A comparative analysis of biomedical research ethics regulation systems in Europe and Latin America with regard to the protection of human subjects

Background: One of the barriers to interprofessional ethics education is a lack of resources that actively engage students in reflection on living an ethical professional life. This project implemented and evaluated an innovative resource for interprofessional ethics education. Objectives: The objective of this project was to create and evaluate an interprofessional learning activity on professionalism, clinical ethics, and research ethics. Design: The Brewsters is a choose-your-own-adventure novel that addresses professionalism, clinical ethics, and research ethics. For the pilot of the book, a pre-test/post-test design was used. Once implemented across campus, a post-test was used to evaluate student learning in addition to a student satisfaction survey. Participants and research context: A total of 755 students in six academic schools in a health science center completed the activity as part of orientation or in coursework. Ethical considerations: The project was approved as exempt by the university’s Committee for the Protection of Human Subjects. Findings: The pilot study with 112 students demonstrated a significant increase in student knowledge. The 755 students who participated in the project had relatively high knowledge scores on the post-test and evaluated the activity positively. Discussion: Students who read The Brewsters scored well on the post-test and had the highest scores on clinical ethics. Clinical ethics scores may indicate issues encountered in mass media. Conclusion: The Brewsters is an innovative resource for teaching interprofessional ethics and professionalism. Further work is needed to determine whether actual and long-term behavior is affected by the activity.

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Research Ethics

Advances in Public Policy and Administration - Teaching Research Methods in Public Administration ◽

10.4018/978-1-4666-8116-3.ch013 ◽

2015 ◽

pp. 217-229

Keyword(s):

Popular Culture ◽

Social Science ◽

Research Ethics ◽

Ethical Dilemmas ◽

Human Subjects ◽

Research Process ◽

Milgram Experiments ◽

Protection Of Human Subjects ◽

The Many

In this chapter, students are presented with the many ethical dilemmas that can potentially confront social science researchers. Research ethics centers of two fundamental principles: 1) the protection of human subjects and 2) maintaining the integrity of the research process. Both of these principles are discussed in the context of popular culture and past transgressions of researchers, specifically the film Ghostbusters, the Tuskegee experiments, and Milgram experiments.

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The Ethics of Human Subjects Protection in Research

Journal of Baccalaureate Social Work ◽

10.18084/1084-7219.10.1.105 ◽

2004 ◽

Vol 10 (1) ◽

pp. 105-117 ◽

Cited By ~ 1

Author(s):

Steve Drewry

Keyword(s):

Twentieth Century ◽

Research Ethics ◽

Human Subjects ◽

Older Men ◽

Concentration Camp ◽

Human Subjects Research ◽

Social Work Theory ◽

History Of ◽

Protection Of Human Subjects ◽

Theoretical Foundations

This article explores the evolution of research ethics in the protection of human subjects. Included in the examination of research ethics are a brief history of twentieth-century critical incidents in human subjects research, a review of formal efforts to define the values and principles of research ethics, theoretical foundations of ethical research, and relevance to contemporary social work theory, practice, and education.Wisdom is sold in the desolate marketWhere none come to buy.—William BlakeGermany, 1948—Rudolph Helwig sits uncomfortably in the witness chair at the trial of accused Nazi scientists in Nuremberg. He is a young man, barely into his twenties, but he wears a look of perpetual fear upon his face. Helwig is afraid right now, and ashamed. Everyone in the courtroom is watching him. The prosecutor approaches the witness stand. Helwig's eyes dart to the defendants' bench, where rows of older men sit, drowsy and unperturbed. The prosecutor asks Helwig why he had been sent to Ravensbruck concentration camp in 1943. Helwig doesn't know. He is asked if he is mentally retarded. Helwig doesn't know. One of the older men smiles. The prosecutor asks Helwig why he was chosen for Ravensbruck's sterilization experiments. This Helwig knows, “I suppose it was because I could not defend myself.”

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Research Ethics Boards: The Protection of Human Subjects

PLoS Medicine ◽

10.1371/journal.pmed.0030472 ◽

2006 ◽

Vol 3 (10) ◽

pp. e472

Author(s):

Valia S Lestou ◽

Nancy Ondrusek ◽

Morris A Blajchman

Keyword(s):

Research Ethics ◽

Human Subjects ◽

Research Ethics Boards ◽

Protection Of Human Subjects

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Research Ethics

Scholarly Ethics and Publishing ◽

10.4018/978-1-5225-8057-7.ch031 ◽

2019 ◽

pp. 633-645

Author(s):

Richard W. Schwester

Keyword(s):

Popular Culture ◽

Social Science ◽

Research Ethics ◽

Ethical Dilemmas ◽

Human Subjects ◽

Research Process ◽

Milgram Experiments ◽

Protection Of Human Subjects ◽

The Many

In this chapter, students are presented with the many ethical dilemmas that can potentially confront social science researchers. Research ethics centers of two fundamental principles: 1) the protection of human subjects and 2) maintaining the integrity of the research process. Both of these principles are discussed in the context of popular culture and past transgressions of researchers, specifically the film Ghostbusters, the Tuskegee experiments, and Milgram experiments.

