The concept of vulnerability in disaster research

Journal of Traumatic Stress, Vol. 17. No. 5 , October 2004, p p . 395402 (0 2004)

The Concept of Vulnerability in Disaster Research

Carol Levinel 3 2

The concept of vulnerability in research derives from a specific set of historical circumstances relating to abuses in biomedical research. Now so many people and groups have been labeled vulnerable that the concept has lost much of its force. In disaster research, participants should not be automatically considered vulnerable unless they are legally designated as such, for example, children. Instead specific aspects of the research should be thoroughly examined. Examples are the potential for the participants to be pressured to participate in several protocols, political or social turmoil surrounding the disaster, and cognitive impairments or mental health problems. In addition to a careful consent process, there should be procedures in place to provide assistance to participants who experience serious distress.

KEY WORDS: vulnerability: consent: decision-making capacity; harms and wrongs; research review.

Consider these four hypothetical research proposals:

A pediatric investigator wishes to study whether a new medication for asthma is as effective as and has fewer side effects than an approved drug.

0 A cardiologist plans to test a novel catheterization procedure on normal, healthy volunteers.

0 A clinical investigator proposes to test a combi- nation antiretroviral regimen on HIV-infected inmates in a maximum security prison.

0 A team of investigators plans to interview dozens of survivors, family members, and rescue person- nel involved in a terrorist attack in which many people were killed.

Are the potential participants in these proposed studies “vulnerable,” and in what sense? And if they are, what are the special ethical responsibilities of researchers, sponsors, Institutional Review Boards (IRBs), and policy makers to afford them protection? Is “vulnerability” even the

‘Prepared for the meeting on “Ethical Issues Pertaining to Research in the Aftermath of Disaster,” sponsored by the New York Academy of Medicine and the National Institute of Mental Health, January 13-14, 2003.

*Families and Health Care Project, United Hospital Fund. 350 Fifth Avenue, 23rd Floor, New York 101 18; e-mail: [email protected].

best way to describe the characteristics of the participants that might raise ethical concerns?

The short answer, of course, is that the studies of children and prisoners, legally deemed “vulnerable” populations in the American research review system, could not ethically proceed without IRB approval based on special regulations, while the catheterization study, arguably the riskiest of the four, requires no such special review. What about the disaster research study? Surely people who have been through such a traumatic event experience a range of intense emotional reactions. Are they thereby “vulnerable” in a way that affects an ethical analysis of protocol design, consent process, IRB review, and implementation?

Although the meeting from which this paper is drawn grew out of American researchers’ and regulators’ concerns about the conduct of disaster research, and did not address international disaster research, many of the concepts and issues are more generally applicable. This paper draws from some international documents and commen- taries, but does not address the broad range of ethical issues arising in the regulation or review of international research (for example, see Alora & Lumitao, 2001; Michael & Zwi, 2002). However, the concept of “vulnerability” is a prominent theme in international discussions, and international researchers working with American colleagues

395 0894-9867/04/1000-0395/l 0 2004 Springer ScienceCBumess Media. Inc.

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or funded by U.S. agencies submit their protocols to U S . IRBs for review.

What Is Vulnerability in Biomedical Research?

In looking at vulnerability as a concept in disaster research, it is important to understand its origin in biomedical research. Derived from the Latin word for “wound” (vulnus), “vulnerability” has many interpreta- tions in ordinary language, from “being at risk” (presumably a bad thing) to “being in touch with one’s feelings” (presumably a good thing). “Vulnerable” can be used to describe populations, individuals or their physical or psychological attributes, places, institutions, societies, even one’s status in a bridge game (where being vulnerable can lead either to penalties or bonuses). But in the context of biomedical research ethics “vulnerability” canies a specific connotation.

A fundamental assumption underlies the modern history of research ethics: certain categories of people are more likely than others to be misled, mistreated, or other- wise taken advantage of as participants in research studies. These populations are deemed “vulnerable,” a status that imposes a duty on researchers, review committees, and regulators to provide special protections for them. While other basic tenets of research ethics-informed consent and risks-benefit analysis, for example-have been the subject of extensive discussion and debate, until recently the concept of vulnerability has been relatively unex- amined. The only significant questions raised have been whether or not to include a particular group in the vulnerability category, and to a lesser degree, what kinds of protections are needed.

