Researchers conduct quantitative research studies to measure relationships between variables, differences between groups, or changes over time. In some cases, the research can lead to cause and effect conclusions. However, cause and effect can only be determined with the most rigorous research designs, such as experimental designs.

QUANTITATIVE RESEARCH

Researchers conduct quantitative research studies to measure relationships between variables, differences between groups, or changes over time. In some cases, the research can lead to cause and effect conclusions. However, cause and effect can only be determined with the most rigorous research designs, such as experimental designs.

The following chart best illustrates the characteristics of quantitative research and some of the potential advantages of this method.

Table 1

Quantitative Research Characteristics

Characteristics

Advantages

Data collected is numeric

Data is collected through structured instruments with clearly defined questions: polls, questionnaires, surveys, or manipulation of pre-existing data

Generalizable across groups to explain a particular phenomenon: results based on a larger sample size representative of the population

Results can be replicated

Study carefully designed before collection

Goal of the study is to create statistical models that explain observations/results

Can be measured or counted

Allows easy collection from a large sample

Can be displayed in graphs, charts, tables, and other formats that allow for better interpretation

Data collection methods can be relatively quick, depending on the type of data being collected

Data analysis is less time-consuming since it can be input into software and analysis can be done using statistical software

Statistical analysis allows for greater objectivity when reviewing results

Results can be generalized if the data is based on random samples and the sample size was sufficient

Major differences can be identified in the characteristics of a population.

Statistical relationships between specific variables and causes can be identified and analyzed.

Results are independent of the researcher.

Numerical quantitative data may be viewed as more credible and reliable, especially to policymakers, decision-makers, and administrators.

Some examples of quantitative research in technology include examining the impact of a process change on workforce productivity (change in mean scores from pre to post process change), comparing the runtime of various algorithms to determine which algorithm is most efficient (comparison of two or more independent means), or measuring the relationship between project staffing allocations and time to complete the project.

Quantitative research can be augmented or complemented with qualitative research. In some cases, qualitative research is conducted to better understand why a particular relationship exists. For example, if we implement a new process within our organization, we want to know that the outcomes we measure are a result of our new process and not something else. Gathering qualitative data can help provide more support for the efficacy of your process change, which is particularly helpful when conducting non-experimental research designs. Gathering qualitative feedback can increase the validity of your non-experimental design by triangulating the qualitative data with the quantitative outcomes of your study to provide support for cause and effect relationships.

Just like with any research, there are ethical standards to uphold when conducting quantitative research. It is imperative that a researcher fully understands and complies with these ethical standards, or their research will become invalid, and the researcher can be discredited by academic peers. Institutional Review Boards (IRB) exist in research institutions to evaluate proposed research based on the extent to which they adhere to ethical principles, guidelines, and requirements. The Belmont Report is a good source to use to determine whether you are upholding all ethical principles regarding research involving human subjects.

Assignment: Examine Technology Research and Theoretical Contributions

Instructions

For this assignment, you will locate three different doctoral dissertations from three different universities that incorporate a quantitative methodology on a technology topic and write a paper examining the quantitative nature of each study

Length: 5-7 pages, not including title and references.

References: Include a minimum of 5 scholarly resources

The completed assignment should address all of the assignment requirements, exhibit evidence of concept knowledge, and demonstrate thoughtful consideration of the content presented in the course. The writing should integrate scholarly resources, reflect academic expectations and current APA standards.

Requirements: Length: 5-7 pages, not including title and references

155 Qualitative and Quantitative Research: Paradigmatic Differences Vishal Arghode, Ph.D. Texas A&M University College Station, Texas Abstract The paper defines qualitative and quantitative research. Subsequently, the two broad research fields are analyzed and compared on the basis of ontological, epistemological, and methodological differences. The underlying assumptions of the quantitative and qualitative research methods are also highlighted in the paper. I have also presented a discussion on how the fundamental beliefs and approaches of qualitative and quantitative methods influence their application. The paper intends to fulfill the need to define the two disciplines by providing a better understanding on the fundamental philosophical building blocks that guide the qualitative and quantitative research. Keywords: Qualitative research, quantitative research, ontology, epistemology, methodology, paradigm, differences Qualitative and Quantitative Research: Paradigmatic Differences Both quantitative and qualitative research approaches hold important positions in the field of research. However, researchers acknowledge the ontological, epistemological, and methodological differences between quantitative and qualitative research paradigms (Onwuegbuzie & Leech, 2005). These differences create a chasm between the quantitative and qualitative researchers’ ideologies (Creswell, 2007). Before considering the paradigmatic differences between quantitative and qualitative research, I am defining paradigm. As mentioned by Lincoln, and Guba (1985), paradigm is “a systematic set of beliefs, together with their accompanying methods” (p. 15). Paradigm is an understanding about the phenomenon or how it works based on the set of assumptions or beliefs. However, paradigm also includes methods governing the system of beliefs or value system (Lincoln & Guba, 1985). Moreover, paradigm is a view or a way of interpreting or explaining the phenomenon based on prior understanding. While quantitative research is rooted in the positivist paradigm, qualitative research is based on phenomenological/interpretivist paradigm (Firestone, 1987). The next section elaborates more on quantitative research which follows a different approach to the research than the qualitative research. The ontology, epistemology, and methodology of the positivist paradigm which is a basis for quantitative research is also enumerated in the following section.

156 Quantitative Research Quantitative researchers seek to “explain the causes of changes in social facts, primarily through objective measurement and quantitative analysis” (Firestone, 1987, p. 16). Quantitative researchers use numbers to study the phenomenon or occurrence. The researchers’ goal is to quantify the participant responses and subsequently interpret them to make decisions. The researchers usually are outsiders and do not influence the outcome of the quantitative research. Quantitative research also focuses on proving or disproving a hypothesis based on a large number of participants’ responses. The idea is also to generalize on larger population by conducting analysis using sophisticated statistical tools. In the next section, I am discussing researchers’ reflections on positivism, which is also the basis for the quantitative research approach. Positivism—A Basis for Quantitative Research Schwandt (2001) while stressing that positivism is based on strict empiricism propounded that experience is the sole basis for generating knowledge. In consonance with Schwandt, Merriam (2002) mentioned knowledge is logically bounded by general laws and is observable. Merriam further highlighted, quantitative research worldview believes on single measurable, observable, and provable truth. Quantitative researchers attempt to uncover this reality. The above explanations emphasize that positivism stresses on the role of general laws and assumptions. Assuming the causal factors for a phenomenon and then searching for the effects of those factors also forms an integral part of the positivist research. Rees (1980) defined positivism as “a family of philosophies characterized by an extremely positive evaluation of science and scientific method” (as cited in Lincoln & Guba, 1985, p. 19). Positivism assumes that if there is a problem, there exists a solution. The interrelationship of cause and effect is the hallmark of the positivist paradigm. The empirical-analytical view as proposed by Coomer (1984) mirrors the positivist paradigm. Coomer stressed that positivism rests on cause-effect or means-end premise and therefore helpful in providing a solution to the technical problems. Ontology According to Schwandt (2001), ontology “is concerned with understanding the kind of things that constitute the world” (p. 190). Ontology of positivist paradigm is rooted deeply into realism, as Gough (2002) confirms, ontology of positivism paradigm is: “Stable external reality; Law-like” (p. 5). The positivist researchers seek the interrelationship between the factors which are part of a constituent of “materialism” and “realism” (Habermas, 1972; Lather, 1991). For example, a research study conducted to explore the causes of work life imbalance in college professors’ lives using survey and statistical techniques may operate on positivist paradigm.

157 The subsequent section highlights the epistemology of the positivist research paradigm. Epistemology The epistemology according to Schwandt (2001) is “the study of the nature of knowledge and justification” (p. 87). Whereas Gough (2002) defines the epistemology of the positivism paradigm as: “objective; detached observer” (p. 5). Lather (1991) and Habermas (1972) defined the epistemology of the positivism paradigm as “Single truth.” Researchers in positivism paradigm seek to establish a relationship (often cause and effect, association, correlation). For example, a research study conducted to find a correlation between student grades and motivation to perform better will seek a single truth thereby falling under positivist paradigm. Methodology Schwandt (2001) described methodology as: “This is the theory of how inquiry should proceed. It involves analysis of the assumptions, principles, and procedures in a particular approach to inquiry” (p. 193). According to Lather (1991) and Habermas (1972) the methodology of the positivism paradigm is scientific method. This may include case study approach, and experimental and control group experiments in which researchers describe the context in detail and remodel questions for field use (Creswell, 2007). In the next section, I am presenting a discussion on qualitative research paradigm. Qualitative Research In qualitative research the researchers explore the meaning as understood by the participants, in a natural setting. The qualitative researchers also seek understanding of the phenomenon or process as shaped by the meanings people bring to them by employing different methods such as interview, case study, observation (Denzin & Lincoln, 2005). Wiersma, and Jurs (2009) clarify in qualitative research, It is the perceptions of those being studied that are important, and, to the extent possible, these perceptions are to be captured in order to obtain an accurate “measure” of reality. “Meaning” is as perceived or experienced by those being studied; it is not imposed by the researcher. (pp. 232-233) The qualitative researchers should not impose their perceptions of the phenomenon to interpret the participants’ views. Rather the participants’ perceptions should be used to gauge the situation and generate knowledge which is the basis for further theoretical explanations. In a qualitative study, the interpretations of the participants are captured based on the participants’ perceptions and understanding of the phenomenon (Swanson, Watkins, & Marsick, 2005). The researcher is more concerned about the perceived meaning rather than the actual meaning. The next section elucidates interpretivism.

