RCR Casebook: Introducation

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Consider two examples of professional decision-making:

Example 1: A physician must decide whether to prescribe antibiotics to an 80-year old woman with terminal cancer who has developed pneumonia. With antibiotics, she might live an additional few weeks, but these weeks will be filled with pain and suffering or will be spent sedated on a feeding tube.

Example 2: A physician must decide whether to prescribe antibiotics to an 8-year old child who has been diagnosed with strep throat, but is otherwise healthy. The child has no allergies to antibiotics.

Which example represents an ethical decision? Both. We readily recognize ethical problems when we see a dilemma as in Example 1, but doing the right thing, and doing it easily, is also a form of ethical decision-making. Ethics is everywhere. It is an integral component of all human endeavors, and a component of good professional practice.

The same is true in research. Ethics in research is not primarily a dimension of philosophy, or law, or institutional policies—though it has been approached through these avenues. It is primarily a dimension of research practice. “Good research” is good in many regards. It generates knowledge through the use of trustworthy methods and honest reporting; it has the potential to advance human wellbeing through the application of knowledge (e.g., developing new practices); and it shows respect in many different ways to all involved in studies—whether human subjects, animals, colleagues, partners or trainees.

Ordinarily, doing good research is as straightforward as the case of medical decision-making in Example 2 above. This fact can make it frustrating when researchers are confronted with numerous regulations or media stories of researchers gone wrong. Even the requirement for training in the responsible conduct of research (RCR) can seem unnecessary.

Why does research attract so much attention from government officials, institutional administrators, and media watchdogs? In large part, because the consequences of good research and bad research are significant to so many people in so many different ways. On the one hand, good research can

• Satisfy intellectual curiosity
• Contribute to the development of new technologies
• Guide public health and educational programs

On the other hand, violations of the standards of responsible conduct of research can

• Pollute the scientific literature
• Harm human and animal subjects
• Contribute to mistrust of researchers
• Lead to fines, loss of funding, and other penalties
• Waste limited resources, including taxpayer dollars

Moreover, institutional policies and training requirements are a response to the fact that some research decisions involve clashing values, imperfect information, and competing stakeholders: Not all ethical decisions are straightforward.

One of the best ways to explore these complex issues is through stories of cases in which researchers have had to deal with ethical problems and to find a way out of moral quagmires.

Aims of the Casebook

The ORI Casebook: Stories about Researchers Worth Discussing (Casebook) does just that. It not only raises awareness of the kinds of ethical dilemmas that researchers are liable to encounter, but it also provides a way for them to learn by working through the dilemmas. Beyond that, the Casebook is meant to assist researchers, institutions, and instructors in meeting several reasonable aims:

• To comply with a recently updated policy of the National Institutes of Health requiring a minimum of eight hours of face-to-face instruction in the responsible conduct of research (RCR).¹ By providing case studies, role plays, and reflection questions, this book offers valuable ways of engaging learners in face-to-face discussion, debate, and enactment of important RCR issues.
• To foster ethical problem-solving skills, including (1) identifying stakeholders, morally relevant facts, pertinent ethical norms or principles, and viable options, and (2) activating strategies for balancing competing principles.^2,3
• To promote the development of sense-making skills, including  “(1) recognizing the complexities of your circumstances, (2) seeking outside help, (3) questioning your own and others' judgment, (4) dealing with emotions, (5) anticipating the consequences of actions, (6) assessing personal motivations, and (7) considering the effects of actions on others.”⁴
• To increase ethical sensitivity, that is, to heighten a researcher’s awareness of many important dimensions of an ethical decision rather than concentrating on one primary point of interest.⁵

This focus on a broad and robust set of aims for RCR instruction is supported by a consensus among experts of various sorts—RCR instructors, journal editors, researchers, trainees, and research administrators—developed using a Delphi panel process.⁶ At the time, this Casebook does NOT aim to replace standard RCR textbooks that teach basic knowledge of RCR regulations and standards.

An accompanying Instructors’ Manual provides a series of brief essays by experts that offer pedagogical reflections and logistic tips that may assist them in using the Casebook to help educate researchers in responsible research practices.

The Spectrum of Ethical Challenges

Not all ethical problems are cut from the same cloth.

