Introduction

From 1932 to 1972 the U.S. Public Health Service conducted a now infamous study called the Tuskegee experiment.[1] This experiment was designed to observe how untreated syphilis progressed in Black men.[2] During the recruitment process researchers did not receive informed consent from the participants; recruiters capitalized on local jargon, telling potential participants that they would be treated for “bad blood”, a term that was colloquially used to refer to illnesses such as anemia and, yes, syphilis.[3] Furthermore, most (if not all) participants in the Tuskegee study were uneducated Black men living in poverty[4] and researchers actively withheld treatment from participants once penicillin became widely available in the middle of the 20^th century.[5][6] Despite these men being told that they would receive “treatment”, researchers only administered iron tonic and aspirin to study participants.[7]

The U.S. Public Health Service lured these men into participation by promising free meals, medical exams, and burial insurance.[8] However, the Tuskegee experiment was ultimately determined to be unethical, given the detrimental health impacts on both the participants and their families:[9] 128 study participants died either directly from syphilis or related health complications, 40 of participants’ wives were infected with syphilis, and 19 of participants’ children had congenital syphilis.[10] The publicization of this horrendous experiment prompted both the passage of the National Research Law and the inception of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research[11] to promote ethical research practices.

How to Consider Ethics in Quantitative Design

According to established and trusted online research service Prolific, research ethics for quantitative research consist of voluntary participation, informed consent, anonymity, confidentiality, potential for harm and fair payment.[12]

Voluntary Participation

Participation is only voluntary if potential research recruits feel as comfortable saying “no” as they do “yes.” Furthermore, participants should be aware that they can opt out of the study at any time even if they initially consented to being involved with the study.[13]

Informed Consent

Besides being integral to ethical research, informed consent is also a legal requirement for research involving human participants.[14] Informed consent means that recruits must know what they are consenting to; this includes both potential benefits and potential risks.[15] Ideally, researchers use a consent form as part of the recruitment process.[16] This form should include: a brief study and research explanation, anticipated of risks and benefits of study participation, how long the study will last, how to contact the research team, and a clear explanation that participants can withdraw consent at any point in the study without repercussion.[17] The Tuskegee study is a prime example of failure to obtain informed consent from participants, given that the participating men were explicitly misled so that they would agree to participate in the study.[18]

Anonymity and Confidentiality

Anonymity refers to participants’ right to not be connected to the study. That is, participant information including name, address, email address, photos, and video footage should not be attached to their study participation.[19] One possible way to anonymize data collected as part of the study is through the creation of a numeric digital ID for participants that is not connected to their real identity.[20] Similar to anonymity in nature, confidentiality refers to keeping participant information private and out of the reach of unauthorized parties.[21] Confidentiality may be achieved through means such as securely storing data, deidentifying sensitive information and not keeping participant information any longer than needed.[22]

Potential For Harm

Potential participants must also be made aware of any potential harm (e.g., psychological harm, social harm, physical harm, and/or legal harm) that may come from study participation.[23] As mentioned earlier, one of the main reasons for protective measures such as the National Research Act and the Belmont Report is the blatant harm that researchers perpetrated against study participants;[24] some of the most noteworthy examples are the aforementioned Tuskegee study,[25] the Milgram[26] experiment, the Stanford prison experiment,[27] and the numerous torturesome operations James Marison Sims performed without anesthesia on nonconsenting enslaved Black women.[28] [29]

Fair Payment

 Participants must also be fairly compensated for their time and involvement with the study. To determine what fair payment is, researchers must consider their institution’s participant reimbursement policy, the nature of the participants’ role in the study, and the population you are seeking to recruit.[30] For example, participants would likely receive a smaller incentive for taking a short survey than they would for participation in an extensive study and researchers who are seeking out a specific type of participant may need to offer a higher incentive to recruit their desired demographic.[31]

Best Practices for Ethical Research

The Belmont Report

Research has best practices for conducting quantitative research in an ethical manner. Perhaps the ultimate summary of best research practices is found in the Belmont report,[32] the lengthy 1979 statement that resulted from the Tuskegee experiment[33] and was produced by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.[34] This report provides guidelines for scholars to maximize ethical practices when conducting research with human participants. These guidelines are known within the Belmont report as “basic ethical principles” and consist of respect for persons, beneficence, and justice.

