Legal and Ethical Issues in Research PDF

LEGAL & ETHICAL ISSUES IN RESEARCH GROUP 3  LIST OF CONTENTS Honesty and Introduction Confidentiality Objectivity Integrity Intellectual Conclusion Plagiarism Au...

LEGAL & ETHICAL ISSUES IN RESEARCH GROUP 3  LIST OF CONTENTS Honesty and Introduction Confidentiality Objectivity Integrity Intellectual Conclusion Plagiarism Authorship Property  INTRODUCTION Researchers are tasked with ensuring that their work adheres to established legal frameworks and ethical guidelines, balancing the quest for innovation with respect for human dignity, privacy, and fairness. That’s Why, It’s vital to adhere LEGAL AND ETHICAL ISSUES HONESTY & INTEGRITY  HONESTY Honestly report data, results, methods and procedures, and publication status. Do not fabricate, falsify, or misrepresent data. HONESTY VS TRUTH ?? HOW DO THEY DIFFER ? ADDING KAALAMAN! Truth is about the correctness or validity of information, while honesty is about the ethical practice of presenting information sincerely, even if it involves admitting mistakes or ignorance  INTEGRITY Keep your promises and agreements; act with sincerity; strive for consistency of thought and action.  EXAMPLE Example of Integrity in Research A researcher discovers an error in their data analysis after publishing a paper. Instead of ignoring the mistake to preserve their reputation, they voluntarily issue a correction or retract the paper if necessary. This act demonstrates research integrity by prioritizing the truth and scientific reliability over personal interests.  Consequences of Failing to Uphold Honesty and Integrity in Research  Loss of Credibility and Trust Falsified or misrepresented data can damage the researcher’s, institution's, and scientific community’s credibility, undermining public trust in research. Harm to Participants Misleading research can harm participants, leading to health complications or even death. Legal Consequences Dishonesty can lead to lawsuits, fines, or penalties for breaching intellectual property, confidentiality, or engaging in fraud ‘’Honesty and integrity in research not only protect the value of knowledge but also uphold the trust that drives scientific progress and discovery."  REFERENCES Mba, C. C. M. (2023, February 9). Honesty, Objectivity, Transparency, Responsibility & Accuracy the 5 tenets of Research Integrity. https://www.linkedin.com/pulse/honesty- objectivity-transparency-responsibility-5-claudio APA PsycNet. (n.d.). https://psycnet.apa.org/record/2008-03308- 004#:~:text=Ethical%20issues%20involve%20rules%20or,community%2C%20state%2 C%20or%20country. An overview of the legal and ethical issues in healthcare | StPatrick. (n.d.). StPatrick. https://www.st-patricks.ac.uk/blog/posts/2019/october/an-overview-of-the-legal-and- ethical-issues-in-healthcare/ CONFIDENTIALiTY  CONFIDENTIALITY Any information relating to the private sphere of a person that they wish not be shared with others is considered ‘confidential’, (Bos, 2020). The obligation of researchers to protect the personal information and data of research participants. Confidentiality is rooted in trust.  SECURING CONFIDENTIALITY A. Informed Consent Most important instrument for securing confidentiality It is based on the principles that participation in research should not negatively impact participants, respect their fundamental rights, and honor their bonds, relationships, and commitments. INFORMED CONSENT TYPICALLY NOTIFIES THE PARTICIPANT OF THE FOLLOWING ITEMS: Name(s) and affiliation of researcher(s) Goal or aim of the research (in comprehensible language) Research techniques or procedures to which the participant is subjected Risks involved (if any) Estimate of time investment Agreement on compensation (if any) Conditions of confidentiality (anonymization or pseudonymization) Storage, usage, and access to data Rights of the participant: - to withdraw at any moment - to review/correct erroneous data (if possible) - to receive/be informed about the results (if interested) Complaint procedures (including contact details of an independent commission or officer)  SECURING CONFIDENTIALITY B. Difficulties with Informed Consent Informed consent is based on Western ideals of autonomy, which may not be universally applicable. Vulnerable groups may lack the capacity or autonomy to fully understand or freely consent. PRIVACY, CONFIDENTIALITY, ANONYMITY Confidentiality pertains to data. Privacy pertains to people. Anonymity pertains to the relationship between the data and the participant's.  BREACHES OF CONFIDENTIALITY Occurs when a fundamental component of the researcher-participant agreement is broken, or when the researcher's duty to ensure that their research respects the participant's autonomy and dignity is not met.  A. CULPABLE BREACH OF CONFIDENTIALITY In cases where participants' private, sensitive, or identifying information is disclosed without their consent and has detrimental effects on the individual (or the community), the researcher may be held accountable if they had the opportunity to stop this from occurring. B. JUSTIFIABLE BREACH OF CONFIDENTIALITY If the researcher is forced to do so by circumstances, there may be a valid reason to reveal private or sensitive information without consent. This can be seen, for instance, if a third party might be put in danger now or in the future if certain information were kept secret.  