Principles of Ethical Research
Establishing Ethical Guidelines
The harmonization of ethics guidelines for research with human subjects in the United States began in the mid-1970s with the passage of the National Research Act of 1974. This act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research — the first national body charged with addressing bioethics policies. Support for the National Research Act was partly in reaction to the abuses of the Tuskegee syphilis study, which gained media attention in 1972 and revealed that a United States Public Health Service study failed to offer known effective treatments to Black men with syphilis in order to continue observing the untreated effects of the disease.
The Commission issued recommendations for the creation of Institutional Review Boards (IRBs) (1978) and the Belmont Report (1978), which established a set of guidelines for human subjects research. The Belmont Report focused on first principles of research ethics and drew on two other foundational documents: the Nuremberg Code, a set of standards created in 1947 during the Nuremberg war crimes trials as a means for prosecuting Nazi doctors who had conducted experiments in concentration camps during World War II (see Shuster 1997), and the Declaration of Helsinki, written in 1964 by the World Medical Association to create ethical principles for medical experiments involving human subjects.
The Belmont Report identified three fundamental ethical principles for evaluating research: respect for persons, beneficence, and justice. These principles have guided the development, standardization, and revision of research ethics practices and oversight and have been codified in the US Code of Federal Regulations (45 CFR 46 Protection of Human Subjects 2023, often called the “Common Rule” because these regulations have been adopted across Federal departments and agencies).
While research ethics is a large, complex, and nuanced field, and these are not the only principles that a researcher may need to consider (we will discuss some additional issues later in this lesson), asking whether a research design exhibits these three principles is a good starting point for evaluating its ethical efficacy.
Respect for Persons
Respect for persons asserts that individuals have autonomy, or the capability of self-determination and decision-making, and should be treated in a way that upholds this autonomy. By extension, this principle establishes requirements for disclosure about research procedures, the data being collected, the potential risks and benefits, informed consent, voluntary participation that is free from coercion, the right to withdraw from participation, and the need to establish additional protections for any person who may have diminished autonomy. Each of these requirements must be met by a proposed research design, and more importantly, practiced by researchers in their interactions with research participants and their data throughout all phases of a research study.
A note on “subjects”
Many researchers question the use of the label “subjects” to refer to people enrolled in a research study. The term subject is rooted in the biomedical traditions of research with human participants and tends to convey the sense of a patient under the care of an expert. Simpson (2011) has described this tradition as an “ethics of the body (with a person attached)” as compared to an “ethics of the person (with body attached)” the considers a broader engagement with people as social beings. Especially in more qualitatively oriented social sciences, such as anthropology and sociology, some researchers argue that the term subject undermines the autonomy of research participants, unnecessarily objectifies them, and concedes too much authority and power to the researcher. Many alternatives attempting to more readily convey the co-production of knowledge have been suggested, including “interlocutors,” “consultants,” “respondents,” and “correspondents” (among others), as well as the more simple “participant.” Each of these options has nuances and connotations making it more or less appropriate in a given context. You will need to consider your personal opinion on this issue and the most appropriate term for your research design. Nevertheless, “subject” is the only term defined int he US Federal Code (45 CFR 46.102(e)(1), necessitating its use in technical discussions of research ethics regulations. This lesson therefore uses “subject” when referring to regulatory definitions and “participant” in general discussions.
Beneficence
Beneficence, or the moral obligation to act in a manner to do good, asserts that research should first seek to do no harm and second should maximize possible benefits while minimizing possible risks. The principle of beneficence obligates researchers to state the reason that the research is being conducted and what they hope to learn and to weigh the potential benefits against potential risks to research participants. Beneficence does not require research to involve no risk or potential for harm (indeed, much medical research could not take place if it did), nor do participants have to benefit directly. Making a contribution to general knowledge about a subject is usually a sufficient benefit for relatively low-risk studies. Meeting the beneficence principle is often a matter of degree and interpretation; higher risk studies require greater potential benefits, and not every researcher or potential participant will necessarily agree on the evaluation. As discussed above, this is why clear disclosure of study procedures is needed so that participants can make an informed decision.
