Seminar on ethics committee, cultural concerns

Research Methodology and Biostatistics

1. Ethics Committee, cultural concerns and true telling. Prepared By :priyanka dinkar tambe. S.Y.M.Pharm (Pharmaceutics) Roll No : PH213 Subject: Research Methodology and Biostatics. Guided By : Mrs. Sunita A Kale. Assist Prof. Pharmaceutics Department.

2. CONTENTS Ethics Committee Cultural Concerns True Telling References.

3. Ethics committee: An ethics committee is a group of peoples responsible for ensuring that medical experimentation and human research are carried out in an ethical manner and accordance with law. Ethics committee members usually represent major clinical services and other stakeholders in health care delivery. Therefore , it is not uncommon for committee members to include clinicians (physicians and nurses ) from medicine , surgery and psychiatry, social workers, chaplains and community representatives. Institutional review board = Ethics committees.

4. Ethics Committee at a glance

5. Ethics committee have some important points as: The Medical Research and Ethics Committee (MREC) is guided in its reflection , advice and decision by the ethical principles expressed in the Declaration of Helsinki (2013). The MREC Seeks to be appropriately informed by researchers and target populations of the impact of the research it has approved. When so requested by institute heads, ethics review committees shall assess research proposals considering both ethical and scientific perspectives ,and provide written evaluation on how the proposal complies with these guidelines and other research methodologies . Ethics review committees shall be organized in a manner that assures fair and unbiased reviews, taking into account and representing the interdisciplinary and pluralistic viewpoints of committee members from various backgrounds . Members of ethics review committees shall not disclose confidential information obtained in the review process without appropriate reason either during and their tenure.

6. Research Ethics Committee

7. Committee members who have conflicts of interest related to research proposal should not be involved in the review process . This restriction ,however ,shall not prevent such members from attending the committee or giving an account of the proposals when requested . Procedures of the review process, the names and credentials of members, and a summary of the review discussion should be disclosed to the public. However, confidential information pertaining to the rights and privacy of study subjects and any intellectual property rights associated with the research proposal may remain confidential. Ethics review committees may include a provision in their regulations agendas and procedures allowing the institute heads the option to delegate review of the proposal ,with respect to its adherence to these Guidelines and other methodology issues , to an alternative ethics review committee or appropriate academic body.

8. Ethics review committees may include a provision in their regulations and procedure allowing for a summary review for minor agendas conducted , for example ,by a single member of the committee appointed by a committee chairperson. These summary reviews should be provided to all other committee members. Minor agendas which are eligible for summary review are generally defined as : 1.Minor alterations in research proposals. 2. Review of a research proposal to be conducted as part of a collaborative study , when ethics review committee approval is already given by the principal investigator of institute. 3.Review of a research proposal that dies not exceed minimal risk for subjects in the study .Minimal risk refers to risks within the normal range of physical ,psychological and social hazards likely encountered in daily living or routine medical exams, and which are socially acceptable .

9. Cultural Concerns: A cultural concern is a rule or expectation in any culture that prevents someone, from outside of that culture, from being included or participating equally. Culture can be defined as the language ,behaviour, customs, values and beliefs that a particular culture , race or country holds. Two of the most common cultural barriers are language and religion.

10. Clinical staff as nurses today are providing care, education ,and case management to an increasingly diverse patient population that is challenged with a triad of cultural, linguistic, and health literacy barriers . For such patients ,culture and language set the context for the acquisition and application of health literacy skills. How to remove some common cultural barriers in the workplace. 1. Do the work of learning for patients behaviour/ culture. 2. Acknowledge the difference between patient need and medical preference. 3. Learn about different cultures.

11. True Telling: Truth telling ,or veracity ,can be defined as the avoidance of lying ,deception ,misrepresentation ,and non disclosure in interactions with patients or relevant to patient care. Being honest with patients about their diagnosis is relatively new addition to the ethics of health care. Until recently ,doctors often avoided telling patients the full extent of serious diagnosis, particularly when there were limited treatment options . In addition ,in some cultures ,it is customary to hide a serious diagnosis from the patient for fear that he or she will lose hope or become demoralized by the truth telling .

12. Truth- telling also involves being forthright about medical errors. Many ethicists argue that the primary physician and observing members of a medical team all have an obligation to report errors not only to oversight committees but directly to the affected patient .This is not always easy to do- particularly when the mistakes harm patients and their families, when it is not obvious that telling the patient will improve the situation, and when the stakes for admitting errors are high . However , physicians have an obligation to report errors and to support colleagues who do so . Only then it is possible to recognize errors when they occur and to develop systems for avoiding the problems in the future.

13. One exception involves the patient who directly tells the physician that he/she does not want to receive any information regarding his /her diagnosis .In this case ,it is ethical to withhold information because the patient does not wish to receive it, thereby upholding patient autonomy, or free will to decide. One must never suppose that the patient prefers nondisclosure, but rather one must ascertain these wishes through direct conversation with the patient. This can be achieved by asking the patient how wishes through direct conversation with the patient .This can be achieved by asking the patient how wishes to receive the information before the test result even arrive ,their by allowing both the patient and physician to plan the logistics of breaking possible bad news ahead of time . Another exception involves a mentally unstable patient who may put himself / herself in harm´s way after receiving the bad news .In this example ,a doctor may be justified in delaying the disclosure of information until after the patient ´s mental health improves and the patient posses appropriate

14. REFERENCE A book of research methodology and biostatics by Dr Vinod Kumar Bias Page no 198 to 200. A book of Research Ethics committee by World Health Organisation page no 31-37.

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