Vulnerable groups .pptx
•Download as PPTX, PDF•
0 likes•2,324 views
The word Vulnerability is derived from a Latin verb “vulnerare” which means “to cause damage or injury”. vulnerability refers to “the tendency of something to be damaged. The Oxford English Dictionary defines “vulnerability” as “the quality or state of being exposed to the possibility of being attacked or harmed, either physically or emotionally. Vulnerable groups are physically, mentally, or socially disadvantaged persons who may be unable to meet their basic needs and may therefore require specific assistance. Refer to segments of the population that are more susceptible to experiencing harm, discrimination, or disadvantage due to various factors such as their social, economic, geographic location, or physical circumstances. These groups may face increased risks, have limited access to resources or opportunities, and require specific support and protection to ensure their well-being and equal participation in society. Vulnerable groups can vary across different contexts, but some common examples include children, elderly, persons with disabilities, women and girls, ethnic and racial minorities, immigrants and migrants, refugees and displaced persons etc. It is important to note that these groups are not mutually exclusive, and individuals can belong to multiple vulnerable groups simultaneously. Persons who are relatively or absolutely incapable of protecting their own interests. They may have insufficient power, intelligence, resources, strength or other needed attributes to protect their own interests through informed consent. limited capacity or freedom to give or decline consent. Each person when measured against the highest standards of capability is relatively vulnerable.
Recommended
More Related Content
What's hot
What's hot (20)
Similar to Vulnerable groups .pptx
Similar to Vulnerable groups .pptx (20)
More from University of Gondar
More from University of Gondar (20)
Recently uploaded
Recently uploaded (20)
Vulnerable groups .pptx
- 1. UNIVERSITY OF GONDAR COLLAGE OF MEDICINE AND HEALTH SCINCES DEPARTMENT OF OPTOMETRY Medical ethics presentation on vulnerable groups By Seblework Adugna and Getachew Kassahun FEBRUARY, 2023 GONDAR, ETHIOPIA 1 11/16/2023
- 2. Objectives • At the end of this session you are expected to: Define vulnerability and identify vulnerable groups Understand causes of vulnerability Explain about protection of special populations Identify mitigation procedures to protect vulnerable groups. 11/16/2023 2
- 3. Outline Definitions of vulnerability Causes of Vulnerability Challenges of Identifying Vulnerability and Vulnerable Groups Lists of Vulnerable groups Informed Consent Protection of special populations Mitigating Procedures for Protection of Vulnerable Subjects 3 11/16/2023
- 4. Definition The word Vulnerability is derived from a Latin verb “vulnerare” which means “to cause damage or injury”. vulnerability refers to “the tendency of something to be damaged. The Oxford English Dictionary defines “vulnerability” as “the quality or state of being exposed to the possibility of being attacked or harmed, either physically or emotionally. Vulnerable groups are physically, mentally, or socially disadvantaged persons who may be unable to meet their basic needs and may therefore require specific assistance. 4 11/16/2023
- 5. Causes of Vulnerability • Serious Health Conditions: Subject is not in a condition to understand the procedure or give consent due to unconsciousness or trauma • Inability to make decision: Not able to make decision due to cognitive disability or lack of communicative inability • Economic: Patients who do not have proper resources to get proper care 5 11/16/2023
- 6. Challenges of Identifying Vulnerability and Vulnerable Groups 1.Defining vulnerability is difficult - vulnerability can stem from external shocks and it also depends on historical, cultural, social, environmental, political, and economic conditions of a given setting. 2) Determinants of vulnerability range from socioeconomic status and living conditions to the power structures that underpin social organization. 3) No universally accepted approach for measuring vulnerability. 4) Vulnerability is dynamic with evolving changes and heterogeneous even with the same vulnerable group 6 11/16/2023
- 7. 5.There is no inclusive process of engaging relevant stakeholders especially lack of engagement of local communities. 6) Lack of aggregated data – ex) population statistics 7) Insufficient technical skills and resources in capturing inequality and social injustice – this puts vulnerable groups at even greater risk of falling further behind. Challenges of Identifying Vulnerability and Vulnerable Groups 7 11/16/2023
