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Ethical considerations of HIV research in Thailand: the HIV-NAT as a case study Praphan Phanuphak, M.D., Ph.D. Faculty of Medicine, Chulalongkorn University & The Thai Red Cross AIDS Research Centre Bangkok, Thailand HIV-NAT The HIV N etherlands A ustralia T hailand Research Collaboration

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ethical considerations of hiv research in thailand the hiv nat as a case study
Ethical considerations of HIV research in Thailand: the HIV-NAT as a case study

Praphan Phanuphak, M.D., Ph.D.

Faculty of Medicine, Chulalongkorn University

&

The Thai Red Cross AIDS Research Centre

Bangkok, Thailand

The HIV Netherlands Australia Thailand Research Collaboration

hiv nat the hiv n etherlands a ustralia t hailand research collaboration
HIV-NATThe HIVNetherlands Australia Thailand Research Collaboration

104 Rajdumri Road

Pathumwan

Bangkok 10330 Thailand

Tel: +66 2 255 7334/5 Fax: +66 2 252 5779

www.hivnat.org

The HIV Netherlands Australia Thailand Research Collaboration

collaborating organizations
Collaborating organizations

Thai Red Cross AIDS Research Centre (TRC ARC)

Bangkok, Thailand

Prof. Praphan Phanuphak

National Centre in HIV Epidemiology and Clinical Research (NCHECR)

University of New South Wales, Sydney, Australia

Prof. David A. Cooper

International AIDS Therapy Evaluation Centre (IATEC)

University of Amsterdam, The Netherlands

Prof. Joep. M.A. Lange

The HIV Netherlands Australia Thailand Research Collaboration

slide4

Mission and Objectives

Conduct multi-centre HIV-related clinical studies according to good clinical practice (GCP) and good laboratory practice (GLP) guidelines in Thailand and the region

Provide access to antiretroviral therapy for HIV-infected people in Thailand

Educate healthcare workers in Thailand and the region on GCP, GLP and HIV medicine

The HIV Netherlands Australia Thailand Research Collaboration

slide5

Milestones

1995 HIV-NAT concept

1996 start of operations

first patients enrolled on study

1997 first presentations at international meetings

1998 Bangkok symposium in HIV medicine

UNAIDS collaborating centre

1999 UNAIDS Best Practice

2000 first pK study of NLV in newborn

2003 approximately 1,500 patients on studies

The HIV Netherlands Australia Thailand Research Collaboration

slide6

009*

HIV-NAT STUDY

TIMELINES

D4T ER

ESPRIT

Decadurabolin

2NN

BMS PI

007

005

004 IL-2 Vanguard

003.2

003.1

The HIV Netherlands Australia Thailand Research Collaboration

003

002.2 extension

002.2

001.4*

002.1

001.3

002

001.2

001.1

* 2new studies started June 2001

001

Mid 1996 1997 1998 1999 2000 2001

ethical considerations
Ethical considerations
  • Biased ethical approval: authoritative or political
  • Unethical conduct or deviation of the approved protocol without 3rd party supervision
  • Ineffective consent process or not telling the whole true story
  • Subjects do not have much choice
  • What to offer to those who cannot enroll or fail the inclusion criteria?
  • End of trial medications
  • Research colonialism

The HIV Netherlands Australia Thailand Research Collaboration

ethics
Ethics
  • Ethical approval, protocols and consent form are just arbitrary processes.
  • Integrity of researchers is most crucial. It is inherent within individuals but can be shaped up if they know that someone is looking after them.
  • Research watchdog is useful to guarantee international standards but sometimes can be a stumble block.
  • Voice of the local affected people should be listened.
  • We need to help them to get the best possible options.

