GUIDANCE TO APPLICANTS FOR THE . - Research.moh.gov.bh

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Version 2Final draft 2GUIDANCE TO APPLICANTS FOR THE APPROVAL OFHEALTH RESEARCH IN HUMAN SUBJECTSHealth Research Committee201619 June 2012Page 1 of 31

Version 2Final draft 2TABLE OF CONTENTSPAGELIST OF ABBREVIATIONS . 5GLOSSARY OF TERMS. 6INTRODUCTION . 8BACKGROUND: THE HEALTH RESEARCH STRUCTURE INTHE MINISTRY OF HEALTH . 9INSTRUCTIONS FOR THE ETHICAL APPROVAL OFHEALTH RESEARCH . 101.GENERAL . 102.RISK ASSESSMENT OF RESEARCH . 113.SCOPE FOR REVIEW . 124.SUBMISSION . 124.1. DOCUMENTATION REQUIRED . 124.1.1.‘Minimal risk’ (low-risk) research . 134.1.2.‘Greater-than-minimal-risk’ (high-risk) research . 134.2. DIRECTING YOUR RESEARCH APPLICATION . 144.3. CONTACT DETAILS FOR SUBMISSION . 154.4. SUBMISSION PROCESS . 175.REVIEW TIMEFRAME & PROCEDURE . 176.APPROVAL . 186.1. APPROVAL LETTERS . 187.APPEALING A RESEARCH COMMITTEE DECISION . 207.1. HOW TO SUBMIT AN APPEAL . 207.2. NOTIFICATION OF THE APPEAL PANEL’S DECISION . 218.RESEARCH FUNDING . 218.1. ELIGIBILITY . 218.2. EXCLUSION CRITERIA DURING PRELIMINARYSCREENING OF APPLICANTS FOR RESEARCHGRANTS . 229.POST-APPROVAL REPORTING REQUIREMENTS . 229.1. AMENDMENTS (Form 3). 229.2. UNANTICIPATED/SERIOUS EVENT REPORTS (Greaterthan-minimal-risk research only) (Form 4) . 239.3. ANNUAL RENEWAL REPORTS AND STUDYCOMPLETION REPORTS (Form 5, Form 6) . 2310. ADDITIONAL CONSIDERATIONS . 2410.1. PARTICIPANT ANONYMITY AND DATACONFIDENTIALITY . Error! Bookmark not defined.19 June 2012Page 2 of 31

Version 2Final draft 210.2. COLLECTION OF BIOLOGICAL SAMPLESError! Bookmark not defined.10.2.1. Informed consent for collection of new samplesError! Bookmark not defin10.2.2. Informed consent for secondary use of old samplesError! Bookmark not d10.2.3. Disclosing results of laboratory tests to researchparticipants. Error! Bookmark not defined.10.3. ACCESS TO PATIENT MEDICAL RECORDS ANDIDENTIFIABLE INFORMATION FROM THE MOHError! Bookmark not define10.4. PARTICIPANT COMPENSATIONError! Bookmark not defined.11. FREQUENTLY ASKED QUESTIONS . 2412. SUGGESTED READING . 2719 June 2012Page 3 of 31

Version 2Final draft 2LIST OF FIGURESPAGEFigure 1Health Research Structure, MOH . 9Figure 2Flowchart: Where should you direct your ResearchApplication? . 15Figure 3Flowchart: Research Review & Approval Process . 19Figure 4Flowchart: Post-Approval Reporting Requirements . 24LIST OF APPENDICESPAGEAppendix A Health Research Application Forms . 29Appendix B Documentation Checklist for Submission Package . 29Appendix C Sample Informed Consent Form . 29Appendix D Post-Approval Forms/Reports . 29LIST OF FORMSPAGEForm 1Application for Approval of Minimal-Risk Research . 29Form 2Application for Approval of Greater-than-Minimal-RiskResearch . 29Form 3Amendment Request Form . 29Form 4Unanticipated/Serious Adverse Event Report . 29Form 5Annual Renewal Report . 29Form 6Study Completion Report . 2919 June 2012Page 4 of 31

