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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

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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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