Ethics in Research and Scholarly Activity, Including Protection of Research Participants

Issues in Ethics

• About This Document
• Issues in Ethics Statements: Definition
• Introduction
• Guidance on Ethical Treatment of Research Participants (Human and Animal)
• Compliance
• Honesty
• Research Misconduct
• Supervision of Research Staff, Practioner Collaborators, and Students
• Conclusion

About This Document

Published 2018. This Issues in Ethics statement is a revision of Ethics in Research and Scholarly Activity (revised in 2008 and 2014) and Ethics in Research and Professional Practice (2002), and incorporated the previous Issues in Ethics statement, Protection of Human Subjects (2014). It has been updated to make any references to the Code of Ethics consistent with the Code of Ethics (2016). The Board of Ethics reviews Issues in Ethics statements periodically to ensure that they meet the needs of the professions and are consistent with ASHA policies.

Issues in Ethics Statements: Definition

From time to time, the Board of Ethics (hereinafter, the "Board") determines that members and certificate holders can benefit from additional analysis and instruction concerning a specific issue of ethical conduct. Issues in Ethics statements are intended to heighten sensitivity and increase awareness. They are illustrative of the Code of Ethics (2016) (hereinafter, the "Code") and are intended to promote thoughtful consideration of ethical issues. They may assist members and certificate holders in engaging in self-guided ethical decision making. These statements do not absolutely prohibit or require specified activity. The facts and circumstances surrounding a matter of concern will determine whether the activity is ethical.

Introduction

This Issues in Ethics statement provides guidance to ASHA members so that they may engage in ethically appropriate research and scholarship activities. The breadth of research and scholarship within the Association and within members' activities has necessitated change in the Code, such that research and scholarship are integrated throughout. This breadth includes research both within and across disciplines.

Research and scholarly activities constitute a professional focus for many, although clinical practice is the primary professional activity of a great majority of Association members. In addition, practicing clinicians often participate in research to increase the evidence base for clinical services they provide. Further, all ASHA members and certificate holders are encouraged to critically evaluate research as it applies to their professional activities. Research and scholarship embrace all participants, both human and animal, and all settings in which the continuum of these activities (e.g., data gathering, analysis, reporting, etc.) occur, including but not limited to

• universities;
• laboratories;
• medical centers and other treatment facilities;
• private practice; and
• public and private schools.

It is therefore fitting that the Association's Code provides guidance when members and certificate holders engage in or use research and other scholarly work. The Code approaches research and scholarship through the themes of (a) ethical treatment of research participants (human and animal); (b) compliance; (c) honesty; and (d) supervision of research staff, practitioner collaborators, and students.

Guidance on Ethical Treatment of Research Participants (Human and Animal)

The ethical treatment of research participants (human and animal) requires informed consent for human participants, humane treatment of animals, nondiscriminatory practices, and confidentiality.

Informed Consent

Informed consent constitutes consent by persons served, research participants engaged, or parents and/or guardians of persons served to a proposed course of action after the communication of adequate information regarding expected outcomes and potential risks. Failure to obtain written consent from individuals participating in research, or from the parents/guardians of individuals participating in research, represents an ethical violation of the following Principles and Rules:

• Principle of Ethics I, Rule H: Individuals shall obtain informed consent from the persons they serve about the nature and possible risks and effects of services provided, technology employed, and products dispensed. This obligation also includes informing persons served about possible effects of not engaging in treatment or not following clinical recommendations. If diminished decision-making ability of persons served is suspected, individuals should seek appropriate authorization for services, such as authorization from a spouse, other family member, or legally authorized/appointed representative.
• Principle of Ethics I, Rule I: Individuals shall enroll and include persons as participants in research or teaching demonstrations only if participation is voluntary, without coercion, and with informed consent.
• Principle of Ethics I, Rule J: Individuals shall accurately represent the intended purpose of a service, product, or research endeavor and shall abide by established guidelines for clinical practice and the responsible conduct of research.

Discrimination

A foundational principle of research is the inclusion of the varied demographics of the population under study. An additional foundational principle is the fundamental respect for individual differences by those who design, execute, and report research. Discrimination in the selection and treatment of human participants may be the result of explicit or implicit bias. One example would be excluding a specific group (e.g., individuals who identify as bisexual) because of personal bias when that variable (sexual orientation) would not influence the research study’s outcome(s). Doing this violates Principle of Ethics I, Rule C, which states, "Individuals shall not discriminate in the delivery of professional services or in the conduct of research and scholarly activities on the basis of race, ethnicity, sex, gender identity/gender expression, sexual orientation, age, religion, national origin, disability, culture, language, or dialect." 

