79C3C34C52B45572883A05D425EB0F82

Guidance to Applicants For the Approval of Health Research In Human Subjects

https://research.moh.gov.bh/Content/Upload/Help/GUIDANCE%20TO%20APPLICANTS%20FOR%20THE%20APPROVAL%20OF%20HEALTH%20RESEARCH%20PROPOSALS2016.pdf

http://leaux.net/URLS/ConvertAPI Text Files/BB4F9619D4251153A36D196A77694F68.en.txt

Examining the file media/Synopses/BB4F9619D4251153A36D196A77694F68.html:

This file was generated: 2020-12-01 07:54:57

Indicators in focus are typically shown highlighted in yellow;

Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink;

"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green;

Trigger Words/Phrases are shown highlighted in gray.

Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	Criminal Convictions	prisoners	2
Political	Illegal Activity	illegal	1
Political	criminal	criminal	1
Political	vulnerable	vulnerable	2
Health	Cognitive Impairment	cognitive	1
Health	Drug Usage	drug	2
Health	Healthy People	volunteers	1
Health	Mentally Disabled	mentally	2
Health	Mentally Disabled	disability	1
Health	Motherhood/Family	family	1
Health	Pregnant	pregnant	2
Health	stem cells	stem cells	1
Social	Access to Social Goods	access	4
Social	Child	children	2
Social	Elderly	elderly	2
Social	Fetus/Neonate	foetuses	2
Social	Incarcerated	restricted	1
Social	Literacy	illiterate	2
Social	Presence of Coercion	coerce	1
Social	Religion	belief	1
Social	Student	student	2
Social	Victim of Abuse	abuse	1
Social	Women	women	2
Social	Youth/Minors	minor	3
Social	education	educational	2
Social	parents	parents	1
Social	philosophical differences/differences of opinion	opinion	2
General/Other	Incapacitated	incapacity	1
General/Other	Relationship to Authority	authority	3
General/Other	cioms guidelines	cioms	2
General/Other	declaration of helsinki	helsinki	3
General/Other	participants in a control group	placebo	1

Political / Criminal Convictions

Searching for indicator prisoners:

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p.000029: - Identifiable surveys or questionnaires
p.000029: - Interviews (structured or unstructured), whether in person or by telephone
p.000029: - Web-based surveys
p.000029: The following studies will require in-depth review:
p.000029: • Major surveys or epidemiological studies involving extensive data collection from patients.
p.000029: • Research involving sensitive, personal or psychologically intrusive interview questions or questionnaires.
p.000029: • Studies involving the extraction of personally-identifiable information from health records.
p.000029: • Research using administrative or secure
p.000029: CLINICAL RESEARCH (Interventional)
p.000029:
p.000029: ‘Clinical’ research (unsponsored or sponsored) includes:
p.000029: • Interventional studies involving use of: drugs, therapeutic devices, surgical techniques or devices, diagnostic
p.000029: procedures or devices, dietary interventions, new indications for approved products. These also include randomization,
p.000029: withdrawal of treatment/services, or use of placebo.
p.000029: • Genetic research, human stem cells research
p.000029: • Interventional research involving vulnerable subjects (minorities, children, elderly, pregnant women, human
p.000029: foetuses, illiterate persons, prisoners or mentally-challenged subjects).
p.000029: • Interventional research that involves offering participants incentives to take part (which exceed reimbursement
p.000029: of travel costs, payment to compensate for work, etc).
p.000029:
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p.000029: Page 11 of 31
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p.000029:
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p.000029: data. Example: HID confidential databases
p.000029: • Research involving invasive procedures, Example: collection of body samples, medical procedures.
p.000029: • Research involving vulnerable subjects (minorities, children, elderly, pregnant women, human foetuses, illiterate
p.000029: persons, prisoners or mentally-challenged subjects).
p.000029: • Research that involves offering participants incentives to take part (which exceed reimbursement of travel costs,
p.000029: payment to compensate for work, etc).
p.000029: Version 2
p.000029: Final draft 2
p.000029:
p.000029: Applications for approval of all observational research studies will be reviewed by the RTST, PHCRC, or SHCRC. For
p.000029: clinical research studies, applications will be reviewed by the HRC after National Health Regulatory Authority ,
p.000029: authorization letter.
p.000029: 3. SCOPE FOR REVIEW
p.000029: The following types of submissions are in scope for review:
p.000029: a. Submission of Research Application for initial review
p.000029: b. Resubmission of Research Application with corrections
p.000029: c. Post-approval submissions (Protocol amendments, progress reports, study completion report, adverse event reports,
p.000029: and renewal of approval)
p.000029: 4. SUBMISSION
p.000029: Submissions to the MOH Research Committees are reviewed on a first-come, first-served basis. Research committee
p.000029: meetings for review of new research are
p.000029: usually scheduled once a week (or less, depending on the number of submissions).
p.000029: The Review Meeting dates and submission deadlines for each month will be posted separately on the MOH intranet and
p.000029: internet websites. These dates will be updates regularly. The first 5 submissions received by the deadline will be
p.000029: included on the Research Committee’s agenda, if complete and ready for research committee review. The remaining
p.000029: submissions will be placed on the next agenda.
p.000029: 4.1. DOCUMENTATION REQUIRED
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Political / Illegal Activity

Searching for indicator illegal:

