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CHAPTER 2
FOUNDATIONS OF AN ETHICAL FRAMEWORK
Key Points:
- The rights and welfare of workers are protected when everyone involved in worker studies understands and applies the Common Rule and the ethical principles of beneficence, justice, and respect for persons as described in The Belmont Report and many professional codes of ethics.
- It is expected that workers who are asked to participate in a study must not face coercion or reprisal for their decision to participate, not to participate, or to withdraw from a study. In the informed consent process, they must receive adequate and understandable descriptions of the study purpose, what is expected of them, why they were selected, and any benefits and risks they may experience if they choose to participate.
- All worker studies should undergo local review by an Institutional Review Board familiar with both the work force and the workplace.
Establishing the Foundation
The Belmont Report: The Principles of Beneficence, Justice, and Respect for Persons
The Belmont Report, issued in 1978 by the National Commission for the Protection of Human Subjects, provides the ethical basis for worker studies. The report identifies the fundamental ethical principles that should govern research involving human subjects—the broad principles of beneficence , justice , and respect for persons. These principles, as defined in The Belmont Report, apply to all research studies involving human subjects, including those carried out in occupational settings.
- Beneficence is the obligation to do no harm to persons and to protect them from harm by maximizing possible benefits and minimizing possible risks. Researchers must acknowledge that damage in the form of discomfort and harm can take place at the physical, emotional, social, and/or economic levels. In worker studies, as in others, there is a tendency to discount emotional, social, and economic stress factors, in part, because they are difficult to assess.
There are five levels of discomfort or harm that a researcher should consider when assessing the effects of a worker-study. There may be: (1) no anticipated effects, (2) temporary discomfort that ceases with the termination of the study (sometimes called minimal risk), (3) unusual levels of temporary discomfort typically lasting beyond the study termination, (4) risk of permanent damage, and (5) certainty of permanent damage.
- Justice is the mandate requiring fairness in the distribution of burdens and benefits that is often expressed in terms of treating persons of similar circumstances or characteristics similarly. Injustice occurs when the selection of subjects results in an uneven distribution of risks or benefits. Researchers should avoid inappropriate, or the appearance of inappropriate, exclusion. For example, the exclusion of workers based on gender or raceoften explained away due to small sample sizemight introduce what is, or is perceived to be, a bias on the part of the researchers or funding agencies, or it may yield skewed scientific results.
- Respect for persons is essential to ensure that individual autonomy is respected and that those persons with diminished capacity are protected. In order to preserve autonomy, subjects must be fully informed about a study before it begins. Covert data collection, deception, and misinformation all deny autonomy.
Another way in which autonomy may be denied is through coercion—real or perceived. Coercion is the threat of physical, economic, or social harm but can also take the form of excessive reward for participation. Workers must be free to
The Belmont Report , issued in 1978, defines three basic principles that apply to all research involving human subjects. These are the principles of beneficence , justice , and respect for persons.
Another factor affecting worker studies is that health-related occupational research is often conducted with a worker population bound by a contract that establishes obligations upon both employers and employees. This contract will influence the way the research is conducted. It will also influence the worker’s attitude, perception, and response to an “offer” to participate in such studies. Moreover, the very fact that a health study is being conducted, regardless of outcome, can cause employees to perceive a threat to their present or future employment.
Criteria for the Informed Consent Process and Documentation
A well-designed process for obtaining informed consent will, at a minimum, meet the criteria established by the following questions:
- Has the researcher provided a comprehensive description of the research in lay terms?
- Has the worker had time to consider the proposal?
- Has a knowledgeable person—able to assure worker understanding—explained details of the worker’s participation and study procedures?
- Have foreseeable risks or discomforts been presented in a realistic, open way that encourages questions from the worker? Have the possibilities of unforeseen risks been explained?
- Does the worker understand how the research methods will protect subjects from physical, social, or economic risks arising from the study?
- Have benefits to the subject and/or the public been explained?
- Where applicable, have alternative courses of treatment been explained to the worker?
- Has compensation for cost to subjects been addressed?
- Is a feedback system in place to keep workers informed of progress and results?
- Has the worker’s preference for right to know, or not know , individual study results been determined?
- Has the worker been assured that best efforts will be made, though not completely guaranteed, to maintain confidentiality (the extent to which confidentiality can be protected) and privacy (up to the defined limits)?
- Does the worker understand the use of pre-existing data or previously collected tissue samples and any foreseeable potential future use of data and/or tissues?
- Has the worker been assured that participation is voluntary and that he or she has the freedom to withdraw at any time without penalty or loss of benefits to which he or she is entitled?
- Does the worker understand what recourse he or she has should participation be coerced?
- Have the project manager, principal investigator, IRB contact, and counselor been identified and their functions described?
- Has a copy of the consent form been provided to the worker?
- Has the worker been given the name and telephone number of someone to contact about questions or concerns?
Other mechanisms to facilitate coordination between two IRBs may include a memorandum of understanding that clearly defines the primary IRB authorities and responsibilities. When a local IRB is presented with numerous worker studies, a subcommittee of the established IRBΧor a separately constituted IRB—may be established to review and approve studies where two IRBs are involved.
Regardless of its role, each IRB should have among its members at least one person not affiliated with any of the stakeholders and at least one worker-member from the worker- study population. Expert counsel can and should be used for all situations in which the IRB membership is not able to address an issue adequately.
Codes of Ethics
Existing professional codes of ethics also provide useful models, ideas, and references that can be used to: (1) develop worker study programs and approaches for addressing the risks to workers, (2) measure research professionals against their own codes, or (3) provide guidance in developing new codes. Examples include the codes of the American College of Occupational and Environmental Medicine, the Human Factors and Ergonomics Society, the International Society for Environmental Epidemiology, and the Council for International Organizations of Medical Sciences (see Appendix E). However, none of the current professional codes fully address the special needs and issues of worker studies, and new models need to be created.
