Chapter 4: Ethics in Research

Belmont Report

summarizes the basic ethical principles identified by the National Commission, which are used as the foundation upon which the federal regulations for protecting human participants are based, even to this day. **U.S guidelines (government)

National Research Act

The Act mandated regulations for the protection of human participants and had the Department of Health, Education, and Welfare create the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (Dunn & Chadwick, 1999). In 1979 the National Commission published The Belmont Report: Ethical Principles and Guideline for the Protection of Human Subjects of Research.

Common Rules

The Common Rule, as it is typically referred to, published in 1991, is based on the principles of the Belmont Report and provides a common set of federal regulations for protecting human participants to be used by review boards

Belmont Report identifies three basic principles

(1) The principle of respect for persons requires that individuals should consent to participate in studies and those who cannot give their consent, such as children, people with diminished abilities, and prisoners, need to be protected; (2) The principle of beneficence requires that the researcher not harm the participants, minimize risks, and maximize possible benefits; (3) The principle of justice requires fairness in procedures for selecting participants

Two basic categories of ethical responsibility

(1) responsibility to ensure the welfare and dignity of the individuals, both human and nonhuman, who participate in their research studies, (2) responsibility to ensure that public reports of their research are accurate and honest.

Ethical principles

(1) what measurement techniques may be used for certain individuals and certain behaviors, (2) how researchers select individuals to participate in studies, (3) which research strategies may be used with certain populations and behaviors, (4) which research designs may be used with certain populations and behaviors, (5) how studies may be carried out with individuals, (6) how data are analyzed, and, finally, (7) how results are reported.

Debriefing (saung yawet chin ko pyan lal ah C ah yim kan the)

-A debriefing is a post-experimental explanation of the purpose of a study that is given to a participant, especially if deception was used. -The final point is that deceived participants must receive a debriefing that provides a full description of the true purpose of the study, including the use and purpose of deception, after the study is completed. The debriefing serves many purposes, including: -conveying what the study was really all about, if deception was used -counteracting or minimizing any negative effects of the study -conveying the educational objective of the research (i.e., explaining the value of the research and the contribution to science of participation in the research) explaining the nature of and justification for any deception used answering any questions the participant has

Active deception

-Active deception (or commission) is the presenting of misinformation about the study to participants. The most common form of active deception is misleading participants about the specific purpose of the study.

Ethics

Is the study of proper action.

Principle of clinical equipoise

a. there is honest uncertainty about which treatment is best. b. there is honest professional disagreement among experts concerning which treatment is best.

Placebo

an ineffective/inert substitute

Anonymity

-Anonymity is the practice of ensuring that an individual's name is not directly associated with the information or measurements obtained from that individual. -Anonymity means that the information and measurements obtained from each participant are not referred to by the participant's name, either during the course of the study or in the written report of the research results.

Seven basic IRB criteira

1. Minimization of Risk to Participants. 2. Reasonable Risk in Relation to Benefits. 3. Equitable Selection. 4. Informed Consent. 5. Documentation of Informed Consent. 6. Data Monitoring. 7. Privacy and Confidentiality.

Confederates (partner, associate,ally, colleague)

Active deception can take a variety of forms. For example, a researcher can state an explicit lie about the study, give false information about stimulus materials, give false feedback about a participant's performance, or use confederates to create a false environment.

Fraud (lie, ah tu ah yaung)

Fraud is the explicit effort of a researcher to falsify or misrepresent data.

Plagiarism

Plagiarism is the representation of someone else's ideas or words as one's own, and it is unethical.

Replication

Replication is repetition of a research study using the same basic procedures used in the original. Either the replication supports the original study by duplicating the original results, or it casts doubt on the original study by demonstrating that the original result is not easily repeated. replication is one of the primary means of revealing error and uncovering fraud in research.

Clinical equipoise

The basic concept is that clinicians have an ethical responsibility to provide the best possible treatment for their patients. However, many research studies evaluate and compare different treatment options by randomly assigning patients to different treatments. If the clinician knows (or even believes) that one of the treatment conditions is inferior to the others, then some patients are being denied the best possible treatment and the ethical principle of no harm is being violated. **Clinician has to provide the best treatment to the participants.

