Ethical principles in research studies
Tative tation ch questions & ts, constructs & ples of research are a number of ethical principles that should be taken into account when performing undergraduate and master's level dissertation research. At the core, these ethical principles stress the need to (a) do good (known as beneficence) and (b) do no harm (known as non-malfeasance). In practice, these ethical principles mean that as a researcher, you need to: (a) obtain informed consent from potential research participants; (b) minimise the risk of harm to participants; (c) protect their anonymity and confidentiality; (d) avoid using deceptive practices; and (e) give participants the right to withdraw from your research. This article discusses these five ethical principles and their practical implications when carrying out dissertation you look at these five basic ethical principles, it may appear obvious that your dissertation should include these. However, there are many instances where it is not possible or desirable to obtain informed consent from research participants. More often than not, such choices should reflect the research strategy that you adopt to guide your y speaking, your dissertation research should not only aim to do good (i. Whilst ethical requirements in research can vary across countries, these are the basic principles of research ethics. This is important not only for ethical reasons, but also practical ones, since a failure to meet such basic principles may lead to your research being (a) criticised, potentially leading to a lower mark, and/or (b) rejected by your supervisor or ethics committee, costing you valuable time. In the sections that follow, we discuss the five of the main practical ethical principles that stem from these basic principles. Each of these basic principles of research ethics is discussed in turn:Principle one: minimising the risk of ple two: obtaining informed ple three: protecting anonymity and ple four: avoiding deceptive ple five: providing the right to sing the risk of tation research should not harm participants.
Research studies that violate ethical principles
Privacy and lly, it is not harm that we need to think about since a researcher does not intentionally go out to cause harm. In order to minimising the risk of harm you should think about:Obtaining informed consent from ting the anonymity and confidentiality of ng deceptive practices when designing your ing participants with the right to withdraw from your research at any discuss each of these ethical principles in the sections that follow, explaining (a) what they mean and (b) instances where they should (and should not) be ing informed of the foundations of research ethics is the idea of informed consent. Simply put, informed consent means that participants should understand that (a) they are taking part in research and (b) what the research requires of them. Such information may include the purpose of the research, the methods being used, the possible outcomes of the research, as well as associated demands, discomforts, inconveniences and risks that the participants may face. We discuss these in more detail under the section: avoiding deceptive ting anonymity and ting the anonymity and confidentiality of research participants is another practical component of research ethics. After all, participants will typically only be willing to volunteer information, especially information of a private or sensitive nature, if the researcher agrees to hold such information in confidence. Whilst it is possible that research participants may be hurt in some way if the data collection methods used are somehow insensitive, there is perhaps a greater danger that harm can be caused once data has been collected. However, this does not mean that all data collected from research participants needs to be kept confidential or anonymous. It may be possible to disclose the identity and views of individuals at various stages of the research process (from data collection through to publication of your dissertation). However, such a stripping of identifiable information may not always be possible to anticipate at the outset of your dissertation when thinking about issues of research ethics.
This is not only a consideration for dissertations following a qualitative research design, but also a quantitative research design [for more information, see the article: research strategy and research ethics]. That your dissertation used a quantitative research design and a survey as your main research method. If the work is later published, adjustments would then need to be made to protect the confidentiality of are also a wide range of potential legal protections that may affect what research you can and cannot perform, how you must treated the data of research participants, and so forth. After all, how can participants know (a) that they are taking part in research and (b) what the research requires of them if they are being deceived? For this reason, in most circumstances, dissertation research should avoid any kinds of deceptive practices. However, this is not always the ion is sometimes a necessary component of covert research, which can be justified in some cases. Covert research reflects research where (a) the identity of the observer and/or (b) the purpose of the research is not known to participants. Cases where you may choose to engage in covert research may include instances where:It is not feasible to let everyone in a particular research setting know what you are observation or knowledge of the purpose of the research may alter the particular phenomenon that is being 's take each of these in turn:It is not feasible to let everyone in a particular research setting know what you are feasibility, we are not talking about the cost of doing research. Instead, we mean that it is not practically possible to let everyone in a particular research setting know what you are doing. This is most likely to be the case where research involves observation, rather than direct contact with participants, especially in a public or online setting.