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p.000029: research project be completed prior to the
p.000029: 12-month renewal date, the researcher must notify the research committee and complete the Study Completion Report (Form
p.000029: 6).
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p.000029: Page 23 of 31
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p.000029: Version 2
p.000029: Final draft 2
p.000029: Figure 4 Flowchart: Post-Approval Reporting Requirements
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p.000029: 10. ADDITIONAL CONSIDERATIONS
p.000029: Researchers must be aware of the following additional considerations while conducting their research projects within
p.000029: MOH healthcare centres or while making use of MOH resources.
p.000029: 10.1. PARTICIPANT ANONYMITY AND DATA CONFIDENTIALITY
p.000029: All health research using identifiable personal information or anonymised data from the MOH that is not already in the
p.000029: public domain must be approved by an MOH Research Committee.
p.000029: Researchers should treat all personal and medical information as confidential. This applies as much to the results of
p.000029: laboratory tests done as part of the research project, as to information obtained directly from participants or their
p.000029: medical records.
p.000029: All personal information must be coded or anonymised as far as possible and as early as possible in the data
p.000029: processing. Principal investigators have personal responsibility to ensure that procedures and security arrangements
p.000029: are sufficient to prevent breaches of confidentiality. A breach of confidentiality is an illegal offence and is subject
p.000029: to legal action according to criminal law.
p.000029:
p.000029:
p.000029: 19 June 2012
p.000029: Page 24 of 31
p.000029:
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p.000029:
p.000029: 10.2. COLLECTION OF BIOLOGICAL SAMPLES
p.000029: Version 2
p.000029: Final draft 2
p.000029: All research using human biological samples must be approved by an MOH research committee, whether these projects
p.000029: involve use of newly collected samples or secondary use of samples collected for previous research.
p.000029: 10.2.1. Informed consent for collection of new samples
p.000029: Informed consent must be taken from participants whenever a new sample is taken for the purposes of research. Research
p.000029: participants must understand what the sample is to be used for and how the results of the research might impact them.
p.000029: Consent must also be obtained for the storage and potential future use of samples. However, it is acceptable for
p.000029: researchers to use human material from a tissue/blood bank without participant consent if the samples are anonymous and
p.000029: unlinked.
p.000029: When obtaining consent to take a biological sample for research, it is important to allow for the fact that it might
p.000029: subsequently be useful for new experiments that cannot be foreseen. Therefore, unless a sample will be used up fully
p.000029: for the initial project or cannot be stored, a two-part consent process is recommended, the participant being first
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Political / criminal

Searching for indicator criminal:

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p.000029: 6).
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p.000029: 19 June 2012
p.000029: Page 23 of 31
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p.000029: Version 2
p.000029: Final draft 2
p.000029: Figure 4 Flowchart: Post-Approval Reporting Requirements
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p.000029:
p.000029: 10. ADDITIONAL CONSIDERATIONS
p.000029: Researchers must be aware of the following additional considerations while conducting their research projects within
p.000029: MOH healthcare centres or while making use of MOH resources.
p.000029: 10.1. PARTICIPANT ANONYMITY AND DATA CONFIDENTIALITY
p.000029: All health research using identifiable personal information or anonymised data from the MOH that is not already in the
p.000029: public domain must be approved by an MOH Research Committee.
p.000029: Researchers should treat all personal and medical information as confidential. This applies as much to the results of
p.000029: laboratory tests done as part of the research project, as to information obtained directly from participants or their
p.000029: medical records.
p.000029: All personal information must be coded or anonymised as far as possible and as early as possible in the data
p.000029: processing. Principal investigators have personal responsibility to ensure that procedures and security arrangements
p.000029: are sufficient to prevent breaches of confidentiality. A breach of confidentiality is an illegal offence and is subject
p.000029: to legal action according to criminal law.
p.000029:
p.000029:
p.000029: 19 June 2012
p.000029: Page 24 of 31
p.000029:
p.000029:
p.000029:
p.000029: 10.2. COLLECTION OF BIOLOGICAL SAMPLES
p.000029: Version 2
p.000029: Final draft 2
p.000029: All research using human biological samples must be approved by an MOH research committee, whether these projects
p.000029: involve use of newly collected samples or secondary use of samples collected for previous research.
p.000029: 10.2.1. Informed consent for collection of new samples
p.000029: Informed consent must be taken from participants whenever a new sample is taken for the purposes of research. Research
p.000029: participants must understand what the sample is to be used for and how the results of the research might impact them.
p.000029: Consent must also be obtained for the storage and potential future use of samples. However, it is acceptable for
p.000029: researchers to use human material from a tissue/blood bank without participant consent if the samples are anonymous and
p.000029: unlinked.
p.000029: When obtaining consent to take a biological sample for research, it is important to allow for the fact that it might
p.000029: subsequently be useful for new experiments that cannot be foreseen. Therefore, unless a sample will be used up fully
p.000029: for the initial project or cannot be stored, a two-part consent process is recommended, the participant being first
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Political / vulnerable

Searching for indicator vulnerable:

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p.000029: testing, educational tests (cognitive, diagnostic, aptitude etc).
p.000029: • Research procedures using the following techniques:
p.000029: - Anonymous questionnaires (where identities cannot be traced in any way)
p.000029: - Coded (potentially identifiable) questionnaires or surveys
p.000029: - Identifiable surveys or questionnaires
p.000029: - Interviews (structured or unstructured), whether in person or by telephone
p.000029: - Web-based surveys
p.000029: The following studies will require in-depth review:
p.000029: • Major surveys or epidemiological studies involving extensive data collection from patients.
p.000029: • Research involving sensitive, personal or psychologically intrusive interview questions or questionnaires.
p.000029: • Studies involving the extraction of personally-identifiable information from health records.
p.000029: • Research using administrative or secure
p.000029: CLINICAL RESEARCH (Interventional)
p.000029:
p.000029: ‘Clinical’ research (unsponsored or sponsored) includes:
p.000029: • Interventional studies involving use of: drugs, therapeutic devices, surgical techniques or devices, diagnostic
p.000029: procedures or devices, dietary interventions, new indications for approved products. These also include randomization,
p.000029: withdrawal of treatment/services, or use of placebo.
p.000029: • Genetic research, human stem cells research
p.000029: • Interventional research involving vulnerable subjects (minorities, children, elderly, pregnant women, human
p.000029: foetuses, illiterate persons, prisoners or mentally-challenged subjects).
p.000029: • Interventional research that involves offering participants incentives to take part (which exceed reimbursement
p.000029: of travel costs, payment to compensate for work, etc).
p.000029:
p.000029: 19 June 2012
p.000029: Page 11 of 31
p.000029:
p.000029:
p.000029:
p.000029: data. Example: HID confidential databases
p.000029: • Research involving invasive procedures, Example: collection of body samples, medical procedures.
p.000029: • Research involving vulnerable subjects (minorities, children, elderly, pregnant women, human foetuses, illiterate
p.000029: persons, prisoners or mentally-challenged subjects).
p.000029: • Research that involves offering participants incentives to take part (which exceed reimbursement of travel costs,
p.000029: payment to compensate for work, etc).
p.000029: Version 2
p.000029: Final draft 2
p.000029:
p.000029: Applications for approval of all observational research studies will be reviewed by the RTST, PHCRC, or SHCRC. For
p.000029: clinical research studies, applications will be reviewed by the HRC after National Health Regulatory Authority ,
p.000029: authorization letter.
p.000029: 3. SCOPE FOR REVIEW
p.000029: The following types of submissions are in scope for review:
p.000029: a. Submission of Research Application for initial review
p.000029: b. Resubmission of Research Application with corrections
p.000029: c. Post-approval submissions (Protocol amendments, progress reports, study completion report, adverse event reports,
p.000029: and renewal of approval)
p.000029: 4. SUBMISSION
p.000029: Submissions to the MOH Research Committees are reviewed on a first-come, first-served basis. Research committee
p.000029: meetings for review of new research are
p.000029: usually scheduled once a week (or less, depending on the number of submissions).
...

Health / Cognitive Impairment

Searching for indicator cognitive:

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p.000029: data, medical records or biological samples from MOH healthcare facilities. Researchers must seek permission and follow
p.000029: procedures as dictated by the concerned departments after presenting them with a valid MOH approval letter.
p.000029:
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p.000029: 2. RISK ASSESSMENT OF RESEARCH
p.000029: Version 2
p.000029: Final draft 2
p.000029: Ethical approval should be considered for any research which involves human beings. Such studies may be of either a
p.000029: quantitative or qualitative nature.
p.000029: Currently, the MOH Research Committees reviews applications of all forms; however, the type of review depends on the
p.000029: type of research study, i.e., observational or interventional.
p.000029: Please consider the following information to determine which category your research belongs to:
p.000029:
p.000029: OBSERVATIONAL STUDIES
p.000029: (Non-interventional)
p.000029: ‘Observational’ research includes:
p.000029: • Most projects involving data collection from a small number of patients.
p.000029: • Almost all projects conducted with previously collected publicly available data.
p.000029: • Non-interventional studies. Example: case- control studies, cohort studies, cross- sectional studies, case
p.000029: reports, case series, descriptive studies.
p.000029: • Projects involving simple non-invasive clinical examinations or educational tests. Example: Blood pressure
p.000029: testing, educational tests (cognitive, diagnostic, aptitude etc).
p.000029: • Research procedures using the following techniques:
p.000029: - Anonymous questionnaires (where identities cannot be traced in any way)
p.000029: - Coded (potentially identifiable) questionnaires or surveys
p.000029: - Identifiable surveys or questionnaires
p.000029: - Interviews (structured or unstructured), whether in person or by telephone
p.000029: - Web-based surveys
p.000029: The following studies will require in-depth review:
p.000029: • Major surveys or epidemiological studies involving extensive data collection from patients.
p.000029: • Research involving sensitive, personal or psychologically intrusive interview questions or questionnaires.
p.000029: • Studies involving the extraction of personally-identifiable information from health records.
p.000029: • Research using administrative or secure
p.000029: CLINICAL RESEARCH (Interventional)
p.000029:
p.000029: ‘Clinical’ research (unsponsored or sponsored) includes:
p.000029: • Interventional studies involving use of: drugs, therapeutic devices, surgical techniques or devices, diagnostic
p.000029: procedures or devices, dietary interventions, new indications for approved products. These also include randomization,
p.000029: withdrawal of treatment/services, or use of placebo.
p.000029: • Genetic research, human stem cells research
...

Health / Drug Usage

Searching for indicator drug:

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p.000015: Figure 4 Flowchart: Post-Approval Reporting Requirements 24
p.000015: LIST OF APPENDICES
p.000015: PAGE
p.000015: Appendix A Health Research Application Forms 29
p.000015: Appendix B Documentation Checklist for Submission Package 29
p.000015: Appendix C Sample Informed Consent Form 29
p.000015: Appendix D Post-Approval Forms/Reports 29
p.000015: LIST OF FORMS
p.000015: PAGE
p.000015: Form 1 Application for Approval of Minimal-Risk Research 29
p.000015: Form 2 Application for Approval of Greater-than-Minimal-Risk Research
p.000029: 29
p.000029: Form 3 Amendment Request Form 29
p.000029: Form 4 Unanticipated/Serious Adverse Event Report 29
p.000029: Form 5 Annual Renewal Report 29
p.000029: Form 6 Study Completion Report 29
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p.000029:
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p.000029: LIST OF ABBREVIATIONS
p.000029: CRO Contract Research Organization
p.000029: EMA European Medicines Agency
p.000029: Version 2
p.000029: Final draft 2
p.000029:
p.000029: FDA Food and Drug Administration, United States
p.000029: ICF Informed consent form
p.000029: ICH International Conference on Harmonization
p.000029: GCP Good Clinical Practice
p.000029: HRC Health Research Committee
p.000029: MOH Ministry of Health
p.000029: NOC No-Objection Certificate
p.000029: PHCRC Primary Health Care Research Sub-Committee
p.000029: REB Research Ethics Board
p.000029: RTST Research Technical Support Team
p.000029: SHCRC Secondary Health Care Research Sub-Committee
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p.000029: GLOSSARY OF TERMS
p.000029: Version 2
p.000029: Final draft 2
p.000029:
p.000029: Adverse event: An adverse event is any unfavourable and unintended
p.000029: sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with
p.000029: the use of a medicinal product or research procedure. For marketed medicinal products, this also includes failure to
p.000029: produce expected benefits (i.e. lack of efficacy), abuse or misuse.
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p.000029: b) Degree of anticipated discomfort or inconvenience
p.000029: c) Duration of the study and impact on work-related income and time lost from work.
p.000029: The MOH Research Committee will review the compensation offered and ascertain the reasonableness of the compensation
p.000029: detailed by the researcher in the application. Additionally, the investigator must indicate the amount of compensation
p.000029: in the informed consent form.
p.000029: 11. FREQUENTLY ASKED QUESTIONS
p.000029: A list of common queries will be posted on the MOH website with our responses. Researchers may refer to this to
p.000029: eliminate any doubts they may have on the Research submission and review process. For any further questions, you may
p.000029: contact the RTST Research Coordinator at +973-17286052
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p.000029: suggested reading
p.000029: Version 2
p.000029: Final draft 2
p.000029:
p.000029: • Bahrain’s Healthcare Agenda – Health Improvement Strategy 2011-2016; Ministry of Health, Kingdom of Bahrain, 2011.
p.000029: • MOH Ethical Guidelines for Health Research, 2008.
p.000029: http://www.moh.gov.bh/PDF/Health%20Research%20Structure%20and%20Pr ocedures%20%20DRAFT.pdf
p.000029: • ICH Harmonized Tripartite Guideline for Good Clinical Practice ICH Topic E6), Good Clin Pract J 3:S3–S27.
p.000029: • Protection of Human Subjects, Code of Federal Regulations, 21CFR50, Food and Drug Administration, USA.
p.000029: • World Medical Association, Declaration of Helsinki: Ethical Principles for Medical Research Involving Human
p.000029: Subjects: Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 and most recent amendments accepted at
p.000029: the 59th WMA General Assembly, Seoul, October 2008. http://www.wma.net/e/policy/b3.htm
p.000029: • Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for
p.000029: biomedical research involving human subjects. (Accessed November 10, 2011 at
p.000029: http://www.cioms.ch/publications/layout_guide2002.pdf)
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p.000029:
p.000029: Version 2
p.000029: Final draft 2
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p.000029: APPENDICES
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Health / Healthy People

Searching for indicator volunteers:

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p.000029: investigational product(s) in human subjects.
p.000029: This document is usually submitted for Research approval in cases of clinical trials involving the use of an unapproved
p.000029: product/device.
p.000029: Research in which the only foreseeable risk to the participant is one of discomfort.
p.000029: This includes any type of communication (e.g. flyer, radio/television script, poster, newspaper advertisement, Internet
p.000029: message) that is directed to potential subjects for the purpose of recruitment. The purpose of submitting this
p.000029: documentation is to ensure that recruitment messages are appropriate and not coercive.
p.000029:
p.000029: Protocol: A document that describes the brief literature review,
p.000029: background, rationale, objective(s), design, methodology, statistical considerations and organization of a study.
p.000029:
p.000029:
p.000029: Product monograph:
p.000029: A factual, scientific document on a product that, devoid of promotional material, describes the properties, claims,
p.000029: indications, and conditions of use for the product, and that contains any other information that may be required for
p.000029: optimal, safe, and effective use of the product.
p.000029: This document is usually submitted for Research approval in cases of research studies involving the use of a marketed
p.000029: and licensed product/device.
p.000029:
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p.000029: Page 7 of 31
p.000029:
p.000029: Version 2
p.000029: Final draft 2
p.000029: INTRODUCTION
p.000029:
p.000029: Health research, whether data obtained by questionnaires, or by means of a physical intervention on patients
p.000029: or health volunteers, seeks to diminish existing uncertainties and improve our understanding of health and disease.
p.000029: Ultimately, the results obtained in such research contribute to appropriate and improved healthcare
p.000029: directed at meeting patients’ needs.
p.000029: The Ministry of Health, Bahrain (MOH) wishes to encourage research related to fundamental biological processes,
p.000029: diseases of national priority and quality of healthcare management, in the belief that a collaborative
p.000029: research effort can accelerate the acquisition of knowledge more effectively than a simple aggregate of research
p.000029: projects that have no interaction or thematic integration. These projects are also viewed as an effective
p.000029: instrument in capacity building of a cadre of scientists and clinicians of the highest calibre.
p.000029: The Health Research Committee (HRC) at the MOH plays a central role in the research process. As well as
p.000029: upholding the rights of research participants, the HRC is tasked with assessing the risk-benefit profile and
p.000029: methodology of research, ensuring consent is valid, protecting confidentiality and privacy of subjects,
p.000029: providing research grants and more recently with the monitoring of ongoing research. The scientific and
p.000029: ethical evaluation of a research protocol is not to be considered as an administrative obstacle but rather as
p.000029: an integral part of the research process.
p.000029: This Guidance manual accompanies the Online MOH Research Application System developed for the approval
...

