Rights Of Human Subjects Research Articles

Hospice research: the importance of program participation.

Hospice research is needed in order to understand the complex phenomena of holistic care for terminally ill persons and their families. Hospice program participation is key to future hospice research efforts. The purpose of this article is to encourage hospice programs to participate in hospice research. The discussion includes why research is done, who undertakes a research project, the role of institutional review boards in assuring rights of human subjects and potential strategies for recruitment of research subjects. The authors use their experiences with conducting hospice research to illustrate potential recruitment strategies.

Nursing research in the United States: The protection of human subjects

In the United States the protection of the rights of human subjects in experimentation has evolved at three levels: professional, public, and private. At the professional level, codes, guidelines and the Patient's Bill of Rights address the issues of protecting the dignity, privacy and autonomy of individuals who serve as research subjects. At the public level, regulations promulgated by the Food and Drug Administration and the Department of Health and Human Services have become the standard for protecting human subjects. At the private level, United States common law regulates the conduct of individual researchers by requiring them to act in a manner consistent with generally accepted standards of care. As professionals, nurses must be actively involved in the formation of public policy regarding the conduct of research and strive to formulate a research agenda that will ensure that the ethics of research in nursing is above question.

Ethical concerns in research with adolescents.

A REVIEW of the nursing literature indicates that there is a scarcity of both theoretical articles and empirical studies published about the adolescent population. Thus, there is more than just a need to advance knowledge in this area; it is essential to build a knowledge base about this critical phase of human development. The absence of a solid knowledge base creates problems for clinicians in keeping current in their practice with adolescents. Perhaps this gap in knowledge is due to the erroneous belief that adolescents are difficult as subjects in research. Nevertheless, in order to increase the knowledge base regarding adolescent health problems and to understand phenomena relevant to adolescents, research must be conducted with this age group. As with any study, when research is planned and conducted, the nurse investigator must carefully guard against infringement of the rights of human subjects by insuring that the ethical guidelines prescribed by the Institutional Review Board (IRB) and the American Nurses’ Association (ANA, 1985) are followed. However, ethical concerns not addressed in IRB reviews can arise in the research process. This column focuses on ethical concerns in the conduct of adolescent research that have been experienced by the authors, along with the strategies used to deal with them. In 1982, we began a program of research on adolescent health care. Although IRB approval was given for each study, we were-and continue to be-vigilant in trying to identify subtle ethical concerns that might arise in the research process concerning the two adolescent populations of interest to us: those who are well and those who

History of FDA Regulation of Clinical Research

Since 1962, when the Food and Drug Administration was given broad power to regulate investigations of new drugs, several major regulatory themes have emerged. First, the FDA has sought to protect the rights of human subjects by demanding adequate preclinical safety studies and requiring that investigators obtain subjects' informed consent and give proper consideration to ethical issues. Second, the FDA has sought to ensure the integrity of data produced by clinical trials through recordkeeping requirements and enforcement actions against investigators and sponsors. Finally, the FDA has to some extent involved itself in the scientific merits of proposed research, although the Agency's role in this regard has been controversial. Recent revisions in the FDA regulations governing investigational new drugs are unlikely to make fundamental changes in the Agency's programs.

Ethics in evaluation: Beyond the standards

First , I'd like to outline some ideas about some criteria for making ethical judgments and when those ethical judgments might be made. In particular, I'm going to focus on two areas: setting up the evaluation question or negotiating the evaluation contract, and instrumentation. The first thing I did when I started thinking about this topic was to look up ethics in the dictionary. I came up with two definitions which I think will help illustrate my point. One definition of ethical behavior is conforming to the standards of conduct for a given profession. I think for most of us that's what we think about when we think about ethical behavior as evaluators-conforming to the standards of our profession. The other definition is conforming to moral standards; having to do with ethics or morality. This presentation deals with more than just conforming to the standards of our profession. I would like to emphasize that to be an ethical evaluator, it's first very important that you conform to the standards of our profession. If you don't do that, clearly you aren't being ethical. But beyond that, evaluation is a peopletype business. We deal with people on a regular basis, and as people dealing with people, there are additional ethical issues that we need to consider.' Obviously we follow the Joint Committee Standards. We look at the ERS Standards. We look at the ethical standards for conduct of research with human participants, the APA standards. We look at standards for conducting anthropological studies put out by the American Anthropological Association. Federally mandated institutional review boards that look at the rights of human subjects are in place for all of us. Those are the kinds of standards we must follow, but is there something else? Are there other considerations that we need to look at?

Comprehension of Informed Consent for Research: Issues and Directions for Future Study

policy to protect the rights of human subjects participating in biomedical and behavioral research,' and each individual investigator bore responsibility for this process. Although the informal procedure appeared, on the surface, to be adequate, a growing body of reports of serious abuses and infringements on the basic human rights of subjects'-5 led to the development of increasingly specific requirements for presentation of written information and for signed documentation of voluntary informed consent.

