This document discusses developing a Biomedical Ethics Ontology (BMEO) to help clarify terms and principles used in clinical trial reviews. It proposes that an ontology could standardize definitions, improve data sharing across institutions, and help ensure consistent application of ethical principles. The document outlines initial steps to create the BMEO, including defining key terms related to clinical trials, ethical concepts, and relations between entities. It also notes challenges in rigorously defining principles like autonomy and justice. Developing the ontology will involve domain experts collaborating with ontologists to define terms, analyze case studies, and test the ontology's usefulness for multi-national clinical trials.
This document discusses several topics related to research ethics including guidelines, codes, and organizations. It provides 10 guidelines for ethical research including honesty, objectivity, integrity, and social responsibility. It summarizes the Nuremberg Code which consists of 10 principles for ethical human experimentation such as voluntary consent and avoiding unnecessary suffering. It also discusses the Belmont Report which established three ethical principles for research involving human subjects: beneficence, justice, and respect for persons. It provides an overview of the roles of WHO, UNESCO, and UNESCO in establishing standards and guidance for ethical research practices globally. It identifies several types of research misconduct and issues that can arise from collaboration, peer review, and conflicts of interest. It
Unit 2,ethical consideration in researchChanda Jabeen
This document discusses ethical considerations in research. It covers objectives like defining ethics terms, discussing historical events that shaped research ethics, and describing informed consent. Key topics include the Nuremberg Code, Declaration of Helsinki, principles of beneficence and respecting human dignity. Research ethics aim to protect participants and ensure their voluntary consent, privacy, and fair distribution of risks and benefits.
This document discusses trends and issues in nursing that nurses need to study. It defines trends as general directions or movements, especially of events and opinions related to nursing. Issues are important topics or problems for discussion. Some key trends and issues identified include the nursing shortage, patient satisfaction, managed care, evidence-based practice, aging population, genetics, globalization of health, and legal/ethical concerns like terrorism or bioterrorism. The document provides details on several of these topics and their implications for nursing practice, education, and research.
Avoiding plagiarism in this era of digital availabilityDr. Utpal Das
This document discusses avoiding plagiarism in research. It defines research and outlines some key characteristics like novelty and originality. It also discusses research ethics and integrity, noting that ethics govern researchers' behavior and distinguish right from wrong. The document outlines six key principles for ethical research according to the Economic and Social Research Council in the UK. It provides examples of ethical principles researchers should follow, such as honesty, objectivity, integrity, and respecting intellectual property. The document concludes by defining three types of research misconduct: fabrication, falsification, and plagiarism.
This document summarizes a conference presentation about strategies for increasing access and success for women in higher education science, technology, engineering, and math (STEM) disciplines in Kenya. The presentation argues that increasing women's participation in STEM fields can help build a more peaceful society by supporting socio-economic development, reducing poverty and conflict over resources, and fostering innovation. However, women remain underrepresented in STEM programs and careers in Kenya. The presentation calls for new policies and interventions to address barriers facing women in STEM and unlock their potential to contribute to peace.
This document discusses the differences between science and engineering, and the legal issues surrounding gene patenting. It summarizes the Supreme Court cases Diamond v. Chakrabarthy and AMP v. Myriad, which established that while natural laws and phenomena are not patentable, human-made compositions can be if they have a distinctive character and use. However, the document argues that "isolated and purified" substances should not necessarily be considered patentable if they are identical to natural occurring substances. It concludes that isolation and purification processes may be patentable as inventions, but the natural products themselves, like DNA sequences, are non-artifactual discoveries not eligible for patent protection.
The document discusses the role of the National Assessment and Accreditation Council (NAAC) in India in promoting both equity and quality in higher education. It outlines how NAAC was established in 1994 to stimulate academic quality and assess institutions. While equity and quality were previously viewed separately, NAAC now focuses on both by assessing equity-related factors during the accreditation process such as access for disadvantaged groups and support for weaker students. The document argues that in massified and competitive higher education, India must balance equity, access, and social justice with quality and success to develop world-class institutions and meet the needs of the economy and society.
The document discusses scientists' moral responsibility regarding dangerous research and development (R&D). It argues that scientists have an individual moral duty to consider the broader consequences of their work, not just legal responsibilities. While traditional views see science as value-neutral, the document contends scientists should apply ethical principles like beneficence and justice when their work could endanger humanity. It suggests governments and institutions should provide ethical education for scientists to help cultivate personal moral responsibility regarding potentially catastrophic technologies.
This document discusses several topics related to research ethics including guidelines, codes, and organizations. It provides 10 guidelines for ethical research including honesty, objectivity, integrity, and social responsibility. It summarizes the Nuremberg Code which consists of 10 principles for ethical human experimentation such as voluntary consent and avoiding unnecessary suffering. It also discusses the Belmont Report which established three ethical principles for research involving human subjects: beneficence, justice, and respect for persons. It provides an overview of the roles of WHO, UNESCO, and UNESCO in establishing standards and guidance for ethical research practices globally. It identifies several types of research misconduct and issues that can arise from collaboration, peer review, and conflicts of interest. It
Unit 2,ethical consideration in researchChanda Jabeen
This document discusses ethical considerations in research. It covers objectives like defining ethics terms, discussing historical events that shaped research ethics, and describing informed consent. Key topics include the Nuremberg Code, Declaration of Helsinki, principles of beneficence and respecting human dignity. Research ethics aim to protect participants and ensure their voluntary consent, privacy, and fair distribution of risks and benefits.
This document discusses trends and issues in nursing that nurses need to study. It defines trends as general directions or movements, especially of events and opinions related to nursing. Issues are important topics or problems for discussion. Some key trends and issues identified include the nursing shortage, patient satisfaction, managed care, evidence-based practice, aging population, genetics, globalization of health, and legal/ethical concerns like terrorism or bioterrorism. The document provides details on several of these topics and their implications for nursing practice, education, and research.
