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

3. SIUT 3 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

4. SIUT 4 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

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

6. SIUT 6 Issues

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

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

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

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

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

15. SIUT 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. SIUT 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

17. SIUT 17