4

Risk Acceptance and Responsibilities in Human Spaceflight and Terrestrial Activities

Society demonstrates a willingness to tolerate high levels of risk to individuals who participate in certain types of activities. Every day, firefighters, law enforcement officers, other first responders, and military service members put their lives and health at risk in defense of persons, property, national security, or other compelling public interests. Other individuals volunteer to participate in biomedical research, which can pose significant health and safety risks. Additionally, many individuals engage in other high-risk occupational and recreational activities with limited external oversight.

As described in Chapter 1, the National Aeronautics and Space Administration (NASA) asked the Institute of Medicine (IOM) to convene the Committee on Ethics Principles and Guidelines for Health Standards for Long Duration and Exploration Spaceflights to identify ethics principles and develop an ethics and policy framework to guide decisions about long duration and exploration space missions, when risks associated with working conditions fail to meet current health standards or when uncertainty prevents development of adequate health standards. As part of its charge, the committee was asked to identify “models or examples of other situations with unknown health risks (or risks that could exceed current standards) that could inform NASA policy and, if so, how?”

In identifying other occupations and situations from which to draw, the committee considered the multiple roles of astronauts and NASA. As key figures in high-risk missions, astronauts concurrently serve a multitude of roles and responsibilities. Astronauts are employed as part of a mission crew, operating as a team to minimize risks to individuals and improve the likelihood of mission success. Each NASA crew performs a variety of mission functions, which may include flight management,



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4 Risk Acceptance and Responsibilities in Human Spaceflight and Terrestrial Activities Society demonstrates a willingness to tolerate high levels of risk to individuals who participate in certain types of activities. Every day, fire- fighters, law enforcement officers, other first responders, and military service members put their lives and health at risk in defense of persons, property, national security, or other compelling public interests. Other individuals volunteer to participate in biomedical research, which can pose significant health and safety risks. Additionally, many individuals engage in other high-risk occupational and recreational activities with limited external oversight. As described in Chapter 1, the National Aeronautics and Space Ad- ministration (NASA) asked the Institute of Medicine (IOM) to convene the Committee on Ethics Principles and Guidelines for Health Standards for Long Duration and Exploration Spaceflights to identify ethics princi- ples and develop an ethics and policy framework to guide decisions about long duration and exploration space missions, when risks associat- ed with working conditions fail to meet current health standards or when uncertainty prevents development of adequate health standards. As part of its charge, the committee was asked to identify “models or examples of other situations with unknown health risks (or risks that could exceed current standards) that could inform NASA policy and, if so, how?” In identifying other occupations and situations from which to draw, the committee considered the multiple roles of astronauts and NASA. As key figures in high-risk missions, astronauts concurrently serve a multi- tude of roles and responsibilities. Astronauts are employed as part of a mission crew, operating as a team to minimize risks to individuals and improve the likelihood of mission success. Each NASA crew performs a variety of mission functions, which may include flight management, 75

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76 LONG DURATION AND EXPLORATION SPACEFLIGHT operations, repairs, retrievals, and research (such as medical experi- ments). Beyond mission-related responsibilities, astronauts serve in a number of public roles, including federally sponsored explorers. Given that space missions are pursued for public good by a federal agency, astronauts are also public servants. Astronauts often participate in re- search as investigators and also as research volunteers. Similarly, NASA, as a federal agency, plays numerous roles (e.g., employer, research spon- sor, international partner, and science educator) and bears responsibilities to various stakeholders with interests in space exploration. The presence of highly uncertain and unquantifiable health and safe- ty risks is not unique to human spaceflight. Many domains have negoti- ated similar challenges in decision making about risk acceptability. However, the degree to which ethics principles are incorporated into a formal decision record varies greatly by occupational domain and profes- sion within a domain. The committee consulted the scientific literature about existing frameworks and spoke with many experts in other high- risk occupations, but was not able to identify existing ethics frameworks or decision-making models for specific occupations that were directly and wholly applicable to decisions about health standards for long dura- tion and exploration spaceflight. From existing ethics frameworks and available occupational health standards, the committee sought to identify common factors that could be used to inform committee deliberations about ethics principles and frameworks. The committee found examples in occupational health, re- search, and exploration that provided useful points for comparison. The first three sections of this chapter examine these domains for useful ex- amples of risk management strategies and duties and, to some extent, identify relevant societal interests. The last section draws from these ex- amples to categorize and synthesize examples of common factors that ap- pear to influence decisions about risk management in terrestrial settings. This chapter does not provide an exhaustive list of occupations and activities that involve high risk to participating individuals. Rather, it provides a few key examples that were selected based on characteristics that are applicable to human spaceflight and because they provide useful insights about the types of factors that may affect decisions related to risk management. Additionally, the factors identified are meant to be illustra- tive and not an exhaustive list of all factors that could be relevant to dis- cussions about the risks of human spaceflight.

