Henry, Rebecca C. PhD; Wright, David E. PhD
OHRP Suspends Research Involving Human Subjects at the [fill in the name of your university] School of Medicine
Anyone who reads the papers, and especially the academic press, has seen more than one of these headlines in the last few years and has dreaded the day when his or her university would appear on the masthead. The OHRP (Office for Human Research Protections), which has replaced the OPRR (Office for Protection from Research Risks), and the Bush administration are reviewing new policies and regulations related to research with human subjects that emerged from the final year of the Clinton Administration. Nevertheless, the standing regulation on research involving human subjects (45 CFR 46)1 and what universities must do to comply with it are still commanding close scrutiny in the academy today. Old questions are being asked with new intensity: what counts as research amongst the array of academic activities? And what protections do institutions owe human subjects of research in the projects they sponsor?
Originally developed to protect against abuses of human subjects in federally funded clinical research, 45 CFR 46 is increasingly being applied more broadly. Each initial application to a new area of research can be met with confusion and resistance. Shea2 describes in detail the impact of this regulation as it has been applied in the social sciences and researchers' concerns about bureaucratic creep. In the context of medical education, faculty and administrators are reexamining the applicability of the human-subjects regulations to activities such as program evaluation that traditionally have not been submitted for review by institutional review boards (IRBs). But in this current climate of scrutiny, the boundaries of what does and does not count as research involving human subjects are being redrawn and retested.
The immediate pressure of regulatory oversight by the federal agencies is not the only reason for this reconsideration. A redefinition of scholarship stimulated by the work of Boyer3 urged a wider view of traditional research activities that places a new scholarly priority on the curriculum and the classroom as a laboratory for inquiry. Fincher and colleagues,4 in a theme issue of Academic Medicine on the application of Boyer's work, called upon medical schools to develop the infrastructure needed to foster, assess, and reward scholarship on teaching-related activities.
All this might be nothing new to those familiar with the regulations protecting human subjects at 45 CFR 46, because the regulations hold that activities that meet the regulatory definition of research “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.”1 That is, if any part of an activity constitutes research, the entire activity should be reviewed and approved by an IRB. This interpretation, when applied to routine program evaluation and learner assessments, is causing consternation in some groups of medical educators and in some local IRBs.
For this discussion let us define as dual-purpose activities those activities where one purpose is research but the other purpose is program evaluation or curriculum development that falls outside the jurisdiction of IRBs. For example, an ongoing program evaluation intended solely for improving the medical school curriculum would not fall under IRB jurisdiction. The same data gathered in that activity and used by the same professionals to present significant findings in a medical education journal arguably would constitute research. At a time when accreditation and outcomes assessment increasingly rely on student performance data and when faculty are invited if not motivated to produce scholarship from these efforts, this issue of dual-purpose data gains new importance.
Another way to discuss this dual-purpose activity is to say that faculty who gather and use these data are “wearing two hats.” One hat is that of the educator, whose primary obligation is to the welfare of the students. The other hat is that of the researcher, whose primary commitment is to generate and disseminate knowledge in a way that advances his or her own career. There is a potential conflict of interest between these two roles that, especially when not disclosed to the students being evaluated, complicates the human-subjects issues involved. Below we return to this point with the argument that this “two hat” problem for educators—evaluators is parallel to the “two hat” problem for clinician/investigators.
In this article we examine the boundary conditions of what does and does not fall under the purview of the IRB in the area of program evaluation and suggest practical steps to deal with the logistic problem of IRB review of routine evaluation and learner-assessment studies. Further, we discuss how this relates to the recent interest in professionalism in the curriculum and how faculty role modeling is central to this issue.
THE BOUNDARIES OF IRB JURISDICTION
When does program evaluation become research that requires prior IRB review and approval? Before this substantive question is addressed, a procedural one must be answered: Who decides? The position of the Office of Human Research Protection (OHRP/DHHS) and that of its predecessor (OPPR) is that scholars* should not determine for themselves whether their projects require IRB review, especially in borderline cases. Specifically, “investigators should not have the authority to make an independent determination that research involving human subjects is exempt.”5
Investigator determination in this context clearly involves conflict of interest. Scholars conducting program evaluations should contact their IRB chairs to discuss whether the activities require review and approval. Will the IRB determination be arbitrary and capricious, as some trepidatious scholars clearly fear, or will it be based on reasonable and transparent criteria? The IRB chair should answer that activities requiring review must meet two criteria: (1) They constitute research and (2) they involve human subjects. Definitions appear in the regulations:
Research means a systematic investigation, including research development, testing and evaluation [emphasis added] designed to develop or contribute 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.
Human subject is defined as a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
Let us stipulate for the moment that medical students are human (subjects). The question, then, is whether any part of the activity meets the above definition of research. The IRB chair will likely ask the scholar (let's call her professor M) the purpose of the project and her intent regarding the results. If she answers, for example, that the only purpose is evaluation toward the goal of program improvement through curriculum modification or development, then the activity will not require IRB review. However, suppose she answers that the activity is intended for program improvement but, in addition, she might share the findings with colleagues through the usual channels of scholarly communication to promote discussion of improving medical school curricula or evaluation procedures. Then the IRB chair will likely conclude that the “generalizable knowledge” standard has been reached and professor M's project constitutes research and therefore requires IRB review and approval.
