Guidelines and Recommendations for Training Ethical Alcohol Researchers

Abstract

Research on alcohol use presents several ethical challenges, and therefore, training of ethical alcohol researchers is particularly important. While the Helsinki Declaration (World Medical Association, 2001), Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978), and American Psychological Association’s (APA) Ethics Code (2002) provide ethical guidelines and aspirational principles for researchers, there are a number of areas in which these principles allow for judgment. For trainees in particular, this ambiguity may be disconcerting. Along with these broader principles, there are also specific considerations for training alcohol researchers in the responsible conduct of research, which may further complicate matters for trainees. Although alcohol research is an important avenue for understanding a large public health concern and investigating risk and protective factors associated with use, it also presents a number of ethical and legal challenges for researchers. Working with high-risk drinking populations presents unique ethical and legal challenges in the areas of informed consent, confidentiality, compensation, and risk-benefit ratios. Additionally, alcohol administration studies present challenges for those supervising, as well as conducting, such experiments. New technology, such as the use of ecological momentary assessment (EMA) or other ambulatory assessment methods to examine risky and illegal behaviors, also presents new ethical challenges that are likely to continue to evolve in the coming years for trainees. Specific recommendations for handling a variety of concerns that may arise when conducting alcohol research are provided. Additionally, suggestions for improving the training of ethical alcohol researchers are discussed.

There are a number of ethical guidelines relevant for psychologists conducting research with human subjects. One of the earliest sources of ethical codes was the 1964 Helsinki Declaration, which has since been revised a number of times (World Medical Association, 2001). Following the Helsinki Declaration, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (The Belmont Report; 1978) and the American Psychological Association (APA; 2002, as amended in 2010, 2017) released their own ethical guidelines for research. While different in their details, these guidelines emphasize a number of similar principles, including respect for persons, beneficence, nonmaleficence, and justice. In addition, the APA’s Ethics Code (2002) establishes fidelity and responsibility, as well as integrity, as guiding principles for psychologists conducting professional work. These aspirational principles and the enforceable standards of the APA Ethics Code (2002) provide a needed foundation for psychologists on the ethical practice of research. However, due to their flexibility and generalizability, the Ethics Code guidelines are not specific in their recommendations and allow for the use of judgment when conducting research. For trainees this may be bothersome, as many are left to make critical decisions based on their own judgments and sometimes with little ethical guidance or prior experience.

Research on health and risky behaviors, like substance use, is one area in which researchers must be particularly careful and considerate in their judgment. Alcohol remains the most widely used substance among Americans, with the vast majority (86.4%) of adults reporting lifetime use of alcohol and over half (56%) reporting past month use (Center for Behavioral Health Statistics and Quality, 2016). In addition to its widespread use, alcohol is a public health concern, costing the United States about $249 billion a year (CDC, 2016) and resulting in a number of negative health outcomes for excessive users (Rehm et al., 2009). For these reasons, research on the effects of alcohol and potential avenues for preventing these harmful outcomes is important. However, this area also presents unique challenges for researchers and trainees, who may be unsure of how to respond to the variety of ethical dilemmas that can emerge when conducting alcohol research. Trainees may feel ill-equipped to deal with these concerns, given that many ethical guidelines for psychologists do not focus on research and do not address research of sensitive topics, like substance use.

Previous scholars have pointed out the numerous ethical issues that emerge for those conducting alcohol and other substance use research (Aldridge & Charles, 2008; Anderson & DuBois, 2007; Fry et al., 2006; Goldman, 2000; Hildebrand et al., 2016; Jacob & Leonard, 1991; McCrady & Bux, 1999; Tucker & Vuchinich, 2000). However, these reviews have typically not addressed new technologies and methodologies emerging in alcohol research, including the use of ecological momentary assessment (EMA) and ambulatory assessment methods, which present additional ethical and legal considerations regarding informed consent and ongoing data monitoring. Furthermore, facilitating the development of ethical research scientists is an important component of training programs, but current practices in training may fall short of addressing trainees’ ethical development as alcohol researchers.

