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Drug use research that involves transnational populations in their worksite nations and in their countries of origin requires special consideration for human subjects. These populations are exposed to similar, if not greater, research related risks than other vulnerable research subjects. If they are to be protected adequately, Internal Review Boards (IRBs) need to become familiar with transnational populations and the possible risks that their members face when participating in research that targets their drug use behaviors and practices. Addressed in this article are a number of challenges that IRBs in United States universities and research institutes encounter in assuring protections against possible research risks. Specific areas of concern are: the dearth of binational IRB reviews, IRB inexperience with transnational populations, mandatory written consent, limited research ethics training for researchers, the absence of a vulnerable population research advisory board, and the need for measures in case of a breach of confidentiality. The discourse of each one of these problem areas includes a recommendation for rectifying it. The article ends with five suggested measures that IRBs should consider in protecting transnational migrants from research related risks in the United States and in their homeland. The discussion of human subject problems and of the measures introduced to alleviate them are based on the author’s experiences with preparing human subjects protocols for his ethnographic substance abuse research in both the United States and Mexico.
Binational research on drug use centers on migrants, immigrants, and other worker populations that transcend borders and establish communities in more than one country. Evaluating and proposing safeguards to protect these populations from unintentional research consequences are major challenges for Internal Review Boards (IRBs). IRBs are responsible for assessing risks, reviewing protections, and monitoring biomedical and behavioral research involving human subjects. A problem with IRB reviews of binational drug use research is that board members are unfamiliar with transnational populations and their cultures. As a consequence, they are not well enough informed to ensure that research safeguards are in place in the United States and abroad. Complicating the matter, transnational populations are high risk research groups and measures for protecting them must go beyond traditional procedures.
Addressed in this article are a number of issues related to IRB reviews of human subject protocols that limit the protection of transnational populations participating in substance abuse research. I draw on my experiences with the IRB at my home university and on accounts of experiences from colleagues at other universities in the United States. i The IRB challenges to be discussed are those found at United States universities and do not represent those encountered in non-academic drug research institutes or centers, or in foreign universities. Particularly, the issues are: the dearth of binational IRB reviews, IRB inexperience with transnational populations, mandatory written consent, limited research ethics training for researchers, the absence of a vulnerable population research advisory board, and the need for measures in case of a breach of confidentiality. The intent in pointing out and discussing these problem areas is not to be hypercritical of IRBs, but to provide them with suggestions that will assist them in making sure that transnational populations in binational research are reasonably protected. Toward this end, recommendations are also made to improve the identified problem areas.
A literature search revealed only a few studies on binational drug use among transnational populations who work in the United States. Nearly all were conducted along the United States-Mexico border by United States researchers (e.g., Maxwell et al. 2006; Spence, Wallisch, and Smith 2007; Wallisch and Spence 2006). Researchers in the home countries of these populations, particularly Mexico, also engage in binational drug use research, mainly in their own nations and as collaborators on projects initiated in the United States. The same literature search did not locate any works that address IRB reviews of binational drug research. The closest studies to this subject are those that address ethics and research abroad, such as the work of Angell (2000), Benatar (2002), and Farmer (2002). Most of the studies examined centered on IRBs and human subjects reviews (e.g., Ceci, Peters, and Plotkin 1985; Marshall 2003; Oakes 2002), research consent (e.g., Ogloff and Otto 1991), and vulnerability and protection concerns (e.g., Levine, Faden, and Grady 2004). This finding was surprising, given the frustrations of researchers over IRB reviews and the debates over the protection of transnational populations. This subject, I learned, is often privately discussed at academic conferences.
Unable to turn to prior literature for guidance due to the dearth of studies on the subject, I draw on my experiences with IRB reviews of three ethnographic studies on substance use among transnational migrants that I have conducted. All three received a full IRB review. Two of the studies were on transnational Mexican migrants in southeastern Pennsylvania (one was on binge drinking and the other on drug use). A recently funded third study was on drug use among the same population of transitional Mexican workers in Pennsylvania and Guanajuato, Mexico. i It identifies and examines the interaction of community, individual, and other factors in the two countries and examines how these multiple factors influence drug use among transnational migrants. In all three studies, the ethnographic method was used. I lived at the research sites and carried out traditional ethnographic fieldwork, including engaging in participant observation, conducting informal and semi-structured interviews, organizing and holding focus groups, and diagramming genealogies.