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RISK ACCEPTANCE AND RESPONSIBILITIES 77 RISK MANAGEMENT IN THE WORKPLACE Efforts to protect the welfare of workers in the United States have been documented since the late 19th century and have led to significant improvements in worker health protections. As described by some in the literature, occupational health regulations and standards “aim to promote and maintain the highest degree of physical[,] mental and social well- being of workers in all occupations; to prevent decline in health caused by their working conditions; to protect workers in their employment from risks resulting from factors adverse to health; and to place and maintain workers in an occupational environmental adapted to their physiological and psychological capabilities” (Serra et al., 2007, p. 304). In many high- risk occupations, health regulations and standards, in addition to serving the interests of individual workers, may also protect the health and safety of others (including bystanders and co-workers), equipment and proper- ty, and the integrity of the work enterprise. Depending on the specific job hazards, employers (including NASA) use a multi-tiered approach to comply with established exposure limits and health and safety regulations. Employees also may be obligated to comply with these regulations and limits, without an option to waive mandatory employee protections, using a variety of techniques and con- trols, such as: • Elimination of the hazard or substitution of less hazardous mate- rials in the work process; • Engineering controls and redesign of the work environment to limit exposure (e.g., ventilation, enclosure and/or isolation of emission source, process control); • Administrative controls (e.g., length of work in a particular area, decision protocols); and • Personal protective equipment and adequate training on correct use (e.g., respirators and gloves worn by firefighters). As an agency involved in high-risk activities, NASA is responsible for astronaut candidate selection and training, resource allocation, risk and research prioritization, determining mission feasibility (taking into account available resources and technological capabilities), and deciding whether associated risks to astronauts, crews, and programs are accepta- ble. Like other analogous high-risk professions, spaceflight involves sub-

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78 LONG DURATION AND EXPLORATION SPACEFLIGHT stantial risk to the short- and long-term health of individuals during ground-based training and during missions, due to numerous uncertain or uncontrollable variables. The space environment includes unique and sometimes unpredictable hazards, including prolonged isolation, reliance on a closed environment, limited basic resources, and high levels of radi- ation (IOM, 2001). These conditions can have profound and, sometimes, lasting effects on an astronaut’s physical, physiological, or psychological health, as described in Chapter 3. NASA actively engages astronauts dur- ing all phases of their training and work in issues regarding health and safety and provides regular updates related to risks associated with spaceflight (Behnken, 2013). Astronauts may choose not to participate in a specific mission, and this decision should have few, if any, repercus- sions for inclusion on future missions (Behnken, 2013). Workplace Risk Management by OSHA and NASA In 1970, the Occupational Safety and Health Act (OSH Act) was en- acted to “ensure safe and healthful working conditions for every working man and woman in the nation insofar as practicable, [so] that no workers will suffer diminished health, functional capacity or life expectancy as a result of their work experience.” 1 To implement this legislation, Con- gress mandated the creation of the Occupational Safety and Health Ad- ministration (OSHA) within the Department of Labor. OSHA promotes worker safety and health through multiple approaches, including the es- tablishment and enforcement of health standards and regulations restrict- ing workplace exposures and mandating exposure and health monitoring, training, and information dissemination. The OSH Act also created the National Institute for Occupational Safety and Health (NIOSH), which conducts research and makes practical recommendations to prevent worker injury, illness, and death (CDC, 2013). OSHA regulations apply to many occupations including those in general industry, agriculture, maritime, and construction; however, OSHA regulations do not cover all workers. OSHA does not have over- sight over self-employed persons, employees of state and local govern- ments (unless covered through an OSHA-approved state plan, which operates under state jurisdiction), or other federal agencies that regulate worker safety under the authority of other federal laws (including work- 1 The Occupational Safety and Health Act of 1970, P.L. 91-596 (December 29, 1970).

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RISK ACCEPTANCE AND RESPONSIBILITIES 79 places in nuclear energy and weapons manufacture, mining, railroad, and aviation). NASA is authorized by the National Aeronautics and Space Act of 1958 “to make, promulgate, issue, rescind, and amend rules and regula- tions governing the manner of its operations and the exercise of the pow- ers vested in it by law”2 related to the planning, direction, and conduct of aeronautical and space activities.3 This effectively exempts NASA from OSHA regulations and authorizes the agency to use its own discretion for programmatic activities, including “health and medical policies and standards that ‘regulate’ aircrew and space flight crew selection, qualifi- cation, and health-related requirements in NASA research aircraft and spacecraft” (Williams, 2013). However, NASA follows OSHA regula- tions for its ground workforce (Williams, 2013). For example, NASA’s Johnson Space Center has qualified for OSHA’s Voluntary Protection Program Star Rating (NASA, 1999; DOL, 2014), reflecting compliance with OSHA standards and periodic audits. For spaceflight, NASA has developed its own safety and health standards, as discussed throughout this report (NASA, 2007, 2011). When not preparing for or actively par- ticipating in space missions, astronauts may be engaged in more tradi- tional occupational roles at NASA such as program development, operations, and management, and OSHA regulations apply to them as to all other NASA employees. It is important to note that—unlike OSHA and NIOSH where re- sponsibilities for regulation and policy research are separate from en- forcement activities—NASA is tasked with assessing, evaluating, developing, and enforcing standards and regulations related to the health of its active astronauts, among other obligations. As described in Chapter 1, NASA is tasked with studying the potential benefits and problems asso- ciated with aeronautical and space activities,4 which include risks to, or impacts on, human health. In this context, NASA functions may be more similar to those of the military in that research, regulatory development, and enforcement are all within the purview of the military. 2 51 U.S.C. 20113(a). 3 The National Aeronautics and Space Act of 2010, P.L. 111-314 (December 18, 2010). 4 The National Aeronautics and Space Act of 1958, P.L. 85-568 (July 29, 1958).

