The Profession of Education: Responsibilities, Ethics and Pedagogic Experimentation 

Shannon Kincaid, Ph.D.

Philip Pecorino, Ph.D.

The art of teaching is to teach, to teach well and to teach even better.


Chapter: VIII.   Ethical Issues in Education: Pedagogic Experimentation  

If, as argued in previous chapters, pedagogic experimentation is a primary obligation of post-secondary educators, how are we to understand the ethical implications involved in such “informal” pedagogical research?  In this chapter, the differences between informal and formal research will be addressed, with special attention given to the distinction between the ethical obligations generated in research falling under the purview of an Institutional Review Board (IRB) and the pedagogical experimentation which is not subject to institutional review.  In claiming that the lack of IRB supervision does not absolve educators from ethical obligation, we will survey the recent literature in practitioner research which takes seriously the ethics of pedagogy.  Recognizing the important contributions of practitioner research, this chapter will attempt to go one step further, and, drawing upon what has already been presented of the basic responsibilities of human beings, professionals and educators, lay out a basic framework for ethical decision-making within the context of pedagogical experimentation.

Pedagogy:  Research or Practice? 

The idea of teacher-as-experimenter raises several important issues.  Foremost among these are the questions concerning the relationships between research and practice, and the role of Institutional Review Boards in pedagogical experimentation, as well as  the incumbent ethical responsibilities of the educator.  If teachers are obligated to research and experiment with effective pedagogical methodologies in the classroom, to what degree is their research, both informal and formal, subject to review by IRBs, as well as a general process of ethical review?  

The majority of American colleges and universities employ Institutional Review Boards to monitor clinical, medical, and psychological experiments to ensure the well-being and safety of human subjects.  Indeed, federal law demands IRB evaluation of all federally-funded research. 

These concerns for human subjects find their roots in events like the Tuskeegee Syphilis Study, research studies in Nazi Germany, and even the psychological studies of researchers like B.F. Skinner and Stanley Milgram.  To address these issues, legislators passed the 1974 National Research Act.  This law created the National Commission for the Protection of Human Subjects of Biomedical Behavioral Research, which was responsible for detailing the ethical obligations of researchers.  The product of this commission, the 1979 Belmont Report, continues to serve as the foundation for IRB decision making.

The Belmont Report defines the role of IRBs, the risk-benefit considerations of human subject research, the guidelines for selection of human subjects, and the criteria of informed consent. (The Belmont Report.  1978.  p. 1)  

Perhaps most significantly, it identifies the basic ethical principles of human subject research: respect for persons, beneficence, and justice.  It also delineates the distinction between practice and research, and identifies the types of research subject to IRB review. This latter distinction is especially important in the context of pedagogic research.  Recognizing the need to distinguish between formal research and variations in standard clinical practice, the authors of The Belmont Report argue that while both formal research and clinical practice were “experimental,” only formal research demands IRB review: 

“The fact that a procedure is ‘experimental’ in the sense of new, untested or different, does not automatically place it in the category of research.  Radically new procedures of this description should, however, be made the object of formal research at an early stage in order to determine whether they are safe and effective.  Thus, it is the responsibility of medical practice committees, for example, to insist that a major innovation be incorporated into a formal research project.”(ibid.)

The government of the United States does not include much of pedagogic research with other forms of research that are subject to IRB review.  Why not?  Informal experimentation/research in the classroom regarding methodologies and curricula appears to be exempt from federally-mandated IRB review.  Indeed, as the Code of Federal Regulations, Title 45, Part 46, 2001 states that “[r]esearch conducted in established or commonly accepted educational settings, involving normal educational practices…” is not required to submit to IRB review.  This type of exempted research includes evaluation of instructional strategies, instructional techniques, educational testing, and even the collection of existing data (provided that subject confidentiality is maintained). 

IRB’s exist to assist humans to achieve the goal of minimizing or eliminating avoidable harm to humans.  They require that researchers consider potential harms and make every effort to eliminate them.  Risks are to be minimized and what risks to humans that there are in a research design (not harms but risks of harm) must be thought to be reasonable in relation to the potential benefit for humans of the research being proposed.  Informed consent is required so as to not harm the autonomy of human beings.

But on these grounds, any “experiment,” be it a research project (and subject to IRB review), or a novel teaching method, is subject to certain, very specific ethical obligations, whether subject to IRB review or not.  And while these obligations will be discussed at length in the following pages, it is important to note that foremost among these obligations is the duty to communicate our “experiments” to others in our profession.  In formal research, this communication takes place primarily in professional journals.  Yet the ethical obligations of all experimenters necessarily include communication, whether it is in professional journals or in correspondence and dialogue with other professionals. 

At this point, it becomes important to understand the distinction between formal experimentation/research (which requires IRB review), and experimental practice (informal research not requiring IRB review, but carrying with it certain ethical obligations).  The Belmont Report defines “research” and “practice” as follows: 

…[T]he term ‘practice’ refers to interventions that are designed solely to enhance the well-being of and individual patient or client and that have a reasonable expectation of success…. 

…[T] term ‘research’ designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge…Research is usually described in a formal protocol that sets forth an objective and a set of procedure designed to reach that objective.”(ibid. p. 3)    

On these grounds, informal research in the classroom regarding methodologies and curricula is exempt from federally-mandated IRB review.  Indeed, as the Code of Federal Regulations, Title 45, Part 46, 2001 states that “[r]esearch conducted in established or commonly accepted educational settings, involving normal educational practices…” is not required to submit to IRB review.  This type of exempted research includes evaluation of instructional strategies, instructional techniques, educational testing, and even the collection of existing data (provided that subject confidentiality is maintained).   Yet the lack of Institutional Review Board supervision over informal educational research does not absolve researchers from proceeding ethically.  In fact, the lack of IRB review makes the awareness of the ethical issues inherent in classroom research even more important.  As the rapidly growing literature on action/practitioner research and pedagogical ethics clearly shows, pedagogic ethics is becoming a central element in the debates over effective teaching. 