158 Interpretivism—A Basis for Qualitative Research According to Schwandt (2001) interpretivism, denotes those approaches to studying social life that accord a central place to Verstehen as a method of the human sciences, that assume that the meaning of human action is inherent in that action, and that the task of the inquirer is to unearth that meaning. (p. 160) The above description suggests that interpretivism seeks meaning by exploring and analyzing. The findings in the interpretivist research gives scope for multitudes of representations and interpretations (Merriam, 2002). The researchers who base their research on interpretivist paradigm seek multitude of explanations and analyze responses in many different ways to uncover the meaning. Ontology According to Schwandt (2001) ontology “is concerned with understanding the kind of things that constitute the world” (p. 190). In addition to Schwandt, who stresses that ontology is seeking meaning by understanding the reality, Gough (2002) defines ontology as: “What is the nature of the ‘knowable’ (or ‘reality’)?” (p. 4). Similarly Gioia and Pitre (1990) stressed that ontology focuses on understanding natural occurences (as cited in Ruona & Lynham, 2004). As the ontology of the interpretivism paradigm is “experienced world” (Habermas, 1972; Lather, 1991), the researchers consider life experiences of the participants as an integral part of their research. Epistemology The epistemology according to Schwandt (2001) is: “the study of the nature of knowledge and justification” (p. 87). In consonance with Schwandt, Gioia and Pitre (1990) describe epistemology as basic understanding about knowledge structure of the phenomenon (as cited in Ruona & Lynham, 2004). To be more specific, the epistemology of the interpretivism paradigm as mentioned is: “Empathetic; Observer intersubjectivity” (Gough, 2002, p. 5). Thus researchers stress on the aspect of epistemology which focuses on the knowledge about the phenomena and the rationale behind the study. According to Lather (1991) and Habermas (1972), the epistemology of the interpretivism paradigm is “multiple truths.” Thus researchers attempt to find more than one explanations for the phenomenon under consideration. Instead of having one answer, the researchers focus on seeking multiple answers.

159 Methodology Schwandt (2001) described methodology as: “theory of how inquiry should proceed. It involves analysis of the assumptions, principles, and procedures in a particular approach to inquiry” (p. 193). In agreement with how Schwandt explained methodology, Gough (2002) defines research methodology as the logic underlying the conduct of research. The methodology according to the authors mentioned above is a way of conducting a research. Methodology also depicts the structure of the research using the principles and fundamental assumptions. According to Lather (1991) and Habermas (1972) the methodology of the interpretivism paradigm is “participant observation.” The research studies in interpretivism paradigm use participant observation. Interviewing the participants to learn about their experiences is thus a commonly used method to understand the phenomenon under consideration. Ontological Differences and Similarities In quantitative research the researcher believes that the reality is objective and controlled by cause and effect relationships. For example a research study about students’ sports participation and student grades, relationship between Graduate Record Exam (GRE) scores and selection of major. The quantitative researchers’ ontological belief springs from establishing a relationship between study variables. Researchers believe that the reality is not time or content specific and thus can be generalized e.g. if a researcher discovers in a study that selection of engineering and science majors correlate positively with higher GRE scores. The researcher may make an assumption that the above statement holds true across population and thus the researcher usually selects random sampling. In qualitative research reality is considered incomprehensible, fluid, and shaped and influenced by social interactions. Qualitative researchers seek meaning from participants’ understanding. Common examples include studying perceptions, opinions, beliefs, values of the participants. Mostly people’s lived experiences are source of data generation in qualitative research. The findings are not generalizable and is considered specifically and uniquely shaped by participants’ experiences. Language used in generation of data also impact data generation. Based on above discussion both quantitative and qualitative researchers seek to understand the reality despite differing on the nature of reality. Thus both the research paradigms acknowledge the existence of reality. Although the approaches followed by the two traditions differ, the research purpose of both qualitative and quantitative research traditions is to uncover the realities that exist. The next section presents epistemological differences and similarities between quantitative and qualitative research paradigm.

160 Epistemological Differences and Similarities The epistemological differences as highlighted in table 1 are presented below. In quantitative research, the researchers believe that there is a single truth or one and only one truth. Thus reality is singular. Knowledge can be generated systematically and explained through structured means. The truth is sought after by the theories. Quantitative researchers seek to control, predict, explain, and describe the scientific phenomenon. Quantitative researchers also believe that knowledge is accurate and the truth can be revealed through experimentation and observations. Quantitative research paradigm generates knowledge by deductive reasoning that is, the research results are generalized and deduced from a large sample. For example, a quantitative research study focusing on the factors impacting job satisfaction of female teachers in a small town school may generate results which will be regarded as the factors responsible for job satisfaction of the teachers. In qualitative research, the researchers believe in the existence of multiple truths. Participants’ understanding, values, beliefs, reasons, and subjective beliefs all contribute towards knowledge generation. The process of knowledge construction is the focus and not just what knowledge is generated or whether the knowledge is constructed or not. Qualitative research paradigm believes in inductive reasoning and seeks to understand multiple realities. Mental, social, and cultural phenomena are examined by qualitative researchers to construct meaning for example, studying the perceptions of small town school teachers to understand the factors impacting the teachers’ job satisfaction. Unlike a quantitative research study, the above study will yield multiple findings and varying results based on individual teacher’s perceptions and understanding. Therefore knowledge generation is open-ended and the researchers do not provide a framework for knowledge construction. Qualitative researchers also follow inductive reasoning as they deal with small participant sample. From the above discussion, it is clear that epistemological differences between quantitative and qualitative research are wide and varied. Nevertheless, both research paradigms accept that reality needs to be unearthed, interpreted, and understood by the researchers. Both quantitative and qualitative researchers believe that knowledge can be generated or constructed and a researcher’s role is to find either the single truth or multiple truths. Both research paradigms believe identically in trueness of the findings. The next section describes the methodological similarities and differences between quantitative and qualitative research paradigms. Methodological Differences and Similarities The methodological differences between quantitative and qualitative research paradigms are described in this segment. In quantitative research, the researchers utilize scientific methods,

161 conduct experiments, and control phenomenon under investigation by altering the variables to achieve objective results. However, the quantitative researchers do not influence the research outcomes. For example study about a newfound brain function improving drug dosages and student grades. The dependent variable i.e. student grades will be controlled by independent variable—drug dosage. Thus researchers can control the variables but do not subjectively impact the outcomes merely by their presence during data collection. Conversely, in quantitative research, the researchers utilize participant observation to create meaning along with the study participants. The investigator also influences the study outcomes by bringing in own subjective experiences. For example, depending on the type of relationship of the researcher in the study, about understanding the perceptions of job satisfaction among small town school teachers, the findings may vary. To elaborate participant responses will be different in each of the following cases: whether the researcher is a school principal, student, fellow teacher, administrator or independent outside researcher. The researchers in qualitative research also seek to comprehend the whole phenomenon under investigation by understanding the sub parts that is in case of the research study described above studying individual teachers’ perceptions. The above discussion highlights noteworthy methodological differences between quantitative and qualitative research paradigms. Nevertheless, the commonality in the methodology between the two research paradigms is that both quantitative and qualitative research paradigms utilize observation to collect data. Both research paradigms focus on creating meaning, quantitative research follows a detached observer stance, whereas qualitative research co-create the meaning by involving the participants. Table 1 summarizes the above discussion about the ontological, epistemological, and methodological similarities and differences between quantitative and qualitative research paradigms. Table 1 Ontological, Epistemological, and Methodological differences and similarities between qualitative and quantitative research paradigms (Attached Separately) Conclusions This paper presents ontological, epistemological, and methodological differences between quantitative and qualitative research paradigms. From the analysis presented in this paper, it is evident that the differences between the two paradigms are significant and guide the approaches of quantitative and qualitative research. Quantitative paradigm utilizes positivist paradigm to support objective nature of reality. Positivists believe that reality can be deciphered through observation. Positivists also believe in predicting the research outcomes by controlling

