Vulnerability in Health Research

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Vulnerability in Health Research

  1. 1. Ghaiath M. A. Hussein MBBS, MHSc. (Bioethics)
  2. 2. <ul><ul><li>What is vulnerability? </li></ul></ul><ul><ul><li>Who is considered vulnerable? </li></ul></ul><ul><ul><li>Ethical considerations (Risk/Vulnerability Matrix) </li></ul></ul><ul><ul><li>Practical points </li></ul></ul>
  3. 4. <ul><ul><li>Vulnerable: “Vulnerable persons are those who are relatively (or absolutely) incapable of </li></ul></ul><ul><ul><li>protecting their own interests. More formally, they may have insufficient power, intelligence, education, resources strength, or other needed attributes to protect their own interests.” (CIOMS, 2002) </li></ul></ul>
  4. 5. Making use of this definition… let’s brainstorm! www.amanet-trust.org
  5. 6. <ul><li>1. WOMEN </li></ul><ul><ul><li>Women in the reproductory age group are usually excluded in drug/vaccine studies where the possible effects on foetus are not known. </li></ul></ul><ul><ul><li>As justice to women, their health conditions should be addressed through involving them in research. </li></ul></ul><ul><ul><li>Types of research that benefit women directly include, obstetrics and gynaecology, sexually transmitted infections, vitamin studies etc. </li></ul></ul>
  6. 7. <ul><li>2. PREGNANT WOMEN </li></ul><ul><ul><li>Should be awarded special protection because of additional health concerns during pregnancy and the risk of damage to the foetus. </li></ul></ul><ul><ul><li>pregnant women must be excluded from research unless the purpose is to meet the health needs of the mother, and </li></ul></ul><ul><ul><li>the foetus will be placed at risk only to the minimum extent necessary to meet such needs or </li></ul></ul><ul><ul><li>the risk to the foetus is minimal </li></ul></ul>
  7. 8. <ul><li>3. CHILDREN </li></ul><ul><ul><li>particularly vulnerable group. The major ethical issue for involving children is that parents are the primary decisions makers for their minor children. </li></ul></ul><ul><ul><li>there must be no undue inducement to participate for parent, guardian or child, although reimbursement of expenses is allowed. </li></ul></ul><ul><ul><li>A “small gift” to the child after completion of the research is however acceptable. </li></ul></ul>
  8. 9. <ul><ul><li>the purpose of the research is to obtain knowledge relevant to the health needs of children </li></ul></ul><ul><ul><li>a parent or legal representative of each child should give permission; </li></ul></ul><ul><ul><li>the agreement (assent) of each child has been obtained to the extent of the child`s capabilities; and </li></ul></ul><ul><ul><li>a child`s refusal to participate or continue in the research should be respected. </li></ul></ul>
  9. 10. <ul><ul><li>Minimal risk </li></ul></ul><ul><ul><li>Greater than minimal risk and with the prospect of direct benefit </li></ul></ul><ul><ul><li>Greater than minimal risk without the prospect of direct benefit to individual subjects, but likely to yield generalisable knowledge about the subjects disorder or condition. </li></ul></ul><ul><ul><li>Significant risk and special opportunity </li></ul></ul>
  10. 11. <ul><ul><li>Minimal Risk- risk in relation to normal experience of average, healthy normal children – daily life/routine physical psychological exams </li></ul></ul><ul><ul><li>Minimal Risk varies with age but not social status, illness or circumstances </li></ul></ul><ul><ul><li>Consultation with experts – paediatricians , social workers etc </li></ul></ul>
  11. 12. <ul><ul><li>Written Parental/Guardian consent only required for those below the “legal age” </li></ul></ul><ul><ul><li>Assumption : best interests of the child should be regarded </li></ul></ul><ul><ul><li>Both parents of the child should sign or just one? </li></ul></ul><ul><ul><li>Institutionalised children? </li></ul></ul><ul><ul><li>Children without any recognisable legal guardian? </li></ul></ul>
  12. 13. <ul><ul><li>After the age of 7 and below legal consenting age (which is different for different countries depending on regulations) those who are competent to understand the opinion of the child should be respected </li></ul></ul><ul><ul><li>“ A child’s affirmative agreement to participate in research. Mere failure to object should not be construed as assent” Silence Assent </li></ul></ul><ul><ul><li>Waiver of parental consent may be granted in adolescent research in certain circumstances i.e. drug abuse, sexual behaviour etc. </li></ul></ul><ul><ul><li>Assent documents may include – age appropriate information sheets and forms where applicable </li></ul></ul>
  13. 14. <ul><li>4. MENTALLY ILL / MENTALLY HANDICAPPED PERSONS </li></ul><ul><ul><li>Is s/he capable of self-determination? </li></ul></ul><ul><ul><li>Respect for the immature and the incapacitated may require protecting them as they mature or while they are incapacitated (Belmont Report) </li></ul></ul><ul><ul><li>it is usually that informed consent will be provided by a surrogate/ legal representative of that person. </li></ul></ul><ul><ul><li>The golden rule for involving mentally ill or handicapped people is that ; The objections of these subjects to involvement should be honoured, unless the research entails pro-providing them a therapy unavailable elsewhere. </li></ul></ul>
  14. 15. <ul><li>5. THE ELDERLY </li></ul><ul><ul><li>Old age alone does not render a person incapable of consenting to health research. </li></ul></ul><ul><ul><li>In the absence of any indication to the contrary, elderly patients are generally assumed to be competent to consent to research. </li></ul></ul><ul><ul><li>However, consideration should be given to the possibility of mental deterioration, the ability to comprehend, and the dependence and vulnerability of the elderly </li></ul></ul>
  15. 16. <ul><li>6. PRISONERS </li></ul><ul><ul><li>Prisons are organisational structures exacerbate vulnerability of the incarcerated individuals. </li></ul></ul><ul><ul><li>They have limited economic power, inadequate protection of human rights, limited availability of health care and treatment options. </li></ul></ul><ul><ul><li>The prison structure makes the incarcerated prisoners confined, stressed, crowded, psychologically devastated with symptoms such as psychosis, severe depression, and complete social withdrawal. </li></ul></ul>
  16. 17. <ul><li>7. CAPTIVE/D ISPLACED/RETURNING POPULATIONS </li></ul><ul><ul><li>Have constrained movements and choices </li></ul></ul><ul><ul><li>refugees, those in police custody, and displaced population, </li></ul></ul><ul><ul><li>hospitalised patients, students, institutionalised persons and military personnel. </li></ul></ul><ul><ul><li>readily available for research activities for extended periods, enhancing their attractiveness to research enterprise. </li></ul></ul><ul><ul><li>Researchers should always have to be sure if participant’s decision making capacity is not compromised. </li></ul></ul>
  17. 18. <ul><ul><li>nature and degree of risk, </li></ul></ul><ul><ul><li>the condition of the particular population involved, and </li></ul></ul><ul><ul><li>the nature and level of the anticipated benefits. </li></ul></ul><ul><ul><li>Relevant risks and benefits must be thoroughly arrayed in documents and procedures used in the informed consent process </li></ul></ul>
  18. 20. <ul><ul><li>Vulnerability is considered to offer better protection, not to stop research on the vulnerable </li></ul></ul><ul><ul><li>Vulnerable groups should not be denied their right to participate in relevant research </li></ul></ul><ul><ul><li>The risk assessment varies with the degree of vulnerability </li></ul></ul>
  19. 21. Discussion… Q & A

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