Course Description

Course Exam

1. Basic Research Ethics

1.1 A Responsible Researcher

Consider what it means to be a responsible researcher. What does it mean to be ethical? Of course, one must be in compliance with rules and regulations. But in addition, ethical researchers think critically about the range of their behaviors that impact others — their research subjects, students and trainees, collaborators, and the scientific community and citizens at large. We like the way researchers at The Center for Ethics at the University of Montana describe it:

“One is ethically responsible for far more than for what one can be held legally accountable. It is wrong to lie in many more instances than the lies for which one can be prosecuted. In an analogous fashion …requirements for compliance prescribe a minimal standard for research practice. It is important to know how to be compliant…. But it is equally important that individuals think about how best to meet their role-related responsibilities in ways that go beyond mere compliance with rules and regulations. … Encourage research that is praiseworthy rather than simply discourage research that is blameworthy.”

From http://ori.dhhs.gov/education/products/NovelApproach/index.htm

1.2 Ethical Issues In Research

The following is excerpted from an Online Research Ethics Course developed by the Practical Ethics Center of the University of Montana 2002-03. The course focuses on a foundation in responsible conduct of research. This excerpted section focuses on the difference between compliance and ethics, and the importance of ethics in research.

Section 1: Ethical Issues in Research

From http://ori.hhs.gov/education/products/montana_round1/issues.html

Ethics matters in academic and scientific research. The study of ethics is no less and no more important in research than it is in any other practice that has the potential of causing harm or creating good for others. It is expected that practitioners will better understand how to be responsible researchers through the study of ethics. The study of ethics helps people think more clearly about professional expectations and encourages them to examine the assumptions that serve as the basis for conventional behavior. The hope is that the researcher’s increased consciousness of his or her role will translate into more ethical action.

Through completing this section, successful participants will be able to:

1. Define and apply basic terms relating to the ethical conduct of research including research misconduct, fabrication, falsification, plagiarism, compliance, ethically prohibited behavior, ethically required behavior, ethically permitted behavior, and ethically encouraged behavior;
2. Distinguish between compliance and ethics; and
3. Describe the minimal requirements for research ethics training set forward by the Public Health Service (PHS).

The first step in learning how to use ethical concepts in dealing with matters of research is to become familiar with the terminology associated with research ethics.

[…]

1) Compliance and Ethics Terms

The terms for this section are separated into compliance and ethics. Compliance and ethics are both necessary for the conduct of responsible research. Compliance means that investigators and institutions follow the rules that are set out for them. Rules regarding research come from the federal government, from funders, and from the institution itself. The essential elements of compliance are that an individual researcher knows the rules and that he or she is motivated to follow the rules.

Ethical behavior requires more than simply following the rules. Ethics is the study of how human action affects other humans, sentient beings, or the ecosystem. Ethical researchers understand that their actions have the potential of causing harm and the potential of promoting good for others, for the profession, for society, and for the natural world. They are aware of the special responsibilities that follow from the researcher role and work to fulfill those responsibilities. In the process of meeting their responsibilities, they seek to promote good when possible. Always, at a minimum, they choose actions that do not cause unjustified harm.

Ethical analysis provides a way of making sense of the rules and regulations. Fabrication, for example, is a type of research misconduct. It is legally and ethically prohibited. Fabrication is the act of making up data or results, then recording or reporting them as part of the research record. It is legally required for funding agencies and research institutions to take punitive actions against researchers who fabricate. They are held accountable for their actions.

Fabrication is ethically wrong because it is likely to lead to harm to others. The harm could be direct to a patient who takes a drug that is erroneously reported as having no serious side effects. The harm could be direct to another researcher who trusts the results of fabricated research and wastes valuable time, money and other resources in using that research as a basis for his or her own work. The harm is almost always indirect as well. Indirect harms include the decrease in trust that the general public has in research when they learn about cases of scientific misconduct. This decrease in trust is harmful to the public, who must depend on the accuracy of research.

