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Ethics in Research

Ethical Standards - Researchers Should...

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Ethics in Clinical Research

Consistent with the scientific purpose, people should be chosen in a way that minimizes risks and enhances benefits to individuals and society. Groups and individuals who accept the risks and burdens of research should be in a position to enjoy its benefits, and those who may benefit should share some of the risks and burdens. Specific groups or individuals for example, women or children should not be excluded from the opportunity to participate in research without a good scientific reason or a particular susceptibility to risk.

Uncertainty about the degree of risks and benefits associated with a drug, device, or procedure being tested is inherent in clinical research — otherwise there would be little point to doing the research. And by definition, there is more uncertainty about risks and benefits in early-phase research than in later research. Depending on the particulars of a study, research risks might be trivial or serious, might cause transient discomfort or long-term changes.

Risks can be physical death, disability, infection , psychological depression, anxiety , economic job loss , or social for example, discrimination or stigma from participating in a certain trial. Has everything been done to minimize the risks and inconvenience to research subjects, to maximize the potential benefits, and to determine that the potential benefits to individuals and society are proportionate to, or outweigh, the risks?

Research volunteers often receive some health services and benefits in the course of participating, yet the purpose of clinical research is not to provide health services. To minimize potential conflicts of interest and make sure a study is ethically acceptable before it even starts, an independent review panel with no vested interest in the particular study should review the proposal and ask important questions, including: Are those conducting the trial sufficiently free of bias?

Is the study doing all it can to protect research volunteers? Has the trial been ethically designed and is the risk—benefit ratio favorable? In the United States, independent evaluation of research projects is done through granting agencies, local institutional review boards IRBs , and data and safety monitoring boards. These groups also monitor a study while it is ongoing.

For research to be ethical, most agree that individuals should make their own decision about whether they want to participate or continue participating in research. This is done through a process of informed consent in which individuals 1 are accurately informed of the purpose, methods, risks, benefits, and alternatives to the research, 2 understand this information and how it relates to their own clinical situation or interests, and 3 make a voluntary decision about whether to participate.

Individuals should be treated with respect from the time they are approached for possible participation—even if they refuse enrollment in a study—throughout their participation and after their participation ends.

Copy on this website is based largely on this article, on an interview with Dr. Grady, and on Dr. Wendler heads the Unit on Vulnerable Populations. Social and clinical value. Respect for potential and enrolled subjects. The purpose of this module is to overview ethical issues that should be considered when designing and conducting research.

Ethical considerations in research are critical. They help to determine the difference between acceptable and unacceptable behaviors. Why are ethical considerations so important in research? First, ethical standards prevent against the fabrication or falsifying of data and therefore, promote the pursuit of knowledge and truth which is the primary goal of research. Ethical behavior is also critical for collaborative work because it encourages an environment of trust, accountability, and mutual respect among researchers.

This is especially important when considering issues related to data sharing, co-authorship, copyright guidelines, confidentiality, and many other issues. Researchers must also adhere to ethical standards in order for the public to support and believe in the research. The public wants to be assured that researchers followed the appropriate guidelines for issues such as human rights, animal welfare, compliance with the law, conflicts of interest, safety, health standards and so on.

The handling of these ethical issues greatly impact the integrity of the research project and can affect whether or not the project receives funding. Because ethical considerations are so important in research, many professional associations and agencies have adopted codes and policies that outline ethical behavior and guide researchers.

These codes address issues such as honesty, objectivity, respect for intellectual property, social responsibility, confidentiality, non-discrimination and many others. These codes and policies provide basic guidelines, but researchers will still be faced with additional issues that are not specifically addressed and this will require decision-making on the part of the researcher in order to avoid misconduct.

The resources on this page address many of those issues and the case studies used in these resources provide excellent examples of these types of issues. One of the most important ethical considerations in research is the use of human subjects.

To address these considerations, most institutions and organizations have developed an Institutional Review Board IRB. An IRB is a panel of people who help to ensure the safety of human subjects in research and who assist in making sure that human rights are not violated.

They review the research methodology in grant proposals to assure that ethical practices are being utilized. The use of an IRB also helps to protect the institution and the researchers against potential legal implications from any behavior that may be deemed unethical. Examples of some of these issues include voluntary participation and informed consent. Kelman believes that an invasion of privacy happens when private information such as beliefs, attitudes, opinions and records, is shared with others, without the patients knowledge or consent.