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80 LONG DURATION AND EXPLORATION SPACEFLIGHT Health Standards One mechanism by which to manage occupational risk includes health standards, which are subject to revision based on new scientific data and require ongoing assessment. As discussed in Chapter 2, health standards may be used to protect workers; guide design, research, and engineering activities; stimulate innovation; serve as criteria for job re- quirements; and provide a condition for collaborative efforts. For exam- ple, some standards are relevant to worker selection or assessment of ongoing fitness for the job, which may involve periodic health monitor- ing. Other health standards protect against exposure to harmful physical agents or work environments during the course of employment and are intended to provide both immediate protection against acute injury and lifetime protection against harm. Health standards may be mandatory (e.g., OSHA standards) or voluntary, although often accompanied by significant incentives for compliance (e.g., the National Fire Protection Association’s [NFPA’s] standards5 or OSHA’s meatpacking guidelines). NASA’s health standards were developed to promote “a healthy and safe environment for crewmembers, and to provide health and medical programs for crewmembers during all phases of space flight,” and in- clude fitness-for-duty standards, space permissible exposure limits, and permissible outcome limits (NASA, 2007, p. 8). Although NASA’s health standards are unique to spaceflight, they are specific manifesta- tions of workplace protections more generally provided for workers. Those protections reflect broader ethical and legal determinations con- cerning risk acceptance within the occupational domain. The following sections explore examples of fitness-for-duty standards and exposure limits in terrestrial settings. Fitness-for-Duty Standards Many high-risk occupations require both applicants and current members within a profession to meet specific fitness-for-duty standards, which typically assess “whether an individual is fit to perform his or her tasks without risk to self or others” (Serra et al., 2007, p. 304) and are based on the definition of essential job functions within a given profes- 5 Some state OSHA rules may incorporate language from otherwise voluntary standards (e.g., NFPA standards), effectively mandating compliance (see, e.g., Alabama Municipal Insurance Corporation and Municipal Workers Compensation Fund, Inc., no date).

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RISK ACCEPTANCE AND RESPONSIBILITIES 81 sion. For example, NFPA has set health standards that apply to both fire- fighter candidates as well as incumbents (i.e., current members within a profession) (NFPA, 2013a). Fitness-for-duty standards are also used by law enforcement (Quigley, 2008; Fischler et al., 2011), the military (NRC, 2006), and interstate truck drivers.6 In addition to physical stand- ards, fitness-for-duty evaluations may also include psychological evalua- tions and mental capacity screenings, especially in jobs with high psychological demands, such as law enforcement (Fischler, 2011) and the military (NRC, 2006), including submarine crews (Kennedy and Zillmer, 2012). The stringency with which medical and physical ability standards apply may differ for job candidates versus active members of a profes- sion. For example, NFPA draws a distinction between health standards for candidates and incumbents, stating that the “intent with incumbents with a medical condition is to rehabilitate them and only restrict them from performing those essential job tasks where their injury or illness would affect the safety of themselves or others on their crew” (NFPA, 2013a, p. 1). The Air Force has a similar approach to fitness-for-duty standards applicable to current fighter and test pilots. In essence, the Air Force’s fitness-for-duty standards serve as a baseline for entry into a field with a waiver process to allow individuals to continue to work, if approved, with some medical conditions (U.S. Air Force, 2013). Limiting Hazardous Exposures A number of federal agencies set exposure standards or guidelines relevant to the hazards and occupations, including the Nuclear Regulato- ry Commission7 and Federal Aviation Administration,8 as well as NASA (NASA, 2007). OSHA sets workplace permissible exposure limits (PELs) for a variety of chemicals and other hazards. For example, OSHA’s lead standard limits the conditions under which an individual is allowed to work when lead is present in the work environment. OSHA’s PEL for lead is 50 micrograms per cubic meter of air as an 8-hour, time- weighted average. 9 If an employee’s lead exposure exceeds the estab- lished PEL more than 30 days per year, the employer is required to im- 6 49 C.F.R. 391.41. 7 See, e.g., 10 C.F.R. 20, Subparts C and D. 8 See, e.g., 14 C.F.R. 25.832. 9 29 C.F.R. 1910.1025(c)(1).

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82 LONG DURATION AND EXPLORATION SPACEFLIGHT plement engineering and work practice controls (including administrative controls) to meet the exposure level, factoring in feasibility.10 Respirators must be used to supplement engineering and work-practice controls when these are insufficient to reduce exposure below the PEL. 11 The standard also requires employers to continually monitor employee expo- sures when baseline levels are exceeded and notify employees about ex- cessive risk exposures and subsequent corrective actions. Health standards may also require specific employer or employee ac- tion based on individual clinical observations if poor health outcomes may be linked to specific occupational exposures. For example, OSHA’s hearing protection standard states that if required audiograms show a “standard threshold shift” in hearing potentially related to occupational noise exposure, the employer must provide hearing protectors even if the noise exposure is within required limits.12 Federal agencies may also have significant latitude in determining what health standards are necessary to address a specific risk or hazard. For example, OSHA’s occupational and health standards must be “rea- sonably necessary or appropriate to provide safe or healthful employ- ment and places of employment.”13 The U.S. Supreme Court has held that “reasonably necessary” requires OSHA to demonstrate a “signifi- cant” risk to employees that can be eliminated or lessened by a change in practices, with two important qualifications. First, OSHA is not required to establish a “significant risk” with scientific certainty. 14 Instead, the agency can regulate on the basis of the best available evidence.15 Second, OSHA is responsible for determining what constitutes a “significant risk.” 16 In its review of OSHA’s benzene standard, the U.S. Supreme Court characterized broad dimensions of significant risk in terms of ac- ceptable and unacceptable risk, stating that, for carcinogens, a reasonable person would find a fatality risk between 1/1,000 (“plainly unaccepta- ble”) and 1/1,000,000,000 (“plainly acceptable”) over a working lifetime to be significant. 17 The wide range between “acceptable” and “unac- 10 29 C.F.R. 1910.1024(e)(1)(i). In these cases, the employer must reduce exposures to the lowest feasible level and must comply with additional respiratory protection requirements. 11 29 C.F.R. 1910.1025(f)(1)(ii). 12 29 C.F.R. 1910.95(j)(3). 13 29 U.S.C. 652(8). 14 Industrial Union Dep’t v. American Petroleum Institute, 448 U.S. 607, 656 (1980). 15 29 U.S.C. 655(6)(b)(5). 16 Industrial Union Dep’t v. American Petroleum Institute, 448 U.S. 607, 655 (1980). 17 29 U.S.C. 655(6)(b)(5).

