SIUT Common issues in ethical review of research: a Pakistani perspective Rana Muzaffar, PhD...
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SIUT
Common issues in ethical Common issues in ethical review of research: a review of research: a Pakistani perspectivePakistani perspective
Rana Muzaffar, PhDDepartment of Microbiology and Immunology
Sindh Institute of Urology & Transplantation (SIUT)Karachi Pakistan
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Outline Research scenario in PakistanIssues Training deficiencies Misinformed consent Conflicting interests Review process
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Research scenario in Pakistan
There are 32 randomized controlled trials registered with clinicaltrials.gov
10 are being conducted by one pharmaceutical company
10 are being conducted by one private university
8 are being conducted by US NIH Institutes or Centers
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National Bioethics Committee under Pakistan Medical Research Council (PMRC)
OHRP (International Compilation of Human Subject
Research Protection) recognizes 12 IRBs
Institutional mechanisms: EMRO study, 24 out of 68 institutions had ERC
Capacity for safeguard: Pakistan
5SIUThttp://www.hhs.gov/ohrp/humansubjects/assurance/renwirb.htm
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Issues
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Training deficiencies
Undergraduate and postgraduateLack of opportunitiesDearth of capacityOver-training versus non exposure
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Informed consent process
Consent forms Lengthy and complex, difficult to read
translation in native language Disclaimer/ legalistic rather than an
informative document Irrelevant information; insurance, nonexistent
support services, regulations etc. Ambiguity about care availability during
research; absence of support services in rural areas not addressed
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Informed consent process
Lack of real choice for participants Take it or leave it option
Social considerations Male dominated decision making; husband,
father, son decide Community leaders decide for communities
Should IRBs take these factors into consideration?
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Misinformed consent
Confusion between research and clinical care
“Randomization”, “placebo” or “control”, “double blind” translated literally
“Placebo” translated as “ineffective drug”
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Conflicting Interests
Incentives for researchers
Incentives for recruitment
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Conflicting interests: incentives for researchers
Level of compensation for Principal Investigator
Reward for recruitment of subjects for research officers
What is the role of IRB’s in this?
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Mechanism of review
Wide variation from institution to institutionQualityTimeReliability
Open to influence
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Conclusions
Training deficiencies
Limited capacity to conduct ethics reviews
Issues with informed consent
Issues with conflict of interest
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Recommendations
Enhance IRBs’ capacity to review beyond guidelines
Probe potential conflict of interest areas Informed consent should be contextual
written for subjects who can read and write verbal and witnessed for subjects who cannot
read and write
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Recommendations contd.
audio-visual materials, brochures etc. to communicate complex information
translations should capture concept
Lack of adequate health care infrastructure requires IRBs in developing world to be more vigilant
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