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DO NO HARM

DO NO HARM. NLU IRRB Home page. IRRB Presentation. Purposes Responsibilities Processes. NLU IRRB Home page. IRRB Purposes. Assure that research follows ethical principles and guidelines. Assist the investigator in examining ethical implications of their research. NLU IRRB Home page.

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DO NO HARM

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  1. DO NO HARM

  2. NLU IRRB Home page IRRB Presentation • Purposes • Responsibilities • Processes

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

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

  5. NLU IRRB Home page 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

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

  7. NLU IRRB Home page 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

  8. NLU IRRB Home page 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.

  9. NLU IRRB Home page 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.

  10. NLU IRRB Home page 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.

  11. NLU IRRB Home page Elements of Informed Consent(Sample forms available at 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

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

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

  14. NLU IRRB Home page Be Informed (cont.) Answer these questions: • 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?

  15. NLU IRRB Home page Give Consent Include the following elements: • 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

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

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

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

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

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

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