Justice
The principle of justice states that both the benefits and the burdens of research should be distributed equitably. Equitable distribution does not mean equal distribution, but rather distribution in a fair manner. Historically, racialized, and especially Black, populations have disproportionately borne the risks and harms of research with human subjects in the United States. For this reason, researchers should take care to ensure their research designs do not place undue burden on particular populations or groups, especially those that may be disadvantaged. Researchers should pay specific attention to potential issues of structural inequality and racism that can sometimes make these burdens difficult to immediately identify. The principle of justice requires researchers to actively describe how risks from research participation will be equitably distributed and how research participants will be equitably identified, selected, and recruited. These issues will be discussed in additional detail later in this lesson.
Exercise
Complete the following exercise in your LPOL Workbook. This exercise will help you check for learning, engage with the material, and work through new ideas.
The 3.3.1: Risk/Benefit Assessment worksheets in your LPOL Workbook can help guide you through the risk/benefit calculation for different types of data you might collect in a research study. You may choose to fill this out now if you are far enough in your project design, save it for later, or skip if your particular research does not involve human-based subjects at all.
Topic 1 References
Code of Federal Regulations. Protection of Human Subjects. 45 CFR 46. 2023. https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Washington, D.C.: U.S. Government Printing Office., 1978.
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Report and Recommendations: Institutional Review Boards. U.S. Washington, D.C.: Government Printing, 1978.
Shuster, Evelyne. “Fifty Years Later: The Significance of the Nuremberg Code.” New England Journal of Medicine 337, 20 (1997): 1436–40. doi.org/10.1056/NEJM199711133372006.
Simpson, Bob. “Ethical Moments: Future Directions for Ethical Review and Ethnography Originating from the anthropology discipline, these qualitative research methods aim to understand thoughts, experiences, and actions of a culture through observation and interpretation..” Journal of the Royal Anthropological Institute 17, 2 (2011): 377–93. doi.org/10.1111/j.1467-9655.2011.01685.x.
Principles of Ethical Research
Establishing Ethical Guidelines
The harmonization of ethics guidelines for research with human subjects in the United States began in the mid-1970s with the passage of the National Research Act of 1974. This act created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research — the first national body charged with addressing bioethics policies. Support for the National Research Act was partly in reaction to the abuses of the Tuskegee syphilis study, which gained media attention in 1972 and revealed that a United States Public Health Service study failed to offer known effective treatments to Black men with syphilis in order to continue observing the untreated effects of the disease.
The Commission issued recommendations for the creation of Institutional Review Boards (IRBs) (1978) and the Belmont Report (1978), which established a set of guidelines for human subjects research. The Belmont Report focused on first principles of research ethics and drew on two other foundational documents: the Nuremberg Code, a set of standards created in 1947 during the Nuremberg war crimes trials as a means for prosecuting Nazi doctors who had conducted experiments in concentration camps during World War II (see Shuster 1997), and the Declaration of Helsinki, written in 1964 by the World Medical Association to create ethical principles for medical experiments involving human subjects.
The Belmont Report identified three fundamental ethical principles for evaluating research: respect for persons, beneficence, and justice. These principles have guided the development, standardization, and revision of research ethics practices and oversight and have been codified in the US Code of Federal Regulations (45 CFR 46 Protection of Human Subjects 2023, often called the “Common Rule” because these regulations have been adopted across Federal departments and agencies).
While research ethics is a large, complex, and nuanced field, and these are not the only principles that a researcher may need to consider (we will discuss some additional issues later in this lesson), asking whether a research design exhibits these three principles is a good starting point for evaluating its ethical efficacy.
Respect for Persons
Respect for persons asserts that individuals have autonomy, or the capability of self-determination and decision-making, and should be treated in a way that upholds this autonomy. By extension, this principle establishes requirements for disclosure about research procedures, the data being collected, the potential risks and benefits, informed consent, voluntary participation that is free from coercion, the right to withdraw from participation, and the need to establish additional protections for any person who may have diminished autonomy. Each of these requirements must be met by a proposed research design, and more importantly, practiced by researchers in their interactions with research participants and their data throughout all phases of a research study.