A researcher cannot decide on behalf of other persons on those delicate issues. All aims, instruments and methodology must be discussed with the prospective subject and the research workers prior to the investigation.

Treece and Treece suggest that whenever subjects refuse to report personal information as they regard it an invasion of privacy, the researcher ought to respect their views. They also imply that privacy can be invaded when researchers study certain groups without their knowledge and without identifying themselves. An example of such a study that the researcher hid his identity, was Humphrie's study "Impersonal Sex in public places" in which, he observed homosexuals during sexual activities in public men's rooms.

Nowadays, there is an increased concern about vulnerable groups and whether it is ethical or not for them to be used as research subjects. The different opinions about their participation in research can be attributed to their inability to give an informed consent and also to their need for further protection and sensitivity from the researcher as they are in a greater risk of being deceived, threatened or forced to participate.

Many are in favour of the use of such subjects in research whilst others would argue strongly against it. Most condition their responses according to the seriousness of the research, the level of potential risk and the availability of alternatives. Persons with diminished autonomy are also more vulnerable to invasion of privacy, since their right to privacy is limited in contrast to other's right to know.

In the case of mentally ill, family as well as employers and colleagues have the right to know while patients may not be able to see the testimony of others in their own record. In the case of mentally ill patients, it is important to measure comprehension and develop valid tools for it, before obtaining informed consent to participate in a research study.

In a descriptive study of Beebe and Smith the Evaluation to Sign Consent ESC form was used in order to document comprehension in 29 schizophrenia outpatients.

Participants prescribed two antipsychotic medications were significantly more likely to require a prompt than those prescribed only one antipsychotic. According to Lasagna there are strong feelings among professionals who disagree with experimentation on vulnerable groups. Jameton declares that in research the three more important elements are the competency of the researcher, the careful design, and worthwhile expected outcomes.

Any lack of knowledge in the area under research must be clearly stated. Inexperienced researchers should work under qualified supervision which has to be reviewed by an ethics committee. What is more, careful choice of method for data collection, to ensure validity and reliability, are two main requirements that must be met in all kinds of research. The choice depends on the object of the study.

When human beings are involved, all the ethical issues, discussed above, must be taken into account. The nature and essence of nursing reflects on human beings and their relationship with health. Raya focuses on the unique element of caring in nursing while Swanson views Nursing in the same scope as "informed caring for the wellbeing of others". Swanson suggests that nursing has to do with "science, concern for humanity and caring.

What exactly does it mean to care? Mayeroff describes caring as an interaction which offers space for personal growth for both the carer and the cared. As McNeil et al say, "care is the basis and precondition of all cure". Doing for, means predicting individual needs, encouraging, performing tasks with adequate skills and competence, protecting the patient from harm and preserving the dignity.

On the other hand, enabling, means enhancing self-care by training, informing and explaining to the patient as well as assisting with finding alternatives. However, caring is not unique in nursing. Other professions can also claim that caring is an important part of their practice.

It can not be stated either that all nursing procedures include caring. The vulnerability of the sick and the lack of patient participation in health care, creates a danger of patient exploitation by nurses. The rapid change and development of nursing emerged the need for a code of professional conduct to guide nurses in their practice. Advocacy primarily used in legal contexts, refers to the protection of human rights of people who cannot defend them for themselves.

The rights protection model implies that nurses helps persons to understand and exercise their rights. They also aim to protect and enhance personal autonomy. They should also support the patients' confidence in their own decisions and prevent limitations of their freedom. Last, the respect for persons model focuses on human dignity, privacy and selfdetermined choices that the nurse has to protect if the person is not autonomous or self-determining.

According to Johnstone all professions with a morally significant relationship with a patient ought to fulfil the role of the advocate. A common feature in professional conduct codes and those specific to research is the principle of non-malificence. The ANA Code of conduct declares that the nurse protects the clients and the public from unethical, incompetent or illegal practice of any person. Even if nurses are certain about the incompetence of the investigator, which is usually very difficult, they have to deal with serious dilemmas.

First they have to consider the fact that if patient learn that they are exposed to professional misconduct, they may lose faith in health care.