Compliance Terms

• Research: Includes all basic, applied, and demonstration research in all fields of science, engineering, and mathematics. This includes, but is not limited to, research in economics, education, linguistics, medicine, psychology, social sciences, statistics, and all research involving human subjects or animals, regardless of originating discipline. Research, according to the Belmont Report, is an “activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalized knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.”
• Research Misconduct: Fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. It does not include honest error or honest differences in interpretations or judgments of data.
• Fabrication: Making up data or results and recording or reporting them as factual results.
• Falsification: Manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
• Research Record: The record of data or results that embody the facts resulting from scientific inquiry and includes, but is not limited to, research proposals, laboratory records, both physical and electronic, progress reports, abstracts, theses, oral presentations, internal reports, and journal articles.
• Plagiarism: The appropriation of another person’s ideas, processes, results, or words without giving appropriate credit, including those obtained through confidential review of others’ research proposals and manuscripts.
• Findings of Research Misconduct: A finding that research misconduct, in fact, occurred requires that the fabrication, falsification, or plagiarism be a significant departure from accepted practices of the relevant research community; and the misconduct be committed intentionally, knowingly, or recklessly; and the allegation be proven by a preponderance of evidence.
• Research Institutions: All organizations using federal funds for research, including, for example, colleges and universities, intramural federal research laboratories, federally-funded research and development center, national user facilities, industrial laboratories, or other research institutes. Independent researchers and small research institutions are also included in this definition. Research institutions have the primary responsibility for prevention and detection of research misconduct.
• Research Integrity Officer: Institutional official responsible for assessing allegations of research misconduct. The Research Integrity Officer at most institutions, is the Vice President for Research, or that person’s designee.
• Legally Required This terminology is used in the course to differentiate actions that are merely in compliance (legally required) from those actions that are ethically permitted.

Ethics Terms

• Ethical (syn. Moral): Within the realm of considerations that looks at the potential harms caused to other persons, sentient beings or systems.
• Moral Agent: Someone who is aware or who has the capacity to be aware of the expectation that he or she not cause unjustified harm to other persons, sentient beings or systems.
• General Morality: The questions relating to ethics in research are a subset of the questions that relate to general morality. General morality dictates that it is not acceptable to cause pain, death, disability, or deprive someone of freedom or pleasure without justification. General morality also requires that acts of deception, cheating, promise-breaking, law-breaking and neglect of responsibility be considered examples of wrongdoing unless there is justification for the acts.
• Publicity: It is reasonable to expect individuals to act ethically only if it possible for them to know what those ethical expectations are and if following those expectations will not cause them unjustified harm. The expectations should be public. Exceptions that people want to make for not doing what is usually expected should be public as well.
• Justification: Ethically acceptable exceptions to doing what is usually expected have the following features: 1) if they are justified for any person, they are justified for every person when all of the ethically relevant features are the same (one cannot justifiably make an exception of oneself if one is not willing to make the same exception for everyone in the same situation); 2) the exception cannot cause unjustified harm to oneself or others; and 3) the exception can be known publicly.
• Ethical Rules: Rules that identify ethically questionable actions that are known to cause suffering or cause an increased risk of causing harm. One set of rules is that it is ethically prohibited to cause pain, death, disability or deprive others of opportunity or pleasure without justification. Another set of rules is that it is also ethically prohibited to do any of the following without good reason: deceive, cheat, break promises, break the law, or neglect one’s duty.
• Ethical Ideals: Ideals are actions that lessen the amount of harm suffered or decrease the risk that people, other sentient beings, or the ecosystem will suffer harm. As long as one is not violating an ethical rule, general morality encourages, but does not require, following ethical ideals. People are praiseworthy for following ethical ideals, but are not blameworthy for not performing the ideal.
• Ethically Prohibited: Actions that are contrary to those required by general morality or by reasonable expectations within the research community and are not justifiable. People are blameworthy for acting in ethically prohibited ways. By way of example, it is ethically prohibited to violate the rules and regulations regarding responsible research that are set out by the federal government, funders, and research institutions.
• Ethically Permitted: Actions that are consistent with those required by general morality and by reasonable expectations within the research community. It is ethically permitted to do more than follow minimal rules and regulations.
• Ethically Required: Actions that follow from the special role-related responsibilities of being a researcher. It is ethically required that researchers be in compliance with federal and institutional rules and regulations.
• Ethically Encouraged: Actions that are ethically permitted and, in addition, are intended to lessen suffering or lessen the risk of suffering harms.
• Blameworthy: One who acts in ethically prohibited ways.
• Praiseworthy: One who acts in ethically encouraged ways.
• Descriptive Ethics: The study of how people do act.
• Normative Ethics: The study of how people should act.

2) Public Health Service (PHS) Policy

The pending PHS policy requires that those who have direct and substantial involvement in proposing, performing, reviewing or reporting research or who receive research training supported by PHS funds or who work on PHS-supported research regardless of PHS support, complete a basic program of instruction in the responsible conduct of research.

