Chapter
SCIENTIFIC AND ETHICAL APPROACHES FOR OBSERVATIONAL EXPOSURE STUDIES
Chapter 1 INTRODUCTION, PURPOSE, AND SCOPE
1.1. Observational Human Exposure Studies
1.2. Ethical Issues in Observational Human Exposure Studies
1.3. Purpose of this Document
1.4. Process for Developing the Document
1.5. Organization of the Document
Chapter 2 ELEMENTS TO BE CONSIDERED IN STUDY CONCEPTUALIZATION AND PLANNING
2.1. Scientific Value of a Proposed Observational Human Exposure Study
2.1.1. Defining the Study Problem
2.1.2. Justifying the Study
2.1.3. Identifying a Research Team To Plan and Implement the Study
2.2. Ensuring Scientific Validity of the Research Study
2.2.3. Sample Size Determination
2.2.4. Representativeness of the Sample
2.2.5. Information Collection Rule
2.2.6. Quality Assurance Project Plan
2.2.7. The Study Design Document
2.3. Ethical Issues in Ensuring Fair Subject Selection
2.4. Ensuring a Favorable Risk-Benefit Ratio
2.4.1. Designing in Benefits for the Participants
2.4.2. Assessing Benefits and Risks of Study Participation
2.5. Independent Scientific and Ethical Review
2.5.1. Scientific Peer Review
2.5.2. Conflicts of Interest
2.5.3. Develop the Human Subjects Protocol for IRB Review
2.5.5. Internal EPA Review of Scientific and Ethical Issues
2.7. Ensuring that Participant Behaviors are not Changed Adversely Because of Being in the Study
2.8. Criteria and Standards for Monitoring Scientific and Ethical Issues
Chapter 3 ENSURING PROTECTION OF VULNERABLE GROUPS
3.1. Identification of Vulnerable Groups
3.2. Justification for Involving Vulnerable Persons in Observational Research
3.3. Minimal Risk and Vulnerable Groups
3.4. Research Involving Children
3.5. Women as Research Subjects
3.6. Other Potentially Vulnerable Groups
Chapter 4 PRIVACY, CONFIDENTIALITY, AND OTHER CONCERNS RELATED TO OBSERVATIONAL HUMAN EXPOSURE STUDIES
4.2.1. Confidentiality of Information
4.2.2. Confidentiality of Participation
4.3. Collateral Observations
4.3.1. Potential Nonstudy Hazards in the Residence
4.3.2. Collateral Observations with Mandated Reporting Requirements
4.3.3. Hazard Communication
4.3.4. Planning and Staff Training
4.4.1. Determining Whether a Third Party Is a Human Subject
4.4.2. Informing Third Parties of Research Activities
4.4.3. Research Results and Third Parties
4.5. Data and Safety Monitoring and Oversight
Chapter 5 CREATING AN APPROPRIATE RELATIONSHIP BETWEEN THE PARTICIPANT AND RESEARCHER
5.1.3. Voluntary Participation
5.2. Payments to Research Participants
5.2.1. Types and Amounts of Payments Offered in Research Studies
5.2.2. Regulations and Guidance Regarding Payment to Research Participants
5.2.3. Payments When Children or Other Vulnerable Populations Are Involved
5.2.4. Payments in Observational Human Exposure Studies
5.3. Research Rights and Grievance Procedures
5.3.2. Community Advisory Board
5.4. Creating a Supportive Environment for Research and Interaction
5.5. Recruitment Strategies
5.6. Retention Strategies
5.7. Ensuring Recruitment or Retention Methods will Not Lead to Unacceptable Risk
Chapter 6 BUILDING AND MAINTAINING APPROPRIATE COMMUNITY AND STAKEHOLDER RELATIONSHIPS
6.1. Approaches to Community Involvement
6.2. Issues in Community Involvement
6.2.1. Defining “Community”
6.2.2. Identifying Who Represents the Community
6.2.3. Building Relationships and Trust
6.2.4. Importance of Language and Communications with the Community
6.2.5. Recognizing and Addressing Cultural Differences
6.2.6. Honesty, Power Relationships, and Partnerships
6.2.7. Building a Lasting Infrastructure
6.3. Community Involvement in Observational Human Exposure Studies
6.4. Identifying and Interacting with Other Stakeholders
Additional Information Resources
U.S. EPA, Office of Environmental Justice Resources
Chapter 7 DESIGNING AND IMPLEMENTING STRATEGIES FOR EFFECTIVE COMMUNICATION
7.1. Communication Strategy and Implementation Plan
7.2. Individuals and Groups Involved in the Communications
7.3. Communications Timetables When to Communicate
7.4. Communicating at Different Levels
7.5. Communications Materials
7.6. Informing the Study Participants and Communities
7.7. Reporting Study Results to the Participant and Community
7.8. Reporting Unanticipated Results or Observations
7.9. Anticipating and Responding to Criticism
7.10. Responding to the Media, Public Inquiries, and Other Stakeholders
Additional Information Resources
Appendix A. Additional Discussion of Observational and Exposure Terminology and Examples of Previous NERL Observational Human Exposure Studies
Regulatory Distinction between Intentional Exposure and Observational Research
Examples of NERL Observational Human Exposure Studies
Appendix B. The Process for Development of this Document: Description of the Expert Panel Workshop (November 28 and 29, 2006), the External Peer Review by the HSRB (October 21-24, 2007), and Public Comment
Review by the EPA Human Studies Review Board and Public Comment
Draft Document on Scientific and Ethical Approaches for Observational Exposure Studies Charge to the Human Studies Review Board (October 4, 2007)
Charge to the Human Studies Review Board
Appendix C. Recommended Content of a Human Subjects Protocol
Items Relevant to Observational Human Exposure Studies
Appendix D. Recommendations for Enhancing Public Trust
Building Trust Through Community Partnerships
Building Relationships with Patients (Participants) (True partnerships with patients may not be possible, but bidirectional relationships must be enhanced.)
Building Partnerships with Community Providers
Building Trust in Scientists
Building Trust in the NIH and Scientific Research
Appendix E. List of Acronyms and Abbreviations
Scientific and Ethical Approaches for Observational Exposure Studies
( Public Health in the 21st Century )
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