162 the research variables. Quantitative research utilizes scientific methods including experiments and do not directly influence the research outcomes by their presence. Qualitative research follows a somewhat different approach in investigating the research problem and believes that reality cannot be comprehended as it is constantly shaped through social interactions. The interpretivist paradigm, which is the basis for qualitative research, believes in multiple truths and seeks to explain the construction of knowledge and not just whether the knowledge is constructed or not. Participant observation is one of the main methods utilized in interpretivist paradigm. In qualitative research, the researchers cannot detach themselves form the researched phenomenon as they bring in their subjective experiences. References Coomer, D. (1984). Critical science: Approach to vocational education research. Journal of Vocational Education Research, 9(4), 34-50. Creswell, J. W. (2007). Qualitative inquiry & research design: Choosing among five approaches (2nd ed.). Thousand Oaks, CA: Sage Publications. Denzin, N. K., & Lincoln, Y. S. (2005). Introduction: The discipline and practice of qualitative research. In N. K. Denzin, & Y. S. Lincoln (Eds.), The sage handbook of qualitative research (3rd ed., pp. 1-32) SAGE Publications. Firestone, W. A. (1987). Meaning in method: The rhetoric of quantitative and qualitative research. Educational Researcher, 16(7), 16-21. Gough, N. (2002). Blank spots, blind spots, and methodological questions in postgraduate research. Paper presented at the Postgraduate Research Conference, Deakin University. Guba, E. G. & Lincoln, Y. S. (2005). Paradigmatic controversies, contradictions, and emerging confluences. In N. K. Denzin, & Y. S. Lincoln (Eds.), The sage handbook of qualitative research (3rd ed., pp. 191-215). Thousand Oaks, CA: Sage Publications. Habermas, J. (1972). Knowledge and human interest. London: Heinemann. Lather, P. (1991). Feminist research in education: Within/against. Geelong: Deakin University Press. Lincoln, Y. S., & Guba, E. G. (1985). Naturalistic inquiry. London: Sage Publications. Merriam, S. B. (2002). Qualitative research in practice: Examples for discussion and analysis. San Francisco: Jossey-Bass. Onwuegbuzie, A. J., & Leech, N. L. (2005). Taking the “Q” out of research: Teaching research methodology courses without the divide between quantitative and qualitative paradigms. Quality and Quantity, 39(3), 267-295. doi:10.1007/s11135-004-1670-0 Ruona, W. E. A., & Lynham, S. A. (2004). A philosophical framework for thought and practice in human resource development. Human Resource Development International, 7(2), 151-164.

163 Schwandt, T. A. (2001). Dictionary of qualitative inquiry. Thousand Oaks, CA: Sage publications. Swanson, B. L., Watkins, K. E., & Marsick, V. J. (2005). Qualitative research methods. In Doing action research in your own organization (2nd ed., pp. 88-113). London: Sage Publications. Wiersma, W., & Jurs, S. G. (2009). Research methods in education (9th ed.). Boston: Pearson Education.

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Journal of Management ResearchVol. 15, No. 1, Jan–March 2015, pp. 23–33Toward A Conceptual Model of Ethics inResearchGail D. CaruthAbstractHistory provides opportunities to look back and evaluate events. Looking back to historical eventssurrounding research provides the possibility for learning from decisions made and actions takenpreviously. It is apparent that both good and bad actions were taken during the early years of research.The purpose of this paper was to take a contemporary and historical look into the evolution of ethics inresearch. This investigation is valuable to higher education because by exploring the events preparationscan be made to recognize potential wrongs, avoid or reduce potential wrongs, and determine who isresponsible for ethical research. A conceptual model of ethical research is presented. Ethics in researchis a shared responsibility. It is dependent on history, the researcher, the reviewers, and the researchcommunity. History guides the researcher, the review process, and the research communities.Keywords: Research Ethics, Research Standards, Research Guidelines, Ethical Review of Research,History of Ethics in ResearchResearch, the quest for knowledge, dates back to thebeginning of humanity. Higher education continuedthis quest to search for, comprehend, and utilizenew knowledge through the establishment andevolution of universities in the Old World as wellas the New. The classical trivium and quadrivium, forexample, played an important part in the desire tostudy the existence of earth. Tied to this processof discovering new knowledge was the acceptedtrust that science was naturally good because it wasfounded on truth by presenting information as it is,care by improving society, innovation by discoveringfresh potentials and bright promises, anddevelopment by enhancing civilization. These basicbeliefs led to confidence in the research communityand that it too was a community based on truth.However, misconduct in university research resultedin mistrust of the research communities and a focuson ethics in research, claimed Lategan (2012).The underpinnings of ethics can be observed as farback as the ancient Greek philosophical study ofmorality and refers to a system of principles thatcan significantly alter prior opinions regardingdecisions and behaviors. Ethics has been referred toas that branch of philosophy pertaining to howchoices are made between what is right and what iswrong. Research is regulated by individual,community, and social principles. Research ethicsrelates to behaviors, processes, protection of humansubjects, and the publication of results (Foukaand Mantzorou, 2011).Henderson, Juengst, King, Kuczynski and Michie(2012) suggested that most of the contemporaryissues surrounding research ethics includes theparticipants’ privacy and confidentiality; authorship;power and distribution of research data; gains onresults and incidental findings; significance of groupinterests and harm; extent of informed consent;and overstatements of medicinal benefits. Theseissues have become major policy challenges.Research that studies ethics, furthermore, hasproliferated in the literature. Consequently,university faculty and students are often uncertainGail D. Caruth1876 Oak Bend DriveRockwall, Texas 75087

24Journal of Management Researchabout exactly what is ethical research practiceclaimed Alfredo and Hart (2011). Ethics specialistsfrequently debate the fine points of misconduct asit relates to research practice and questions of ethicsas opposed to careless or unskilled errors on thepart of researchers. Additionally, technologicaladvances have changed the world of publishingwhich has resulted in more questions.Research standards aimed at the protection ofhuman subjects have progressed from a myriad ofhistorical experiences. Researchers, therefore, mustbe knowledgeable about federal regulations, ethicalstandards, state laws, internal review board policies,institutional policies, professional best practices, andhistory. Researchers often refer to these resourcesin addition to striving to be proficient andthoughtful while conducting research. Inasmuch asresearch has the potential to add to the body ofknowledge, ethical considerations will continue tobe taxing for research communities. Meticulousoversight by institutional review boards or ethicsreview committees is just one level in the overallprocess of research in institutions. Proceduresgoverning the institutional review process willcontinue to evolve claimed Hart and Belotto (2010).This evolution will require additional effort on thepart of research communities to protect theresearchers, participants, the research itself, theresearch institutions, and the public.History provides the opportunity to look back andevaluate events. Looking back to historical eventssurrounding research provides the possibility forlearning from decisions made and actions takenpreviously. It is apparent that both good and badactions were taken during the early years ofresearch. The purpose of this paper was to take acontemporary and historical look into the evolutionof ethics in research. This historical investigation isvaluable to higher education because “it isimportant to listen to the narratives of the past andpresent” (Aultman, 2013). By listening to thesenarratives and understanding vulnerabilities and“the ways that people have become vulnerable inthe past, we are better equipped to recognizepossible wrongs, prevent or minimize those wrongs,and identify those who have a duty to protectvulnerable persons.” This paper asked the followingexploratory questions: What happened during theevolution of ethics in research? What does theliterature tell us that we need to do in the future?How can a research community be trustworthywhen conducting research? Most importantly, howdo ethical frameworks contribute to trustworthinessof a research community?HISTORICAL CONSIDERATIONSEthical standards in research are designed to assistresearchers with an awareness of potential conflictsinvolving moral principles. Ethics also provide rulesof conduct for handling situations involvingquestions of moral obligations and duties (Avasthi,Ghosh, Sarkar and Grover, 2013). Researchersoften consult these ethical standards for guidancewith resolving questions of ethics in research (Hartand Belotto, 2010).During the late 1800s research experiments onhumans grew in the United States along withadvances in science and medicine. For example,from the year 1873 to 1909 the number of hospitalbeds increased from 50,000 to 421,065 and thenumber of hospitals increased from 178 to 4,359.In 1893 Johns Hopkins University School ofMedicine opened and in 1910 the RockefellerInstitute Hospital opened to conduct clinicalresearch. In 1896 the Journal of Experimental Medicineand the Journal of Medical Research were established,followed by the American Journal of Physiology in1898 (Horner and Minifie, 2011).Researchers used animals, hospitalized patients,children in orphanages, indigents, terminally illpatients, and soldiers without their knowledge orconsent. These studies were conducted toinvestigate the transmission of cancer, gonorrhea,and other diseases; the surgical effects on stomachand brain functions; usefulness of serial X-rays; andthe effects of new drugs and vaccines. Thesestudies resulted in media attention and debateduring the late 1800s and early 1900s (Horner andMinifie, 2011).