Avoiding plagiarism in this era of digital availabilityDr. Utpal Das
This document discusses avoiding plagiarism in research. It defines research and outlines some key characteristics like novelty and originality. It also discusses research ethics and integrity, noting that ethics govern researchers' behavior and distinguish right from wrong. The document outlines six key principles for ethical research according to the Economic and Social Research Council in the UK. It provides examples of ethical principles researchers should follow, such as honesty, objectivity, integrity, and respecting intellectual property. The document concludes by defining three types of research misconduct: fabrication, falsification, and plagiarism.
This document summarizes a conference presentation about strategies for increasing access and success for women in higher education science, technology, engineering, and math (STEM) disciplines in Kenya. The presentation argues that increasing women's participation in STEM fields can help build a more peaceful society by supporting socio-economic development, reducing poverty and conflict over resources, and fostering innovation. However, women remain underrepresented in STEM programs and careers in Kenya. The presentation calls for new policies and interventions to address barriers facing women in STEM and unlock their potential to contribute to peace.
This document discusses the differences between science and engineering, and the legal issues surrounding gene patenting. It summarizes the Supreme Court cases Diamond v. Chakrabarthy and AMP v. Myriad, which established that while natural laws and phenomena are not patentable, human-made compositions can be if they have a distinctive character and use. However, the document argues that "isolated and purified" substances should not necessarily be considered patentable if they are identical to natural occurring substances. It concludes that isolation and purification processes may be patentable as inventions, but the natural products themselves, like DNA sequences, are non-artifactual discoveries not eligible for patent protection.
The document discusses the role of the National Assessment and Accreditation Council (NAAC) in India in promoting both equity and quality in higher education. It outlines how NAAC was established in 1994 to stimulate academic quality and assess institutions. While equity and quality were previously viewed separately, NAAC now focuses on both by assessing equity-related factors during the accreditation process such as access for disadvantaged groups and support for weaker students. The document argues that in massified and competitive higher education, India must balance equity, access, and social justice with quality and success to develop world-class institutions and meet the needs of the economy and society.
The document discusses scientists' moral responsibility regarding dangerous research and development (R&D). It argues that scientists have an individual moral duty to consider the broader consequences of their work, not just legal responsibilities. While traditional views see science as value-neutral, the document contends scientists should apply ethical principles like beneficence and justice when their work could endanger humanity. It suggests governments and institutions should provide ethical education for scientists to help cultivate personal moral responsibility regarding potentially catastrophic technologies.
This document discusses key principles of research ethics including guidelines for authorship, the Nuremberg Code, Declaration of Helsinki, Belmont Report, and Philippine laws and guidelines. Ethical research requires voluntary informed consent, favorable risk-benefit ratio, scientific validity, fair subject selection, and independent review. Research ethics aims to protect human subjects and ensure scientific integrity by applying principles like respect for persons, beneficence, and justice.
The Belmont Report summarizes the basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. It discusses three principles that should guide research with human subjects: respect for persons, beneficence, and justice. The report was created to identify ethical standards for research and outline how risks and benefits, informed consent, and subject selection should be handled.
This document provides an overview of medical ethics. It begins with definitions of ethics and discusses how ethics became important in medicine due to crimes against humanity in the 20th century. It then outlines the major developments in medical ethics codes and guidelines over time, including the Nuremberg Code, Declaration of Helsinki, and U.S. regulations. The document also covers ethical principles of beneficence, justice and respect for persons. It discusses types of ethics like professional, medical, bio and clinical ethics. Finally, it emphasizes the importance of ethical norms and codes in promoting responsible research and protecting subjects.
THE BELMONT REPORT Office of the Secretary Ethical Princip.docxtodd541
THE BELMONT REPORT
Office of the Secretary
Ethical Principles and Guidelines for the Protection of Human
Subjects of Research
The National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research
April 18, 1979
AGENCY: Department of Health, Education, and Welfare.
ACTION: Notice of Report for Public Comment.
SUMMARY: On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the
charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical
and behavioral research involving human subjects and to develop guidelines which should be followed to assure that
such research is conducted in accordance with those principles. In carrying out the above, the Commission was
directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine
practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of
research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in
such research and (iv) the nature and definition of informed consent in various research settings.
The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of
its deliberations. It is the outgrowth of an intensive four-day period of discussions that were held in February 1976 at
the Smithsonian Institution's Belmont Conference Center supplemented by the monthly deliberations of the
Commission that were held over a period of nearly four years. It is a statement of basic ethical principles and
guidelines that should assist in resolving the ethical problems that surround the conduct of research with human
subjects. By publishing the Report in the Federal Register, and providing reprints upon request, the Secretary intends
that it may be made readily available to scientists, members of Institutional Review Boards, and Federal employees.
The two-volume Appendix, containing the lengthy reports of experts and specialists who assisted the Commission in
fulfilling this part of its charge, is available as DHEW Publication No. (OS) 78-0013 and No. (OS) 78-0014, for sale by
the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.
Unlike most other reports of the Commission, the Belmont Report does not make specific recommendations for
administrative action by the Secretary of Health, Education, and Welfare. Rather, the Commission recommended that
the Belmont Report be adopted in its entirety, as a statement of the Department's policy. The Department requests
public comment on this recommendation.
National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Resea.
This document provides definitions and explanations of key concepts in clinical research involving human subjects. It defines human subject research according to the Department of Health and Human Services as involving systematic investigation designed to contribute to generalizable knowledge and obtaining data from living individuals through intervention, interaction, or access to private information. The history of regulations is summarized, from early events like the Tuskegee Syphilis Study to key documents like the Belmont Report that established ethical principles of respect for persons, beneficence, and justice. Common definitions and types of research designs are also outlined.