The current paper begins with a review of ethical challenges in alcohol research (e.g., working with high-risk populations, providing alcohol to participants in alcohol administration studies, and navigating emerging technologies) and provides specific recommendations that may be helpful for trainees who need concrete guidelines rather than the broad principles outlined in general research ethics. Additionally, in light of these ethical concerns, the paper concludes by proposing recommendations for programs to facilitate the development of engaged and responsible alcohol researchers. Foremost, this paper serves as a resource for trainees, though training programs may also find this paper to be an aid for facilitating discussions about research ethics among trainees and faculty and may wish to incorporate relevant recommendations.

High-Risk Populations

When conducting alcohol research, high-risk populations require special precautions and ethical considerations. Those with a current or lifetime alcohol use disorder (AUD), intoxicated individuals, and underage drinkers are special populations that alcohol researchers are interested in studying and better understanding. Psychologists are tasked with avoiding harm of others and striving to bring benefit to those with whom they work. However, working with high-risk populations could lead to harm, and psychologists must determine whether research benefits outweigh potential harm that may be done to participants and others. Such considerations require a careful understanding of ethical challenges in working with these populations.

Alcohol Use Disorder

Conducting alcohol research with problem drinkers, or individuals who have received a lifetime AUD diagnosis, might reveal insights into the development of substance use disorders, provide a population on which to investigate new relapse prevention medications, and suggest potential pathways to reduce use or facilitate abstinence. Historically, though, there has been concern that individuals with histories of or current AUD might be negatively impacted by participating in alcohol research (Beutler & Kendall, 1991; Gallant, 1993), particularly alcohol administration studies, which involve providing alcohol to participants in order to study its effects. Potential risks and benefits of conducting alcohol research with those currently seeking treatment for AUD have been discussed elsewhere (Enoch et al., 2009); however, alcohol investigators should also be cognizant that concerns emerge with current heavy users who are not seeking treatment or long-term abstainers (Cohen, 2002; Tucker & Vuchinich, 2000).

One concern is that current problem drinkers might be more vulnerable to coercion from researchers, with incentives, including the provision of alcohol, potentially unduly influencing these individuals to agree to participate in research. There has been widespread debate over the use of incentives in research involving those with AUD. While past research has shown that the use of incentives for healthy research volunteers did not negate processing of risk information related to participation (Grant & Sugarman, 2004), other research has found financial incentives are an important motivator for potential participants in research (Tishler & Barholomae, 2002). As these studies consider the influence of inducements on healthy participants, it is unclear whether someone with an AUD who was being provided alcohol would assess risk accurately or instead would be unduly coerced into participation by a monetary or substance use incentive. Despite the concern and debate regarding the use of payments in substance abuse research, the use of monetary compensation is widespread (Dickert et al., 2002; Fry et al., 2005), and trainees will need to consider these issues throughout their careers.

Informed consent procedures might also be complicated when conducting research among high-risk populations. Alcohol abuse has been found to be associated with sexual assault perpetration (Abbey et al., 2014) and intimate partner violence (Testa & Derrick, 2014). Additionally, alcohol abuse is associated with a history of victimization (Kilpatrick et al., 1997). Despite this, only about half of National Institute on Alcohol Abuse (NIAAA) and National Institute on Drug Abuse (NIDA) funded researchers reported that they informed participants of these potential limits of confidentiality (McCrady & Bux, 1999). As psychologists are often mandated reporters or permitted to report instances of harm to self or others, trainees should familiarize themselves with the limits to confidentiality for research participants. When discussing limits of confidentiality, the APA requires that psychologists inform participants of relevant limits of confidentiality. As this population is at higher risk of both posing a danger to others and being victimized themselves, researchers and trainees should consider whether guidelines require an explicit discussion of these limits to confidentiality.

Other unique situations may arise when working with high-risk populations. One such event is withdrawal, which occurs after repeated, prolonged exposure to a drug is halted. Individuals experiencing alcohol withdrawal may exhibit a number of symptoms, including anxiety, depression, sweating, headache, and rapid heart rate. The most severe form of alcohol withdrawal, or delirium tremens, requires immediate medical attention. Symptoms of delirium tremens include fever, hallucinations, seizures, and confusion (U.S. National Library of Medicine, 2017). Trainees should be taught to recognize these symptoms and should be knowledgeable of procedures in the event that a participant needs medical attention.

