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Ethical issues in recruiting Mexican immigrant mothers and children as research subjects

Ethical issues in recruiting Mexican immigrant mothers and children as research subjects. Julia Muennich Cowell PhC, RNC, FAAN, Diane McNaughton, PhD, RN Sarah Ailey, PhD (c ), RN. Rush College of Nursing, Chicago, IL R01 NR05008-01, National Institute of Nursing Research. Introduction.

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Ethical issues in recruiting Mexican immigrant mothers and children as research subjects

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  1. Ethical issues in recruiting Mexican immigrant mothers and children as research subjects Julia Muennich Cowell PhC, RNC, FAAN, Diane McNaughton, PhD, RN Sarah Ailey, PhD (c ), RN. Rush College of Nursing, Chicago, IL R01 NR05008-01, National Institute of Nursing Research

  2. Introduction • Investigators’ responsibilities • Assurance • Participants’ rights • Informed consent

  3. Ethical theories • Utilitarianism • benefit to the group • Deontology • benefit to the individual

  4. Veracity Beneficence Nonmaleficence Justice Autonomy Fidelity Be truthful Do good Do no harm Distribute goods fairly Individuals’ free choice Keeping one’s word Ethical principles

  5. Purpose ...address ethical issues related to: • recruitment • informed consent • assurance

  6. Mexican American Problem Solving Program (MAPS) • mother and child linked problem solving intervention designed to • meet the individual needs of participants by • increasing mental health status • family functioning • school adaptation for the child

  7. Methods • Design…randomized clinical trial • Schools randomly assigned to treatment & control conditions • Measures • Measures initially tested and translated • Mexican immigrant advisory review

  8. Population/Sample • Chicago a point of entry • Schools A & B in Hispanic community • Schools C & D in multinational community

  9. Recruitment People • School based coordinators • School nursing coordinator • Research staff

  10. Recruitment Process • Flyers to classrooms-Coordinators • Flyers to classrooms-School nursing coordinator • Flyers to classrooms-Research Staff • Flyers & meetings with parents and teachers-Research Staff • Letters to teachers-Research Staff

  11. Informed consent Definition ...voluntary choice of an individual to participate in research based on an accurate & complete understanding of its purposes, procedures, risks, benefits, alternatives and any other factors that may affect a person’s decision to participate. DHHS, OHRP, 2001

  12. Informed consent Basic Concepts 1. Full disclosure 2. Adequate comprehension 3. Voluntary choice to participate

  13. Informed consent General requirements 1. Obtained before the research begins 2. Information must be understandable 3. Participants must have time to consider 4. Consent without coercion 5. Participants must not be required to give up legal rights 6. Competency to consent

  14. Informed consent Elements of informed consent 1. Description of potential risks and benefits 2. Explanation of confidentiality protection 3. Compensation 4. Voluntary nature of participation 5. Program is research 6. Contacts for questions about research & participant rights OHRP, 2001

  15. 1st wave ethical issues Informed consent 1. Flyer 2. Consent by treatment group 3. Informed consent as a process

  16. 1st wave ethical issues Compensation issue 1. Social security numbers 2. Preference for grocery certificate

  17. 1st wave ethical issues Referral for mental health problems 1. Risk of control group contamination 2. Benefit of best practices

  18. Summary of ethical issues, principles & strategies

  19. Summary of ethical issues, principles & strategies

  20. Summary of ethical issues, principles & strategies

  21. Conclusions • Ethical principles illuminate solutions • Assurance process is continuous • Ethical theoretical base guides local IRB • DHHS.gov

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