This document provides definitions and explanations of key concepts in clinical research. It defines human subject research according to the Department of Health and Human Services as involving systematic investigation designed to develop generalizable knowledge and obtaining data from living individuals through intervention or identifiable private information. The document outlines the history of regulations protecting human subjects from the Nuremberg Code to the Belmont Report. It also describes types of study designs including observational studies like cohorts and case-controls and experimental designs involving interventions. Resources for conducting research like the IRB and Human Immunology Research Office are presented.
EMPHNET-PHE Course: Module seven ethical issues in public health research& in...Dr Ghaiath Hussein
This is a series of presentations I gave in the Eastern Mediterranean Public Health Network (EMPHNET)'s Public Health Ethics (PHE) that was held in Amman in June 2014.
This presentation outlines the ethical issues in research, especially the international research in low-middle income countries
This document discusses regulations for human subject research and the IRB review process. It provides an overview of the ethical principles from the Belmont Report including respect for persons, beneficence, and justice. It also reviews key events in research ethics history. The document outlines the steps for developing a research study including distinguishing research from quality improvement. It discusses the MSU reliance process and IRB submission requirements such as elements of a consent form and HIPAA authorization documentation.
The document provides an overview of research ethics and guidelines for master's and doctoral students. It defines ethics and research, discusses the key differences between clinical and social science research. It also summarizes the international evolution of research ethics codes and regulations, including the Nuremberg Code, Declaration of Helsinki, Belmont Report, CIOMS Guidelines, and ICH Guidelines. The document outlines ethical principles of respect, beneficence, and justice in research and considerations at different stages of the research process.
This document discusses ethical considerations in nursing research. It outlines various codes of ethics that were developed in response to human rights violations in medical experiments, including the Nuremberg Code and Helsinki Declaration. The document also discusses principles for protecting research participants, such as beneficence, respect for human dignity, and justice. It describes guidelines from the Indian Council of Medical Research and ethical review procedures that require research proposals involving human participants to be cleared by an institutional ethics committee.
EVB-Evidence Based Practice- principles,purposes,valuechristenashantaram
This brief out the principles,purposes,value involved in EVB-Evidence Based Practice and helps health, scoial care practisioner to know more about the EVB-Evidence Based Practicein health and scocial care international base.
Running Head Quantitative research1Quantitative research3.docxtoltonkendal
Running Head: Quantitative research 1
Quantitative research 3
QUANTITATIVE RESEARCH
Student
University
School
Couse
Course code
Lecturer
Due date
Type of quantitative research conducted
The study was a longitudinal nature as information was collected continuously over a period of time of time in regards to the variables. The article by Johnson, (1977), was to be conducted all through time without proper specification of what the data collection was to be conducted and its end.
Variables under investigation and their measurement
The article seek to measure to justify the overall connection between the term validity and how it is utilized in quantitative research. The article reviews five types of validity namely descriptive, interpretive, theoretical, internal and external validity. In relation to the nature to the research study conducted, the discussions conducted are descriptive in nature and therefore measurement was largely based on predictions acquired from data sources, phenomenon, information acquired from investigators, perspectives acquired from theories, respondent reviews and from discussions acquired from peer reviewed articles. Critical self-reflections and critical examinations of the negative studies that offer alternative explanations to what the original findings portray is about.
Scientific merit and how and it can be improved
Research studies must have a certain quality in order to exhibit the most relevant results attainable. Quality in research can be used by organizations in the effort to alleviate the situation that a particular study reveals and should the results be incorrect it would lead to wastage in resources. Scientific merit therefore ensures that all research conducted is reliable and can be use with other sources for positive actions.
Efforts to enforce and improve scientific merit must firstly include expert review that should begin all through from development of the proposal all through to the final research. The advisors must also have the required expertise to ensure quality of the papers. The peer reviewers must also be selected in accordance to clearly articulated criteria. The researchers can thereby acquire the proper and reliable feedback based on the rules and procedures.
It would also be critical to fairly assess the research papers based on the properly defined processes. Moreover, it would be important to point areas where the study reveals conflict of interest. Consequently, the process of review must be in relation to the need of the area being addressed with regards to the amount of resources invested and the how complex the study is(Canadian Diabetes Association, 2016).
Lastly, all through the research study, and ethical committee should be paramount to properly and effectively institute the review process. Properly dealing with issues would help ensure confidence in the review and utilization of is data and other properties.
References
Canadian Diabetes Association. (2 ...
Topic for capstone .Implementing Opiod Risk assessment tool .docxnanamonkton
Topic for capstone
.Implementing Opiod Risk assessment tool from a multidisciplinary pain management approach
The purpose of the doctoral capstone project was to: (a) provide education to nursing staff on implementing a structured risk assessment tool in order to identify risk for imminent aggression, manage risk for imminent aggressive behaviors
Write a 6-8 page double-spaced paper with an additional template in which you analyze potential ethical considerations that may arise from your doctoral project. Determine strategies to address these ethical considerations.
Introduction
Ethical researchers act in honest ways. Ethics are conduct norms or standards that distinguish between right and wrong and acceptable and unacceptable behaviors. Ethical considerations matter because they guard against the fabrication or falsification of data. They promote the pursuit of knowledge and truth, research’s primary goal. Ethical behavior is also crucial for collaborative work because it encourages an environment of trust, accountability, and mutual respect among team members. Likewise, researchers must adhere to ethical standards for the public to support and believe in the research. Although most quality improvement and evidence based practice projects pose minimal risk to human subjects, an IRB screening process for your capstone project is required to ensure the project is meeting the appropriate ethical standards.
