Benefits & Risks in Research Involving Human Particpants


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  • These Nazi experiments included hypothermia experiments depicted in this slide whereby prisoners were submerged in a tank filled with cold water. The goal of this type of these experiments was to determine how long German pilots, who had to parachute into the cold north sea, would survive.
  • High altitude experiments were performed to test how long pilots would survive after being ejected from their planes. Prisoners were put into low-pressure tanks with little oxygen. Many of those who did not die immediately were put under water until they died. Autopsies followed. .
  • Benefits & Risks in Research Involving Human Particpants

    1. 1. Benefits & Risks in Research Involving Human Particpants Ghaiath M. A. Hussein MBBS, MHSc. (Bioethics)
    2. 2. Acknowledgment <ul><li>This presentation is based on presentations given by: </li></ul><ul><ul><li>Henry Silverman </li></ul></ul><ul><ul><li>Naeema Abdallah </li></ul></ul>
    3. 3. Outline of the presentation <ul><ul><li>What is meant by benefits? </li></ul></ul><ul><ul><li>Types of Benefit </li></ul></ul><ul><ul><li>What is risk? </li></ul></ul><ul><ul><li>What are the types of risk? </li></ul></ul><ul><ul><li>How to assess risk? </li></ul></ul>
    4. 4. Benefits <ul><ul><li>Benefits to research subjects </li></ul></ul><ul><ul><li>Benefits to society </li></ul></ul><ul><ul><ul><li>Specific new, effective intervention </li></ul></ul></ul><ul><ul><ul><li>Knowledge which some time in the future may lead to effective interventions </li></ul></ul></ul>
    5. 5. Benefits to Research Subjects <ul><ul><li>Direct Benefit </li></ul></ul><ul><ul><ul><li>arising from the intervention being studied </li></ul></ul></ul><ul><ul><ul><li>information that can influence care, e.g., diagnostic </li></ul></ul></ul><ul><ul><li>Collateral Benefit </li></ul></ul><ul><ul><ul><li>Also called “indirect” benefit </li></ul></ul></ul><ul><ul><ul><li>Arising from being a subject, even if one does not receive the experimental intervention </li></ul></ul></ul><ul><ul><ul><li>extra supervision from being in the research study (?) </li></ul></ul></ul><ul><ul><ul><li>access to medical care not available for economic reasons </li></ul></ul></ul><ul><ul><ul><li>unplanned or unanticipated benefits </li></ul></ul></ul>
    6. 6. Benefits to Research Subjects <ul><ul><li>Inspirational </li></ul></ul><ul><ul><li>Aspirational </li></ul></ul><ul><ul><ul><li>benefit to society (arises from the results of the study) </li></ul></ul></ul><ul><ul><li>Payments or incentives – benefits??? </li></ul></ul><ul><ul><li>Should not be considered as benefits </li></ul></ul><ul><ul><li>Inappropriately skew judgments concerning risks and potential benefits </li></ul></ul><ul><ul><li>Any level of research risk could be offset by such gains if they were significant enoug </li></ul></ul>
    7. 7. Benefits to Research Subjects <ul><ul><li>No benefits from the research </li></ul></ul><ul><ul><ul><li>Phase I trials testing maximum tolerated dose </li></ul></ul></ul><ul><ul><ul><li>Non-therapeutic research procedures </li></ul></ul></ul><ul><ul><ul><ul><li>Mechanism of disease </li></ul></ul></ul></ul>
    8. 8. Definition <ul><ul><li>Risk: </li></ul></ul><ul><li>Means any harm or injury that affect the subject or the participant under study. </li></ul><ul><ul><li>Risk: </li></ul></ul><ul><li>“ A state of uncertainty where some of the possibilities involve a loss, catastrophe, or other undesirable outcome. ” (1) </li></ul>
    9. 9. Types of risks <ul><ul><li>Physical risks: </li></ul></ul><ul><li>1.Cold: </li></ul><ul><li>As the Nazi Experiments used Tanks filled with cold water to submerge prisoners to determine how long German pilots would survive after parachuting into the cold North Sea. </li></ul>
    10. 10. Nazi Experiments
    11. 11. 2. Pressure: Low oxygen pressure as happened with the Nazi experiments when high altitude experiments where performed to test how long pilots would survive after being ejected from their planes.
    12. 12. High Altitude Experiments
    13. 13. 3. Heat: Heat stroke; Burn; Exhaustion 4.Noise: High noise may lead to impairment or loss of hearing 5. Light: Dim light may affect the vision
    14. 14. <ul><ul><li>Medical Risks: </li></ul></ul><ul><ul><li>Therapeutics: </li></ul></ul><ul><ul><li>As happened with black Americans who's being prevented from syphilis treatment to study the disease natural course. </li></ul></ul><ul><ul><li>Stop antibiotics from bacterial infected patients as happened with patients of Rheumatic Fever. </li></ul></ul><ul><ul><li>Placebo that used in control groups of diseased participants. </li></ul></ul>
    15. 15. 2. Preventive: New vaccines e.g. Salk polio vaccine when a lump of a live polio vaccine given to children and most of them eventually developed polio.
