Comparison between biomedical and behavioral research

 Read the Belmont’s Report, write about the report’s background, and components. Describe the need for a code of conduct in research. Compare and contrast the difference between biomedical and behavioral research and the boundaries between practice and research and basic ethical principles. 

BIOMEDICAL RESEARCH

Biomedical research employs many methods and research designs. Studies designed to evaluate the safety, effectiveness, or usefulness of an intervention include research on therapies (e.g., drugs, diet, exercise, surgical interventions, or medical devices), diagnostic procedures (e.g., CAT scans or prenatal diagnosis through amniocentesis, chorionic villi testing, and fetoscopy), and preventive measures (e.g., vaccines, diet, or fluoridated toothpaste). Research on normal human functioning and development can include studies of the human body while exercising, fasting, feeding, sleeping, or learning, or responding to such things as stress or sensory stimulation. Some studies compare the functioning of a particular physiological system at different stages of development (e.g., infancy, childhood, adolescence, adulthood, or old age). Others are directed at defining normal childhood development so that deviations from normal can be identified. Sometimes research, particularly records research, is used to develop and refine hypotheses. Research on specific disease processes is often needed before improved methods of prevention, diagnoses, and treatment can be developed (e.g., research on the biochemical changes associated with AIDS or schizophrenia, or the neurological changes associated with senile dementia of the Alzheimer type). Research on the human genome and genetic markers is expected to create new avenues for understanding disease processes and their eventual control.

Subjects of some biomedical studies engage in ordinary tasks (e.g., exercise, learn a series of words, or respond to various sensory stimuli) while measurements of physiological and bodily functions are made. Although many procedures used in biomedical research are similar to those used in routine physical examinations, at times more invasive procedures (e.g., "spinal taps," skin or muscle biopsies, or X-rays used in conjunction with contrast dyes) must be used if a desired measurement is to be made. Although research designed to generate information about normal physiology or a disease process is not concerned with evaluating a medical intervention, it may still require the use of invasive procedures. When the research deals with subjects whose condition is not normal, the research can have either therapeutic or nontherapeutic purposes.

Other biomedical studies do not involve human subjects or are exempt from the human subjects regulations, and, therefore, do not require IRB review. This category includes research with animals and research on preexisting samples of materials (tissue, blood, or urine) collected for other purposes, where the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects [Federal Policy 否__.101(b)(4)]. It also includes research based on records, when the data are recorded in such a manner that the individuals to whom the records pertain cannot be identified, either directly or through identifiers linked to them [Federal Policy 否__.101(b)(4)]. [See Guidebook Chapter 4, "Considerations of Research Design."]

Some biomedical studies, particularly those conducted to evaluate new therapies or treatments, use such rigorous experimental methods as random assignment to treatment and control groups. Other studies, such as those directed at establishing the normal range of some element in the blood, may involve no experimental intervention and no assignment of subjects to groups. [See Guidebook Chapter 4, "Considerations of Research Design."]

The fact that much biomedical research is conducted for the purpose of evaluating new therapies or treatments leads to two problems for IRBs. The first is to some degree a problem of IRB jurisdiction; the second is a problem of risk/benefit assessment. The distinction between research and treatment can become blurred in patient care settings, as well as in some educational and training settings. This distinction raises questions of IRB jurisdiction over the research: Is the proposed activity one that requires IRB review (pursuant either to federal regulations or institutional policy)? A discussion of this issue appears in the Guidebook in Chapter 1, Section A, "Jurisdiction of the Institutional Review Board."

BEHAVIORAL RESEARCH

The scope and diversity of research areas in the behavioral and social sciences is quite broad. Some research is readily applicable to human affairs; other studies may broaden understanding without any apparent or immediate application. Some research is designed to test hypotheses derived from theory; other research is primarily descriptive. Still other research may be directed at evaluating an intervention or social program.

