จริยธรรมการวิจัยในคน กับ การวิจัยทางสังคมศาสตร์

1. จริยธรรมการวิจัยในคน กับ การวิจัยทางสังคมศาสตร์ พรรณแข มไหสวริยะ ที่ปรึกษาคณะกรรมการจริยธรรมการวิจัยในคน มหาวิทยาลัยมหิดล

2. General ethical principles • Respect for person • Beneficence and non maleficence • justice

3. Biomedical VS. Social & Behavioral science research • Recruitment process – community level, local culture • Informed consent process • Verbal consent – waive of written informedconsent for survey questionnaire • Imply consent – survey • Informed of protocol amendment and reconsent • Deception and debrief

4. Biomedical VS. Social & Behavioral science research • Risk and benefit ratio • Risk category • Psychological risk: upset or worry • Social risk: stigma, discrimination • Financial risk: loss of employment • Legal risk: disclosure of illegal activities • Physical risk: domestic violence

5. Biomedical VS. Social & Behavioral science research • Research methodology • Sample size calculation • Some special technique – amendment cannot be approved before implement • Secondary subjects • Privacy and confidentiality protection • Language, translator • Focus group discussion • Responsibility for research related injury: counseling

6. Category for exemption • Not involve human subjects: anonymous samples and data • Quality assurance, in-house program evaluation • Educational research conducting in normal educational settings • Survey/interview/observational research with adults • Secondary use of de-identified pre-existing data • Evaluation of public benefit or service program • Taste and food quality studies • wholesome foods without additives • contains a food ingredient at or below the level and for a use found to be safe • Contains agricultural chemical or environmental contaminant at or below the level found to be safe