Practitioner Research, Action Research, and the “Case-Study” Approach 

At least since the 1989 publication of The Ethics of Educational Research, (Burgess, R. G (ed.).  London:  Falmer Press ) one of the most persistent trends in discussions of the ethics of pedagogic research is the emphasis on a “case-study” approach.  This approach to ethics rightly attempts to move beyond the abstract generalizations of traditional ethics, and to help provide insight into the nature and nuance of ethical issues by offering case-studies (or “narratives”) in the effort to illuminate the complex moral landscapes of ethical decision-making.   The case study approach to ethics has an important role in moral deliberation, and it not our intention to dismiss the many important contributions made to the field using this approach.  The case study approach is uniquely effective in raising people’s awareness of ethical issues, and to “get them thinking” about the complexities of ethical deliberation.  Indeed, this approach is useful in many areas and disciplines.   (Hutchings, Pat. Using Cases to Improve College Teaching: A Guide to More Reflective Practice. Washington, D.C.: American Association of Higher Education, 1993.) Yet this approach, while generally effective in introducing issues and starting conversations, has its limits, particularly in the context of normative ethical theory.  In other words, while it is important to raise awareness of the ethical issues inherent in pedagogic research, it is just as important to generate principles and guidelines to assist teacher/researchers in their practice.

 As Robert Burgess rightly points out, inquiry into the ethics of educational research demands that “…philosophers, sociologists and psychologists involved in the study of education [should] bring together their expertise to focus on ethical questions in educational research.”   (Burgess, ibid, p. 1) Yet where Burgess lamented the lack of any investigation into the ethics of educational research in 1989, since then there has been a rapid (and  much needed ) growth of academic inquiry into this importance facet of pedagogy.  Yet still largely absent from these important debates are philosophers; those professionals trained in the historical and technical features of ethical inquiry.   Why?  Part of the problem stems from philosophers themselves.  Professional philosophy has, over the course of the last 50 years, tended to focus on logico-linguistic issues, as well as the epistemological questions concerning the philosophy of science.  All of this has taken place at the expense of more “practical” philosophical approaches, and while the discipline itself is now experiencing a resurgence of applied philosophical inquiry, the tendency toward analysis remains strong.

Yet the absence of professional philosophers in the discussions of pedagogic research can also be explained partly by the hesitance of educational practitioners and researchers to make strong normative claims.  There is a pronounced (and somewhat) justified hesitation on the part of academicians to tell people what they “ought to do,” especially given the increasing societal emphasis on cross-cultural recognition and respect. 

This growing commitment to epistemic pluralism( “Epistemic pluralism” entails the claim that knowledge and truth are not the product of one “privileged” perspective (i.e. science, the church, etc.), but that “truth” can be generated from many different perspectives (art, literature, cultural, etc.).  It is also important to note that a commitment to epistemic pluralism does NOT entail a commitment to relativism – individualistic or cultural.)   in the academy has had a profound influence on the nature and function of higher education.  Above and beyond the challenges to the “canons” of history, literature, art, and culture, there have also been significant challenges to the methods and epistemological status of academic research.

Research in general is defined by the U.S. Department of Health and Human Services as the “systematic investigation designed to develop or contribute to generalizable knowledge.” (Gray 1992; p. 341)  Classic scientific research is quantitative; that is, it produces numerical data, and it has long been considered the epistemological “holy grail” of the academy.  The methodologies and numerical analysis of quantitative research lends it a high level of generalizability in its findings.  Quantitative research provides analytically sound, repeatable observations, and extends from these observations our ability to anticipate or predict future events.  In the social sciences, such research involves randomly selected subjects, control groups, the collection of numerical data, and the statistical analysis of that data, as well as the probability calculations which determine the generalizability of a finding.

Yet as the academy has shifted from epistemological monism to epistemological pluralism, the privileged epistemic status of quantitative research has been called into question.  This does not mean that quantitative research no longer enjoys epistemological benefits.  The rigor, repeatability, and statistical analysis of its method do indeed provide its practitioners with a level of certainty and generalizability typically unmatched in other forms of research.    

Over the course of the last 100 years, the exclusive focus on quantitative research in the academy has been questioned.  Most significantly, there has been a growing emphasis on “qualitative” research, or research which focuses on the collection of narrative data which are analyzed both linguistically and logically. 

Qualitative research (also called “ethnographic,” “case study,” or “naturalistic” research) is not without its critics.  As Eisner and Peshkin point out:

            …[T]he tradition has denigrators who remain uncomfortable with a        nonquantitative approach to research.  At best, they are uneasy with what they      view as a rival paradigm:  They are reacting to the fact of competition.  At worst  they dismiss it as unworthy of the name of scholarship.”  (Eisner and Peshkin,1990:  p. 2)

Perhaps the most significant critique of qualitative research involves the issue of generalizability.  Qualitative research studies are generally viewed by their detractors as lacking in objective methodological criteria, and are therefore too subjective to provide justifiable generalizable claims. 

Defenders of qualitative research often argue that its generalizability lies not in its observations but in its logical method. (cf. Donmeyer 1990; pp. 175-201).  In this sense, qualitative research is best understood as a specific method of inquiry, focusing not solely on data and statistical analysis, but on the “narrative,” personal experiences, and specific situations studied by sociologists, ethnologists, and educators.  In other words, the generalizability of qualitative research lies in the logic of its method.

In pedagogic research, qualitative analysis has taken several forms.  First, there are teacher/researchers who generate collaborative inquiry into their own methods and practices in the classroom and the community.  Second, and stemming from the British pedagogic tradition, there is “action research.”  Action research focuses on the reciprocity between theory and practice, and it emphasizes the attempts by educators to improve their teaching while developing a deeper understanding of their practice by contributing to the pedagogical developments in their respective fields.   (This distinction between “teacher/researcher” and “action researcher” is found in (Zeni 2001; p. xiv).  

Finally, both action research and teacher research are subsumed under the larger qualitative heading of “practitioner research.”  As Jane Zeni points out, “Practitioner research, whatever its tradition, relies on qualitative or descriptive methods (e.g. participant observation, interviewing, journaling) rather than quantitative, statistical, or experimental methods.  It typically results in a classroom ethnography or case study.”  (Zeni 2001; p. 1)

Here is where the lack of philosophers becomes most problematic in the continuing conversations on the ethics of pedagogic research.  Philosophers, using the methodological tools of their discipline (logic, argumentation, technical ethical theory, etc.) are best able to extend the findings of pedagogic research past the individual classroom and into public discussion and application, as well as surpassing the normative limitations of the case study approach. 