Version 2Final draft 2LIST OF ABBREVIATIONSCROContract Research OrganizationEMAEuropean Medicines AgencyFDAFood and Drug Administration, United StatesICFInformed consent formICHInternational Conference on HarmonizationGCPGood Clinical PracticeHRCHealth Research CommitteeMOHMinistry of HealthNOCNo-Objection CertificatePHCRCPrimary Health Care Research Sub-CommitteeREBResearch Ethics BoardRTSTResearch Technical Support TeamSHCRCSecondary Health Care Research Sub-Committee19 June 2012Page 5 of 31

Version 2Final draft 2GLOSSARY OF TERMSAdverse event:An adverse event is any unfavourable and unintendedsign (including an abnormal laboratory finding),symptom, or disease (new or exacerbated) temporallyassociated with the use of a medicinal product orresearch procedure. For marketed medicinal products,this also includes failure to produce expected benefits(i.e. lack of efficacy), abuse or misuse.Case Report Form:A printed or electronic document designed to record allof the protocol-required information to be reported tothe sponsor on each research participant.Good ClinicalPractice:A standard for the design, conduct, performance,monitoring, auditing, recording, analyses, and reportingof clinical trials that provides assurance that the dataand reported results are credible and accurate, and thatthe rights, integrity, and confidentiality of researchsubjects are protected (a guideline developed by theICH).Greater thanminimal riskresearch:Research procedures that may include risk beyond thatordinarily encountered by participants. This researchrequires full review by the research committee.Informed consent:ICH GCP defines informed consent as a process bywhich a subject voluntarily confirms his or herwillingness to participate in a particular research study,after having been informed of all aspects of the researchthat are relevant to the subject’s decision to participate.Informed consent is documented by means of a written,signed and dated informed consent form.Informed assent:“Assent” is a term used to express willingness toparticipate in research by persons who are by definitiontoo young to give informed consent but who are oldenough to understand the proposed research in general,its expected risks and possible benefits, and theactivities expected of them as subjects. Assent by itself,however, is not sufficient. If assent is given, informedconsent must still be obtained from the subject's parentsor guardian.19 June 2012Page 6 of 31

Version 2Final draft 2Informed consentform:Signed approval form by which the subject confirms hisor her willingness to participate in a particular researchstudy.Investigationalproduct:A form of an active ingredient being tested in a researchstudy, including a marketed product when used in away different from the approved form, or when used foran unapproved indication, or when used to gain furtherinformation about an approved use.Investigator’sbrochure:A compilation of the clinical and non-clinical data onan investigational product(s), which is relevant to thestudy of investigational product(s) in human subjects.This document is usually submitted for Researchapproval in cases of clinical trials involving the use ofan unapproved product/device.Low-risk / Minimalrisk:Research in which the only foreseeable risk to theparticipant is one of discomfort.Participantrecruitmentmaterial:This includes any type of communication (e.g. flyer,radio/television script, poster, newspaper advertisement,Internet message) that is directed to potential subjectsfor the purpose of recruitment. The purpose ofsubmitting this documentation is to ensure thatrecruitment messages are appropriate and not coercive.Protocol:A document that describes the brief literature review,background, rationale, objective(s), design,methodology, statistical considerations and organizationof a study.Productmonograph:A factual, scientific document on a product that, devoidof promotional material, describes the properties,claims, indications, and conditions of use for theproduct, and that contains any other information thatmay be required for optimal, safe, and effective use ofthe product.This document is usually submitted for Researchapproval in cases of research studies involving the useof a marketed and licensed product/device.19 June 2012Page 7 of 31