Theories and methods vary both across and within disciplines; the same problems may be approached by researchers trained in different disciplines. For example, some research psychologists work in laboratories studying the neurology, anatomy, and physiology that underlies perception, learning, instinctual behavior, and emotional responses. Other psychologists may perform survey research, observational studies, or small group experiments that differ little from work done by some sociologists. Within anthropology, physical anthropology overlaps with paleontology, anatomy, and genetics, while the social or cultural anthropologist studies the organization, institutions, and belief and value systems of societies or groups of people.

Behavioral research involving human subjects generates data by means of questionnaires, observation, studies of existing records, and experimental designs involving exposure to some type of stimulus or intervention. Many variations of these four basic methods are used. Questions may be asked in person, over the telephone, or by means of a questionnaire. Observation may or may not be covert, and the observer may or may not be a participant in the activity being studied. Records studied in research may be public (e.g., vital statistics, motor vehicle registrations, or court records) or non-public and sensitive (e.g., medical or educational records in which the subjects are identified). Experimental studies may be conducted in public places, in private settings (e.g., a clinic or therapist's office), or in laboratories. Interventions in such studies range from the innocuous, such as varying the package design of commercial products, to the potentially significant, such as varying behavior modification techniques in studying the treatment of alcoholism. Not all behavioral research involves human subjects. Studies of human migration are often undertaken using anonymous U.S. Census data, and much research in behavioral psychology is done with animals. In addition, many categories of behavioral research that do involve human subjects are exempt from the federal regulations for protection of human subjects. [See Federal Policy 否__.101.] This exemption does not imply that investigators have no ethical responsibilities to subjects in such research; it means only that IRB review and approval of the research is not required by federal regulations.

Most behavioral research involves no physical intervention and no physical risk. However, some studies do present a risk of social harm (e.g., harm to a subject's reputation, which is sometimes a danger if confidentiality is not maintained) or psychological harm, which may occur if the research involves deception or provides subjects with unwelcome and disturbing information about themselves. When deception is involved, the IRB needs to be satisfied that the deception is necessary and that, when appropriate, the subjects will be debriefed. (Debriefing may be inappropriate, for example, when the debriefing itself may present an unreasonable risk of harm without a counterveiling benefit.) The IRB should also make sure that the proposed subject population is suitable. [See Guidebook Chapter 3, Section A, "Risk/Benefit Analysis."]

Some studies involve the possibility of a moral wrong, which is what some commentators have labeled the ethical problems posed by deception of subjects or invasions of their privacy. Although some psychologists have overemphasized the value and necessity of using deception, deception or incomplete disclosure may be the only scientifically valid approach for certain research. An example of such research would be a study designed to determine the effect of group pressure (i.e., responses of others) on a subject's estimate of the length of a series of lines. In some groups, pseudo-subjects would be told in advance to give incorrect answers to questions about the length of the lines to determine the effect of such misinformation on the real subjects' responses. Obviously, if the subjects were told all about the research design and its purpose in advance, it would not be possible to do the research. IRBs need to determine whether any deception or invasion of privacy involved in a research protocol is justified.

Some social and behavioral researchers are concerned that IRB judgments at times seem to be influenced more by the subject matter of the study than by concerns about informed consent or risks to subjects. Researchers cite examples of studies that involve minimal risk and pose no consent questions, but that encounter difficult with some IRBs, particularly IRBs in medical settings. Some researchers believe that IRBs are more likely to object to research on the behavior or values of the powerful (e.g., physicians, professors, or managers) than to research using similar methods but on subjects of lower status (e.g., patients, students, or workers). Other researchers believe that IRBs sometimes perceive research on controversial topics, such as deviant sexual behavior or fraud in science, as presenting ethical problems because of the nature of the activity being studied, rather than because of research methods, risks, or the rights of subjects. Still others complain of a less specific prejudice against social and behavioral research on the grounds that it is "soft" or concerned with trivial questions.