[…]

Case Studies

Note: The case study will open in a new window. When you have completed all of the alternatives for a case, close the window to return to this section.

Case Study 1:Expedience, Misrepresentation, or Falsification?

Case Study 2:Crashing into Law.

2. The Belmont Report

2.1 What was the Belmont Report?

Following the public outrage over the Syphilis Study at Tuskegee, Congress established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1974. The National Commission was charged with:

1. Identifying the ethical principles to guide all research involving human subjects
2. Developing guidelines for the conduct of ethical research involving human subjects

In 1979, the National Commission drafted The Belmont Report – Ethical Principles and Guidelines for the Protection of Human Subjects of Research. The Belmont Report identified three principles essential to the ethical conduct of research with humans:

1. Respect for persons
2. Beneficence
3. Justice

These three basic principles serve as the foundation of the current HHS regulations and guidelines for the ethical conduct of human subjects research supported by HHS.

From: https://phrp.nihtraining.com/codes/02_codes.php

2.2 Research vs. Practice

The following is a section is excerpted from the Belmont Report:

Part A. Boundaries Between Practice and Research

It is important to distinguish between biomedical and behavioral research, on the one hand, and the practice of accepted therapy on the other, in order to know what activities ought to undergo review for the protection of human subjects of research. The distinction between research and practice is blurred partly because both often occur together (as in research designed to evaluate a therapy) and partly because notable departures from standard practice are often called “experimental” when the terms “experimental” and “research” are not carefully defined.

For the most part, the term “practice” refers to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success. The purpose of medical or behavioral practice is to provide diagnosis, preventive treatment or therapy to particular individuals. By contrast, the term “research” designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.

When a clinician departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research. 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.

Research and practice may be carried on together when research is designed to evaluate the safety and efficacy of a therapy. This need not cause any confusion regarding whether or not the activity requires review; the general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects.

2.2 Basic Ethical Principles

This is another section excerpted from the Belmont Report:

Part B. Basic Ethical Principles

The expression “basic ethical principles” refers to those general judgments that serve as a basic justification for the many particular ethical prescriptions and evaluations of human actions. Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice.

1. Respect for Persons. — Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.

An autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of such deliberation. To respect autonomy is to give weight to autonomous persons’ considered opinions and choices while refraining from obstructing their actions unless they are clearly detrimental to others. To show lack of respect for an autonomous agent is to repudiate that person’s considered judgments, to deny an individual the freedom to act on those considered judgments, or to withhold information necessary to make a considered judgment, when there are no compelling reasons to do so.

However, not every human being is capable of self-determination. The capacity for self-determination matures during an individual’s life, and some individuals lose this capacity wholly or in part because of illness, mental disability, or circumstances that severely restrict liberty. Respect for the immature and the incapacitated may require protecting them as they mature or while they are incapacitated.

Some persons are in need of extensive protection, even to the point of excluding them from activities which may harm them; other persons require little protection beyond making sure they undertake activities freely and with awareness of possible adverse consequence. The extent of protection afforded should depend upon the risk of harm and the likelihood of benefit. The judgment that any individual lacks autonomy should be periodically reevaluated and will vary in different situations.

In most cases of research involving human subjects, respect for persons demands that subjects enter into the research voluntarily and with adequate information. In some situations, however, application of the principle is not obvious. The involvement of prisoners as subjects of research provides an instructive example. On the one hand, it would seem that the principle of respect for persons requires that prisoners not be deprived of the opportunity to volunteer for research. On the other hand, under prison conditions they may be subtly coerced or unduly influenced to engage in research activities for which they would not otherwise volunteer. Respect for persons would then dictate that prisoners be protected. Whether to allow prisoners to “volunteer” or to “protect” them presents a dilemma. Respecting persons, in most hard cases, is often a matter of balancing competing claims urged by the principle of respect itself.

2. Beneficence. — Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. Such treatment falls under the principle of beneficence. The term “beneficence” is often understood to cover acts of kindness or charity that go beyond strict obligation. In this document, beneficence is understood in a stronger sense, as an obligation. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms.

