Reporting of Ethical Approval and Informed Consent in Clinical Research Published in Leading Anesthesia Journals

2003 ◽  
Vol 99 (5) ◽  
pp. 1209-1213 ◽  
Author(s):  
Paul S. Myles ◽  
Nicole Tan
Keyword(s):  
Informed Consent ◽  
Human Subjects ◽  
Case Reports ◽  
Research Subjects ◽  
Publication Type ◽  
Chi Square ◽  
Patient Demographics ◽  
Institutional Review ◽  
Significant Difference ◽  
Ethical Approval

Background Ethical conduct in human research in anesthesia includes approval by an institutional review board (IRB) or ethics committee and informed consent. Evidence of these is sometimes lacking in journal publications. Methods The authors reviewed all publications involving human subjects in six leading anesthesia journals for the year 2001 (n = 1189). Rates of IRB approval and informed consent were examined and compared with potential predictors that included journal, type of publication, and patient demographics (age, sex, elective or emergency status). Rates were compared by use of chi-square and logistic regression. Results The authors found that IRB approval was documented in 71% of publications and consent was obtained in 66% of publications. Significant variation in IRB approval and consent was found among journals (P < 0.0005) and according to type of publication (P < 0.0005). Because publication type affected rates of IRB approval and consent (trials > mechanistic studies > observational studies > case reports), an analysis restricted to prospective studies also found a significant difference in IRB approval and consent among journals (P < 0.0005). Conclusions This study suggests that rates of IRB approval and informed consent vary among publications in anesthesia journals. Clearer guidelines (and author adherence) for all types of publication are needed, both as a protection for research subjects and to maintain public trust in the process.

scholarly journals Tuskegee Syphilis Study of 1932–1973 and the Rise of Bioethics as Shown Through Government Documents and Actions

2019 ◽  
Vol 47 (4) ◽  
pp. 11
Author(s):  
Laura A. Barrett
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Information Science ◽  
Human Subjects ◽  
Medical Studies ◽  
Research Subjects ◽  
Tuskegee Syphilis Study ◽  
Institutional Review ◽  
Government Documents ◽  
Science Community

One government source regarding clinical trials is Clinicaltrials.gov (https://clinicaltrials.gov), which is available to health information seekers as a resource to find information about past, current, and recruiting clinical trials. Currently, if you participate in a clinical trial you are required to provide your “informed consent.” This means you have been informed of the risks, benefits, purpose of the study, and your rights. This information is provided to you so that you, as the potential participant, can make an informed decision before deciding whether or not to participate. If you work with or in research, you will become very familiar with the term IRB, which stands for “Institutional Review Board.” An IRB is a panel intended to oversee the entire scope of one or more medical research studies including protecting the rights and welfare of human research subjects. Although it may seem like common sense that these two things are necessary, there was a time when they did not exist. A new approach to bioethics and the regulation of clinical trials and medical studies using living human subjects came about from public and governmental outrage over one study, known as the Tuskegee Syphilis Study. By looking specifically at this case, which led to the rise of bioethics at the federal-government level in the 1970s, the origin of IRBs and informed consent as they relate to medical studies and human subjects will be illuminated. The issues of IRBs, informed consent, and bioethics are important in the library and information science community because we often interact with a public that is impacted by the policies and regulations related to these issues. In addition, we are the very researchers, or hold relationships with researchers, that are held to the strict standards set in place by IRBs and bioethics in general.

The Ethical Analysis of Risk

2000 ◽  
Vol 28 (4) ◽  
pp. 344-361 ◽  
Author(s):  
Charles Weijer
Keyword(s):  
Informed Consent ◽  
Human Subjects ◽  
Research Subjects ◽  
Human Subjects Research ◽  
Selection Procedures ◽  
Subject Selection ◽  
Research Protocols ◽  
Institutional Review ◽  
The Social ◽  
Potential Benefits

The institutional review board (IRB) is the social-oversight mechanism charged with protecting research subjects. Performing this task competently requires that the IRB scrutinize informed-consent procedures, the balance of risks and potential benefits, and subject-selection procedures in research protocols. Unfortunately, it may be said that IRBs are spending too much time editing informed-consent forms and too little time analyzing the risks and potential benefits posed by research. This time mismanagement is clearly reflected in the research ethics literature. A review of articles published between 1979 and 1990 in IRB: A Review of Human Subjects Research, for example, reveals a large number of articles on informed consent and confidentiality (142 articles) and considerably fewer on the assessment of risks and potential harms (40), study design (20), and subject-selection procedures (5).

