Common issues in ethical review of research: a Pakistani perspective - PowerPoint PPT Presentation

1 / 17
About This Presentation
Title:

Common issues in ethical review of research: a Pakistani perspective

Description:

Sindh Institute of Urology & Transplantation (SIUT) Karachi Pakistan. 2. SIUT. Outline ... There are 32 randomized controlled trials registered with ... – PowerPoint PPT presentation

Number of Views:256
Avg rating:3.0/5.0
Slides: 18
Provided by: Rmuz
Category:

less

Transcript and Presenter's Notes

Title: 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 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
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/re
nwirb.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 IRBs 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

17
(No Transcript)
Write a Comment
User Comments (0)
About PowerShow.com