    16. 16. <ul><li>3. Diagnostic: </li></ul><ul><ul><li>Irradiation: </li></ul></ul><ul><li>- Teratogenic effect to the fetus. </li></ul><ul><li>- Carcinogenic effect. </li></ul><ul><ul><li>Samplings: </li></ul></ul><ul><li>- Biopsies: tissues that contain genetic information about the participant. </li></ul><ul><li>- Surgical hazards. </li></ul><ul><li>-Too risky procedures (under anesthesia) </li></ul>
    17. 17. The Forgotten Risks! <ul><ul><li>Social Risks: </li></ul></ul><ul><li>Stigma (As patients with HIV-AIDS, STDs). </li></ul><ul><ul><li>Emotional Risks: </li></ul></ul><ul><li>On families when their children chosen for trial of new vaccine; research in war. </li></ul><ul><ul><li>Psychological Risks: </li></ul></ul><ul><li>Questionnaires with sensitive questions to participants in sensitive positions, as to ask poor people about there nutrition and houses. </li></ul>
    18. 18. Risk to the Society: <ul><ul><li>Manipulating environmental factors (Pathogenic organisms and toxic chemicals) which affect the community under that study. </li></ul></ul><ul><ul><li>Legal risks: </li></ul></ul><ul><ul><li>Vulnerable groups, e.g., prisoners, children, pregnant women. </li></ul></ul>
    19. 19. Economic risk: <ul><ul><li>- Burden of traveling cost as for diagnostic or therapeutic procedures conducted far from the participant residential area. </li></ul></ul><ul><li>- Absentees, may loss their job or work. </li></ul>
    20. 20. Categorization of Risk <ul><li>According to the severity of the risk, it can be categorized to: </li></ul><ul><ul><li>Minimal Risk: As routine blood sample , throat swabs, vaginal swabs, sputum exams </li></ul></ul><ul><ul><li>Above Minimal Risk: That can be minimized, and within the toleration of the participant. </li></ul></ul><ul><ul><li>Too Risky: the most dangerous type, and the Researcher should not be allowed to conduct A research that endanger the life of the participants e.g. live cancer cells , live virus </li></ul></ul>
    21. 21. Minimal Risk <ul><ul><li>The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during routine performance of physical or psychological examination or tests </li></ul></ul>
    22. 22. Clinical Equipoise <ul><ul><li>The start of the trial, there must be a state of clinical equipoise regarding the merits of the regimens to be tested, and the trial must be designed in such a way as to make it reasonable to expect that, if it is successfully conducted, clinical equipoise will be disturbed.&quot; </li></ul></ul>
    23. 24. Clinical Equipoise <ul><ul><li>Clinical equipoise means a genuine uncertainty on the part of the expert medical community about the comparative therapeutic merits of each arm of a clinical trial. </li></ul></ul><ul><ul><li>The tenet of clinical equipoise provides a clear moral foundation to the requirement that the health care of subjects not be disadvantaged by research participants. </li></ul></ul>
    24. 25. Minimization of Risk -Adequate facilities ,procedures and personnel for dealing with emergencies . -Arrangement made for monitoring and detecting adverse out comes . -All trials should be reviewed by a Data Safety Monitoring Board (DSMB). -All potential toxins, mutagens or teratogens used should be justified. -The National Committee for Atomic Energy should completed risk assessment for the use of the radiation and radioactive substances .
    25. 26. Minimization of Risk <ul><ul><li>For Drugs: </li></ul></ul><ul><li>- Registration, its trade name, chemical name and pharmacological class . </li></ul><ul><li>- Recommended dose, form of administration in the study. </li></ul><ul><li>- Known or possible interaction with other drugs, side effects and adverse reactions. </li></ul><ul><li>- Placebo should be justified. </li></ul>
    26. 27. Minimization of Risk <ul><ul><li>Social Risks: </li></ul></ul><ul><li>- The research should have potential to enhance the future health of the society . </li></ul><ul><ul><li>For vulnerable groups : </li></ul></ul><ul><li>- Additional safeguards needed to protect there rights and welfare . </li></ul><ul><ul><li>For recruitment materials: </li></ul></ul><ul><li>(posters, newspapers, T.V, videos ……). </li></ul><ul><li>Should be acceptable if submitted . </li></ul>
    27. 28. Minimization of Risk <ul><ul><li>For Psychological Risks : </li></ul></ul><ul><ul><li>Sensitive questions for sensitive group like those with AIDS ,STDs,T.B, can be questioned through 3rd person or ask the help of psychologists . </li></ul></ul><ul><ul><li>Economic Risks : </li></ul></ul><ul><ul><li>Traveling cost can be solved out. </li></ul></ul><ul><ul><li>Absentees issues should also be solved out. </li></ul></ul>
    28. 29. Minimization of Risk <ul><ul><li>Legal : </li></ul></ul><ul><li>- The risk should be reasonable in relation to the anticipated benefits to the subjects or society . </li></ul><ul><li>- Privacy of subject should be adequately protected . </li></ul><ul><li>- For tissue samples containing genetics information the subject should have option to withdraw at any time . </li></ul>
    29. 30. References <ul><ul><li>Douglas Hubbard &quot;How to Measure Anything: Finding the Value of Intangibles in Business&quot; pg. 46, John Wiley & Sons, 2007. </li></ul></ul><ul><ul><li>National Guidelines for Health Research involving Human subjects (Sudan, 2008) </li></ul></ul>