The Nuremberg Code (1947) protects human rights and is the leading code for conducting ethical research. It focuses on:
Voluntary informed consent.
Freedom to withdraw from research.
Protection from physical and mental harm.
Protection from suffering and death.
It also emphasizes the risk-benefit balance of conducting research. The Declaration of Helsinki (1964) underscored the importance of protecting subjects in research and strongly proclaimed that individuals’ well-being takes precedence over scientific and social interests.
Good research is well planned, appropriately designed, and ethically approved. Developing and following a research protocol helps to ensure this. Research needs to seek to answer specific questions rather than just collect data. Researchers must obtain approval from the Institutional Review Board or Ethics Committee. Researchers also need to pay special attention to vulnerable subjects to avoid breech of ethical codes. Although most quality improvement and evidence based practice projects pose minimal risk to human subjects, an IRB screening process for your capstone project is required to ensure the project is meeting the appropriate ethical standards.
The major ethical issues in conducting research usually involve:
Informed consent.
Beneficence—do no harm.
Respect for anonymity and confidentiality.
Respect for privacy.
You are responsible to ensure your project is conducted ethically and responsibly from planning to publication. Be familiar with ethical principles and follow them strictly. Di.
This document provides an overview of evidence-based orthodontics. It defines evidence-based orthodontics as integrating the best available research evidence with clinical expertise and patient values. The need for evidence-based orthodontics is that it allows practitioners to provide the currently best care available to patients. Evidence-based orthodontic practice differs from traditional practice by regularly accessing new evidence, identifying risk factors, and providing continuous, patient-centered, and efficient care. Systematic reviews are used to summarize research evidence in an unbiased manner to inform clinical decision making.
This document provides an outline and slides for a course on information ethics and clinical decision making. The course introduction discusses the topics to be covered, including information ethics, privacy, security, and case studies. An introduction to ethics and bioethics defines key terms and discusses the relationships between law, professional codes, and ethics. The document then reviews several important historical cases in bioethics that shaped modern ethical principles, such as the Nuremberg Code, Beecher's research ethics violations, and the Tuskegee Syphilis Study. It introduces models of clinical decision making and describes how clinical decision support systems can integrate into decision making processes.
This document discusses ethical issues in medical research. It provides an overview of key topics like the historical perspectives on medical ethics including the Nuremberg Code and Tuskegee Syphilis Study. It describes the origin of guidelines like the Declaration of Helsinki and ICH-GCP. It discusses informed consent processes and the roles of ethics committees in reviewing research protocols and ensuring ethical standards are followed.
Presented at the Health Informatics and Health Information Technology Course, Doctor of Philosophy and Master of Science Programs in Data Science for Health Care (International Program), Faculty of Medicine Ramathibodi Hospital, Mahidol University on October 31, 2017
This is a presentation I gave to the Research Coordinators in the Federal Ministry of Health, Sudan (04.03.2015).
It included the following topics:
• Overview on the Knowledge Management Cycle and how research fits in it
• Brief historical background on research ethics
• What makes research ethical?
• Definition and examples of scientific misconduct
• How to make your research ethical and avoid scientific misconduct?
This document provides an introduction to evidence-based practice (EBP). It defines EBP as using the best available research evidence, along with clinical expertise and patient values, to guide patient care. The document discusses the history and importance of EBP, outlines the steps of EBP including framing clinical questions and searching for evidence, and identifies some barriers and facilitators to implementing EBP. The overall purpose is to familiarize readers with the core concepts and process of evidence-based practice in nursing.
This document outlines the key ethical issues in conducting research. It begins by defining research and explaining where research fits within the knowledge management cycle. It then discusses what makes research ethical, outlining principles such as social or scientific value, scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, and informed consent.
The document goes on to discuss specific ethical issues in research, including benefit-harm analysis, vulnerability and the risk-vulnerability matrix, informed consent, fairness and equity, privacy and confidentiality, conflicts of interest, and ethical issues after research is conducted. It provides examples of vulnerable populations like women, pregnant women, and children.
This document discusses the principal-agent relationship between scientists and the public. It uses the example of Ron Fouchier's controversial H5N1 flu research to illustrate how scientists' and the public's interests can conflict regarding basic science, public health, and security. The document argues that viewing the relationship through a principal-agent lens can help reconcile these conflicts by aligning interests and improving communication between scientists and the public. Symmetrical information flow is important to build understanding and trust between principal and agent.
This document summarizes a presentation on establishing ethical guidelines for scientific research. It discusses:
- The need to ensure public safety given increasing availability of technology while allowing scientific progress.
- Whether scientists have a moral duty to refrain from certain dangerous research.
- Arguments for unfettered scientific inquiry into nature but allowing regulation of technology given potential harms.
- The distinction between basic scientific research, which should not be regulated, and applied technology, which can be if significant harm is possible and regulation is the least restrictive means. Open sharing of scientific findings is important.
This document discusses key principles of research ethics including guidelines for authorship, the Nuremberg Code, Declaration of Helsinki, Belmont Report, and Philippine laws and guidelines. Ethical research requires voluntary informed consent, favorable risk-benefit ratio, scientific validity, fair subject selection, and independent review. Research ethics aims to protect human subjects and ensure scientific integrity by applying principles like respect for persons, beneficence, and justice.
The Belmont Report summarizes the basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. It discusses three principles that should guide research with human subjects: respect for persons, beneficence, and justice. The report was created to identify ethical standards for research and outline how risks and benefits, informed consent, and subject selection should be handled.
This document provides an overview of medical ethics. It begins with definitions of ethics and discusses how ethics became important in medicine due to crimes against humanity in the 20th century. It then outlines the major developments in medical ethics codes and guidelines over time, including the Nuremberg Code, Declaration of Helsinki, and U.S. regulations. The document also covers ethical principles of beneficence, justice and respect for persons. It discusses types of ethics like professional, medical, bio and clinical ethics. Finally, it emphasizes the importance of ethical norms and codes in promoting responsible research and protecting subjects.