 As Burgess points out, philosophers tend to examine abstract issues, whereas social scientists are more likely to focus on specific circumstances.  (Burgess, 1989 – p. 1)  The normative limitations of the case study approach are most apparent when attempting to frame general principles and guidelines that should be used to guide ethical conduct in classroom research.   As a century of applied ethics has demonstrated, to deal with ethical concerns we must take seriously the role of principles and generalizability, all of which goes well beyond the analysis and discussion of empirical data and case studies.  An ethics of pedagogic research demands we pay attention to the underlying ethical principles of professional obligations of faculty members (as both teachers and researchers).  And in that sense, it is the construction of a context-sensitive yet normatively significant framework of ethical guidelines that becomes the crucial next step in the growing emphasis on the scholarship of teaching and learning. Normative discourse is possible once educators reflect and accept that they voluntarily assumed a dual set of responsibilities when they entered the profession and decided to perform research: they have both the fiduciary responsibilities towards their learners to benefit them and the basic responsibility of a human subject researcher to cause no harm.  With these basic positive and negative responsibilities moral problems and dilemmas arising from pedagogic research, and particularly from the dual role of researcher/educator, can be productively considered and more satisfactory resolutions reached than through ungrounded discourse.  It is here where philosophy can make an important contribution to the understanding of the ethics of pedagogic experimentation.

 Pedagogic Experimentation and Improved Teaching Methods

How is this latter goal of teaching even better to be accomplished?  It can be achieved only through research into the very enterprise of education: teaching.  Some, if not all, of that research will necessarily involve a variety of forms of experimentation.  When the experimentation involves human subjects there arise ethical concerns and foremost amongst them is the overriding duty to cause no harm.   Be this as it may many, if not most, educators conducting such experimentation appear to be little aware of or concerned with the ethical aspects of what they do when conducting pedagogic experiments with human subjects.  There is a tendency of researchers and experimenters to pass all ethical review onto IRBs, and when IRB approval is not needed, to dismiss the need for ethical review.  Robert G. Burgess (1989,1) notes this by quoting and agreeing with the observations of Cassell and Jacobs (1987,1) that moral principles…

…seem to have little relation to our daily activities as researchers, students, and practitioners…We do not wish to make this seem merely a matter of isolated choices in crucial situations.  Much of our lives proceeds undramatically, and often our decisions are almost imperceptible, so that only with hindsight are we aware that our course of action had consequences that we had not foreseen and now regret…to improve ethical adequacy…we must consider not only exceptional cases but everyday decisions, and reflect not only upon the conduct of others but also upon our own action. Cassell and Jacobs (1987,1)

This quotation is informative, and it highlights one of the central concerns of this text.  While the community of educators may have matured to the point where ethical considerations are now being discussed, it may be quite a while before the ethical awareness that bears on everyday decisions made in the classroom takes firm root in the minds of professional educators.  And perhaps more importantly, it identifies the fundamental obligation of each and every teacher to minimize the very real harms that can take place in the classroom.

From what source stems this duty to cause no harm to others, and in this case, to the subjects of the pedagogic experiment with humans? The etiology of a set of basic ethical duties out of the injunction to cause no harm will be examined at some length because there appears to be either an insensitivity to the full significance of the rather simple injunction or, worse yet, a lack of awareness that there is such an injunction and that it applies to educators in what they do daily and to what they do when they examine what they do: experiment with teaching methodologies.

Patricia Hutchings is a vice President of the Carnegie Foundation for the Advancement of Teaching. She is a director of the Carnegie Academy for the Scholarship of Teaching and Learning.  Consider that in her work Ethics of Inquiry: Issues in Scholarship of Teaching and Learning, while she appears quite concerned with the ethical aspects of that scholarship, she hesitates  to delve into normative discourse, and instead seems to argue that it is not principles and ethical frameworks which can help guide the ethics of pedagogy, but instead holds that thought and discourse will be sufficient for the handling the very real ethical issues faced by post-secondary educators. She appears to focus attention in her listing of ethical issues away from that of harm to the learners onto other matters such as experimental design and ownership of materials.  Beyond that she holds for no simple or singular answers as to the morally correct course of action and appears to think of ethical issues as involving competing goods so that agonizing of the decision and using reflective thought is sufficient for producing a acceptable decision as to how to act. As Hutchings argues,

“…ethical issues often do not lend themselves to definite answers…and there can be no one-size-fits-all rules.  Like other aspects of the scholarship of teaching and learning, its ethical dimensions are shaped by discipline, context, and purpose.  What’s needed most is not, then, a set of rules but a process of reflection, self-questioning, and discussion.”Pat Hutchings.  2002.  “Introduction.”  Ethics of Inquiry:  Issues in the Scholarship of Teaching and Learning.  (Pat Hutchings, ed.)  Menlo Park:  The Carnegie Foundation for the Advancement of Teaching.  p. 2. 

Hutchings deserves a lot of credit for framing the debate over pedagogical ethics, and she offers some important questions that she hopes will shape practice in the research into teaching and learning, and which do illuminate the issues facing pedagogical experimentation.  She means to be suggestive and offers her listing freely and invites copying and adaptations and adoptions of it.  Here are the twelve questions and their headings as she has supplied them. (Hutchings, p 85ff)

Purposes and Preparation

            1. What is the question or problem that you want to investigate, and why is it important enough to spend your own and others’ time and energy on it?

2.        What power relationships need to be taken into account in negotiating roles, permissions, and involvements by various participants in your work?  Are there issues of gender, race, culture, and status differences that need to be especially taken into account?

3.        What concerns might students have about your work and their participation in it?  What choices do they have if they are uncomfortable?

4.        Does your campus have an Institutional Review Board? What expectations exist about IRB review of projects in the scholarship of teaching and learning? Is this unfamiliar ground for you, Where can you turn for information?


5.        What methods will you use in your investigation? Whose consent, permission, cooperation, involvement or collaboration will be required by these methods? What are the best ways to seek this consent, permission, etc., and what point(s) in the work? How can roles and permissions be negotiated and renegotiated over time?

6.        How can students be involved in your investigation? Might they play a role in gathering and analyzing data?  How can the project be made educationally valuable for students?

Results and the Presentation of Results to Various Audiences

7.        Whose perspectives will be represented in the work?  How can various perspectives be honored?  What special concerns do you have about representing individuals or groups who have less power in the educational system?

8.        What negative or embarrassing data can you anticipate emerging from your scholarship of teaching and learning, and who might be harmed as a consequence?  How can you create a context for understanding “bad news”?  How, in particular, can examples of work by students who are novices, or who are struggling with the new material, be treated with respect?