You may not be intentionally trying to engage in deceptive practices, but clearly participants are not giving you their informed observation or knowledge of the purpose of the research may alter the particular phenomenon that is being observations or a participants? Knowledge of the true purpose of the research have the potential to alter the particular phenomenon that you are interested in, this is a major concern in terms of the quality of your ore, when you think about whether to engage in covert research and possibly deceptive practices, you should think about the extent to which this could be beneficial in your dissertation, not research in general; that is, everything from the research paradigm that guides your dissertation through to the data analysis techniques you choose affect issues of research ethics in your dissertation [see the article: research strategy and research ethics]. Some of the following scenarios where covert research may be considered justifiable:You are conducting a piece of research looking at prejudice. Furthermore, participants are not told that the research is about prejudice because it is felt that this could alter their responses. You feel that observation would be an appropriate research method in such a naturalistic setting. Therefore, you may have received permission to go undercover or provide a story to explain why you are there, which is not the such covert research and deceptive practices, especially where used intentionally, can be viewed as controversial, it can be argued that they have a place in ing the right to the exception of those instances of covert observation where is not feasible to let everyone that is being observed know what you are doing, research participants should always have the right to withdraw from the research process. Furthermore, participants should have the right to withdraw at any stage in the research process. When a participant chooses to withdraw from the research process, they should not be pressured or coerced in any way to try and stop them from your supervisor and/or ethics committee expect you to complete an ethics consent form, it is likely that you will have to let participants know that they have the right to withdraw at any time [see the article: ethics consent form]. That you have read these basic principles of research ethics, you may want to understand how the research strategy you have chosen affects your approach to research ethics [see the article: research strategy and research ethics]. You will need to understand the impact of your research strategy on your approach to research ethics when writing up the research ethics section of your research strategy chapter (usually chapter three: research strategy).
2012 lund research are herehome » health information » nih clinical research trials and clinical research trials and g principles for ethical researchpursuing potential research participants protections. When people are invited to participate in research, there is a strong belief that it should be their choice based on their understanding of what the study is about, and what the risks and benefits of the study are,” said dr. Christine grady, chief of the nih clinical center department of bioethics, to clinical center radio in a al research advances the understanding of science and promotes human health. There are precautions researchers can take – in the planning, implementation and follow-up of studies – to protect these participants in research. Ethical guidelines are established for clinical research to protect patient volunteers and to preserve the integrity of the clinical center researchers published seven main principles to guide the conduct of ethical research:Social and clinical subject ble risk-benefit t for potential and enrolled and clinical research study is designed to answer a specific question. In other words, answers to the research question should contribute to scientific understanding of health or improve our ways of preventing, treating, or caring for people with a given disease to justify exposing participants to the risk and burden of research. Study should be designed in a way that will get an understandable answer to the important research question. This includes considering whether the question asked is answerable, whether the research methods are valid and feasible, and whether the study is designed with accepted principles, clear methods, and reliable practices. Invalid research is unethical because it is a waste of resources and exposes people to risk for no subject primary basis for recruiting participants should be the scientific goals of the study — not vulnerability, privilege, or other unrelated factors. Participants who accept the risks of research should be in a position to enjoy its benefits.
Specific groups of participants (for example, women or children) should not be excluded from the research opportunities without a good scientific reason or a particular susceptibility to ble risk-benefit ainty about the degree of risks and benefits associated with a clinical research study is inherent. Everything should be done to minimize the risks and inconvenience to research participants to maximize the potential benefits, and to determine that the potential benefits are proportionate to, or outweigh, the minimize potential conflicts of interest and make sure a study is ethically acceptable before it starts, an independent review panel should review the proposal and ask important questions, including: are those conducting the trial sufficiently free of bias? The panel also monitors a study while it is ial participants 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 t for potential and enrolled duals 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. This includes:Respecting their privacy and keeping their private information ting their right to change their mind, to decide that the research does not match their interests, and to withdraw without a ing them of new information that might emerge in the course of research, which might change their assessment of the risks and benefits of ring their welfare and, if they experience adverse reactions, unexpected effects, or changes in clinical status, ensuring appropriate treatment and, when necessary, removal from the ing them about what was learned from the information on these seven guiding principles and on bioethics in page last reviewed on march 16, media & are now leaving the nih clinical center external link is provided for your convenience to offer additional information. Atrocities committed by nazi physicians on jewish prisoners during world war ii prompted an international tribunal, convened in the city of nuremberg, germany between 1945-1946, to elaborate 10 principles, called the nuremberg code, by which research involving human subjects should be governed. Publication of the nuremburg code in 1947 ushered in the modern era of research ethics, which mandated balancing the advancement of science with the rights and welfare of humans who serve as research nuremburg, a multitude of regulations and policy statements have been developed by domestic and international bodies. These regulatory guidance documents, including the world medical association declaration of helskinki (world medical association); the belmont report and the federal regulations at 45 cfr 46 and 21 cfr 50 share a common purpose: to protect the autonomy, safety, privacy, and welfare of human research subjects. Within institutions where clinical research is conducted, responsibility for the interpretation and application of these ethical principles and regulations rests with committees comprised of scientist and non-scientists, called institutional review boards for the protection of human subjects (irbs). Ethical principles applied to research with human belmont report, which provides the ethical foundation for research regulations and guides irb deliberations, was generated by a federally commissioned group of scientists, physicians, ethicists, and philosophers and published in 1979.