Transnational migrants are vulnerable research populations in both the United States and in their home countries. Vulnerable populations are defined in the literature in a variety of ways:
The Department of Health and Human Services has designated a number of populations as vulnerable populations, and has set up special federal regulations designed to protect them. Children, pregnant women, and prisoners are examples of these populations. The regulations for each vulnerable population define levels of risks associated with participation in research, special protections for ensuring the rights and welfare of the research subjects, and the appropriate consent required. Mandated protections designed to protect them also stipulate the required composition of the IRB and additional duties of the IRB to ensure proper safeguards.
The transnational migrants in my three substance abuse studies are also members of a vulnerable population. The migrants are poor, semi-literate in their native language, limited in their comprehension of the English language, and do not understand the laws and their rights in the United States and/or Mexico. They also are not accustomed to exercising their rights, should they be familiar with them, because of a distrust and fear of government. In the United States, some of the migrants may also be unauthorized workers and subject to criminal proceedings and deportation should their immigration status be discovered by United States authorities. The migrants’ drug use and drug-related activities and behaviors compound these vulnerabilities. Some migrants use or may be in possession of illegal drugs that are aggressively targeted by United States Drug Enforcement Agency (DEA) for abatement, such as cocaine or crystal methamphetamine. They may also sell, transport, and/or distribute these drugs. While under the influence of these and other substances, some migrants engage in other illegal activities, such as operating a motor vehicle, engaging in disorderly behavior, destroying public or private property, or simply loitering and being a public nuisance. Likewise, they may also become victims of crimes, such as robberies, assaults, and extortion, but because of being under the influence or possessing drugs, they too may be arrested and prosecuted. These vulnerabilities place the migrants at high risk for a number of possible consequences should their use and related activities be discovered.
Some of the major consequences in both the United States and Mexico include:
In the two countries, transnational migrants can be stigmatized should their drug use and related activities in the United States or Mexico be discovered. They may be shunned by community members, including family and kin, and may not be able to find housing or employment.
Additionally, the drug use behavior and activities of transnational migrants may place them at risk for criminal sanctions or civil liability. They may be arrested, fined, and incarcerated for drug possession, drug sales, or drug use in the United States or Mexico. In the United Sates, the sentencing of the migrants for drug related infractions is politically charged and driven by government policies aimed at stemming “illegal immigration,” if not halting altogether the unauthorized entry of foreigners into the country. Currently, the immigration policies of the second George W. Bush administration (2004–2008) continue in the Barak Obama administration. An orchestrated nationwide crackdown on unauthorized foreign workers remains in place. These laborers are being targeted through a number of means, such as United States Immigration and Custom Enforcement (ICE) raids at worksites and traffic violation stops by local police departments. They can be convicted for entering the country without proper documentation or point of entry inspection together with other infractions of the law, then incarnated in prison and after their release, deported to their country of origin. Drug-related sentences, particularly those associated with felonies, are mandatory and lengthy, attempting to serve as a deterrent for others contemplating similar crimes.
In their homeland, migrants may be incarcerated indefinitely without due process for drug use and drug-related infractions. There is also the possibility that Mexican authorities may try to extort money from the migrants and their kin with the promise of releasing them from jail and dropping the charges.
If arrested, transnational migrants who are residing illegally or without proper governmental authorization in the United States may be deported to their countries of origin. Deportation may keep them and their immediate family members from regularizing their immigration status and entering and staying in the country legally in the future. Transnational migrants who are legal or authorized residents may lose their legal status in the country, become a persona non grata, and be deported. Deported migrants, regardless of their legal status in the United States, may also be detained by Mexican authorities upon being returned and may undergo additional criminal proceedings, sentencing, and incarceration.
Some of these risks, such as stigmatization, criminal sanctions and civil liability, are also possibilities in other populations participating in substance abuse research projects. However, given their non-citizen and/or illegal status in the United States, the consequences of these risks are graver for transnational migrants than for other groups. These workers do not have the same access to free or affordable legal counsel and are treated differently in the judicial system if they are in the United States without proper governmental authorization. As discussed earlier, if found guilty, they may be subject to deportation and legal proceedings in their native Mexico.