- 8. Who are vulnerable groups? 8 11/16/2023
- 9. Who are vulnerable groups?... • Persons who are relatively or absolutely incapable of protecting their own interests. • They may have insufficient power, intelligence, resources, strength or other needed attributes to protect their own interests through informed consent. • limited capacity or freedom to give or decline consent. • Each person when measured against the highest standards of capability is relatively vulnerable. 9 11/16/2023
- 10. Vulnerable groups WHO considers children, pregnant women, elderly people, malnourished people and ill people are particularly vulnerable. United Nations High Commission for Refugees (UNHCR,2005) identified women, survivors of violence, people with physical or mental disabilities and ethnic minorities as vulnerable groups. 10 11/16/2023
- 11. Vulnerable groups Infants Children Disabled individuals Elderly and frail Child Abuse/ Neglect Domestic Violence Sexual Assault/Abuse 11/16/2023 11 Comatose patients Patients on mechanical ventilation Substance Abuse Mental Retardation Patient in crisis
- 12. Kinds of Vulnerability Kinds of Vulnerability Sample Vulnerable Population Cognitive or communicative Children, fetuses, decisionally impaired, seriously ill Institutional or deferential Prisoners, students, employees Medical Terminally or incurably ill patients Economic Impoverished populations Social Racial, ethnic, sexuality minorities 12 11/16/2023
- 13. Involvement of Vulnerable Subjects • The proposed involvement of hospitalized patients, other institutionalized persons, or disproportionate numbers of racial or ethnic minorities or persons of low socioeconomic status should be justified. 13 11/16/2023
- 14. Special Populations Fetuses, pregnant women and human In-vitro fertilization (IVF) Prisoners Children 14 11/16/2023
- 15. Uncomprehending Subjects Persons unable to understand and cooperate may defeat purpose of the research or harm themselves Includes: • Mentally retarded • Uneducated • Senile -having the weakness or disease of old • Linguistically disadvantaged • Inebriated / intoxicated • Unconscious 15 11/16/2023
- 16. Sick Subjects • Illness is indicative of the disturbance of the capacity to perform roles and tasks effectively • Types: • Persons with prolonged chronic illness – more prone to take risks to gain relief, even if remote • Depressed persons • Suffering persons • Emergency cases • Hospitalized patients • Dying 16 11/16/2023
- 17. Dependent Subjects • Dependence by virtue (asset, good quality, good feature …) of relationship with investigator • Types of dependence: – Administrative availability – patients, students, employees, prisoners, etc. – Threatened relationships – fear of jeopardizing (put in danger) relationships if they refuse to participate – Poor subjects – unable to secure money by ordinary means 17 11/16/2023
- 18. Minority Groups Determined by age, race, sex, ethnicity, etc. Culturally different – indigenous peoples Elderly – Ageism - deep and profound prejudice (injustice) against the elderly 18 11/16/2023
- 19. Subjects in Unusual Circumstances • Sexual abuse / rape victims • Domestic violence victims • HIV-AIDS / STD cases • Victims of war 19 11/16/2023
- 20. Use of vulnerable persons Not forbidden by ethical codes or regulations Need for justification for their inclusion • Unsuitability of less vulnerable populations • Use of mitigation (easing) to address vulnerability 20 11/16/2023
- 21. Informed Consent • Upholds autonomy or respect for persons • Requires: • Legal capacity to give consent • Free power of choice, without undue force or coercion • Fiduciary relationship (duty to protect) between investigator and subject 21 11/16/2023
- 22. How Vulnerabilities May Compromise Consent ? Kinds of Vulnerability Possible Threat to Consent Cognitive or communicative Lack of understanding, appreciation or reasoning with consent information Institutional or deferential Difficulty saying no Medical May be desperate for a cure and use biased reasoning; cognitive deficits Economic May be unduly influenced Social May less information due to bias among IRBs or researchers; language barriers 22 11/16/2023
- 23. Protection of Special Populations Fetuses, pregnant women and human in virtro-fertilization o Appropriate studies on animals and non pregnant individuals have been conducted o Minimal risk o Investigators should have no part and no procedures introduced to terminate pregnancy or determine viability of fetus o No inducement (monetary, etc.) to terminate pregnancy 23 11/16/2023
