DOE Human Subjects Resources

Creating an Ethical Framework for Studies That Involve the Worker Community

Suggested Guidelines

Prepared by
Human Subjects Protection Program
Office of Biological and Environmental Research, SC-72
Office of Science
U.S. Department of Energy

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Contents

Preface

Acknowledgements

Executive Summary

Chapter 1 - The Need to Protect Workers as Human Research Subjects
The physical, economic, and social risks faced by workers who are the subjects of workplace studies, as well as the application of the "Common Rule" to protect worker-subjects are described. A brief history of DOE occupational health studies is included. Worker studies, "research," and "non-research" are defined.

Chapter 2 - Foundations of an Ethical Framework
The principles of beneficence, justice, and respect for persons published in the Belmont Report are described. The importance of informed consent is explained, and criteria for obtaining informed consent are provided. The roles and constitution of Institutional Review Boards are described.

Chapter 3 - The Challenge of Genetic Information in Worker Studies
Challenges specific to the collection, management, and protection of individual genetic data are described. The differences between the use of genetic data for treatment versus generalized research are explained. Unique aspects of genetic data that must be addressed in the informed consent process, or that must be considered by Institutional Review Boards, are included.

Chapter 4 - Privacy, Confidentiality, and Protection of Personal Information
The importance of protecting the privacy of human research subjects is explained and federal regulations affecting the use and protection of worker-subjects' personal information are described. Explanations of "routine use," access to worker records, applicable "systems of records," and exceptions to the protection of data are presented.

Chapter 5 - Stakeholders: Their Interests, Concerns, and Responsibilities
The concerns and responsibilities of each typical stakeholder in worker studies are listed.

Chapter 6 - In Conclusion: Planning and Conducting Ethical Worker Studies
Guidelines and suggestions for planning and implementing worker-studies are presented. The choices of potential worker-subjects to participate are explained. A suggested model for a "clearinghouse" of study-related information, intended to avoid unnecessary replication of studies and anxiety among the worker-subjects, is described.

Appendices

A - Historical Background on Worker Health Studies at the Department of Energy
Protecting the health of workers has been a basic responsibility of government agencies and private industry. The history of DOE's worker health monitoring and maintenance programs is traced from the early days of the Manhattan Project to the present.

B - The NIOSH Approach to Workplace Studies
The National Institute for Occupational Safety and Health (NIOSH), as part of the Centers for Disease Control and Prevention, has conducted research on work-related illnesses and injuries since 1970. NIOSH's approach to defining "human research" is presented here.

C - Centers for Disease Control and Prevention's Guidelines for Defining Public Health Research and Public Health Non-Research
The Centers for Disease Control and Prevention has well established policies relating to, and definitions for public health research and non-research that are applicable to, worker health studies.

D - Update on Department of Energy Policy for the Protection of Human Subjects in Research
In 1998, the Secretary of Energy, Federicio Pena issued a statement on the DOE's policy relating to the protection of human subjects in research.

E - Access Handbook, Conducting Health Studies at Department of Energy Sites, Appendix 2: DOE/CDC Institutional Review Board Procedures
Provides procedures for IRB review of health research and related studies at DOE facilities when the study is managed by the Department of Health and Human Services (HHS) under the Memorandum of Understanding (MOU) between HHS and DOE.

F - Conducting a Worker Health Study at a Department of Energy (DOE) Site by Non-DOE Agencies
This brief discussion clearly defines the requirement for submitting worker health and research study protocols to both the researchers and the site IRBs.

G - Professional Codes of Ethics
Codes of ethics developed by the American College of Occupational and Environmental Medicine, the Human Factors and Ergonomics Society, the International Society for Experimental Epidemiology, and the Council for International Organizations of Medical Sciences are provided as examples of ethics guidelines relating to the protection of human subjects in research.

H - Executive Order 13145: "To Prohibit Discrimination in Federal Employment Based on Genetic Information"
The complete text of President Clinton's executive order to prohibit discrimination in federal employment based on genetic information also provides a definition of genetic monitoring.