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RISK ACCEPTANCE AND RESPONSIBILITIES 83 ceptable” risk, as defined by the U.S. Supreme Court, leaves ample room for philosophical debate. Although health standards are generally set based upon reasonably mature scientific knowledge, establishing health standards may be challenging in the context of a high degree of risk un- certainty. Monitoring and Surveillance Programs The threat of harm from specific exposures may trigger specific monitoring and surveillance efforts. In some cases, the federal govern- ment has committed to long-term research to better understand the risks of certain workplace exposures and to provide long-term screening for possible adverse health effects. During the Deepwater Horizon oil spill in 2010, clean-up workers were exposed to various hazards including oil, particulates, and oil dispersants (IOM, 2010). The National Institute of Environmental Health Sciences initiated the Gulf Long-term Follow-up Study (GuLF STUDY) to collect and analyze data to determine both acute and long-term physical and mental health effects of nearly 33,000 participants related to the Deepwater Horizon oil spill (NIEHS, 2014a). The GuLF STUDY “collected questionnaire data about oil-spill clean-up related exposures, health at the time of the spill and at enrollment, and lifestyle and other factors that might confound associations between ex- posures and health” (NIEHS, 2014b). Biological samples were collected for future research; and clinical measurements, including measures of pulmonary function, were made. Some participants may submit to more comprehensive clinical exams, and cancer and mortality records are linked to state cancer registries and mortality records (NIEHS, 2014b). Similarly, the Federal Coal Mine Health and Safety Act of 1969,18 as amended by the Federal Mine Safety and Health Act of 1977,19 required NIOSH to jointly administer a program for early detection and preven- tion of coal worker’s pneumoconiosis with the Mine Safety and Health Administration (CDC, 2014). The resulting Coal Workers’ Health Surveil- lance Program includes the Coal Workers’ X-ray Surveillance Program, requiring operators of underground coal mines to provide chest x-rays to new miners “as part of a pre-placement physical examination or within 18 The Federal Coal Mine Health and Safety Act of 1969. P.L. 91-173 (December 30, 1969). 19 The Federal Mine Safety and Health Amendments Act of 1977. P.L. 95-164 (No- vember 9, 1977).

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84 LONG DURATION AND EXPLORATION SPACEFLIGHT six months after being hired” and then 3 years later to screen for pneu- moconiosis (CDC, 2014). The program also requires operators to offer chest x-rays approximately every 5 years to all underground coal miners (CDC, 2014). If “black lung” disease is confirmed, then individuals in environments where dust concentration is more than 1.0 milligram per cubic meter of air may transfer to a mine where the dust concentration falls below this cutoff and have their exposures monitored frequently (CDC, 2014). Other Duties and Responsibilities In addition to health standards and surveillance or monitoring pro- grams, other employer and societal responsibilities may apply. The U.S. workers’ compensation statutes aim to assist individuals who are injured or sickened on the job. The general purpose of such funds are to replace lost wages, cover medical expenses associated with on-the-job injuries, and provide vocational rehabilitation if a worker cannot return to a pre- vious position due to an occupational illness or injury (Guyton, 1999). For some high-risk public service occupations, the risks taken on be- half of society provide justification for long-term commitments to pro- mote and protect the health of individuals within specific high-risk professions. For example, long-term health care benefits are available for all individuals who have served in the active military (VA, 2014a). Through the Veterans Health Administration, the Department of Veter- ans Affairs serves more than 8.7 million veterans each year (VA, 2014b) and provides “inpatient hospital care, outpatient care, laboratory services, pharmaceutical dispensing, rehabilitation for a variety of disabilities and conditions, mental health counseling, and custodial care” (CBO, 2007, p. 1). RISK MANAGEMENT IN RESEARCH WITH HUMAN PARTICIPANTS After a series of highly visible abuses in human research during the past century, governments and society established regulations to protect individuals who participate in research. The U.S. Office for Human Re- search Protections defines “research” as “a systematic investigation, in- cluding research development, testing, and evaluation, designed to