Volume 15, Number 1•January–March 201525In 1939, Mary Tudor, a graduate student at theUniversity of Iowa and her advisor, WendellJohnson, conducted a study on the effects ofadverse responses from individuals on stuttering innormally developing children. The 22 studyparticipants were orphans between the ages of 5-16 from the Soldiers and Sailor’s Orphanage inDavenport, Iowa. Results from the study revealedthat several surviving participants had sufferedpsychological damage and hesitant speech patterns.Neither the children nor the orphanage staff wereinformed of the study intent. Tudor in her thesis,had noted hesitant speech and embarrassedreactions by the children. Furthermore, students atIowa University referred to Tudor’s thesis as “TheMonster Study” (Horner and Minifie, 2011).Horner and Minifie (2011) claimed that this studyremains controversial today and is a good case studyfor university faculty and students to analyze.Additional examples of experiments on humansinclude a study on dysentery in 1943 wherephysicians injected children at the Ohio Soldiers andSailor’s Orphanage with bacteria. Physicians laterinjected children at Willowbrook State School formentally retarded children with hepatitis betweenthe 1950s and the 1970s. Then in 1963, doctorsinjected live cancer cells into debilitated patients atthe Jewish Chronic Disease Hospital (Horner andMinifie, 2011).The first international standards were published in1947 in the Nuremberg Code. At the conclusion ofWorld War II, German military leaders were triedbefore an international military court at theNuremberg Palace of Justice, in Nuremberg,Germany. A United States military court tried 23physicians and administrators for war crimes, crimesagainst humanity, and conducting human researchwithout informed consent. The defendants weretried for experiments on concentration campprisoners for the benefit of the German armedforces. The list of offenses included: (a)temperature experiments – submersing prisoners infreezing waters to establish length of survival rates,(b) wounds – inflicting and infecting prisoners withmustard gas and bacteria to investigate medicinalremedies, and (c) contamination – transmittingmalaria to prisoners to study immunization effects.Seven defendants were cleared, nine incarcerated,and seven were executed (Hart and Belotto, 2010).Evidence existed that the German physicians knewof their responsibilities to patients prior toconducting the atrocious experiments maintainedHorner and Minifie (2011).The court issued its decision in August of 1947 andthe Nuremberg Code, a document of ethicalstandards to guide the conduct of research onhuman subjects. The Code laid down 10 clearprinciples to be followed by researchers and madevoluntary consent essential, allowed participants towithdraw from experiments at any time, prohibitedexperiments that could result in major injury ordeath of participants, and required preclinical dataprior to beginning experiments on humans. Thestandards included a required explanation of thenature, purpose, and duration of an experiment andthe right of subjects to bring an experiment to aclose (Avasthi et al., 2013; Hart and Belotto, 2010;Horner and Minifie, 2011).The creation of the National Institutes of Health(NIH) in 1953 played a major role in the evolutionof human research subjects’ protection in theUnited States. Prior group review by researchcommittees was required for research studies. TheClinical Research Committees (panel of experts)reviewed the ethical and scientific merits of researchproposals. Written consent was required ofemployees at the NIH who volunteered to beresearch subjects. These clinical research committeeswere the forerunners of the internal review boards(Hart and Belotto, 2010).During the 1950s a German company called theChemie Grunenthal Company of Germanyproduced thalidomide, an over-the counter sedativedrug that was approved and sold in Europe. It wasalso prescribed for women who were pregnant andsuffering with morning sickness. The daughter ofan employee of the company was born withmalformations on Christmas Day in 1956. Theemployee’s wife had taken thalidomide during herpregnancy. During the next few years, obstetriciansobserved an increase in the incidence of

26Journal of Management Researchtetraphocomelia, a condition in which limbs wereshortened to the extent that hands and feet wereattached directly to the torso. During this same timeperiod, marketers of the drugs were attempting toget the drug approved in the United States (Hartand Belotto, 2010).Dr. Frances Kelsey, in her first assignment as aFood and Drug Administration (FDA) medicalreviewer, was given the task of reviewingthalidomide. Dr. Kelsey conveyed wellbeing andeffectiveness concerns of the drug. Also, there wasa lack of human data provided by the ChemieGrunenthal Company. Dr. Kelsey continued towithhold her approval and required the company toresubmit its application six times in spite ofmounting pressure from the company’s lawyers andher own coworkers. As a result, thalidomide wasnever approved in the United States. During thistime, the harmful effects of thalidomide becamemore evident. The Chemie Grunenthal Companyultimately withdrew the drug. These events laid thegroundwork for the next surge of federalregulations in the United States (Hart and Belotto,2010).The Food and Drug Law of 1906 was the first lawin America mandating that food and drugs beunaltered, labeled accurately describing the productcontents and intended uses, and be tested beforemarketing. Later, the Food, Drug, and Cosmetic Actof 1938 required safety testing prior to marketing.Then in 1962, the Kefauver-Harris amendment tothe Food, Drug, and Cosmetic Act was passed as aresult of the experiences from thalidomide. Thisamendment gave the FDA additional regulatorypower over manufacturing procedures and allowedthe FDA to require manufacturers to performeffectiveness and safety testing. Researchers werealso required to obtain informed consent fromresearch participants and FDA approval of a newdrug prior marketing the drug (Hart and Belotto,2010).The World Medical Association created TheDeclaration of Helsinki in 1964. This documentreiterated the standards initially outlined in theNuremberg Code. The Declaration required thathuman medical research be based on acceptedscientific principles, have a thorough understandingof the scientific literature, and obtain sufficientlaboratory and animal testing. All research must beopenly explained in a code of behavior andsubmitted to an independent research ethicscommittee before the start of the study. TheDeclaration goes beyond the Nuremberg Codeaddressing issues of consent and has been amendedto reflect current issues, most recently in 2008 (Hartand Belotto, 2010).At Yale University, during the 1960s, StanleyMilgram conducted studies to determine the effectsof authority on obedience. Students were asked todeliver electric shocks to peers who were trying tolearn word association lists. Findings showed thatparticipants were willing to deliver increasinglyintense electric shocks to poorly performinglearners even after the learners cried of pain. Theparticipants were not aware that shocks were neverdelivered to the learners. The participants were alsoencouraged to deliver the shocks even after showingsigns of distress themselves. Milgram’s studies havereceived ongoing scrutiny especially concerningdeception during human experimentation. TheMilgram studies should be required reading for anystudent interested in research suggested Horner andMinifie (2011).In 1963 physicians at the Brooklyn Jewish ChronicDisease Hospital conducted cancer experiments onmature patients without prior consent. Later thatyear a transplant of a chimpanzee kidney to ahuman was completed at Tulane University andfailed. The experiment had not been previouslyreviewed by an independent institutional committee.In 1965 Henry Beecher, a respected physician,issued a condemnation of the entire biomedicalresearch community in his paper “Ethics andClinical Research” which was published in 1966 inthe New England Journal of Medicine. Beecherexamined 100 studies that had been published in1964. He discovered 22 ethical problems of the100 studies examined. The Willowbrook StateSchool for retarded was one of the 22 studiesaddressed where children were infected withhepatitis. The reporting of this case in the late

Volume 15, Number 1January–March 2015271960s and early 1970s by the media raised publicawareness of problems with research as similarstories received attention (Hart and Belotto, 2010).In 1972 the Tuskegee Syphilis Study represented themost reprehensible historical research experimenton humans according to Hart and Belotto (2010).Tuskegee University, founded by Booker T.Washington, offered its hospital and medicalfacilities to the United States Public Health Serviceto carry out research. The study was conductedfrom 1932 to 1972 and was besieged with manyethical problems. A majority of the subjects wereinfected with syphilis, were not well educated, hadnot seen a doctor previously, and were vulnerableand never told what the name of the disease waswith which they were afflicted. The participantswere coerced with hot meals and promises oftreatment at no cost and penicillin was withheld.The government was pressured by public scrutinyto stop the 40-year-old experiment when the storywas released to the media. On July 12, 1974,President Richard Nixon signed the NationalResearch Act into law. The National Commissionfor the Protection of Human Subjects ofBiomedical and Behavioral Research was created.Federal regulations governing research were codifiedin what is known as the Common Rule.Susan M. Reverby, a Wellesley College historian,uncovered the Guatemalan studies while researchingthe Tuskegee Syphilis Study. The United Statesgovernment publicly revealed the details in October,2010. The Guatemalan studies occurred between1946 and 1948 and demonstrated substandardethics according to The Presidential Commissionfor the Study of Bioethical Issues. The studies wereled by John Cutler, a United States Public HealthService researcher, who was also a part of theTuskegee Syphilis Study. He infected prisoners,soldiers, patients with mental illnesses, prostitutes,and children with sexually transmitted diseases todetermine if penicillin would guard against syphilis,gonorrhea, and chancroid. Physician-researcherstook blood and fluid samples from over 5,000patients without their consent; intentionally exposed1,300 people to syphilis, gonorrhea, or chancroid(some of whom were encouraged to have contactwith prostitutes who either had the diseases or whowere infected with the diseases); infectedparticipants bacteria onto the wounds from thediseases; injected infected material into some of theparticipants’ spines; and gave only 700 participantstreatment. A total of 83 known participants died asa result of unknown causes (Aultman, 2013).During the 1970s, the United States Congresspassed the National Research Act and the NationalCommission for the Protection of Human Subjectsof Biomedical and Behavioral Research wasestablished. Consequently, professional associationsbegan to establish codes of ethics and researchstandards. In 1982, for example, the Association ofAmerican Medical Colleges formed guidelines forhandling research fraud and in 1985 Congresspassed the Health Research Extension Act. TheAssociation of American Universities created theReport of the Association of American UniversitiesCommittee on the Integrity of Research and Framework forInstitutional Policies and Procedures to Deal with Fraudin Research. In addition, the Institute of Medicineand National Research Council examined TheResponsible Conduct of Research in the Health Sciences in1989. In 1995, the Commission on ResearchIntegrity prepared the Integrity and Misconduct inResearch report that led to enhancedcommunications between scientists, academicinstitutions, and the federal government (Hornerand Minifie, 2011).RELATED LITERATUREMore current illustrations of unethical humanexperimentation often involving industry-sponsoredresearch with little, or no, oversight betweeninstitutional review boards and ethics reviewcommittees occurred within and external to theUnited States. For example, there were a number ofunethical research practices that have occurred inLatin America and countries globally. Theseexamples of unethical research practicesdemonstrated financial, political, and socio-culturalpressures that can compromise the health andsecurity of human subjects. Moreover, theseexamples of unethical research practices tend tobring about anxiety and suspicion from the publiccautioned Aultman, (2013).

