Informed Consent in Clinical Trials (CT)

1. Informed Consent in Clinical Trials(CT) • WhatisInformedConsentProcess? • Inclinical research(CR) trial Informed Consent Process is a series of conversions between the clinical trial participants andprinciple investigators. It is very essential before enrolling a participant and ongoing process. As new medical products are being developed, no one knows for sure how well they willwork,orwhatriskstheywillfind. • Iftheparticipantwantstogetinvolvedinthe clinicalresearchtrial,heorshe givesvoluntaryconsentbysighininganddatingthewritteninformedconsent document of which he or she also receives a copy. The potential participant hasrighttobackoutfromconsentatanytimewithoutpenalty,reverberation orreason. • WhyIsInformedConsentsoImportant? • InformedconsentisaveryimportantpartofenrollinginaCTbecauseityields thepotentialpatientalltheinformationthattheyrequiretounderstandwhat theyarevolunteeredfor. • It is very essential for people thinking about participating in a CR trial to accepttheirroleinstudy.Thesestudiesareexpectedtotesttheassuranceand efficacy of new treatments and therapies on people. Due to this, participants must be aware that they are acting as subjects in clinical research study and not aspatients. • Even supposing participants may receive personal treatment and care from physiciansordoctorsoverthecourseoftrial,theymustalsoinformedthat • TherearehazardsinvolvedinCTparticipation • Researchteamdoesn’tguaranteeaboutthebenefits • Investigators have right to exit theCT • Sometimesthestudymaynotfollowstandardmedicalprocedures • This information provided through the informed consent process allows you toknowwhatyouaresigningupfor.

2. ParticipantsofInformedConsentprocess • The informed consent process in clinical research trials consists of a documentandaseriesofconversationbetweenthetrialparticipant(Potential Participant) and the principal investigator (PI). The main participants of informed consent process are potential patient and principle investigator whereasthisactivityrequiresdoctors,researchersandinvestigators. • RoleofPrincipleInvestigatorinInformedConsentProcess • Principle Investigator discusses the risks, benefits and other aspects of clinical trial with potential participant and, if required the participants legal representative before the trial begin. Informed consent is an open endedprocessthatconsistsofdocumentanda • The Principle Investigator provides enough time to the potential participantandconveniencetoaskquestionsabouttheclinicaltrialand discussthemwithhisrelativesandfamilymembers. • GuidelinesofInformedConsentProcess • The principle Investigator must follow the International Council on Harmonization (ICH) good clinical practice (GCP) guidelines. Investigators should obey to national and local regulatory requirements, sponsor requirements and personal d data security regulations applicable in the country in which the study is being conducted, in addition to following ICH guidelines. • The informed consent document must have to fully approve by an institutional review board i.e. IRB or an independent ethics committee- ICE priortoitsusewithtrialparticipants. • ElementsIncludedinInformedConsentdocument • An appropriate informed consent document should include the following elements

3. Unexpected risks in the trial for example unborn baby, if the subject is or may become pregnant. Hence the document should include a statementaboutresearchtreatment. • Reasons when the clinical trial investigator ends research subject participation.e.g.failingtofollowtherequirementsofthetrial • Consequencesofleavingatrialbeforeitiscompleted • Numberofsubjectsthatwillbeenrolledinthestudy. LanguageusedinInformedConsentprocess The language used for documentation should be simple and easy to understandtothepotentialpatientsandinvestigators.Generallymanyclinical research trials insist to use the universal language or the language of that particular countryfor documentation.