Conscientious, well-informed, and good-intentioned people throughout the profession of medicine have arrived at differing conclusions on the ethical acceptability of research involving human volunteers. Investigation that poses risk to the physical health of vulnerable participants has historically been the source of greatest concern (R1—R3). Recently, however, ethicists, policy makers, and federal regulatory groups have begun to give greater attention to human studies that entail primarily psychosocial risk (R1, R5—R6). Moreover, a greater sensitivity to "special" or "vulnerable" participant populations in research has also evolved in recent years. (R4) For these reasons, ethical and regulatory considerations in educational research, with its specific psychosocial risks and learner-participant populations, are emerging as topics of renewed interest nationally (R5—R6).

Conducting ethically sound education-related studies is an important commitment for academic psychiatrists (R7). Because empirical work in psychiatric education commonly involves the gathering of data on the personal experiences, knowledge, attitudes, and performance of our students, these considerations are particularly salient for professionals in our field. Educational research has typically required few formal safeguards beyond confidentiality measures and exemption by an institutional review board (R8). The potential sensitivity and ethical complexity of educational research and the adequacy of current regulatory guidelines therefore merit the attention of readers of our journal (R5—R6, R7, R9).

Given the importance of the topic and its relative neglect in the medical education literature, our purpose in this editorial is to outline four questions of importance to understanding ethical and regulatory considerations in educational research: (1.) What is educational research? (2.) Do students constitute a vulnerable population? (3.) What safeguards exist to protect learner-participants? (4.) How can we improve the ethical caliber of educational research?

What is educational research? Educational research is inquiry focusing on students, teachers, teaching methods, curricular initiatives, or educational processes and outcomes with the intent to share these findings with the broader scholarly community (R7, R9). Federal regulations specify that educational research is "… conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i.) research on regular and special education instructional strategies, or (ii). Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods" (R8).

There is considerable overlap in the usual excellent practices of teachers and the activities of educational researchers. For example, an excellent teaching practice is to seek evaluative feedback after introducing a new teaching approach in the classroom. Similarly, the educational researcher may seek evaluative feedback after performing an educational intervention that is, essentially, introducing a new teaching approach in the classroom. Excellent teaching practice is to evaluate knowledge after providing instruction. Likewise, the educational researcher may assess retention of knowledge in learner-participants once they have been instructed on a topic. Excellent teaching practice is to notice which students perform especially well or seem particularly receptive to a particular area; the educational researcher will note the same things in interactions with learner-participants.

So, how does one discern between educational efforts and educational research? They are purposeful, rigorous, creative and scholarly activities that may be subject to peer review and academic dissemination in various forms, so it may be challenging to distinguish them materially. Indeed, different IRBs, educational institutions and individual scholars have differed in their interpretations of "quality assurance" for educational research, creating both complexity and controversy. (R7) The federal regulations, however, highlight an ethically important distinction. Human research is characterized as systematic investigation involving living human beings with the intent to contribute to generalizable knowledge (t1). In other words, the difference between educational practice and educational research is not about what is done by teachers or researchers—although educational research may be more deliberate or systematic in its design—but, rather, by what is intended by teachers or researchers, respectively.

Setting aside regulatory issues, from an ethical perspective, both teacher and researcher must fulfill ethical commitments in their work. Nevertheless, the fundamental professional obligations of teachers and researchers essentially differ. A teacher’s primary responsibility is to serve the best interests of the student whereas the researcher’s duties are focused first on gathering and promulgating knowledge and then, when possible, serving the interests of the learner-participant. In the future, it is hoped that we will be better able to develop valid and reliable means of discerning and instantiating such distinctions, as this will be crucial for the appropriate regulatory protection of learner-participants as well as the ethical anchoring of academic research.

Do student participants constitute a vulnerable population? Early conceptual work in human research ethics emphasized how constraints on autonomy may create vulnerability in certain populations such as prisoners or institutionalized patients (R10—R12). The dependent status of these individuals necessitates safeguards to protect against manipulation or exploitation in the context of research (R11).

It is counterintuitive to think of students and residents as "vulnerable." Nevertheless, there are some important parallels with other, similarly "dependent" or "convenient" participant populations. For instance, psychiatry trainees are certainly dependent in the institutional hierarchy in that their status and even continued enrollment in professional school hinge on the evaluations of their teachers and preceptors. Roberts et al have shown that this dynamic can lead students to ignore serious health problems should they believe seeking care could potentially jeopardize their academic standing (R13). The same faculty who evaluate students often conduct research, creating a role conflict and potential conflict of interest analogous to that of the clinician/researcher. This can generate a "scholarly misconception" on the part of both students and faculty (R14—R15). Students are also vulnerable in that they have few routes for safe advocacy and appeal. Students may feel that negative academic or personal consequences will ensue if they decline participation in a faculty-led research project and fear the same ramifications should they protest the ethicality of the research. These concerns may intensify when the research deals with sensitive information on gender, sexual orientation, race, academic performance, substance use or mental illness.