- 24. Protection of Special Populations… • Prisoners IRB not related to prison One prisoner or prison representative in IRB No special privileges to prisoners recruited to the study Fair selection of prisoner subjects Risks commensurate to risks of non prisoners Information given in understandable language 24 11/16/2023
- 25. Protection of Special Populations… • Regular hospital patients should not be deprived of standards of care. • Determination of appropriate subject population related to risks in study intervention. • Use of less risky subjects if possible. • Vulnerability issues should take higher precedence than investigator convenience • Risk of washout periods should assessed. 25 11/16/2023
- 26. Protection of Special Populations… • Children • Permission of parents or guardians required • Children’s assent • Documentation of consent and assent • State wards may be included in research IRB approval Appointment of ward for the child 26 11/16/2023
- 27. Addressing Placebo Concerns Regulation of placebo controls • No permanent damage • Clinical equipoise • Access to available therapy after the study Undertaken under controlled circumstances • Limited period of time • Done in a hospital • Monitoring by physicians 27 11/16/2023
- 28. Mitigating Procedures for Protection of Vulnerable Subjects • Exclusion of vulnerable subjects. • Increased capacity of vulnerable subjects to give free consent • Improvement of quality of consent process. • Creative and innovative ways of giving information and improving comprehension. • Institutional policies regarding recruitment of patients, students, etc. • Careful calculation of fees paid to participants. 28 11/16/2023
- 29. Mitigating Procedures for Protection of Vulnerable Subjects… • Adherence to confidentiality rules. • Setting up physical structures to ensure protection of privacy • Debriefing procedures after data gathering • Counseling subjects at risks • Avoiding circumstances that will expose subjects to social risks or stigmatization during the research process 29 11/16/2023
- 30. 1. World Medical Association (WMA). Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, Seoul, Korea, October 2008. 2. International Ethical Guidelines for Health-related Research Involving Humans. Prepared by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with WHO. 3. GIZ, The Vulnerability Sourcebook: Concept and guidelines for standardized vulnerability assessments https://www.preventionweb.net/files/38849_38849vulnerabilitysourcebookguideli.pdf References 30 11/16/2023
- 31. 31 11/16/2023
Editor's Notes
- Underpin support, justify, or form the basis for.
- : Having spatially distributed demographic data helps quantifying the population at risk of or affected by a disaster.
- National Bioethics Advisory Commission
- Informed Consent and Assent Process and Forms “Informed consent” is the voluntary agreement of an individual, or his or her authorized representative, who has the legal capacity to give consent, and who exercises free power of choice without any form of constraint or coercion to participate in research. Consenting is a process where the researcher clearly communicates the risks and benefits of the study, the voluntary nature of participation in the study, and the expectations from the subject if they agree to participate in the study. Informed consent is a conversation between the researcher and potential research participants, and the consent form is a record of this conversation. “Assent” is a term used to express willingness to participate in research by persons who are by definition too young to give informed consent but are old enough to understand the proposed research in general, its expected risks and possible benefits, and the activities expected of them as subjects. Assent by itself is not sufficient, however. If assent is given, informed consent must still be obtained from the subject’s parents or guardian. A person 18 years and older are considred adult and therefore one who can provide consent without parental permission. Informed consent is not a single event or just a form to be signed – rather, it is an educational process that takes place between the investigator and the prospective subject. The informed consent and assent process is usually documented with a consent form and an assent form signed by the research participant and/or read to the research participant. In certain cases, documentation of consent may be waived and an information sheet used instead.