Confidentiality

-Confidentiality is the practice of keeping strictly secret and private the information or measurements obtained from an individual during a research study. -Confidentiality ensures that the information obtained from a research participant will be kept secret and private. The enforcement of confidentiality benefits both the participants and the researcher. -First, participants are protected from embarrassment or emotional stress that could result from public exposure. Also, researchers are more likely to obtain willing and honest participants. Most individuals demand an assurance of confidentiality before they are willing to disclose personal and private information.

Deception

-Deception occurs when a researcher purposefully withholds information or misleads participants with regard to information about a study. There are two forms of deception: passive and active. -Often, the goal of a research study is to examine behavior under "normal" circumstances. To achieve this goal, researchers must sometimes use deception. For example, if participants know the true purpose of a research study, they may modify their natural behaviors to conceal embarrassing secrets or to appear to be better than they really are. To avoid this problem, researchers sometimes do not tell participants the true purpose of the study. **it has to be justice

Passive deception

-Passive deception (or omission) is the withholding or omitting of information; the researcher intentionally does not tell participants some information about the study. (Inactive) **You just not telling them the study

Research ethics

-Research ethics concerns the responsibility of researchers to be honest and respectful to all individuals who are affected by their research studies or their reports of the studies' results. Researchers are usually governed by a set of ethical guidelines that assist them to make proper decisions and choose proper actions. In psychological research, the American Psychological Association (APA) maintains a set of ethical principles for research (APA, 2002). -Consider the following examples. Suppose that, as a topic for a research study, you are interested in brain injury that may result from repeated blows to the head such as those suffered by boxers and soccer players. For obvious ethical reasons (physical harm), you could not plan a study that involved injuring people's brains to examine the effects.

APA Ethics Code

-The APA Ethics Code contains 10 ethical standards, and you should be completely familiar with all of them before beginning any research with human participants. -"This Ethics Code provides a common set of principles and standards upon which psychologists build their professional and scientific work. This Ethics Code is intended to provide specific standards to cover most situations encountered by psychologists. It has as its goals the welfare and protection of the individuals and groups with whom the psychologists work and the education of members, students, and the public regarding ethical standards of the discipline." -10 ethical: 1-No harm 2-Privacy and confidentiality 3-Institutional approval 4-Competence 5- Record keeping 6-Informed consent to research 7-Despensing with informed consent 8-Offering Inducements for research participation 9-Deception in research and 10- Debriefing *** Especially for Psychological research guideline

Institutional Animal Care and Use Committee (IACUC)

-The Institutional Animal Care and Use Committee (IACUC) is a committee that examines all proposed research with respect to its treatment of nonhuman subjects. IACUC approval must be obtained prior to conducting any research with nonhuman subjects. -Institutions that conduct research with animals have an animal research review board called the Institutional Animal Care and Use Committee (IACUC). -The IACUC is responsible for reviewing and approving all research using animal subjects in much the same way that the IRB monitors research with humans. The purpose of the committee is to protect animal subjects by ensuring that all research meets the criteria established by the code of ethics.

Institutional Review Board (IRB)

-The Institutional Review Board (IRB) is a committee that examines all proposed research with respect to its treatment of human participants. IRB approval must be obtained before any research is conducted with human participants. -which is composed of both scientists and nonscientists. The IRB examines all proposed research involving human participants with respect to seven basic criteria. If the IRB finds that a proposed research study fails to satisfy any one of the criteria, the research project is not approved. In addition, the IRB can require a research proposal be modified to meet its criteria before the research is approved.

Informed consent Information, understanding, and voluntary participation

-The principle of informed consent requires the investigator to provide all available information about a study so that an individual can make a rational, informed decision to participate in the study. -The general concept of informed consent is that human participants should be given complete information about the research and their roles in it before agreeing to participate. They should understand the information and then voluntarily decide whether to participate.

Nuremberg Code

-a set of 10 guidelines for the ethical treatment of human participants in research. -laid the groundwork for the ethical standards that are in place today for both psychological and medical research. ** International Guidelines

Consent form

A consent form contains a statement of all the elements of informed consent and a line for the participant's and/or guardian's signature. The form is provided before the study so the potential participants have all the information they need to make an informed decision regarding participation. Consent forms vary according to the specifics of the study but typically contain some common elements.

Peer review

A second safeguard against fraud is peer review, which takes place when a researcher submits a research article for publication. In a typical peer review process, the editor of the journal and a few experts in the field review the paper in extreme detail. The reviewers critically scrutinize every aspect of the research from the justification of the study to the analysis of data.