The Hippocratic maxim “do no harm” has long been a fundamental principle of medical ethics. Claude Bernard extended it to the realm of research, saying that one should not injure one person regardless of the benefits that might come to others. However, even avoiding harm requires learning what is harmful; and, in the process of obtaining this information, persons may be exposed to risk of harm. Further, the Hippocratic Oath requires physicians to benefit their patients “according to their best judgment.” Learning what will in fact benefit may require exposing persons to risk. The problem posed by these imperatives is to decide when it is justifiable to seek certain benefits despite the risks involved, and when the benefits should be foregone because of the risks.

The obligations of beneficence affect both individual investigators and society at large, because they extend both to particular research projects and to the entire enterprise of research. In the case of particular projects, investigators and members of their institutions are obliged to give forethought to the maximization of benefits and the reduction of risk that might occur from the research investigation. In the case of scientific research in general, members of the larger society are obliged to recognize the longer term benefits and risks that may result from the improvement of knowledge and from the development of novel medical, psychotherapeutic, and social procedures.

The principle of beneficence often occupies a well-defined justifying role in many areas of research involving human subjects. An example is found in research involving children. Effective ways of treating childhood diseases and fostering healthy development are benefits that serve to justify research involving children — even when individual research subjects are not direct beneficiaries. Research also makes it possible to avoid the harm that may result from the application of previously accepted routine practices that on closer investigation turn out to be dangerous. But the role of the principle of beneficence is not always so unambiguous. A difficult ethical problem remains, for example, about research that presents more than minimal risk without immediate prospect of direct benefit to the children involved. Some have argued that such research is inadmissible, while others have pointed out that this limit would rule out much research promising great benefit to children in the future. Here again, as with all hard cases, the different claims covered by the principle of beneficence may come into conflict and force difficult choices.

3. Justice. — Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of “fairness in distribution” or “what is deserved.” An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly. Another way of conceiving the principle of justice is that equals ought to be treated equally. However, this statement requires explication. Who is equal and who is unequal? What considerations justify departure from equal distribution? Almost all commentators allow that distinctions based on experience, age, deprivation, competence, merit and position do sometimes constitute criteria justifying differential treatment for certain purposes. It is necessary, then, to explain in what respects people should be treated equally. There are several widely accepted formulations of just ways to distribute burdens and benefits. Each formulation mentions some relevant property on the basis of which burdens and benefits should be distributed. These formulations are (1) to each person an equal share, (2) to each person according to individual need, (3) to each person according to individual effort,(4) to each person according to societal contribution, and (5) to each person according to merit.

Questions of justice have long been associated with social practices such as punishment, taxation and political representation. Until recently these questions have not generally been associated with scientific research. However, they are foreshadowed even in the earliest reflections on the ethics of research involving human subjects. For example, during the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients. Subsequently, the exploitation of unwilling prisoners as research subjects in Nazi concentration camps was condemned as a particularly flagrant injustice. In this country, in the 1940’s, the Tuskegee syphilis study used disadvantaged, rural black men to study the untreated course of a disease that is by no means confined to that population. These subjects were deprived of demonstrably effective treatment in order not to interrupt the project, long after such treatment became generally available.

Against this historical background, it can be seen how conceptions of justice are relevant to research involving human subjects. For example, the selection of research subjects needs to be scrutinized in order to determine whether some classes (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied. Finally, whenever research supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.

3. Research-Ethics Library

3.1 Learn More About Research Ethics

Study in-depth the following sites, follow some links:

• Research in Ethics
  • What is Ethics in Research & Why is it Important? by David B. Resnik, J.D., Ph.D.
  • http://www.niehs.nih.gov/research/resources/bioethics/whatis/
• Ethics Timeline
  • Research Ethics Timeline (1932-Present) by David B. Resnik, J.D., Ph.D.
  •  http://www.niehs.nih.gov/research/resources/bioethics/timeline/
• Confidentiality and Ethics
  • Chapter 7 from the Texas Juvenile Justice Department Volunteer Services Program Handbook
  • “This chapter reminds us of or maybe even enlightens our awareness about how we make decisions – ethical decisions – choosing between right and wrong. We will also discuss the importance of confidentiality and how it applies to not only our daily lives but its necessity to protect TYC youth and personnel.”
  • http://www.tjjd.texas.gov/programs/volunteer_training/Chapter7_Confidentiality_Ethics.pdf (older copy, just the chapter on Confidentiality and Ethics)
  • http://www.tjjd.texas.gov/docs/VolunteerTrainingManual.pdf (more recent edition, includes all chapters)
• Research Ethics Slides
  • Presented at in the Symposium on Scientific Publishing, ACS National Meeting, Atlanta, GA March 2006 by Prashant V. Kamat
  • http://www3.nd.edu/~pkamat/pdf/ethics.pdf
• Research Ethics Training Curriculum
  • A detailed lesson: Review it carefully.
  • Research Ethics Training Curriculum, published by Family Health International, a non-profit human development organization, 2009
  • Recommended – the Macromedia Flash “Concise” Version:
    http://www.fhi360.org/sites/all//libraries/webpages/fhi-retc2/Resources/RETC2_Edition_Concise.swf
  • Non-flash alternate versions are also available, but may be more detailed:
    http://www.fhi360.org/resource/research-ethics-training-curriculum-retc-second-edition
• Online Research Ethics Course
  • From the University of Montana and the (Health and Human Services) Office of Research Integrity
  • http://ori.hhs.gov/education/products/montana_round1/research_ethics.html
  • We read excerpts from one of the six sections of this course, leaving much additional depth available for optional further study.