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Readability of Pediatric Biomedical Research Informed Consent Forms

PEDIATRICS ◽

10.1542/peds.85.1.58 ◽

1990 ◽

Vol 85 (1) ◽

pp. 58-62 ◽

Cited By ~ 1

Author(s):

Kenneth J. Tarnowski ◽

Denise M. Allen ◽

Christine Mayhall ◽

Patricia A. Kelly

Keyword(s):

Informed Consent ◽

Biomedical Research ◽

Human Subjects ◽

Linear Increase ◽

Willingness To Participate ◽

Consent Forms ◽

Flesch Reading Ease ◽

Informed Consent Form ◽

Consent Document ◽

Protection Of Human Subjects

Informed consent forms are used in biomedical research as a mechanism to convey study information to potential subjects so that they may arrive at a decision concerning their willingness to participate. Although the Department of Health and Human Services Regulations for the Protection of Human Subjects require the presentation of specific study information at a level that is easily understood, according to research concerning adult biomedical consent forms, the typical form is not readily comprehensible. Unfortunately, no data exist concerning the readability of informed consent forms that are used in the context of pediatric biomedical research. In the present study, readability analyses were conducted on a large sample (N = 238) of pediatric biomedical informed consent forms obtained during a 10-year period from a large midwestern children's hospital. For the entire sample, results derived from two readability estimates (Fry grade equivalent and Flesch Reading Ease methods) indicated that the consent forms were written at the college graduate level. Although there was a linear increase in the length of the consent document during the 10-year period evaluated, expanded length was not associated with improved readability. According to analyses, a differential pattern of reading difficulty was associated with specific sections of the informed consent document. Findings are highly consistent with those from studies of adult biomedical consent forms and document that the purpose of the informed consent form is being compromised, in part, by a readability factor. Suggestions for solving this critical problem are advanced.

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Ethical and Legal Problems in Resuscitation Research

Prehospital and Disaster Medicine ◽

10.1017/s1049023x00043788 ◽

1985 ◽

Vol 1 (S1) ◽

pp. 59-60

Author(s):

Norman Abramson ◽

Alan Meisel ◽

Peter Safar

Keyword(s):

World War Ii ◽

Biomedical Research ◽

Government Regulation ◽

Human Subjects ◽

Human Experimentation ◽

National Commission ◽

Federal Drug Administration ◽

Department Of Health ◽

Institutional Review ◽

Protection Of Human Subjects

Medicine has made great advances in the past decade, and is now opening the frontiers of brain resuscitation. Coinciding with the advances in medicine, society has witnessed great changes. There is an increasing awareness of patients' rights, an increasing desire for self determination, a rejection of the once-accepted paternal role of the physician, and an increasing willingness to challenge physicians in the courts. At the same time, government regulation of biomedical research has been expanding rapidly. The origin of this regulation dates back to the post-World War II Nuremburg trials. In 1974, the National Research Act established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The evolving concern about human experimentation has led to the current Department of Health and Human Services (DHHS) and the Federal Drug Administration (FDA) regulations which became effective July 27,1981. All biomedical research supported by federal funds must conform to these legal requirements. One aspect of these regulations is that all research protocols be approved by an institutional review board (IRB) established at the institution where the research is conducted.

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Teaching About Systemic Ethical Misconduct Increases Awareness of Ethical Principles: A Replication and Extension of Grose-Fifer’s (2017) Tuskegee Role-Play Activity

Teaching of Psychology ◽

10.1177/00986283211015981 ◽

2021 ◽

pp. 009862832110159

Author(s):

Maya C. Rose ◽

Jessica E. Brodsky ◽

Elizabeth S. Che ◽

Patricia J. Brooks

Keyword(s):

Research Ethics ◽

Human Subjects ◽

Social Activism ◽

Role Play ◽

Public Health Research ◽

Play Activity ◽

Ethics Instruction ◽

Ethical Misconduct ◽

Unethical Research ◽

Human Subjects Protections

Background: Introductory Psychology students rarely learn about unethical biomedical research outside the Tuskegee syphilis study, but these practices were widespread in U.S. public health research (e.g., at the Willowbrook State School researchers infected children with disabilities with hepatitis). Objectives: Replicate and extend Grose-Fifer’s research ethics activity by evaluating if an online homework and in-class role-play increased awareness of unethical research and abuses at Tuskegee (replication) and Willowbrook (extension) and subsequent changes in human subjects protections. Method: As homework, students read about the studies and wrote statements from perspectives of individuals involved. In class, students read their statements and discussed how outrage led to research conduct regulations. Online pre/posttests asked students why it was important to learn about both studies. Results: At posttest, students were more aware of unethical research at Willowbrook and that Tuskegee led to changes in human subjects protections. Students who completed the role-play activity were less likely to mention abuses for Tuskegee than students who did not participate. Conclusion: We were partially successful in replicating and extending Grose-Fifer. Teaching Implications: Research ethics instruction should draw attention to historical precedents and how public outrage and social activism led to increased protections for research participants.

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