9.        Who will see the results and products of your work? What conclusions might be drawn by various audiences: About student? About teaching? About your department, discipline or campus? About higher education? About you? How is your choice of medium (e.g., video) related to these concerns?

10.     How can contributions to your work by various participants (including both colleagues and students) be acknowledged and/or cited, while maintaining confidentiality where appropriate?

Reflection and Development

11.     Whom can you talk to about the above questions? How can you create occasions for discussion and reflection about them with colleagues?

12.     What are you learning from your project that can inform future practice related to ethical issues in the scholarship of teaching and learning?

This list is an excellent introduction into some of the very real and profound ethical issues faced by educators who take their teaching seriously.  However, it interesting to note that concern for the possibility of causing harm to learners does not figure prominently into this list of questions. There appear to be more questions dealing with what is needed to get the experiment or research accomplished than in dealing with the various ways in which the subjects of the experiments can be harmed.  Yet it was and is the possibility of harm to human beings that generates the need and the legal requirement for a review process and the legally mandated IRB’s.

Hutchings considers that ethical issues are not resolvable and that they produce a context for expressions of what we care about, what we value (Hutchings, 16).  The discourse that ensues upon discovery of the issue and concern and reflection over it is somehow in itself sufficient for resolution of whatever dilemmas may exist. 

While she claims that the SOTL presents ethical issues that are new to many faculty she offers a suggestive listing that indicates an odd sense of what is an ethical issue in the first place.

Is it necessary to have permission to use excerpts from student papers, or data from their exams, in my scholarship of teaching and learning?

If so, what kind of permission is appropriate, and how should it be secured?

Should I (must I?) submit my project design to the campus Institutional Review Board (IRB), which monitors work with human subjects?

Do I need their informed consent to begin my work? To publish it?

The scholarship of teaching and learning calls on us to “make teaching community property” (Lee Shulman’s phrase), but what are the appropriate boundaries between public and private?

 Who owns what goes on in the classroom?

Who benefits, and who is at risk, when the complex dynamics of teaching and learning are documented and publicly represented? (Hutchings, p 1)

Some of these are, to be sure, involved most directly with issues about what the “good” of education is, but others are also most clearly about what the law requires or the  regulatory guidelines to be observed as established by regulatory bodies.  None of them deal most directly with the basic issues out of which are generated the concern over research with humans in the first place.

According to Hutchings, people understand and deal with ethical issues by mapping themes, clarifying contexts and providing examples. (Hutchings, p 2)  There is no single way to deal with the issues or resolve the dilemmas encountered, but there is in the discourse an increase in awareness and reflection that serves as a resource for educators facing ethical issues and that appears as the only valued outcome of the discourse as morally correct decisions are ruled out from the start. 

“…[E]thical issues often do not lend themselves to definite answers…and there can be no one-size-fits-all rules.  Like other aspects of the scholarship of teaching and learning, its ethical dimensions are shaped by discipline, context, and purpose.  What’s needed most is not, then, a set of rules but a process of reflection, self-questioning, and discussion.” (Hutchings, p 2) 

Hutchings describes the seven contributors of cases, as well as any educator who takes ethics seriously, as individuals who have:

         Respect for the students

         Commitment to advancing the profession of teaching

         Thoughtfulness about resolving what are essentially competing goods (Hutchings, p. 4)

For Hutchings ethics has to do with the core dilemma of competing goods and the “dilemmas of fidelity” as expressed in the work of Helen Dale and others. (Dale, Helen. “Dilemmas of Fidelity: Qualitative Research in the Classroom.” In P. Mortensen and G. E. Kirsch (eds.), Ethics and Representation in Qualitative Studies of Literacy. Urbana, Ill.: National Council of Teachers of English, 1996.)

Hutchings also  argues that educators must proceed with no clear norms or rules to direct them or inform their moral deliberations.  What is needed in her view is “professional judgment, which is developed at least in part through discussion with scholarly and professional colleagues…” (Hutchings, p 8)

For Hutchings there is an “Ethic of Inquiry” …that puts the emphasis not so much on the specific issues to be grappled with but on a larger sense of professional responsibility and aspiration that motivates and shapes the scholarship of teaching and learning.”( Hutchings, p 14).  Such scholarship enacts a professional responsibility by calling on the inherent obligations and commitments that come with the professional role- that is

         To seek knowledge

         To share what our investigations uncover

         To contribute to the larger community of scholars and practitioners

This is the ethic that Lee Shulman has described as the “professional rationale “for the scholarship of teaching and learning.  According to Shulman, such scholarship of teaching and learning

affords all of us the opportunity to enact the functions of scholarship for which we were all prepared.  We can treat our courses and classrooms as laboratories or field sites in the best sense of the term, and can contribute through our scholarship to the improvement and understanding of learning and teaching in our field. (Shulman, 2000: 50)

Institutional Review Boards and the Process of Ethical Review

IRB’s exist to assist humans to achieve the goal of minimizing or eliminating avoidable harm to humans.  They require that researchers consider potential harms and make every effort to eliminate them.  Risks are to be minimized and what risks to humans that there are in a research design (not harms but risks of harm) must be thought to be reasonable in relation to the potential benefit for humans of the research being proposed.  Informed consent is required so as to not harm the autonomy of human beings. (See the endnote for the federal regulation on IRB section 46.111)

The government of the United States does not include much of pedagogic research with other forms of research that are subject to IRB review.  Why not?  Informal experimentation/research in the classroom regarding methodologies and curricula appears to be exempt from federally-mandated IRB review.  Indeed, as the Code of Federal Regulations, Title 45, Part 46, 2001 states that “[r]esearch conducted in established or commonly accepted educational settings, involving normal educational practices…” is not required to submit to IRB review.  This type of exempted research includes evaluation of instructional strategies, instructional techniques, educational testing, and even the collection of existing data (provided that subject confidentiality is maintained).  (See endnote for the regulatory section 46.101)

 Yet the lack of Institutional Review Board supervision over informal educational experimentation/research does not absolve researchers from proceeding ethically, a basic fact rightly recognized by Shulman and Hutchings.  In fact, we claim that the lack of IRB review makes the awareness of the ethical issues inherent in classroom experimentation even more important.  As the rapidly growing literature on action/practitioner research and pedagogical ethics clearly shows, pedagogic ethics has become a central element in the debates over effective teaching.