IRB Creep: Federal Regulations Protecting Human Research Subjects and Increasing Instructors' Responsibilities

2009 ◽  
Vol 24 (1) ◽  
pp. 31-43 ◽  
Author(s):  
Diane A. Riordan ◽  
Michael P. Riordan
Keyword(s):  
Review Process ◽  
Human Subjects ◽  
Institutional Review Boards ◽  
Federal Regulations ◽  
Federally Funded ◽  
Research Subjects ◽  
Accounting Faculty ◽  
Institutional Review ◽  
Human Research Subjects ◽  
Review Boards

ABSTRACT: Federal regulations require oversight of federally sponsored research involving human subjects. Universities have responded by forming Institutional Review Boards (IRBs). Although these regulations only apply to federally funded projects, universities have extended the oversight to include all projects involving human subjects. From our own experience, we observe that not all accounting faculty are aware of their responsibilities to their local boards. The sanctions for failing to follow required procedures depend on the infraction, and range from an order to cease work on the project to termination of university service for the faculty member and expulsion for the student. This report helps accounting faculty understand how the review process may affect their role as instructors and serves as encouragement to them to become familiar with the requirements of local review boards.

scholarly journals Characterizing Current Attitudes and Practices for Human Subject Safety in Studies Involving Pupil Dilation

2020 ◽  
pp. 155626462096898
Author(s):  
Jacob Szpernal ◽  
Joseph Carroll ◽  
Ryan Spellecy ◽  
Jane A. Bachman Groth
Keyword(s):  
Informed Consent ◽  
Adverse Effects ◽  
Vision Research ◽  
Human Subject ◽  
Human Subjects ◽  
Pupil Dilation ◽  
Institutional Review Boards ◽  
Human Subjects Research ◽  
Attitudes And Practices ◽  
Institutional Review

Standards in pupil dilation practices regarding the safety of human subjects are not present in vision research despite the potential for significant adverse effects. We developed two surveys to examine current practices around pupil dilation among vision researchers and individuals associated with oversight of human subjects research. While both groups note an absence of adverse events associated with pupil dilation, vision researcher practices differed with informed consent use and measures taken to minimize complications. For Institutional Review Boards, general risk assumption associated with dilation was not unanimous and there was a lack of specific guidance available to researchers for minimizing risk. These results uncover the need for standardized practices regarding pupil dilation in human subjects research.

scholarly journals Randomized controlled trial of erdosteine for acute cough in children with colds

2011 ◽  
Vol 51 (2) ◽  
pp. 111
Author(s):  
Yenny Yenny ◽  
Roni Naning ◽  
Amalia Setyati
Keyword(s):  
Randomized Controlled Trial ◽  
Clinical Improvement ◽  
Common Cold ◽  
Controlled Trial ◽  
Research Subjects ◽  
Acute Cough ◽  
Chi Square ◽  
Double Blind ◽  
Randomized Controlled ◽  
Significant Difference

Background T h e prevalence of the common cold in children is high, v.ith 30% of cases exhibiting an acute cough, the most common complaint by parents. Erdosteine, a recently developed cough medicine, is available for children. Erdosteine has been reported to increase mucodliary clearance, act as an antioxidant and prevent bacterial adhesion.Objective To assess the clinical improvement in acute cough in children \\lith a common cold taking erdosteine vs. a placebo.Methods We conducted a double􀀾blind, randomized, controlled trial at the Public Health Center of Gedongtengen, Yogyakarta with 140 children selected by a consecutive sampling method. Research subjects were randomized by computer program into two treatment groups, those receiving erdosteine therapy and those receiving a placebo. Both groups were monitored for 6 days. A scoring system was used to assess the improvement of acute cough symptoms and analyzed by Chi-square test.Results No significant differences in basic characteristics, cough severity, or environment were found among the 140 children with common cold in the two groups. After 6 days of treatment, no significant difference in clinical improvement of acute cough was found between the erdosteine (65 subjects improved out of 70) and placebo groups (62/70),92.5% and 88.6%, respectively (P=0.382).Conclusion Erdosteine was not more effective than the placebo for treatment of acute cough in children with common cold.