Version 2Final draft 2INTRODUCTIONHealth research, whether data obtained by questionnaires, or by means of aphysical intervention on patients or health volunteers, seeks to diminish existinguncertainties and improve our understanding of health and disease. Ultimately, theresults obtained in such research contribute to appropriate and improvedhealthcare directed at meeting patients’ needs.The Ministry of Health, Bahrain (MOH) wishes to encourage research related tofundamental biological processes, diseases of national priority and quality ofhealthcare management, in the belief that a collaborative research effort canaccelerate the acquisition of knowledge more effectively than a simple aggregateof research projects that have no interaction or thematic integration. These projectsare also viewed as an effective instrument in capacity building of a cadre ofscientists and clinicians of the highest calibre.The Health Research Committee (HRC) at the MOH plays a central role in theresearch process. As well as upholding the rights of research participants, the HRCis tasked with assessing the risk-benefit profile and methodology of research,ensuring consent is valid, protecting confidentiality and privacy of subjects,providing research grants and more recently with the monitoring of ongoingresearch. The scientific and ethical evaluation of a research protocol is not to beconsidered as an administrative obstacle but rather as an integral part of theresearch process.This Guidance manual accompanies the Online MOH Research ApplicationSystem developed for the approval of health-related research studies conductedwithin MOH healthcare facilities. It is a reference document that provides detailedcontext for the questions asked and directs applicants to other related sources ofinformation.Undoubtedly, this document will significantly contribute to a more streamlinedapproach that should facilitate efficient ethical review of health research studies,and should improve the calibre of applications completed by researchers andsubmitted to the HRC. It will also be key in facilitating communication andinteraction between researchers and the HRC, allowing both to work together aspartners in the process of ethical review. It is therefore, strongly suggested thatinterested researchers consult the following instructions for proposed healthresearch.19 June 2012Page 8 of 31

Version 2Final draft 2BACKGROUND: THE HEALTH RESEARCH STRUCTUREIN THE MINISTRY OF HEALTHHealth research was identified as one of the twelve strategic goals in the "BahrainHealth Strategy: Framework for Action 2015-2018" under the Strategic GoalNo. 2:Integration of services in the Health system throughout Ministry of Healthand with other governmental and private institutes , initiative No. 2: DevelopHealth Research Management System and link it with concerned stakeholdersRecognizing the importance of institutionalizing health research in the country,and in an effort to devote more resources towards establishing centres ofexcellence in biomedical research, the MOH set up a central Health ResearchCommittee (HRC) in 2005 by Ministerial Order No. (19) based on which, aResearch Technical Support Team (RTST) and three sub-committees; PrimaryHealthcare Research Sub-Committee (PHCRC), Secondary Health Care ResearchSub-Committee (SHCRC) and College of Health Sciences Research SubCommittee (CHSRC), were established. The aim of the RTST is to ensure thathigh ethical standards are maintained in research projects to protect the interests ofresearch participants, investigators and the MOH.Figure 1Health Research Structure, MOH19 June 2012Page 9 of 31

Version 2Final draft 2INSTRUCTIONS FOR THE ETHICAL APPROVAL OFHEALTH RESEARCHThis guidance details the procedure for application to the RTST and the peripheralresearch sub-committees. For ease, the general term ‘MOH Research Committee’has been applied to refer to the above mentioned committees throughout thedocument.1.GENERALa. Health-related research may be conducted within MOH hospitals/health centresonly after official approval has been sought and obtained from an MOHResearch Committee.b. To ensure that the participants in research studies are not unduly exposed tounreasonable or unnecessary research risks, researchers must confirm that theyhave read the “MOH Ethical Guidelines for Health Research”, the Declarationof Helsinki, and Good Clinical Practice (GCP), and ensure that their research iscompliant with these guidelines.c. The ‘applicant’ for review and approval of a research project must be thePrincipal Investigator of the study (a student/ staff who is professionally basedin Bahrain). The MOH Online Research Application System is accessiblevia the MOH intranet and internet websites.d. Completing the application in accordance with the following recommendedguidelines will speed up the process of approval and minimize any delays thatcould otherwise occur. Applicants can use the Documentation Checklists(Appendix B) for help with the completion and collation of the requisitesupporting documents.e. Only an application that satisfies all of the necessary information anddocumentation will be considered a ‘complete’ application and will bescheduled for a review. Incorrect or incomplete applications will not bereviewed until all corrections / necessary documents are in place.f. Researchers must conduct a feasibility assessment of the proposed sites forcarrying out their research, ahead of submitting an application to the MOHResearch Committees – to ensure that the facilities/departments can spare therequired staff, supplies or equipment required.g. Approval from an MOH Research Committee does not automaticallyimply that the researcher is granted access to data, medical records orbiological samples from MOH healthcare facilities. Researchers must seekpermission and follow procedures as dictated by the concerned departmentsafter presenting them with a valid MOH approval letter.19 June 2012Page 10 of 31

