Editorial

Academic Psychiatry, 29:1, Spring 2005 http://ap.psychiatryonline.org 1

Ethical and Regulatory Considerationsin Educational Research

Laura Weiss Roberts, M.D.Cynthia M.A. Geppert, M.D., Ph.D.

John Coverdale, M.D., M.Ed., FRANZCPAlan Louie, M.D.

Kristin Edenharder, B.A.

Conscientious, well-informed, and good-inten-tioned people throughout the profession of med-

icine have arrived at differing conclusions on the eth-ical acceptability of research involving humanvolunteers. Investigation that poses risk to the physi-cal health of vulnerable participants has historicallybeen the source of greatest concern (1–3). Recently,however, ethicists, policy makers, and federal regu-latory groups have begun to give greater attention tohuman studies that entail primarily psychosocial risk(1, 5–6). Moreover, a greater sensitivity to “special”or “vulnerable” participant populations in researchhas also evolved in recent years. (4) For these reasons,ethical and regulatory considerations in educationalresearch, with its specific psychosocial risks andlearner-participant populations, are emerging as top-ics of renewed interest nationally (5–6).

Conducting ethically sound education-relatedstudies is an important commitment for academicpsychiatrists (7). Because empirical work in psychi-atric education commonly involves the gathering ofdata on the personal experiences, knowledge, atti-tudes, and performance of our students, these consid-erations are particularly salient for professionals inour field. Educational research has typically requiredfew formal safeguards beyond confidentiality mea-sures and exemption by an institutional review board(8). The potential sensitivity and ethical complexityof educational research and the adequacy of currentregulatory guidelines therefore merit the attention ofreaders of our journal (5–6, 7, 9).

Given the importance of the topic and its relativeneglect in the medical education literature, our pur-

pose in this editorial is to outline four questions ofimportance to understanding ethical and regulatoryconsiderations in educational research: (1.) What iseducational research? (2.) Do students constitute avulnerable population? (3.) What safeguards exist toprotect learner-participants? (4.) How can we im-prove the ethical caliber of educational research?

What is educational research? Educational researchis inquiry focusing on students, teachers, teachingmethods, curricular initiatives, or educational pro-cesses and outcomes with the intent to share thesefindings with the broader scholarly community (7, 9).Federal regulations specify that educational researchis “. . . conducted in established or commonly ac-cepted educational settings, involving normal edu-cational practices, such as (i.) research on regular andspecial education instructional strategies, or (ii). Re-search on the effectiveness of or the comparisonamong instructional techniques, curricula, or class-room management methods” (8).

There is considerable overlap in the usual excel-lent practices of teachers and the activities of educa-tional researchers. For example, an excellent teachingpractice is to seek evaluative feedback after introduc-ing a new teaching approach in the classroom. Simi-larly, the educational researcher may seek evaluativefeedback after performing an educational interven-tion that is, essentially, introducing a new teachingapproach in the classroom. Excellent teaching prac-tice is to evaluate knowledge after providing instruc-tion. Likewise, the educational researcher may assessretention of knowledge in learner-participants oncethey have been instructed on a topic. Excellent teach-

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ing practice is to notice which students perform es-pecially well or seem particularly receptive to a par-ticular area; the educational researcher will note thesame things in interactions with learner-participants.

So, how does one discern between educationalefforts and educational research? They are purpose-ful, rigorous, creative and scholarly activities thatmay be subject to peer review and academic dissem-ination in various forms, so it may be challenging todistinguish them materially. Indeed, different IRBs,educational institutions and individual scholars havediffered in their interpretations of “quality assur-ance” for educational research, creating both com-plexity and controversy. (7) The federal regulations,however, highlight an ethically important distinction.Human research is characterized as systematic inves-tigation involving living human beings with the in-tent to contribute to generalizable knowledge (Table1). In other words, the difference between educationalpractice and educational research is not about whatis done by teachers or researchers—although educa-tional research may be more deliberate or systematicin its design—but, rather, by what is intended byteachers or researchers, respectively.