28Journal of Management ResearchResearch universities in the United States havethrived since the turn of the 21st century. Alongwith the burgeoning of research new issues haveemerged for higher education and public policy. Amajor issue is whether research universities can goon exercising independence from accountability.Universities have shown unethical research practicescompromising the protection of human subjects.Monetary benefits, support from industry, andquestions of intellectual property rights have addedto the complications with research in universities.Therefore, Smith and Korn (2000) encourageduniversities to prepare transparent polices andprocedures for faculty, review institutional missionsand strategies, and enhance administrative oversightto meet the needs of the societies higher educationserves.The most important reason for conductinginstitutional oversight in research with humans isthe ethical protection of the research participants.Whether referred to as an institutional review boardor an ethics review committee, those overseeing theresearch activities are responsible for evaluating therisk/benefit ratio, the quality of informed consentprocedures and materials, the competence of theresearcher(s), and the compliance with obligationsto participants. Both international guidelines andnational legislation require researchers to obtainethics approval prior to conducting research(Vayena and Tasioulas, 2013).Gaining approval is an important step in researchbut can be lengthy and overwhelming forinexperienced researchers with all the burdensomedocumentation requirements. However, ethicalapproval can be expedited if the study has nominalrisk. There are case studies that have been publishedoutlining some of the approval challenges thatexisted when presenting studies for review andapproval. Occasionally, institutional review boardsor ethics review committees have required unethicalchanges resulting in delays. This practice maydiscourage researchers from continuing a researchcareer or have the overall effect of reduced futureresearch cautioned Condell and Begley (2012).One opinion for placing higher standards onactivities that are considered research is that “highethical standards are needed to protect the socialstanding and reputation of research” (Hansson,2011). On the other hand, when risky activity isgoing to be conducted, it is usually better toconduct it in research so what is learned can add tothe body of knowledge for future use. Accordingto Hansson, it is better to maintain higher ethicalstandards in research that can be applied to otheractivities, such as traffic, consumer, and workplacesafety.Researchers are encouraged to think of institutionalreview boards or ethical review committees asspecialists in the field of ethics in researchencouraged Lindorff (2010). These experts can bean invaluable resource and add value to researchstudies. Institutional review boards or ethics reviewcommittees should not be viewed as reducingresearcher autonomy but should be thought of asjust one step in the process that facilitates andguarantees research excellence. Members of thecommittee have expertise that includes experienceas well as provide a third party review. Often,suggested Lindorff, the committee can alert aresearcher to concerns in the study ultimatelyprotecting the research, the institutions, and theresearcher. Institutional review boards or ethicsreview committees and researchers are advised towork in partnership to propose research to engageparticipants who assist with research and viewresearch positively. This positive viewpoint fromresearch participants will ultimately lead toenhanced public support for researchers to continuethe important work of adding to the body ofknowledge.Ethical or internal reviews are frequently beset withmisinterpretations between researchers andcommittees claimed Schrems (2013). Researchersand committee members together are accountablefor ensuring harmless and ethical research.Researchers focus on adding to the body ofknowledge while committee members focus onprotection of research participants. Schrems alsomaintained that committee members often lacksufficient knowledge in the types of research usedby researchers resulting in issues of ethical

Volume 15, Number 1January–March 201529standards; this is especially true for nursing research.Committee deliberations on ethical standards inresearch on nursing targets vulnerable groups andthis research is often more complex research.Research on nursing is not limited to participantsbut frequently includes families of participants andcommunities of participants. Therefore, researchersand committee members should be guided by wellcommunicated Codes of Conduct recommendedSchrems. The review process is a one-timeprocedure and is concluded with a final decision.Therefore, more than understanding ethicalstandards, researchers are advised to alsounderstand the research committee protocols.Anderson and DuBois (2012) suggested that theinstitutional review board or ethics reviewcommittee evaluations of research studies bestructured to ensure that determinations are basedon all obtainable information to uphold “evidence-based decision-making.” Committee members needsufficient training on evidence-based standardsspecifically addressing factors affecting intuitivejudgment, psychological influences, and committeedecision-making procedures. Accomplishingresearch on institutional review boards or ethicsreview committees has been next to impossible,particularly with gaining consent and support toobserve deliberations.Juritzen, Grimen and Heggen (2011) questioned,“how a practice which is intended to monitor theexercise of power (by researchers and the researchestablishment)” has turned into an “exercise ofpower which is not . . . subject to the same kind ofcritical review.” Current literature, according toAnderson and DuBois, provides minimalinformation on the quality of committee decisionmaking, such as, how the committee makes itsdecisions or what information is used to makedecisions on proposals. Customarily, research oncommittee deliberations has been limited tointerviews with committee chairs or membersregarding processes. Thorough observationalstudies of committee meetings or review of theminutes are necessary to obtain accurate findings.The researchers suggested that additional researchinto institutional review board or ethics reviewcommittee deliberations would add to the body ofknowledge regarding actual evidence-baseddecision-making. Anderson and DuBois maintainedthat “the culture of IRB review and decision-making must change” to become a moretransparent process.Over 40% of researchers surveyed indicated thatthey knew that misconduct occurred but failed toreport the wrongdoing, claimed Gupta (2013). Theeffect of this deception can lead to a study losingits reliability, useless or risky treatment for patients,or patient treatment deprivation. Deception inresearch occurs frequently, which suggests that asignificant problem exists. Consequently, Gupta(2013) posed the question: “Is fraud andmisconduct the same?” Fraud and misconduct areused interchangeably; however, the researchersuggested that the two terms have two entirelydifferent definitions. Research fraud or misconductoften refers to an infringement of the standardcodes of conduct and ethical behavior in research.On the one hand, fraud as defined as knowinglyviolating the standard codes of conduct and ethicalbehavior in research and is intentional dishonestyfor personal gain. Misconduct, on the other hand,may not be deliberate. In other words, fraud isintentional while misconduct in not intentional.Gupta (2013) recommended that the oversightcapacity of institutional review boards or ethicsreview committees needs to be enhanced regardingprotecting the interests of participants. Thesecommittees should have internal control and reviewprocedures and policies for overseeing the moralcharacteristics and overall value of research. Allinstitutions, according to the researcher, areencouraged to have standards that are streamlinedand efficient to minimize fraud or misconduct andto provide safe environments for potentialdisclosure of fraud or misconduct. Gupta suggestedthat the focus of institutional research should be on“quality” rather than “quantity” of research.Investigators and institutional review boards orethics review committees should, suggested King(2012), be attentive to the need to formulatedisclosures of risks and benefits specific to each

