Ethics in Biostatistics: Responsible Use of Data in Research PDF

Ethics in Biostatistics: Responsible Use of Data in Research Biostatistics for Pharmaceutical Sciences - PHRM 103 – Theory Department of Pharmacy Practice, College of Pharmacy, Taibah University 2024-1446...

Ethics in Biostatistics: Responsible Use of Data in Research Biostatistics for Pharmaceutical Sciences - PHRM 103 – Theory Department of Pharmacy Practice, College of Pharmacy, Taibah University 2024-1446 1  ‫بسم هللا الرمحن الرحمي‬ ‫اُه يِف الْ َ ريب َوالْ َب ْح ير َو َر َز ْقنَ ماُه يرم َن‬ ‫[ َولَ َق ْد َك َّر ْمنَا ب َ يِن آ َد َم َو َ َمحلْنَ ْم‬ ‫اُه عَ َ َٰل َك يث ٍري يرم َّم ْن َخلَ ْقنَا تَ ْف يض ايًل (‪])70‬‬ ‫ات َوفَضَّ لْنَ ْم‬ ‫ا َّلط ي ري َب ي‬ ‫(ا إلرساء‪)70:‬‬ ‫‪2‬‬  Introduction Why Ethics in Biostatistics? To maintain public trust, ensure valid conclusions from research, and support and maintain participant rights. ‫ اهمية األخالقيات في اإلحصاء الحيوي؟‬ ‫ ودعم وحماية حقوق‬،‫ وضمان استنتاجات صحيحة من األبحاث‬،‫للحفاظ على ثقة المرضى‬.‫المشاركين‬ 3  Ethical Principles in Biostatistics Respect for Persons: informed consent. Beneficence: Maximize benefits, minimize harm. 4  Ethical Principles in Biostatistics- continue Justice: Fairness in participant selection and benefits distribution. Integrity and Transparency: Honest reporting and responsibility. 5 Importance of Ethics in Biostatistics Prevent Misuse of Data: Protect against data fabrication or manipulation. Ensure Validity: Unethical practices compromise scientific credibility. Protect Participants: Safeguard confidentiality and informed consent. 6  Ethical Approval Ethical Approval: – All research involving human subjects must be approved by an (Institutional Review Boards)IRB or ethics committee ( ‫لجنة أخالقيات‬.)‫البحث العلمى‬ – Ensures study design minimizes risks and protects participants. 7  Informed Consent Informed Consent: Provide participants with study details, including purpose, risks, and rights. Ensure consent is voluntary, documented, and comprehensible. Ongoing Review: Ethical oversight continues throughout the research. 8  Data Collection Ethics Obtain Ethical Approval from Institutional Review Boards (IRBs). Use Informed Consent for participant inclusion. Avoid pressure or undue influence during recruitment. 9  Data Management Ethics Data Storage: Use encrypted and secure systems. Access Control: Restrict access to sensitive data. Anonymization: De-identify personal information (patient name, medical record number, phone number)) 10  Statistical Analysis Ethics Use appropriate statistical tools and methods. Avoid p-hacking (manipulating p-values for desired outcomes). Report assumptions and limitations of methods used. 11  Responsible Data Sharing Share data with transparency and reproducibility in mind. Ensure compliance with data privacy laws. Provide detailed metadata to support future analysis. 12  Common Ethical Violations in Biostatistics 1. Fabrication and Falsification: Inventing or altering data. 2. Selective Reporting: Publishing only favorable results. 3. Misleading Visualizations: Presenting data to exaggerate effects. 4. Ignoring Conflicts of Interest: Hiding financial or personal biases. 13  Ethical Guidelines in Biostatistics Declaration of Helsinki: Ethical principles for research involving humans. Belmont Report: Foundation for research ethics in the U.S. American Statistical Association (ASA) Guidelines: Standards for professional statisticians. 14  Challenges in Maintaining Ethical Standards Pressure to Publish: Leads to cutting corners. Data Misinterpretation: Lack of statistical literacy among collaborators. Emerging Issues: Ethical considerations for AI and big data analytics. 15  Example Scenario Description: A pharmacy researcher is conducting a study to evaluate the effectiveness of a new antihypertensive drug. The study compares patients taking the new drug to those taking a standard medication over six months. The researcher has received funding from the drug manufacturer. 16  Example-cont What Happened: 1.Data Exclusion: 1. The researcher excludes patients who experienced severe side effects from the new drug, justifying it as "outliers," to make the drug appear safer than it is. 2.Selective Reporting: 1. Only significant reductions in blood pressure (seen in a subgroup of younger patients) are reported, while results from older patients, which show no improvement, are omitted. 3.Falsifying Results: 1. The researcher alters some patient data to show a more significant reduction in blood pressure to meet the expectations of the funder. 4.Impact on Literature: 1. The manipulated results are published in a reputable journal, misleading healthcare providers and policymakers into believing the drug is highly effective and safe. 17  Example-cont Consequences: 1.Patient Harm: 1. Patients are prescribed the new drug based on false claims, leading to adverse effects and potentially worse health outcomes. 2.Erosion of Trust: 1. Colleagues, institutions, and the public lose trust in pharmacy research and the profession. 3.Ethical Violations: 1. The study violates ethical principles of transparency, honesty, and patient safety, leading to potential legal actions and retraction of the study. 18  Conclusion Ethical biostatistics is essential for scientific progress and public trust. Key responsibilities include data accuracy, confidentiality, and unbiased reporting. Let ethics guide every step of research. 19