The U.S. federal regulations (45 CFR 46), following the Belmont Report on which they are based, do not define vulnerability but provide special protections for “particularly vulnerable populations”: children; prisoners; and pregnant women, fetuses, and neonates (US National Commission for the Protection of Human Sub- jects of Biomedical and Behavioral Research, 1979). Al- though the Belmont Report linked the requirement to protect the autonomy of persons with diminished capacity to the ethical principle of respect for persons, it addressed vulnerability in the context of the principle of justice as applied to the selection of subjects. Vulnerable groups, the report stated, should not bear unequal burdens in research. The Belmont Report explained that its examples of vulnerable populations-“racial minorities, the economically disadvantaged, the very sick, and the institutionalized”- may continually be sought as research subjects because of their “ready availability in settings where research is con-

ducted.” They require special protections because of their “dependent status and frequently compromised capacity for free consent.”

Although used freely in the Institutional Re- view Board (IRB) Guidebook on the website of the Office of Human Research Protections (OHRP) (http://ohrp.osophs.dhhs.gov/irb-guidebook.htm), vulnerability is not defined in the site’s extensive glossary. In the international arena, the most recent revision of the World Medical Association’s Declaration of Helsinki (2000) also does not define vulnerability but simply states: “Some research populations are vulnerable and need special protection.” Perhaps vulnerability is not defined in these documents because its meaning seems self-evident. However, using it in real-world situations turns out to be philosophically and operationally complex.

The concept’s prominence in the Belmont Report and its staying power in clinical research ethics undoubtedly derives from post-World War I1 history. Revulsion against the abuses of research on captive populations in World War I1 by the Nazis (and, as later revealed, by the Japanese as well) profoundly affected the development of international codes of research ethics (Katz et al., 1972). However, the impetus for the creation of the National Commission for the Protection of Human Sub- jects of Biomedical and Behavioral Research in 1974 was a series of domestic scandals, first revealed in a New Eng- fundJournuf ofMedicine article by Beecher (1966). These scandals included the Jewish Chronic Disease Hospital study in which elderly patients were injected with live cancer cells without consent, and the Willowbrook vaccine studies, in which parents of institutionalized children were offered special living conditions not available to others if they consented to the studies. The U.S. Public Health Service syphilis studies of poor black men in Al- abama, which had numerous ethical violations, played a major role in supporting a regulatory climate in which protection was paramount (Rothman, 199 1). Research came to be seen as a risky enterprise, from which institutionalized or cognitively impaired individuals in particular needed protections that they were not able to provide for themselves.

While the early guideline and regulation drafters were reacting to a series of specific historical events, the more recent history of the use of vulnerability in biomedical research seems based more on general concerns about political, economic, and social inequality. In the international context, the Council for International Organiza- tions of Medical Sciences’ (CIOMS) 2002 guidelines for biomedical research does define, if not vulnerability, then at least vulnerable persons: “those who are relatively or (absolutely) incapable of protecting their own interests

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because they may have “insufficient power, intelligence, education, resources, strength, or other needed attributes” (Commentary on Guideline 13, p. 26). Commenting on an earlier (2000) draft of the CIOMS guidelines, Zion, Gillam, and Loff (2002) define vulnerable people in political terms: “those who lack basic rights and liberties that make them particularly open to exploitation.. . .”

Beyond individuals or groups, Macklin suggests that whole communities or countries may be vulnerable to exploitation, particularly if “investigators or sponsors are from a powerful industrialized country or a giant pharmaceutical company and the research is conducted in a developing country” (Macklin, 2003, p. 472). In arguing against “double standards” in research in multinational studies-permitting research in destitute countries that would not be approved in wealthy ones-Kottow distin- guishes between vulnerability and susceptibility. Vulner- ability, he says, applies to everyone; what really matters in research ethics is susceptibility, which means being poor, undernourished, and lacking in medical care and therefore predisposed to additional harm (Kottow, 2003, p. 460).

These definitions and comments reflect concerns that poor people in developing countries will be used, as they have been in the past, to test drugs that are destined for developed country markets, without compensating benefit to the participants or their communities in terms of improved access to health care.

What Is Vulnerability in Social Science Research?

Although there does not seem to be a single definition of vulnerability in social science research, there is some overlap with definitions in biomedical research. The characteristics of a vulnerable population in social science research are typically described in terms of a group’s social status, powerlessness, and potential for exploitation, that is, one type of vulnerability described by the CIOMS guidelines for biomedical research. Similarly, Flaskerud and Winslow (1998) define vulnerable populations in health services research as “social groups who experience limited resources and consequent high rela- tive risk of morbidity and premature mortality.” Among the groups “recognized as vulnerable” are “the poor; persons subject to discrimination, intolerance, subordination and stigma; and those who are politically marginalized, disenfranchised, and denied human rights.”

