Chapter 4, Problem 1E

To determine

To explain:

Explain the given terms.

Explanation of Solution

Ethics:

These are set of principles, policies and guidelines that define the conduct of individuals, groups and organizations as a whole. These are also termed as code of conduct. Ethical codes help us define what is right and what is wrong. Ethics is important in our day to day working to make sure we do not harm anyone even unknowingly. In corporate world it is important to follow ethical conduct to stay in the market for long term.

In research field many a times research related to living beings may cause harm to them. In such cases it is important to ensure ethical behavior so that nobody is harmed just for the sake of research process. Many authorities and regulatory bodies have defined the ethical guidelines for the researchers who include humans and animals to participate in their research.

Nuremberg code:

In 1946, criminal proceedings commenced against 23 German Physicians, because they had participated in crimes against humanity. They conducted medical experiments on prisoners without taking their consent. This in itself is a very big crime against humanity. Most of the prisoners died due to such research experiments.

This gave rose to a code, that asked for voluntary consent of people for research and that the risks of research must be lesser than the benefits it offers.

This kind of documentation called Nuremberg code which asked for consented participation in research field was the first of its kind in this field.

National Research Act:

This was the consequence of Tuskegee Syphilis study. It aimed at protecting human objects from biomedical research. Ethical principles and guidelines were laid down for the same. This act was created by the Notional commission. It aims at protecting the human participants in the researches that deal with medical field or behavioral study. It ensures no harm is caused to the human subjects in the research.

Belmont report:

The Belmont report was written for protection of human subjects in research field. The basic principles were identified that underlie the conduct of such researches designed to study behavior or medical concerns. It summarizes the three basic principles: respect for persons, beneficence and justice. It requires the researchers to take informed consent of human subjects, assess the risks and benefits and select well tried methods and procedures.

Principle of respect:

This principle deals with the fact that all individuals must be treated with respect. It consists of two aspects. Firstly, individuals must be treated as autonomous and secondly, additional protection must be provided to people with diminished autonomy. Informed content from participants must be obtained. They must be provided with understandable details about the research.

Application of this principle can be done in following ways:

• Providing relevant information to the participants of research
• It is necessary to convey the information in a manner that can be easily understood and interpreted correctly by the participants
• There must be no pressure on the participants; they must provide voluntary consent for it.

Principle of Beneficence:

This principle aims at securing the well-being of the participants. The main concern of this principle is to ensure that the research does not harm anyone and it is carried out in a manner to maximize the benefits and minimize the risks included in the research.

Application of this principle can be done in following ways:

• Assess the nature and scope of risk and benefits.
• Assess justifiability of the research.
• It should be observed whether it is necessary to include human subjects at all in the research.
• If the research includes significant risk of serious impairment or health loss, then there must be some valid justification provided to support such an act.

Principle of Justice:

The fundamental principle of justice implies that there needs to be a balance of costs, risks and benefits. The society that bears the cost must get the reward and the benefit of the research conducted. This ensures a justified approach of the research. Selection of subjects must be done by fair means.

Application of this principle can be done in following ways:

Social justice can be ensured by knowing which groups in the society ought to be part of the research, and which must not be the part of the research. There must be an order of preference in selection of classes of subjects.

Individual justice can be ensured by providing fair selection, and making sure not only few participants get benefitted and not the rest of them. This is considered under individual justice.

APA Ethic Code:

The APA 2002 ethic code deals with non-human objects, like animals. It provides the guidelines of dealing with non-human participants and ensuring that they are neither harmed nor injured during the course of the research. Research that incorporates non-human animals has helped to a great extent in understanding many processes. Thus it is important to prescribe legible guidelines for research that deal with non-human animals.

Clinical Equipoise:

In clinical research field, at times there are more than one alternative ways available to be chosen from. But there is no strong basis on which the selection can be made. It is then that the principle of clinical equipoise is used, which allows the selection on the basis of ethical consideration of the available alternatives.

Consent form:

It is a document which is legally important to be obtained before the research begins. This document states the personal approval of the participant to proceed with the research. It is a well-known fact that all the participants must be informed about the research and how it may affect them, and only when the participants give their consent, they are included in the research. Thus this document provides the written consent of the participants to be a part of the research.

Confederate:

It is a person who actually works for the researcher, but for the purpose of the research he acts as one of the subjects of the research. In simple terms is a part of the research. When dealing with the process of research, a confederate is also called a stooge.

Placebo:

In an experiment where treatment is to be tested on the subjects, there are a group of subjects who are not given the treatment, but in order to make them feel that they all have been given the treatment, this groups of subjects is given a substance or solution which contains no treatment. In this manner the subjects would never get to know whether they received the treatment or not. This substance given to the subjects which actually has no treatment effect is called Placebo. It is specifically used in experimental designs, to find the true difference between treatment effect and no treatment effect.

Common rule:

These are a set of ethical rules that apply in the research conducted in US. These rules are governed by Institutional review board. These are the baseline standards of ethics. All the government funded research is held based on these common rules. These rules relate to the research that involves human subjects as participants.

Peer review:

This is method of reviewing the research work of one researcher, by other researchers who are experts in the same field. This helps scrutinize the process of research and ensure that all ethical considerations have been taken care of. The perspective of other researchers provides insightful feedback and helps to improve the original research to a great extent.