© 2010 Jones and Bartlett Publishers, LLC CHAPTER 2 Ethics and Research ISE 493 Dr. Joan Burtner Fall 2015 © 2010 Jones and Bartlett Publishers, LLC

© 2010 Jones and Bartlett Publishers, LLC Ethics and Research Health care research on humans requires safeguards Basic set of humans rights Legal guidelines for human participation in research ISE 493 Dr. Joan Burtner Fall 2015 © 2010 Jones and Bartlett Publishers, LLC

Institutional Review and Human Subjects’ Rights All research involving humans must be approved before starting by Institutional Review Board (IRB) IRB assembled by institution to review human subject research ISE 493 Dr. Joan Burtner Fall 2015 © 2010 Jones and Bartlett Publishers, LLC

Functions of Institution Review Board Protect human subjects who participate in research Ensure research studies adhere to protocol established by Department of Health and Human Services Assess risks, potential benefits, and informed consent ISE 493 Dr. Joan Burtner Fall 2015 © 2010 Jones and Bartlett Publishers, LLC

IRB Grants Approval When: 1. The risks to the (research) subject are so outweighed by the sum of the benefits to the subject and the importance of the knowledge to be gained as to warrant a decision to allow the subject to accept these risks. 2. Legally effective informed consent will be obtained by adequate and appropriate methods. 3. The rights and welfare of any such subjects will be adequately protected. ISE 493 Dr. Joan Burtner Fall 2015 © 2010 Jones and Bartlett Publishers, LLC

© 2010 Jones and Bartlett Publishers, LLC IRB Human research cannot begin before IRB approval Researchers sometimes have to modify research ISE 493 Dr. Joan Burtner Fall 2015 © 2010 Jones and Bartlett Publishers, LLC

© 2010 Jones and Bartlett Publishers, LLC Composition of IRB Comprised of diverse group such as administrators, community leaders, clinicians etc Helps ensure many perspectives are examined before approval is granted Members should be of high character and professional standing ISE 493 Dr. Joan Burtner Fall 2015 © 2010 Jones and Bartlett Publishers, LLC

© 2010 Jones and Bartlett Publishers, LLC Approval of IRB (Part 1) 1 A complete description of the study’s intended purpose and procedures to be followed. 2 A description of potential risks the subject may incur from participation in the study. 3 A description of potential benefits, either direct or indirect, the subject may incur from participation in the study. 4 A description of how data will be handled such that the subject’s identity remains anonymous. 5 A statement that the subject may withdraw from the study at any time without a prejudicial effect on his or her continuing clinical care. ISE 493 Dr. Joan Burtner Fall 2015 © 2010 Jones and Bartlett Publishers, LLC

© 2010 Jones and Bartlett Publishers, LLC Approval of IRB (Part 2) 6 The name and number of the investigator, should any questions arise regarding the subject’s participation in the study. 7 Copy of the complete informed consent form. 8 A list of available alternate procedures and therapies. 9 A statement of the subject’s rights, if any, to treatment or compensation in the event of a research related injury. ISE 493 Dr. Joan Burtner Fall 2015 © 2010 Jones and Bartlett Publishers, LLC

© 2010 Jones and Bartlett Publishers, LLC Informed Consent “Voluntary permission” given by participant Historical basis for informed consent: Nuremburg Trials Informed is having information on all pros and cons of participation in study Revocation of consent-a subject can withdraw at any point from a research study ISE 493 Dr. Joan Burtner Fall 2015 © 2010 Jones and Bartlett Publishers, LLC

Ethical Issues-Basic Principles Respect for person-autonomous and self determining Justice-fair and equal treatment Beneficence- do no harm, maximizing benefits reducing harm ISE 493 Dr. Joan Burtner Fall 2015 © 2010 Jones and Bartlett Publishers, LLC

Objective Patient Care Best for every patient and to do no harm-Hippocratic Promise Does patient understand a placebo group and treatment group Should all patients have access to treatment ISE 493 Dr. Joan Burtner Fall 2015 © 2010 Jones and Bartlett Publishers, LLC

Reporting Research Results Results from studies should be accurate and without “intentional bias”. Independent replication or verification needed ISE 493 Dr. Joan Burtner Fall 2015 © 2010 Jones and Bartlett Publishers, LLC