1. Greg Nezat CRNA, PhD CDR/NC/USN Chairman, IRB II
Understanding the IRB

2. Objectives
Review the ethical principles underlying the conduct of research
Respect for persons
Beneficence
Justice
Review the seven step ethical framework in which IRB decisions are made

3. Background
Research is a systematic investigation designed to contribute to generalizable knowledge
Benefit to participants is not the purpose of research (although it does occur)
Subjects are the means to developing useful knowledge; and are thus at risk of exploitation

4. Background Ethical requirements in clinical research aim to:
minimize the possibility of exploitation
ensure that the rights and welfare of subjects are respected while they contribute to the generation of knowledge

5. Essential Elements of Ethical Research
Informed Consent Respect for Persons 1) Respect for autonomy 2) Protection of persons with impaired or diminished autonomy

6. VULNERABLE POPULATIONS
“When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.” 32 CFR

7. Essential Elements of Ethical Research
Fair Subject Selection
Justice
Requires fair and equitable distribution of both benefits and risks associated with protocol

8. Essential Elements of Ethical Research
Balance of Risks and Benefits
Non-maleficence and Beneficence
Minimize risks to subjects
Maximize benefits to individual subjects and to society
Benefits should be proportional to or outweigh risks

9. Ethical framework: Seven guidelines
Valuable scientific question
Valid scientific methodology
Fair subject selection
Favorable risk-benefit evaluation
Independent review
Informed consent
Respect for enrolled subjects
Emanuel E, Wendler D, Grady C. What makes clinical research ethical? Journal of the American Medical Association 2000; 283(20):

10. Valuable Scientific Question
Limited resources and avoidance of exploitation
A socially, clinically, or scientifically useful research question that will generate useful new knowledge about human health

11. Valid Scientific Methodology
Appropriate scientific methods are necessary to justify exposure of subjects to risk
Requires the scientific review of all protocols

12. Fair Subject Selection
Consistent with scientific goals:
Select subjects to minimize risks and maximize benefits
Do not exclude subjects without a good reason of science, vulnerability, or susceptibility to risk or burden
Consider distribution of burdens and benefits of research

13. Favorable Risk/Benefit Evaluation
Defining risks
Probability and magnitude
Types of risk
Uncertainty
Minimizing/limiting risk

14. Favorable Risk/Benefit Evaluation
Interests other than those of the subject may
on some occasions be sufficient by
themselves to justify the risks involved in the
research, so long as the subjects’ rights
have been protected.
The Belmont Report

15. Independent Review Review free from undue influence
Scientific review
Ethical review
Freedom from conflict of interest

16. Informed Consent
The voluntary consent of the human subject is absolutely essential
For all biomedical research involving human subjects, the investigator must obtain the informed consent of the prospective subject…or authorized representative

17. Informed Consent
“To the degree subjects are capable, they should be given the opportunity to choose what shall or shall not happen to them”. The Belmont Report
Extra protections for those with limited capacity to consent

18. Respect for Enrolled Subjects
Beneficence and Respect for Persons
Right to withdraw
Confidentiality of subject data
Informing subjects of new information and of study results
Monitoring subject welfare

19. Respect for Enrolled Subjects
During the course of the experiment the human subject should be at liberty to bring the experiment to an end… Nuremberg Code
Every precaution should be taken to:
Respect the privacy of the subject
Respect the confidentiality of the subject’s information
Physical and mental suffering and injury should be avoided

20. Choice of Control
“The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods.” (Helsinki 2000)

21. Pointers Write IC documents at the eighth grade level Avoid jargon
Explain medical terms
Avoid language with negative connotations (e.g. spinal tap)
Have a clear scientific rationale for inclusion/exclusion criteria
As PI, attend the IRB review of your protocol

22. Questions?