Confidentiality

Sharing information that can be used to identify a research participant is a violation of the Code. Even disclosing minimal information (e.g., initials of participant’s name, disorder, address of participant, aspects of treatment) through any form of communication, including social media, may allow others to identify the participant and may be a violation of the following Principles and Rules:

• Principle of Ethics I, Rule O: Individuals shall protect the confidentiality and security of records of professional services provided, research and scholarly activities conducted, and products dispensed. Access to these records shall be allowed only when doing so is necessary to protect the welfare of the person or of the community, is legally authorized, or is otherwise required by law.
• Principle of Ethics I, Rule P: Individuals shall protect the confidentiality of any professional or personal information about persons served professionally or participants involved in research and scholarly activities and may disclose confidential information only when doing so is necessary to protect the welfare of the person or of the community, is legally authorized, or is otherwise required by law.

Compliance

Regardless of the research setting (e.g., university, school, industry, private practice), each project involving human or animal participants must undergo an initial review to ensure compliance with applicable local, institutional, state, and federal regulations. Failure to conduct research without this review violates the following Principles and Rules:

• Principle of Ethics I, Rule J: "Individuals shall accurately represent the intended purpose of a service, product, or research endeavor and shall abide by established guidelines for clinical practice and the responsible conduct of research."
• Principle of Ethics II, Rule C: "Individuals who engage in research shall comply with all institutional, state, and federal regulations that address any aspects of research, including those that involve human participants and animals."
• Principle of Ethics IV, Rule R: "Individuals shall comply with local, state, and federal laws and regulations applicable to professional practice, research ethics, and the responsible conduct of research."

In order to ensure that research results are accurate, safe, and reliable, research must be conducted using commonly accepted principles regarding equipment maintenance and calibration. Failure to conduct research in such a manner violates Principle of Ethics II, Rule H, which states, "Individuals shall ensure that all technology and instrumentation used to provide services or to conduct research and scholarly activities are in proper working order and are properly calibrated." 

Individuals who are aware that those conducting research, either in their professional area or other professional areas, are in violation of the Association’s Code or standards of care appropriate for other professions have a responsibility to report those activities or they will be in violation of the following Principles and Rules:

• Principle of Ethics IV Rule M: "Individuals with evidence that the Code of Ethics may have been violated have the responsibility to work collaboratively to resolve the situation where possible or to inform the Board of Ethics through its established procedures."
• Principle of Ethics IV, Rule N: "Individuals shall report members of other professions who they know have violated standards of care to the appropriate professional licensing authority or board, other professional regulatory body, or professional association when such violation compromises the welfare of persons served and/or research participants."

Individuals conducting research or other scholarly activities are expected to do so within their areas of competence. Failure to adhere will be a violation of Principle of Ethics I, Rule A, which states, "Individuals shall provide all clinical services and scientific activities competently."

Conflicts of interest in research and scholarly activity can involve personal or commercial interests, or financial arrangements. If a researcher is offered, or receives, gifts or incentives—even something as minor as a free lunch—there may be a conflict of interest that may violate Principle of Ethics III, Rule B, which states, "Individuals shall avoid engaging in conflicts of interest whereby personal, financial, or other considerations have the potential to influence or compromise professional judgment and objectivity." Consideration of the de minimis nature of a gift also is relevant, however.

Honesty

Honesty refers to being accurate and truthful about one’s self, one’s work, and the work of others. For example, while conducting research and scholarly activity, misrepresenting a Clinical Fellow or a student as either a practicing audiologist or speech-language pathologist would violate the following Principles and Rules: 

• Principle of Ethics I, Rule D: "Individuals shall not misrepresent the credentials of aides, assistants, technicians, support personnel, students, research interns, Clinical Fellows, or any others under their supervision, and they shall inform those they serve professionally of the name, role, and professional credentials of persons providing services."
• Principle of Ethics III, Rule A: "Individuals shall not misrepresent their credentials, competence, education, training, experience, and scholarly contributions."

Research Misconduct

The Office of Research Integrity (ORI) of the U.S. Department of Health & Human Services defines research misconduct as "fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results," and further states that "research misconduct does not include honest error or differences of opinion." 

ORI defines fabrication as "making up data or results and recording or reporting them." Examples of fabricating research data or results and recording or reporting them include creating spreadsheets that contain demographic information and performance results for research participants who do not exist, and creating figures for public presentation that contain results of physical measures of sound outputs for auditory devices that cannot produce these levels. These examples may be a violation of the following Principles and Rules:

• Principle of Ethics I, Rule Q: "Individuals shall maintain timely records and accurately record and bill for services provided and products dispensed and shall not misrepresent services provided, products dispensed, or research and scholarly activities conducted."
• Principle of Ethics III, Rule C: "Individuals shall not misrepresent research and scholarly activities, diagnostic information, services provided, results of services provided, products dispensed, or the effects of products dispensed." 

