CSD 5XXX Introduction to Research Methods in CSD

1. CSD 5XXXIntroduction to Research Methods in CSD Ethics in Research Introductory remarks Some examples to get you thinking History Professional codes and ethics Ethical issues of the research process Applying for IRB approval

2. Research Ethics Rules of conduct based on a history of sound and logical research practices Ethical standards are designed to encourage Honesty in reporting data Accuracy in describing procedures Fairness in treating subjects

3. Case Studies To Get You Thinking… A client’s dilemma: As an SLP, your client, Mr. Smith, is recruited for an experiment planned by you and Dr. Mizuko, your Plan B advisor. Mr. Smith is being treated for problems related to a head injury. The research plan includes experimental and control groups, and assignment to each group is random. Mr. Smith has a 50% chance of being selected for the experimental group (gets treatment) and a 50% chance of being selected for the control group (doesn’t get treatment). What are the potential ethical issues here, and what do you think you should do?

4. Case Studies To Get You Thinking… Deception in the classroom: You and Dr. Brorson are planning a research study in several 2nd grade classrooms to investigate teachers’ perceptions of students with language impairment. You plan to tell the teachers that the study is about nutrition and its effect on classroom behavior. What are the potential ethical issues here, and how should you proceed?

5. Case Studies To Get You Thinking… Authorship: You’re completing your Plan B project with your advisor, Dr. Spillers. You and Dr. Spillers agreed during the initial planning that you would be the first author and she would be the second author on any presentation or publication of the results. However, Dr. Spillers received statistical advice from Dr. Loven, and now Dr. Spillers wants to include Dr. Loven’s name on a presentation of results. What are the potential ethical issues here, and what should you do?

6. Historical Cases Shaping Today’s Approach to Research Ethics Today’s formalized rules of conduct in experimentation and research comes from a long history of human rights abuses Cleopatra Children’s Hospital of Boston spinal tap study Nazi human experiments Tuskegee airmen study

7. A Recent High Profile Case From Our Own Profession Wendell Johnson and Mary Tudor University to Iowa study on childhood disfluency “Monster study”

8. And a Case That Rocked the University of Minnesota… John Najarian and the ALG scandal

9. Professional Codes of Ethics and Research Code of ethics Set of principles that guide the conduct of professional activities, including research Codes for practice Interventions with the sole purpose of improving the well-being of an individual Codes for research Activities that tests hypotheses, makes conclusions, and extends results to the population of interest

10. Basic Ethical Principles for Research Respect for persons Requires researchers to recognize participants as persons of worth who participate by free choice Informed consent Full disclosure Beneficence Make every effort to insure the well-being of research participants Justice Concerned with the equal treatment of people in society Selection bias Vulnerable populations

11. ASHA’s Statements of Ethics in Research ASHA members are obliged to abide by the following rules of conduct regarding research: Individuals shall honor their responsibility to hold paramount the welfare of persons they serve professionally or participants in research and scholarly activities and shall treat animals involved in research in a humane manner Individuals shall not discriminate in the delivery of professional services or the conduct of research and scholarly activities on the basis of race or ethnicity, gender, age, religion, national origin, sexual orientation or disability Individuals shall inform participants in research about the possible effects of their participation in research conducted Individuals shall use persons in research or as subjects of teaching demonstrations only with their informed consent

12. Special Issues in Research Ethics Research participants Informed Consent Privacy and confidentiality Withholding treatments Collecting data, describing procedures, and reporting results Conflicts of interest Honoring promises and commitments to participants

13. Research Participants More broadly viewed than just “subjects” Participants must be chosen based on the study’s purpose and methodology Distributive justice The inclusion or exclusion of subjects based on genuine needs and not on social, racial, sexual, or cultural bias

14. Informed Consent Barriers to informed consent Vulnerable populations Children Adults with diminished cognitive abilities Institutionalized participants Prisons, nursing homes, schools Comprehension Reading levels Adjustments for special populations Open communication with participants before, during and after the study Subject’s right to consent or decline Opportunity of ask questions Opportunity to express concerns Opportunity of withdraw Full disclosure Deceit is only used in rare instances where the truth would make the study impossible If deception is necessary, subjects must be debriefed as soon as possible once the study is over

15. Privacy and Confidentiality Data are privileged information Steps to insure confidentiality Anonymity of participants Maintaining and appropriately securing research records Not revealing any personal information about research participants in publication of the study

16. Withholding Treatments Controlling for the implications Risk-benefit analysis Benefit is a product of the scientific worth of the study and the value to the individual participants Risk is any potential harm to the welfare of the participant Physical, emotional, monetary, deceit Employing other research designs

17. Collecting Data, Describing Procedures, and Reporting Results Accuracy of observations Honest report of the details of the study Problems like subject attrition need to be reported All publishable research results should be made available to the public by means of publication Authorship Reserved for those who conceive, design, perform, and write the manuscript for publication or presentation First author

18. Conflict of Interest Arises when either the participant or the researcher unfairly gains or losses as a result of the research study

19. Honoring Promises and Commitments The researcher should ensure that any and all promises and commitments made to participants are fulfilled Monetary compensation Summary of research results Continuing therapy

20. The Internal Review Board Almost all universities have IRBs They are charged with reviewing research proposals to determine their compliance with existing research regulations and protecting the rights and safety of research subjects They have the power to approve, disapprove, or require revision of a research plan as they see fit The UM website you need to visit for IRB review is http://www.research.umn.edu/irb/

21. Your IRB Proposal What they are checking for Risk/benefit ratio Usually not a factor in our requests because most of our studies have minimal/no risks Some studies even are exempt from review, or expedited because the risks are negligible—see the IRB website for criteria for these studies Means of obtaining informed consent How will you recruit your subjects? Will you be recruiting subjects that are considered “vulnerable”? Where will you find your subjects? Consent form Confidentiality issues Data collection issues Form? Type? Duration?

22. Next Week… Choosing a research problem and the literature review…