30Journal of Management Researchstudy. In addition, disclosures need to be relevantto research subjects making decisions on whether toparticipate in a study and on the potential thatexpressed benefits from the study may beexaggerated. According to the researcher, it is thereviewers’ responsibility to help researcherscommunicate accurately the details of participationto participants. This is particularly important forfirst-in-human nanomedicine research studies wherethe objectives are to make a generalizablecontribution and protect the safety of the studyparticipants. Participants should not be approachedto participate in a study before the reviewingcommittee has determined that any potential risksare reasonable and have been minimized.Rotenberg and Rudnick (2011) maintained that eventhough there has been an increase in reportingethics procedures during the last decade, ethicsprocedures are still underreported. For example, outof 751 articles reviewed less than half of theresearchers did not report voluntary informedconsent or ethics approval in their articles.Furthermore, the researchers discovered that thereasons for the underreporting were not clear.Rotenberg and Rudnick recommended thatattention to underreporting be given to guaranteeand maintain the accepted ethics standards and toprevent the decline of public trust in empiricalresearch. Communicating to researchers and all themembers of a research community the importanceof ethics procedures in all research may benecessary to establish an institutional reputation asan ethical research community.Lategan (2012) suggested that in establishing anethical research community, it is not enough tosimply think of ethics in research as only plagiarism,falsification of data, misconduct in clinical researchand on human subjects, and other possible harmfulresearch events. Ethics in research need to beapplied to all activities within institutions. Ethicsimpacts all disciplines. Following is a list ofpotential ethical dimensions for universities to becommitted to: acceptance of the dictum of do noharm; responsibility of all staff to the institutionalcore functions of teaching, research, andcommunity service; supportive postgraduatesupervision; current teaching and learninginformation; research team integrity; quest for newknowledge; avoidance of potential unfair benefits toindividuals; accuracy of data; confidential use ofdata; authorship; appropriate use of research fundsand equipment; potential risks; privacy rights andobligations; proper disclosure of potential conflictsof interest; correct use and disposal of hazardousmaterials; and professional relationships amongresearch community members.Chalmers (2011) suggested that institutional reviewboards or ethics review committees should devotetheir time and effort on the ethical substance of astudy rather than on the editorial form of theconsent and study information forms. Thoroughand efficient oversight is essential to protectconsistently the rights and welfare of studyparticipants while allowing ethical and responsibleresearch to advance in a timely manner. However,the quality of ethics in research is highly dependenton the researchers. The primary responsibility touphold the codes of research practice for theintegrity of research design and conduct in researchand respect for research participants lies with theresearchers themselves. Researchers are the first stepin ethical oversight. Ethics in research depends onthe integrity of the researchers (Chalmers, 2011;Fouka and Mantzorou, 2011). Institutional reviewboards or ethics review committees represent thesecond step of oversight of research studies andcannot be expected to “police” (Chalmers, 2011)the process.Alfredo and Hart (2011) encouraged universities toprovide the following workshops to assist faculty:(a) design training environments that encouragefaculty and student conversations on theimportance of ethics in all areas of research, (b)develop and conduct regular training for faculty onresearch conduct exploring the gray areas of ethicalconduct, (c) create institutional conduct policiesproviding faculty and students with standards,resources, and preparation for potential problems inresearch, and (d) offer graduate students neededResponsible Conduct of Research orientation andtraining. These workshops will be most effective ifthey are opportunities for training for all university

Volume 15, Number 1January–March 201531research participants. The researchers furtherrecommended that universities take action tocommunicate to advisors, students, and all involvedin research the importance of responsible research.In summary, a review of the literature suggestedthat ethics in research is a shared responsibility. Itis dependent on:•History as a constant reminder of how abusesand bad research can be carried out byostensibly reliable researchers, institutionalreview boards or ethics review committees,and research communities. History forms thebasis for review and approval processes andguidelines through regulations and policies atthe institutional, state, national, and globallevels (Aultman, 2013). These approvalprocesses and guidelines evolve fromcountless historical events (Hart and Belotto,2010).•The researcher is responsible for remainingup-to-date about all the regulations, acceptedprocedures, and history relating to ethicalresearch (Hart and Belotto, 2010). They areresponsible for the integrity of the research(Chalmers, 2011; Fouka and Mantzorou,2011).•The institutional review boards or ethicsreview committees having oversightresponsibility for evaluating research involvinghuman subjects prior to researchersconducting the research (Gupta, 2013; Vayenaand Tasioulas, 2013). They are alsoresponsible for assisting with effectivecommunication to participants for makingknowledgeable decisions regardingparticipation in studies (King, 2012) Thesereviewers can be a helpful source providingreliability to the studies and ensuring that thestudy is of value (Lindorff, 2010).•The research communities or universities areresponsible for creating a cultural climate thatencourages ethical research and for assistingadvisors with their responsibilities to graduatestudents for overseeing all elements of theresearch project (Alfredo and Hart, 2011).Ethics impacts all activities within institutionsand all disciplines (Lategan, 2012) anduniversities are responsible for providingsufficient education and training on ethics inresearch (Alfredo and Hart, 2011).CONCEPTUAL MODEL OF ETHICALRESEARCHEthics in research is a shared responsibility. It isdependent on history, the researcher, theinstitutional review board or ethics reviewcommittee, and the research community. Historyguides the researcher, the institutional review boardsor ethics review committees, and the researchcommunities. Responsibility for ethical research lieswith the researcher, institutional review boards orethics review committees, and the researchcommunities.History establishes the parameters of what isacceptable or not acceptable in research. Historyprovides the laws and codes of conduct. Theresearcher brings his or her interpretation of whatis right or wrong to the process. This interpretationof the researcher is based on training, education,and understandings of ethical standards. Theinstitutional review boards or ethics reviewcommittees are experienced researchers whoprovide oversight. They guide the research to ensureall research follows ethical standards. They alsoserve as correcting forces that ensure research stayson track. The research community is the institutionwhere research is conducted. It is made up of allthe staff of the institution and supports ethicalresearch activities and provides training andeducation in ethical standards and expectations.When the researcher, the institutional review boardsor ethics review committees, and the researchcommunities work together, with the guidance fromhistory, the output is ethical research thatcontributes to the body of knowledge. Therefore,it is recommended that researchers, reviewers, anduniversities view their research responsibilities as apartnership.

32Journal of Management ResearchIMPLICATIONS ANDRECOMMENDATIONSViewing research as a partnership has the followingimplications. First, research is likely to be moreethical and reliable if all those responsible do theirpart to ensure quality research. Viewing research asa partnership with each entity of the partnershipunderstanding the roles will enhance the process.Second, as research becomes more ethical andreliable the end result will be a more sound bodyof knowledge. As research improves contributionswill also improve. Third, as the public gainsconfidence in how research is conducted they willview those involved with research more favorably.Society will also be able to accept the end result.Fourth, as the public gains trust in research they arelikely to be more interested in participating inresearch projects when called upon to do so.Participation rates will increase as society becomesmore interested in advancing research. Fifth, goodresearch will intimately drive out bad research.It is recommended that additional studies beconducted in ethics in research to determine if thesame findings are repeated. It is also recommendedthat research be conducted on the public’sperceptions of ethical standards of research toascertain what society thinks of research at thepresent time.REFERENCESAlfredo, K. and Hart, H. (2011), The University and the Responsible Conduct of Research: Who is Responsible for What?Science And Engineering Ethics, 17(3): 447–57.Anderson, E. E. and DuBois, J. M. (2012), IRB Decision-making with Imperfect Knowledge: A Framework for Evidence-based Research Ethics Review, Journal of Law, Medicine & Ethics, 40(4): 951–69.Aultman, J. M. (2013), Abuses and Apologies: Irresponsible Conduct of Human Subjects Research in Latin America, Journalof Law, Medicine & Ethics, 41(1): 353–68.Avasthi, A., Ghosh, A., Sarkar, S. and Grover, S. (2013), Ethics in Medical Research: General Principles with Special Referenceto Psychiatry Research, Indian Journal of Psychiatry, 55(1): 86–91.Chalmers, D. (2011), Viewpoint: Are the Research Ethics Committees Working in the Best Interests of Participants in anIncreasingly Globalized Research Environment? Journal of Internal Medicine, 269(4): 392–395.Condell, S. L. and Begley, C. (2012), Clinical Research Ethics in Irish Healthcare: Diversity, Dynamism and Medicalization,Nursing Ethics, 19(6): 810–818.Fouka, G. and Mantzorou, M. (2011), What are the Major Ethical Issues in Conducting Research? Is There a Conflict betweenthe Research Ethics and the Nature of Nursing? Health Science Journal, 5(1): 3–14.Gupta, A. (2013), Fraud and Misconduct in Clinical Research: A Concern, Perspectives in Clinical Research, 4(2): 144–147.Hansson, S. O. (2011), Do We Need a Special Ethics for Research? Science & Engineering Ethics, 17(1): 21–29.Hart, R. and Belotto, M. (2010), The Institutional Review Board, Seminars in Nuclear Medicine, 40(5): 385–92.Henderson, G. E., Juengst, E. T., King, N. M. P., Kuczynski, K. and Michie, M. (2012), What Research Ethics should Learnfrom Genomics and Society Research: Lessons from the ELSI Congress of 2011, Journal of Law, Medicine & Ethics,40(4): 1008–1024.Horner, J. and Minifie, F. D. (2011), Research Ethics I: Responsible Conduct of Research (RCR)—Historical andContemporary Issues Pertaining to Human and Animal Experimentation, Journal Of Speech, Language, And HearingResearch, 54(1): S303–329.Lategan, L. O. K. (2012), The Building of a Responsible Research Community: The Role of Ethics, Journal of ResearchAdministration, 43(1): 85–97.Lindorff, M. (2010), Ethics, Ethical Human Research and Human Research Ethics Committees, Australian Universities’ Review,52(1): 51–59.