In the context of HIV/AIDS prevention studies, Delor and Hubert (2000) note that “vulnerability” is com- monly used to define populations or individuals at risk of contracting HIV, 10% of the abstracts presented in the epidemiology, prevention and public health, and social

and behavioral sciences at the international AIDS con- ference in Geneva in 1998 used the term. These authors worry that the concept of vulnerability “runs the risk of losing its heuristic capacity and political and practical relevancy through increasingly frequent but ambiguous use.” They cite Theys’s admonition in the context of tech- nological risk: “. . . there are still too few languages and tools for analyzing vulnerability. The word itself suffers from a semantic overflow, since it refers to dependency or fragility as well as insecurity, centrality, complexity, the absence of effective regulation, gigantism, and low resilience” (Theys, 1987). In reviewing disaster research and vulnerability, Delor and Hubert again focus on the broader social, political, and economic structures in a given community but also caution against reductionism. They point out that “all of the people who feel the influences of the same factors do not suffer the same way.”

Recognizing both the individual and social aspects of vulnerability, Chambers (1983) notes that “vulnerability has two sides: an external side of risks, shocks, and stress to which an individual or household is subject; and an individual side which is defencelessness, meaning a lack of means to cope without damaging loss.” Watts and Bolhe (1993) offer three coordinates of vulnerability: “the risk of being exposed to crisis situations (exposure), the risk of not having the necessary resources to cope with these situations (capacity), and the risk of being subjected to serious consequences as a result of the crises (potentiality).”

In brief, then, as it is used in biomedical research, the concept of vulnerability emphasizes limitations to an individual’s or group’s decision-making capacity and the potential for coercion among populations that are literally or figuratively “captive” (Moreno, 1998). In social science research the concept most often describes people who may have decision-making capacity but who lack the power and resources to make truly voluntary choices.

What Is Vulnerability in Mental Health Research?

Another way of looking at vulnerability is in the context of mental health studies. Here disciplinary per- spectives may play a role. Tierney (2000) suggests that the main disciplinary divisions “tend to be between psychologically and clinically oriented researchers, on the one hand, and sociologically oriented researchers, on the other.” In her view, psychologically oriented researchers tend to see many short- and long-term mental health problems, including posttraumatic stress disorder (PTSD) following a disaster. These researchers might tend to see potential participants as vulnerable to these negative effects. Sociologically oriented researchers, in contrast, tend

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to see disasters as having both positive and negative effects, and to see mental health problems as relatively rare and mild. While recognizing the role of individual responses to trauma, they are equally interested in the social-structural and community level factors that influ- ence these responses. These researchers might tend to see potential participants’ vulnerability in a different light.

From a mental health perspective, in reviewing the ethical implications of vulnerability for participants in research conducted by the Substance Abuse and Mental Health Services Administration (SAMHSA), McGovem (1998) asserts, “Vulnerability is a universal and ongoing human experience. The awareness of being wounded and the potential for same gnaws at our sense of security. We are capable of being hurt at many levels: physical, mental, emotional, and spiritual. . . . Our greatest vulnerability centers on assaults from within and without that threaten our integrity and dignity as persons.” In bioethics termi- nology, vulnerability in this sense involves not just the risk of being harmed physically, socially, or psychologically but also the risk of being wronged-of being treated in ways that assault one’s dignity or one’s personhood.

The mental health literature often links vulnerability with its opposite or antidote-resiliency. “Why do some people collapse under life stresses while others seem un- scathed by traumatic circumstances, such as severe illness, the death of loved ones, and extreme poverty, or even by major catastrophes such as natural disasters and war?” In seeking to answer this question, the Basic Behavioral Science Task Force of the U.S. National Advisory Men- tal Health Council developed, if not a definition, a good description of vulnerability: “Studies to date suggest that there is not single source of resilience or vulnerability. Rather, many interacting factors come into play. They include not only individual genetic predispositions, which express themselves in enduring aspects of temperament, personality, and intelligence, but also qualities such as social skills and self-esteem. These, in turn, are shaped by a variety of environmental influences” (Basic Behavioral Science Task Force, 1996).

