1. © 2010 Jones and Bartlett Publishers, LLC
CHAPTER 2
Ethics and Research
ISE Dr. Joan Burtner Fall 2015
© 2010 Jones and Bartlett Publishers, LLC

2. © 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 Dr. Joan Burtner Fall 2015
© 2010 Jones and Bartlett Publishers, LLC

3. 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 Dr. Joan Burtner Fall 2015
© 2010 Jones and Bartlett Publishers, LLC

4. 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 Dr. Joan Burtner Fall 2015
© 2010 Jones and Bartlett Publishers, LLC

5. 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 Dr. Joan Burtner Fall 2015
© 2010 Jones and Bartlett Publishers, LLC

6. © 2010 Jones and Bartlett Publishers, LLC
IRB
Human research cannot begin before IRB approval
Researchers sometimes have to modify research
ISE Dr. Joan Burtner Fall 2015
© 2010 Jones and Bartlett Publishers, LLC

7. © 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 Dr. Joan Burtner Fall 2015
© 2010 Jones and Bartlett Publishers, LLC

8. © 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 Dr. Joan Burtner Fall 2015
© 2010 Jones and Bartlett Publishers, LLC

9. © 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 Dr. Joan Burtner Fall 2015
© 2010 Jones and Bartlett Publishers, LLC

10. © 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 Dr. Joan Burtner Fall 2015
© 2010 Jones and Bartlett Publishers, LLC

11. 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 Dr. Joan Burtner Fall 2015
© 2010 Jones and Bartlett Publishers, LLC

12. 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 Dr. Joan Burtner Fall 2015
© 2010 Jones and Bartlett Publishers, LLC

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