The Embassy of Good Science - User contributions [en]

Theme:D44fd22a-ed5d-4120-a78b-8881747131fd

2021-03-25T16:07:41Z

Ružica.Tokalić:

{{Theme
|Theme Type=Good Practices
|Has Parent Theme=Theme:B14a910a-3bc4-40ff-a0e6-eb7119f51ed9
|Title=Research with humans
|Is About=In research with humans, human beings are not only researchers, but also the main subjects of research. Such research can be observational or interventional, and can be medical (including biology, physiology, and clinical trials) or non-medical (social science, political science). Because of ethical issues arising from human research, this area is heavily regulated, to protect the rights and dignity of research participants.<ref>World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. World Medical Association Declaration of Helsinki Special Communication. JAMA. 2013;310(20):2191-4.</ref>
<references />
|Important Because=New drugs. procedures and treatments require detailed testing to ensure they are safe, effective and do not harm those undergoing the treatment or taking the drug. While a lot can be answered using in vitro experiments and animal testing, testing on humans is necessary in order to verify the safety and efficacy of novel treatments.<references />
|Important For=Researchers; Bachelor students; Master students
|Has Best Practice=Throughout history, multiple violations of ethical principles in human research have occurred. The most widely known are perhaps the inhumane experiments conducted by the Nazis and Japanese during the WW2. In the aftermath of the WW2, the Nuremberg Code was published to provide basic guidelines in human research. To further improve the ethics of human research, the World Medical Association developed the Declaration of Helsinki in 1964. While providing some guidance, instances of unethical research persisted. In the United States, a large study was conducted to assess the impact of syphilis, and hundreds of participants were barred from seeking treatment in what was known as the Tuskegee experiment. Following the public outcry, the Belmont report was published in 1978. These documents set important standards in human research and provide the foundations of medical ethics. Some of the important points are respect for the person, personal autonomy (and informed consent), justice, and beneficence. Nowadays, different countries have national laws, informed by the aforementioned international guidance, regarding clinical research and oversight by research ethics committees.

'''Related guidelines'''

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*[https://history.nih.gov/research/downloads/nuremberg.pdf Nuremberg code]
*[https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ Declaration of Helsinki]
*[https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html Belmont report]

'''Related cases'''

<br />

*[https://www.cdc.gov/tuskegee/timeline.htm Tuskegee syphilis experiment]
*[https://encyclopedia.ushmm.org/content/en/article/nazi-medical-experiments Nazi human experiments]
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{{Tags
|Has Virtue And Value=Respect; Responsibility
|Has Good Practice And Misconduct=Research with Humans
}}

Theme:D61666e2-58df-470f-bfb6-9f8ac2eea64f

2021-03-25T16:06:53Z

Ružica.Tokalić:

{{Theme
|Theme Type=Good Practices
|Has Parent Theme=Theme:B14a910a-3bc4-40ff-a0e6-eb7119f51ed9
|Title=Research with animals
|Is About=The basic tenet of animal research is that studying the disease in animals, due to their likeness to humans, can help patients and health research in general. Therefore, animal research in such a context is considered beneficial to human beings and that is the reason why it’s considered to be ethically justified. This does not mean that anything is allowed, and avoiding unnecessary suffering should be a priority of any researcher who works with animals.
|Important Because=Use of animals in research has a long tradition and has been the subject of various debates. From ancient Greece, to physiological research of the 17th century and drug testing today, animals were used in place of human models to gain insight and improve knowledge. It is considered that animal research has contributed to about 70% of Nobel prizes in Medicine or Physiology. Various vaccines, antibiotics, insulin and organ transplants have been developed with help of animal research. In development and testing of new drugs, animal testing is still obligatory. New methods, such as computer simulations, models and cell and tissue cultures, have been used to replace animal research, but in some areas there is still no replacement of equal value.
|Important For=Ethics committee members; Researchers; Junior researchers; Senior researchers; PhD students
|Has Best Practice=Starting in the 18th century, more and more arguments against research with animals have been voiced. Today, guidance for ethical use of animals in research is represented by so called 3R principles. 3R stands for replacement, reduction and refinement.<ref>Russell, W. M. S., Burch, R. L., & Hume, C. W. (1959).The principles of humane experimental technique (Vol. 238). London: Methuen.</ref><ref>Kilkenny C, Browne WJ, Cuthill IC, Emerson M, Altman DG. Improving bioscience research reporting: the ARRIVE guidelines for reporting animal research. PLoS Biol. 2010;8(6):e1000412.</ref> Replacement implies that animals as an experimental system should be replaced with a system from which the identical conclusion could be made if it is available. Reduction means that minimal numbers of animals should be used to prove something in experiments. Refinement means that if suffering of animals is present in the experiment it should be refined with pain killing medications and other support measures. In 2013, European Union formally applied EU Directive 2010/63/EU on the protection of animals used for scientific purposes.<ref>Directive 2010/63/EU of The European Parliament and of The Council of 22 September 2010 on the protection of animals used for scientific purposes (2013).</ref>This directive refers to 3R principles, and its ultimate goal is to replace animals in research altogether.
<references />
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{{Tags
|Has Virtue And Value=Reliability; Accountability
|Has Good Practice And Misconduct=Animal ethics; Research involving animals
}}