Educational institutions take a variety of stances with regard to the federal regulations and their application to educational research and thus the need for IRB’s.  They are also in flux with regard to exactly how to oversee pedagogic experimentation/research in relation to IRB regulations and it can be expected that there will come an emerging consensus as to what ought to be required of educators conducting pedagogic research with human subjects that might be codified through legislative action.  For now the applicability of the federal regulations and the need for IRB review is treated differently according to institution and the type of research being proposed.   In order for educational experimentation/research to be exempted form the regulatory requirements it needs to be declared as such by an IRB.   It is that declaration that is most avidly sought.  Some institutions appear to have made blanket declarations concerning some forms of pedagogic research and experimentation with humans so as to avoid the IRB involvement entirely.

IRB is not a review of proposed research in consideration of the ethical problems that might be involved.  The IRB is by statute and in practice seen as a legal requirement and formality.  For most educators doing pedagogic experimentation the IRB review is a necessary formality for obtaining an exclusion from the requirements otherwise posed on researchers working with human subjects.

There is in this formal IRB review little or no concern for the very basic principles which generate the positive value for review in the first place.  There is little or no concern in current operation of IRB for the wide range of ways in which harm can be caused to learners who are subjects of pedagogic experiments.

Pedagogic researchers hope for the exclusion from further review or approval of their experimentation/research protocol so that they can proceed with their work rather than for an expansion of their ethical concern and expressions of their moral responsibilities to those they are to serve and protect. 

Exemption from IRB review does not mean that the pedagogic experimentation/research is exempt from an ethical review of the possible harms and risks of harm that learners would be subject to in the research being proposed.    One of the central themes of this book is the claim that each and every pedagogic experiment is fraught with potential for harm and must be closely examined through a framework of ethical decision making which makes apparent the moral dilemmas involved in pedagogical experimentation.

Many discussions of ethics with educators center around legal and practical concerns, and very few evidence substantive reference to fundamental ethical principles, thus undermining the very real concern educators have for for the learner/subject. The limiting of concern to the legal requirements being met are evidence of practitioners operating out of the codal model of the relationship of educator to learner and researcher to subject.  This limitation of ethical concern often takes on a defensive posture, one generated more for concern of the members of the profession or guild than for concern over the well being of those served by the profession or guild: the learner/subject. (See more on this in chapter three above.)

A review of the current literature on ethics and pedagogic experimentation/research exhibits  a reluctance to accept that there are any norms that ought to govern the conduct of educators and educational researchers.  Some authors declare that problems and moral dilemmas faced by such researchers have no solutions.  In Robert Burgess’ review of the literature in Ethics and Educational Research  (1989) he remarks that:

 A common theme to all these suggestions for handling ethical dilemmas in research is the notion that there is no ‘solution’ to the problems identified by researchers. Such a situation means that researchers need to regularly reflect on their work so as to develop their understanding of the ethical implications associated with social and educational investigation.  Inevitably, it will be found that ethical dilemmas and their ‘solution’ will be problematic…(8)

How can it be that solutions would be problematic?  And as Burgess uses no qualifiers with his claim it would appear to include any and all solutions. This conclusion appears to be at best drawn from an observation of the current discourse and based on an absence of any conceptual foundation within which ethical discourse would have some normative material with which to work out solutions.  It should appear almost as obvious that any research with human beings that had a substantial risk of harm should appear as a violation of some basic precept or moral rule or ethical principle. Thus such research should be deemed as morally unacceptable.  But would such a conclusion be “problematic” for Burgess?   Burgess does not appear to have any normative vocabulary with which to work to arrive at non-problematic solutions.  It appears as if such vocabulary is deemed inappropriate for discourse about pedagogic research.   

It must be noted that a solution to a moral dilemma or the answer to an ethical question is not by any means one that provides a satisfaction of the interests of all involved.  Even with a Utilitarian approach to moral decision making there is no necessity to please every single person.  A solution to a moral problem is not at all one that makes everyone happy or pleases all.

Some non-philosophers writing in the field of education appear to be willing to accept that the best that can be done when confronting moral questions or dilemmas is to reflect seriously on the issues presented by the situation, and then make a decision as to the best course of action.  There is no talk about some basic set of principles of an ethical nature that one might want to employ and apply to the situation or some core set of virtues to realize. 

Why all of this reluctance to talk about basic ethical principles within the context of educational practice?  The authors believe that the foundation of this reluctance regarding the development of normative ethical claims is not in itself a bad thing.  There is a very real need for a deep recognition and respect of other moral perspectives, especially within the context of the American Academy.  However, it is possible to maintain (even promote) respect for a plurality of moral perspectives AND develop fundamental, guiding principles that most, if not all educators, can come to some level of agreement on. 

Talking About Ethics is not the Same as Doing Ethics

Doing ethics involves careful and critical thinking about basic principles of the moral good in a manner that leads to or defends a position taken on some moral problem or dilemma.  It involves using the tools of philosophical thinking (logic, epistemology, etc.) to better understand and resolve moral conflict.  On these grounds, ethical thinking and the attempt to provide a resolution to moral dilemmas involves normative claims.  

As a professional educator ethical discourse must be conducted in order to bring about resolutions of moral dilemmas and to provide guidance for others in similar situations.  In this manner the profession moves forward and establishes criteria and expectations by which its members can be evaluated as to their performance.   It does not serve the profession of education to accept as being sufficient for an ethical resolution simply to discourse concerning moral decisions without some grounding in basic values and principles that are shared by the members of the profession and that help to define the group.   Different people enter the discourse over the same issue and may arrive at different conclusions as to the morally correct decision and course of action to take.  Differing discourses can produce not only different but inconsistent and contradictory conclusions about what is the most morally proper behavior.  The profession can ill-afford to maintain inconsistent and contradictory conclusions about what is ethically acceptable behavior.  Ethical inquiry can serve to provide the guidelines and paradigms for members of the profession.   Accepting ungrounded discourse is to issue the directive that “anything goes” in resolving moral quandaries as long as one agonizes or at least deliberates over the matter.  To expect that moral discourse be grounded in common principles and values of the profession is not to indicate that there is not a consideration of the particular details of each situation that might figure in a significant way in the critical analysis and reasoning as to the morally correct course of action.  Such considerations will lead to a variation in conclusions reached, but any and all conclusions reached would be consonant with the basic values, and thus not inconsistent with or contradictory to other conclusions using the same values.  They can vary from the specifics but not from the basics and the common values.