Version 2Final draft 22.RISK ASSESSMENT OF RESEARCHEthical approval should be considered for any research which involves humanbeings. Such studies may be of either a quantitative or qualitative nature.Currently, the MOH Research Committees reviews applications of all forms;however, the type of review depends on the type of research study, i.e.,observational or interventional.Please consider the following information to determine which category yourresearch belongs to:OBSERVATIONAL STUDIES(Non-interventional)‘Observational’ research includes: Most projects involving data collectionfrom a small number of patients. Almost all projects conducted withpreviously collected publicly availabledata. Non-interventional studies. Example: casecontrol studies, cohort studies, crosssectional studies, case reports, case series,descriptive studies. Projects involving simple non-invasiveclinical examinations or educational tests.Example: Blood pressure testing,educational tests (cognitive, diagnostic,aptitude etc). Research procedures using the followingtechniques: Anonymous questionnaires (whereidentities cannot be traced in any way) Coded (potentially identifiable)questionnaires or surveys Identifiable surveys or questionnaires Interviews (structured or unstructured),whether in person or by telephone Web-based surveysThe following studies will require in-depthreview: Major surveys or epidemiological studiesinvolving extensive data collection frompatients. Research involving sensitive, personal orpsychologically intrusive interviewquestions or questionnaires. Studies involving the extraction ofpersonally-identifiable information fromhealth records. Research using administrative or secureCLINICAL RESEARCH (Interventional)‘Clinical’ research (unsponsored or sponsored)includes: Interventional studies involving use of:drugs, therapeutic devices, surgicaltechniques or devices, diagnostic proceduresor devices, dietary interventions, newindications for approved products. These alsoinclude randomization, withdrawal oftreatment/services, or use of placebo. Genetic research, human stem cells research Interventional research involving vulnerablesubjects (minorities, children, elderly,pregnant women, human foetuses, illiteratepersons, prisoners or mentally-challengedsubjects). Interventional research that involves offeringparticipants incentives to take part (whichexceed reimbursement of travel costs,payment to compensate for work, etc).19 June 2012Page 11 of 31

Version 2Final draft 2data. Example: HID confidential databases Research involving invasive procedures,Example: collection of body samples,medical procedures. Research involving vulnerable subjects(minorities, children, elderly, pregnantwomen, human foetuses, illiterate persons,prisoners or mentally-challenged subjects). Research that involves offeringparticipants incentives to take part (whichexceed reimbursement of travel costs,payment to compensate for work, etc).Applications for approval of all observational research studies will be reviewed bythe RTST, PHCRC, or SHCRC. For clinical research studies, applications will bereviewed by the HRC after National Health Regulatory Authority , authorizationletter.3.SCOPE FOR REVIEWThe following types of submissions are in scope for review:a. Submission of Research Application for initial reviewb. Resubmission of Research Application with correctionsc. Post-approval submissions (Protocol amendments, progress reports, studycompletion report, adverse event reports, and renewal of approval)4.SUBMISSIONSubmissions to the MOH Research Committees are reviewed on a first-come,first-served basis. Research committee meetings for review of new research areusually scheduled once a week (or less, depending on the number of submissions).The Review Meeting dates and submission deadlines for each month will beposted separately on the MOH intranet and internet websites. These dates will beupdates regularly. The first 5 submissions received by the deadline will beincluded on the Research Committee’s agenda, if complete and ready for researchcommittee review. The remaining submissions will be placed on the next agenda.4.1.DOCUMENTATION REQUIREDThe following documents are required to be included in the submission package.The Documentation Checklist in Appendix B serves as a quick guide to ensurethat

This guidance details the procedure for application to the RTST and the peripheral research sub-committees. For ease, the general term ‘MOH Research Committee’ has been applied to refer to the above mentioned committees throughout the document. 1. GENERAL a. Health-related research may be conducted within MOH hospitals/health centres

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