“But,” argues professor M, “don't the regulations exclude from IRB jurisdiction research that poses no more than minimal risk to subjects, such as that involved in many evaluation projects?” “Yes and no,” answers the IRB chair, who then points out that the federal regulations at 45 CFR 46.101 (b) (1) exempt from IRB review
research 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 comparisons among instructional techniques, curricular or classroom management methods.
This certainly seems to describe much of evaluation research. However, many research universities go beyond the federal minimum standard to require that all research involving human subjects be submitted for IRB review and approval. These policies address in part the problem of self-exemption by scholars.
Professor M reluctantly but good-naturedly accepts the IRB's jurisdiction over her evaluation research, and moves on to try to negotiate the least invasive IRB requirements. She says to the chair, “These activities involve collection of multiple data points from each subject. Surely I won't have to get consent from the subjects for each of these components. In fact, isn't this like chart review when consent is not required?” She goes on to remind the IRB chair that Cassarett and colleagues6 argue that such an activity should be considered research and subject to IRB review only when the majority of subjects are not expected to benefit directly, or if additional risks or burdens are imposed to make the results generalizable.
“This is an important and sensitive point” says the IRB chair, and notes that the regulations at 45 CFR 46.116(d) list four criteria that must be met before an IRB can waive the requirement for informed consent:
* The research involves no more than minimal risk to the subjects.
* The waiver or alteration will not adversely affect the rights and welfare of the subjects.
* The research could not practicably be carried out without the waiver or alteration.
* Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Those criteria are not met, in the chair's opinion, in many projects presented as “chart review,” that is, in research utilizing existing data collected for non-research purposes.
“This is a widespread problem,” asserts the IRB chair, warming to his topic. “Some investigators, e.g., physician—investigators, collect data that they know they will use both for clinical care and for research without seeking prior IRB review and approval. Then they apply to the IRB for ‘chart review’ approval, asking for a waiver of the requirement for subjects' consent. There are several reasons why a physician—investigator might take this route. One is to maximize the N in a project by assuring that all the subjects will (unknowingly) participate. Another possible reason is that some physician—investigators are uncomfortable explaining their dual, and potentially conflicting, roles as clinician and researcher to their patients/subjects. In any case, this practice deprives subjects of the opportunity to provide fully informed consent before agreeing to participate in research.”
“This is the ‘two hats’ problem. The clinician's primary obligation is to be an advocate for the health of the patient. The investigator's primary obligation is to gather unbiased data that will hopefully advance knowledge and his or her career. There is no guarantee, and none may be offered, that the research will help the subject in any way. The subject is a volunteer who is promised nothing and, in fact, may be exposed to some risk by participating. That's why securing the subject's informed consent before gathering the data is critical,” concludes the IRB chair.
“So,” professor M says, “I conclude that you're suggesting that not only physician—investigators but also educator—evaluators face this ‘two hats’ problem.”
The professor observes that medical education is now placing increased emphasis on the ethical issues in the doctor—patient relationship, and states that perhaps as part of their mentoring obligation, faculty should lead by example by explaining to medical students that they are subjects of research as well as students, and according them the full protection of the regulations in their latter role. But what happens if they decline to participate? One can't do evaluation studies on a fraction of a class. The IRB chair responds that if participating in evaluation is part of the standard requirements of the medical school, then students have no choice but to participate. Where they do have a choice, continues the IRB chair, is in those cases when their data may be used for research purposes.
The IRB chair attempts to reassure professor M that seeking consent should not significantly lower the N for research purposes. “Americans are,” he says, “remarkably receptive to requests to participate in research, especially biomedical research, even when it poses inconvenience and risk. What they want is straight talk and adequate information. Medical students should be no different.”
“But,” says professor M, “are we going to have to seek consent every time we collect data that we might possibly want for research?” “No,” answers the IRB chair “there is some latitude in devising a consent process that adequately informs the subjects without overburdening them or the investigators.”
ROLE MODELING PROFESSIONAL BEHAVIOR
Emphasis on Professionalism in the Curriculum
Our discussion thus far has been guided by the requirements of 45 CFR 46, also known in combination with the companion agency regulations as “The Common Federal Rule.” However, other, non-regulatory, issues warrant attention when determining whether IRB review is needed. The previously mentioned issue of medical educators' “wearing two hats” is also at the heart of a larger national dialogue on professionalism. According to the Accreditation Council for Graduate Medical Education (ACGME),7 professionalism is, in part, the ability of physicians to be responsive “to the needs of patients that supercedes self interest … and to demonstrate a commitment to ethical principles pertaining to provision of clinical care, confidentiality of patient information and informed consent.”