Health / Mentally Disabled

Searching for indicator mentally:

(return to top)
p.000029: - Interviews (structured or unstructured), whether in person or by telephone
p.000029: - Web-based surveys
p.000029: The following studies will require in-depth review:
p.000029: • Major surveys or epidemiological studies involving extensive data collection from patients.
p.000029: • Research involving sensitive, personal or psychologically intrusive interview questions or questionnaires.
p.000029: • Studies involving the extraction of personally-identifiable information from health records.
p.000029: • Research using administrative or secure
p.000029: CLINICAL RESEARCH (Interventional)
p.000029:
p.000029: ‘Clinical’ research (unsponsored or sponsored) includes:
p.000029: • Interventional studies involving use of: drugs, therapeutic devices, surgical techniques or devices, diagnostic
p.000029: procedures or devices, dietary interventions, new indications for approved products. These also include randomization,
p.000029: withdrawal of treatment/services, or use of placebo.
p.000029: • Genetic research, human stem cells research
p.000029: • Interventional research involving vulnerable subjects (minorities, children, elderly, pregnant women, human
p.000029: foetuses, illiterate persons, prisoners or mentally-challenged subjects).
p.000029: • Interventional research that involves offering participants incentives to take part (which exceed reimbursement
p.000029: of travel costs, payment to compensate for work, etc).
p.000029:
p.000029: 19 June 2012
p.000029: Page 11 of 31
p.000029:
p.000029:
p.000029:
p.000029: data. Example: HID confidential databases
p.000029: • Research involving invasive procedures, Example: collection of body samples, medical procedures.
p.000029: • Research involving vulnerable subjects (minorities, children, elderly, pregnant women, human foetuses, illiterate
p.000029: persons, prisoners or mentally-challenged subjects).
p.000029: • Research that involves offering participants incentives to take part (which exceed reimbursement of travel costs,
p.000029: payment to compensate for work, etc).
p.000029: Version 2
p.000029: Final draft 2
p.000029:
p.000029: Applications for approval of all observational research studies will be reviewed by the RTST, PHCRC, or SHCRC. For
p.000029: clinical research studies, applications will be reviewed by the HRC after National Health Regulatory Authority ,
p.000029: authorization letter.
p.000029: 3. SCOPE FOR REVIEW
p.000029: The following types of submissions are in scope for review:
p.000029: a. Submission of Research Application for initial review
p.000029: b. Resubmission of Research Application with corrections
p.000029: c. Post-approval submissions (Protocol amendments, progress reports, study completion report, adverse event reports,
p.000029: and renewal of approval)
p.000029: 4. SUBMISSION
p.000029: Submissions to the MOH Research Committees are reviewed on a first-come, first-served basis. Research committee
p.000029: meetings for review of new research are
p.000029: usually scheduled once a week (or less, depending on the number of submissions).
p.000029: The Review Meeting dates and submission deadlines for each month will be posted separately on the MOH intranet and
p.000029: internet websites. These dates will be updates regularly. The first 5 submissions received by the deadline will be
p.000029: included on the Research Committee’s agenda, if complete and ready for research committee review. The remaining
p.000029: submissions will be placed on the next agenda.
p.000029: 4.1. DOCUMENTATION REQUIRED
p.000029: The following documents are required to be included in the submission package. The Documentation Checklist in Appendix
...

Searching for indicator disability:

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p.000029: described in the form.
p.000029: 3. Submit the above to the concerned research committee for review.
p.000029: Amendments can be minor (in which case the Chairperson of the Research committee can authorize their approval) or more
p.000029: substantial (in which case they are sent to one/more of the original reviewers of the protocol for assessment and
p.000029: approval). If the proposed amendment requires revision, or further information is needed, the researcher will be
p.000029: notified in writing. Once the amendment is approved, the researcher is provided with an amendment approval letter. Only
p.000029: after the amendment has been approved can the changes be implemented.
p.000029:
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p.000029:
p.000029: 9.2. UNANTICIPATED/SERIOUS EVENT REPORTS
p.000029: Version 2
p.000029: Final draft 2
p.000029: (Greater-than-minimal-risk research only) (Form 4)
p.000029: An unanticipated adverse event is defined as any adverse event or outcome experienced by any participant, which exceeds
p.000029: the risk that the participants were informed of during the consent process.
p.000029: A serious adverse event (SAE) is an adverse event that:
p.000029: • Results in death; or
p.000029: • Is life-threatening; or
p.000029: • Requires in-patient hospitalisation or prolongation of existing hospitalisation; or
p.000029: • Results in persistent or significant disability or incapacity; or
p.000029: • Causes congenital malformation/birth defect.
p.000029: Should any unanticipated/serious adverse events occur in relation to a research project involving human participants,
p.000029: these must immediately (maximum within three calendar days) be reported to the Chairperson of the concerned research
p.000029: committee by a telephone call (Section 0) followed by a filled Unanticipated/ Serious Adverse event Report Form (Form
p.000029: 4).
p.000029:
p.000029: 9.3. ANNUAL RENEWAL REPORTS AND STUDY COMPLETION REPORTS (Form 5, Form 6)
p.000029: For all projects, researchers are required to notify the research committee upon completion of the research study, and
p.000029: fill out a Study Completion Report (Form 6). Study completion is defined as the time point when it is clear that there
p.000029: will be no more requirements for data collection or analysis. Following submission of Form 4, the research committee
p.000029: archives the research file.
p.000029: For greater-than-minimal-risk research projects extending beyond one year, researchers must submit an annual progress
p.000029: report for review in order to have their approval extended. Several weeks in advance of the expiry of their 12-month
p.000029: approval, researchers must submit a completed Annual Renewal Report (Form 5), prior to the expiry date. Should a
p.000029: research project be completed prior to the
p.000029: 12-month renewal date, the researcher must notify the research committee and complete the Study Completion Report (Form
p.000029: 6).
p.000029:
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p.000029:
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p.000029: Page 23 of 31
p.000029:
p.000029: Version 2
p.000029: Final draft 2
...

