Common issues in ethical review of research: a Pakistani perspective

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