The ethical approach we are defending is a sort of “principlistic contextualism,” one that recognizes the important differences posed by specific individuals operating within specific contexts while at the same time asserting that some basic ethical principles can be seen to apply across a wide variety of situations.  On these grounds, the conversations of ethical discourse are rooted in a recognition of some very fundamental ethical principles, ones which have been developed as “points of navigation” for the promotion of effective ethical deliberation and decision-making.

In chapter four the case was made that there are norms governing the behavior of professionals and that those norms are reflective of the values held by the society served by the profession.

The chief values relevant to professional ethics are: governance by law, freedom, protection from injury, equality of opportunity, privacy and welfare. Norms for professional roles are to be justified by their promoting and preserving the values of liberal society. -- Michael D. Bayles, Professional Ethics , Belmont, CA: Wadsworth Inc., 1981. p 5.

What are the common values of professional educators as humans and as educators that help to define them as a group and serve as the basis for making moral decisions and resolving moral dilemmas?  In a pluralistic society there are undoubtedly a wide variety of values, but one of the most important, and often-neglected in discussions of the principles of educational ethics, is most certainly that education should not harm people.   Educators, often hiding behind a veil of beneficence, often do things that bring harm to their students, whether the educator or the student is aware of it.  These harms range from the academic and intellectual to the psychological and social.  The special obligation to cause no harm in the case of a professional educator issues from two sources: the fiduciary relationship of the educator to the learner and from the relationship of an experimenter to the subjects of the experiment.

Within every educational context, there are three fundamental “layers” of human interaction, each of which generates its own unique sets of moral obligation.  First, there are the duties and obligations generated by the fundamental human equality of each and every person involved in the situation.  Echoing Kant’s practical imperative, the fundamental equality of all human beings demands that we treat others with respect and dignity, and refrain from harming others, regardless of our “status” in the relationship.

Yet the emphasis on non-maleficence is but one point in the constellation of pedagogical ethics.  Educators qua educators (as members of the profession) are also bound by duties of beneficence.   As we have argued above, educators are bound to act in the best interests of their students, to promote effective learning, and to fulfill the requirements of educational institutions regarding democratic citizenship.

Finally, the third “layer” of interaction in educational contexts is the relationship between experimenter and subject.  Here, besides the obligations of beneficence and non-maleficence, there is an obligation on the part of the educator/experimenter to maintain a commitment to responsible inquiry, and to the advancement of the profession of education itself.      

Primum non nocere:  First, Do No Harm

The concept of harm in pedagogy has received little attention, yet it is one of the most significant issues relating to the ethics of education.  When people think of “harm” in a classroom, they tend to think of physical abuse.  Yet there is a wide variety of potential ways educators can and do cause significant harm to their students.  If there is a change in a pedagogic technique (research-experiment) or a new instructional design utilized by an educator such changes could result in some learners not doing as well as they may have had the change not been made.  Not doing as well as one could have constitutes a harm to the learner and it can be manifested in a variety of ways. A partial list of potential harms is offered below. Individual learners can experience more than one of these harms from a single change in pedagogy.  Before the listing consider the following case:

A faculty member has been offering instruction with a common instructional design for class that incorporates the basic lecture format with a traditional short answer objective items form of assessment.  Now the faculty member wants to introduce a change to determine what the difference might be in terms of learning objective outcomes.  The change involves having the students make individual presentations in class and work in small groups.  Some of the members of class have problems with communicating with others and some have performance anxieties and find it very difficult to speak before others, even the smallest groups.  These earners do very poorly on the new assignments and as a result receive poor grades and their final grades are less than they generally get in classes using the more common lecture format.   These learners have thus suffered a lower grade, a lowering of their GPA.  Some withdrew from the class rather than needing to experience speaking before a group.  Those that withdrew will need to take the class at another time with another instructor and they have hade their progress to graduation impeded.  So something so simple as having students speak in class or work in small groups can produce ill effects.

Now the partial listing of potential harms is offered:


  • --completion rate

  • --success rate-GPA

  • --inability to perform at the next level of study

  • --inability to use skills that are needed post study


  • --failure to develop critical thinking skills

  • --failure to develop information processing skills

  • --failure to acquire new knowledge


  • --inability to function as a fully educated member of a democratic society

  • --inability to realize socio-economic goals (career, etc…)


  • --decrease in self esteem

  • --increase in hostility to the educator/institution

  • --negative impact on future educational success (cf. Bluestone, 2004 on self-efficacy)


  • --loss of time

  • --loss of tuition 

  • --student loans

Pedagogical Ethics:  A Guide for Practical Action

Given these potential harms to learners, what is required of professional educators regarding their educational practice and pedagogical experimentation?  First, it means that each and every educator “come to terms” with inherently ethical dimensions of their practice, and that each one be willing to engage in the difficult process of ethical evaluation and decision-making.

Second, this process of decision-making and evaluation need not take place in a vacuum.  And while what follows is far from a comprehensive listing of the decision-making process and principles at work in pedagogical ethics, it can be seen as a rudimentary guide by which to navigate the processes of ethical review. 

1)  Ethical Review of Proposed Experiments with Human Subjects

In any pedagogical experiment, the first step is to determine whether or not the experiment is likely to cause harm to those human beings who are involved as the subjects of the experiment.  There are several things an educator can do to reach a determination as to the possibility or degree of potential harm.  The most direct is to rethink the the proposed experiment from the perspective of the student and consider the possible impact of the experiment or the changes in pedagogic method or materials on the learner and the learning.  If there appear to be significant risks of impeding the learning process for some students or the risk of discouragement or the inducement to withdraw from the learning or the class itself then the project would need to be seriously reconsidered if not abandoned altogether if the risks were high and the probability of harm was high.  This would be the case regardless of the potential value of what might be learned.  If the risks were not high and the probability of harm was low then they would be weighed against the potential value of what might be learned.

Another indispensable and invaluable part of the process of determining risk is to conduct a search of the literature to determine if the experiment has already been performed and if so, what were the outcomes.  This sort of thing is common place in medical research, a field that should provide several paradigms for pedagogic research.   This literature search would include a search for similar experiments with similar groups of learners (subjects).  If it has already been done and there were harmful outcomes then the repetition of the experiment would not be morally condoned.  If  it has already been done and there were little or no reported harmful outcomes then a repetition of the experiment to confirm the findings would be morally condoned.  If  it has already been done and there were little or no reported harmful outcomes then the educator proposing the project would need to reexamine the need for doing the research and instead consider adopting the pedagogic innovation previously tested and proven to be both effective and safe.

