Inform informed consent to be involved in a

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Last updated: February 28, 2019

Inform consent is aprincipal means for ensuring the rights of research subject or participants instudies are protected. It means that subjects agree to participate in studiesabout which they have complete understanding of the study before the study begins.Informed consentreflects the practical, ethical and legal conceptions (Adams, et.al.,2007).

Therefore,the it is a must for a researcher to document that informed consent wasobtained. Informed consent may be obtained in written or oral form. As for oralpermission informed consent, it must be witnessed by a third person (Nieswiadomy, 2014). If self-reportquestionaires are used, a statement like “RETURN OF THIS QUESTIONAIRE WILLINDICATE YOUR CONSENT TO PARTICIPATE IN THIS STUDY” should be included on thequestionaire.

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Subjects are well informed and free to make decision whereby theyare allowed to withdraw at any time. Victorian Charter of Human Rights (2006) states thatinformed consent: “must be voluntary and the person concerned must have beengiven sufficient information for an informed decision to be made.” According to Neff (2008), the importance and integrity of informed consent isbased on partnership agreement between researchers and subjects in sharingtheir understanding of a study. It is not merely to have a signature on a formbut it is a process that involves exchange of information and communicationbetween reseacher and subjects in the decision- making process (U.S. Food and Drug Administration, 2014).

To the general community, informedconsent is an important issue which in many ways defines the commitment of thehealth system to genuine consumer engagement beyond diagnostic services whileat a broader level, consent processes help deliver services that are moreclosely aligned with the priorities and concerns of the community (Consumers Health Forum of Australia, 2013).The concept of informedconsent is embedded in the principles of Nuremberg Code, The Declaration ofHelsinki and The Belmont Report (Nijhawan,2013). The BelmontReport indentified three basic principles to be followed by all researchers.

One of it is all human participants are to “be treated as autonomous agentscapable of self-determination”. This implies that all participants must giveinformed consent to be involved in a research project, after given adequateinformation, understand the researchs protocol, and they are allowed towithdraw from the project at any point. Few studies support the position thatimproved communication between clinicians and consumers overall contributes toboth increased adherence to treatment regimes (Bull,  Hu & Hunkeler, 2002), improved long-termhealth outcomes, increased patient satisfaction, faster recovery, reducedemotional distress, a lower level of pain relief used and in some cases areduced length of stay in hospital (Consumers Health Forum of Australia, 2013).However, there are still many covertbarriers to understanding the informed consent process that lead to ineffectivecommunication between the participants and researchers (Escobedo et. al 2007) involvinglanguage barriers and cultural and religious influences. LanguagebarriersManyindividuals sign the consent form without being full understanding, whichresults in withdrawal of subject at later stages of ongoing clinical studies (Nijhawan, 2013).

Although  the responsibility of researcher enlargeswhen a study is performed in multilingual subjects, it is still very difficultto evaluate participant’s viewpoint about trial since there is no establishedmethod to measure the level of understanding that a participant has. Appelbaum et al. (2002) reportsthat 69% of the participants in their study “research subjects systematicallymisrepresent the risk/benefits ratio of participating in research.” failed tounderstand the meaning of randomization.Culturaland Religious influencesBeyondlanguage, cultural and religious issues will also affect a patient’sunderstanding of the consent process and content. In some cases, for example, apatient’s community or self-identified group may have a relative lack ofbackground knowledge about a certain disease or risk factor (Fleisher et.

al.,2018). In other cases, the patient may share a set of core beliefs thatessentially rule out a proposed procedure or test for example Jehovah’sWitnesses believers refuse blood transfusions, including autologoustransfusions in which a person has their own blood stored to be used later in amedical procedure (British Broadcasting Corporation, 2009).

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