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UM Policies & Procedures - HSRO/IRB
1. Preface
2. Background Topics
3. Authorities and Responsibilities
4. Conflict of Interest
5. Institutional Review Boards
6. IRB Meetings
7. General Principles for IRB Reviews
8. Definition of IRB Review Types
9. IRB Review of Initial Studies
10. IRB Review of Continuing Studies
11. Amendments
12. Closing Studies and Final Reports
13. Suspension, Termination and Administrative Closure of IRB Approved Research
14. Unanticipated Problems and Adverse Events
15. Study Violations
16. Compliance Audits
17. Data Safety Monitoring Boards
18. Ancillary Committees
19. External IRB's
20. Policies Specific to Certain Types of Research
21. Informed Consent
22. Participant Recruitment Methods, Advertising Materials and Recruitment-Relevant Payment Arrangements
23. Vulnerable Populations
24. Privacy, Security, Confidentiality and HIPAA
25. Subcontracts/Agreements for UM-Initiated Studies that Engage or Involve non-UM Institutions or Investigators
26. International Research
27. Emergency Use
28. Record Retention
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eProst User Guide
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About the HSRO

Basic Folder Information

2.2 Ethical Principles

Approval Date

Review Responsibility:

IRB Policy and Procedure Committee

Original Approval Date:

November 30, 2005

Revised: May 10, 2011

2.2 Ethical Principles

The Declaration of Helsinki and the Belmont Report provide the ethical foundation for these Written Policies and Procedures. The latter document emphasizes three principles that are central to the ethical treatment of human research subjects and that should guide the conduct of human studies:

a.   Respect for Persons
Individuals should be treated as autonomous agents and those persons with diminished autonomy should be entitled to protection. This principle is applied by obtaining informed consent with due consideration of privacy, confidentiality, and additional protections for vulnerable populations


b.   Beneficence
Individuals should be treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. This principle is applied by appropriately weighing risks and benefits


c.   Justice
All individuals should equally share the burdens and benefits of research. This principle applied by the equitable selection of research subjects

An important aspect of respect for persons is that individuals should be treated as being autonomous. Potential study participants should be given information about a study without undue influence or coercion, so that they can make a reasoned decision on their own. However, there are certain individuals who are particularly subject to influences that may limit their ability to make decisions freely (e.g., children and prisoners). They are considered to be vulnerable and are entitled to additional protections. Respect for persons is particularly relevant to the consent process.

In striving for beneficence, harm should be minimized and benefits maximized. Investigators should attempt to seek alternative ways of investigating hypotheses that would lead to a more favorable risk-benefit ratio.

Justice involves the equitable treatment of human subjects. Thus, care should be taken to avoid performing studies that might cause excessive risks or benefits for one group over another group. In other words, to the extent possible, risks and benefits should be equally distributed. Justice is highly relevant to the selection of research subjects for a study.

In accordance with the above ethical principles, in reviewing research studies, UM Institutional Review Boards must consider all of the following:

a.   The rights and welfare of the individual or group involved

b.   The minimization of risks to human subjects by using procedures consistent with sound research design

c.   The appropriateness of the procedures and methods employed to the aims, underlying hypotheses and goals of the research

d.   The adequacy and appropriateness of the consent form and the process by which consent would be obtained

e.   The medical, social or psychological risks to the subject and the reasonableness of these risks in relation to the anticipated medical and/or psychosocial benefits of the investigation, if any, to the subjects and the importance of the knowledge that may reasonably be expected to result

f.    The fairness and equitability of the inclusion of individuals according to race, ethnicity, gender, and age

These policies and procedures are based on the shared commitment by the University of Miami and its community of faculty, students, employees and affiliated individuals to the dignity and welfare of individuals who participate in its research. The ethical principles are fundamental to the University's conduct of research.

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