INFORMED CONSENT IN INTERNATIONAL RESEARCH Patricia Marshall, PhD Case Western Reserve University.

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Presentation transcript:

INFORMED CONSENT IN INTERNATIONAL RESEARCH Patricia Marshall, PhD Case Western Reserve University

INFORMED CONSENT: INTERNATIONAL GUIDELINES National and international guidelines recognize informed consent is an essential requirement for ethical conduct in scientific research. Consensus about core components of informed consent, but application often problematic.

INFORMED CONSENT Bioethics practice based on western philosophical principle of respect for persons, strong emphasis on individual autonomy. Informed consent as ethical ideal. Informed consent as social process. Informed consent as praxis.

CHALLENGES: INFORMED CONSENT Underlying assumptions: ability to understand, ask questions, provide voluntary consent. Vulnerable populations, structural inequities: racism, poverty, low literacy rates, gender issues. Less familiarity with Western biomedical and behavioral research. In some settings, human rights abuses.

CHALLENGES: INFORMED CONSENT Scientific concepts difficult to communicate. Consent forms lengthy, confusing, difficult to understand. Translation of consent forms from one language to another problematic. IRB requirements for informed consent (e.g., written documentation) do not always mesh with local realities.

COMMUNITY “PERMISSION”/INDIVIDUAL CONSENT: YORUBA BREAST CANCER STUDY “ It depends on the area…in a village it is important to take permission from the leaders of the community.” When asked what she would do if the elders disapproved, she replied, “Yes, I will participate because I have known the benefit of getting involved in this research.” (woman, control group)

YORUBA BREAST CANCER STUDY “It is not going to be dangerous once my husband did not say I should not do it. Individual opinion has power over community opinion because one is not forced to do it. But if the community opinion (is to disapprove) then one may not open up to the questions the researcher will be asking. But individual opinion has power over community opinion.” (woman, control group)

INFORMED CONSENT AS A SOCIAL PROCESS  Higher congruence between researcher/ participant, greater likelihood of consent conditions.  Greater dissonance, less likely to achieve consent conditions.  Goal: develop strategies to diminish dissonance.

FUTURE CHALLENGES How are current guidelines being applied? Who is being served? Great need for empirical research:   Investigating existing informed consent practices.   Developing/testing new approaches to informed consent.   Evaluating IRB/ERC protocol review of consent.   Analyzing impact of structural inequities (global/local) on application of informed consent.