Health / Motherhood/Family

Searching for indicator family:

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p.000029: researcher’s Department
p.000029: Head/Chairperson’s signature/Head of Research).
p.000029: c. Completed, signed and dated Research Application Form.
p.000029: d. Curriculum vitae of the Principal Investigator (applicant)and co-investigator(s)
p.000029: e. Detailed Protocol, including amendments to the protocol, if any
p.000029: f. Investigator’s brochure/Product monograph (for clinical studies involving a pharmaceutical/ biological/device
p.000029: product)
p.000029: g. Participant recruitment material: advertisement, information letters
p.000029: h. Informed consent/Informed assent form in English
p.000029: i. Informed consent/assent form in Arabic (with signature and seal by a certified translator/translation service)
p.000029: j. Data collection tools: Case Report Form, questionnaire, etc.
p.000029:
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p.000029: Page 13 of 31
p.000029:
p.000029:
p.000029:
p.000029: k. Patient instruction card, identity card, diary, etc.
p.000029: Version 2
p.000029: Final draft 2
p.000029: l. Regulatory permissions (approvals from other Ethics Review Boards, FDA, EMA, etc.)
p.000029: m. Signed agreements/contracts between different parties:
p.000029: - Investigator / institution and sponsor
p.000029: - Investigator / institution and CRO
p.000029: - Sponsor and CRO
p.000029: n. No. of centres & sample size for each centre (for multi-centre studies)
p.000029: 4.2. DIRECTING YOUR RESEARCH APPLICATION
p.000029: Research applicants must direct their applications to the relevant MOH Research Committees according to the guidelines
p.000029: below:
p.000029: Observational Research
p.000029: a. MOH Primary Healthcare staff and Family Practice Residency Program (FPRP) residents who intend to conduct research
p.000029: within a primary health care centre must submit their applications to the PHCRC.
p.000029: b. Staff from MOH secondary healthcare facilities and Salmaniya Medical Complex (SMC) staff who intend to conduct
p.000029: research within SMC or any of the secondary healthcare centres must submit their applications to the SHCRC.
p.000029: c. Applications from other MOH staff, faculty/students of academic institutions, government and non-government staff,
p.000029: and from external sponsors (e.g., pharmaceuticals) must be submitted to the RTST.
p.000029: d. Applications for national surveys from any applicant must be submitted to the RTST.
p.000029: Following review, the PHCRC and SHCRC may forward applications requiring further scientific / ethical opinion and/or
p.000029: research funding to the RTST. Projects that need funding are assessed by the RTST for priority and validity, and
p.000029: subsequently recommendations will be raised to the HRC.
p.000029:
p.000029:
p.000029:
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p.000029: Page 14 of 31
p.000029:
p.000029: Version 2
p.000029: Final draft 2
p.000029: Figure 2 Flowchart (Observational Research): Where should you direct your Research Application?
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
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p.000029:
p.000029: Clinical Research
p.000029: Any applicant (MOH staff or external researchers) who intends to conduct clinical trials within an MOH health care
...

Health / Pregnant

Searching for indicator pregnant:

(return to top)
p.000029: • Research procedures using the following techniques:
p.000029: - Anonymous questionnaires (where identities cannot be traced in any way)
p.000029: - Coded (potentially identifiable) questionnaires or surveys
p.000029: - Identifiable surveys or questionnaires
p.000029: - Interviews (structured or unstructured), whether in person or by telephone
p.000029: - Web-based surveys
p.000029: The following studies will require in-depth review:
p.000029: • Major surveys or epidemiological studies involving extensive data collection from patients.
p.000029: • Research involving sensitive, personal or psychologically intrusive interview questions or questionnaires.
p.000029: • Studies involving the extraction of personally-identifiable information from health records.
p.000029: • Research using administrative or secure
p.000029: CLINICAL RESEARCH (Interventional)
p.000029:
p.000029: ‘Clinical’ research (unsponsored or sponsored) includes:
p.000029: • Interventional studies involving use of: drugs, therapeutic devices, surgical techniques or devices, diagnostic
p.000029: procedures or devices, dietary interventions, new indications for approved products. These also include randomization,
p.000029: withdrawal of treatment/services, or use of placebo.
p.000029: • Genetic research, human stem cells research
p.000029: • Interventional research involving vulnerable subjects (minorities, children, elderly, pregnant women, human
p.000029: foetuses, illiterate persons, prisoners or mentally-challenged subjects).
p.000029: • Interventional research that involves offering participants incentives to take part (which exceed reimbursement
p.000029: of travel costs, payment to compensate for work, etc).
p.000029:
p.000029: 19 June 2012
p.000029: Page 11 of 31
p.000029:
p.000029:
p.000029:
p.000029: data. Example: HID confidential databases
p.000029: • Research involving invasive procedures, Example: collection of body samples, medical procedures.
p.000029: • Research involving vulnerable subjects (minorities, children, elderly, pregnant women, human foetuses, illiterate
p.000029: persons, prisoners or mentally-challenged subjects).
p.000029: • Research that involves offering participants incentives to take part (which exceed reimbursement of travel costs,
p.000029: payment to compensate for work, etc).
p.000029: Version 2
p.000029: Final draft 2
p.000029:
p.000029: Applications for approval of all observational research studies will be reviewed by the RTST, PHCRC, or SHCRC. For
p.000029: clinical research studies, applications will be reviewed by the HRC after National Health Regulatory Authority ,
p.000029: authorization letter.
p.000029: 3. SCOPE FOR REVIEW
p.000029: The following types of submissions are in scope for review:
p.000029: a. Submission of Research Application for initial review
p.000029: b. Resubmission of Research Application with corrections
p.000029: c. Post-approval submissions (Protocol amendments, progress reports, study completion report, adverse event reports,
p.000029: and renewal of approval)
p.000029: 4. SUBMISSION
p.000029: Submissions to the MOH Research Committees are reviewed on a first-come, first-served basis. Research committee
p.000029: meetings for review of new research are
p.000029: usually scheduled once a week (or less, depending on the number of submissions).
p.000029: The Review Meeting dates and submission deadlines for each month will be posted separately on the MOH intranet and
p.000029: internet websites. These dates will be updates regularly. The first 5 submissions received by the deadline will be
...

