1. Describe the meaning of informed consentand identify issues relating to it on research human subjects Avoluntary agreement to participate in research is called informed consent.State as ethical codes and regulations in research, it is vital to protectconfidentiality and the rights of a volunteer who participate in a research.
Thereare three basic principles of informed consent which is autonomy, beneficenceand justice. Two elements of the informed consent is information element andconsent element. Informedconsent is an important requirement before a participant especially vulnerablepopulation taking part in a research. Informed consent should be documentedusing a simple language purposely to ensure it is easily understood by theparticipant. More than just a form that is signed but it is actually a process inwhich the subject has an understanding of the research and its risks. TheBelmont Report and the Nuremberg Code both state voluntary informed consent asfundamental for the ethical conduct of human subject research. So essentialselements should be included in an informed consent. Informed Consent shouldinclude all this component for all human subject research such as therapeutic,interventional, diagnostic, social and behavioral studies.
A good informedconsent also provide information to the subject about his rights, the purpose andobjective of the study, the flow of the procedures, and explanation regarding thepotential risks and benefits of participation. Not only physical injury butalso possible psychological, social, or economic harm, discomfort, orinconvenience Subjects feel free to participate or not. Statement regarding thesubjects’ right to confidentiality and right to withdraw from the study at anytime without any consequences. Person to contact for answers regarding anyquestion related to research or study should be clearly written.There is some issues related to informed consent onhuman research subject. Firstly, language barriers. All participant was assumedto understand the informed consent once it was signed but misunderstandingstill can occur because incorrect or inadequate information. Most of thesubject or participant signing the informed consent without being fully aware ornot fully understand what its all about.
Poor translation is one of the factor.So, researcher must performed informed consent in multilingual.Secondissues is religious influence. Aparticipant’s decision making sometimes influenced by their religious belief.Hence, not all subject willing to taking part in research voluntarily. Informed consent is important tool in researchand no any research activity will be carried out until it is complete.Another issues related to human subjects is false expectations and false perceptions.
Although explanation andinformation was clearly provide and given, most of participant-to-be fear of being as experimental model or hadrumors known to them regarding the misconduct or failure of the study.Vulnerable people and groups includethe person who is absolutely or relatively incapable of protecting theirinterests. As the example prisoners, children under age, pregnant women,elderly people or disable people .To obtain informed consent is difficult toget from them. So that they are creating many problem because their misunderstandingregarding the research purpose, their role in the research and the process ofthe research. Hence, special approach must to be taken to develop theappropriate strategies to communicate properly with them and to make sure thatthe message is delivered clearly. 2) Discussthe major ethical principles that guide researchers in the works.Researchis usually done using human beings with feelings and experiences.
Method ofdata in some studies also touched confidential, emotional, rights, personalthings, and the truth of the subjects. Respondents have secret or confidentialinformation, which cannot be known by others. When disclosed or announced willhave a negative impact on certain parties, researchers need to know the ethicsof research before planning and conducting research.Ethicsis derived from the Greek word meaning “ethos” which means the commonsense that is commonly matched by systematic studies of the concept of ‘good’,’bad’, ‘right’ and ‘wrong’. Ethical issues are the dilemmas and conflicts thatmay arise on a ‘suitable’ method for conducting research.
Ethics determine whatcan be done by a researcher and things cannot be done by the researchers.Basedon ethics in research, a researcher must:a) ResearchParticipant Protectionb) Confidentialityof Research Participant Informationc) PowerOptions for Engagement in Research / Issue Coerciond) InitialExplanation About Research / Informed Consente) AvoidingDeceptive Practices a) ResearchParticipant ProtectionDuringresearch, participating participants should be protected against any negativeeffects that may be either physically or mentally. Allow sufficient time forthe respondent to answer questions and not ask questions that embarrass, orcause emotional turmoil unpleasant experiences. Hence, the researcher mustfully inform the subject of any possible occurrence during the research. b) Confidentialityof Research Participant InformationAnyparticipant’s information should be protected from the general publicinformation unless the participants have given written consent that allows theresearcher to disclose such information to the public. For example, in surveysurveys, respondents’ names need not be stated. Researchers should neverdisclose information about the sample of the study until it can interfere withthe safety or dignity of the respondents.
Personal rights must be protected andcannot be known c) PowerOptions for Engagement in Research / IssueParticipant has the right to be involvedin or not in research, without compulsion. Although elected, the participant isentitled to withdraw from involvement in the research at any time, with orwithout any reason. d) InitialExplanation About Research / Informed ConsentAninitial explanation should be given to the participants about the research theywill participate in so they can choose whether to engage or not in theresearch. One of the measures to ensure ethics in research is through the useof an informed consent form. The form must be read and signed by theparticipant or guardian/parent (if it involves a child).
e) Avoidingdeceptive practicesResearchers must clearlydisclose the data and findings, explaining the procedure of the investigationand publishing status with honesty. Researchers absolutely cannot falsify dataor attempt to deceive colleagues or involved agencies and the general publicabout them. It is unethical if a researcher only refers to and reports theliterature that is in agreement with the problem and avoids any other study.For example, if a researcher enters financial aid for his study it is likelythat it will exaggerate the importance of his research and wilfully does notrefer to a study that does not support his request. (Gay & Diehl, 1992:96;Forcese & Richer, 1973:5) Good researchfeatures include scientific and ethical perspectives.
Issues become morepronounced in social research where the subject is a human who has feelings,intellect and is influenced by social and religious values. Research such asweapons is neutral but human beings determine whether it is used to advancesociety or destroy it.