Informed consent is an authorization verbally or writtenagreement to participate in research.
Basically, participant involves arevoluntarily without compulsion and there are rational decision to participate.There is a common procedure to go through before starting any study orresearch. Informed consent document must be clearly written and must beunderstandable by the participant. The consent must use the easy language andshould be define or explained in lay terms if the words are scientific or thereis medical terms. The informed consent is an important agreement beforeregister a participant.Indeed, the informed consent is described an ethical codesand legal for human subjects research. The aim of informed consent process isto provide sufficient detailed information on the study.
The participants areentitled to ask question and researcher must answer those question.Furthermore, allowing sufficient time for participant to make their decision.Therefore, the participant will make decision whether they are enroll or not tocontinue in the study. However, the participants have the right to refuse toparticipate in this study without penalty if they wish. However, there are some issues relating research on humansubject:1. Potential risk to subjectPotential risk can be widely categorized in human research.
Researcher need to take precaution to minimize potential of risk. The potentialrisk in human research included; a) Risk ofphysical includes injury, physical discomfort, illness or disease cause byresearch method and procedure.b) Psychologicalrisks include the level of muscle tension such as depression, anxiety and lossof self-esteem.c) Risks oflegal happened when the method of research violate the law rules designated. Ithappen either by exposing the subject or other person engaging in an activitywhere the subject can be a criminal.d) Social oreconomic risk occur due to changes in the relationship between subjects andothers people who are disadvantage such as shame, loss of respect of others andlabeling the subject in a way that bring negative. While economically includingpayment by subject to unnecessary procedures, loss of salary and any financialcosts such as damage to the subject’s marketability as a result ofparticipation in research. 2.
Deceptive practiceDeceptive happen when a researcher gives false informationto the subject or deliberately misleads them about some of the key aspect ofresearch. This may include feedback on the subject involving creating falsebeliefs about relationship or the manipulation of self-concept.3. Confidentially. Confidentially needs to be maintained in order not to leakinformation.
The subjects have the right to be protected from injury or unauthorizedintrusions into their privacy and the preservation of their personal dignity.Benefits of maintaining confidentially will help to establish trust between theparticipant and researcher and participant feels more respected. Research Ethics is essential to comply with ethicalprinciples and protect the rights and well-being of research participants.Therefore, all research involving humans should be reviewed by ethicalcommittees to ensure that appropriate ethical standards are maintained.The existing source of research ethics is the Belmont Reportpublished in 1979. It is a major work on ethics and healthcare research. Itsmain purpose is to protect subjects and participants in clinical trials orresearch studies.
The Belmont Report was written by a panel of experts andproposed three ethical research principles involving human subjects. The threemajor ethical principles cited in Belmont are autonomy, beneficence, andjustice.In general, autonomy can be defined as the right of anindividual to determine the activities they want or not to participate.Specifically, autonomy requires an individual to understand what they areasking to do, make a reasonable decision about the inclusion of theirimpression on them, and make the choice to freely participate from the forcesof coercion.The principle of protecting autonomy is known as the consentprocess, in which a researcher provides potential research participants withcomplete disclosure of the types of research, risks, benefits and alternatives,and gives a chance to ask before deciding to participate.The population isconsidered as a reduced autonomy, based on the declining cognition such aschildren, cognitive disabilities or the subject of mental illness. Otherconditions such as prisoners or people with severe illnesses are consideredvulnerable populations. In some cases, children and prisoners have specificprotection to protect their autonomy as required by regulations.
Beneficence can be substantially defined for the benefit ofresearch participants. The beneficence principle is behind research efforts tominimize risk for participants and maximize benefits to participants andcommunities. Justice requires the careful selection of participants,avoiding the population of imposed participants unfair to participate, such asprisoners and organized children. The principle of justice requires that thosewho carry out the burden of inquiry should benefit from the investigation, andprinciples that are often violated by the export of clinical trials to lessdeveloped countries.