Intoxicated Participants

When conducting research with intoxicated participants, obtaining truly informed consent can be a challenge (Aldridge & Charles, 2008; Klein et al., 2016). Those conducting roadside surveys or studying alcohol use behaviors in natural settings, such as bars and restaurants, might encounter intoxicated participants frequently. The APA Ethics Code (2002) requires that psychologists “obtain informed consent…using language that is reasonably understandable” (pg. 6). Furthermore, the Belmont Report (1978) requires that participants comprehend and voluntarily agree to participate in research in order for informed consent to be valid. For intoxicated individuals, capacity to consent to participation might be impaired, and trainees will need to assess comprehension of study procedures in intoxicated participants.

One way to assess comprehension is by asking potential participants questions about the informed consent procedure. A recent study examining capacity for informed consent among intoxicated patients in the emergency department found that less than 4% (3.9%) were able to answer all questions correctly (Klein et al., 2016). These estimates were much lower than the researchers had anticipated and suggested that working with intoxicated participants in emergency settings might pose problems for obtaining informed consent. Further research is needed to assess capacity to consent across a variety of other settings. Students working in field settings should be trained in how to handle cases where informed consent needs to be withdrawn or where it becomes apparent that a participant is not able to consent in their intoxicated state. For example, participants who are unable to answer a set proportion of questions should not be allowed to continue with the study. Furthermore, if participants wish to withdraw at a later time due to a lack of informed consent while intoxicated, researchers should honor this request by destroying or excluding participants’ data from analysis. Depending on the study’s purpose, researchers may choose to document the withdrawal of the subject (Office for Human Research Protections, 2016). If participants wish to withdraw at a later time for other reasons, informed consent procedures should clearly outline how previously collected data will be handled.

Underage Drinkers

The use of underage drinkers requires researchers to consider ethical concerns related to exposing participants to alcohol’s toxic effects while the brain is still developing. Research shows that those who engage in heavy alcohol use in adolescence often show impaired or reduced neurocognitive performance (Jacobus & Tapert, 2013). Alcohol researchers regularly conduct alcohol administration research, which involves providing alcohol to participants and studying its effects in a laboratory setting, using participants who are 18-21, and these subjects might be at risk for experiencing harmful neurocognitive effects of alcohol. While the Declaration of Helsinki (World Medical Association, 2001) states that “considerations related to the well-being of the human subject should take precedence over the interests of science and society,” (pg. 373) researchers often consider the greater benefits to society that come with understanding the effects of alcohol administration on underage drinkers. Additionally, researchers typically administer alcohol only to participants who are not alcohol naive and who regularly subject themselves to similar levels of alcohol use. Despite this, psychologists working with underage drinkers have an ethical obligation to consider the risks of alcohol administration and minimize harm to subjects.

While providing alcohol to subjects under 18 is rare in the field, the use of underage participants for alcohol research is likely to become more common with the development of new EMA and ambulatory assessment technologies that allow researchers to bypass administration of alcohol. However, alcohol research with those under 18 still presents ethical challenges related to confidentiality, disclosures, and obtaining informed consent, as working with this population requires parental consent and youth assent (Hildebrand et al., 2016; Lothen-Kline et al., 2003; Mammel & Kaplan, 1995).

Maintaining confidentiality for participants under the age of legal majority is crucial, as these individuals will be reporting on illegal substance use behaviors of which parents might be unaware. While the APA Ethics Code (2002) recognizes the importance of maintaining confidentiality, the code also allows for judgment in limits to confidentiality. However, determining whether to disclose potentially hazardous levels of underage alcohol use to parents or other professionals can present a difficult ethical challenge, particularly for trainees who may be less experienced with making such decisions.

