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 adhering to ethicalprinciples and protecting the safety and wellness rights of researchparticipants. Then, all human-involved research should be reviewed by ethicalcommittees to ensure that appropriate ethical standards are maintained.The existing research ethics source is the Belmont Reportpublished in 1979. It is a major work on ethics in healthcare research. Itsmain purpose is to protect subjects and participants in clinical trials orresearch studies. The Belmont Report is written by a panel of experts andproposes three ethical research principles involving human subjects.
The threekey ethical principles quoted from Belmont’s report are autonomy, beneficence,and justice.In general, autonomy can be defined as an individual’s rightto determine the activities they want or not participate. In particular,autonomy requires an individual to understand what they are asking to do,making a reasonable decision about their entry and effect, and making thechoice to freely participate in force. The principle of protecting autonomy isknown as the consent process, in which a researcher provides potential researchparticipants with complete disclosure of the types of research, risks, benefitsand alternatives, and gives a chance to ask before deciding to take any part.
Participants are considered as reduced autonomy, based on decreased cognitionssuch as children, cognitive disabilities or mental illness. Other conditionssuch as prisoners or people with severe illnesses are considered vulnerablepopulations. In some cases, children and inmates have certain protections toprotect their autonomy as required by law. Beneficence can be clearly defined is the benefit ofresearch participants.
Profitable principles are behind research efforts tominimize risk to participants and maximize benefits to participants andcommunities. Justice requires careful selection of participants, preventingparticipants from being unfair participants to participate, such as prisonersand organized children. The principle of justice requires those who carry outthe burden of inquiry to benefit from the investigation, and principles thatare often violated by the export of clinical trials to less developedcountries.