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To make guidelines serve as more than wishful thinking, someone must back them up by sanctions external reviewers. For example, a postulation of the Nuremberg Code permits a degree of risk to subject up to the “humanitarian importance of the problem.

“This guideline, if left to the researcher, could lead to the subjective overvaluing of the “importance” of the study and/or undervaluing of the subject’s risk. Two general enforcement approaches to these ethical principles exist. The first tries to discourage violations of ethical guidelines through penalties.

The second uses prior review of research proposals to deny resources for unethical research.

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I. Punishing Human Subject Violations

Legal Remedies:

All citizens enjoy the protection of their lives and liberty to the extent guaranteed by state and federal laws. Suppose a demented social researcher physically pulls you off the street and forces you to serve as a subject.

In this case you can look to the criminal justice system for the punishment of this violation of the kidnapping laws. However, you are much more likely to encounter unethical research that comes under the civil code.

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As one example, the Tuskegee Study ultimately concluded with an out-of-court financial settlement of a class action civil suit. The federal government agreed to pay the subjects for their physical and mental stress. Similarly, every social researcher stands liable to lawsuit by human subjects who feel mistreated. Although rare, such suits provide one check on researchers.

Both criminal and civil law provide two essential ingredients for punishment. First, a formal and neutral judge or jury decides whether someone has violated a law or caused a personal injury. Second, the law can levy a financial or other penalty.

However, before this judicial process can operate, someone must file a complaint. As shown by the Tuskegee Study, making effective use of the legal system will often prove difficult for the least powerful subjects.

In that case, civil action derived not from the sub­jects but rather from civil rights activists outraged by the study. In less extreme cases of abuse, even well-informed and resourceful subjects may decide that the cost of seeking legal redress exceeds the discomfort caused by their research experience.

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Professional Associations:

To provide protection of human subjects while maximizing the freedom of their members, professional associations and universities offer an alternative outside the legal system. Most social research organizations provide their members with ethical guidelines.

Anyone, including research subjects or other professionals, can call attention to violations of these guidelines. Indeed the members of these associations have an obligation not only to adhere to their group’s standards but also to see that their fellow members adhere to them as well.

These organizations and their members can enforce their principles in various ways. Most of these associations own journals and can deny publication of research reports based on unethical treatment of human subjects.

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Some associations issue public reprimands to unethical members, which can threaten their continued employment and funding. The ultimate sanction that such voluntary groups can impose is removal from the membership.

The human subject portions of the ethical guidelines illustrate the similarities and differences across different disciplines. Anthropologists’ wide use of field observation methods creates special concern for their key informants and the protection of the general population being studied (often minority or Third World cultures).

Psychologists’ extensive use of experimental designs explains their special concern with such matters as deception. Psychologists also sometimes use animals in their research, and these subjects are also protected in the American Psychological Association’s ethical guidelines. Sociologists’ frequent use of archival records and surveys accounts for their emphasis on matters related to confidentiality.

Ideally, scholars will learn and internalize the guidelines detailed in these tables and in turn identify and eliminate threats to human subjects. Sadly, not all members of a discipline obey these codes. Moreover, some of these principles seem unclear. As a result, professional associations sometimes need procedures to clarify and enforce their rules.

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For example, the American Psychological Association (APA) has an Ethics Committee that reviews complaints about APA members and reports to the membership on trends in these complaints and their adjudication. Such complaints have increased with the membership from an average of about 57 per year in the 3-1/2 years up to 1980 (Sanders & Keith-Spiegel, 1980) to 88 per year in 1986 and 1987 (Ethics Committee of the American Psychological Association, 1988). However, most of these ethical cases involve issues outside the research domain.

The Ethics Committee opened only 3 cases regarding improper research techniques in the years 1990 through 1992 out of 264 total cases in those years (Ethics Committee of the American Psychological Association. 1993).

Given the large membership of APA (over 72,644 in 1992) and the relatively intrusive nature of many psychological experiments, this record suggests little need for concern. However, another report based on a large sample (n = 19,000) of the membership yielded 5,000 descriptions of ethically troubled human research studies (Ad Hoc Committee on Ethical Standards in Psychological Research, 1973).

The number and severity of these descriptions suggest that the association’s Ethics Committee may fail to hear many violations. Some psychologists may refuse to report fellow psychologists for ethics violations.

The percentage of complaints to the APA filed by psychologists fell from 32 percent in 1983 to 18 percent in 1987 (Ethics Committee of the American Psychological Association. 1988). Perhaps this drop reflects that government policy to protect human subjects may have succeeded in preventing research infractions common in the past.

II. Preventing Human Subject Violations

Federal Requirement of Prior Review:

Moved by the Tuskegee Syphilis Study scandal, Congress passed the National Research Act in 1974, which led to the establishment of the National Commission on the Protection of Human Subjects of Biomedical and Behavioral Research. Its recommendations in 1978 led the Department of Health and Human Services to issue regulations finalized in 1981.

Because of the seeming inability of the legal system and professional organizations to protect human subjects, the federal government took charge of stopping harmful research practices. Because it provides a large share of the funds for social research, the government can set guidelines that directly or indirectly influence most research.

