BIO 550 Describe a historical event that has shaped current guidelines and regulations for the ethical conduct of epidemiologic research with human subjects

DQ1 Describe a historical event that has shaped current guidelines and regulations for the ethical conduct of epidemiologic research with human subjects.

DQ2 Describe the key principles, guidelines, and regulations governing research with human subjects and relate them to the Tuskegee experiment and the Guatemalan syphilis study.

he National Research Act of 1974¹ created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.² The act charged the commission with identifying the “basic ethical principles which should underlie the conduct of biomedical and behavioral research involving human subjects” and with developing associated guidelines for the ethical conduct of research.³ The resulting Belmont Report, issued in 1978, drew a sharp distinction between research, defined as “an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge,” and practice, or “interventions…designed solely to enhance the wellbeing of an individual patient or client.”⁴ In addition, and most important, the report articulated three basic principles that provide the ethical foundation for the conduct of research involving human subjects.

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Respect for persons involves two ethical considerations: (1) individuals are and should be treated as autonomous agents and (2) BIO 550 Describe a historical event that has shaped current guidelines and regulations for the ethical conduct of epidemiologic research with human subjects individuals with diminished autonomy, due to youth, illness, mental disability, or restricted liberty (e.g., prisoners) should receive additional protections. The principle of respect for persons means recognizing the authority of an individual’s preferences and choices about his or her life. In the context of research, the principle of respect for persons is expressed primarily in the use of informed consent, which requires that, as a general rule, individuals be afforded the opportunity to choose whether or not to be involved in research. It is incumbent upon investigators to disclose information about a study in language that is comprehensible to potential subjects so that they can provide meaningful and voluntary informed consent. These disclosures typically include the purpose of the research, the research procedures, risks, anticipated benefits (if any) to the subject, the opportunity to ask questions and receive satisfactory responses, and a statement that participation is voluntary and that the subject has the right to withdraw from the study at any time, for any reason.

Beneficence involves two considerations: (1) the maximization of possible benefits for society and subjects; and (2) the minimization of possible harm to subjects. The principle of beneficence presents obligations that are woven throughout the research enterprise. Investigators, institutions, and sponsors must always endeavor to design and conduct research studies so that these obligations are met. Defining the optimum balance between the obligation to maximize benefit and minimize harm is often challenging. Notably, although the principle of beneficence refers to maximizing benefits for society, the Belmont Report does not expand upon this requirement.

Justice is articulated in the Belmont Report as “fairness in distribution” of research benefits and burdens.⁵ Questions of justice and equal treatment in the research context are critical in the selection of subjects. The application of justice means that investigators must not offer potentially beneficial research only to some groups, nor select only some accessible, vulnerable, or disadvantaged groups for research that involves high risk or little prospect of direct benefit.

Grid View

	Excellent	Good	Fair	Poor
Main Posting	45 (45%) – 50 (50%) Answers all parts of the discussion question(s) expectations with reflective critical analysis and synthesis of knowledge gained from the course readings for the module and current credible sources. Supported by at least three current, credible sources. Written clearly and concisely with no grammatical or spelling errors and fully adheres to current APA manual writing rules and style.	40 (40%) – 44 (44%) Responds to the discussion question(s) and is reflective with critical analysis and synthesis of knowledge gained from the course readings for the module. At least 75% of post has exceptional depth and breadth. Supported by at least three credible sources. Written clearly and concisely with one or no grammatical or spelling errors and fully adheres to current APA manual writing rules and style.	35 (35%) – 39 (39%) Responds to some of the discussion question(s). One or two criteria are not addressed or are superficially addressed. Is somewhat lacking reflection and critical analysis and synthesis. Somewhat represents knowledge gained from the course readings for the module. Post is cited with two credible sources. Written somewhat concisely; may contain more than two spelling or grammatical errors. Contains some APA formatting errors.	0 (0%) – 34 (34%) Does not respond to the discussion question(s) adequately. Lacks depth or superficially addresses criteria. Lacks reflection and critical analysis and synthesis. Does not represent knowledge gained from the course readings for the module. Contains only one or no credible sources. Not written clearly or concisely. Contains more than two spelling or grammatical errors. Does not adhere to current APA manual writing rules and style.
Main Post: Timeliness	10 (10%) – 10 (10%) Posts main post by day 3.	0 (0%) – 0 (0%)	0 (0%) – 0 (0%)	0 (0%) – 0 (0%) Does not post by day 3.
First Response	17 (17%) – 18 (18%) Response exhibits synthesis, critical thinking, and application to practice settings. Responds fully to questions posed by faculty. Provides clear, concise opinions and ideas that are supported by at least two scholarly sources. Demonstrates synthesis and understanding of learning objectives. Communication is professional and respectful to colleagues. Responses to faculty questions are fully answered, if posed. Response is effectively written in standard, edited English.	15 (15%) – 16 (16%) Response exhibits critical thinking and application to practice settings. Communication is professional and respectful to colleagues. Responses to faculty questions are answered, if posed. Provides clear, concise opinions and ideas that are supported by two or more credible sources. Response is effectively written in standard, edited English.	13 (13%) – 14 (14%) Response is on topic and may have some depth. Responses posted in the discussion may lack effective professional communication. Responses to faculty questions are somewhat answered, if posed. Response may lack clear, concise opinions and ideas, and a few or no credible sources are cited.	0 (0%) – 12 (12%) Response may not be on topic and lacks depth. Responses posted in the discussion lack effective professional communication. Responses to faculty questions are missing. No credible sources are cited.
Second Response	16 (16%) – 17 (17%) Response exhibits synthesis, critical thinking, and application to practice settings. Responds fully to questions posed by faculty. Provides clear, concise opinions and ideas that are supported by at least two scholarly sources. Demonstrates synthesis and understanding of learning objectives. Communication is professional and respectful to colleagues. Responses to faculty questions are fully answered, if posed. Response is effectively written in standard, edited English.	14 (14%) – 15 (15%) Response exhibits critical thinking and application to practice settings. Communication is professional and respectful to colleagues. Responses to faculty questions are answered, if posed. Provides clear, concise opinions and ideas that are supported by two or more credible sources. Response is effectively written in standard, edited English.	12 (12%) – 13 (13%) Response is on topic and may have some depth. Responses posted in the discussion may lack effective professional communication. Responses to faculty questions are somewhat answered, if posed. Response may lack clear, concise opinions and ideas, and a few or no credible sources are cited.	0 (0%) – 11 (11%) Response may not be on topic and lacks depth. Responses posted in the discussion lack effective professional communication. Responses to faculty questions are missing. No credible sources are cited.
Participation	5 (5%) – 5 (5%) Meets requirements for participation by posting on three different days.	0 (0%) – 0 (0%)	0 (0%) – 0 (0%)	0 (0%) – 0 (0%) Does not meet requirements for participation by posting on 3 different days.
Total Points: 100