ◽  
Protection Of Human Subjects

For more than tlrree decades, Canada and the United States have used similar mechanisms for ensuring the protection of human subjects involved in biomedical and behavioural research: written guidelines that specify the substantive and procedural requirements of investigators and institutions; individual informed consent, and prior review and approval by interdisciplinary committees. Given the proximity of the countries to one another and the massive amount of trade and commerce that transpires between them, it is not surprising that these countries share a number of values in research. During the past fifteen years, however, both countries have experienced new challenges to their systems. Sorne of the challenges relate to new trends in research, such as genetics studies and massively increased private sector funding for pharmacological research. Other challenges relate to emerging trends in oversight policies and procedures, such as accreditation of ethics committees. Research reflects a country's particular social policies. The responses to emerging trends illustrate how such policies are evolving in sometimes quite different ways in both countries. This reflects the related but distinct political cultures and structures in the two countries. This paper will explore these trends and emerging responses, drawing lessons from each.

New Beginnings

2017 ◽  
pp. 39-78
Author(s):  
J. Benjamin Hurlbut
Keyword(s):  
Human Subjects ◽  
National Commission ◽  
Vitro Fertilization ◽  
Department Of Health ◽  
Human In Vitro Fertilization ◽  
First Child ◽  
New Beginnings ◽  
Protection Of Human Subjects

Chapter 1 examines the period from the mid-1960s to 1980. During this period, scientific advances made in human in vitro fertilization and embryo culture led to the birth of Louise Brown, the first child conceived through IVF, in 1978. The chapter examines the deliberations of two federal bioethics bodies: the National Commission for the protection of Human Subjects of Behavioral and Biomedical research, and the Ethics Advisory Board of the Department of Health, Education and Welfare.

Informed Consent in Healthcare

2020 ◽  
pp. 1222-1253
Author(s):  
Bo Yu ◽  
Duminda Wijesekera ◽  
Paulo Cesar G. Costa
Keyword(s):  
Informed Consent ◽  
Open Source ◽  
Human Subjects ◽  
Sensitive Information ◽  
Electronic Documents ◽  
Implementation Challenges ◽  
Patient Participant ◽  
New Challenges ◽  
Participant Information

Informed consents, either for treatment or sensitive information use/disclosure, that protect the privacy of patient/participant information subject to law that in certain circumstances may override patient wishes, are mandatory practice in healthcare. Similarly, for protecting and respecting research participants, informed consents are also prerequisite for human subjects research. Although the healthcare industry has widely adopted Electronic Medical Record (EMR) systems, consents are still obtained and stored primarily on paper or scanned electronic documents. Integrating a consent management system for different purposes into an EMR system involves various implementation challenges. A case study, informed consent for genetic services, is used to show how genetic informed consents placed new challenges on the traditional ethical standards of informed consent, and how appropriate consents can be electronically obtained and automatically enforced using a system that combines medical workflows and hierarchically, ontologically motivated rule enforcement. Finally, this chapter describes an implementation that uses the open-source software-based addition of these components to an open-source EMR system, so that existing systems do not need to be scrapped or otherwise rendered obsolete.

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