Course Outline

PART I
(Note: Depending on the lecturer, discussion of Utilitarianism, Kantianism, ethical issues involving the media may also be covered)

1. The NIH Requirement
NIH Notice OD-00-039

2. Historical Developments Which Led to the Current Legislation

3. OHRP/FDA Shutdowns of Major Research Programs

PART II

I. Definitions

What is research?
What is clinical research?

II. Belmont Report

A . Beneficence

1. Do not harm
2. Minimize risk, maximize benefit

a. What's a benefit?
b. What's a risk? How do you minimize it?

B. Justice

1. Inclusion/exclusion criteria
2. Women, minorities, minors
3. Social justice
4. Justifiable exclusions
5. Inclusion of women of child-bearing potential

C. Respect for persons:

1. treat people as individuals; general consent discussion
2. protection of vulnerable populations, e.g., minors, populations with diminished
    capacity
3. Deception: Ethical?

III. CORIHS Jurisdiction: 45CFR46

A. Assurance of Compliance: M1036-01

B. FDA Regulations (general discussion):

21 CFR 50, 56, 312, 600, 812

C. Subparts

1. Subpart A: Federal Common Rule
2. Subpart B: Additional Protections: Fetuses, Pregnant Women, and Human
     In Vitro Fertilization
3. Subpart C: Additional protections pertaining to prisoners
4. Subpart D: Additional protections pertaining to use of children as subjects

IV. CORIHS Submission Requirements

V. Review Categories

A. Exempt Review Category 45CFR46.101

1. Exempt Review Procedure

B. Expedited Review Category 45 CFR 46 110

1. Expedited Review Procedure

C. Full Committee Review and Procedure

VI. Criteria for IRB Approval 45 CFR 46.111

VII. Responsibilities of CORIHS-approved Investigators

VIII. Continuing Review

A. Renewal of Approval
B. Amendments
C. Adverse Events

IX. Consent

A. Mandated Elements of Informed Consent 45CFR46.116,7

B. Waiver/alterations of informed consent , OHRP, FDA

C. Waivers of documentation of informed consent , OHRP, FDA

D. Role of the Person Obtaining Consent

E. The Consent Process

F. Capacity to Consent

1. Criteria for capacity
2. Characteristics of diminished capacity
3. Independent assessment of capacity
4. Confirmed diminished capactiy and Surrogate consent

a. allowable types of research
b. allowable surrogates

X. Biological Specimens

A. Moore Case
B. Retrospective vs. Prospective Collections
C. Anonymous vs. Identifiable/Coded
D. Risks in research involving biological specimens
E. Rights of subjects who are the sources of tissue

XI. Conflict of Interest

A. The ethics of 'Per patient' $$ from drug companies

1. USB 'checks and balances'

C. Financial interests of the Investigator

1. 'SUNY -2' process

Updated:  2005-06-02