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RISK ACCEPTANCE AND RESPONSIBILITIES 85 develop or contribute to generalizable knowledge.” 20 Biomedical re- search is often the focus of scrutiny because it can pose significant risk to the health and well-being of research participants and “its findings can have important implications for health” (IOM, 2002a, p. 17). The moral and social purposes of research regulations and policies are to guide judgments about when risks to an individual are low enough to justify inclusion in research protocols that may cause harm to the individual for the benefit of society, especially if there is no direct benefit to the indi- vidual participant. Moreover, the regulations promote distribution of potential benefits to individuals who chose to participate in research (or at least to the groups from which participants are recruited) and encour- age trust from policy makers and the public by ensuring ethical research practices. Biomedical research that is conducted to further the role of human beings in space exploration has been part of the space program since the outset. Astronauts serve a wide array of research capacities, including investigator, research coordinator, study team member, and finally study participant. In some cases, astronauts serve as the principal investigator for the research but, in other cases, astronauts contribute as study team members or inflight research coordinators to carry out medical experi- ments and collect data at the direction of an on-ground principal investi- gator. Astronauts also have the option of serving as research study participants, allowing their biomedical information to be collected, de- identified, and analyzed for research purposes. Within the context of research, NASA as a government agency also plays multiple roles. It funds and supplies resources (such as equipment and labs in space) to facilitate research, provides mandatory oversight to ensure compliance with all applicable regulations, and plays a role in researcher and participant selection. As described in Chapter 2, NASA’s Human Research Program focuses on research in physiology, environ- ment, and technology to better understand the risks and opportunities associated with human spaceflight (NASA, 2014). 20 45 C.F.R. 46.102(d).

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92 LONG DURATION AND EXPLORATION SPACEFLIGHT draw conclusions. However, when taken as a whole, the examples include some common ethical norms embedded within decisions about risk in terrestrial settings, which parallel many of the factors described by the NRC. Factors Influencing Risk Assessment and Tolerance No single, simple summary statement adequately describes our na- tional willingness to accept risks or our commitment to reduce them. However, the committee identified a number of common factors that un- derlie decisions about risk across a wide range of oversight. This section examines some of these factors, including types and severity of risk; the presence of actual harm; types and distribution of potential risks and benefits; activity purpose; the nature of the relationship between individ- uals approving, and those subject to, risk; the presence of independent oversight; and feasibility. This list of factors is merely illustrative and is not meant to represent an exhaustive list of factors that may influence risk assessment and tolerance. Type and Severity of Risk Societal tolerance for risk of harm to an individual typically reflects moral judgments about the probability of an adverse event occurring and the severity of a specific harm or resulting loss. For example, the OSH Act requires employers to provide, to the extent practicable, workplaces free of recognized hazards, assuring that employees do not suffer materi- al impairment of health as a result of their lifetime of exposures to toxic agents or hazardous conditions at work. Permissible exposure limits are established to limit risk to individual workers, thereby maintaining the health of the working population and the functionality of society. Un- known environmental conditions, as described in the deep sea diving ex- ample, can increase risks to individual workers and participants, which may trigger increased governmental regulation of risk acceptance within those fields. Presence of Actual Harm When actual harms to individuals do occur in the context of high-risk activities, social morals may dictate follow-up actions. For example, workers’ compensation programs are designed to protect workers from

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RISK ACCEPTANCE AND RESPONSIBILITIES 93 the negative impacts of actual injury or illness resulting from job-related activities. In rare cases, including exposures to hazards during the Deep- water Horizon oil spill cleanup, the threat of actual harm led to additional research and monitoring responsibilities on behalf of the government (NIEHS, 2014b). Potential Risks and Benefits and Their Distribution Specific classes of potential benefits trigger higher levels of societal risk acceptance. As described in the context of law enforcement and first responders, serious threats to life and, to a lesser extent, property will often justify increased risk exposures to individuals. Similarly, threats to national security also justify participation in activities that carry serious risks of mortality and morbidity. The need for a well-trained workforce and technological and scientific advancement are also commonly used to justify increased risk to individuals engaged in high-risk activities. In addition to the class of benefit, the number of individuals who may receive a potential benefit (or avoidance of harm) also plays a role in risk acceptability. For example, the IAEA allows for greater radiation exposure for workers in emergency situations to prevent severe out- comes, including loss of life and catastrophic conditions with significant impacts on humans and the environment (IAEA, 2011). The protection of large populations also justifies increased radiation exposures under EPA regulations (EPA, 2013). The equitable distribution of risk and benefit also affects regulations governing clinical research involving humans.39 Activity Purpose In general, society appears to be more willing to impose limits on risks within the same environment if the risks are related to conditions of employment. Consider the example of commercial deep sea diving. Al- though commercial diving operations may occur under conditions similar to deep sea diving for recreational or instructional purposes, governmen- tal regulation is more robust in the context of commercial diving. Simi- larly, federally supported research involving humans immediately triggers review of risks to individual research participants. These deci- sions seem to embody the societal perception that workers and research participants deserve or require additional legal protections to regulate 39 45 C.F.R. 46.111.

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94 LONG DURATION AND EXPLORATION SPACEFLIGHT how decisions about risk acceptance are made. Although similar to poten- tial benefits, activity purpose is distinct. Potential benefits are typically balanced against potential risks or harms to determine risk acceptability; whereas, activity purpose may be used to broadly encompass an activity within the scope of governmental regulation. Presence of Independent Oversight Society may accept additional levels of risks to an individual’s health and safety if objective, independent review bodies are in place to protect that individual’s interests. As described above, in research involving hu- man participants, IRBs provide independent oversight to ensure that all research protocols do not present excessive risks to individual partici- pants, and that individuals voluntarily consent to participate in research. The Common Rule may allow a potentially high-risk research protocol if a DSMB exists to detect evidence of harms to patient health and safety early on and throughout the study. Similarly, an independent oversight body typically reviews and must approve operational test flights before an individual pilot can consent to high-risk activities. Independent oversight may also take the form of either an external or internal advisory body, which is not responsible for ultimate decision making. For example, federal advisory committees “provide advice that is relevant, objective, and open to the public” across a broad range of issues and topics covered by federal policies and programs (GSA, 2013). The distinction between an independent body that serves as an ultimate decision maker versus a body that serves in an advisory role is critical, and the committee was cognizant of this distinction as it considered the ethics governing decisions about health standards for long duration and exploration spaceflights. Nature of the Relationship Between Individuals The nature of the relationship between individuals affects the crea- tion and scope of the duties incumbent on professionals, which influence the responsibilities to mitigate risk of harm and the risk levels that socie- ty deems acceptable. U.S. statutory and common law creates affirmative duties of care to prevent unreasonable loss or harm to others through an overt act or omission. The duty of care, which often includes actions to mitigate or limit risk, may arise from “special relationships,” including relationships between employers and employees, ones who assume con-