Federal regulations now require that each institution that sponsors any research funded by the Department of Health and Human Services establish local review committees to screen proposals. Even if a researcher could function without federal funds, he or she usually still needs the permission of an institution to use its facilities, subject pool, and graduate assistants.

Institutional Review Boards:

In 1981, the current federal regulations appeared in the Federal Register. These guidelines define the types of prior review provided by institutional review boards (IRBs).

Although required only for projects with or seeking federal funds, these guidelines usually apply to all research at each institution. Each institution must state how it will review nonfederal funded research.

Voluntary agreement to apply the federal guidelines to nonfederal funded research shows the institution’s commitment to the protection of human subjects.

Human research proposals fall into three categories of review: exempt, expedited, and full. The first category, exempt, includes no- or very low-risk proposals as judged by the investigators and applies to research not requiring formal review by the IRB. A researcher with a proposal that he or she judges to fall in the exempt category need file only an Exempt Registration Form with the IRB showing evidence that the researcher’s department chair or dean has reviewed the proposed research. Exempt studies include the following categories:

1. Research on “normal educational practices”

2. Use of educational tests, surveys, or observations of public behavior unless the subjects can be identified and disclosure of their responses could harm their legal or financial standing or their reputations

3. Use of educational tests, surveys, or observations of public behavior not exempt under the second category if the subjects are elected or appointed public officials or candidates for public office or if federal statutes require that the confidentiality of the personally identifiable information be maintained

4. Study of existing data if the data are publicly available or if subjects cannot be identified

5. Research and demonstration projects conducted by approval of federal agency heads that are designed to promote or improve public service programs

6. Taste and food quality studies not involving additives or with ingredients at levels found safe by federal agencies

The option of researchers to exempt their own research from review has raised concern in those who want maximum federal protection of human subjects {Veatch, 1981).

In contrast, others have noted some types of nonexempt research that they believe should have been exempted {Thompson et al., 1981). Finally, remember that the federal procedures define a minimum level of protection to which each institution or IRB can add higher standards.

If the researcher claims no exemption, he or she must submit the research proposal for review by the IRB. Full review involves a formal evaluation by the entire IRB. A speedier form of review, called expedited review, can be conducted by a single experienced member of the IRB (for example, its chairperson).

Expedited review applies to relatively low-risk research involving mainly biomedical techniques such as collecting hair, nail clippings, sweat, small amounts of blood, or dental plaque.

Social research techniques considered low risk for expedited review include noninvasive physiological recordings of adults (for example, testing sensory acuity); voice recordings; the use of existing documents; and nonstressful studies of group behavior, perception, and cognition.

Full review applies to proposals that do not fall in the exempt or expedited categories. In full review, the committee tries both to assure no excessive risk of harm and to weigh the relation of benefit to harm in the utilitarian sense.

The full review judges the adequacy of the informed consent procedure and the protection of the subjects’ identity where appropriate.

The IRB must decide whether the subjects have the ability to give informed consent (for example, in studies using children and mentally disabled subjects) and whether the study poses any risk of coercion (for example, studies of students or prisoners in a dependent relationship to the investigator).

Informed Consent:

The matter of informed consent often plays a key role in deciding approval for research. Where the researcher can obtain such prior consent, the standards for the procedure seem clear. Ordinarily, the researchers should provide the prospective subject with verbal and written information about the study and a waiver form for his or her signature.

The information that provides the basis for this consent usually includes the study’s purpose and duration, subject confidentiality procedures, risks and benefits, which to contact for further details, and a statement that participation is voluntary with no penalty for stopping at any time.

After receiving and considering this information, the subjects can indicate their consent to participate in writing. This written consent does not waive any of the subject’s legal rights or release the researcher from liability for negligence in the research project.

Federal rules permit IRBs to waive the requirement for written informed consent, but they do so reluctantly and only for very good reason. An IRB may waive informed consent when the research cannot proceed without the waiver.

For example, experiments that depend on deception would not succeed if the subjects knew of the deception in advance.

In some field studies, the participant- observer can gain entry only by concealing his or her research role. Such studies would become impossible if prior informed consent were needed. The IRB will grant such waivers only if the risk to the subjects appears minimal and warranted by the benefits expected from the study.

Usually, the researcher, in exchange for the waiver of prior consent, must provide full information to the subjects at the end of the study.

The IRB’s deliberations take place in the context of continuing debate between those who oppose deceptive research procedures on principle (Baumrind, 1985) and those who have found significant effects of such ethical requirements on research outcomes (Trice, 1987).

Not surprisingly, IRB decisions have varied in response to the social sensitivity of the research topic. In one survey, IRBs were more likely to reject proposals that dealt with issues such as racial or sexual discrimination (Ceci, Peters, & Plotkin, 1985).

Some researchers who desire more consistent IRB decisions have proposed supplying a casebook of actual research protocols to help standardize decisions over time and across different IRBs (Rosnow, Rotheram-Borus, Ceci, Blanck, & Koocher, 1993). For further discussion of ethically troublesome research that an IRB might evaluate, see Reynolds (1979, 1982).

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