The three primary ethical principles cited in belmont are: autonomy, beneficence, and my refers to the right of an individual to determine what activities they will or will not participate in. The cornerstone of protecting autonomy is the informed consent process, whereby an investigator provides a potential research participant with full disclosure about the nature of the study, the risks, benefits and alternatives, and an extended opportunity to ask questions before deciding whether or not to participate. Maximizing potential benefits is predicated on sound experimental design, thus research proposals must undergo rigorous scientific review before proceeding to the irb for ethical review. The principle of justice requires that those who undertake the burdens of research must be likely to benefit from the research, and is a principle often violated by the export of clinical trials to underdeveloped ing ethical research primary concern of the investigator should be the safety of the research participant. Protecting subject safety requires the investigator to use all available information to identify potential risks to the subject, to establish means of minimizing those risks, and to continually monitor the ongoing research for adverse events experienced by subjects. The investigator must be prepared to stop the study if serious unanticipated risks are scientific investigator must obtain informed consent from each research participant. Researchers must have mechanisms in place to prevent the disclosure of, or unauthorized access to, data that can be linked to a subject’s individual investigator must consider how adverse events will be handled. A true null hypothesis should exist at the onset regarding the outcome of the trial, that is, if a new intervention is being tested against the currently accepted treatment, the investigator should be genuinely uncertain which approach is ents of ethically valid informed consent for the appreciation that informed consent is at the crux of human subjects protection, it is not surprising that the regulations reflect extensively upon the necessary elements of the consent document itself as well as on the informed consent process. For an informed consent to be ethically valid, the following components must be present:Disclosure: the informed consent document must make clear that the study is a research study, and not clinical therapy. The potential participant must be informed as fully as possible of the nature and purpose of the research, the procedures to be used, the expected benefits to the participant and/or society, the potential of reasonably foreseeable risks, stresses, and discomforts, and alternatives to participating in the research.
The informed consent document must also disclose what compensation and medical treatment are available in the case of a research-related injury. The document should make it clear whom to contact with questions about the research study, research subjects' rights, and in case of tanding: the participant must understand what has been explained and must be given the opportunity to ask questions and have them answered by someone fully conversant in the study particulars. Consent forms for multinational research must be translated into the respective language for each participating country and back-translated to verify ariness: the participant's consent to participate in the research must be voluntary, free of any coercion or inflated promise of benefits from participation. In the event that there is a question about competence, mental status exams may be t: the potential human subject must authorize his/her participation in the research study, preferably in writing. No investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. Review of research: full-board, expedited, and exempt board: clinical trials that expose subjects to more than minimal risk must be reviewed by the irb at a convened meeting of the full board. Studies that qualify for expedited review are those that present no more than minimal risk to subjects, and involve only procedures commonly done in clinical settings, such as taking hair, saliva, excreta or small amounts of blood. A study that qualifies for expedited review is held to the same ethical standards of autonomy, beneficence and justice that are used in full board review, but the approval process may take less : some research with humans can be designated as exempt from irb review. Research that is part of a routine educational experience, or in which participants will be anonymous or effectively de-identified falls into this category and may be granted a certificate of exemption. The proposal must still be reviewed by a member of the irb to assign exempt status, but the application process may be considerably t the university irb if you have questions about the category under which your study deception of subjects allowed when doing research?
Using deception jeopardizes the integrity of the informed consent process and could harm participants, as well as eroding trust between the public and researchers. In some instances deception is necessary to conduct the research: for example, a study of how the decision-making practices of physicians affect their practice of medicine might be presented as a study of "communication behaviors. They will require an in-depth justification of why deception is necessary for the study and the steps that will be taken to safeguard participants, including a plan to debrief subjects at the end of the research. For example, if a subject consents to have their blood sample evaluated for markers of diabetes and the investigator or other scientists use the blood sample for purposes unrelated to diabetes research, the subject has effectively been deceived about the nature of their research participation and they have been denied autonomous agency over their own actions. The havasupai tribe illustrates the ethical pitfalls and legal consequences of biological sample sharing without explicit prior consent (drabiak-syed, 2010).