Improving Participation and Quality of Clinical Research in a University-Based General Surgery Residency Program

2010 ◽  
Vol 76 (7) ◽  
pp. 741-742 ◽  
Author(s):  
Carla Fisher ◽  
Megan K. Baker
Keyword(s):  
Clinical Research ◽  
General Surgery ◽  
Human Subjects ◽  
Case Reports ◽  
Compliance Rate ◽  
Research Participation ◽  
Laboratory Research ◽  
General Surgery Residency ◽  
Institutional Review ◽  
Surgery Residency Program

At a university-based general surgery training program, post-graduate year (PGY) to 5 categorical general surgery residents had been required to complete an annual clinical research project and a year of laboratory research. Since the 80-hour work week, the laboratory experience was made optional, with a resultant decline in laboratory and clinical participation by 50 per cent and 75 per cent, respectively. Our goal was to review the effect of a simple programmatic intervention on the research compliance rate and quality. The Department was informed about the clinical research requirement via e-mail, memo, and announcements. Faculty submitted lists of novel or on-going projects. This was compiled and e-mailed to the Department with a list of project milestones. This included identification of a research mentor and project, Human Subjects Course certification, institutional review board submission dates, a midyear progress report, and final submission date. Rates of compliance and nature of research were recorded the year before and the 2 years after the intervention. Before the intervention, 2 of 16 residents were compliant. Faculty submitted 76 projects for resident review. One hundred per cent compliance with all aspects of the program was seen at the end of both year 1 and 2. Case reports rate fell from 65, to 30, to 25 per cent by the end of year 2. Publications increased from three preintervention to 13 by year 2. Presentations increased from five preintervention to 13 by end of year 2. This study demonstrates that small inexpensive interventions can have a dramatic effect on research participation.

The Role of the Institutional Review Board in Research Involving Human Subjects

1983 ◽  
Vol 17 (11) ◽  
pp. 828-834 ◽  
Author(s):  
John A. Bosso
Keyword(s):  
Experimental Research ◽  
Human Subjects ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Federal Regulations ◽  
Research Subjects ◽  
Basic Composition ◽  
Institutional Review ◽  
Policies And Procedures

Concern with the rights and welfare of human experimental research subjects has given rise to the evolution of institutional review boards. This article describes the basic composition and purposes of these boards, as well as the federal regulations by which they are governed. Since many of these regulations are open to interpretation, the policies and procedures of one such board are included to represent an example of how these regulations are interpreted and applied.

Educational Research and the Protection of Human Subjects

1977 ◽  
Vol 2 (2) ◽  
pp. 477-519 ◽  
Author(s):  
Benjamin S. DuVal
Keyword(s):  
Educational Research ◽  
Human Subjects ◽  
Institutional Review Boards ◽  
Research Subjects ◽  
Institutional Review ◽  
Legal Restrictions ◽  
Research On Human Subjects ◽  
Protection Of Human Subjects ◽  
Judicial Recognition ◽  
Review Boards

Educational research is increasingly subject to legal restrictions designed for the protection of human subjects of research. In this article the author discusses legal restrictions–both in the courts and under HEW regulations–on educational research, comparing these restrictions with those on biomedical research. He finds that although educational research in particular instances may give rise to suits for damages for invasion of privacy or intentional infliction of psychological distress, the legal issues relating to educational research will most often be resolved in proceedings before institutional review boards charged by HEW with the responsibility for passing upon proposals to conduct research on human subjects. He argues that the interests protected in proceedings before institutional review boards are not limited to those that have received judicial recognition in suits for damages. The author finds that the requirement that the informed consent of subjects be obtained presents difficult issues for educational research. He notes in particular the problems presented by research proposals that as an element of the research design contemplate the observation of subjects without their knowledge and the use of children as research subjects.

