Obtaining inform consent isa necessary process for the researcher to proceed in their research study. Informedconsent is an ethical and legal requirement for an individual who is participating in a research study. It is the action where all participants areprovided sufficient information on the study, adequate opportunity for theparticipant to ask questions and answered. The languages that use in informedconsent must be written in terms that they can understand.
Inform consent isusually in the form of document signed by the subject and relevant researchinformation, such as the purpose of the study, expected duration of study,experimental procedure to be undertake, benefits and potential risks ofparticipation, also important for the participant to make decision and confirmsfor individual willingness to involve in peculiar clinical trial andsignificance of the study for advancement of medical knowledge and socialwelfare. The subject must be given enough time to consider participation. The informedconsent document should be altered when the shortageis noted or when additional information will improve the consent process.
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However, obtaining informedconsent may sound simple enough, but there are some challenges and littleattention has been paid to these issues while preparing the consent on humansubjects. The first challenge islanguage barrier. Some of the participant that singing the consent form may ormay not have a full understanding or understanding in wrong way of what isstated on the consent forms given. Furthermore, some of the individual signsthe consent form without giving full attention to what they are singing. Nonetheless, it is quite impossible to identify everyperson’s angle of understanding since there is no special formula to measuringthe individual understanding level. This misunderstanding can occur by reasonof inadequate or incorrect language translations. This problem not only affectsthe future participants to use up the information but also may affect decisionthey are going to make.
The second challenge thatresearcher may face to obtaining informed consent is when a study involveschildren. The research study that requirethe participation of children who are under 18 years old, permission or consentmust be obtained from their parents or guardian. If the child is more than 7 years old, it ismandatory for “child assent”. Which is children are capable of becoming partners in research and that theyhave right to get information. The major challenge that arises when parents orguardian agrees and gives their permission to everything while child refuses toparticipate. There are so many different ways of perception. The patient’s perceptionalso can consider as one of the challenge to researcher.
Some individuals believe that trial is a good forfinding new things while some will put an extraburden on them. They are afraid of the risk or side effect of theprocedure. Obtaining an informed consent from such person is most difficult andchallenge for researcher. The informed consent ispurposed to distribute to everyparticipant the feel free to decide whether “do” or “do not” to be involved in a research study.
Some of individual’s decision toward toparticipating in a research study may influence by the religious. REFERENCE Astra Nova . (2016). Retrieved from 5 COMMON CHALLENGES WHEN OBTAINING INFORMED CONSENT IN CLINICAL RESEARCH: https://crotraining.co.uk/5-common-challenges-when-obtaining-informed-consent-in-clinical-research/ Escobedo, C., Guerrero, J., Lujan, G.
, Ramirez, A., & Diana. (n.d.). Retrieved from Ethical Issues with Informed Consent: http://cstep.cs.utep.
edu/research/ezine/Ezine-EthicalIssueswithInformedConsent.pdf Nijhawan, L. P., Janodia, M. D.
, Muddukrishna, B. S., Bhat, K. M., Bairy, K.
L., Udupa, N., et al. (2013). Retrieved from Informed consent: Issues and challenges: https://www.ncbi.nlm.nih.
gov/pmc/articles/PMC3777303/ Shahnazarian, D., Hagemann, J., Aburto, M., & Rose, S. (n.
d.). Retrieved from Office for the Protection of Research Subjects (OPRS): https://oprs.usc.edu/files/2017/04/Informed-Consent-Booklet-4.4.13.pdf