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’ responsibilitiesInvestigators’ responsibilities –Assurance Participants’ rightsParticipants’ rights –Informed consent

3. Ethical theories UtilitarianismUtilitarianism –benefit to the group DeontologyDeontology –benefit to the individual

4. Ethical principles VeracityVeracity BeneficenceBeneficence NonmaleficenceNonmaleficence JusticeJustice AutonomyAutonomy FidelityFidelity Be truthfulBe truthful Do goodDo good Do no harmDo no harm Distribute goods fairlyDistribute goods fairly Individuals’ free choiceIndividuals’ free choice Keeping one’s wordKeeping one’s word

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 tomother and child linked problem solving intervention designed to –meet the individual needs of participants by increasing mental health status increasing mental health status family functioningfamily functioning school adaptation for the childschool adaptation for the child

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

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

21. Conclusions Ethical principles illuminate solutionsEthical principles illuminate solutions Assurance process is continuousAssurance process is continuous Ethical theoretical base guides local IRBEthical theoretical base guides local IRB DHHS.govDHHS.gov