Many of our leading educational societies and organizations embrace public positions that give prominence to the role of professionalism in both the undergraduate and the graduate medical education curricula. Both the Association of American Medical Colleges' Medical School Objectives Project (MSOP)8 and the ACGME identify professional behavior as core content for all medical schools and residency training programs. Similarly, the specialty organizations are setting explicit requirements that professional behavior should be routinely evaluated during training.9 In all of these initiatives the domain of professional behavior includes the expectation that physicians recognize their own conflicts of interest when disclosing relevant information to patients about their care. These two competencies (identifying conflict situations and fully disclosing relevant information to patients) clearly overlap with the concept of “wearing two hats.” Physicians' integrity rests upon recognizing when to disclose which hat is being worn. If such professional behavior should be taught to students and assessed throughout the continuum of medical education, shouldn't faculty also be held to a similar standard of professional behavior? Perhaps this begins with faculty role-modeling the same behaviors we expect of our learners. How does this issue present itself in the context of medical education?
At our school, an example emerged when faculty sought to publish or present program evaluation findings obtained through gathering routine student performance data.
Example: Addressing Conflict of Interest and Informed Consent within the Curriculum
Like all other medical schools, the College of Human Medicine (CHM) at Michigan State University keeps a program database that permits monitoring of many aspects of the curriculum and student progress. Data such as these are invaluable for determining curriculum quality and deficits. It is commonplace, if not expected, that faculty share notable findings with the educational community. The pressing task is to establish an efficient mechanism to honor the rights and protect the welfare of students as human subjects when results of program evaluations will be publicly disseminated.
In consultation with the chair of the university's IRB, CHM faculty developed a student consent from designed for implementation early in each year of the curriculum, when students are first exposed to topics of professionalism. Inviting discussion of scholarship on program evaluation as part of the consent process highlights several essential points for the students. First, they become aware of how program evaluation and the database are used by the college to improve curriculum. Second, they learn the benefits of participating in a network of scholarship. In short, fully informing students of their role as human subjects and of their role in this scholarship supports the college's values in disseminating important findings from the evaluation.
Using this approach, faculty now role-model for students the proces of professionals' “changing hats” and demonstrate disclosure of intent to use aggregated student data for scholarly pursuits. Students have a forum to ask questions, to discuss procedures, and to consent (or not) to use of their performance data in any external scholarship. The issue of students' approval centers only on whether their data will be used for research purposes; students are not excused from full participation in evaluation activities. This procedure covers only those evaluations that are required components of the curriculum and related evaluation. Any new educational research or externally funded research on curricular innovations would be considered research and require separate IRB review. This strategy involving students in the role of actual human subjects for discussing conflict-of-interest and human-subject issues has just been implemented and, contrary to common fears, students permitted the use of their data in research.
Many faculty who engage in institutional research are simply confused by the perceived inconsistent positions of IRBs at different institutions. Frequently we hear that local IRBs don't require review for research involving data from program evaluation. In other cases, some hospitals exempt all educational studies. Michigan State University's application of the federal regulations requires IRB review for even minimal-risk routine program and student evaluations if the data are disseminated as scholarship (e.g., generalizable knowledge). Further, the salience of professionalism in the medical community suggests medical schools should take the extra effort to consider the ethical benefits for students as well.
We recommend several steps to strengthen institutional policies to protect the rights of learners when scholarship rests upon student data. Many of these activities push the jurisdiction of IRBs and other organizations beyond current boundaries on this issue. Our intent is to initiate substantive discussions that will inform all parties involved.
1. Medical schools should implement requirements that all institutionally sponsored evaluations that constitute research and that use student data must include documentation of IRB approval.
2. The profession should monitor itself by establishing a new policy for publication by journals in medical education. This policy would ask the lead author to sign a statement that IRB approval was obtained for research involving students as subjects or that the activity is exempt from IRB review at his or her institution. Funding agencies and professional societies should provide more explicit policies to protect students who unknowingly become subjects in educational scholarship.
3. During students' orientation to medical school, faculty should, as part of their professional obligation, inform the students about the institutional database, how the data are used, and how provision is made for scholarly dissemination of findings. Korn10 notes the public angst about the erosion of privacy in our society. Students are no less anxious about how their performance data are used. Institutions must provide evidence of safeguards designed to protect the privacy of students' records when data from the records are used in institutionally sponsored research.
4. IRBs should assist faculty in developing appropriate and efficient procedures for informing students and seeking their consent for evaluations based on students data. This might include offering faculty development in this area.
5. Institutions must assure that their IRBs have adequate staff support, equipment, and space.11 This is critical not only for compliance with 45 CFR 46, but also to provide for timely review of protocols and responses to queries, like those of professor M, about how to conduct research ethically and efficiently.
Institutional board review need not be an unreasonable burden on investigators. On the contrary, when faculty and administrators seek counsel from IRB leaders, the result is often productive, leading to better research. The case example presented here, in which medical school faculty worked closely with IRB staff, actually decreased the number of consent forms that students and faculty were required to complete. Even more important, the students were better informed of the college's position on the use of institutional data and their rights as human subjects.