- In vitro fertilization (IVF) is the joining of a woman's egg and a man's sperm in a laboratory dish. In vitro means outside the body. Fertilization means the sperm has attached to and entered the egg. Description Normally, an egg and sperm are fertilized inside a woman's body. If the fertilized egg attaches to the lining of the womb and continues to grow, a baby is born about 9 months later. This process is called natural or unassisted conception. IVF is a form of assisted reproductive technology (ART). This means special medical techniques are used to help a woman become pregnant. It is most often tried when other, less expensive fertility techniques have failed. There are five basic steps to IVF: Step 1: Stimulation, also called super ovulation Medicines, called fertility drugs, are given to the woman to boost egg production. Normally, a woman produces one egg per month. Fertility drugs tell the ovaries to produce several eggs. During this step, the woman will have regular transvaginal ultrasounds to examine the ovaries and blood tests to check hormone levels. Step 2: Egg retrieval A minor surgery, called follicular aspiration, is done to remove the eggs from the woman's body. The surgery is done in the doctor's office most of the time. The woman will be given medicines so she does not feel pain during the procedure. Using ultrasound images as a guide, the health care provider inserts a thin needle through the vagina into the ovary and sacs (follicles) containing the eggs. The needle is connected to a suction device, which pulls the eggs and fluid out of each follicle, one at a time. The procedure is repeated for the other ovary. There may be some cramping after the procedure, but it will go away within a day. In rare cases, a pelvic laparoscopy may be needed to remove the eggs. If a woman does not or cannot produce any eggs, donated eggs may be used. Step 3: Insemination and fertilization The man's sperm is placed together with the best quality eggs. The mixing of the sperm and egg is called insemination. Eggs and sperm are then stored in an environmentally controlled chamber. The sperm most often enters (fertilizes) an egg a few hours after insemination. If the doctor thinks the chance of fertilization is low, the sperm may be directly injected into the egg. This is called intracytoplasmic sperm injection (ICSI). Many fertility programs routinely do ICSI on some of the eggs, even if things appear normal. Watch this video about:Intracytoplasmic sperm injection Step 4: Embryo culture When the fertilized egg divides, it becomes an embryo. Laboratory staff will regularly check the embryo to make sure it is growing properly. Within about 5 days, a normal embryo has several cells that are actively dividing. Couples who have a high risk of passing a genetic (hereditary) disorder to a child may consider pre-implantation genetic diagnosis (PGD). The procedure is most often done 3 to 5 days after fertilization. Laboratory scientists remove a single cell or cells from each embryo and screen the material for specific genetic disorders. According to the American Society for Reproductive Medicine, PGD can help parents decide which embryos to implant. This decreases the chance of passing a disorder onto a child. The technique is controversial and not offered at all centers. Step 5: Embryo transfer Embryos are placed into the woman's womb 3 to 5 days after egg retrieval and fertilization. The procedure is done in the doctor's office while the woman is awake. The doctor inserts a thin tube (catheter) containing the embryos into the woman's vagina, through the cervix, and up into the womb. If an embryo sticks to (implants) in the lining of the womb and grows, pregnancy results. More than one embryo may be placed into the womb at the same time, which can lead to twins, triplets, or more. The exact number of embryos transferred is a complex issue that depends on many factors, especially the woman's age. Unused embryos may be frozen and implanted or donated at a later date.
- What is the Institutional Review Board (IRB)? The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The IRB is charged with the responsibility of reviewing, prior to its initiation, all research (whether funded or not) involving human participants. The IRB is concerned with protecting the welfare, rights, and privacy of human subjects. The IRB has the authority to approve, exempt, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy. The IRB shall have at least five members of varying backgrounds in order to provide complete and adequate review of human research and its institutional, legal, scientific, and social implication
- Before taking part in a clinical trial, they are asked for their assent. Assent means that they agree to take part. They may also dissent, which means they do not agree. Unlike informed consent, assent is not always required by law, though IRBs may require it.
- Equipoise a situation in which things are perfectly balanced
- Confidentiality is one of the core duties of medical practice. It requires health care providers to keep a patient's personal health information private unless consent to release the information is provided by the patient.