What safeguards exist to protect learner-participants? Human research is founded on the principles of Respect for Persons, Beneficence, and Justice which find their translation in a number of safeguards, such as informed consent, confidentiality protections, institutional review board (IRB) review and oversight, and peer review (R11, R16). In general, the rights and well-being of learner-participants are protected through these same safeguard procedures. However, because most educational research involves only minimal risk and because this risk is more likely to be psychosocial than biological in nature, the federal regulations permit some educational research—under specific circumstances—to be exempt from certain of these safeguards (t1). For example, projects in which data are gathered in a manner that is fully protective of learner-participant anonymity (i.e., no one anywhere can identify the participant including the members of the research team) may be formally deemed exempt from full IRB review and oversight (F1). Thus, mail out survey studies may be exempt from formal, witnessed informed consent procedures.

Some argue that while IRBs are the most critical protection for student populations, they can be easily bypassed by naïve or ill-informed educational investigators who may not fully appreciate the potential vulnerabilities of learner-participants (R9, R15). This issue has remerged from an early debate (R17—R18) in the wake of increased federal scrutiny in response to a number of high-profile ethical lapses in academic research (R17—R20). Tomkowiak and colleagues encourage caution in their discussion of a good faith misadventure in curricular innovation that initially bypassed formal IRB review and resulted in charges of research misconduct and ultimately destruction of the data (R21). It is their contention that before student information is gathered and shared, even among colleagues, an educator must ensure that standards of confidentiality and informed consent are met. Additionally, no longer can the educator or the institutional leadership make the determination that medical education data are exempt from IRB processes because they can only be provided after review of the research application (R21). Students who participate in educational research would then be the beneficiaries of the protections mediated through IRB’s independent appraisal of each study. All projects would be formally assessed based on methodological, potential risks and benefits, and processes related to selection, recruitment, informed consent and confidentiality for participant-learners. The growing consensus is that any educational research that is intended to be published or disseminated should be submitted to the local IRB for review; these projects can no longer be automatically considered to fall into an exempt or even expedited category (R22).

How can we improve the ethical caliber of educational research? The first and essential step in improving the ethical caliber of educational research is, paradoxically, education. Two of us (LWR, CG) conducted a review of 424 research reports published in 1988-1989 and 1998-1999 in two leading medical education journals. We found that nearly half documented no ethically important safeguards such as informed consent, confidentiality, or conflict of interest. Further, the rate of ethical protections did not improve over the 10 years examined (R7). Instruction in pertinent institutional, state and federal regulations and in accepted procedures related to research ethics should be a component of medical educator development. Additionally, there is a need for improved communication between medical education researchers and IRB staff, especially around "dual purpose activities or potential conflicts as researchers and educators" (R15).

Faculty can model procedural excellence by using their own research to demonstrate use and understanding of core ethical principles (e.g. Respect for Persons) and safeguards (e.g. informed consent and confidentiality). As in all ethically sound research, students must be provided adequate opportunities to refuse participation in research with a clear written understanding that refusal will not in, in any way, jeopardize their academic or personal standing. As noted previously however, the line between research and teaching or research and routine program evaluation is not always clear. This reinforces the need for seeking consultation from time to time to provide needed guidance for researchers and educators on how and when evaluative assessments "become" research. Similarly, sharing with students the results of educational research can further enhance the learning experience.

As academic psychiatrists, we are well-suited to recognize tensions in the overlapping activities and roles of teachers and educational researchers. Given the nature of our daily work, we should also be especially well-attuned to understand the subtle and significant pressures that learner-participants may experience. Many agree that research proposals should routinely undergo stricter scrutiny by IRBs to approve design methodologies, selection and recruitment processes, and mechanisms that protect anonymity, confidentiality and consent. On the other hand, we need to appreciate the importance of rigorously developing and promulgating the results of educational research. It is through this type of research that we will be able to better prepare medical students, physicians-in-training, and our professional colleagues for their future.

Our challenge is an important one. We must seek to validly and reliably delineate educational practices from educational research, and to improve the ethical caliber of our research. In doing so, we will faithfully serve the interests of our students and actively advance the academic basis of our field.