To ensure the protection of research subjects in all research projects, including binational drug studies, IRBs require that all researchers develop a human subjects protocol, or a plan with safeguards for protecting research subjects. This plan must describe the research, the methods, the possible risks and potential benefits, the safeguards against risks, and the procedures for maintaining the confidentiality of the research subjects. When high-risk populations are involved, IRBs and federal funding agencies require that researchers include a Certificate of Confidentiality as part of their human subjects protocol. Issued by the Department of Health and Human Services, the Certificate of Confidentiality helps researchers protect the privacy of research participants against compulsory legal demands (e.g., court orders and subpoenas) that seek the names of, or other information about, the research subjects.
There is more than one type of IRB review of research projects: exempted, expedited, and full. A number of criteria, such as the potential risks for the research subjects and the safeguards proposed to protect them against these risks, are considered in determining whether a research project should be exempted from review or should receive an expedited or a full IRB review. Projects with very minimal risk to research subjects may be exempted from an IRB review. ii However, if certain vulnerable populations, such as prisoners or the mental impaired, are the focus of the research, the projects are ineligible for exemption. The chair or another member of the IRB makes this decision after reviewing the request for an exemption. In many cases, exemptions are granted to research projects in which data are recorded anonymously; that is, subjects cannot be identified either directly or through any “identifiers.”
A research project with minimal risks may receive an expedited review, but not if the research subjects are identifiable and/or their responses may result in criminal proceedings or civil liability, interfere with their livelihood, damage their reputation, or stigmatize them. If the project is eligible, the chair or another IRB member selected by the chair conducts the expedited review. It covers the same areas as a full IRB review, and the IRB member in charge of the expedited review may approve, request modifications, or refer a protocol to the IRB chair for a full IRB review.
A human subjects protocol will require a full review if the study poses more than minimal risks to the research subjects, involves activities that are not listed in the criteria for an exemption or a expedited review, or proposes the use of deception in the research approach. Full reviews are conducted by the entire IRB body and decisions are made by a majority vote of a quorum of the IRB. The IRB may request that the researcher attend a meeting in order to respond to questions about a protocol but he or she is not to be present for the discussion and vote. The review, as described in the Office of Human Research Protections (OHRP) - Code of Federal Regulations, considers a number of questions, among them: Does the human subjects protocol minimize the risks to the research subjects? Are the risks reasonable in relation to anticipated benefits? Is the selection of research subject equitable? Are adequate procedures to ensure privacy and confidentiality in place? Will proper informed consent be sought?
More often than not, given the nature of the ethnographic method, research projects that use this method to examine drug use receive full IRB reviews. In this research approach, in which the researcher lives on-site and has daily contact with his or her research subjects, there is a greater possibility that the research subjects will be identified and/or that their responses to queries, if discovered, may place them at risk of a number of consequences discussed earlier.
Despite the best efforts and good intentions of the IRBs, as I have discovered, there are issues that are not considered in the protection of transnational populations. The six issues and recommendation alluded to in the introduction are:
As I have discovered from my own experiences, as well as those of colleagues, IRBs in the United States do not always require that human subjects protocols of binational drug use research projects include reviews from IRBs abroad. This was the case with my third study, a binational (Pennsylvania-Mexico) research project of drug use among transnational workers. My university’s IRB reviewed my human subjects protocol for this project independently from the IRBs of the home institutions of my Mexican collaborators. This unilateral review of human subject protocols is problematic because the IRB in one country is not necessarily in a position to ensure that all of the possible risks in another country are identified and that corresponding safeguards are adequate enough to provide the necessary protections. Board members may not be familiar with the people or cultures of another county and may not have research experience abroad. For example, with the exception of one of the IRB members at my home institution, an anthropologist who has conducted research in Africa and Southeast Asia, none of the members had experience conducting research abroad.
The National Institute of Drug Abuse (NIDA), the funding agency of my third study, on the other hand, required that I obtain human subjects approval in both the United Sates and Mexico. The protocol was reviewed by the IRBs at my home institution and at the National Institute of Psychiatry in Mexico City.
IRBs in the United States and the home communities of the research subjects should review the human subjects protocol of binational research. Binational review of the protocol will guarantee that all possible risks for the research subjects, as well as the researcher, in the two countries are identified and that all the safeguards proposed are adequate enough to provide protection. Additionally, as I learned, not all universities or research centers in Mexico have IRBs or require that social science research, regardless of the risks, undergo a human subjects review. The human subject emphasis in Mexico is only on bio-medical research. If IRBs are absent at an institution abroad or if they are not available to review social science research, experienced researchers in the corresponding country’s institution should be consulted by United States IRBs at the partner university or research institute to ensure safeguards are in place to protect the researcher and research subjects.