Health / stem cells

Searching for indicator stem cells:

(return to top)
p.000029: reports, case series, descriptive studies.
p.000029: • Projects involving simple non-invasive clinical examinations or educational tests. Example: Blood pressure
p.000029: testing, educational tests (cognitive, diagnostic, aptitude etc).
p.000029: • Research procedures using the following techniques:
p.000029: - Anonymous questionnaires (where identities cannot be traced in any way)
p.000029: - Coded (potentially identifiable) questionnaires or surveys
p.000029: - Identifiable surveys or questionnaires
p.000029: - Interviews (structured or unstructured), whether in person or by telephone
p.000029: - Web-based surveys
p.000029: The following studies will require in-depth review:
p.000029: • Major surveys or epidemiological studies involving extensive data collection from patients.
p.000029: • Research involving sensitive, personal or psychologically intrusive interview questions or questionnaires.
p.000029: • Studies involving the extraction of personally-identifiable information from health records.
p.000029: • Research using administrative or secure
p.000029: CLINICAL RESEARCH (Interventional)
p.000029:
p.000029: ‘Clinical’ research (unsponsored or sponsored) includes:
p.000029: • Interventional studies involving use of: drugs, therapeutic devices, surgical techniques or devices, diagnostic
p.000029: procedures or devices, dietary interventions, new indications for approved products. These also include randomization,
p.000029: withdrawal of treatment/services, or use of placebo.
p.000029: • Genetic research, human stem cells research
p.000029: • Interventional research involving vulnerable subjects (minorities, children, elderly, pregnant women, human
p.000029: foetuses, illiterate persons, prisoners or mentally-challenged subjects).
p.000029: • Interventional research that involves offering participants incentives to take part (which exceed reimbursement
p.000029: of travel costs, payment to compensate for work, etc).
p.000029:
p.000029: 19 June 2012
p.000029: Page 11 of 31
p.000029:
p.000029:
p.000029:
p.000029: data. Example: HID confidential databases
p.000029: • Research involving invasive procedures, Example: collection of body samples, medical procedures.
p.000029: • Research involving vulnerable subjects (minorities, children, elderly, pregnant women, human foetuses, illiterate
p.000029: persons, prisoners or mentally-challenged subjects).
...

Searching for indicator access:

(return to top)
p.000024: 8. RESEARCH FUNDING 21
p.000024: 8.1. ELIGIBILITY 21
p.000024: 8.2. EXCLUSION CRITERIA DURING PRELIMINARY SCREENING OF APPLICANTS FOR RESEARCH
p.000024: GRANTS 22
p.000024: 9. POST-APPROVAL REPORTING REQUIREMENTS 22
p.000024: 9.1. AMENDMENTS (Form 3) 22
p.000024: 9.2. UNANTICIPATED/SERIOUS EVENT REPORTS (Greater-
p.000024: than-minimal-risk research only) (Form 4) 23
p.000024: 9.3. ANNUAL RENEWAL REPORTS AND STUDY
p.000024: COMPLETION REPORTS (Form 5, Form 6) 23
p.000024: 10. ADDITIONAL CONSIDERATIONS 24
p.000024: 10.1. PARTICIPANT ANONYMITY AND DATA
p.000024: CONFIDENTIALITY Error! Bookmark not defined.
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p.000024:
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p.000024: Final draft 2
p.000024: 10.2. COLLECTION OF BIOLOGICAL SAMPLESError! Bookmark not defined.
p.000024: 10.2.1. Informed consent for collection of new samplesError! Bookmark not defi
p.000024: 10.2.2. Informed consent for secondary use of old samplesError! Bookmark not d
p.000024: 10.2.3. Disclosing results of laboratory tests to research participants Error! Bookmark not
p.000024: defined.
p.000024: 10.3. ACCESS TO PATIENT MEDICAL RECORDS AND
p.000024: IDENTIFIABLE INFORMATION FROM THE MOHError! Bookmark not define
p.000024: 10.4. PARTICIPANT COMPENSATIONError! Bookmark not defined. 11. FREQUENTLY ASKED QUESTIONS
p.000024: 24
p.000024: 12. SUGGESTED READING 27
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p.000024: LIST OF FIGURES
p.000024: Version 2
p.000024: Final draft 2
p.000024:
p.000024:
p.000024: PAGE
p.000024:
p.000024: Figure 1 Health Research Structure, MOH 9
p.000024: Figure 2 Flowchart: Where should you direct your Research Application?
p.000015: 15
p.000015: Figure 3 Flowchart: Research Review & Approval Process 19
p.000015: Figure 4 Flowchart: Post-Approval Reporting Requirements 24
p.000015: LIST OF APPENDICES
p.000015: PAGE
p.000015: Appendix A Health Research Application Forms 29
p.000015: Appendix B Documentation Checklist for Submission Package 29
p.000015: Appendix C Sample Informed Consent Form 29
...

