scholarly journals The Limits of Disclosure: What Research Subjects Want to Know about Investigator Financial Interests

2006 ◽  
Vol 34 (3) ◽  
pp. 592-599 ◽  
Author(s):  
Christine Grady ◽  
Elizabeth Horstmann ◽  
Jeffrey S. Sussman ◽  
Sara Chandros Hull
Keyword(s):  
Clinical Research ◽  
Research Design ◽  
Biomedical Research ◽  
Research Participant ◽  
Public Trust ◽  
Good Position ◽  
Research Subjects ◽  
For Profit ◽  
Financial Interests ◽  
Scientific Results

Concerns about the influence of financial interests on research have increased, along with research dollars from pharmaceutical and other for-profit companies. Researchers’ financial ties to industry sponsors of research have also increased. Financial interests in biomedical research could influence research design, conduct, or reporting, and could compromise data integrity, participant safety, or both. Investigators’ financial ties with for-profit companies may influence reported scientific results, and may have compromised research participant safety.Disclosure is one commonly accepted method of managing financial relationships in order to minimize possible threats to scientific objectivity, the safety of research participants, or public trust in the integrity of clinical research. Disclosure is presumed useful to the extent that “it gives those who would be affected, or who are otherwise in a good position to assess the risks, information they need to make their own decision.”

scholarly journals Normative framework of informed consent in clinical research in Germany, Poland, and Russia

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marcin Orzechowski ◽  
Katarzyna Woniak ◽  
Cristian Timmermann ◽  
Florian Steger
Keyword(s):  
Informed Consent ◽  
Clinical Research ◽  
Biomedical Research ◽  
Human Subjects ◽  
Ethical Conduct ◽  
Vulnerable Groups ◽  
Research Subjects ◽  
Normative Framework ◽  
Declaration Of Helsinki ◽  
Normative Requirements

Abstract Background Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in biomedical research in Germany, Poland, and Russia to determine how each national regulatory framework relates to the provisions of the Declaration of Helsinki. Methods For this analysis, we conducted a search of the legal databases “Gesetze im Internet” for Germany, “Internetowy System Aktow Prawnych” for Poland, and “ГAPAHT – Garant” for Russia. The search was complemented by a review of secondary literature contained in the databases Google Scholar, PubMed, Polish National Library, and eLibrary.ru. We have identified 21 normative regulations containing provisions on informed consent in clinical research in all three countries. The content of these documents was systematically categorized and analyzed. Results The normative framework in all three countries shows a strong commitment towards the core ethical principles of research envisaged in the Declaration of Helsinki. Nevertheless, provisions on informed consent vary between these three countries. The differences range from the method and language in which information should be provided, through the amount of information required to be disclosed, to the form of documenting consent or withdrawal. In the case of research on vulnerable groups, these differences are particularly visible. Conclusions The identified differences can negatively impact the ethical conduct of international clinical studies. Attention needs to be paid that flexibilities within national regulations are not misused to undermine the protection of research subjects. Achieving global or regional legislative harmonization might prove impossible. Such lack of legal consensus reinforces the significance of the international ethical agreements. Trial registration: Not applicable.

scholarly journals Intentional Observational Clinical Research Design: Innovative Design for Complex Clinical Research Using Advanced Technology

2021 ◽  
Vol 18 (21) ◽  
pp. 11184
Author(s):  
Tetsuya Tanioka ◽  
Rozzano C. Locsin ◽  
Feni Betriana ◽  
Yoshihiro Kai ◽  
Kyoko Osaka ◽  
...  
Keyword(s):  
Clinical Research ◽  
Research Design ◽  
Language Processing ◽  
Advanced Technology ◽  
Data Generation ◽  
Research Subjects ◽  
Healthcare Facilities ◽  
Clinical Nursing ◽  
New Research ◽  
Electrocardiogram Ecg

The growing use of robots in nursing and healthcare facilities has prompted increasing research on human–robot interactions. However, specific research designs that can guide researchers to conduct rigorous investigations on human–robot interactions are limited. This paper aims to discuss the development and application of a new research design—the Intentional Observational Clinical Research Design (IOCRD). Data sources to develop the IOCRD were derived from surveyed literature of the past decade, focusing on clinical nursing research and theories relating robotics to nursing and healthcare practice. The distinction between IOCRD and other research design is the simultaneous data generation collected using advanced technological devices, for example, the wireless Bonaly-light electrocardiogram (ECG) to track heart rate variability of research subjects, robot application programs on the iPad mini to control robot speech and gestures, and Natural Language Processing programs. Even though IOCRD was developed for human–robot research, there remain vast opportunities for its use in nursing practice and healthcare. With the unique feature of simultaneous data generation and analysis, an interdisciplinary collaborative research team is strongly suggested. The IOCRD is expected to contribute guidance for researchers in conducting clinical research related to robotics in nursing and healthcare.