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RISK ACCEPTANCE AND RESPONSIBILITIES 95 trol or custody of another,40 or if a fiduciary duty exists (Easterbrook and Fischel, 1993). Other examples of special relationships include the doctor- patient relationship (ACP, 2012) and attorney-client relationship (Small, 2009). In occupational health, concerns about coercion may stem from real and perceived power imbalances between employers and employees (Hogbin, 2006). Similar concerns about power imbalance, as well as information assymmetries and patient confidentiality, exist between doctors and patients (ACP, 2012). Individual employees may be willing to tolerate unsafe or hazardous conditions due to limited alternative em- ployment options, concerns about job security, incomplete information about relevant risks, and lack of control over the working environment. Conversely, employers select their employees, set wages, create and oversee working conditions, assign work and determine work pace, eval- uate employees, and initiate employee termination. Similar concerns about coercion and undue influence exist in research involving human participants. Feasibility Decisions about acceptable levels of risk are often impacted by con- siderations of the feasibility of reducing hazardous exposures. In some cases, feasibility limits are employed in an effort to drive acceptable risk to the lowest level possible. For example under several environmental health statutes the paradigm is to set the allowable limits as low as feasi- ble, even if the risks become vanishingly small. The OSH Act’s use of feasibility allows higher risk than more conservative applications of fea- sibility. The OSH Act authorizes standards for exposure to workplace hazards that will ensure “no employee will suffer material impairment of health or functional capacity” but only “to the extent feasible.”41 Federal courts have interpreted “feasibility” to include both technical and eco- nomic feasibility in the context of OSHA rulemaking, but OSHA is not required to balance the cost and benefits of a proposed rule.42 Other regu- latory agencies may select exposure levels that are “as low as reasonably achievable,” for example, to ensure that specific exposures are “as far below the dose limits as practical, consistent with the purpose for which the licensed activity is undertaken, taking into account the state of technol- 40 Restatement (Second) of Torts §§ 314A, 314B, and 320 (1965). 41 29 U.S.C. 655(6)(b)(5). 42 ATMI v. Donovan, 452 U.S. 490 (1981).

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96 LONG DURATION AND EXPLORATION SPACEFLIGHT ogy, the economics of improvements in relation to state of technology, the economics of improvements in relation to benefits to the public health and safety, and other societal and socioeconomic considerations.”43 SUMMARY In its task to look for analogs and models of how other occupations and efforts deal with uncertain health risks and risk management deci- sions, the committee found a lack of explicit frameworks but a variety of examples from terrestrial settings that inform deliberations about health standards for long duration and exploration spaceflights. Many of the efforts are focused on avoiding harm to workers and others who are will- ing to take risks to protect society. Both the context of the risk and the extent to which government, employers, or others are involved also af- fect the nature of the responsibilities and risk management approaches. Moreover, these factors implicitly embody ethics principles relevant to NASA decision making and provide valuable insights about considera- tions when designing an ethics framework to guide decision making about health standards for long duration and exploration spaceflights. Finally, it is important to emphasize that space travel—with almost predictable certainty—will be fatal in some cases. Even so, the United States has continued to engage in human space travel for more than half a century. As described in Chapter 1, it is not within the charge of this committee to opine on the ultimate justification for human spaceflight. However the committee recognized that astronauts have volunteered, and are likely to continue to volunteer, for missions despite the uncertainty concerning the risks they will face. The committee kept this in mind as it considered ethics principles, responsibilities, and decision frameworks that are relevant to decisions about health standards for human space- flight in Chapters 5 and 6. REFERENCES ACP (American College of Physicians). 2012. The physician and the patient. In American College of Physicians Ethics Manual. Philadelphia, PA: ACP. 43 10 C.F.R. 20.1003.