Jameton though, believes that patient should be informed as they will appreciate the trust shown to him by frankness. However, even if nurses decide that their duty of caring and being loyal to the patient is more important, they may have to deal with the hierarchical and bureaucratic systems of institutions which demand loyalty to subordinates to the institution.

In case the incompetent researcher is a higher status professional, nurses may be obliged to show loyalty, but this can conflict with loyalty to patients. Consequently, nurses may feel that their patients are vulnerable and exposed and that they can not prevent it because they do not have a voice or power to resist.

This is merely why many authors believe that it may not be possible for nurses to act as advocates of subjects in research. According to the Belmond commission the general aim of practice is to enhance the well being of individuals while the purpose of research is to contribute to general knowledge.

This distinction highlights the differences in the aims of a nurse practitioner and a researcher. It is therefore very difficult for nurses to be engaged in studies whose aim is not directly beneficial to the subject. They must though, consider that these studies may generate and refine nursing knowledge. Another problem that nurses may have to face is taking part in randomised control trials. According to Brink and Wood dedicated nurses are finding themselves under pressure when they are asked to exclude some patients from an obvious beneficial treatment such as relaxation techniques for relief of post operative pain.

Skodol Wilson implies that there should be some provisions for alternative effective care. In order to prevent human exploitation, ethics committees were introduced. If instead of the patient and his needs, the central aims of the committee are personal interests, profits and academic prestige, then nurses will have none to share their concerns with, and deal with their dilemmas in research.

The issue of confidentiality which is stated as very important in the Hippocratic oath, is another possible issue of conflict for nurses either as practitioners or researchers.

Clause 10 of the ICN Code for nurses emphasises that all information obtained during nursing practice should be kept secret apart from cases that it should be reported in a court, or in cases that the interests of society are important.

According to the professional code they can not reveal confidential information not even to the members of the research team. It is important therefore, to seek advice in ethics committees to get approval for disseminating the results of the data collection including an account of what happened.

The trust showed to them must not be jeopardised. Patients reveal information concerning their body and mind and expect them to be used only in a therapeutic manner. When dilemmas according to confidentiality arise, trust as a basic element of a therapeutic relationship should be considered and maintained. Nurses involved in research, have to consider many ethical problems relating to the issue of informed consent. The ICN code for nurses in research, states that nurses as practitioners may be called upon to witness that informed and voluntary consent has been obtained from the subjects of research.

It suggests that they should make sure that patients have fully understood what has been proposed, which means that they are aware of potential risks or discomforts. Nurses who spend more time with patients are in a good position to judge it. In addition, they must ascertain that patients have understood their right to withdraw at any time. In order to maintain the self-determination of patients, nurses must be fully informed themselves about the study and its purpose.

If nurses find out that it was not obtained in an appropriate manner, they should inform patient and refuse co-operation. Webb suggests that the informed consent is an obligation of the researcher and no nurse should obtain it on behalf of another professional, nor agree to give the explanation as a substitute. Another conflicting issue is that giving information to patients is accepted as a major role of the nurse; but if for the sake of a research, nurses have to withhold information, this may create conflicts when they have to decide whether to participate or not.

Consent, can however, be a major ethical issue for nurses when it involves persons with diminished autonomy, such as children, aged, mentally ill etc. Nurses should ascertain that consent has been obtained either from the individual, when possible, or, by relatives or guardians.

Ethical Issues

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Ethical issues are important in all types of research. Regardless of the type of research, the researcher should take into consideration both general research principles and those that are more specific to the type of research being conducted.

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While these issues are indeed a key part of research ethics, there are also wider issues about standards of conduct. These include the importance of publishing findings in a transparent way, not plagiarising others’ work, and not falsifying work. The Importance of Research Ethics.

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Ethical Issues There are a number of key phrases that describe the system of ethical protections that the contemporary social and medical research establishment have created to try to protect better the rights of their research participants. Background: Research ethics involve requirements on daily work, the protection of dignity of subjects and the publication of the information in the research.

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Stem cell research is one example of an area with difficult ethical considerations. As a result, stem cell research is restricted in many countries, because of the major and problematic ethical issues. Education in research ethics is can help people get a better understanding of ethical standards, policies, and issues and improve ethical judgment and decision making. Many of the deviations that occur in research may occur because researchers simply do not know or have never thought seriously about some of the ethical norms of research.