A note on “subjects”
Many researchers question the use of the label “subjects” to refer to people enrolled in a research study. The term subject is rooted in the biomedical traditions of research with human participants and tends to convey the sense of a patient under the care of an expert. Simpson (2011) has described this tradition as an “ethics of the body (with a person attached)” as compared to an “ethics of the person (with body attached)” the considers a broader engagement with people as social beings. Especially in more qualitatively oriented social sciences, such as anthropology and sociology, some researchers argue that the term subject undermines the autonomy of research participants, unnecessarily objectifies them, and concedes too much authority and power to the researcher. Many alternatives attempting to more readily convey the co-production of knowledge have been suggested, including “interlocutors,” “consultants,” “respondents,” and “correspondents” (among others), as well as the more simple “participant.” Each of these options has nuances and connotations making it more or less appropriate in a given context. You will need to consider your personal opinion on this issue and the most appropriate term for your research design. Nevertheless, “subject” is the only term defined int he US Federal Code (45 CFR 46.102(e)(1), necessitating its use in technical discussions of research ethics regulations. This lesson therefore uses “subject” when referring to regulatory definitions and “participant” in general discussions.
Beneficence
Beneficence, or the moral obligation to act in a manner to do good, asserts that research should first seek to do no harm and second should maximize possible benefits while minimizing possible risks. The principle of beneficence obligates researchers to state the reason that the research is being conducted and what they hope to learn and to weigh the potential benefits against potential risks to research participants. Beneficence does not require research to involve no risk or potential for harm (indeed, much medical research could not take place if it did), nor do participants have to benefit directly. Making a contribution to general knowledge about a subject is usually a sufficient benefit for relatively low-risk studies. Meeting the beneficence principle is often a matter of degree and interpretation; higher risk studies require greater potential benefits, and not every researcher or potential participant will necessarily agree on the evaluation. As discussed above, this is why clear disclosure of study procedures is needed so that participants can make an informed decision.
Justice
The principle of justice states that both the benefits and the burdens of research should be distributed equitably. Equitable distribution does not mean equal distribution, but rather distribution in a fair manner. Historically, racialized, and especially Black, populations have disproportionately borne the risks and harms of research with human subjects in the United States. For this reason, researchers should take care to ensure their research designs do not place undue burden on particular populations or groups, especially those that may be disadvantaged. Researchers should pay specific attention to potential issues of structural inequality and racism that can sometimes make these burdens difficult to immediately identify. The principle of justice requires researchers to actively describe how risks from research participation will be equitably distributed and how research participants will be equitably identified, selected, and recruited. These issues will be discussed in additional detail later in this lesson.
Exercise
Complete the following exercise in your LPOL Workbook. This exercise will help you check for learning, engage with the material, and work through new ideas.
The 3.3.1: Risk/Benefit Assessment worksheets in your LPOL Workbook can help guide you through the risk/benefit calculation for different types of data you might collect in a research study. You may choose to fill this out now if you are far enough in your project design, save it for later, or skip if your particular research does not involve human-based subjects at all.
Topic 1 References
Code of Federal Regulations. Protection of Human Subjects. 45 CFR 46. 2023. https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Principles and Guidelines for the Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Washington, D.C.: U.S. Government Printing Office., 1978.
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Report and Recommendations: Institutional Review Boards. U.S. Washington, D.C.: Government Printing, 1978.
Shuster, Evelyne. “Fifty Years Later: The Significance of the Nuremberg Code.” New England Journal of Medicine 337, 20 (1997): 1436–40. doi.org/10.1056/NEJM199711133372006.
Simpson, Bob. “Ethical Moments: Future Directions for Ethical Review and EthnographyEthnography Originating from the anthropology discipline, these qualitative research methods aim to understand thoughts, experiences, and actions of a culture through observation and interpretation..” Journal of the Royal Anthropological Institute 17, 2 (2011): 377–93. doi.org/10.1111/j.1467-9655.2011.01685.x.