Prior research has found that the majority of teenagers would feel betrayed by researchers if substance use behaviors were disclosed to parents (Fisher, 2003). However, almost half of parents (46%) who were surveyed stated that they felt researchers would be responsible if substance use problems got worse and the investigator had not reported the issue (Fisher, 2003). These results reveal the hefty costs that might be associated with choices at either end of the spectrum; trainees must balance respecting the privacy of adolescent participants while protecting adolescents from harm. Disclosure determinations should be made in conjunction with experienced researchers, and students should consult professionals who are well-versed in the state’s ethical and legal codes for psychologists. State statutes guide what information can or must be disclosed to parents when working with underage participants.

Guidelines and Recommendations for Alcohol Researchers Working with High Risk Groups

1. To avoid coercing participation, researchers should omit information on payments in recruitment flyers or provide gift cards rather than cash. As alcohol itself may be an inducement, informed consent procedures should include a clear outline of potential risks of the study as they apply to the participant in question so they may carefully consider these risks before agreeing to participate. High-risk participants should also be provided resource sheets with local treatment providers and emergency numbers.

2. Trainees should be aware of signs of severe alcohol withdrawal (i.e., hallucinations, confusion, shaking) and associated procedures, which should include recommending medical treatment for the participant and contacting a local hospital, alerting a supervisor, and notifying the Institutional Review Board (IRB) of an adverse event.

3. When working with intoxicated individuals, potential participants should be required to answer questions about the informed consent process to ensure comprehension. A clear guideline on what constitutes a “passing” score should be set beforehand. Additionally, participants may be contacted following participation and given the option of withdrawing data from the study, if feasible.

4. Researchers administering alcohol to those under 21 should minimize harm by having participants only reach levels of intoxication required for the purposes of the study and that are typical of their alcohol consumption. Furthermore, researchers should consider the risk-benefit ratio of conducting alcohol administration research in younger populations. For trainees, this analysis of risks and benefits should be conducted in conjunction with experienced and ethically responsible supervisors.

5. To ensure confidentiality, researchers should consider applying for the National Institutes of Health’s certificate of confidentiality (CoC), which protects privacy for research participants by prohibiting disclosure of identifiable information to those not involved in the research without participant consent. An important development as of December 31, 2016 is that NIH-funded researchers will automatically be awarded a CoC as a condition of the award (NIH, 2017). Trainees should be aware of whether studies are protected by a CoC and make efforts to secure a CoC in instances where this may be important for protecting study integrity.

6. Researchers working with those under the legal age of majority should incorporate other ways of increasing confidentiality. When possible, data should be kept anonymous. If anonymizing data is not possible, informed consent procedures should clearly outline what information will or will not be disclosed to parents. Researchers should carefully discuss with parents and participants the reasons for these decisions. Researchers must also be aware of relevant state statutes regarding confidentiality and disclosures, as they apply to minors.

Alcohol Administration Studies

Training Research Assistants in the Administration of Alcohol

Alcohol administration studies are a staple among alcohol research protocols. These studies involve administering alcohol (orally or intravenously) to participants in lab settings. Typically, research assistants (RAs) conduct these studies under the supervision of a more senior graduate student or faculty member. When delegating work to RAs, psychologists must consider the competence of those RAs at performing the duties assigned to them. While many concerns related to alcohol administration designs have been discussed in the literature (Wood & Sher, 2000), concerns regarding the competence of RAs have largely gone unmentioned. Graduate students in training may find it especially difficult to take on a supervisory role and monitor performance of RAs effectively. Therefore, it is important that trainees are aware that issues of incompetence can emerge, particularly in such ethically and legally complex studies.

Appropriate supervision of alcohol administration research should include extensive training of those who will be interacting with participants, including establishing guidelines for emergencies or other incidents that may occur. Trainees should have knowledge of the National Institute on Alcohol Abuse and Alcoholism’s (NIAAA) guidelines regarding alcohol administration to humans and should be aware of their responsibilities in case of adverse effects (“Administering Alcohol in Human Studies”). For example, a number of effects are relatively common following administration of alcohol, including nausea, vomiting, headache, dysphoria, and disinhibited behavior (Wood & Sher, 2000). In order to minimize harm to participants, supervisors should have plans in place and be available in case of any of these events. Furthermore, investigators should ensure that trainees are aware of what to do in case of rare adverse events, such as physical aggression, flushing responses, and alcohol and drug interactions. Additionally, senior researchers should consider it their responsibility to sit in on random alcohol administration sessions to ensure that trainees are following guidelines and procedures regarding ethical treatment of participants.

