HUMAN SUBJECTS MANUAL
Institutional Review Board (IRB)
Revised
August 2, 2007
Revised
August 2, 2007
TABLE OF CONTENTS
Chapter 1. Introduction .. 1
Establishes the authority and rationale for a system
of human subjects protection in research and reviews the components of
1.1 Background and Rationale
1.2 Federal Regulations
1.3
Introduces the ethical standards governing the review and
conduct of research and discusses the various ethical codes that have laid the
groundwork for human subjects regulations.
2.1 Values and
Conflicts
2.2 Ethical Codes
2.3 The
2.4 Professional
Organizations
2.5 International
Codes
Chapter 3. Regulations 12
Provides an overview of the regulatory framework governing
institutions, IRBs, and researchers
3.1 The Common
Rule
3.2 Federal Agencies
3.3 Good Clinical Practice
3.4 State Regulations
3.5 Institutional Rules
3.6 Individual Responsibilities
Chapter 4. Principal Investigators Responsibilities . 17
Summarizes the responsibilities of Principal
Investigators (PI) as well as Faculty Sponsors and Student/Staff Researchers
4.1 Overview
4.2 Protocol
Development
4.3 Professional Judgment
4.4 Study Conduct
4.5 Administration
4.6 Research Personnel
4.7 Interaction with IRB
4.8 Informed Consent
4.9 Confidentiality
of Data
4.10 GSU Faculty Sponsors
4.11 Faculty Advisors
4.12 Student/Staff Researchers
4.13
Departmental Chairs Responsibilities
4.14 Education and Training
Defines the specific roles and functions of
5.1 GSUs IRB
5.2 IRB Membership
5.3 IRB Voting Requirements
5.4 IRB Decisions
5.5
Confidentiality of IRB Proceedings
Chapter 6. The Review Process
34
6.1 Review
Qualifications
6.2 IRB Review
6.3 Types of IRB Review
6.4 Full Review
6.5 Expedited Review
6.6 Exempt Review
6.7 Emergency Review
6.8 Appeals
6.9 Additional Considerations
6.10 Amendment/Modification Review
6.11 Adverse Events
6.12 Renewal Review
Chapter
7. Review Criteria
49
Presents the review criteria for
assessing human subjects research at
7.1 Harm
and Risk
7.2 Basic
Criteria
7.3 Additional
Criteria
7.4 Vulnerable
Populations and Special Protection
7.5 Research
Conducted Off-Site
7.6 Recruitment
of Participants
7.7 International
Research
7.8 Student
Projects
7.9 Pilot
Studies
7.10 Protection
of Data
7.11 Administrative
Study Withdrawals
Chapter 8. Informed
Consent
. 61
Lists the considerations and required elements of
informed consent
8.1 Introduction
8.2 Respect for Persons
8.3 Special Protections
8.4 Waiving the Requirement for Documented or Signed Consent
8.5 Special Considerations
8.6 Required Elements
8.7 Additional Elements
8.8 Consent Process
8.9 Consent Procedures Involving Minors
8.10 Documentation
Chapter 9. Post-Approval
Requirements
74
Details the post-approval
requirements for continuing IRB approval
9.1 Conditions of Approval
9.2 Principal Investigators Responsibilities
9.3 Privacy of Subjects
9.4 Changes and New Information
9.5 Reporting Adverse Events
9.6 Renewal Applications
9.7 Study Closure Reports
9.8 Auditing of Approved Protocols
Chapter 10. Social Behavioral Research
. 78
Explores
some of the common research issues faced in social and behavioral
research
10.1 Introduction
10.2 Study
Design
10.3 Involvement of Human Subjects
10.4 Risks and Benefits
10.5 Deception/Coercion
10.6 Privacy and Confidentiality
10.7 Oral Histories
Chapter 11. Protected Health Information
.. 92
The purpose of this module is to
provide researchers with the information they will need to comply with the
Privacy Rule associated with the Health Insurance Portability and
Accountability Act of 1998 (HIPAA), and other relevant state and federal laws.
