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Ethics & Medical Research Sharing the experience

Ethics & Medical Research Sharing the experience. R.K. Baxi Professor Medical College, Baroda. Ensure Purpose of research is towards betterment of all Research is conducted with professional fair treatment and transparency Evaluation at all stages of proposal –

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Ethics & Medical Research Sharing the experience

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  1. Ethics & Medical ResearchSharing the experience R.K. Baxi Professor Medical College, Baroda

  2. Ensure • Purpose of research is towards betterment • of all • Research is conducted with professional • fair treatment and transparency • Evaluation at all stages of proposal – • research design • declaration of results • use of results

  3. 12 PRINCIPLES OF ETHICS IN MEDICAL RESEARCH (Declaration of Helsinki) Essentiality Voluntariness, informed consent and community agreement Non-exploitation Privacy and confidentiality Precaution and risk minimization Professional competence

  4. 12 PRINCIPLES OF ETHICS IN MEDICAL RESEARCH (Declaration of Helsinki) Accountability and transparency Maximization of the public interest Institutional arrangements Public domain Totality of responsibility Compliance

  5. HIV related research has brought to focus • many issues related to Ethics as now we know • that HIV is not Bio-medical alone • HIV necessitated robust socio-behavioral • research • HIV research brought to fore the issues • related to stigma, disclosure, power equations • between providers and clients • Pandemic is also moving from “only high risk • behaviour groups” to general population, • hence more diverse and complex

  6. Vulnerability to HIV is also beyond physiological • reasons • Though virus does not discriminate per se, • pattern of HIV infection as a public health • problem does show powerful influence of • socio-cultural, economic and related behavioral • factors • Hence, Ethical considerations also will have to • be embedded into socio-cultural realities

  7. Ethics in Indian Research • Ethics in Indian research scenario is guided by • ICMR, statement of General Principles on • ethical considerations • Most of which, as we all know, is in line with • International Guidelines and Principles • These guidelines have precious little specifics • on socio-behavioural research, which is so • important to HIV related research, however, • at places within the document, it expects • researchers to be sensitive to the local cultural • context

  8. Availability of ART and rapid expansion of • ART services open up several other issues • related to Ethics: • Equal opportunity to access and availability • Ability to pay for the same • Priority treatment to vulnerable groups • At times, populations studied are NOT the • ones who are beneficiaries! • Gender based disadvantage • Issues related to consent for treatment of • adolescents/children are some other issues • with NO final answer.

  9. NACO Ethical Guidelines • NACO Ethical Guidelines for Operational • research on HIV/AIDS(2008) is another set of • guidelines which help. • This particular guideline is more explicit on • issues like anonymity, confidentiality, patient • information, partner notification and • compensation • Social context of clinical /biomedical • intervention is now more in focus as eventual • impact favorable or otherwise depends a lot on • the same.

  10. Social science research should be relevant to • the community and be beneficial to • marginalized, vulnerable. • Selection of respondents should not mean • targeting or stigmatizing • Given the cultural and social diversity, • generalisability of research findings may be • done carefully, giving due weightage to the • “outliers” • Hope, someday ,we would afford the luxury of individual, issue-based counseling..

  11. Issues and problems • Independence and Competence: • Are our Institutional Ethics Committee (IEC) • independent and competent? • Do we have a proper constitution of the same? • Are members trained in Ethics/GCP? • Are there SoPs for the conduct of IEC?

  12. Issues and problems • Do we perceive the need to have separate • technical/scientific review from the Ethical • review? • Do members have adequate time for this • serious business? Are they adequately • compensated? • A lot remains to be done………

  13. Dilemma… • Disclosure of status to wife/husband • Disclosure at workplace • Why not disclose to school authority? • Counselors and Out reach workers not • maintaining confidentiality • Compensation to whom? How much is the right • compensation? • How about the human rights of the health care • providers in face of general non-availability of • Universal precautions? • Knowing the status, disclosure, loss of • confidentiality and its impact on sexual • behaviour

  14. THANK you

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