Advocacy and Research: A Parent's Perspective

The reduction in public expenditures for research and the rise in consumerism have combined to make parent advocate groups a potentially powerful and active force on behalf of research. This article attempts to outline this present situation from the parents' viewpoint, including parental hesitation about research and researchers, suggestions on developing a “research constituency,” areas of research of particular interest to parents, the rights of human subjects, and the implications of parent involvement in accountability.

Privacy, Privilege, and Transportation Research

The increasing danger of legal entanglement for researchers who disregard the rights of human subjects used in research, in particular their right of privacy, is examined. The broad definition of a human subject and the equally broad definition of injury are discussed. The implications of the Privacy Act of 1974 are noted, and the critical need for a researcher-privilege statute set forth.

Reader response to: ethical inquiry in nursing research.

The last Nursing Forum (Vol. VI, No. 1) Contained an article by Dr. Florence S. Downs which raised certain issues about the ethical Standards that should prevail in nursing research, particularly those needed to ensure the rights of human subjects of research. In the belief that these Issues merit considerable thought from different point of view, we asked several nurses who were or had been involved in research to discuss Dr. Downs's article. The three reactionnaires presented here are the immediate responses to this request.

Privacy and Behavioral Research

From our examination of the relation of behavioral science research to the right to privacy, we have been led to the following conclusions. 1) While most current practices in the field pose no significant threat to the privacy of research subjects, a sufficient number of exceptions have been noted to warrant a sharp increase in attention to procedures that will assure protection of this right. The increasing scale of behavioral research is itself an additional reason for focusing attention in this area. 2) Participation by subjects must be voluntary and based on informed consent to the extent that this is consistent with the objectives of the research. It is fully consistent with the protection of privacy that, in the absence of full information, consent be based on trust in the qualified investigator and the integrity of his institution. 3) The scientist has an obligation to insure that no permanent physical or psychological harm will ensue from the research procedures, and that temporary discomfort or loss of privacy will be remedied in an appropriate way during the course of the research or at its completion. To merit trust, the scientist must design his research with a view to protecting, to the fullest extent possible, the privacy of the subjects. If intrusion on privacy proves essential to the research, he should not proceed with his proposed experiment until he and his colleagues have considered all of the relevant facts and he has determined, with support from them, that the benefits outweigh the costs. 4) The scientist has the same responsibility to protect the privacy of the individual in published reports and in research records that he has in the conduct of the research itself. 5) The primary responsibility for the use of ethical procedures must rest with the individual investigator, but government agencies that support behavioral research should satisfy themselves that the institution which employs the investigator has effectively accepted its responsibility to require that he meet proper ethical standards. 6) Legislation to assure appropriate recognition of the rights of human subjects is neither necessary nor desirable if the scientists and sponsoring institutions fully discharge their responsibilities in accommodating to the claim of privacy. Because of its relative inflexibility, legislation cannot meet the challenge of the subtle and sensitive conflict of values under consideration, nor can it aid in the wise decision making by individuals which is required to assure optimum protection of subjects, together with the fullest effectiveness of research.

Privacy and behavioral research: Preliminary summary of the report of the Panel on Privacy and Behavioral Research.

From our examination of the relation of behavioral science research to the right to privacy, we have been led to the following conclusions. 1) While most current practices in the field pose no significant threat to the privacy of research subjects, a sufficient number of exceptions have been noted to warrant a sharp increase in attention to procedures that will assure protection of this right. The increasing scale of behavioral research is itself an additional reason for focusing attention in this area. 2) Participation by subjects must be voluntary and based on informed consent to the extent that this is consistent with the objectives of the research. It is fully consistent with the protection of privacy that, in the absence of full information, consent be based on trust in the qualified investigator and the integrity of his institution. 3) The scientist has an obligation to insure that no permanent physical or psychological harm will ensue from the research procedures, and that temporary discomfort or loss of privacy will be remedied in an appropriate way during the course of the research or at its completion. To merit trust, the scientist must design his research with a view to protecting, to the fullest extent possible, the privacy of the subjects. If intrusion on privacy proves essential to the research, he should not proceed with his proposed experiment until he and his colleagues have considered all of the relevant facts and he has determined, with support from them, that the benefits outweigh the costs. 4) The scientist has the same responsibility to protect the privacy of the individual in published reports and in research records that he has in the conduct of the research itself. 5) The primary responsibility for the use of ethical procedures must rest with the individual investigator, but government agencies that support behavioral research should satisfy themselves that the institution which employs the investigator has effectively accepted its responsibility to require that he meet proper ethical standards. 6) Legislation to assure appropriate recognition of the rights of human subjects is neither necessary nor desirable if the scientists and sponsoring institutions fully discharge their responsibilities in accommodating to the claim of privacy. Because of its relative inflexibility, legislation cannot meet the challenge of the subtle and sensitive conflict of values under consideration, nor can it aid in the wise decision making by individuals which is required to assure optimum protection of subjects, together with the fullest effectiveness of research.