2. DO NO HARM

3. IRRB Presentation Purposes Responsibilities Processes NLU IRRB Home page

4. IRRB Purposes Assure that research follows ethical principles and guidelines. Assist the investigator in examining ethical implications of their research. NLU IRRB Home page

5. Nuremberg Code Voluntary consent of the human subject absolutely essential. Risk should never exceed benefits. The Doctors Trial NLU IRRB Home page

6. Belmont Report Practice - Interventions that enhance well-being of an individual and are likely to be successful. Research - Activities designed to contribute to generalizable knowledge and/or interpretive understanding. The Belmont Report NLU IRRB Home page

7. Basic Ethical Principles Respect for Persons - informed consent Beneficence - do no harm Justice - fair distribution of burdens & benefits The Tuskegee Syphilis StudyU.S. Dept of Health and Human Services Office for Human Research Protections NLU IRRB Home page

8. Federal Definition of “Human Research Subject” A living individual about whom an investigator (whether professional or student) conducting research obtains: Data through intervention or interaction with individual, or Identifiable private information. Title 45, Part 46 NLU IRRB Home page

9. When does research not meet federal definition? Study of private information about dead people; Study of public information about living persons; Observation of public behavior; Study of publicly available information in which persons are not identifiable. NLU IRRB Home page

10. Federal Requirements Institutions conducting research will create: A statement of ethical principles, An institutional research review board (IRRB), Written procedures for conducting reviews of research and reporting actions to investigators. NLU IRRB Home page

11. IRRB Actions Review and approve or disapprove all research activities. Require informed consent and documentation of informed consent. Notify investigators of its decision in writing. Conduct continuing review of research at appropriate intervals. NLU IRRB Home page

12. Elements of Informed Consent (Sample forms available at NLU)NLU Purpose of the research Participants’ right to see your study Contact for further information Advisor’s/chair’s address, telephone, and e-mail Affiliation with the university Signatures—you and the participant Two copies: for you and the participant NLU IRRB Home page

13. Informed Consent (Do no harm!) Participant must… Be informed, and Give consent NLU IRRB Home page

14. Be Informed Who do I contact for information? What is the purpose of the study? How will data be used? How long will my participation take? Answer these questions: NLU IRRB Home page

15. Be Informed (cont.) How will confidentiality be protected? Who will have access to transcripts, field notes? What are the risks and benefits? How will you report the research findings? Answer these questions: NLU IRRB Home page

16. Give Consent Participation is voluntary Right to withdraw Free of coercion and undue influence Consent of parent or guardian when required Consent cannot be assumed, but must be explicit and written Include the following elements: NLU IRRB Home page

17. Who Applies? Those engaged in research: Faculty and staff Doctoral Students: Dissertation Masters Students: Thesis IDS Students: Action Research NLU IRRB Home page

18. Who Does Not Apply? Students conducting research as part of a class Faculty and staff collecting institutional data for self study and accreditation NLU IRRB Home page

19. Designated Category Exempt Expedited Full Review Criteria Standards NLU IRRB Home page

20. Disposition of Application Sent to Office of the Provost Checked for completeness Reviewed Database updated Proposal filed Researcher notified NLU IRRB Home page

21. THANK YOU! For additional information: Visit NLU IRRB Home page or contact the Office of the Provost (312) 261-3683