Theme:0d054575-ca21-4209-b7c5-6120fc0ed647

2021-03-25T15:50:50Z

Ružica.Tokalić:

{{Theme
|Theme Type=Good Practices
|Has Parent Theme=Theme:B14a910a-3bc4-40ff-a0e6-eb7119f51ed9
|Title=Informed consent
|Is About=Informed consent is a process of acquiring permission from potential participants, before conducting some sort of medical intervention, collection of personal data or enrollment in a study.<ref>Cocanour CS. Informed consent-It's more than a signature on a piece of paper. Am J Surg. 2017;214(6):993-7.</ref>
<references />
|Important Because=In order to maintain high standards of research ethics, personal dignity and autonomy must be respected. To achieve this, before conducting research, researchers have to seek informed consent from participants.
|Important For=Junior researchers; Research subjects; Senior researchers; PhD students; Early career researchers
|Has Best Practice=The idea of written informed consent is not new. It first appeared in the early 20<sup>th</sup> century in Walter Reed’s research of yellow fever.<ref>Cutter L. Walter Reed, Yellow Fever, and Informed Consent. Mil Med. 2016;181(1):90-1.</ref> The development of human rights after the second World War brought to life numerous declarations and rules (e.g., the Nuremberg Code) regarding human experimentation.<ref>Merz JF. The Nuremberg Code and Informed Consent for Research: JAMA. 2018 Jan 2;319(1):85-86. doi: 10.1001/jama.2017.17704.</ref>

In order for informed consent to be valid, four conditions need to be met<ref>Beauchamp, T. L., & Childress, J. F. (2009). ''Principles of Biomedical Ethics''. Oxford University Press.</ref>:

*Voluntariness: subjects should not be coerced. This could be a tricky condition sometimes, especially when subjects have no alternative choice (e.g., when a terminally ill patient is offered to join an experiment that might save their life)
*Capacity: subjects should have the capacity to understand and judge provided information. This could become a thorny issue when dealin with vulnerable subjects (e.g., children) or patients with mental problems (e.g., those suffering from illnesses such as dimensia)
*Information: subjects should be provided with adequate amount of information. These may include methodology, process, duration of the experiment, but also research goals, beneficiaries, data retention schedule, others uses of extracted data (e.g., publication of research articles, use of material in tangent projects, etc.).
*Comprehension: subjects should understand the provided information. Relevant considerations include using straightforward language that is understandable for the least advantaged members of the target group, and avoding the use of scientific jargon.

Before accepting a manuscript for publication, editors should make sure authors have all the necessary research ethics permissions and signed informed consent forms from all participants.
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{{Tags
|Has Virtue And Value=Respect
|Has Good Practice And Misconduct=Informed consent; Vulnerable and non-competent subjects
}}

Theme:E5629f68-81f6-490d-84d6-fd1e63b8dbc7

2021-03-25T15:44:52Z

Ružica.Tokalić:

{{Theme
|Theme Type=Good Practices
|Has Parent Theme=Theme:B14a910a-3bc4-40ff-a0e6-eb7119f51ed9
|Title=Balancing harms and benefits
|Is About=Every research project that involves humans should balance harms and benefits.
|Important Because=When considering any research project, the potential net benefit should outweigh the potential net harm. This is in line with the universally recognized ethical principles of beneficence (doing good) and non-maleficence (not doing harm). These two principles stem from the belief that human beings have inherent dignity, which was formalized in the UN Declaration of Human Rights.<ref>UN General Assembly. Universal Declaration of Human Rights. Accessed 28 May 2019. Available at: https://www.un.org/en/universal-declaration-human-rights/</ref> In biomedical research, harms will almost inevitably be experienced alongside benefits. That’s why it’s important to carefully assess how important the benefits are and under what cost. These dilemmas should always be communicated to research participants, to ensure fully informed consent.