Moreover, there are resources posted on the OHRP webpage that should be consulted in preparing a human subject protocol for drug use abroad (http://www.hhs.gov/ohrp). One document in particular, the International Compilation of Human Research Projections (http://www.hhs.gov/ohrp/International/), lists the laws, regulations, and guidelines on human subjects, privacy or data protection, human biological materials, and genetic research in 84 countries. It also includes standards issued by international organizations, information for general studies and drug research, and over 400 direct web links to each country’s key organizations and laws, when available. This information is provided to help IRBs, researchers, and others meet regulatory requirements to assure that research studies comply with applicable research protection standards in participating countries.
Another issue is that IRBs do not always have the familiarity with transnational populations to draw upon when assessing human subject protocols of drug research involving these populations. Researchers proposing to examine drug use in these populations may also lack the necessary background in developing appropriate human subject protocols. Additionally, more often than not, their training and research is limited to one country, namely the United States. Needed on IRBs are members with backgrounds that include working with transnational populations, preferably in both the United States and abroad.
Ideally, IRBs who review this type of research proposal should have members with experience working with transnational populations in binational settings. At the very least, a candidate with knowledge of vulnerable populations should be recruited for membership. Anthropologists should also be considered for IRB service. Many of them have conducted research abroad and, given their use of the ethnographic method, are sensitive to human subject concerns. The number of candidates may be limited at small universities or research institutes. If this is the case, an alternative may be to include an external IRB reader in the review – one who is on an IRB at another university and possesses the needed background and experience. The responsibilities of the external reader would be to review the protocol and forward his or her evaluation and comments to the chair of the IRB. Should it be required to keep costs down, this individual may participate in a discussion of the protocol via a conference call.
The use of written consent to inform transnational migrants of possible risks and the measures designed to protect them is another IRB issue in need of attention. To begin with, administering written consent to drug using members of this population may actually place them at risk. It may link them to the research project and place them at risk for legal action that may result in their incarceration or deportation from the country.
A related problem is that many transnational migrants are semi-literate in their native languages, and at best, they are at a sixth grade reading level. This limited reading comprehension is complicated by a culture among the migrants that does not stress reading beyond popular culture novellas. Instead, many of the migrants are accustomed to receiving their information on many subjects from non-print sources, such as television or radio. Closely related, the way in which consent forms are prepared and written further prevents comprehension. The forms are required to be written in a format similar to that of a contract, with specific legal language that comes across as intimidating, if not confusing, to the migrants. I suspect that the specific legal language is included to shield the funding agency from possible liability, and not necessarily to protect the research participants. Consequently and much too often, the migrants do not always understand the text in the forms and do not truly understand what they are acknowledging or agreeing to with their signatures. Time and again, many of the migrants had problems understanding the consent forms used in my studies, even when the text was read aloud to them with explanations or examples. On many occasions, after a reading, when I inquired if a research participant understood the reading of the contents on a consent form, the response was “no.” When I asked why they signed and agreed to participate in the study, the responses often were “because I know you, and I trust you,” or “because I want to help you out.”
In all three of my NIH funded research projects on substance abuse among transnational migrants, the IRB at my home institution and my program officers at the National Institute of Alcohol Abuse and Alcoholism (NIAAA) and the National Institute of Drug Abuse (NIDA) required that I obtain written consent. I argued against it on the grounds that it was unethical to have research subjects sign a document that they did not comprehend. I stated that, in my opinion, having them sign the form under this false pretext was fraud. My research participants, I claimed, were not signing to confirm that they understood the text on the form. They were rendering their signatures because they trusted me and believed that my explanations of some of the legal clauses in the document were factual. In lieu of written consent, I suggested conveying risk and protections orally in language that they could understand in front of a witness and obtaining the signature of the witness to provide verification that I informed research subjects of research risks and protections. In all three instances, the IRB and program officers declined my suggestion, arguing that if the research subjects were literate in their native language, they should be able to understand the text, and therefore should sign the consent form.