Respect For Persons

Respect for persons refers to the ethical principles that 1) potential research participants must be treated as human beings (i.e., with respect) and 2) vulnerable persons must be protected. The concept of “respect for persons” encompasses both respect for one’s autonomy and acknowledgement that some individuals have compromised autonomy and are entitled to extra protection from exploitation. In other words, both the ability to choose and the inability to choose must be honored and upheld.

Beneficence

Scholars also have a responsibility to maximize participant benefits from the research which they are conducting. Researchers must respect participant choices, protect them from any potential harm resulting from participation in the study, and ensuring their wellbeing.[35] In summary, beneficence consists of two complementary rules: 1) do no harm and 2) maximize potential benefits and minimize any potential harm to participants.[36]

Justice

According to the Belmont report, justice in a research ethics context refers to “fairness in distribution” or “what is deserved.”[37] Conversely, an injustice occurs when either a) a person is denied a benefit for no good reason or b) a person is unduly burdened or punished[38] (or both). Vulnerable populations (e.g., racialized minority groups, the incarcerated, people on welfare, disabled people, pregnant people, etc.), in particular, must be protected from injustices perpetrated by unethical research;[39] this includes the Black men coerced into participating in the Tuskegee study.

Institutional Review Boards (IRBs)

Perhaps the most widely known and most effective method of enforcing the principles of the Belmont Report is through Institutional Review Boards or IRBs. IRBs are guided by FDA regulations and both review and monitor human research.[40] The FDA tasks IRBs to protect human research participants from any potential harm;[41] IRBs generally carry out this charge through approving, denying, or requiring modifications to research proposals in order to maximize human safety.[42] Many IRBs are functions of universities, particularly research universities with a high volume of scholarship amongst faculty.[43]

Conclusion

The legacy of the Tuskegee experiment underscores the profound importance of ethical considerations in quantitative research involving human subjects. The Tuskegee study’s egregious violations of informed consent, lack of voluntary participation, and the deliberate infliction of harm highlight the necessity for rigorous ethical standards. These ethical lapses not only resulted in significant harm to the participants and their families but also led to broader mistrust in medical and scientific research within affected communities. While this experiment was not quantitative in nature, there are still clear implications for quantitative research: adherence to ethical principles such as voluntary participation, informed consent, anonymity, confidentiality, and fair compensation is paramount. These principles, enshrined in guidelines such as the Belmont Report and enforced by Institutional Review Boards (IRBs), are essential for protecting participants and maintaining the integrity of research.

Quantitative researchers must ensure that all participants are fully informed about the nature of the study, the potential risks and benefits, and their right to withdraw at any time. Additionally, researchers have a duty to protect vulnerable populations from exploitation and to ensure that the benefits and burdens of research are equitably distributed. By upholding these ethical standards, researchers can conduct studies that not only advance scientific knowledge but also respect and protect the rights and dignity of all participants. The lessons from the Tuskegee experiment serve as a stark reminder of the consequences of ethical neglect and the ongoing need for vigilance in the pursuit of ethical research practices.

Take Away

The Tuskegee experiment underscores the importance of ethical standards in quantitative research, including informed consent, voluntary participation, and protection from harm. As the article notes, ‘Participation is only voluntary if potential recruits feel as comfortable saying “no” as they do “yes.”‘ Adhering to these principles preserves research integrity and safeguards participants, especially vulnerable populations. Guidelines like the Belmont Report and Institutional Review Boards help prevent exploitation and ensure fair distribution of research benefits and burdens.