THE BELMONT REPORT Office of the Secretary Ethical Princip.docxtodd541
THE BELMONT REPORT
Office of the Secretary
Ethical Principles and Guidelines for the Protection of Human
Subjects of Research
The National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research
April 18, 1979
AGENCY: Department of Health, Education, and Welfare.
ACTION: Notice of Report for Public Comment.
SUMMARY: On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the
charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical
and behavioral research involving human subjects and to develop guidelines which should be followed to assure that
such research is conducted in accordance with those principles. In carrying out the above, the Commission was
directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine
practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of
research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in
such research and (iv) the nature and definition of informed consent in various research settings.
The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of
its deliberations. It is the outgrowth of an intensive four-day period of discussions that were held in February 1976 at
the Smithsonian Institution's Belmont Conference Center supplemented by the monthly deliberations of the
Commission that were held over a period of nearly four years. It is a statement of basic ethical principles and
guidelines that should assist in resolving the ethical problems that surround the conduct of research with human
subjects. By publishing the Report in the Federal Register, and providing reprints upon request, the Secretary intends
that it may be made readily available to scientists, members of Institutional Review Boards, and Federal employees.
The two-volume Appendix, containing the lengthy reports of experts and specialists who assisted the Commission in
fulfilling this part of its charge, is available as DHEW Publication No. (OS) 78-0013 and No. (OS) 78-0014, for sale by
the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.
Unlike most other reports of the Commission, the Belmont Report does not make specific recommendations for
administrative action by the Secretary of Health, Education, and Welfare. Rather, the Commission recommended that
the Belmont Report be adopted in its entirety, as a statement of the Department's policy. The Department requests
public comment on this recommendation.
National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Resea.
This document provides definitions and explanations of key concepts in clinical research involving human subjects. It defines human subject research according to the Department of Health and Human Services as involving systematic investigation designed to contribute to generalizable knowledge and obtaining data from living individuals through intervention, interaction, or access to private information. The history of regulations is summarized, from early events like the Tuskegee Syphilis Study to key documents like the Belmont Report that established ethical principles of respect for persons, beneficence, and justice. Common definitions and types of research designs are also outlined.
This document provides definitions and explanations of key concepts in clinical research. It defines human subject research according to the Department of Health and Human Services as involving systematic investigation designed to develop generalizable knowledge and obtaining data from living individuals through intervention or identifiable private information. The document outlines the history of regulations protecting human subjects from the Nuremberg Code to the Belmont Report. It also describes types of study designs including observational studies like cohorts and case-controls and experimental designs involving interventions. Resources for conducting research like the IRB and Human Immunology Research Office are presented.
EMPHNET-PHE Course: Module seven ethical issues in public health research& in...Dr Ghaiath Hussein
This is a series of presentations I gave in the Eastern Mediterranean Public Health Network (EMPHNET)'s Public Health Ethics (PHE) that was held in Amman in June 2014.
This presentation outlines the ethical issues in research, especially the international research in low-middle income countries
This document discusses regulations for human subject research and the IRB review process. It provides an overview of the ethical principles from the Belmont Report including respect for persons, beneficence, and justice. It also reviews key events in research ethics history. The document outlines the steps for developing a research study including distinguishing research from quality improvement. It discusses the MSU reliance process and IRB submission requirements such as elements of a consent form and HIPAA authorization documentation.
The document provides an overview of research ethics and guidelines for master's and doctoral students. It defines ethics and research, discusses the key differences between clinical and social science research. It also summarizes the international evolution of research ethics codes and regulations, including the Nuremberg Code, Declaration of Helsinki, Belmont Report, CIOMS Guidelines, and ICH Guidelines. The document outlines ethical principles of respect, beneficence, and justice in research and considerations at different stages of the research process.
This document discusses ethical considerations in nursing research. It outlines various codes of ethics that were developed in response to human rights violations in medical experiments, including the Nuremberg Code and Helsinki Declaration. The document also discusses principles for protecting research participants, such as beneficence, respect for human dignity, and justice. It describes guidelines from the Indian Council of Medical Research and ethical review procedures that require research proposals involving human participants to be cleared by an institutional ethics committee.
EVB-Evidence Based Practice- principles,purposes,valuechristenashantaram
This brief out the principles,purposes,value involved in EVB-Evidence Based Practice and helps health, scoial care practisioner to know more about the EVB-Evidence Based Practicein health and scocial care international base.
Running Head Quantitative research1Quantitative research3.docxtoltonkendal
Running Head: Quantitative research 1
Quantitative research 3
QUANTITATIVE RESEARCH
Student
University
School
Couse
Course code
Lecturer
Due date
Type of quantitative research conducted
The study was a longitudinal nature as information was collected continuously over a period of time of time in regards to the variables. The article by Johnson, (1977), was to be conducted all through time without proper specification of what the data collection was to be conducted and its end.
Variables under investigation and their measurement
The article seek to measure to justify the overall connection between the term validity and how it is utilized in quantitative research. The article reviews five types of validity namely descriptive, interpretive, theoretical, internal and external validity. In relation to the nature to the research study conducted, the discussions conducted are descriptive in nature and therefore measurement was largely based on predictions acquired from data sources, phenomenon, information acquired from investigators, perspectives acquired from theories, respondent reviews and from discussions acquired from peer reviewed articles. Critical self-reflections and critical examinations of the negative studies that offer alternative explanations to what the original findings portray is about.