Limitations of the Concept of Vulnerability

As conventionally understood even if not formally defined, the concept of vulnerability is an extraordinarily elastic concept, capable of being stretched to cover almost any person, group, or situation, and then of being snapped back to describe a narrow range of characteristics like age or incarceration. The concept gathers people with widely varying characteristics and capacities under one large umbrella without analyzing whether they all fit,

whether they have their own well-functioning raingear, or indeed, whether or not it is even raining. In the research context the concept of vulnerability is both too broad because it includes too many categories and too narrow because it fails to include others at risk for different rea- sons other than their cognitive or dependent status.

Consider how the labeling of groups as vulnerable has mushroomed. In U.S. regulations, for example, beyond the protected classes covered by special regulations, other “special classes of subjects” are not covered by specific regulations but are highlighted for special consideration. These include cognitively impaired persons; traumatized and comatose patients; terminally ill patients; elderly/aged persons; minorities; students, employees, and normal volunteers; and participants in international research.

The World Health Association’s latest version of the Declaration of Helsinki advises: “The particular needs of the economically and medically disadvantaged must be recognized. Special attention is also required for those who cannot give or refuse consent for themselves, for those who may be subject to giving consent under duress, for those who will not benefit personally from the research and for those for whom the research is combined with care.”

With an even more specific list, the 2002 CIOMS guidelines include as vulnerable “junior or subordinate members of a hierarchical group,” such as “medical and nursing students, subordinate hospital and laboratory per- sonnel, employees of pharmaceutical companies, and members of the armed forces or police.” Furthermore, the guidelines describe elderly people as “likely to acquire attributes that define them as vulnerable.” Other categories include residents of nursing homes, people re- ceiving welfare benefits or social assistance and other poor people and the unemployed, people in emergency rooms, some ethnic and racial minority groups, homeless persons, nomads, refugees or displaced persons, prisoners, patients with incurable disease, individuals who are politically powerless, and members of communities unfa- miliar with modern medical concepts” (Commentary on Guideline 13, p, 27). To these extensive lists, should we now add “persons who have been involved in, witnessed, or responded to natural or manmade disasters”?

Under one or another of these rubrics, nearly everyone is vulnerable, especially since the benefits of research can never be guaranteed in advance. If everyone is vulnerable, then the concept is so nebulous that it becomes almost meaningless.

While most members of groups involved in research share some identifying characteristics (disease, health status, demographic characteristic, or economic or social

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status), in disaster research the participants are likely to have no other common feature than their being in the same wrong place at the same wrong time-an airplane, a subway, a tall building. Even people in an earthquake zone or flood plain generally have only their common area of residence as a unifying factor. The fact that they, and only they, have experienced this particular event is of course what makes them desirable to researchers. The very ran- domness and chance associated with their being caught in a traumatic event adds to the psychological distress and reinforces a loss of security and safety, not just for those directly involved but also for those who only experience the event secondhand. This is at least one of the intentions in a terrorist attack.

Because the concept of vulnerability as it is used in biomedical research focuses almost exclusively on decision-making capacity or dependent status, it is too narrow. The reason for much of the recent concern in the United States about research ethics stems in large part from the deaths of four study participants. Three women were healthy volunteers. Two were affiliated with the medical centers as student or employee; the third was a nurse. Their deaths were attributed to serious problems in the protocols, not to coercion or undue inducements (Steinbrook, 2002). (In the Johns Hopkins case, however, newspaper reports suggested that the lab in which Ellen Roche worked expected research participation from its employees.) The fourth research fatality was 18-year-old Jesse Gelsinger. A participant in a gene therapy study, he fell into the vulnerable category of a person with an incurable illness. But his genetic disease was not advanced, he was old enough and had the capacity to consent on his own, and his father was closely involved in his decision to participate. Under even the most expansive definitions of vulnerability, these individuals would have been accorded only limited protection from what turned out to be the lethal result of research participation. In these cases, there seemed to be no question of the participant’s capacity to consent.

While consent is surely a serious concern, it bypasses questions of the potential of physical, psychological, or social harm in some protocols and of wronging people in others. These are the most likely types of harm or wronging to arise in disaster research protocols.

Vulnerability has been criticized on other grounds. As a matter of justice, the concept of vulnerability stereo- types whole categories of individuals, without distinguish- ing between individuals in the group who indeed might have special characteristics that need to be taken into account and those who do not. Particular concerns have been raised about considering all poor people, all pregnant women, all members of ethnic or racial minorities,

and all people with terminal illness as inherently unable to know their own best interests and to make appropriate choices for themselves.

