Ethical Issues in Patients’ Safety Practice &research
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Ethical Issues in Patients’ Safety Practice &research
- 1. Bioethical Issues in Patients’ Safety Practice & Research Ghaiath M.A. Hussein MBBS, MHSc. (Bioethics) Patients’ Safety Proposal Development Workshop July 29, 08
- 8. Part I Ghaiath Ethics of Pt. Safety, July 08.
- 21. Part II Ghaiath Ethics of Pt. Safety, July 08.
- 45. Before enrolling patients As part of the completed protocol, PI details safety monitoring plans and procedures including assessing, documenting, and reporting adverse events. PI sends to program officer or medical officer for approval. Program officer or medical officer review Does the PO or MO have concerns about patient safety? Yes, concerned PO or MO sends recommendations to the PI for collaborative revisions. No concerns Approval PO or MO approves safety plan and adverse event reporting plan. Patients may be enrolled once the trial meets all approval requirements. Needs IRB approval of complete protocol as well as approval by other parties such as the DSMB, FDA, and division regulatory staff. After peer review NIAID commits funds. During a clinical trial PO monitors compliance with monitoring plan and adverse event reporting requirements. IRB, FDA, and NIAID address DSMB and SAE reports PO must email or fax PI within 10 days and send official letter within 30 days of receipt. NIAID can terminate award or take other action if PI does not comply with monitoring plan. Serious adverse events PI provides reports of serious adverse events following NIAID Clinical Terms of Award Guidance . For multi-site trials, PI also sends DSMB summary reports to all IRBs and program officer. Last reviewed June 27, 2007 (jlg) Relevant Extramural SOP: Adverse Events Reporting Requirements Example of Clinical Trial Safety Monitoring and Reporting Requirements
- 47. Ghaiath Ethics of Pt. Safety, July 08.
Notas del editor
- When there is conflict of moral values , beliefs, and objectives e.g. between the health care providers and the patients. For instance, the classical example of blood transfusion to a severely bleeding Jehovah Witness who refuses to take blood, even this refusal can lead to severe life threat and eventually death. When there is conflict of commitments and responsibilities : for example at one hand there is the commitment of the health care provider to preserve his/her patients' lives, however there is the responsibility to "rationally" use the resources available to him/her on the other hand. The classical example of which is "one ICU bed, and two patients: whom to choose?" When there is the concern that our patients rights/values are not respected . When the issue in focus is related to justice in allocating the available resources . A classical example is which of the cancer drugs should be funded publicly. Should we choose a drug which efficiently improves the quality of life of few patients? Or a drug that makes little improvement for a larger number of patients. Finally, when we, as care providers feel that we are not sure what we should do .
- this is usually the hardest exercise, and commonly known in the bioethics literature as "moral reasoning". There are 10s of ethical approaches, theories, principles etc. to make a sound ethical/moral reasoning.
- Community care ethics is now being developed as a subset of this category;
- Prospective IC: This approach suffers from all the weaknesses associated with advance directives, and is rarely applicable to the conditions relevant to emergency research, such as sudden cardiac arrest or motor vehicle trauma.
- The easiest answer to overcome the ethics bore is to say, “ok. You’re talking about research ethics. This is not research”
- This protocol should be submitted for consideration, comment, guidance, and where appropriate, approval to a specially appointed ethical review committee, which must be independent of the investigator, the sponsor or any other kind of undue influence. This independent committee should be in conformity with the laws and regulations of the country in which the research experiment is performed.
- Incompetent: who is legally incompetent, physically or mentally incapable of giving consent or is a legally incompetent minor
- it is necessary during the study planning process to identify post-trial access by study participants to prophylactic, diagnostic and therapeutic procedures identified as beneficial in the study or access to other appropriate care.