IRBs should be aware of the cultural backgrounds of transnational populations and their historical experiences with legal documents. Researchers in Mexico do not use consent forms in research projects that involve rural populations in their country. Instead, they inform participants verbally of possible risks and the safeguards in place to protect them. In their view, the use of written consent among peasant populations is deceptive because many are semi-literate and do not truly understand the contents of the documents, even when they claim that they do. Additionally, signing a document to verify an agreement in a dyadic relationship among rural Mexican folk, including the one established between researcher and research participant, is not culturally appropriate. It implies that one of the parties does not trust the other. Moreover, with this population, documents are seen as suspect. Historically, peasants and other rural people have lost land and other resources after signing documents prepared by unscrupulous individuals or organizations. Consequently, they are generally highly suspicious of this practice.
Transnational migrants who find themselves in the United States share the same cultural background and suspicions regarding legal documents. Ignoring these similarities and requiring their written consent not only creates suspicion among the migrants, but these actions also make them vulnerable to the risks discussed earlier.
Researchers conducting research among transnational migrants should be allowed to inform research participants of risks in a culturally appropriate manner, such as informing them verbally and using study notices written with the research subject’s education level in mind. If a written consent form is required, the researchers should be permitted to depart from the script and to use idioms and examples within the cultural realm of the research participants to effectively communicate risks, safeguards, and benefits.
IRBs also need to consider the ethics training of researchers. Missing in IRB reviews, at least at my home institution, is attention to the ethics training of researchers studying transnational and other vulnerable populations. IRBs should not assume that researchers have received instruction in research ethics. As Marshall (2003) points out, social scientists and biomedical investigators are not always trained in the ethical guidelines necessary to ensure the safety and well-being of their research subjects. For example, my formal instruction in ethics prior to my first NIH funded project was limited to a research development course in graduate school. The course only devoted a couple of weeks to the topic of ethics and human subjects. Some IRBs and funding agencies, such as NIH, require that researchers in the project undergo human subjects education as a stipulation for funding. In the case of NIH, this instruction occurs online and consists of a series of modules that cover research ethics, possible risks, and the measures to be followed for providing safeguards against risks.
Researchers planning to conduct research among transnational workers and other vulnerable populations should be required to take a research ethics course, if not a number of workshops on the subject, that underscore the dangers to research participants and the need for effective safeguards to protect them. This ethics training should not be limited to online modules, such as the ones required by the NIH. It should also include a series of seminars or workshops that allow the researchers to ask questions, share concerns, and discuss hypothetical issues and concrete cases with instructors and, under ideal conditions, with experienced researchers.
Another IRB related issue is the need to establish a resource center that researchers can turn to when they need answers to human subject questions. Often, researchers encounter ethical dilemmas in the field that were not anticipated in the preparation of their human subjects protocols. When these situations occur, as they frequently do, researchers must make judgment calls. During my first NIH funded project, a few human subject concerns arose in the field that I did not contemplate in my human subjects protocol. For example, should research subjects who are unauthorized workers in the county use their real names in consent forms? Should research subjects under the influence of alcohol or drugs be asked questions about sensitive subjects? When, if at all, should researchers intervene and assist research subjects with serious addiction problems that are leading to health and medical problems? As I found, research ethics training alone was not enough to make the correct decisions in these and other cases. I found that having a sounding board of experienced researchers, who have encountered similar issues, helped to assure that the proper decisions are made. I was fortunate enough to have access to seasoned researchers at my research institute and other institutions who had experience working with vulnerable populations.
IRBs at the institutional and national levels should assist in establishing a vulnerable population research advisory board – one that will provide researchers and IRB members with guidance and recommendations regarding ethics concerns. This recommendation should be considered by universities and research institutes with researchers who conduct research among high risk populations, such as transnational populations. Board members should be available to answer questions online or through telephone conversations. This advisory board can be similar to, but on a smaller scale than, the OHRP. To increase the pool of researchers, universities and institutes may want to create this board through consortiums or, in the case of my home university which is a member of a public university system, at the state-system level.
Another issue within the scope of the IRB is the need to develop, preferably with the researcher, measures to be taken in the case of a breach of confidentiality or another serious adverse effect. IRBs do not only review and approve human subject protocols the boards are also responsible for guiding the researcher in resolving human subject problems when they arise. A possible major problem with serious repercussions for all parties involved in the research, particularly the research subjects, is breach of confidentially. IRBs should assure that measures are in place in the United States and abroad, should a transnational migrant participating in a drug study be identified as a research participant.