[1] Office of Science. Untreated Syphilis Study at Tuskegee: About. Centers for Disease Control and Prevention. https://www.cdc.gov/tuskegee/about.html

[2] Office of Science. Untreated Syphilis Study at Tuskegee: About. Centers for Disease Control and Prevention. https://www.cdc.gov/tuskegee/about.html

[3] Bioethics Center. About the USPHS Syphilis Study. Tuskegee University. https://www.tuskegee.edu/about-us/centers-of-excellence/bioethics-center/about-the-usphs-syphilis-study

[4] Bioethics Center. About the USPHS Syphilis Study. Tuskegee University. https://www.tuskegee.edu/about-us/centers-of-excellence/bioethics-center/about-the-usphs-syphilis-study

[5] Office of Science. Untreated Syphilis Study at Tuskegee: About. Centers for Disease Control and Prevention. https://www.cdc.gov/tuskegee/about.html

[6] Bioethics Center. About the USPHS Syphilis Study. Tuskegee University. https://www.tuskegee.edu/about-us/centers-of-excellence/bioethics-center/about-the-usphs-syphilis-study

[7] Equal Justice Initiative. Tuskegee Syphilis Experiment. https://eji.org/news/history-racial-injustice-tuskegee-syphilis-experiment/

[8] Office of Science. Untreated Syphilis Study at Tuskegee: The Untreated Syphilis Study at Tuskegee Timeline. https://www.cdc.gov/tuskegee/timeline.htm

[9] Bioethics Center. About the USPHS Syphilis Study. Tuskegee University. https://www.tuskegee.edu/about-us/centers-of-excellence/bioethics-center/about-the-usphs-syphilis-study

[10] Equal Justice Initiative. Tuskegee Syphilis Experiment. https://eji.org/news/history-racial-injustice-tuskegee-syphilis-experiment/

[11] Denison, G. Ethical considerations in research: Best practices and examples. Prolific. https://www.prolific.com/resources/ethical-considerations-in-research-best-practices-and-examples

[12] Denison, G. Ethical considerations in research: Best practices and examples. Prolific. https://www.prolific.com/resources/ethical-considerations-in-research-best-practices-and-examples

[13] Billikopf Encina, G. Milgram’s Experiment on Obedience to Authority. University of Berkeley. https://nature.berkeley.edu/ucce50/ag-labor/7article/article35.html

[14] Billikopf Encina, G. Milgram’s Experiment on Obedience to Authority. University of Berkeley. https://nature.berkeley.edu/ucce50/ag-labor/7article/article35.html

[15] Billikopf Encina, G. Milgram’s Experiment on Obedience to Authority. University of Berkeley. https://nature.berkeley.edu/ucce50/ag-labor/7article/article35.html

[16] Billikopf Encina, G. Milgram’s Experiment on Obedience to Authority. University of Berkeley. https://nature.berkeley.edu/ucce50/ag-labor/7article/article35.html

[17] Billikopf Encina, G. Milgram’s Experiment on Obedience to Authority. University of Berkeley. https://nature.berkeley.edu/ucce50/ag-labor/7article/article35.html

[18] Bioethics Center. About the USPHS Syphilis Study. Tuskegee University. https://www.tuskegee.edu/about-us/centers-of-excellence/bioethics-center/about-the-usphs-syphilis-study

[19] Billikopf Encina, G. Milgram’s Experiment on Obedience to Authority. University of Berkeley. https://nature.berkeley.edu/ucce50/ag-labor/7article/article35.html

[20] Billikopf Encina, G. Milgram’s Experiment on Obedience to Authority. University of Berkeley. https://nature.berkeley.edu/ucce50/ag-labor/7article/article35.html

[21] Bioethics Center. About the USPHS Syphilis Study. Tuskegee University. https://www.tuskegee.edu/about-us/centers-of-excellence/bioethics-center/about-the-usphs-syphilis-study

[22] Billikopf Encina, G. Milgram’s Experiment on Obedience to Authority. University of Berkeley. https://nature.berkeley.edu/ucce50/ag-labor/7article/article35.html

[23] Billikopf Encina, G. Milgram’s Experiment on Obedience to Authority. University of Berkeley. https://nature.berkeley.edu/ucce50/ag-labor/7article/article35.html

[24] Denison, G. Ethical considerations in research: Best practices and examples. Prolific. https://www.prolific.com/resources/ethical-considerations-in-research-best-practices-and-examples

