A community-based assessment of seafood consumption along the lower James River, Virginia, USA: Potential sources of dietary mercury exposure ☆☆☆☆Evidence of review and approval for human subject research: This project was found to comply with appropriate ethical standards and was exempted from the need for formal review by the College of William and Mary Protection of Human Subjects Committee (Tel.: +7572213966) on 2007-06-18 and expired on 2008-06-18.

2010 ◽  
Vol 110 (3) ◽  
pp. 213-219 ◽  
Author(s):  
Erica L. Holloman ◽  
Michael C. Newman
Keyword(s):  
Human Subject ◽  
Human Subjects ◽  
Mercury Exposure ◽  
Ethical Standards ◽  
Seafood Consumption ◽  
Human Subject Research ◽  
Community Based ◽  
James River ◽  
Potential Sources ◽  
Protection Of Human Subjects

The Concept of Vulnerability and the Protection of Human Subjects of Research

2007 ◽  
Vol 21 (3) ◽  
pp. 156-173 ◽  
Author(s):  
Elizabeth R. A. Beattie ◽  
Terry M. VandenBosch
Keyword(s):  
Vulnerable Populations ◽  
Human Subject ◽  
Human Subjects ◽  
Vulnerable Groups ◽  
Federal Regulations ◽  
Current Controversy ◽  
Vulnerable Subjects ◽  
Protection Of Human Subjects ◽  
The U.S

This article provides an overview of the concept of vulnerability through the lens of the U.S. federal regulations for the protection of human subjects of research. General issues that emerge for nurse researchers working with regulated vulnerable populations are identified. Points of current controversy in the application of the regulations and current discourse about vulnerable groups are highlighted. Suggestions for negotiating the tension between federally regulated human subject requirements and the realities of research with vulnerable subjects are given. The limitations of the designation of vulnerable as a protection for human subjects will also be discussed.

scholarly journals Conditions of Legality of Medical Human Subject Research

Medicne pravo ◽  
2021 ◽  
pp. 69-77
Author(s):  
M. V. Mendzhul
Keyword(s):  
Human Rights ◽  
Medical Research ◽  
Human Genome ◽  
Human Subject ◽  
Human Subjects ◽  
Research Process ◽  
Embryo Research ◽  
Human Subject Research ◽  
Nuremberg Code

The article examines international acts and national legislation and highlights the conditions for the legality of medical research with human participation. The provisions of the Nuremberg Code (1947), the Helsinki Declaration of the World Medical Association «Ethical principles for medical research involv- ing human subjects» (1964), the Universal Declaration on the Human Genome and Human Rights (1997), the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (1997) and the Addi- tional Protocols to the Convention, Regulation of the European Parliament and of the Council (EU) No 536/2014. The support of the recommendation to ratify the Convention on Human Rights and Biomedicine and its additional protocols in Ukraine has been expressed. It has been established that international acts stipulate that the design and implementation of each human subject research must be clearly described in the research protocol. In addition, research protocols must be subject to prior review by the Ethics Committees. It has been substantiated that international acts set for medical research standards, which are based on the principles of respect for dignity and human rights, the priority of interests of the person over the interests of society or sci- ence, compliance with safety requirements and prevention of harm to humans, mandatory permission to conduct medical examination, research and control- lability of the research process and its results, compensation for any damage caused by medical research. Conditions of legality of medical research can be divided into general (obser- vance of which is always necessary if a person participates in experiments) and special (additional conditions of legality, which are put forward depend- ing on the field or object of research, namely in the field of experiments com- bined with medical care , human genome research, in vitro embryo research, in the field of clinical trials of drugs).

scholarly journals Confronting and Resolving an Ethical Dilemma Associated with a Practice Based Evaluation Using Observational Methodology of Health Information Technology

2010 ◽  
Vol 01 (03) ◽  
pp. 244-255
Author(s):  
H.A. Taylor ◽  
P.S. Sockolow
Keyword(s):  
Health Care ◽  
Information Technology ◽  
Health Information Technology ◽  
Health Information ◽  
Human Subject ◽  
Human Subjects ◽  
Human Subject Research ◽  
Actual Case ◽  
Clinic Management ◽  
Institutional Review

SummaryAs the adoption of health information technology (HIT) has escalated, efforts to evaluate its uptake have increased. The evaluation of HIT often requires direct observation of health care practitioners interacting with the system. When in the field, the evaluator who is not a trained health care provider may observe suboptimal use of the technology. If evaluators have plans to share the results of the evaluation at the conclusion of the study, they face a decision point about whether to disclose interim results and the implications of doing so. To provide HIT evaluators with guidance about what issues to weigh when observing the implementation of HIT, this paper presents a study of an actual case and discusses the following considerations: (1) whether the evaluation of HIT is considered to be human subject research; (2) if the evaluation is human subject research, whether the Institutional Review Board will consider it exempt from review or subjected to expedited or full review; and (3) how interim disclosure to the clinic management impacts the research study. The recommendations to evaluators include use of a protocol for interim disclosures to patients, clinicians, and/or clinical management for both quality assurance initiatives and human subjects research.