Scientific merit and how and it can be improved
Research studies must have a certain quality in order to exhibit the most relevant results attainable. Quality in research can be used by organizations in the effort to alleviate the situation that a particular study reveals and should the results be incorrect it would lead to wastage in resources. Scientific merit therefore ensures that all research conducted is reliable and can be use with other sources for positive actions.
Efforts to enforce and improve scientific merit must firstly include expert review that should begin all through from development of the proposal all through to the final research. The advisors must also have the required expertise to ensure quality of the papers. The peer reviewers must also be selected in accordance to clearly articulated criteria. The researchers can thereby acquire the proper and reliable feedback based on the rules and procedures.
It would also be critical to fairly assess the research papers based on the properly defined processes. Moreover, it would be important to point areas where the study reveals conflict of interest. Consequently, the process of review must be in relation to the need of the area being addressed with regards to the amount of resources invested and the how complex the study is(Canadian Diabetes Association, 2016).
Lastly, all through the research study, and ethical committee should be paramount to properly and effectively institute the review process. Properly dealing with issues would help ensure confidence in the review and utilization of is data and other properties.
References
Canadian Diabetes Association. (2 ...
Topic for capstone .Implementing Opiod Risk assessment tool .docxnanamonkton
Topic for capstone
.Implementing Opiod Risk assessment tool from a multidisciplinary pain management approach
The purpose of the doctoral capstone project was to: (a) provide education to nursing staff on implementing a structured risk assessment tool in order to identify risk for imminent aggression, manage risk for imminent aggressive behaviors
Write a 6-8 page double-spaced paper with an additional template in which you analyze potential ethical considerations that may arise from your doctoral project. Determine strategies to address these ethical considerations.
Introduction
Ethical researchers act in honest ways. Ethics are conduct norms or standards that distinguish between right and wrong and acceptable and unacceptable behaviors. Ethical considerations matter because they guard against the fabrication or falsification of data. They promote the pursuit of knowledge and truth, research’s primary goal. Ethical behavior is also crucial for collaborative work because it encourages an environment of trust, accountability, and mutual respect among team members. Likewise, researchers must adhere to ethical standards for the public to support and believe in the research. Although most quality improvement and evidence based practice projects pose minimal risk to human subjects, an IRB screening process for your capstone project is required to ensure the project is meeting the appropriate ethical standards.
The Nuremberg Code (1947) protects human rights and is the leading code for conducting ethical research. It focuses on:
Voluntary informed consent.
Freedom to withdraw from research.
Protection from physical and mental harm.
Protection from suffering and death.
It also emphasizes the risk-benefit balance of conducting research. The Declaration of Helsinki (1964) underscored the importance of protecting subjects in research and strongly proclaimed that individuals’ well-being takes precedence over scientific and social interests.
Good research is well planned, appropriately designed, and ethically approved. Developing and following a research protocol helps to ensure this. Research needs to seek to answer specific questions rather than just collect data. Researchers must obtain approval from the Institutional Review Board or Ethics Committee. Researchers also need to pay special attention to vulnerable subjects to avoid breech of ethical codes. Although most quality improvement and evidence based practice projects pose minimal risk to human subjects, an IRB screening process for your capstone project is required to ensure the project is meeting the appropriate ethical standards.
The major ethical issues in conducting research usually involve:
Informed consent.
Beneficence—do no harm.
Respect for anonymity and confidentiality.
Respect for privacy.
You are responsible to ensure your project is conducted ethically and responsibly from planning to publication. Be familiar with ethical principles and follow them strictly. Di.
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1. 1
Toward a Biomedical Ethics
Ontology
David Koepsell, Delft University of Technology, NL
Robert Arp, NCBO
2. April 23, 2014 2
Human Subjects Protection
• Applied biomedical ethics derives from historical
failures in protecting human subjects (e.g. Nuremberg
code, Belmont Report, etc.) Principles and institutions
followed:
• Principles include: beneficence, justice, non-
malificence, and dignity
• Principles enforced through institutions such as
• IRBs (US)
• Ethics comittees (EU)
3. April 23, 2014 3
Human Subjects Protection
• Disparate IRBs and ECs decide on the ethics of a
proposed protocol based upon common principles. In
theory, this depends upon clarity and coherence of
terms:
• What is a “minimal risk” vs. a “risk”?
• What is autonomy
• What is justice?
• What is dignity?
4. April 23, 2014 4
Human Subjects Protection
• Currently, IRB and EC members are expected to
educate themselves as to the current standards of
review practice.
• Journals
• Newsletters
• Case notes and abstracts
• Continuing education programs
5. April 23, 2014 5
Human Subjects Protection
• How can currently accepted parameters of a critical
term be captured and disseminated so that searching
can best be accommodated?
• How can EC and IRB members in diverse places
ensure that principles are applied similarly in similar
cases?
• How to deal with an overwhelming amount of largely
wasted data?
7. April 23, 2014 7
Clarity and Coherence
Benefits:
- assistance to those seeking clarity or
consensus about how to apply ethical
principles in similar situations
- fostering detection of inconsistencies in use of
terminologies
8. April 23, 2014 8
Clarity and Coherence
Benefits:
• generating standardized forms
• standardized vocabulary for submissions to
regulatory agencies
• improving collection of data from past studies
9. April 23, 2014 9
Clarity and Coherence
• How do we achieve these benefits?
ONE WAY:
A Biomedical Ethics Ontology (BMEO)
10. April 23, 2014 10
Alternative Approaches
• Thesaurus Ethics in the Life Sciences (TELS)
German Reference Centre for Ethics in the Life
Sciences (DRZE), University of Bonn:
http://www.drze.de/BELIT/thesaurus/
- string matching, at best
e.g., find all string instances of the word:
‘risk’
12. April 23, 2014 12
TELS
- no reasoning
Ontology
- some reasoning
brain part_of nervous system, and
nervous system part_of body, therefore
brain part_of body.