Protection of Participants and the Public

Along with the supervisory concerns related to alcohol administration, researchers must consider a number of other factors. When administering alcohol, researchers occasionally use designs that involve some level of deception. For example, deception can be an important feature of studies attempting to piece apart the effects of alcohol expectancies, or ideas about the effects of alcohol, from the actual physiological effects of use. Ethics Code (2002) Standard 8.07 Deception in Research states, “Psychologists do not conduct a study involving deception unless they have determined that the use of deceptive techniques is justified” and “psychologists explain any deception that is an integral feature of the design and conduct of an experiment to participants as early as is feasible” (pg. 11). When considering the use of deception, researchers should be mindful of the potential harmful effects of deception for participants and public trust in psychologists and researchers.

Alcohol administration studies place participants in an intoxicated state that usually results in some degree of impairment. When individuals participate in alcohol administration designs, a blood alcohol concentration (BAC) of around 0.08g% or above is typically reached, meaning that participants typically reach levels of legal intoxication. Following administration, participants remain in the laboratory until they reach a BAC of between 0.02g% and 0.04g%, at which point effects of alcohol are minimal. After an already lengthy administration procedure, a participant may become restless and wish to leave the study early. At this point, researchers are tasked with ensuring that the participant’s desires and needs do not lead to harm to others. If participants refuse transportation or do not wish to wait for their BAC to return to a predetermined threshold, trainees should contact their supervisors and inform the participant of the need to break confidentiality in the event that they decide to leave.

While the above scenario represents a more obvious ethical dilemma, researchers should consider the risks of releasing participants even once they have reached a threshold BAC, particularly if researchers are using a BAC of 0.04g% as the threshold for release. At this BAC level, participants are not legally intoxicated but may still experience physical and psychological effects of alcohol. As alcohol reduces inhibitions even at BAC levels as low as 0.04g%, individuals may leave the laboratory setting and engage in behaviors they otherwise would not. Researchers should consider their legal and ethical obligations in the rare case of participants who engage in behaviors they later regret following an alcohol administration study, and should use these considerations to inform the threshold BAC that is set in a given study.

Finally, there are a couple of more common ethical challenges. Vomiting is one effect of alcohol, and trainees are likely to have to deal with this situation at some point if conducting alcohol administration studies. Though vomiting may not seem like a major event to the participant, a supervisor should be contacted as an adverse event will need to be reported, and the participant should be monitored and followed up with to ensure that no further negative effects occurred. In the moment, the trainee will need to clean up and should provide the participant with an area in which to take a break and consume fluids, like a sports drink or water. Secondly, particularly for women, unwanted sexual advances might be an issue when conducting alcohol research. In these cases, trainees should decline the advances and remind participants of their professional role. If at any point in time a trainee becomes uncomfortable with the situation or is concerned for their safety, the participant should be asked to leave. Trainees may also wish to contact a supervisor or local law enforcement, depending on the severity of the offense.

Guidelines and Recommendations for Alcohol Researchers Conducting Alcohol Administration Studies

1. Trainees should ensure RAs are well-versed in ethical guidelines regarding alcohol administration to humans and have contact information of supervisors in the case of an adverse event; additionally, trainees should be aware of these procedures themselves. As handling emergencies may be outside the boundaries of competence of some RAs, particularly undergraduate RAs, graduate or higher-level supervisors should be available.

2. Researchers using deception in alcohol administration studies should discuss the use of these techniques during a debriefing period following participation. If this is not feasible, participants should be told of the use of deception following data collection procedures.

3. Debriefing procedures should include a discussion of potential risks of engaging in certain behaviors following alcohol administration. For example, researchers should warn participants about use of a motor vehicle until their BAC has returned to baseline, as well as potential disinhibition that might result from even a relatively low BAC.