C. ENFORCED BREACH OF CONFIDENTIALITY There are only a few circumstances that could force a scientist to breach confidentiality. One of those is the enforcement of state regulations. D. WAIVER OF CONFIDENTIALITY Finally, we take into account situations in which participants themselves want to be identified or give up their right to confidentiality. In theory, these would be agreements to waive confidentiality rather than violations of confidentiality. REFERENCES Bos, J. (2020). Confidentiality. In Springer eBooks (pp. 149–173). https://doi.org/10.1007/978-3-030-48415-6_7 The SAGE Handbook of Interview Research. (n.d.). Google Books. https://books.google.com.ph/books? hl=en&lr&id=VCFsZsvZdwkC&oi=fnd&pg=PA457&dq=confidentiality+i n+research&ots=aSUjIvOuG9&sig=tNxgd_ezA1wt_APuZt5eu-K7- 1M&redir_esc=y&fbclid=IwY2xjawG5d1RleHRuA2FlbQIxMAABHRwI_u O41_2WcITUvIhcnrZTL_Y8fVBvSzm2eCjiUZb09m9WP8rLIA75oQ_ae m_SIEFHwzEWBs3da_VCIZZ6g#v=onepage&q=confidentiality%20in %20research&f=false OBJECTIVITY IN RESEARCH Objectivity in research, particularly within bioethics, is defined as the pursuit of knowledge that is free from personal biases and subjective influences. Misconduct, such as data manipulation and misrepresentation, undermines research integrity and public trust. Ethical conduct requires accurate and honest data reporting, as emphasized by professional codes of conduct (Marco & Larkin, 2000). Ensuring objectivity in research is a fundamental ethical obligation for researchers. 1. Researchers should avoid bias in experimental design, data analysis, and interpretation of results. 2. Researchers must be committed to truthfulness in all aspects of research, to make sure that findings are reported accurately and honestly (Barnhart, 2023). 3. Researchers should avoid bias in experimental design, data analysis, and interpretation of results. AUTHORSHIP plagiarism  PLAGIARISM is the act of taking someone else's ideas, words, processes, or results without giving them the proper credit. It's a concern in both scientific and academic research communities.  TYPES OF PLAGIARISM DIRECT SELF PLAGIARISM PLAGIARISM ACCIDENTAL MOSAIC PLAGIARISM PLAGIARISM Authorship  AUTHOR The author is the creator of the original expression in a work.  AUTHORSHIP The state or condition of being the person who wrote a specific book, article, play, etc. (Cambridge Dictionary, n.d.).  AUTHORSHIP In academic settings, authorship typically refers to the individuals who contribute to the research and writing of a scholarly article, paper, or book.  AUTHORSHIP The order of authors often indicates the degree of contribution.  AUTHORSHIP In bioethics, authorship gives credit to those who contribute to research, writing, and developing ethical perspectives on scientific and healthcare issues.  IMPORTANCE OF AUTHORSHIP It not only acknowledges a person’s intellectual contribution but also plays a role in career advancement, such as promotions, tenure, and securing funding. In bioethics, authorship is particularly important because it recognizes contributions to crucial ethical discussions and decisions in science, healthcare, and policy.  THE TREND IN MULTIPLE AUTHORSHIP IN BIOETHICS Increase in Authorship: There has been a noticeable increase in the number of authors per paper in various fields, including bioethics. A study by Borry et al. (2006) showed that from 1990 to 2003, the average number of authors per bioethics paper increased from 1.46 to 1.85. This increase is mainly attributed to the rise in empirical research, which often requires more collaborative efforts.  ETHICAL ISSUES IN MULTIPLE AUTHORSHIP Fairness in Authorship: The ethical issue arises when people who have not made substantial contributions are still credited as authors, which may lead to inflated academic records for individuals who did not do enough to earn that recognition.  ETHICAL ISSUES IN MULTIPLE AUTHORSHIP Accountability in Authorship: Accountability becomes more complex with multiple authors. When errors or misconduct occur in multi-author papers, it can be difficult to assign responsibility.  GUIDELINES FOR ETHICAL AUTHORSHIP ICMJE Guidelines: The International Committee of Medical Journal Editors (ICMJE) According to these guidelines, authorship should be based on substantial contributions in three key areas:: conception and design of the study, data acquisition or analysis, and manuscript drafting and revision. Authors must also approve the final version of the manuscript.  GUIDELINES FOR ETHICAL AUTHORSHIP Application to Bioethics: While ICMJE guidelines are widely used for empirical research, they can also be adapted for bioethics. For bioethics research, particularly conceptual papers, guidelines should be based on contributions like formulating arguments, analyzing ethical issues, and drafting and revising the paper. This is different from empirical research, which requires more direct involvement with data collection and analysis. REFERENCES Resnik, D. B., & Master, Z. (2011). Criteria for authorship in Bioethics. The American Journal of Bioethics, 11(10), 17–21. https://doi.org/10.1080/15265161.2011.603795 INTELLECTUAL PROPERTY  INTELLECTUAL PROPERTY Intellectual property (IP) refers to creations of the mind, such as inventions; literary and artistic works; designs; and symbols, names and images used in commerce. TYPES OF INTELLECTUAL PROPERTY COPYRIGHT TRADEMARK PATENT GUESS IT TO WIN IT "Walang Kuskos Balungos" "Walang Kuskos Balungos"  Types of Intellectual Property  COPYRIGHT Copyright is a legal term used to describe the rights that creators have over their literary and artistic works.  