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Common issues in ethical review of research: a Pakistani perspective

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17 diapositives · 308 Views · Sep 20, 2014

This paper examines the ethical review landscape of research in Pakistan, identifying critical issues such as training deficiencies, misinformed consent, and conflicting interests in the review process. The study highlights the limited capacity for ethical oversight, with only a fraction of institutions possessing effective ethics review boards (IRBs). Recommendations include enhancing IRB capacities, improving informed consent processes through accessible language and resources, and addressing community dynamics in decision-making. This analysis aims to strengthen ethical standards and research integrity in Pakistan's evolving research environment.

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  1. Common issues in ethical review of research: a Pakistani perspective Rana Muzaffar, PhD Department of Microbiology and Immunology Sindh Institute of Urology & Transplantation (SIUT) Karachi Pakistan

  2. Outline • Research scenario in Pakistan • Issues • Training deficiencies • Misinformed consent • Conflicting interests • Review process

  3. Research scenario in Pakistan • There are 32 randomized controlled trials registered withclinicaltrials.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

  4. Capacity for safeguard: Pakistan • 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

  5. http://www.hhs.gov/ohrp/humansubjects/assurance/renwirb.htm

  6. Issues

  7. Training deficiencies • Undergraduate and postgraduate • Lack of opportunities • Dearth of capacity • Over-training versus non exposure

  8. 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

  9. 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?

  10. Misinformed consent • Confusion between research and clinical care • “Randomization”, “placebo” or “control”, “double blind” translated literally • “Placebo” translated as “ineffective drug”

  11. Conflicting Interests • Incentives for researchers • Incentives for recruitment

  12. 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?

  13. Mechanism of review • Wide variation from institution to institution • Quality • Time • Reliability • Open to influence

  14. Conclusions • Training deficiencies • Limited capacity to conduct ethics reviews • Issues with informed consent • Issues with conflict of interest

  15. 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

  16. 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