DeBruin (2001) makes this argument from a philo- sophical perspective. She asserts, “Vulnerability ought not to be conceived of as a characteristic of groups. Rather, certain traits may render certain persons vulnerable in certain situations.” In this view, putting poor people or poorly educated people in the class of vulnerable participants deprives individuals of asserting their autonomy. The argument that people with life-threatening illnesses can still make their own health care and research decisions has been made most forcefully by people with HIV/AIDS, but it is by no means limited to them.

Furthermore, some people may be vulnerable in certain ways or circumstances and not in others (de Beurs et al., 2001). After all, the mythic archetype of the vulnerable person is Achilles, immortal except for that one little spot on his heel which his goddess mother failed to dip in the sacred waters of the River Styx. Just as “decision- making capacity” for health care decisions is now generally understood to depend on the question being asked and the consequences of the decision, an individual’s needs for special protections in the research context depend on the kind of study, the implications of participating or not participating, and the alternatives available.

Past and Current Challenges to Vulnerability

Inclusion in the category of vulnerable has been challenged in the past, albeit on different grounds than those offered here. In the 1970s the National Commis- sion for the Protection of Human Subjects considered at great length the use of prisoners as research subjects. Prison inmates had been used in research during World War I1 in the U.S. Interviews with prisoners at Jackson State Prison in Michigan revealed that prisoners did not want to be protected from research studies; they wanted to have the opportunity to participate, both for the money, the better living conditions, and the relief from boredom (Levine, 1986). Nevertheless, current federal regulations concerning prisoners set very high barriers for research. Essentially the only research studies that can be conducted in prisons are those that study a disease from which the prisoner suffers, or that examines prison conditions more generally. Even so, there are strict restrictions and special regulations for IRBs that consider this type of research.

A more successful challenge-indeed, the only successful challenge to inclusion in the vulnerability category in the U.S.-came in the 1990s. as women’s health advocates marshaled support for more representation of

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women among study populations. Following an Institute of Medicine report (Mastroianni, Faden, & Federman, 1994) that concluded that “volunteers for clinical studies should be offered the opportunity to participate without regard to gender, race, ethnicity or age,” the National In- stitutes of Health announced that women could not be ex- cluded from studies on the grounds that they were or might become pregnant. However, inclusion of pregnant women is governed by regulations on fetuses and neonates.

Analytic challenges are increasing as well. For the U.S. National Bioethics Advisory Commission, Kipnis (2001) outlined a new taxonomy for vulnerability. He described six types of vulnerability, based on characteristics of the individual or society: (1) cognitive, the ability to understand information and make decisions; (2) juridic, being under the legal authority of someone such as a prison warden; (3) deferential, customary obedience to medical or other authority; (4) medical, having an illness for which there is no treatment; (5) allocational, poverty, educational deprivation; and (6) infrastructure, limits of the research setting to carry out the protocol. While this taxonomy offers useful distinctions, it is limited by its dependence on consent and by the inference that everyone who fits into any of these categories is vulnerable.

When Is “Special Scrutiny” Appropriate?

If most advocacy has focused on keeping people out of the vulnerable category, and guideline writers keep adding them in, who is in fact vulnerable? And is vulnerable even the best term to describe those needing special protections? Infants and young children as a group do not have the cognitive capacity to understand medical facts and to make well-thought-out decisions for themselves. The age or mental status at which youngsters do acquire this capacity is debated; certainly by mid- to late ado- lescence many have the same abilities in this regard as adults. This does not mean that they do not need guidance and advice from family or counselors, but only that protocols involving them must take serious consideration of their preferences and concerns. Whatever the problems with the current children’s research regulations, the need for special rules governing their participation category seems secure. However, not all protocols involving children present particularly difficult decisions. Many, perhaps most, of these protocols follow well-accepted pat- terns. They should be rigorously reviewed to make sure all the rules have been followed, but they do not require an additional level of scrutiny.

Similarly, people with permanent cognitive impairments, such as severe mental retardation or advanced Alzheimer’s disease, will not attain or regain a state of

cognitive capacity. Special U.S. regulations regarding this category have been mired in dissension for years; whatever the outcome, if there even is one, special protections will undoubtedly be present.

