research ethics.ppt

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First page of “Chapter 4: Research Ethics”

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Chapter 4: Research Ethics

2014, Doing Research in the Real World, 3rd edn

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Ethics in research involving humans were first codified in 1946 as Nuremberg code. Subsequently other ethical declarations and guide lines were developed to protect the research participants as well as the researchers. The basic research bioethics includes three principles-respects for person, beneficence, and justice. To make a research with human subjects ethically sound the research protocol should have social and scientific values, fair subject selection, favorable risk benefit ratio, independent review, and informed consent of and respect for the participants. Above all the researcher should be honest and responsible enough to safeguard the rights and welfare of the research subjects. DOI: 10.3329/bjpp.v24i1.5734Bangladesh J Physiol Pharmacol 2008; 24(1&2) : 24-26

This work provides a framework for approaching ethical and policy predicaments in research with human subjects from the perception of trust. It explains how trust is important not only between plainclothesmen and subjects but also between and among other participants involved in the research enterprise, including research staff, sponsors, institutions, communities, oversight committees, government agencies, and the general public. Thus, research involving human subjects are important to develop new therapeutics for the betterment of the human race. Adopting an analytical method, one can argue that to take part in such research as a volunteer is the moral duty of any human. But such experiments should be justifiable and have minimal risk for the participants. The history of unethical research involving humans led to the development of many guidelines to make such research ethical as well as to gain the maximum possible output. Several guidelines have been formulated to ensure research with human participants is ethical. All the guidelines emphasize on one thing in particularinformed consent of the human subjects. Other considerations include rational benefit-harm ratio, beneficence, justice, adequate research design, and approval from proper authorities. All these guidelines aim to prevent any unethical research involving humans against their will.

Research involving human subjects are important to develop new therapeutics for the betterment of the human race. To take part in such research as volunteers is moral duty of any human. But such experiments should be justifiable and minimal risky for the participants. History of unethical research involving humans led to the development of many guidelines to make such research ethical as well as to gain maximum possible output. Several guidelines have been formulated to ensure research with human participants ethical. All the guidelines emphasize on one thing in particular- informed consent of the human subjects. Other considerations include rational benefit-harm ration, beneficence, justice, adequate research design and approval from proper authorities. All these guidelines aim to prevent any unethical research involving humans against their will.

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The twentieth century witnessed a succession of heinous experiments on human subjects in the name of science. The deplorable nature of these experiments led to the development of several guidelines that laid down the principles of research ethics. Respect, bene cence, and justice are the principles that form the foundation of research ethics today. These principles should be implemented through the channels of the informed consent process, privacy and con dentiality, risk bene t analysis, and fair recruitment. Proper implementation of research ethics ensures the protection of the rights and well-being of the participants. Some individuals are considered to be “vulnerable” in the research context because their autonomy is either diminished or lacking. Examples include children, some elderly persons, those with temporary or permanent cognitive impairment, prisoners, and refugees. Vulnerable groups require additional protection measures if they are involved in research. Public health research differs from general health research that necessitates additional ethical considerations. Research involving public health interventions or research conducted during public emergencies, such as natural disasters and disease outbreaks, has unique ethical challenges. Furthermore, in public health research, an understanding or familiarity with the community in which the research will be done is essential to ethical conduct of research. research ethics committees [otherwise known as institutional review boards (IRB)] play a central role in research involving human participants. The proposed research must be reviewed and approved prior to initiation and monitored thereafter with ongoing reviews of safety reports, progress reports, and emerging information or circumstances that may impact the study. A substantial number of conditions need to be met to ensure research starts and then remains ethical. Researchers should be quali ed by education, training, and experience to take on the role of investigators. The scienti c aspects of the research should be robust and valid and the research itself should be purposeful. It is important that ethical considerations be a constant, integrated into the research undertaking, from inception right through to the dissemination and or sharing of the results.

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Research Integrity & Publication Ethics: a global perspective

Published by Patrick Woods Modified over 9 years ago

Presentation on theme: "Research Integrity & Publication Ethics: a global perspective"— Presentation transcript:

Authorship APS Professional Skills Course:

Biomarkism: taming the revolution? May 12 th 2014 PSI Conference David Lovell St George’s Medical School University of London.

Customs for authorship in Biomedicine Peter G Robinson School of Clinical Dentistry.

Submission Process. Overview Preparing for submission The submission process The review process.

The Publishing Cycle Closing the Ethical Loop October 2011, University of Maryland Gert-Jan Geraeds, Executive Publisher

Professor Ian Richards University of South Australia.

Moral  the person’s individual set of values Ethics  consensus of a social system Both try to define what is good and what is bad CUDOS (Robert Merton.

Authorship and Joint Creation: Academic Convention and Standards Frank Lancaster UT Office of the General Counsel Presented at The University of Tennessee.

RESPONSIBLE AUTHORSHIP Office for Research Protections The Pennsylvania State University Adapted from Scientific Integrity: An Internet-based course in.

ROLE OF THE REVIEWER ESSA KAZIM. ROLE OF THE REVIEWER Refereeing or peer-review has the advantages of: –Identification of suitable scientific material.

Publication Issues GCP for clinical trials in India R.Raveendran Chief Editor Indian Journal of Pharmacology.

III. Research Integrity, authorship and attribution Yves A DeClerck MD Professor of Pediatrics and Biochemistry and Molecular Biology.

Research Ethics: Review and Resources 2008 Summer Seminar for Postdocs UNC-Chapel Hill Douglas MacLean and Jamaal Pitt.

APA Ethics Guidelines for publication. Goals To ensure the accuracy of scientific knowledge To protect intellectual property rights.

How does the process work? Submissions in 2007 (n=13,043) Perspectives.

Ethical issues in publishing research and ethics committees Richard Smith Editor, BMJ Verona October

Research Ethics in Undergraduate Research Timothy Sparklin Administrator, Human and Animal Research Protections Office University of Maryland, Baltimore.

Operational Research in the 21 st Century. International Union Against Tuberculosis and Lung Disease (The Union) World’s oldest humanitarian organization.

Do ethics make a difference? Roger Watson Professor of Nursing University of Hull 12 April 2015.

Ethics In Research: Duties, Decisions and Dilemmas Colleen M. Gallagher, PhD, FACHE Chief & Executive Director Section of Integrated Ethics Associate Professor,