Informed consentis a fundamental ethical requirement for research with human subjects.
It iswhen a subject voluntarily agrees to participate in a research study in whichhe or she has full understanding of the study before the study begins,(Nieswiadomy, 2014). The informed consent process is where the participant isinformed regarding all aspects of the trial, which are important for the participantto make a decision and after studying all aspects of the trial, the participantvoluntarily confirms his or her willingness to participate in a particularclinical trial and significance of theresearch for advancement of medical knowledge and social welfare (Nijhawan etal., 2013). The informed consent process might create or result several ethicalissues if it is not being done properly.
Misunderstandings between the researchers and the participants willresult due to communication barriers such as language differences and religiousdogma. The individual who signed the informed consent is assumed to have fullyunderstands the information that is stated in the consent form but it isdifficult to evaluate the level of understanding in the individual’s point ofview. Therefore, there might some degree of misunderstanding that might occurwhich in the end caused the participant to withdraw from theongoing studies (Nijhawan, 2013). Manyresearchers come out with inform consent in multilingual form as solution, butit is still difficult to evaluate individual’s viewpoint on a study as there areno verified method established to measure the level of participant’s understanding.For example, there was one study by Appelbaum et al. (2002), found that 69% of participantsmisunderstood the meaning of the word ‘randomization’.
Besides that,other issue is the participants may have a false expectation regarding theresearch. Moreover, the participants might get involved in research projectsthat they did not approve of due to misunderstandings or misinterpretationconcerning the experimental procedures (Escobedo et al., 2007).
In addition theparticipant’s perception regarding the research might affect the process ofobtaining the informed consent because they afraid of the consequences of theresearch on them. In this case, disclosing information to them might scare themaway. Therefore, it is recommended that researchers ensure all the elements ofinformed consent is described clearly and identified then documented in theconsent form. For example, in self-report types of questionnaires a statementlike “RETURN OF THIS QUESTIONAIRE WILL INDICATE YOUR CONSENT TO PARTICIPATE INTHIS STUDY” must be included. The elements ofinformed consent play an important part in the informed consent process (Nieswiadomy, 2014).The major elements include presentation of researcher’s identification and credentialed;it also describe the selection process of participants, study purposes, studyprocedures, potential risk and benefits. Besides, it also discuss about anycompensation if applicable and disclose alternative procedures involved. Anotherelement is assurance of participant’s anonymity and confidentiality.
Anindividual should be treated as autonomous which means that the individual capableof making their own decision about important personal matters. The individualshould only be involved in research if they have voluntarily give their consentand been fully informed about the nature, purpose and consequences of theresearch. Therefore the individuals’ right need to be respected and they canmake their own decision whether to participate in the research or they willrefuse to be the participant.
Thesecond requirements in the principle of autonomy is people with diminishedautonomy should be protected. This is to ensure that the persons concerned arenot involved in research which could be harmful for them with regard to aresearch project. This is because some people in society may not have thecapacity to make fully informed decisions. Beneficenceis the act that is done for the benefit of others or a duty to ensure thewelfare of the persons concerned.
This principal states that the researchshould do no harm and maximize benefits for participants and minimize risks forparticipants. Participant must be safe and feel protected by the researcherwhenever they sign he consent and agree to participate. Full explanations andinformation must be detailed to participants.
To use easy words and simple language for details so that they willfully understand and to avoid miss understand of the concepts.Thepurpose of the research is to discover new information that would be helpfulfor the society in future. It should never cause harm or injured to anyone orfind out information at the expense of other people. There is dilemma arisesfrom the researcher in this case because to avoid the risks, the researcherneeds to know what is harmful. Never take for granted that the participant willunderstand the researcher language used. The evidence obtained from the studywill show whether it is beneficence or not. In order to identify what canbenefit the patients, it may be necessary to exposed them to risks although theresearchers are obligated to do their best to minimize those possible risks andto maximize the benefits for participants.
Never exposed the participants’details to public or other researcher in any way. Participants’ personalmatters must be well kept in the separate location and data are recorded andsubjects’ name are only can be access by the researcher or members of theresearcher. Offerto answer All Questions Is made. Potential subjects must always be given theopportunity to ask any questions they may have about the research.
It is almost impossible for the researcher toinclude every aspect of the study in a verbal or written explanation. Participants frequently have questions aboutthe study and an opportunity should be presented for these questions during theverbal explanations of the research. Theresearcher is obligated to be available (by phone/email/letter) if thequestions arise at a time of if participants have questions when reading thewritten explanation of research.Anonymityor Confidentiality is assured. Anonymityoccurs when no one, including the researcher, can link to the participants’data they provide. If participants canbe linked to data, the researcher has the obligation to addressconfidentiality. Confidentiality involve protections of the participants’identity by the researchers. In manystudies, it is not possible to maintain anonymity.
The researcher will usually come face to facewith the participants in an experimental research. To assure anonymity or confidentiality,participants and the site where the conclusion of the study was conductionshould be described in general terms in the description of the sample and thesetting.Right to refuse toparticipate or to withdraw from research without penalty is assured. All participant in nursing research must bevoluntary. Even if a random sampling procedure is used to obtain participants,these people must be given the opportunity to decide if they which toparticipate.
No form of coercion shouldbe involved. There must be no penaltyfor nonparticipation. Potential researchparticipants must be informed that they may withdraw from a study at any timeand for any reason. This is particularlyimportant in experimental studies in which a treatment is involved. Participants may withdraw for any reason