Setting aside regulatory issues, from an ethicalperspective, both teacher and researcher must fulfillethical commitments in their work. Nevertheless, thefundamental professional obligations of teachers andresearchers essentially differ. A teacher’s primary re-sponsibility is to serve the best interests of the studentwhereas the researcher’s duties are focused first ongathering and promulgating knowledge and then,when possible, serving the interests of the learner-participant. In the future, it is hoped that we will bebetter able to develop valid and reliable means of dis-cerning and instantiating such distinctions, as thiswill be crucial for the appropriate regulatory protec-tion of learner-participants as well as the ethical an-choring of academic research.

Do student participants constitute a vulnerable popu-lation? Early conceptual work in human researchethics emphasized how constraints on autonomymay create vulnerability in certain populations suchas prisoners or institutionalized patients (10–12). Thedependent status of these individuals necessitatessafeguards to protect against manipulation or exploi-tation in the context of research (11).

It is counterintuitive to think of students and res-idents as “vulnerable.” Nevertheless, there are some

important parallels with other, similarly “dependent”or “convenient” participant populations. For in-stance, psychiatry trainees are certainly dependent inthe institutional hierarchy in that their status andeven continued enrollment in professional schoolhinge on the evaluations of their teachers and pre-ceptors. Roberts et al have shown that this dynamiccan lead students to ignore serious health problemsshould they believe seeking care could potentiallyjeopardize their academic standing (13). The samefaculty who evaluate students often conduct research,creating a role conflict and potential conflict of inter-est analogous to that of the clinician/researcher. Thiscan generate a “scholarly misconception” on the partof both students and faculty (14–15). Students are alsovulnerable in that they have few routes for safe ad-vocacy and appeal. Students may feel that negativeacademic or personal consequences will ensue if theydecline participation in a faculty-led research projectand fear the same ramifications should they protestthe ethicality of the research. These concerns may in-tensify when the research deals with sensitive infor-mation on gender, sexual orientation, race, academicperformance, substance use or mental illness.

What safeguards exist to protect learner-participants?Human research is founded on the principles of Re-spect for Persons, Beneficence, and Justice which findtheir translation in a number of safeguards, such asinformed consent, confidentiality protections, insti-tutional review board (IRB) review and oversight,and peer review (11, 16). In general, the rights andwell-being of learner-participants are protectedthrough these same safeguard procedures. However,because most educational research involves onlyminimal risk and because this risk is more likely tobe psychosocial than biological in nature, the federalregulations permit some educational research—un-der specific circumstances—to be exempt from cer-tain of these safeguards (Table 1). For example, pro-jects in which data are gathered in a manner that isfully protective of learner-participant anonymity (i.e.,no one anywhere can identify the participant includ-ing the members of the research team) may be for-mally deemed exempt from full IRB review and over-sight (Figure 1). Thus, mail out survey studies maybe exempt from formal, witnessed informed consentprocedures.

Some argue that while IRBs are the most criticalprotection for student populations, they can be easily

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FIGURE 1. Appropriate Steps to Ensure Safeguards in Educational Research

Project idea

No

No

No

No

No

No

Yes

Yes Yes Yes

Yes

Yes

Yes

Yes

No No

Revise projectidea

Do notproceed

with project

Proceedwith project

Revise projectidea

Is it research?

Does theIRB want full

review?

Seek fullIRB review

Is thefull reviewapproved?

Is theexpedited review

approved?Is therisk greater than

minimal?

No need toseek IRBapproval

at this time

Does thescientific question

justify the risk?

Is theparticipationanonymous?

Seek formalIRB exemption

Seek IRBexpedited

reviewCan therisk be reduced

to minimal?

bypassed by naı̈ve or ill-informed educational inves-tigators who may not fully appreciate the potentialvulnerabilities of learner-participants (9, 15). This is-sue has remerged from an early debate (17–18) in thewake of increased federal scrutiny in response to anumber of high-profile ethical lapses in academic re-search (17–20). Tomkowiak and colleagues encouragecaution in their discussion of a good faith misadven-ture in curricular innovation that initially bypassedformal IRB review and resulted in charges of researchmisconduct and ultimately destruction of the data(21). It is their contention that before student infor-mation is gathered and shared, even among col-leagues, an educator must ensure that standards ofconfidentiality and informed consent are met. Addi-tionally, no longer can the educator or the institu-tional leadership make the determination that medi-cal education data are exempt from IRB processesbecause they can only be provided after review of theresearch application (21). Students who participate in

educational research would then be the beneficiariesof the protections mediated through IRB’s indepen-dent appraisal of each study. All projects would beformally assessed based on methodological, potentialrisks and benefits, and processes related to selection,recruitment, informed consent and confidentiality forparticipant-learners. The growing consensus is thatany educational research that is intended to be pub-lished or disseminated should be submitted to thelocal IRB for review; these projects can no longer beautomatically considered to fall into an exempt oreven expedited category (22).