4. If a participant wishes to leave the alcohol administration session before their BAC reaches a pre-determined threshold level, guidelines should be in place for RAs, and supervisors should be contacted. Researchers should arrange for transportation for the participant and strongly encourage the participant to use the offered transportation. If participants are unwilling to use transportation arranged by the researcher, informed consent procedures should clearly state the researcher’s policy, which may include a need to contact local police.

5. If a participant vomits during or after alcohol administration, the trainee should ensure that the participant is okay and is provided with fluids and a place to take a break. Trainees should contact their supervisor and clean up the area. The participant should also be contacted at a later date to ensure no further negative effects occurred.

6. If trainees encounter unwanted sexual advances, they should first decline and attempt to remind the participant of their professional role. If advances persist or the trainee becomes uncomfortable or feels unsafe, the trainee should ask the participant to leave and/or contact a supervisor or local law enforcement, depending on the nature of the situation.

New Technologies and Methodologies in Alcohol Research

While alcohol administration studies allow researchers to understand the effects of alcohol in a controlled setting, researchers are also often interested in understanding the contexts, emotions, and motivations associated with use in daily life. Ecological momentary assessment (EMA) is one method that allows researchers to evaluate alcohol use as it occurs without the researcher needing to be present (Shiffman et al., 2008). EMA data are typically collected using an electronic diary or smartphone, but other methods may also be used to collect additional information, including wearable devices that collect physiological measures. The use of these devices is sometimes referred to as ambulatory assessment. Collectively, this information provides a picture of participants’ experiences with alcohol without the pitfalls of retrospective self-report data collection or unnatural lab settings.

Despite the advantages of using EMA data in alcohol research, these emerging methods present unique ethical and legal challenges related to psychologists’ duty to protect and obligations for ensuring participants’ privacy and confidentiality. Trull (2015) reviewed the general ethical challenges when conducting research using ambulatory assessment methods. Other researchers have pointed out concerns as they relate to research involving mood disorders (Wenze & Miller, 2010). However, ethical concerns are amplified when studying sensitive and potentially illegal behaviors, like underage alcohol use or drinking and driving.

For many of the modern devices used to collect EMA data, researchers receive data almost immediately and could access or become aware of a participant’s response. In such circumstances, what obligation do researchers have if participants report engaging in dangerous or harmful behaviors, like driving while intoxicated? Tarasoff v. Regents of the University of California led to a ruling that states that psychologists have a duty to protect individuals who are at risk of being harmed by a client (Cal., 1974, 1976). While there is currently no case law that establishes such an obligation for researchers, many researchers might feel an ethical obligation to report dangerous activities, particularly if they become aware of these as they occur (Appelbaum & Rosenbaum, 1989). Furthermore, what duty do researchers have to protect their own participants if they become aware that they are in danger of being harmed? These new and emerging questions are particularly important for alcohol researchers, as intoxication has been found to put individuals at greater risk of adverse events, such as sexual assault (Testa et al., 2004). It is currently not known what a researcher’s obligation would be to participants, attorneys, etc. if such a situation was inadvertently captured by EMA devices.

Ambulatory assessment methods collect increasingly more data, including ambient noise data, from participants using smartphones and other devices (Mehl & Robbins, 2012). Ambient noise data may be used to determine whether participants were alone, engaged in conversation, or fighting with others, all of which can be useful for understanding alcohol use. With new technology, collecting this information becomes easier and easier to do using participants’ own devices. However, the collection of all of these data raises questions about privacy. Researchers might inadvertently capture sensitive life moments or other situations that participants might not anticipate occurring when they agree to participate. Beyond this, outside individuals could attempt to gain access to data for a variety of purposes.