TRADEMARK A trademark is a sign, symbol, or logo distinguishing goods or services of one entity from another. It protects brand identity and assures consumers of the source and quality.  REPUBLIC ACT NO. 8293 Also known as the Intellectual Property Code of the Philippines provides a comprehensive legal framework for the protection, regulation, and enforcement of intellectual property rights in the Philippines  SECTION 121. DEFINITION OF MARKS "A mark means any visible sign capable of distinguishing the goods or services of an enterprise."  SECTION 123. REGISTRABILITY. Section 123.1 "A mark shall be registered in the name of the person who has the right to use the mark in commerce, whether or not the mark is actually used in commerce at the time of application." SECTION 145 & 146. DURATION & RENEWAL OF REGISTRATION "Each registration shall remain in force for ten (10) years; Provided, that it is renewed within six (6) months before its expiration."  ETHICAL ISSUES Misleading Branding There are concerns when trademarks are used to misrepresent the efficacy of research-derived products.(Baker, 2015).  ETHICAL ISSUES Impact on Collaboration Trademarks can also create barriers to collaboration in academia and research. When research outputs are commercialized with exclusive branding, the open sharing of knowledge may be restricted, which is detrimental to scientific progress. Trademarks must be used ethically to balance commercialization with open access to scientific advancements (WIPO, 2023)  EXAMPLE CASE In Zuneca Pharmaceutical v. Natrapharm, Inc. (G.R. No. 211850, September 8, 2020), Zuneca used the trademark ZYNAPS for its drug, while Natrapharm registered ZYNAPSE for a different product. Natrapharm sued for trademark infringement, claiming confusion, while Zuneca argued it had prior use and accused Natrapharm of bad faith.  EXAMPLE CASE The Supreme Court ruled in favor of Natrapharm, stating that trademark ownership in the Philippines is based on registration, not prior use, and allowed both companies to continue using their marks due to their distinct product markets, reducing potential confusion  PATENT A patent is an exclusive right granted for an invention, allowing the patent holder to exclude others from making, using, or selling the invention without permission for a limited time. SECTION 21. PATENTABLE INVENTIONS "Any technical solution of a problem in any field of human activity which is new, involves an inventive step, and is industrially applicable shall be patentable."  SECTION 22. NON- PATENTABLE INVENTIONS "The following shall be excluded from patent protection: a) Discoveries, scientific theories, and mathematical methods; b) Schemes, rules, and methods of performing mental acts, playing games, or doing business, and programs for computers; c) Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body."  SECTION 54. TERM OF A PATENT "The term of a patent shall be twenty (20) years from the filing date of the application."  ETHICAL ISSUES Commodification of Life Patenting life forms, such as genetically modified organisms or human genes, raises ethical concerns. ex: The Diamond v. Chakrabarty case Critics argue this reduces life’s inherent dignity by treating it as property  ETHICAL ISSUES Access to Technologies Patents on medical innovations can restrict access to critical drugs and treatments, especially for low-income populations. ex: patenting of the BRCA1 and BRCA2 genes by Myriad Genetics This sparked legal challenges that culminated in a Supreme Court ruling in 2013, which invalidated Myriad’s gene patents  ETHICAL ISSUES Informed Consent Ethical concerns also arise when human tissues or biological samples are used in research without informed consent. ex: Moore v. Regents of the University of California case This raised questions about the ethics of patenting human biological material (California Supreme Court, 1990). CONCLUSION  WHAT TO TAKE NOTE IS........ Ethical and legal issues are vital in research because they ensure the protection of participants' rights, the integrity of the research process, and compliance with laws and professional standards  REFERENCES California Supreme Court. (1990). Moore v. Regents of the University of California. Retrieved from https://law.justia.com/cases/california/supreme-court/3d/51/120.html Republic of the Philippines. (1997). Republic Act No. 8293: Intellectual Property Code of the Philippines. Retrieved from https://www.officialgazette.gov.ph/1997/06/06/republic-act-no-8293/ Supreme Court of the United States. (1980). Diamond v. Chakrabarty. Retrieved from https://supreme.justia.com/cases/federal/us/447/303/ Supreme Court of the United States. (2013). Association for Molecular Pathology v. Myriad Genetics, Inc. Retrieved from https://www.supremecourt.gov/opinions/12pdf/12-398_1b7d.pdf World Intellectual Proprty Organization. What is Intellectual Property? Retrieved December 9, 2024 from https://www.wipo.int/about-ip/en/ THANK YOU