I - Office for Protection from Research Risks: Issues to Consider in the Research Use of Stored Data or Tissues
The Department of Health and Human Services, Office of Protection from Research Risks, defines regulatory requirements, policies, and guidelines for the collection, storage, and distribution of human tissue samples for use in research.

J - Protecting Workers Who are Human Research Subjects
This pamphlet, prepared by the Department of Energy, describes the rights, concerns and protections to be afforded workers who are the subjects of workplace studies.

K - Bibliography and Resources
References used in this document are listed and identified, and a list of Internet Web site addresses is also provided.

L - Department of Energy Order (DOE O) 443.1B, Protection of Human Research Subjects
The order establishes Department of Energy (DOE) procedures and responsibilities for implementing the policy and requirements set forth in Title 10 Code of Federal Regulations (CFR) Part 745, Protection of Human Subjects, 45 CFR Part 46, and the Secretarial Policy Memorandum on Military or Intelligence-Related Human Subject Research, December 9, 2009.

Attachments

  1. A Bill of Rights for Human Subjects Participating in Research
    (Example: ""Pacific Northwest National Laboratory, Research Subject's Bill of Rights")
  2. Announcement of Worker Study Information Sent to Site Media, Workers, the Community, and All Stakeholders
    (Example: "Announcement - Hanford Former Workers Medical Surveillance Program")
  3. A Site Overview of Health Studies and Medical Screening Programs
    Example: "Announcement - Hanford Health Studies - RL No. 98-049")
  4. Information Sent to Employees on Exposure to Beryllium
    (Example: "ES&H Exchange - Beryllium, January 13, 1998")
  5. Study Fact Sheet
    (Example: "Beryllium Fact Sheet")
  6. Invitation to Workers to Participate in a Worker Study Screening Program
    (Example: "Hanford Building Trades Medical Screening Program - Letter of Invitation")
  7. Information Pamphlet for Workers on Phase I of a Medical Screening Program
    (Example: "Hanford Former Workers Project - Medical Monitoring Project - Phase I - Needs Assessment")
  8. Information Pamphlet for Workers on Phase II of a Medical Screening Program
    (Example: "Hanford Former Workers Project - Phase II Medical Surveillance Program - Worker Identification)
  9. Building Trades and Their Policies and Procedures About Worker Interviews
    (Example: " Hanford Building Trades Medical Program - Policies and Procedures Governing Interviews")
  10. Informed Consent for Workers to Participate in an Occupational History Survey
    (Example: "Informed Consent to Participate in the Work History Questionnaire")
  11. An Occupational History Survey for Workers
    (Example: "Hanford Former Worker Study - Occupational History Survey Part 1 - Personal and General Health Information")
  12. Letter to Workers to Report Occupational History Interview Findings and Recommend a Medical Examination
    (Example: "Letter to Participants with Findings of Risk after the Work History Questionnaire")
  13. Letter to Workers to Report Occupational History Interview Findings and Recommend That No Medical Examination Take Place
    (Example: "Letter to Participants with No Adverse Findings Following the Work History Questionnaire")
  14. Medical Surveillance Procedures for Former Construction Workers
    (Example: "Medical Surveillance of Former Construction Workers at the Hanford DOE Facility" )
  15. Informed Consent for Workers to Participate in a Medical Examination
    (Example: "Informed Consent to Participate in a Medical Examination")
  16. Letter to Workers Reporting the Results of Their Medical Examination
    (Example: "Pacific Family Medicine, October 6, 1998")
  17. Form Authorizing Physicians to Release Private Information Gathered During the Worker's Medical Examination
    (Example: "Authorization to Release Medical Information")
  18. Data Management Plans, or the Measures Taken to Protect Personally Identifiable Information
    (Example: "Data Management Policies and Procedures")
  19. The Coordinated IRB Review, or the Process Used When Multiple Institutional Review Boards are Involved
    (Example: "University of Washington - Subject: IRB Coordinated Review" [UW 28-0167-C] [PNNL IRB 97-2]

Content reviewed: May 7, 2012