scholarly journals Reporting of ethical considerations in clinical trials in Chinese nursing journals

2017 ◽  
Vol 26 (4) ◽  
pp. 973-983 ◽  
Author(s):  
Yanni Wu ◽  
Michelle Howarth ◽  
Chunlan Zhou ◽  
Xue Ji ◽  
Jiexia Ou ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Human Subjects ◽  
Journal Citation Report ◽  
Mainland China ◽  
Ethical Guidelines ◽  
Ethical Considerations ◽  
Research Papers ◽  
Technology Journal ◽  
Ethical Approval

Background: It is acknowledged that publishers now require all primary research papers to demonstrate that they have obtained ethical approval for their research. Objectives: To assess the rate of reporting of ethical approval in clinical trials in core nursing journals in mainland China. Research design: A retrospective observational study. Participants: All clinical trials published in all of the 12 core nursing periodicals from 2016 edition China Science and Technology Journal Citation Report (core version) between 2013 and 2016 were retrieved by hand to explicate rate of reporting ethical approval and informed consent. Ethical considerations: The study did not require approval from the research ethics committee as it did not involve human subjects or records. Results: In total, 40,278 papers were published in 12 nursing periodicals between 2013 and 2016. Out of these, 9488 (23.6%) focused on clinical trials. Informed consent obtained from patients or the legally authorized representative was reported in 51.8% of clinical trials. Notably, only 27.4% of clinical trials reported that they had obtained written consent. Furthermore, 25.9% of clinical trials described ethical approval; however, the rate of reporting informed consent and ethical approval in these 12 nursing journals in China during 4 years from 2013 to 2016 improved markedly, with 38.1%, 44.0%, 59.0% and 66.6%, respectively ( p < 0.001), and 17.6%, 21.9%, 28.6% and 35.8%, respectively ( p < 0.001). In addition, both reporting informed consent and reporting written informed consent had a positive significant correlation with the reporting ethical approval ( p < 0.05 or < 0.01). Conclusion: Chinese scientific nursing journals have improved the rate of reporting informed consent and ethical approval in clinical trials during the last 4 years. However, it should be noted that nearly half of clinical trials still did not report either ethical approval or whether informed consent was obtained. Efforts from editors, researchers, sponsors and authors are needed to ensure the transparency of ethical scrutiny and adherence to ethical guidelines in publishing clinical trials in Chinese nursing journals.

A Review of Lateral Ankle Ligamentous Reconstructions

Foot & Ankle ◽  
1982 ◽  
Vol 3 (2) ◽  
pp. 114-123 ◽  
Author(s):  
Rick St. Pierre ◽  
Fred Allman ◽  
Frank H. Bassett ◽  
J. Leonard Goldner ◽  
Lamar L. Fleming
Keyword(s):  
Tilt Angle ◽  
Clinical Results ◽  
Grading System ◽  
Chi Square ◽  
Reconstructive Procedures ◽  
Lateral Ankle ◽  
Institutional Review ◽  
Significant Difference ◽  
Talar Tilt

We have performed an ongoing retrospective and prospective multi-institutional review of 50 patients who underwent 53 lateral ligamentous reconstructive procedures of the ankle. The point grading system used for postoperative evaluation of our patients allowed for classification of functional activity. The grading system included evaluation of the patient's return to preinjury activities and athletics, degree of pain, degree of swelling, number of recurrent sprains, and any disability that the patient incurred secondary to the tendon transfer. Preoperative and postoperative stress radiographs were obtained to evaluate the talar tilt angle. Of our 53 lateral ankle ligamentous reconstructions, we consider 45 to be excellent, with the patients returning to full activity and athletics. Our results show no statistically significant difference in long-term function among the five ligamentous repairs employed in this series (Pearson Chi-square test; χ2 = 2.30, df = 4, P = 0.68). No correlation could be made between the long-term clinical response of the various procedures and the postoperative talar tilt angle. We conclude that lateral ligamentous reconstructive repairs of the ankle are indicated, and that good or excellent clinical results, greater than 91 %, can be obtained with any of the five reconstructive procedures, performed correctly.

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