3.2 Additional Ethical Conduct Links

Want to go farther in expanding your knowledge about Ethical Conduct in Research? The following list includes optional additional resources relating to ethical conduct in research. They are taken from the “Online Research Ethics Course” developed by the Practical Ethics Center of the University of Montana referenced earlier.

Ethics and Compliance Issues

Below are links that may help you understand ethics and compliance issues a little better:

• Ethics and Compliance Strategies: “When it comes to developing effective ethics and compliance programs, the key to success is knowing how to present content rich material in an innovative manner. Whether it’s developing a code of conduct, writing policies or designing a training session, you need to be creative, informative and cost effective. To get the most out of your ethics and compliance program, contact Ethics & Compliance Strategies. We know how to design programs that will win high praise from the world’s most demanding audiences — your employees.”
• Ethics Programs of the National Institutes of Health: “This site deals with standards of ethical conduct for federal employees.”
• Ethics Resource Center: “The Ethics Resource Center (ERC) is a nonprofit, nonpartisan educational organization whose vision is a world where individuals and organizations act with integrity.”
• Ethics in Science: This Web site contains many links to science ethics resources.
• Ethics Updates: “Ethics Updates is designed primarily to be used by ethics instructors and their students. It is intended to provide updates on current literature, both popular and professional, that relates to ethics.”
• Guidelines for the Conduct of Research: “The Guidelines for the Conduct of Research expound the general principles governing the conduct of good science as practiced in the Intramural Research Programs at the National Institutes of Health. They address a need arising from the rapid growth of scientific knowledge, the increasing complexity and pace of research, and the influx of scientific trainees with diverse backgrounds. Accordingly, the Guidelines should assist both new and experienced investigators as they strive to safeguard the integrity of the research process.”
• Office of Research Integrity: “The Office of Research Integrity (ORI) promotes integrity in biomedical and behavioral research supported by the Public Health Service (PHS) at about 4,000 institutions worldwide. ORI monitors institutional investigations of research misconduct and facilitates the responsible conduct of research through educational, preventive, and regulatory activities. Organizationally, ORI is located in the Office of Public Health and Science within the Office of the Secretary of Health and Human Services.”
• Online Ethics Center for Engineering and Science: “Our mission is to provide engineers, scientists, and science and engineering students with resources for understanding and addressing ethically significant problems that arise in their work, and to serve those who are promoting learning and advancing the understanding of responsible research and practice in science and engineering.”
• NIH Bioethics Resources: “The Internet is replete with resources available to those with an interest in bioethics including education, research involving human participants and animals, medical and health care ethics, and the implications of applied genetics and biotechnology. This website contains a broad collage of annotated web links, and while this list is comprehensive, it is not totally inclusive. The listed resources provide background information and various positions on issues in bioethics.”
• NIH Office of Intramural Research: Links to training guides and ethical procedures developed by the US government.
• Research Conduct and Ethics Instruction Materials: A collection of research ethics guidelines with cases studies from the NIH.
• The US Public Health Service: The main Web site for access to the National Institutes of Health, Centers for Disease Control, Food and Drug Administration, and other health-related agencies.
• US Office of Government Ethics: “On this site you will be able to access data about OGE and the services it provides. We hope that this site will help you understand the executive branch ethics program and our effort to reach Federal employees and the general public.”

Source: http://ori.hhs.gov/education/products/montana_round1/issues.html

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