The second step in preparing for a pedagogic experiment with human subjects is to determine whether or not the experiment is subject to institutional review.  In the appendix of this volume there are excerpts of “The Belmont Report,” as well as references and web-sites where educators can get more information on making this determination.  Also important are the policies and procedures unique to each institution.  And if the experiment does indeed fall under the purview of IRB review, the next step lies in contacting the board itself.  They will then conduct a thorough review of the proposed experiment.

However, the real work of pedagogical ethics begins with step one and the review of the proposal for potential harms even if an experiment in the classroom does not need IRB approval.  For too long, educators have “quarantined” the ethics of education in the IRB office.  Yet the ethics of pedagogical experimentation involves some tough questions.  Am I causing harm to any of my students?  How can I minimize the risk of harming my students?  Do the potential pedagogical benefits justify the potential risks to my students?  Does the proposed experiment maintain or strengthen my professional obligations and commitments?

On these grounds, another important part of the ethical review process involves investigation and communication with colleagues.  There is a huge growth in literature on pedagogy, and researching the topic is relatively painless, given the advances in internet technology.  Also important is communication with colleagues.  Here the question becomes “have you tried this?”   Colleagues owe it to their colleagues to make known the results, whether successful or otherwise, of their experiments, large and small, formal and informal, funded and unfunded.  They owe it to them as fulfillment of their professional obligations as professional educators.  With the results widely disseminated educators can have more fruitful searches of the literature to better determine both the safety and efficacy of the pedagogic techniques and materials they were thinking of using in their own experiments.


2)Communication of Results of Pedagogic Research or Experimentation

As a basic professional responsibility and a duty towards education colleagues each educator who conducts research into pedagogy has the obligation to communicate the results of that research, whether it be a literature search and investigation or an experiment in a classroom, formal or informal.  The dissemination of the results of that research can take place in a variety of ways and to a variety of communities. 

As members of two professions, post-secondary educators encounter a dual set of responsibilities as educators and as a members of a discipline.  Often that dual set places a nearly unmanageable workload upon educators so that there needs to be a prioritizing of the responsibilities.  At times, some members may neglect the entire range of responsibilities for the other.  The most obvious cases of this occur at the level of pre- and post-secondary education.  Some post- secondary educators favor research and publication within their disciplines to the near total neglect of such work in pedagogy itself, while some in elementary and secondary education focus on development of effective pedagogy to the neglect of discipline related research.

When there is a need to analyze and disseminate the results of pedagogic research, the dual set of memberships facilitates the opportunity for communication as it offers two communities within which the results may be made known: the community of the discipline and the community of educators.  Research into classroom pedagogy should be disseminated to fellow educators in one's own department, institution, and professional affiliates, and then (depending on the nature of the experiment and the suspected validity or generalizability of the results) to the entire community of educators in the field of the experimenter, or at the level of education as the experiment took place.

When there are no colleagues in the discipline of the researcher at the institution where the researcher has been conducting the research and teaching, the researcher/experimenter should communicate the results to colleagues in the discipline through intra disciplinary mechanism: publications and conferences.  In any case, the researcher should communicate the results to educators teaching similar subjects to similar learners.

If an educator has substituted materials for those in a textbook because the textbook materials were not achieving the results intended for the learners and the substituted materials did, then that information should be communicated to both the textbook author and to colleagues who may be using the same textbook with similar communities of learners.

If an instructor works with one class at 10 am and then, believing that certain materials, illustrations, or exercises were less effective than desired uses different materials, illustrations, or exercises in another section of the same class meeting at a later time and finds that there is a difference in its efficacy not attributable to a mere change in time those results should be communicated to colleagues within the discipline teaching the same or similar classes where the results of the experiment might have value in the consideration of colleagues working with similar groups of learners.

3) Reconsideration of the Results of the Pedagogical Experiment

After dissemination of the results of the research or experimentation, there will be a response from the community to which the results were communicated.  The researcher/experimenter is obliged to reconsider the results of the initial research and its publication (if applicable), and to revise findings or conduct further research and experimentation to answer critics if necessary, and actively contribute to the inquiry and development of even more effective pedagogies.

It is through an ongoing review of findings and exchanges with colleagues that the strength and reliability and generalizability of claims can be assessed and corrections made to oversights and other forms of  "mistakes".  This is a necessary part of the process that establishes what is "known".  This is the self correcting part of the process of research and publication of results of research that advances knowledge.

Ethical Considerations and Decision-making in Pedagogic Experimentation

In Chapter Six, we presented a range of ethical issues associated with pedagogical experimentation.  These included the potential for harm to learners, considerations of experimental design, informed consent, privacy, and the professional obligations of the educator as both researcher and teacher. 

As Shulman, Hutchings, and others have demonstrated, pedagogical ethics is not so much concerned with coming up with “right” answers, but in asking the right sort of questions.  They correctly identify some of the questions that  educators should be asking themselves when they experiment in the classroom. A list of such questions is provided below.  Before representing these questions it is necessary to present the conceptual framework and basic normative elements that will enable moral discourse concerning these questions to reach solutions that will not be problematic but instead well founded on basic principles that would govern human action in the situations suggested by the questions.

The questions posed are posed to educators and to educators who are also researchers and some who are also conducting pedagogic experimentation with human subjects.  As such they are professionals who are to be guided by the obligations of professionals and in particular the fiduciary responsibility that educators have towards those they teach. 

A recapitulation of a few basic points about the the three sets of obligations is in order as the responsibilities and obligations that are part of the three simultaneous relationships that obtain between researcher and subject provide guidance for  moral decision making:  Educators do have three relationships to those they teach and each generates its own unique sets of moral obligation. 

First, there are the duties and obligations generated by being a human being and the very least of these demands that we treat others with respect and dignity, and refrain from harming others, regardless of our “status” in the relationship. Primum non nocere:  First, Do No Harm

Second,  educators qua educators (as members of the profession) are also bound by duties of beneficence.   As fiduciaries , educators are bound to act in the best interests of their students, to promote effective learning, and to fulfill the requirements of educational institutions regarding democratic citizenship.

Finally, as researchers and experimenters educators have besides the obligations of beneficence and non-maleficence, the obligation to maintain a commitment to responsible inquiry, and to the advancement of the profession of education itself.   