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RISK ACCEPTANCE AND RESPONSIBILITIES 97 Alabama Municipal Insurance Corporation and Municipal Workers Compensa- tion Fund, Inc. No date. NFPA Standards for Fire Services. Montgomery, AL: AMIC. Allenby, B., and C. Mattick. 2009. Macroethical and social issues in emerging technologies and the military. Presented at IEEE International Symposium on Sustainable Systems and Technology, Tempe, AZ. http://ieeexplore. ieee.org/xpls/abs_all.jsp?arnumber=5156788&tag=1 (accessed February 5, 2014). AAUS (American Academy of Underwater Sciences). 2013. Standards for sci- entific diving. Dauphain Island, AL: AAUS. Arizona Division of Emergency Management. 2012. Emergency response and recover plan: Basic plan. http://www.dem.azdema.gov/preparedness/docs/ basic_plan.pdf (accessed March 24, 2014). Behnken, R., M. Barratt, S. Walker, and P. Whitson. 2013. Presentation to the Institute of Medicine, Ethics Principles and Guidelines for Health Standards for Long Duration and Exploration Spaceflights: Astronaut office. PowerPoint presented at the second meeting of the Committee on Ethics Principles and Guidelines for Health Standards for Long Duration and Exploration Spaceflights. Washington, DC, July 25. http://www.iom.edu/ ~/media/Files/Activity%20Files/Research/HealthStandardsSpaceflight/ p resen- tationfinal2.pdf (accessed November 8, 2013). CBO (Congressional Budget Office). 2007. The healthcare system for veterans: An interim report. Washington, DC: CBO. CDC (Centers for Disease Control and Prevention). 2013. The National Institute for Occupational Safety and Health (NIOSH). http://www.cdc.gov/niosh/ about.html (accessed February 19, 2014). CDC. 2014. Occupational respiratory disease surveillance: Coal Workers’ Health Surveillance Program (CWHSP) resource list. http://www.cdc. gov/niosh/topics/surveillance/ords/cwhsp-resources.html (accessed January 15, 2014). Cockerham, W., and L. Cohen. 1981. Volunteering for foreign combat missions: An attitudinal study of U.S. Army paratroopers. The Pacific Sociological Review 24(3):329-354. DoD (Department of Defense). 2011. Special Operations. Joint Publication 3-05. Washington, DC: Joint Chiefs of Staff. http://www.dtic.mil/doctrine/new_pubs/ jp3_05.pdf (accessed March 24, 2014). DOL (Department of Labor). 2014. OSHA voluntary protection programs: Current federal and state-plan sites. https://www.osha.gov/dcsp/vpp/ sitebystate.html (accessed January 15, 2014). Easterbrook, F., and D. Fischel. 1993. Contract and fiduciary duty. Journal of Law and Economics 36(1):425-446. EPA (Environmental Protection Agency). 2013. PAG manual: Protective action guide and planning guidance for radiological incidences. Washington, DC: EPA.

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98 LONG DURATION AND EXPLORATION SPACEFLIGHT FEMA (Federal Emergency Management Agency). 2008. Planning guidance for protection and recovery following radiological dispersal device (RDD) and improvised nuclear device (IND) incidents. Federal Register 73(149): 45029. Feyst, M. 2014. Live-fire training: Much preparation for safety. http://www. fireengineering.com/articles/2013/01/life-fire-training-much-preparation-for- safety.html (accessed January 15, 2014). Fischler, G., H. McElroy, L. Miller, S. Saxe-Clifford, C. Stewart, and M. Zelig. 2011. The role of psychological fitness-for-duty evaluations in law enforcement. The Police Chief—The Professional Voice of Law Enforcement 8(LXXVIII). GSA (General Services Administration). 2013. The Federal Advisory Committee Act (FACA) brochure. http://www.gsa.gov/portal/content/101010 (accessed February 27, 2014). Guyton, G. 1999. A brief history of workers’ compensation. The Iowa Orthopaedic Journal 19:106-110. HEW (Department of Health, Education, and Welfare). 1979. The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. Washington, DC: DHEW. http://www.hhs.gov/ohrp/ policy/belmont.html (accessed February 5, 2014). HHS (Department of Health and Human Services). 1993. Chapter 1A: Jurisdiction of the Institutional Review Board. In Institutional Review Board Guidebook. Washington, DC: HHS. Hogbin, G. 2006. Power in employment relationships: Is there an imbalance? Wellington, NZ: New Zealand Business Roundtable. http://archive. hrnicholls.com.au/articles/hrn-hogbin1.pdf (accessed February 5, 2014). IAEA (International Atomic Energy Agency). 2011. Safety standards: Radiation protection and safety of radiation sources—international basic safety standards. In General Safety Requirements Part 3. Vienna, Austria: IAEA. IOM (Institute of Medicine). 2001. Safe passage: Astronaut care for exploration missions. Washington, DC: National Academy Press. IOM. 2002a. Integrity in scientific research: Creating an environment that promotes responsible conduct. Washington, DC: The National Academies Press. IOM. 2002b. Responsible research: A systems approach to protecting research participants. Washington, DC: The National Academies Press. IOM. 2010. Assessing the effects of the Gulf of Mexico oil spill on human health: A summary of the June 2010 workshop. Washington, DC: The National Academies Press. Kennedy, C. H., and E. A. Zillmer. 2012. Military psychology: Clinical and operational applications, 2nd ed. New York: The Guilford Press.