11.1 Protected Health Information (PHI)
11.2 Authorization
(Consent) Requirements
11.3 Human
Subjects Rights
11.4 Subject
Recruitment
11.5 Resources
Chapter
12. Research Conduct
102
Many ethical questions are raised during the conduct of studies. This
chapter discusses some of the most commonly encountered
research conduct issues.
12.1 Conflict
of Interest
12.2 Privacy
and Confidentiality
12.3 Non-Compliance
Chapter One
INTRODUCTION
Purpose: Establishes the authority and rationale for a system of human
subjects protection in research and reviews the major components of
Sections: 1.1 Background and Rationale
1.2 Federal Regulations
1.3
1.1 Background
and Rationale
CDC Centers
for Disease Control and Prevention
DHHS Department
of Health and Human Sciences
FDA Food
and Drug Administration
HIPAA Health
Insurance Portability and Accountability Act
IRB Institutional
Review Board
NIH National
Institutes of Health
OHRP Office
for Human Research Protections
PI Principal
Investigator
FA Faculty
Advisor
FWA Federal
Wide Assurance
B. Definitions
Federal regulations have provided the following definitions:
RESEARCH - A systematic
investigation designed to develop or contribute to generalizable knowledge.
HUMAN SUBJECT - A living individual
about whom a researcher (whether professional or student) obtains
1.
data through intervention or interaction with the individuals, or
2.
identifiable private information, e.g., school transcripts.
Informally defined, Human
Subjects mean individuals whose responses are the object of study. Some
examples include:
·
individuals who are asked to complete questionnaires, participate
in interviews, or whose behavior is observed in daily activities;
·
participants in pilot studies;
·
when the data will be used for a research publication;
·
oral history interviewees whose subjective perceptions are
studied; and
·
students
and teachers observed in the classroom for the study of various teaching
methods or development of curricula
While scientific research has produced substantial social benefits throughout history, it has also posed some troubling ethical questions. Past abuses and violations of the rights and welfare of human subjects have resulted in various codes and regulations at the federal level. State and local regulations and institutional policies provide additional protection for research subjects. Together these laws and policies make up a system of human subjects protection.
D.
IRB History
1. Increased Federal Funding 1950s
and 1960s
Following the Second World
War, the amount of federal funding directed toward research in the
But with the increase of
federally funded studies came alarming ethical problems. Between 1966 and 1981,
in an era of development of civil and consumer rights, the framework for today's
system of protection of human subjects was set in place.
2. Assurance of Compliance and
Institutional Review Board - 1966
In 1966, Surgeon General
Stewart issued a very short memorandum, in which he said that any institution
receiving Public Health Service funding, which includes NIH funding, was
required to certify to the granting agency that it had reviewed the activity to
determine that human subjects would be adequately protected.
By this action, each recipient institution was required to assure that it had a functioning committee to review the applications. Thus, the current system with a Federal-Wide Assurance of Compliance establishing an Institutional Review Board (IRB) was begun.
1.2 Federal Regulations
A. 45 CFR 46 1974
The first federal regulations (45 CFR 46)
became effective in 1974 and formalized the system that was already working.
This system included institutional assurances, institutional committees, diversity
in membership, and very subjective and open-ended review criteria.
B. The
The National Commission on the
Protection of Human Subjects, which was appointed in 1974, is well remembered
for the publication of The Belmont Report. The Belmont Report is the
cornerstone statement of ethical principles for human subjects protection.
This and a series of reports on involvement of vulnerable subject populations
became regulation as sub-parts to the basic regulation.
C. 21 CFR 50 and 21 CFR 56 - 1981
During the same era, the Food and Drug Administration (FDA) requirements were developing. These regulations (21 CFR 50 and 56), first published in 1981, require that researchers seek approval from an IRB for investigational use of drugs, devices and biologics. The FDA review criteria, consent elements, and IRB membership were similar (but not identical) to those in 45 CFR 46.
D. The
Common Rule - 1991
In 1991, the various rules of seventeen federal agencies were reconciled and published in