Ethical Issues Related to the Use of Humans in Human Factors and Ergonomics

1994 ◽  
Vol 38 (6) ◽  
pp. 404-408
Author(s):  
William F. Moroney
Keyword(s):  
Human Subject ◽  
Ethical Issues ◽  
Human Subjects ◽  
Federal Regulations ◽  
Critical Area ◽  
Human Factors And Ergonomics ◽  
Research Material ◽  
Protection Of Human Subjects ◽  
Changing Role

As professionals, we must be aware of our ethical responsibilities when engaged in research and testing. The purpose of this paper is threefold: 1) to increase the reader's awareness of some of the issues specific to our discipline, 2) to provide some guidelines and references regarding the use of human subjects, and 3) to increase the dialog in this critical area. The material discussed focuses on Federal Regulations related to the protection of human subjects. The changing role of the human subject from “research material” to “participant partners” is also discussed.

scholarly journals Analysis of Faculty Knowledge of Human Subjects Protections in Research

2016 ◽  
Vol 6 (4) ◽  
pp. 20
Author(s):  
Anissa Ybarra ◽  
Lori Kupczynski ◽  
Marie-Anne Mundy ◽  
Stephen D. Oller
Keyword(s):  
Higher Education ◽  
Human Subject ◽  
Human Subjects ◽  
Statistical Tests ◽  
Statistical Significance ◽  
Human Subject Research ◽  
Human Subjects Research ◽  
Faculty Knowledge ◽  
Research Protections ◽  
Faculty Experience

Institutions of higher education are continually engaging in human subject research at the faculty and student level. It is extremely important that all research involving human subjects is in compliance with the UnitedInstitutions of higher education are continually engaging in human subject research at the faculty and student level. It is extremely important that all research involving human subjects is in compliance with the United States (U.S.) Federal Policy for the Protection of Human Research Subjects. If faculty and students are not following the guidelines for the ethical conduct of human subject research, their institution will be at risk of losing any federal funding acquired through these studies and risk the possibility of having all research shut down. The lack of faculty knowledge in the area of human subjects research protections has been considered non-compliance for human subjects research. The purpose of this study was to determine if a significant relationship exists between the areas of faculty research experience in higher education and knowledge of the Total Governing Principles of U.S. Codes and Regulations. The study sought to find if faculty experience in research could predict their knowledge of human subjects research protections. In order to test each hypothesis, two statistical tests were conducted. A Multiple Linear Regression (MLR) was utilized as well as a One-Way Multivariate Analysis of Variance (MANOVA). Findings indicated that there is no statistical significance between the amount of faculty experience in research and their knowledge of the U.S. Codes and Regulations for human subjects research protections. States (U.S.) Federal Policy for the Protection of Human Research Subjects. If faculty and students are not following the guidelines for the ethical conduct of human subject research, their institution will be at risk of losing any federal funding acquired through these studies and risk the possibility of having all research shut down. The lack of faculty knowledge in the area of human subjects research protections has been considered non-compliance for human subjects research. The purpose of this study was to determine if a significant relationship exists between the areas of faculty research experience in higher education and knowledge of the Total Governing Principles of human subjects research protections U.S. Codes and Regulations. The study sought to find if faculty’s experience in research could predict their knowledge of human subjects research protections. In order to test each hypothesis, two statistical tests were conducted. A Multiple Linear Regression (MLR) was utilized as well as a One-Way Multivariate Analysis of Variance (MANOVA). Findings indicated that there is no statistical significance between the amount of faculty experience in research and their knowledge of the U.S. Codes and Regulations for human subjects research protections. 

Ethical issues in action-oriented research in Indonesia

2017 ◽  
Vol 24 (6) ◽  
pp. 686-693 ◽  
Author(s):  
Rini Rachmawaty
Keyword(s):  
Research Ethics ◽  
Human Subject ◽  
Ethical Issues ◽  
Human Subjects ◽  
Ethics Committee ◽  
International Standards ◽  
Local Health ◽  
Human Subject Research ◽  
Research Ethics Committee ◽  
Oriented Research

Background: Action-oriented research is one of the most frequent research types implemented to transform community health in Indonesia. Three researchers and 11 graduate students from a developed country in East Asia conducted a fieldwork program in a remote area in South Sulawesi Province. Although the project was completed, whether or not the international standards for human subject research were applied into that study remains unclear. Objectives: This study aimed to examine ethical issues raised from that case, analyze constraints to the problems, and recommend alternatives to protect vulnerable populations from being exploited by local/international researchers. Methods: A problem-solving approach was used in this study. It began with problem identification, evaluation of the action-oriented research goal, investigation of the constraints to the problem, and recommendation of some relevant alternatives to address the central issue. Ethical Consideration: The approval for conducting the action-oriented research that being investigated in this work was only obtained from the Head of local district. Results: Some ethical issues were found in this case. No special protection for this population, no informed consent was obtained from the participants, exposure to social and economic risks, no future benefits for the subjects, and conflict of interests. Lack of control from the local research ethics committee and lack of competence of local researchers on human subject research were considered as the constraints to the problems. Discussion: Creating an independent research ethics committee, providing research ethics training to the local researchers, obtaining written/video consents from underserved populations, and meeting local health needs were recommended alternatives to solve these problems. Conclusion: Indonesian government bodies should reform their international collaborative system on research involving human subjects. Exploitation may not occur if all participants as well as all local and national governing bodies understand the research ethics on human subjects and apply it into their practice.

scholarly journals Practical challenges and Obligations for conducting Clinical Trial in Nepal: A call for improvement

2019 ◽  
Vol 9 (3) ◽  
pp. 769-771
Author(s):  
Muhamed Ibnas ◽  
Mohammad Asim ◽  
Ahammed Mekkodathil ◽  
Brijesh Sathian
Keyword(s):  
Health Care ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Human Subject ◽  
Human Subjects ◽  
Human Subject Research ◽  
Investigational Product ◽  
Safety And Efficacy ◽  
Health Care Outcomes ◽  
Care Outcomes

Clinical trials play a central role in human subject research for the betterment of health care outcomes. Clinical trials are based on experimental research design in which human subjects are being enrolled in a study arm to assess the safety and efficacy of an investigational product in a protocolized manner.

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).

Sign in / Sign up

Export Citation Format

Share Document