Overview of clinical research design

2009 ◽  
Vol 66 (4) ◽  
pp. 398-408 ◽  
Author(s):  
Daniel M. Hartung ◽  
Daniel Touchette
Keyword(s):  
Clinical Research ◽  
Research Design

scholarly journals Privacy of Clinical Research Subjects: An Integrative Literature Review

2018 ◽  
Vol 14 (1) ◽  
pp. 33-48 ◽  
Author(s):  
Sanna-Maria Nurmi ◽  
Mari Kangasniemi ◽  
Arja Halkoaho ◽  
Anna-Maija Pietilä
Keyword(s):  
Clinical Research ◽  
Privacy Protection ◽  
Personal Data ◽  
Comparison Method ◽  
Health Data ◽  
The Body ◽  
Social Benefits ◽  
Theoretical Studies ◽  
Research Practice ◽  
Research Subjects

With changes in clinical research practice, the importance of a study-subject’s privacy and the confidentiality of their personal data is growing. However, the body of research is fragmented, and a synthesis of work in this area is lacking. Accordingly, an integrative review was performed, guided by Whittemore and Knafl’s work. Data from PubMed, Scopus, and CINAHL searches from January 2012 to February 2017 were analyzed via the constant comparison method. From 16 empirical and theoretical studies, six topical aspects were identified: the evolving nature of health data in clinical research, sharing of health data, the challenges of anonymizing data, collaboration among stakeholders, the complexity of regulation, and ethics-related tension between social benefits and privacy. Study subjects’ privacy is an increasingly important ethics principle for clinical research, and privacy protection is rendered even more challenging by changing research practice.

scholarly journals Matching research design to clinical research questions

2012 ◽  
Vol 33 (1) ◽  
pp. 49 ◽  
Author(s):  
Sadaf Aslam ◽  
Kedar Mehta ◽  
Helen Georgiev ◽  
Ambuj Kumar
Keyword(s):  
Clinical Research ◽  
Research Design ◽  
Research Questions

Clinical Research Design

2003 ◽  
pp. 31-41
Author(s):  
Betsy Singh ◽  
Sivarama Vinjamury ◽  
Vijay John Singh
Keyword(s):  
Clinical Research ◽  
Research Design

scholarly journals Effect of Exercise and Resistance Methods on Increasing 800 Meter Range Results

2019 ◽  
Vol 8 (6S3) ◽  
pp. 463-467
Keyword(s):  
Physical Education ◽  
Research Design ◽  
Experimental Research ◽  
Interval Training ◽  
Training Methods ◽  
Research Subjects ◽  
Continuous Training ◽  
Study Program ◽  
Training And Education ◽  
Rigorous Study

The purpose of the research is to reveal what is to be achieved with the final results 1) Completion of the problems that have arisen to produce new wisdom, 2) Prevent all predicted problems will arise, 3) as a comparison of existing theories. Specifically, the purpose of this study was to determine whether there was a direct influence between training methods and the efficacy of increasing 800 meters running distance at Pattimura University Students Teacher Training and Education Faculty 2015/2016 Physical Education and Recreation Physical Education Study Program. This research was conducted at Patimura University, Faculty of Health and Education, Penjaskesrek Study Program involving 60/17 students in the 2016/17 semester as research subjects. The method used in this study is an experimental method based on SuarsiminArikunto's reference. Experimental research, according to Ali Maksum, is a rigorous study to find out the causal relationship between variables. One of the main characteristics in experimental research is the existence of treatments (treatments) that are worn on the subject or object of the researcher. Research design or research design is a plan and structure of inquiry arranged so that researchers will be able to obtain answers to their research questions. The results showed that to increase the results of 800 meters running in Unipatti Ambon FKIP Penjaskesrek students can be improved through interval training methods, continuous training methods, and fartlek training methods by controlling endurance first.

scholarly journals Let’s do better: public representations of COVID-19 science

FACETS ◽  
2021 ◽  
Vol 6 (1) ◽  
pp. 403-423
Author(s):  
Timothy Caulfield ◽  
Tania Bubela ◽  
Jonathan Kimmelman ◽  
Vardit Ravitsky
Keyword(s):  
Biomedical Research ◽  
Public Trust ◽  
Research Process ◽  
Research Community ◽  
Public Communication ◽  
The Public ◽  
Research Communities ◽  
Key Issues ◽  
Bad Data

COVID science is being both done and circulated at a furious pace. While it is inspiring to see the research community responding so vigorously to the pandemic crisis, all this activity has also created a churning sea of bad data, conflicting results, and exaggerated headlines. With representations of science becoming increasingly polarized, twisted, and hyped, there is growing concern that the relevant science is being represented to the public in a manner that may cause confusion, inappropriate expectations, and the erosion of public trust. Here we explore some of the key issues associated with the representations of science in the context of the COVID-19 pandemic. Many of these issues are not new. But the COVID-19 pandemic has placed a spotlight on the biomedical research process and amplified the adverse ramifications of poor public communication. We need to do better. As such, we conclude with 10 recommendations aimed at key actors involved in the communication of COVID-19 science, including government, funders, universities, publishers, media, and the research communities.

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