Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research

2007 ◽  
Author(s):  
DEPARTMENT OF DEFENSE WASHINGTON DC
Keyword(s):  
Human Subjects ◽  
Ethical Standards ◽  
Protection Of Human Subjects

The French Law on “Protection of Persons Undergoing Biomedical Research”: Implications for the U.S.

2003 ◽  
Vol 31 (3) ◽  
pp. 434-441 ◽  
Author(s):  
Ivan Berlin ◽  
David A. Gorelick
Keyword(s):  
Human Subjects ◽  
The United States ◽  
National Commission ◽  
Ethical Standards ◽  
World Medical Association ◽  
Nuremberg Code ◽  
Research Participants ◽  
World Medical Association Declaration ◽  
Protection Of Human Subjects ◽  
Clinical Advances

Because research involving human subjects exposes people to risk not always for their own potential benefit, the question arises as to how best ensure that: (1) research participants are protected and benefited according to the highest ethical standards, while, on the other hand, (2) researchers are protected and free to do research that will produce clinical advances for both research participants and society as a whole.The balancing of the risk to research participants versus the benefits derived from the research is performed in many counrries by a system for the protection of human research participants that is laid out in national laws and regulations. In the United States, this system is based on principles emanating from the Nuremberg Code, the World Medical Association Declaration of Helsinki,and the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (the Belmont Rept).

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.

Donor-funded research: permissible, not perfect

2018 ◽  
Vol 45 (1) ◽  
pp. 36-40 ◽  
Author(s):  
Mike King ◽  
Angela Ballantyne
Keyword(s):  
Health Research ◽  
Human Subjects ◽  
Trial Participation ◽  
Ethical Standards ◽  
Human Subjects Research ◽  
The Public ◽  
Funded Research ◽  
Personal Liberty ◽  
Institutional Review ◽  
Trial Intervention

Donor-funded research is research funded by private donors in exchange for research-related benefits, such as trial participation or access to the trial intervention. This has been pejoratively referred to as ‘pay to play’ research, and criticised as unethical. We outline three models of donor-funded research, and argue for their permissibility on the grounds of personal liberty, their capacity to facilitate otherwise unfunded health research and their consistency with current ethical standards for research. We defend this argument against objections that donor-funded research is wrongly exploitative, unfair and undermines the public good of medical research. Our conclusion is that, like all human subjects research, donor-funded research should be regulated via standard health research legislation/guidelines and undergo Research Ethics Committee/Institutional Review Board and scientific peer-review. We expect that, measured against these standards, some donor-funded research would be acceptable.

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.

Office for Protection from Research Risks (OPRR)

1994 ◽  
Vol 13 (2) ◽  
pp. 271-273 ◽  
Author(s):  
Gary B. Ellis
Keyword(s):  
Human Services ◽  
Public Health Service ◽  
Human Subjects ◽  
Laboratory Animals ◽  
Department Of Health ◽  
Research Risks ◽  
Policies And Procedures ◽  
Primary Responsibility ◽  
Protection Of Human Subjects ◽  
The U.S

The Office for Protection from Research Risks (OPRR) has primary responsibility within the U.S. Department of Health and Human Services (DHHS) for developing and implementing policies, procedures, and regulations for the protection of human subjects involved in research. It also has primary responsibility within the U.S. Public Health Service for developing and implementing policies and procedures for the care and use of laboratory animals. And, it has responsibility for coordinating the development and implementation of policies, procedures, and regulations for the protection of human subjects involved in research for all U.S. federal departments and agencies that conduct or support such research.

Biobanking Research and Privacy Laws in the United States

2016 ◽  
Vol 44 (1) ◽  
pp. 106-127 ◽  
Author(s):  
Heather L. Harrell ◽  
Mark A. Rothstein
Keyword(s):  
Human Subjects ◽  
The United States ◽  
Common Rule ◽  
State Laws ◽  
Privacy Rule ◽  
Biobank Research ◽  
Privacy Laws ◽  
The Us ◽  
Protection Of Human Subjects ◽  
Hipaa Privacy Rule

Privacy is protected in biobank-based research in the US primarily by the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule and the Federal Policy for Protection of Human Subjects (Common Rule). Neither rule, however, was created to function in the unique context of biobank research, and therefore neither applies to all biobank-based research. Not only is it challenging to determine when the HIPAA Privacy Rule or the Common Rule apply, but these laws apply different standards to protect privacy. In addition, many other federal and state laws may be applicable to a particular biobank, researcher, or project. US law also does not directly address international sharing of data or specimens outside of the EU–US Safe Harbor Agreement, which only applies to receipt of data by certain US entities from EU countries, and is in the process of revision. Although new rules would help clarify privacy protections in biobanking, any implemented changes should be studied to determine the sufficiency of the protections as well as its ability to facilitate or hinder international collaborations.

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