Volume 15, Number 1January–March 201533King, N. M. P. (2012), Nanomedicine First-in-human Research: Challenges for Informed Consent, Journal of Law, Medicine &Ethics, 40(4): 823–30.Juritzen, T., Grimen, H. and Heggen, K. (2011), Protecting Vulnerable Research Participants: A Foucault-inspired Analysisof Ethics Committees, Nursing Ethics, 18(5): 640–650.Rotenberg, M. A. and Rudnick, A. (2011), Reporting of Ethics Procedures in Psychiatric Rehabilitation Peer-reviewedEmpirical Research Publications in the Last Decade, American Journal of Psychiatric Rehabilitation, 14(2): 97–108.Schrems, B. M. (2013), Mind the Gaps in Ethical Regulations of Nursing Research, Nursing Ethics, 20(3): 336–347.Smith, B. L. and Korn, D. (2000), Is there a Crisis of Accountability in the American Research University? Minerva, 38(2):129–45.Vayena, E. and Tasioulas, J. (2013), Adapting Standards: Ethical Oversight of Participant-led Health Research. PLoS Medicine,10(3): 1–5.

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THE BELMONT REPORT Office of the Secretary Ethical Principles and Guidelines for the Protection of Human Subjects of Research The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research April 18, 1979 AGENCY: Department of Health, Education, and Welfare. ACTION: Notice of Report for Public Comment. SUMMARY: On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles. In carrying out the above, the Commission was directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such research and (iv) the nature and definition of informed consent in various research settings. The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations. It is the outgrowth of an intensive four-day period of discussions that were held in February 1976 at the Smithsonian Institution’s Belmont Conference Center supplemented by the monthly deliberations of the Commission that were held over a period of nearly four years. It is a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects. By publishing the Report in the Federal Register, and providing reprints upon request, the Secretary intends that it may be made readily available to scientists, members of Institutional Review Boards, and Federal employees. The two-volume Appendix, containing the lengthy reports of experts and specialists who assisted the Commission in fulfilling this part of its charge, is available as DHEW Publication No. (OS) 78-0013 and No. (OS) 78-0014, for sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402. Unlike most other reports of the Commission, the Belmont Report does not make specific recommendations for administrative action by the Secretary of Health, Education, and Welfare. Rather, the Commission recommended that the Belmont Report be adopted in its entirety, as a statement of the Department’s policy. The Department requests public comment on this recommendation.

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Members of the Commission Kenneth John Ryan, M.D., Chairman, Chief of Staff, Boston Hospital for Women. Joseph V. Brady, Ph.D., Professor of Behavioral Biology, Johns Hopkins University. Robert E. Cooke, M.D., President, Medical College of Pennsylvania. Dorothy I. Height, President, National Council of Negro Women, Inc. Albert R. Jonsen, Ph.D., Associate Professor of Bioethics, University of California at San Francisco. Patricia King, J.D., Associate Professor of Law, Georgetown University Law Center. Karen Lebacqz, Ph.D., Associate Professor of Christian Ethics, Pacific School of Religion. *** David W. Louisell, J.D., Professor of Law, University of California at Berkeley. Donald W. Seldin, M.D., Professor and Chairman, Department of Internal Medicine, University of Texas at Dallas. *** Eliot Stellar, Ph.D., Provost of the University and Professor of Physiological Psychology, University of Pennsylvania. *** Robert H. Turtle, LL.B., Attorney, VomBaur, Coburn, Simmons & Turtle, Washington, D.C. *** Deceased. Table of Contents Ethical Principles and Guidelines for Research Involving Human Subjects A. Boundaries Between Practice and Research B. Basic Ethical Principles 1. Respect for Persons 2. Beneficence 3. Justice C. Applications 1. Informed Consent 2. Assessment of Risk and Benefits 3. Selection of Subjects

Ethical Principles & Guidelines for Research Involving Human Subjects Scientific research has produced substantial social benefits. It has also posed some troubling ethical questions. Public attention was drawn to these questions by reported abuses of human subjects in biomedical experiments, especially during the Second World War. During the Nuremberg War Crime Trials, the Nuremberg code was drafted as a set of standards for judging physicians and scientists who had conducted biomedical experiments on concentration camp prisoners. This code became the prototype of many later codes [1] intended to assure that research involving human subjects would be carried out in an ethical manner. The codes consist of rules, some general, others specific, that guide the investigators or the reviewers of research in their work. Such rules often are inadequate to cover complex situations; at times they come into conflict, and they are frequently difficult to interpret or apply. Broader ethical principles will provide a basis on which specific rules may be formulated, criticized and interpreted. Three principles, or general prescriptive judgments, that are relevant to research involving human subjects are identified in this statement. Other principles may also be relevant. These three are comprehensive, however, and are stated at a level of generalization that should assist scientists, subjects, reviewers and interested citizens to understand the ethical issues inherent in research involving human subjects. These principles cannot always be applied so as to resolve beyond dispute particular ethical problems. The objective is to provide an analytical framework that will guide the resolution of ethical problems arising from research involving human subjects. This statement consists of a distinction between research and practice, a discussion of the three basic ethical principles, and remarks about the application of these principles. Part A: Boundaries Between Practice & Research 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 [2]. 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 [3]. 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. Part B: Basic Ethical Principles 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. Part C: Applications C. Applications Applications of the general principles to the conduct of research leads to consideration of the following requirements: informed consent, risk/benefit assessment, and the selection of subjects of research. 1. Informed Consent. — Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied. While the importance of informed consent is unquestioned, controversy prevails over the nature and possibility of an informed consent. Nonetheless, there is widespread agreement that the consent process can be analyzed as containing three elements: information, comprehension and voluntariness. Information. Most codes of research establish specific items for disclosure intended to assure that subjects are given sufficient information. These items generally include: the research procedure, their purposes, risks and anticipated benefits, alternative procedures (where therapy is involved), and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research. Additional items have been proposed, including how subjects are selected, the person responsible for the research, etc. However, a simple listing of items does not answer the question of what the standard should be for judging how much and what sort of information should be provided. One standard frequently invoked in medical practice, namely the information commonly provided by practitioners in the field or in the locale, is inadequate since research takes place precisely when a common understanding does not exist. Another standard, currently popular in malpractice law, requires the practitioner to reveal the information that reasonable persons would wish to know in order to make a decision regarding their care. This, too, seems insufficient since the research subject, being in essence a volunteer, may wish to know considerably more about risks gratuitously undertaken than do patients who deliver themselves into the hand of a clinician for

needed care. It may be that a standard of “the reasonable volunteer” should be proposed: the extent and nature of information should be such that persons, knowing that the procedure is neither necessary for their care nor perhaps fully understood, can decide whether they wish to participate in the furthering of knowledge. Even when some direct benefit to them is anticipated, the subjects should understand clearly the range of risk and the voluntary nature of participation. A special problem of consent arises where informing subjects of some pertinent aspect of the research is likely to impair the validity of the research. In many cases, it is sufficient to indicate to subjects that they are being invited to participate in research of which some features will not be revealed until the research is concluded. In all cases of research involving incomplete disclosure, such research is justified only if it is clear that (1) incomplete disclosure is truly necessary to accomplish the goals of the research, (2) there are no undisclosed risks to subjects that are more than minimal, and (3) there is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them. Information about risks should never be withheld for the purpose of eliciting the cooperation of subjects, and truthful answers should always be given to direct questions about the research. Care should be taken to distinguish cases in which disclosure would destroy or invalidate the research from cases in which disclosure would simply inconvenience the investigator. Comprehension. The manner and context in which information is conveyed is as important as the information itself. For example, presenting information in a disorganized and rapid fashion, allowing too little time for consideration or curtailing opportunities for questioning, all may adversely affect a subject’s ability to make an informed choice. Because the subject’s ability to understand is a function of intelligence, rationality, maturity and language, it is necessary to adapt the presentation of the information to the subject’s capacities. Investigators are responsible for ascertaining that the subject has comprehended the information. While there is always an obligation to ascertain that the information about risk to subjects is complete and adequately comprehended, when the risks are more serious, that obligation increases. On occasion, it may be suitable to give some oral or written tests of comprehension. Special provision may need to be made when comprehension is severely limited — for example, by conditions of immaturity or mental disability. Each class of subjects that one might consider as incompetent (e.g., infants and young children, mentally disable patients, the terminally ill and the comatose) should be considered on its own terms. Even for these persons, however, respect requires giving them the opportunity to choose to the extent they are able, whether or not to participate in research. The objections of these subjects to involvement should be honored, unless the research entails providing them a therapy unavailable elsewhere. Respect for persons also requires seeking the permission of other parties in order to protect the subjects from harm. Such persons are thus respected both by acknowledging their own wishes and by the use of third parties to protect them from harm. The third parties chosen should be those who are most likely to understand the incompetent subject’s situation and to act in that person’s best interest. The person authorized to act on behalf of the subject should be given an opportunity to observe the research as it proceeds in order to be able to withdraw the subject from the research, if such action appears in the subject’s best interest. Voluntariness. An agreement to participate in research constitutes a valid consent only if voluntarily given. This element of informed consent requires conditions free of coercion and undue influence. Coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance. Undue influence, by contrast, occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance. Also, inducements that would ordinarily be acceptable may become undue influences if the subject is especially vulnerable. Unjustifiable pressures usually occur when persons in positions of authority or commanding influence — especially where possible sanctions are involved — urge a course of action for a subject. A continuum of