The HIV Netherlands Australia Thailand Research Collaboration

slide9

Quantitative studies of the quality of the informed consent given by the Thai researchers in the ESPRIT study

Christine Pace, Ezekiel J. Emanuel, et al

Department of Clinical Bioethics

NIH

esprit
ESPRIT
  • A phase III international study of SC IL-2
  • 4000 subjects worldwide, 368 from Thailand
  • Randomized 1:1 with ARV alone, a 5-year study
  • 141 patients immediately after signing the informed consent to join ESPRIT were invited to participate in in-person interview before learning of their randomization assignments
  • The survey was administered by Thai personnel trained by NORC who had no affiliation with ESPRIT
  • ESPRIT staff had no access to the completed Q&A

The HIV Netherlands Australia Thailand Research Collaboration

the informed consent process
The informed consent process
  • Initial information given by M.D. or VCT counselor
  • Group discussion of the protocol led by a nurse coordinator (20-30 min)
  • Thai version of the informed consent document provided with 20 minutes to read
  • Q & A session before signing the 2600 words long standard NIH informed consent

The survey used a 67-question questionnaires, developed by NORC, Univ. Chicago, with an average of 33 minutes long in-person interview

The HIV Netherlands Australia Thailand Research Collaboration

main findings of the survey
Main findings of the survey
  • High level of knowledge about the study (over 93% vs 28% in US study) including the side-effects
  • 21% felt that the discussion was more useful than the written materials
  • None had pressure from the ESPRIT research team to join the study
  • 30% had pressure from their health-related circumstances to join
  • Understanding treatment randomization was a problem, only 31%

The HIV Netherlands Australia Thailand Research Collaboration

conclusion
Conclusion

The results challenge the claim that research participants in developing countries cannot give voluntary and fully informed consent. However, independent monitoring such as this is essential.

Of note: 48% of the subjects had completed college or graduate schools.

The HIV Netherlands Australia Thailand Research Collaboration

end of trial medications strategies of hiv nat
End of trial medications: strategies of HIV-NAT
  • Try to negotiate for at least 2 years of ARV supply or life-long if possible
  • If patients do not yet need ARV, for example, in a pK study, 2 years guarantee of ARV when ARV is needed in the future. Grant is given for future ARV.
  • Request ARV support from the MOPH, some success
  • Roll-over protocols
  • HIV-NAT Drug Fund

The HIV Netherlands Australia Thailand Research Collaboration

hiv nat 001 series
HIV-NAT 001 series
  • 001 : Half-dose vs. full-dose ZDV/ddC
  • 001.1: d4T/ddI/SQV-SGC vs. ZDV/3TC/SQV-SGC (1400 mg bid)
  • 001.2: 001.1 +/- itraconazole 100 or 200 mg OD to look for SQV plasma level
  • 001.3: SQV-SGC 1600 mg + RTV 100 mg OD (for undetectable VL) vs. SQV-SGC 1400 mg bid (for detectable VL)
  • 001.4: Continuous OD SQV/RTV vs. week on-week off vs. CD4-guided (STI)

The HIV Netherlands Australia Thailand Research Collaboration

hiv nat drug fund
HIV-NAT drug fund
  • Initiated in November 2001
  • Subsidize antiretroviral drugs based on “a Co-Pay and a Sliding Scale System” for post-trial patients and patients in trials with intolerance or resistance
  • Rule: patient pays at least 1500 Baht and HIVNAT at most 5000 Baht
  • Funding of 2 million baht (first year) and 1 million baht (subsequent years)

The HIV Netherlands Australia Thailand Research Collaboration

progress report end of year 2002
Progress report (End of year 2002)
  • 868 in-trial, 278 post-trial
  • 83 patients requested assistance
  • 62 patients received assistance
  • Budget used: 413,321 Baht

The HIV Netherlands Australia Thailand Research Collaboration

future plans
Future plans
  • Re-evaluate patients’ financial status every 12 months
  • Patient questionnaire to assess
    • Benefits
    • Problems
    • Suggestions for improvement

The HIV Netherlands Australia Thailand Research Collaboration

summary
Summary
  • Ethics in performing HIV research is a real concern in Thailand but can be improved.
  • Good and ethical HIV research can be done but it should be closely monitored.
  • Ethical standardization is ideal but should not be a barrier for doing research in developing countries and should be tailored to fit each country, taking into the consideration of all stakeholders in the country, not only from the North or the funding agencies.

The HIV Netherlands Australia Thailand Research Collaboration