A number of mid-20th century studies, such as the Tuskegee syphilis experiment, were conducted to examine the natural history of a disease by either deliberately exposing human subjects to damaging stimuli, or by not giving them effective treatment.<ref>Alsan M, Wanamaker M. Tuskegee and the health of black men. Q J Econ. 2018;133(1):407–455.</ref> These are some of the most prominent examples of disproportionate harm to benefit.
<references />
|Important For=All stakeholders in research; Research subjects; Ethics committee members; Principal investigators; PhD Students; Scientists
|Has Best Practice=The Belmont report, <ref>National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Accessed 28 May 2019. Available at: https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html</ref> the Declaration of Helsinki <ref>World Medical Association. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. JAMA. 2013;310(20):2191–2194.</ref> and similar ethical and legal documents were enacted by governing bodies and professional associations.
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|Is Flagged=true
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|Related To Theme=Theme:D44fd22a-ed5d-4120-a78b-8881747131fd
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{{Tags
|Has Virtue And Value=Respect; Honesty
|Has Good Practice And Misconduct=Informed consent; Balancing harms and benefits
|Related To Research Area=LS - Life Sciences; SH - Social Sciences and Humanities
}}

Theme:3a32df5c-e6e8-45f9-8132-434db3985a65

2021-03-25T14:55:40Z

Ružica.Tokalić:

{{Theme
|Theme Type=Good Practices
|Has Parent Theme=Theme:2268825c-a874-4dd7-b302-4af6b0e55b36
|Title=Peer review card game
|Is About=The peer review card exchange game was developed by researchers from the University of Split School of Medicine as a hands-on training session for a summer school on peer review. <ref>Peer review card exchange game, available at: http://europeanscienceediting.eu/articles/a-peer-review-card-exchange-game/</ref> It is an educational tool designed to inform young researchers about integrity in peer review. The game is free to use, and available [http://europeanscienceediting.eu/articles/a-peer-review-card-exchange-game/ here].
<references />
|Important Because=Peer review is an important part of scientific process, because it identifies both quality and possible flaws in submitted research, and offers room for improvement. However, the peer review process is not perfect, and is susceptible to a number of conflicts, dilemmas and insecurities. <ref>Hames I. Peer review at the beginning of the 21st century. Science Editing. 2014;1(1):4-8</ref><ref>Csiszar A. Peer review: Troubled from the start. Nature. 2016;532(7599):306-8. Epub 2016/04/26.</ref>
<references />
|Important For=Students; phd students; Supervisors; Postdocs; Reviewers
|Has Best Practice=The use of card exchange games is an approach used in teaching the philosophy of science. It was developed by Bergquist and Phillips in 1975 and later popularized by Cobern. <ref>Cobern WW. Introducing teachers to the philosophy of science: The card exchange. Journal of Science Teacher Education. 1991;2(2):45-6.</ref> The idea of card games is to foster dialogue between participants about statements written on cards, and such games have been effective in improving students’ knowledge.

In the peer review card exchange game, six different domains of peer review are explored by different statements written on cards. Participants can agree or disagree with the statements, but they are asked to discuss them and reach a consensus as a group. The explored domains are: responsiveness, competence, impartiality, confidentiality, constructive criticism and responsibility to science. Participants have to find which cards they all agree on. After that, they participate in a moderated discussion.
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|Has Reference=a
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{{Tags
|Has Timepoint=2018
|Has Location=Croatia
|Has Virtue And Value=Respect; Honesty; Reliability; Accountability
|Has Good Practice And Misconduct=Peer review; Publication Ethics
}}

User:Ružica.Tokalić

2021-03-25T14:55:24Z

Ružica.Tokalić: create user page