West Texas petroleum is_a petroleum, and
petroleum is_a flammable liquid, therefore
West Texas petroleum is_a flammable liquid.
is_a and part_of
are transitive
14. April 23, 2014 14
Clarity and Coherence
• An ontology provides a controlled, structured
vocabulary that supports reasoning and which includes
a standardized consensus-based list of terms for use
by all of those working in a given community, above all
when describing data to be entered into a computer
15. April 23, 2014 15
Clarity and Coherence
Ontologies help:
• ensure that the different bodies of information collected by
different researchers in the same domain should all be
represented in the same way, which assists interoperability
and shareability of that information
• improve retrieval and dissemination of information
• make the information more easily searchable by human
beings and more efficiently and reliably processable by
computers
16. April 23, 2014 16
Clinical Trial Reviews
• “It’s a huge paperwork mess.”
—Randy Juhl, University of Pittsburgh Vice Chancellor
for Research Conduct and Compliance
(University of Pittsburgh, University Times: The Faculty
and Staff Newspaper, 36 (21), 2004)
18. April 23, 2014 18
Biomedical Ethics
Ontology (BMEO)
- detect inconsistencies in use of
terminologies
- provides a standardized vocabulary for
submissions to regulatory agencies
-assistance to those seeking clarity or
consensus about how to apply ethical
principles in similar situations
19. April 23, 2014 19
Biomedical Ethics
Ontology (BMEO)
- improving the collection of data
from past studies
- generating standardized forms, in a
compatible way, across investigations
20. April 23, 2014 20
Clinical Trial Reviews
TEST CASE:
• STEP ONE (BFO methodology):
list the terms that correspond to the entities, and
provide clear and coherent definitions.
21. April 23, 2014 21
Clinical Trials ReviewFigure 5: Typical IRB Review Form:
I. ResearchDesign YES
NO NA
A. Rationale x
B. Objective/Problem Statement x
C. Background, Previous Studies x
D. Methods 1. experimental vs.standard x
2a.requiredfor standard care x
2b. required only for purposeof research
3. useof placebo (if applicable)
4. likelihood of accomplishing objective x
E. DateSafety Monitoring Plan x
F. Statistical Plan x
G. Mechanism for Reporting SAE’s(seriousadverseevents) x
III. Risks/Benefits YES
NO NA
A. Minimal Risk x
B. Greater than Minimal Riskbut presenting theprospectof directbenefit x
C. Greater than Minimal Riskand no prospect of directbenefit butlikely to
yield generalizable knowledge
D. Protectionsin placefor vulnerablepopulations x
Standard documents provide
A starting point for picking
The low-hanging fruit
22. April 23, 2014 22
Clinical Trials ReviewFigure 5: Typical IRB Review Form:
I. ResearchDesign YES
NO NA
A. Rationale x
B. Objective/Problem Statement x
C. Background, Previous Studies x
D. Methods 1. experimental vs.standard x
2a.requiredfor standard care x
2b. required only for purposeof research
3. useof placebo (if applicable)
4. likelihood of accomplishing objective x
E. DateSafety Monitoring Plan x
F. Statistical Plan x
G. Mechanism for Reporting SAE’s(seriousadverseevents) x
III. Risks/Benefits YES
NO NA
A. Minimal Risk x
B. Greater than Minimal Riskbut presenting theprospectof directbenefit x
C. Greater than Minimal Riskand no prospect of directbenefit butlikely to
yield generalizable knowledge
D. Protectionsin placefor vulnerablepopulations x
Minimal Risk
Vulnerable
Population
Standard Care
23. April 23, 2014 23
Aristotelian Definitions
• an A is a B that/which is C (or Cs)
a board (A) is a group of persons (B) that is organized
to monitor, assess, and evaluate some activity (C)
a review board (A) is a board (B) that participates in
some review (C)
an institutional review board (A) is a review board (B)
that participates in a clinical trial review (C)
24. April 23, 2014 24
Aristotelian Definitions
• a review is a process in which persons participate that
involves the understanding, assessing, and evaluating
of some idea or project
• a clinical trial review is a review that is performed by an
IRB of a proposed clinical trial (an investigation…
human subjects)
• an expedited clinical trial review is a clinical trial review
that is conducted by the institutional review board
chairperson because the proposed clinical trial involves
minimal risk
27. April 23, 2014 27
Clinical Trial Reviews
TEST CASE
• STEP TWO:
list the terms that correspond to the relations, and
provide clear and coherent definitions
28. April 23, 2014 28
Relations
• is_owed: Def.=a relationship between persons
whereby the person owed has a claim against those
who fail to abide by some duty
owes_a: Def.=a relationship between persons
whereby the person owing has a duty to perform some
action or intended action to the person owed
e.g.
30. April 23, 2014 30
Social Ontologies and Biomedicine
• Objection: the terms and categories of ethics are
unclear and culturally relative.
• Response: and yet they are universalized in
international documents, and applied through ethics
committees
• The institutions assume to existence and reality of
principles
• We can collect decisions and help clarify principles
through application
31. April 23, 2014 31
Social Ontologies and Biomedicine
• The fundamental principles of bioethics are re-
articulated and adopted world-wide since the
Nuremberg Code, including in The Belmont Report,
Declaration of Helsinki, Declaration of Geneva,
International ethical guidelines for biomedical research
involving human subjects. 2002 CIOMS.
• These reiterate basic principles of the Nuremberg
Code, adopted in regional (EU) and national laws and
codes
32. April 23, 2014 32
Social Ontologies and Biomedicine
• An ontology can capture, express, or normalize local
differences in interpretation of universally-recognized
principles.
• Moreover, much of the “justice” of human subjects
research depends upon procedures, which are more
easily standardized than principles.