ORI defines falsification as "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." Examples of falsifying research data and/or reporting such data include (a) reporting data that were not collected, (b) altering data collected to achieve a particular outcome, (c) reporting only data that support your hypotheses and/or interests, and (d) making false claims in promotional materials about what one’s research has demonstrated or supported. These examples may be a violation of the following Principles and Rules:

• Principle of Ethics III, Rule C: "Individuals shall not misrepresent research and scholarly activities, diagnostic information, services provided, results of services provided, products dispensed, or the effects of products dispensed."
• Principle of Ethics III, Rule D: "Individuals shall not defraud through intent, ignorance, or negligence or engage in any scheme to defraud in connection with obtaining payment, reimbursement, or grants and contracts for services provided, research conducted, or products dispensed."
• Principle of Ethics III, Rule E: "Individuals' statements to the public shall provide accurate and complete information about the nature and management of communication disorders, about the professions, about professional services, about products for sale, and about research and scholarly activities."
• Principle of Ethics III, Rule F: "Individuals' statements to the public shall adhere to prevailing professional norms and shall not contain misrepresentations when advertising, announcing, and promoting their professional services and products and when reporting research results."

ORI defines plagiarism as "the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit." Representing any part or parts of another’s work as one’s own is considered plagiarism and may be a violation of Principle of Ethics III, Rule A (see above) and Principle of Ethics IV, Rule K, which states, "Individuals shall reference the source when using other persons' ideas, research, presentations, results, or products in written, oral, or any other media presentation or summary. To do otherwise constitutes plagiarism."

Failing to recognize students or any other contributors as authors of research or scholarly work, or assigning authorship credit to an individual who has not contributed to research or scholarly work, may result in violation of Principle of Ethics III, Rule A (see above) and Principle of Ethics IV, Rule J, which states, "Individuals shall assign credit only to those who have contributed to a publication, presentation, process, or product. Credit shall be assigned in proportion to the contribution and only with the contributor's consent."

Using direct quotes or paraphrasing published research to suggest that the author(s) of the research endorsed a product, treatment, or product may violate the following Principles and Rules: 

• Principle of Ethics III, Rule E: "Individuals' statements to the public shall provide accurate and complete information about the nature and management of communication disorders, about the professions, about professional services, about products for sale, and about research and scholarly activities."
• Principle of Ethics III, Rule F: "Individuals' statements to the public shall adhere to prevailing professional norms and shall not contain misrepresentations when advertising, announcing, and promoting their professional services and products and when reporting research results."

Supervision of Research Staff, Practitioner Collaborators, and Students

Supervision of research staff, collaborators, and students is an integral part of scholarly activity and research. All individuals involved in research must be held to the highest levels of ethical conduct. Supervisors must ensure that all individuals involved in the research project receive appropriate training and are competent to conduct assigned research activities. The research supervisor shall maintain professional supervisor–supervisee relationships and assign credit appropriately.

Failure of individuals in supervisory or administrative roles to delegate research responsibilities appropriately to students or staff may result in violation of the following Principles and Rules:

• Principle of Ethics II, Rule E: "Individuals in administrative or supervisory roles shall not require or permit their professional staff to provide services or conduct research activities that exceed the staff member’s certification status, competence, education, training, and experience."
• Principle of Ethics IV, Rule I: "Individuals shall not knowingly allow anyone under their supervision to engage in any practice that violates the Code of Ethics."

Failure of individuals in supervisory or administrative roles to maintain appropriate relationships with all those involved in the research process may result in a violation of the following Principles and Rules:

• Principle of Ethics IV, Rule G: "Individuals shall not engage in any form of harassment, power abuse, or sexual harassment."
• Principle of Ethics IV, Rule H: "Individuals shall not engage in sexual activities with individuals (other than a spouse or other individual with whom a prior consensual relationship exists) over whom they exercise professional authority or power, including persons receiving services, assistants, students, or research participants." 

Conclusion

ASHA members and certificate holders conduct research, scholarly activities, and protect human and animal participants in a variety of settings with multiple disciplines. For some individuals, these are considered primary activities; for others, these activities are completed in conjunction with other professional activities, including clinical practice. The above scenarios are only a few examples of ethical challenges. Many other challenges may arise, and individuals must remain alert and should consult the Code for guidance on appropriate courses of action.