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RISK ACCEPTANCE AND RESPONSIBILITIES 99 Lang, M. A. 2013. Diving in extreme environments: The scientific diving experi- ence. PowerPoint presented at the second meeting of the IOM Committee on Ethics Principles and Guidelines for Health Standards for Long Duration and Exploration Spaceflights. Washington, DC, July 25. NASA (National Aeronautics and Space Administration). 1999. Johnson Space Center: Johnson Space Center shines with OSHA star rating. http://www. nasa.gov/centers/johnson/news/releases/1999_2001/j99-20.html (accessed January 15, 2014). NASA. 2007. NASA space flight human system standard. Volume 1: Crew health. NASA-STD-3001. https://standards.nasa.gov/documents/detail/ 3315622 (accessed November 8, 2013). NASA. 2011. NASA space flight human system standard. Volume 2: Human factors, habitability, and environmental health. NASA-STD-3001. https://standards.nasa.gov/documents/detail/3315785 (accessed December 4, 2013). NASA. 2014. Human Research Program: Human health and safety. http://www.nasa.gov/exploration/humanresearch/areas_study/overview/index. html (accessed January 15, 2014). NFPA (National Fire Protection Association). 2013a. Standard 1582: Standard on comprehensive occupational medical program for fire departments. Quincy, MA: NFPA. NFPA. 2013b. Standard 403: Live Fire Training Evolutions in Structures. Quincy, MA: NFPA. NIDCR (National Institute of Dental and Craniofacial Research). 2014. Data and Safety Monitoring Board (DSMB) guidelines. http://www.nidcr. nih.gov/Research/ToolsforResearchers/Toolkit/DSMBGuidelines.htm (acc- essed January 15, 2014). NIEHS. 2014a. About the study: Gulf long term follow-up study. https://gulfstudy. nih.gov/en/about.html (accessed January 14, 2014). NIEHS. 2014b. The GULF STUDY. http://www.niehs.nih.gov/research/atniehs/ labs/epi/studies/gulfstudy (accessed January 14, 2014). NIH (National Institutes of Health). 1998. NIH policy for data and safety monitoring. Bethesda, MD: NIH. NRC (National Research Council). 1989. Improving risk communication. Washington, DC: National Academy Press. NRC. 2006. Assessing fitness for military enlistment: Physical, medical, and mental health standards. Washington, DC: The National Academies Press. Nuremburg Military Tribunal. 1949. Trials of war criminals before the Nuremberg military tribunals under Control Council Law No. 10., Vol II. Washington, DC: U.S. Government Printing Office. OSHA (Occupational Safety and Health Administration). 1977. Occupational safety and health requirements: Commercial diving operations. Federal Register 42:37650. OSHA. 1982. Educational/scientific diving. Federal Register 47:53357.

OCR for page 75
100 LONG DURATION AND EXPLORATION SPACEFLIGHT OSHA. 2014a. Commercial diving laws. https://www.osha.gov/SLTC/ commercialdiving/laws.html#table_1 (accessed March 24, 2014). OSHA. 2014b. Commercial diving: Dysbarisms and other selected health effects.https://www.google.com/search?q=hyperbaric+conditions&rls=com. microsoft:en-us:IE-SearchBox&ie=UTF-8&oe=UTF-8&sourceid=ie7&rlz= 117NDKB117NDKB_enUS552 (accessed March 24, 2014). Quigley, A. 2008. Fit for duty?: The need for physical fitness programs for law enforcement officers. The Police Chief—The Professional Voice of Law Enforcement 6(LXXV). Serra, C., M. Rodriguez, G. Delclos, M. Plana, L. Gomez Lopez, and F. Benavides. 2007. Criteria and methods used for the assessment of fitness for work: A systematic review. Occupational and Environmental Medicine 64(5):304- 312. Small, D. 2009. Lawyer and witness: A special relationship. In: Preparing Wit- nesses: A Practical Guide for Lawyers and Their Clients, 3rd Edition, edit- ed by D. I. Small. Chicago, IL: American Bar Association. University National Oceanographic Laboratory System. 2009. Research vessel safety standards. UNOLS: Narragansett, IR. https://www.unols.org/ publications/manuals/saf_stand/2009RVSS_web2012updates.pdf (accessed March 23, 2014). U.S. Air Force. 2012. Nellis Air Force Base: 414th combat training squadron “Red Flag.” http://www.nellis.af.mil/library/factsheets/factsheet.asp?id= 19160 (accessed March 24, 2014). U.S. Air Force. 2013. Aerospace medicine: Medical examinations and standards. Air Force instruction 48-123. http://static.e-publishing.af.mil/production/1/af_ sg/publication/afi48-123/afi48-123.pdf (accessed March 23, 2014). U.S. Army Combined Arms Center. 2010. Disaster response staff officer’s handbook:Observations, insights, and lessons. Ft. Leavenworth, KS: Combined Arms Center. http://www.uscg.mil/hq/cg5/cg534/nsarc/Disaster%20Response %20Response%20Staff%20Officers%20Handbook%20(Nov%2010)8.pdf (ac- cessed March 24,2014). U.S. Coast Guard. 2013. United States Coast Guard standard operating proce- dures for the Coast Guard Training System: Volume 14—High-risk train- ing. Washington, DC: U.S. Coast Guard. http://www.uscg. mil/forcecom/training/docs/HRT_SOP_01_Feb_13v3.pdf (accessed March 23, 2014). VA (Department of Veterans Affairs). 2014a. Health benefits: Veteran eligibility. http://www.va.gov/healthbenefits/apply/veterans.asp (accessed January 15, 2014). VA. 2014b. Veterans Health Administration. http://www.va.gov/health (accessed February 27, 2014).

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RISK ACCEPTANCE AND RESPONSIBILITIES 101 Williams, R. 2013. Charge to the IOM Committee on Ethics Principles and Guidelines for Health Standards for Long Duration and Exploration Space- flights. PowerPoint presented at the second meeting of the IOM Committee on Ethics Principles and Guidelines for Health Standards for Long Duration and Exploration Spaceflights. Washington, DC, May 30. http://www.iom. edu/~/media/Files/Activity%20Files/Research/HealthStandardsSpaceflight/Rich %20Williams.pdf (accessed November 8, 2013). WMA (World Medical Association). 1964. Declaration of Helsinki. Ferney- Voltaire, France: WMA. http://www.wma.net/en/30publications/10policies/ b3 (accessed February 5, 2014).

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