33. April 23, 2014 33
Social Ontologies and Biomedicine
• A BMEO will interact with the OBI. The OBI ought to capture
data on social as well as scientific aspect of biomedical
investigations. There is already overlap.
how OBI would represent the term
will add to OBI based on this
work In OBI at this time Term BMEO Def additional notes
homo sapiens (alt term:person)
OBI DEF: a human being
regarded as an individual 〈 person:
a person is a human being that
is conscious and the bearer of
rights and privileges in a
society
(also see the issue of a natural
person, which turns out to be a
technical definition to distinguish
a human from a corporation)
add to OBI: Researcher role is a
worker role which inheres in a
person and realized through a
process of investigating and
seeking to explain and predict
some aspect of reality (cite
BMEO) 〈 researcher
a researcher is a role of a
person whereby that person is
investigating and seeking to
explain and predict some
aspect of reality
we would add this by the specific study design
used; if it is a clinical trial then the researcher
would necessarily be a clinical trial researcher 〈 clinical trial researcher:
a clinical trial researcher is a
researcher that conducts
research using human subjects
in a clinical trial
study subject role OBI DEF: a
study subject role is a study
participant role which inheres in
an entity and is realized by the
implementation of (1) an
observation design specifying
how the entity is to be observed
and/or (2) an intervention design
speci Study subject role
we would add this by defining the entity playing
the study subject role; in this case the entity
would be a person 〈 human subject:
a human subject is a role of a
person whereby that person is
the subject of study in a
clinical trial
we would add this by defining the entity playing
the study subject role; in this case the entity
would be "an organism other than human". At
the moment in OBI orgnaism includes homo
sapiens, and i would like to make a class of all
organisms with the exce 〈 animal subject:
an animal subject is a role of
an animal whereby that
animal is the subject of study
in a trial
OBI considers a clinical trial to be a type of
investigation, with study design being clinical
study design and subject role inhering in entity
= person. 〈 clinical trial:
a clinical trial is a process
aggregate where tests,
experiments, and other
evaluations are carried out on
human subjects in order to
assess the effects of a clinical
trial drug or clinical trial
device look at OBI and use
the definition from there
At the moment both of our
definitions exclude purely
observational clinical trials; we
should fix this in the future
34. April 23, 2014 34
Social Ontologies and Biomedicine
Difficult part: defining basic ethical principles.
Q: what are “justice” or “dignity”
• “Justice: 1. The ethical principle that persons who
have similar circumstances and conditions should
be treated alike; sometimes known as distributive
justice.” -Medilexicon
35. April 23, 2014 35
Social Ontologies and Biomedicine
Informed consent, autonomy, beneficence… can these
be satisfactorily defined from first principles?
No. But they are not treated as though they can be in
applied ethics. IRB members review cases, make
judgments based upon past experiences, and
generalize from those experiences to similar cases.
36. April 23, 2014 36
Social Ontologies and Biomedicine
• Past instances of injustice, lack of autonomy, or failure
of informed consent currently provide the guide for
IRBs and ECs making decisions about proposed
research now…
• The BMEO will help coordinate by clarifying relations
among past instances, solidifying the present state of
these objects within and across various jurisdictions.
• Will assist with relating past instances with proposed
studies through ontology
37. April 23, 2014 37
The Task
• Test cases must be devised, model ontology built:
• developing rigorous definitions of biomedical ethics terms
common to ethics committee reviews everywhere. For
instance, the term autonomy should be well defined, and
given the vast repository of cases in the literature, examples
of autonomy and counter-examples can be compared. The
same should be done with the terms: informed consent,
minimal risk, harm, study, research, human subject, sample,
vulnerable population, and other similarly critical terms.
• (source: central institutional documents for human subjects
research in Europe and the U.S., as well as other
internationally important documents and institutions directing
ethical treatment of human subjects)
38. April 23, 2014 38
The Task
• Domain specialists (e.g. ethics committee members,
professional and theoretical ethicists, and lawyers) will
need to work with professional ontologists to construct
a working ontology. We will need to gather a group of
ontologists and domain specialists to generate a useful
number of terms and relations before putting it to real-
world tests.
39. April 23, 2014 39
The Task
• Case studies will be developed as a proof of concept
for use in clinical trials for a hypothetical multi-national,
multi-center research study involving human subjects.
For the purpose of the study, hypothetical trials will be
devised, protocols written, and the various institutional
and governmental requirements for ethical human
subject research from between three and five legal
jurisdictions (with differing standards and institutions)
will be used
40. April 23, 2014 40
The Task
• We will use a prototype Biomedical Ethics Ontology to
standardize review procedures and to fill out checklists
for requirements in an electronic review form and
consent documents incorporating ethical and
procedural requirements in protocol reviews across all
the hypothetical study centers. We will test these
hypothetical cases against real studies and real review
forms and associated comments that have been de-
identified or otherwise useable without breaching
confidentiality
41. April 23, 2014 41
References:
• Koepsell D, Arp R, Fostel J, Smith B, “Creating a
controlled vocabulary for the ethics of human research:
towards a biomedical ethics ontology.” J Empir Res
Hum Res Ethics. 2009 Mar;4(1):43-58.
• Koepsell D., Smith B, “Letter to the Editor: Dealing with
Socially Constructed Concepts in an Ontology” J Empir
Res Hum Res Ethics. June 2009, Vol. 4, No. 2, Pages
75–76 , DOI 10.1525/jer.2009.4.2.75
42. April 23, 2014 42
Thank you!
• This work was funded by the National Institutes of
Health through the NIH Roadmap for Biomedical
Research, Grant 1 U 54 HG004028.
• Information on the National Centers for Biomedical
Computing can be found at:
http://nihroadmap.nih.gov/bioinformatics.