Focusing only on the characteristics of individuals or groups fails to take account of the many other circumstances in which special scrutiny may be appropriate. The context of research has changed dramatically since the 1970s when the National Commission deliberated. These conditions include: increasing privatization of research; growth of complex multisite trials and office-based trials with treating physicians as researchers; novel agents and procedures; and most recently, an increasing concern with public health threats such as bioterrorism. These conditions create situations in which researchers and reviewers cannot look solely to the past for guidance but must develop new ways to protect human participants. All the participants in some trials are inherently “vulnerable,” that is, embarked on a path for which the stumbling blocks are still unknown.

Nevertheless, merely identifying a research protocol as involving participants who come from particular groups or who might be vulnerable in particular ways is not the only way to determine which research protocols warrant more intensive review, or “special scrutiny” (Levine et al., 2004), in what particular areas, and then to determine how to strengthen protections. There should be a broad discussion among researchers, sponsors, study coordina- tors, ethicists, IRB members, policy makers, and research participants to determine ways in which the concept of vulnerability is useful, but also how to provide more targeted forms of protection for participants in protocols where vulnerability misses the mark.

Studies of public health disasters or threats are can- didates for such special scrutiny. If HIV/AIDS is the quintessential novel disease of our times (so far), then the potential of bioterrorist attacks, until 2001 largely a theo- retical threat in the United States, looms as the quintessential public health threat of our times. The anthrax-related deaths of late 2001 revealed how little prepared the public health infrastructure was for such an episode. While research on chemical and biological agents has been conducted in the military for some time, and with considerable controversy once it has been revealed, such studies have not been part of the spectrum of civilian research. That will undoubtedly change.

When public health is at issue, it is tempting for researchers, policy makers, and research reviewers to place individual rights and welfare second to the immediate need for information. Interventions that might ordinarily be classified as research, such as vaccine studies, might not undergo ethical review at all if they are presented as

The Concept of Vulnerability in Disaster Research

public health measures. Yet it is precisely at these points that the principles of research ethics must be honored and the participants protected both from physical harm and wrongful disregard of their autonomy.

Other kinds of public health research may also present the need for special scrutiny. These may be environmental studies following a disaster, natural or man-made; research on sexually transmitted diseases and vaccines, especially among adolescents; and studies of the emotional impact on persons affected by disasters- the topic of this meeting (Arnold, 2002; Can; Lewin, Webster, & Kenardy, 1997; Fleischman & Wood, 2002; Fordham, 1999; Newman, Walker, & Gefland, 1999; North & Pfefferbaum, 2002; Ruzek & Zatzick, 2002; Tierney, 2000).

Are there procedures in place to provide assistance for anyone who experiences difficulty during or after the planned interview? Is there a procedure for informing the participants of the results?

If vulnerability is part of the human condition, another part is the desire to make sense of an experience that seems senseless. Participating in a research project is one way that people can begin to bring meaning to even hor- rible experiences. While acknowledging this trait, and the general willingness of people to share their experiences so that others may benefit, researchers and reviewers should be mindful of the many different ways individuals respond to disaster and of their ethical responsibility to respect those differences.

Questions for Disaster Research Review Acknowledgment

The concept of vulnerability in research derives from a specific set of historical circumstances and has been extended to include so many people, groups, and situations that it has lost much of its force. While people who lack decisional capacity or whose capacity is limited by their dependent status continue to require protection under law and regulation, protocols that present truly novel or high risk or uncertain risk-benefit ratios should be subject to more intensive review. In the context of disaster research, the kinds of questions that should be asked might include:

Is the population at risk of being "exploited," in the sense of being asked to participate in several protocols, or subject to pressure because of their status as first responders, thereby increasing whatever potential for harm or wronging may exist? What other kinds of interviews have already taken place or will take place, e.g., by the police, military, news media? Have the participants been affected by these interviews in ways that alter their perception of their ability to refuse to participate in a research study? Is there political or social turmoil surrounding the disaster that may affect participants' ability to make an informed choice? Are children or adolescents to be involved as partic i pants? Is there some screening method to determine which of the potential participants might have cognitive impairments or which might be at particular risk for a serious mental health outcome? Are the consent procedures clear, unambiguous about the right to refuse to participate, and candid about risks and benefits?

Some of the material in this paper is drawn from discussions in clinical research held by the Consortium to Examine Clinical Research Ethics, of which the author is a member. Other CECRE members are not, however, responsible for the specific formulations in this paper.

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Documents

The concept of vulnerability in disaster research