[25] Bioethics Center. About the USPHS Syphilis Study. Tuskegee University. https://www.tuskegee.edu/about-us/centers-of-excellence/bioethics-center/about-the-usphs-syphilis-study

[26] Billikopf Encina, G. Milgram’s Experiment on Obedience to Authority. University of Berkeley. https://nature.berkeley.edu/ucce50/ag-labor/7article/article35.htm

[27] Stanford Libraries. Stanford Prison Experiment. Stanford University. https://exhibits.stanford.edu/spe

[28] Equal Justice Initiative. Rethinking the Legacy of Marion Sims. https://eji.org/news/rethinking-the-legacy-of-marion-sims/

[29] Cronin, M. Anarcha, Betsey, Lucy, and the women whose names were not recorded: The legacy of J Marion Sims. Anesthesia and Intensive Care. https://journals.sagepub.com/doi/full/10.1177/0310057X20966606

[30] Billikopf Encina, G. Milgram’s Experiment on Obedience to Authority. University of Berkeley. https://nature.berkeley.edu/ucce50/ag-labor/7article/article35.html

[31] Billikopf Encina, G. Milgram’s Experiment on Obedience to Authority. University of Berkeley. https://nature.berkeley.edu/ucce50/ag-labor/7article/article35.html

[32] Office of Science. Untreated Syphilis Study at Tuskegee: The Untreated Syphilis Study at Tuskegee Timeline. https://www.cdc.gov/tuskegee/timeline.htm

[33] Office of Science. Untreated Syphilis Study at Tuskegee: The Untreated Syphilis Study at Tuskegee Timeline. https://www.cdc.gov/tuskegee/timeline.htm

[34] Office for Human Research Protections. Read the Belmont Report. U.S. Department of Health and Human Services. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html

[35] U.S. Food and Drug Administration. Institutional Review Boards (IRBs) and Protection of Human Subjects in Clinical Trials. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/institutional-review-boards-irbs-and-protection-human-subjects-clinical-trials

[36] U.S. Food and Drug Administration. Institutional Review Boards (IRBs) and Protection of Human Subjects in Clinical Trials. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/institutional-review-boards-irbs-and-protection-human-subjects-clinical-trials

[37] Denison, G. Ethical considerations in research: Best practices and examples. Prolific. https://www.prolific.com/resources/ethical-considerations-in-research-best-practices-and-examples

[38] U.S. Food and Drug Administration. Institutional Review Boards (IRBs) and Protection of Human Subjects in Clinical Trials. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/institutional-review-boards-irbs-and-protection-human-subjects-clinical-trials

[39] U.S. Food and Drug Administration. Institutional Review Boards (IRBs) and Protection of Human Subjects in Clinical Trials. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/institutional-review-boards-irbs-and-protection-human-subjects-clinical-trials

[40] U.S. Food and Drug Administration. Institutional Review Boards (IRBs) and Protection of Human Subjects in Clinical Trials. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/institutional-review-boards-irbs-and-protection-human-subjects-clinical-trials

[41] Government Accountability Office. Institutional Review Boards: Actions Needed to Improve Federal Oversight and Examine Effectiveness. https://www.gao.gov/products/gao-23-104721#:~:text=Institutional%20review%20boards%20(IRB)%20are,subjects%2C%20such%20as%20clinical%20trials.&text=Most%20IRBs%20are%20based%20at,Human%20Services%20(HHS)%20data.

[42] Government Accountability Office. Institutional Review Boards: Actions Needed to Improve Federal Oversight and Examine Effectiveness. https://www.gao.gov/products/gao-23-104721#:~:text=Institutional%20review%20boards%20(IRB)%20are,subjects%2C%20such%20as%20clinical%20trials.&text=Most%20IRBs%20are%20based%20at,Human%20Services%20(HHS)%20data.

[43] Government Accountability Office. Institutional Review Boards: Actions Needed to Improve Federal Oversight and Examine Effectiveness. https://www.gao.gov/products/gao-23-104721#:~:text=Institutional%20review%20boards%20(IRB)%20are,subjects%2C%20such%20as%20clinical%20trials.&text=Most%20IRBs%20are%20based%20at,Human%20Services%20(HHS)%20data.