such influencing factors exists, however, and it is impossible to state precisely where justifiable persuasion ends and undue influence begins. But undue influence would include actions such as manipulating a person’s choice through the controlling influence of a close relative and threatening to withdraw health services to which an individual would otherwise be entitled. 2. Assessment of Risks and Benefits. — The assessment of risks and benefits requires a careful arrayal of relevant data, including, in some cases, alternative ways of obtaining the benefits sought in the research. Thus, the assessment presents both an opportunity and a responsibility to gather systematic and comprehensive information about proposed research. For the investigator, it is a means to examine whether the proposed research is properly designed. For a review committee, it is a method for determining whether the risks that will be presented to subjects are justified. For prospective subjects, the assessment will assist the determination whether or not to participate. The Nature and Scope of Risks and Benefits. The requirement that research be justified on the basis of a favorable risk/benefit assessment bears a close relation to the principle of beneficence, just as the moral requirement that informed consent be obtained is derived primarily from the principle of respect for persons. The term “risk” refers to a possibility that harm may occur. However, when expressions such as “small risk” or “high risk” are used, they usually refer (often ambiguously) both to the chance (probability) of experiencing a harm and the severity (magnitude) of the envisioned harm. The term “benefit” is used in the research context to refer to something of positive value related to health or welfare. Unlike, “risk,” “benefit” is not a term that expresses probabilities. Risk is properly contrasted to probability of benefits, and benefits are properly contrasted with harms rather than risks of harm. Accordingly, so-called risk/benefit assessments are concerned with the probabilities and magnitudes of possible harm and anticipated benefits. Many kinds of possible harms and benefits need to be taken into account. There are, for example, risks of psychological harm, physical harm, legal harm, social harm and economic harm and the corresponding benefits. While the most likely types of harms to research subjects are those of psychological or physical pain or injury, other possible kinds should not be overlooked. Risks and benefits of research may affect the individual subjects, the families of the individual subjects, and society at large (or special groups of subjects in society). Previous codes and Federal regulations have required that risks to subjects be outweighed by the sum of both the anticipated benefit to the subject, if any, and the anticipated benefit to society in the form of knowledge to be gained from the research. In balancing these different elements, the risks and benefits affecting the immediate research subject will normally carry special weight. On the other hand, interests other than those of the subject may on some occasions be sufficient by themselves to justify the risks involved in the research, so long as the subjects’ rights have been protected. Beneficence thus requires that we protect against risk of harm to subjects and also that we be concerned about the loss of the substantial benefits that might be gained from research. The Systematic Assessment of Risks and Benefits. It is commonly said that benefits and risks must be “balanced” and shown to be “in a favorable ratio.” The metaphorical character of these terms draws attention to the difficulty of making precise judgments. Only on rare occasions will quantitative techniques be available for the scrutiny of research protocols. However, the idea of systematic, nonarbitrary analysis of risks and benefits should be emulated insofar as possible. This ideal requires those making decisions about the justifiability of research to be thorough in the accumulation and assessment of information about all aspects of the research, and to consider alternatives systematically. This procedure renders the assessment of research more rigorous and precise, while making communication between review board members and investigators less subject to misinterpretation, misinformation and conflicting judgments. Thus, there should first be a determination of the validity of the presuppositions of the research; then the nature, probability and magnitude of risk should be distinguished with as much clarity as possible. The method of ascertaining risks should be explicit, especially where there is no alternative to the use of such vague categories as small or slight risk. It should also be determined whether an investigator’s estimates of the probability of harm or benefits are reasonable, as judged by known facts or other available studies.

Finally, assessment of the justifiability of research should reflect at least the following considerations: (i)Brutal or inhumane treatment of human subjects is never morally justified. (ii) Risks should be reduced to those necessary to achieve the research objective. It should be determined whether it is in fact necessary to use human subjects at all. Risk can perhaps never be entirely eliminated, but it can often be reduced by careful attention to alternative procedures. (iii) When research involves significant risk of serious impairment, review committees should be extraordinarily insistent on the justification of the risk (looking usually to the likelihood of benefit to the subject — or, in some rare cases, to the manifest voluntariness of the participation). (iv) When vulnerable populations are involved in research, the appropriateness of involving them should itself be demonstrated. A number of variables go into such judgments, including the nature and degree of risk, the condition of the particular population involved, and the nature and level of the anticipated benefits. (v) Relevant risks and benefits must be thoroughly arrayed in documents and procedures used in the informed consent process. 3. Selection of Subjects. — Just as the principle of respect for persons finds expression in the requirements for consent, and the principle of beneficence in risk/benefit assessment, the principle of justice gives rise to moral requirements that there be fair procedures and outcomes in the selection of research subjects. Justice is relevant to the selection of subjects of research at two levels: the social and the individual. Individual justice in the selection of subjects would require that researchers exhibit fairness: thus, they should not offer potentially beneficial research only to some patients who are in their favor or select only “undesirable” persons for risky research. Social justice requires that distinction be drawn between classes of subjects that ought, and ought not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens and on the appropriateness of placing further burdens on already burdened persons. Thus, it can be considered a matter of social justice that there is an order of preference in the selection of classes of subjects (e.g., adults before children) and that some classes of potential subjects (e.g., the institutionalized mentally infirm or prisoners) may be involved as research subjects, if at all, only on certain conditions. Injustice may appear in the selection of subjects, even if individual subjects are selected fairly by investigators and treated fairly in the course of research. Thus injustice arises from social, racial, sexual and cultural biases institutionalized in society. Thus, even if individual researchers are treating their research subjects fairly, and even if IRBs are taking care to assure that subjects are selected fairly within a particular institution, unjust social patterns may nevertheless appear in the overall distribution of the burdens and benefits of research. Although individual institutions or investigators may not be able to resolve a problem that is pervasive in their social setting, they can consider distributive justice in selecting research subjects. Some populations, especially institutionalized ones, are already burdened in many ways by their infirmities and environments. When research is proposed that involves risks and does not include a therapeutic component, other less burdened classes of persons should be called upon first to accept these risks of research, except where the research is directly related to the specific conditions of the class involved. Also, even though public funds for research may often flow in the same directions as public funds for health care, it seems unfair that populations dependent on public health care constitute a pool of preferred research subjects if more advantaged populations are likely to be the recipients of the benefits. One special instance of injustice results from the involvement of vulnerable subjects. Certain groups, such as racial minorities, the economically disadvantaged, the very sick, and the institutionalized may continually be sought as research subjects, owing to their ready availability in settings where research is conducted. Given their dependent status and their frequently compromised capacity for free consent, they should be protected against the danger of being involved in research solely for administrative convenience, or because they are easy to manipulate as a result of their illness or socioeconomic condition.

[1] Since 1945, various codes for the proper and responsible conduct of human experimentation in medical research have been adopted by different organizations. The best known of these codes are the Nuremberg Code of 1947, the Helsinki Declaration of 1964 (revised in 1975), and the 1971 Guidelines (codified into Federal Regulations in 1974) issued by the U.S. Department of Health, Education, and Welfare Codes for the conduct of social and behavioral research have also been adopted, the best known being that of the American Psychological Association, published in 1973. [2] Although practice usually involves interventions designed solely to enhance the well-being of a particular individual, interventions are sometimes applied to one individual for the enhancement of the well-being of another (e.g., blood donation, skin grafts, organ transplants) or an intervention may have the dual purpose of enhancing the well-being of a particular individual, and, at the same time, providing some benefit to others (e.g., vaccination, which protects both the person who is vaccinated and society generally). The fact that some forms of practice have elements other than immediate benefit to the individual receiving an intervention, however, should not confuse the general distinction between research and practice. Even when a procedure applied in practice may benefit some other person, it remains an intervention designed to enhance the well-being of a particular individual or groups of individuals; thus, it is practice and need not be reviewed as research. [3] Because the problems related to social experimentation may differ substantially from those of biomedical and behavioral research, the Commission specifically declines to make any policy determination regarding such research at this time. Rather, the Commission believes that the problem ought to be addressed by one of its successor bodies.

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