When capturing data passively, researchers should be aware that data may be captured on non-consenting individuals who are in contact with the participant (Trull, 2015). Those who engage in conversation with the participant might have their voices or images recorded without their knowledge and consent. This presents a unique ethical concern, as Ethics Code (APA, 2002) Standard 8.03 states, “Psychologists obtain informed consent from research participants prior to recording their voices or images for data collection unless (1) the research consists solely of naturalistic observations in public places… or (2) the research design includes deception, and consent for the use of the recording is obtained during debriefing” (pg. 10). As EMA research would typically not meet either of these criteria, trainees should consult with supervisors to determine how to minimize harm and protect the privacy of ancillary individuals.

While having a large amount of data is useful for researchers interested in investigating behavior in natural settings, a large amount of data also requires more extensive security protocols (Trull, 2015). Because alcohol investigators are collecting sensitive information, ensuring confidentiality of participants’ data becomes even more important. While an increasing number of applications and devices are being developed for the purpose of EMA data collection, researchers are tasked with evaluating the security of these apps and devices and their compliance with relevant guidelines. As more EMA methods are developed, the competence of researchers for working with these technologies and understanding and implementing appropriate data security measures must also be considered. As increasingly complex data encryption procedures are required and new technologies emerge, psychologists and trainees might have difficulty keeping up with trends in data collection and data security.

Guidelines and Recommendations for Adapting to New Technologies and Methodologies

1. As EMA methodology can allow for rapid transmission of sensitive data to researchers, ethical challenges might emerge related to protection of others. In order to avoid a potential disclosure situation, researchers should limit viewing of real-time data during its collection.

2. When conducting research using EMA methodologies, researchers should collect only that data which are necessary for answering the proposed research questions. Additionally, researchers should notify participants about all forms of data being collected, especially data which are collected passively (i.e., ambient noise data, physiological data, etc.).

3. As information on non-consenting individuals might be captured by passive data collection methods, researchers might recommend that participants discuss this possibility with individuals they routinely interact with.

4. Researchers should allow participants to turn off data collection in private moments they do not wish to be recorded. Additionally, researchers could let participants review data collected prior to its analysis, allowing participants to withdraw data for any reason.

5. If data regarding alcohol use and other daily life behaviors is compromised, participants can be harmed financially and/or psychologically. As such, devices used for data collection should be password-protected, with participants being required to enter a password to answer prompts (Trull, 2005). Data on smartphones or other devices and data transmission should be encrypted so that outside individuals cannot access data. All those with access to the data need to be trained in IRB protocols, as well as HIPAA guidelines.

Suggestions for Training Programs

Alcohol research is an ever-evolving area of study that presents many unique ethical challenges for researchers and trainees in particular. Trainees may not yet be comfortable evaluating complex ethical challenges on their own and may require more guidance and concrete instructions than current ethical guidelines typically provide. With a framework understanding of these guidelines, trainees might find the current paper and other reviews helpful for navigating ethically ambiguous situations. However, there are other ways that training programs can aid in increasing trainees’ comfort with making complex ethical decisions in alcohol research.

New trainees may be paired with more senior trainees in order to gain exposure to methods that will be used in their research. This could include having the trainee sit in on several alcohol administrations before allowing them to conduct a study themselves. With other methods, like EMA, this pairing could be more of a conversation, with the senior trainee handing down knowledge on frequently encountered ethical issues that might emerge. For those working in field settings, such as bars or emergency rooms, the trainee may shadow the senior trainee for a period of time or may practice different aspects of the methodology, including assessing capacity for informed consent. In fact, role-playing can be helpful in many regards for trainees by giving them risk-free situations in which to practice their ethical decision making skills.

Finally, training programs should prioritize ethics by creating a culture between senior researchers and trainees that emphasizes ethical values over other objectives. Trainees may see their main goals in research as getting publications or research experiences. However, it is important that trainees are able to openly communicate with supervisors. Trainees should be able to admit mistakes and ask questions without fear or shame. This aids in the development of a sense of belonging within the alcohol research community and a professional sense of identity, which will be important whether the trainee remains a lifelong alcohol researcher or not.

Public Significance Statement:

While research on alcohol use is important for addressing public health concerns, it also presents unique ethical and legal challenges. For trainees, these issues may be difficult to navigate. Therefore, training should emphasize developing a complex understanding of research ethics and the appropriate recommendations for situations that trainees may encounter.