• Some matters of ethics are well defined and guidelines are clear within society. These are often codified in regulations, institutional policies, or professional ethics codes—or are so clear they “go without saying”. Examples include, “do not publish fabricated data” and “disclose common risks in informed consent forms”. Such guidelines provide important boundaries for legitimate ethical decision-making.
• Other matters of ethics are less clear and require the exercise of discretion, taking into account many situational factors. On these matters, people of good will may disagree and practices may vary from lab to lab or institution to institution. Nevertheless, gaining practice applying problem-solving frameworks (through critical group discussions of cases and role plays) may assist in navigating the complex cognitive problems that can arise in the responsible conduct of research, avoiding illegitimate decisions even as we negotiate one of several acceptable alternatives.
• In still other cases, it is clear what is the right thing to do; however, interpersonal factors, such as power dynamics, may make it difficult to do the right thing. In these cases, role plays—particularly those that present the views of wise and seasoned “trusted others”—can be valuable in practicing strategies for navigating complex relationships.
• Finally, researchers sometimes find themselves in the difficult position of observing inappropriate or negligent practices among colleagues and collaborators, but do not always know how to handle their own role in it. While federal regulations require reporting research misconduct, many other forms of wrongdoing exist and appropriate responses may vary widely depending on situational factors (e.g., the level of evidence available, the individual’s position in a lab hierarchy, and the seriousness of the problem).

The Casebook attempts to address these different kinds of ethical matters through its various chapter topics and components.

Chapter Topics

The Casebook consists of nine chapters that largely mirror the “subject matter” recommendations of the NIH “Update on the Requirement for Instruction in the Responsible Conduct of Research” (NOT-OD-10-019):¹

• Authorship and publication
• Research misconduct
• Collaboration
• Data acquisition and management
• Peer review
• Conflicts of interest
• Mentor and trainee relationships
• Social responsibility

While the cases and role plays are divided by chapter topics, it is important to note that most cases—like most real world situations—include overlapping issues. For example, authorship problems often overlap with collaboration or mentor-trainee relationship problems; research misconduct typically involves inappropriate management of data; and human subjects’ research often spills over into social responsibilities. The Index found in the Instructors’ Manual will help instructors to identify the various topics that the cases engage beyond what the chapter headings immediately convey.

Chapter Components

Each chapter of the Casebook contains several components that serve a specific purpose:

• An Introduction that explains why the topic is important and identifies the specific problems that are addressed in the subsequent cases and role plays.
• Cases that describe ethically challenging situations that researchers have faced. While all cases have been de-identified, most are based on actual cases that the editors have observed or that researchers shared with the editors in the course of interviews. Cases vary significantly in terms of ethical complexity. Each case is followed by two further components:
  • Open-ended action item: What should the person (e.g., a post-doc fellow) do in this situation? Action items provide participants with the opportunity to make a decision. They are intentionally open-ended, inviting participants to seek further information and use problem-solving or sense-making skills.
  • Discussion questions: Some questions point readers to resources, others raise awareness of issues that may be easily overlooked, and others encourage participants to relate the case to their own experiences. Questions marked with an asterisk (*) may be suitable for group debate. (See essay by Stephanie Solomon in the Instructor’s Manual on facilitating debates.)
  • The Instructor’s Manual provides guidance on how to use the open-ended and discussion questions in various ways. Instructors should feel no pressure to address all questions; they may want to adopt one approach to using a case (e.g., a sensemaking framework) or supplement a key approach with open discussion or debates.
• Informational textboxes that call out standard information that participants may need to make good decisions, e.g., the federal definition of research misconduct and basic guidelines for earning authorship.
• Role plays that frequently revolve around interpersonal conflicts, including conflicts that arise in the face of power discrepancies.
  • Each role play includes the option of including a discussion with a “trusted other”, e.g., a former mentor or a more senior colleague. The “trusted other” is provided with a list of “Socratic questions” that may gently guide participants toward wise decisions—or spur lively debate.

Background Resources: Materials to Support Informed Discussion

Group discussion can remedy many individual deficits—correcting mistaken beliefs and challenging biased decisions.⁷ However, a group’s baseline of knowledge will ultimately affect the outcomes of case discussions and role plays.

We therefore encourage RCR instructors and participants in using the Casebook to obtain a basic foundation of knowledge of research regulations, ethical principles, and societal expectations regarding RCR. In recent years, the number of didactic materials addressing these foundational matters have burgeoned—printed textbooks, electronic reading materials, videos (both traditional and interactive), and slides are all now available. We point readers to three educational resources from the Office of Research Integrity (ORI) available online at no cost:

• ORI Introduction to the Responsible Conduct of Research

This introductory text by Nicholas Steneck provides an overview of RCR that can be read in just a few hours.

http://ori.hhs.gov/ori-introduction-responsible-conduct-research

• “The Lab: Avoiding Research Misconduct”

This is an interactive video. In "The Lab” you become the lead characters and make decisions about integrity in research that can have long-term consequences.

http://ori.hhs.gov/thelab

In addition, the “RCR Resources” page of the ORI website (ori.hhs.gov) lists more than 100 RCR instructional resources indexed by topic and format.

In short, the Casebook is designed to develop ethical problem-solving skills as well as to foster sensitivity to ethical issues in the conduct of research. By examining ethical dilemmas in research, participants can explore consequences of ethical decision-making, practice problem-solving strategies, and acquire the ability to respond appropriately to observed wrongdoing.