Now it is possible to reach solutions to the questions posed below and to do so in a manner that is not maximizing the problematic nature of those solutions by taking the very basic obligations as are contained in the three relationships with those of the human being as most basic or foundational and then those of the educator, and finally, those of the researcher in order of importance.   Thus, and for example,  the welfare of the individual human being is not to be diminished for the sake of pedagogic research. 

With the rubric of the various sets of responsibilities and the notions of individual. collective and institutional responsibilities it is possible to arrive at answers to ethical questions such as those posed immediately below and reach conclusions as to what would be morally correct in many instances.  For some practical considerations the reader can look to chapter X and a guide for practice.  Chapter XI offers two sample case studies with in depth analyses and sample "solutions".

1)  Potential for Harm 

How is to be resolved that any new pedagogy might result in harm to some of the learners involved with it or subject to it?

How is it justifiable to subject learners to potential harm by requiring that they get involved with sets of experiences with which they have no prior experiences? 

How is it possible to arrange for research subjects to withdraw from participation in a pedagogic experiment when doing so constitutes harm or exposes them to further harm such as a loss of credits or progress towards the next level or grade? 

How is it justified to continue to use pedagogies that are indicated to be less effective, if not harmful, than others that have been shown to be more effective? 

If there is a control group involved in pedagogic research and the experimental group is performing better and learning more should the control group continue on using what becomes more and more apparent as a lees effective pedagogic technique? 

2)  Experimental Design and Methodology 

How are conflicts between the role of educator-teacher and that of educator-researcher to be resolved?  Must the experiment be done? Must it continue the full course of the original plan? 

How does being a participant in a pedagogic experiment influence what the learner does?  Does it work against establishing claims that the results are replicable under similar circumstances of the learners without consideration of their status as self conscious research subjects? 

3)  Informed Consent 

How is it possible to obtain an informed consent or its equivalent when there are no other options available to the learner?  There is only the one class? 

How informed can informed consent be with learners who are very young or unfamiliar with all the implications of the work? 

How consensual can informed consent be when the educator-researcher holds so much influence and power over the learner-subject? 

How is it possible to obtain an informed consent or its equivalent when the context is one of a total institution wherein choices are severely limited and exercising an option out of the research exposes the learner to loss of some benefit or to some harm?  Is it proper to require students to participate in the research or to conduct research on themselves and their peers as part of a course requirement? 

How does informing learners that they are part of an experiment influence their work and skew the results that are meant to be generalized to all similar cases of learners and not just to experimental subjects? 

How much time and how many resources should be devoted to research with a group of learners when compared to continuing with the proven effective pedagogy already in place?  Does such research necessarily degrade or put at risk the quality of the pedagogy already in place? 

“The class is a class first and a research laboratory second; the students are students first and research subjects second.  Under this view, and change in course design or content to promote a research should be subject to the condition that it at least not detract from the educational value of the course. -- Peter Markie, quoted in ibid, p. 29

 4)  Privacy and Confidentiality 

How is the need to make public the research balanced against the need to keep private the sources of information? 

How are the identities of the learners to be safeguarded when the pedagogic technique being tested has learners producing work that when the research is made public can identify them? 

How is a test site to be kept confidential when the details of the testing site are relevant to a careful and critical consideration of the finings and for any attempt to apply the tested pedagogy in a similar setting?  The details need to be reported and yet doing so presents a possible exposure of the test subjects. 

How are reports of the failures of learners or their initial starting points beset with difficulties to be reported so as to not subject the learners to the psychological harm caused by possible exposure and consequent embarrassment? 

To what extent should the learner-subjects be acknowledged for their contributions to the research? 

To what extent must the learner-subjects be acknowledged for their contributions to the research? 

Under what circumstances is privacy to be protected while still acknowledging the contributions made by the learner –subjects?  How is it possible to do both?

“Are the transactions among students and faculty members, and the work that students do in the classroom, a form of privileged communication, analogous to the work of a therapist or lawyer?  Or are they, in Shulman’s phrase, ‘community property’” - - - Hutchings 2003, p. 31

5)  Research Obligations

To what extent are educators morally bound to conduct research into the literature of pedagogy before attempting their own pedagogic experiments?

To what extent are educators morally bound to conduct research themselves involving experimental projects?

To what extent are educators morally bound to publish their experiences and findings with regard to pedagogic developments and research efforts?

“The ‘pedagogical imperative’ includes the obligation to inquire into the consequences of one’s work with students.  This is an obligation that devolves on individual faculty member, on programs, on institutions, and even on disciplinary communities.  Shulman 1992, p. vii 

6)  Research Strategies and Techniques

 How is informed consent to be obtained in research involving surveys where the consent procedure would not influence the responses of those surveyed

7)  Paternalism 

To what extent can an educator exercise paternalism in the design, management and conducting of pedagogic experiments with minors and the incapacitated.


In the next chapter there are a number of cases or scenarios in which there are moral issues.  They are presented in terms of the responsibilities that are possessed by individual educators, by the collective of educators or the faculty and by educational institutions themselves.  They are followed by a guide to practice and then a chapter that takes two cases and analyzes and resolves issues through an application of the basic notions of responsibilities of professional educators as individuals and as collectives.

End Notes

§46.111 Criteria for IRB approval of research.

(a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:

(1) Risks to subjects are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

(3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.

(4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by §46.116.

(5) Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117.

(6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

(7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

(b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects. 

§46.101 To what does this policy apply?

(a) Except as provided in paragraph (b) of this section, this policy applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any Federal Department or Agency which takes appropriate administrative action to make the policy applicable to such research. This includes research conducted by Federal civilian employees or military personnel, except that each Department or Agency head may adopt such procedural modifications as may be appropriate from an administrative standpoint. It also includes research conducted, supported, or otherwise subject to regulation by the Federal Government outside the United States.

(1) Research that is conducted or supported by a Federal Department or Agency, whether or not it is regulated as defined in §46.102(e), must comply with all sections of this policy.

(2) Research that is neither conducted nor supported by a Federal Department or Agency but is subject to regulation as defined in §46.102(e) must be reviewed and approved, in compliance with §46.101, §46.102, and §46.107 through §46.117 of this policy, by an Institutional Review Board (IRB) thatoperates in accordance with the pertinent requirements of this policy.

(b) Unless otherwise required by Department or Agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy:1

(1) 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 comparison among instructional techniques, curricula, or classroom management methods.

(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if:
(i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

(4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

(5) Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine:
(i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.


@copyright 2004 by S. Kincaid and P. Pecorino

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