The researcher is required to report, in writing, breaches of confidentiality and other incidents to the IRB. Care should be taken to classify the incident correctly and to describe it as best as possible. Some incidents may be classified as “protocol deviations” or anticipated or unanticipated “serious adverse events” (SAEs); events that place research subjects or others at greater risk of harm than was previously known or anticipated in the human subjects protocol. The associated risks for the research subject should also be included and described so that the IRB can make appropriate recommendations for dealing with them.
IRBs are aware that a SAE is always a possibility. Some IRBs, such as the one at my university, request that human subjects protocols include measures that should be taken in the case of an anticipated or unanticipated SAE. When transnational migrants are involved, dropping them from the research project and destroying all information related to their participation is not enough. As argued earlier, these migrants are vulnerable and at high risk for a number of consequences, from criminal proceedings and deportation to being shunned by community and family. Given these possible adverse effects, the IRB may want to recommend that the following measures be taken:
I have identified six issues within the domain of Internal Review Boards that should be addressed to ensure adequate protection of transnational migrants who participate in binational drug research. Drawing on the discussions around these issues, I outline and recommend the following measures that IRBs should consider to assist researchers to protect transnational migrants:
The mandate of Internal Review Boards is broad; it does not only consist of protecting human subjects, but also calls for protecting the researcher and the institutions that are sponsoring and administering the research project. The emphasis of this article is on how IRBs in the United States can help researchers protect transnational migrants who participate in binational drug research from research related risks, consequences, and harm. As pointed out, there is quite a bit that IRBs can do in this important area. I have made recommendations that IRBs should consider in reviewing human subject protocols and in helping researchers develop mechanisms for protecting research subjects. However, the onus of assuring this protection should not fall on the shoulders of the IRB members alone. The IRB and the researchers should work in tandem to make sure transnational migrants are protected. The adversarial relationship that at times exists between the two must be transcended for the good of the research and the protection of vulnerable research populations. Specifically, they should work in collaboration to develop and implement a comprehensive human subjects protection protocol.
There is much the researcher can do to prepare a sound human subjects protocol that meets all the necessary criteria and demonstrates how research subjects will be protected from risks and harm. He or she should become familiar with the IRB mandate and mission and with the evaluation guidelines used by the IRB at his or her home institution to approve a protocol and to monitor the protection of human subjects. Efforts should also be made to be as thorough as possible in the development of the protocol, making sure that all requested information is addressed and described in detail. Should questions arise in the preparation of the protocol or when in the field, the researcher should contact and consult with the IRB at his or her home institution.
More discussion is needed on how to protect transnational migrants in the United States and Mexico who participate in binational drug research. Although there is plenty of anecdotal information on the subject, there are no empirical studies on the best measures for protection, or any formal investigations by federal funding agencies to discover if transnational and other vulnerable populations are being protected adequately from the risks associated with their participation in drug use research. Anthropologists have an opportunity to lead the way in this discussion and to suggest and make improvements that will protect transnational populations participating as research subjects in both qualitative and quantitative research.
I want to thank two colleagues at my institution, Indiana University of Pennsylvania, for looking over early drafts of this manuscript and providing insightful recommendations. The two are Dr. Edward Gondolf, Professor of Sociology and Associate Director of the Mid-Atlantic Research Training Institute, and Dr. Susan Boser, Associate Professor of Sociology and former member of the Internal Review Board on campus. I am also appreciative of the valuable comments from the three anonymous reviewers. Their suggestions strengthen areas of this article.
iThe three studies are: “Problem Drinking Among Migrant Mexican Farmworkers,” National Institute Alcohol Abuse and Alcoholism, Grant # 1R03 AA12659-01, “Drug Use Among Migrant Mexican Farmworkers,” National Institute of Drug Abuse, Grant # R03 DA17915, and “The Origin and Development of Drug Use Among Transnational Mexican Farmworkers,” Grant # 5R01DA019690-03.
iiMinimal risks are defined as: “The probability and magnitude of possible harms implied by participation in the research can reasonably be expected by participants to be no greater than those encountered by the subject in those aspects of his or her everyday life that relate to the research, or during the performance of routine physical or psychological examinations or tests.” (For more information, see http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.)