How can we improve the ethical caliber of educationalresearch? The first and essential step in improving theethical caliber of educational research is, paradoxi-cally, education. Two of us (LWR, CG) conducted areview of 424 research reports published in 1988-1989and 1998-1999 in two leading medical education jour-nals. We found that nearly half documented no ethi-cally important safeguards such as informed consent,

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confidentiality, or conflict of interest. Further, the rateof ethical protections did not improve over the 10years examined (7). Instruction in pertinent institu-tional, state and federal regulations and in acceptedprocedures related to research ethics should be a com-ponent of medical educator development. Addition-ally, there is a need for improved communication be-tween medical education researchers and IRB staff,especially around “dual purpose activities or poten-tial conflicts as researchers and educators” (15).

Faculty can model procedural excellence by us-ing their own research to demonstrate use and un-derstanding of core ethical principles (e.g. Respect forPersons) and safeguards (e.g. informed consent andconfidentiality). As in all ethically sound research,students must be provided adequate opportunities torefuse participation in research with a clear writtenunderstanding that refusal will not in, in any way,jeopardize their academic or personal standing. Asnoted previously however, the line between researchand teaching or research and routine program eval-uation is not always clear. This reinforces the need forseeking consultation from time to time to provideneeded guidance for researchers and educators onhow and when evaluative assessments “become” re-search. Similarly, sharing with students the results of

educational research can further enhance the learningexperience.

Conclusion

As academic psychiatrists, we are well-suited to rec-ognize tensions in the overlapping activities and rolesof teachers and educational researchers. Given the na-ture of our daily work, we should also be especiallywell-attuned to understand the subtle and significantpressures that learner-participants may experience.Many agree that research proposals should routinelyundergo stricter scrutiny by IRBs to approve designmethodologies, selection and recruitment processes,and mechanisms that protect anonymity, confidenti-ality and consent. On the other hand, we need to ap-preciate the importance of rigorously developing andpromulgating the results of educational research. It isthrough this type of research that we will be able tobetter prepare medical students, physicians-in-train-ing, and our professional colleagues for their future.

Our challenge is an important one. We must seekto validly and reliably delineate educational practicesfrom educational research, and to improve the ethicalcaliber of our research. In doing so, we will faithfullyserve the interests of our students and actively ad-vance the academic basis of our field.

TABLE 1. Information on Federal Regulations Applicable to Education Research

Definition of human participantA living individual about whom an investigator (whether professional or student) conducting research obtains (1) data throughintervention or interaction with the individual or (2) identifiable private information. (45 CFR 46, Section F 1)1

Definition of research

Research means a systematic investigation, including research development, testing and evaluation, designed to develop orcontribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy,whether or not they are conducted or supported under a program which is considered research for other purposes. For example,some demonstration and service programs may include research activities. (45 CFR 46, Section F.1)1

Guidelines for Oversight by Institutional Review Boards

(Minimal risk) Research involving the collection and study of existing data, documents, records, pathological specimens ordiagnostic specimens are subject to expedited review. This stands if these sources are publicly available or if the information isrecorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked tosubjects. (45 CFR 46, Section F 1.4)1

(Minimal risk) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures,interview procedures, or observation of public behavior are exempt from regulation unless: (1) information obtained is recordedin such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (b) anydisclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk or criminal orcivil liability or could be damaging to the subjects’ financial standing, employability, or reputation. (Section 3, F1,3)1

(Minimal risk) Research conducted in established educational settings, involving normal educational practices such as (1)research on regular and special education instructional strategies, or (b) research on the effectiveness of or the comparisonamong instructional techniques, curricula, or classroom management methods are exempt from coverage by federal regulations.(Section 3, F1,1)

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