p.000029: b. To ensure that the participants in research studies are not unduly exposed to unreasonable or unnecessary research
p.000029: risks, researchers must confirm that they have read the “MOH Ethical Guidelines for Health Research”, the Declaration
p.000029: of Helsinki, and Good Clinical Practice (GCP), and ensure that their research is compliant with these guidelines.
p.000029: c. The ‘applicant’ for review and approval of a research project must be the Principal Investigator of the study (a
p.000029: student/ staff who is professionally based in Bahrain). The MOH Online Research Application System is accessible via
p.000029: the MOH intranet and internet websites.
p.000029: d. Completing the application in accordance with the following recommended guidelines will speed up the process of
p.000029: approval and minimize any delays that could otherwise occur. Applicants can use the Documentation Checklists (Appendix
p.000029: B) for help with the completion and collation of the requisite supporting documents.
p.000029: e. Only an application that satisfies all of the necessary information and documentation will be considered a
p.000029: ‘complete’ application and will be scheduled for a review. Incorrect or incomplete applications will not be reviewed
p.000029: until all corrections / necessary documents are in place.
p.000029: f. Researchers must conduct a feasibility assessment of the proposed sites for carrying out their research, ahead of
p.000029: submitting an application to the MOH Research Committees – to ensure that the facilities/departments can spare the
p.000029: required staff, supplies or equipment required.
p.000029: g. Approval from an MOH Research Committee does not automatically imply that the researcher is granted access to
p.000029: data, medical records or biological samples from MOH healthcare facilities. Researchers must seek permission and follow
p.000029: procedures as dictated by the concerned departments after presenting them with a valid MOH approval letter.
p.000029:
p.000029:
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p.000029:
p.000029:
p.000029: 2. RISK ASSESSMENT OF RESEARCH
p.000029: Version 2
p.000029: Final draft 2
p.000029: Ethical approval should be considered for any research which involves human beings. Such studies may be of either a
p.000029: quantitative or qualitative nature.
p.000029: Currently, the MOH Research Committees reviews applications of all forms; however, the type of review depends on the
p.000029: type of research study, i.e., observational or interventional.
p.000029: Please consider the following information to determine which category your research belongs to:
p.000029:
p.000029: OBSERVATIONAL STUDIES
p.000029: (Non-interventional)
p.000029: ‘Observational’ research includes:
p.000029: • Most projects involving data collection from a small number of patients.
p.000029: • Almost all projects conducted with previously collected publicly available data.
p.000029: • Non-interventional studies. Example: case- control studies, cohort studies, cross- sectional studies, case
p.000029: reports, case series, descriptive studies.
p.000029: • Projects involving simple non-invasive clinical examinations or educational tests. Example: Blood pressure
p.000029: testing, educational tests (cognitive, diagnostic, aptitude etc).
p.000029: • Research procedures using the following techniques:
...

p.000029: related research.
p.000029: 10.2.2. Informed consent for secondary use of old samples
p.000029: Secondary use of biological samples, whether previously collected for clinical purposes or for purposes of other
p.000029: research projects, may be authorised provided:
p.000029: 1. The new research proposal is approved by the MOH Research Committee.
p.000029: 2. The research subjects did not object to the use of their sample in future research projects.
p.000029: The MOH Research Committee will decide on a case-by-case basis whether:
p.000029: 1. The new research is covered by the previous consent, if any, or
p.000029: 2. Subjects should be contacted to obtain a new consent, or
p.000029: 3. A consent can be waived
p.000029: 10.2.3. Disclosing results of laboratory tests to research participants
p.000029: Research participants have a right to know individual research results that affect their interests. Researchers must
p.000029: decide at the beginning of a project what information about the results of laboratory tests done on samples should be
p.000029: made available to the participants or their clinicians, and share these plans with the MOH Research Committee. If
p.000029: research results have immediate clinical relevance, there is a clear duty of care to ensure the participant or his/her
p.000029: clinician is informed.
p.000029:
p.000029:
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p.000029:
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p.000029: Final draft 2
p.000029: 10.3. ACCESS TO PATIENT MEDICAL RECORDS AND IDENTIFIABLE INFORMATION FROM THE MOH
p.000029: No more information than that needed to accomplish the study must be recorded. The datasheet which contains the
p.000029: information to be recorded must be submitted with the protocol for MOH Research Committee approval.
p.000029: Following MOH Research Committee approval, access to paper or electronic medical records require authorization from the
p.000029: official data custodian of the records (e.g. Health Information Directorate, head of the medical record department of
p.000029: the appropriate health centre or hospital, or the patients’ clinician).
p.000029: 10.4. PARTICIPANT COMPENSATION
p.000029: The HRC believes that no amount of compensation or payment must be provided which will serve to coerce an informed
p.000029: subject to consent to participate. The principal investigator may be allowed to reimburse participants for:
p.000029: a) Out-of-pocket expenses borne by the subject for travel, meals, etc
p.000029: b) Degree of anticipated discomfort or inconvenience
p.000029: c) Duration of the study and impact on work-related income and time lost from work.
p.000029: The MOH Research Committee will review the compensation offered and ascertain the reasonableness of the compensation
p.000029: detailed by the researcher in the application. Additionally, the investigator must indicate the amount of compensation
p.000029: in the informed consent form.
p.000029: 11. FREQUENTLY ASKED QUESTIONS
p.000029: A list of common queries will be posted on the MOH website with our responses. Researchers may refer to this to
p.000029: eliminate any doubts they may have on the Research submission and review process. For any further questions, you may
p.000029: contact the RTST Research Coordinator at +973-17286052
p.000029:
p.000029:
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p.000029:
p.000029:
p.000029:
...

Searching for indicator children:

Searching for indicator elderly:

Searching for indicator foetuses:

(return to top)
p.000029: - Anonymous questionnaires (where identities cannot be traced in any way)
p.000029: - Coded (potentially identifiable) questionnaires or surveys
p.000029: - Identifiable surveys or questionnaires
p.000029: - Interviews (structured or unstructured), whether in person or by telephone
p.000029: - Web-based surveys
p.000029: The following studies will require in-depth review:
p.000029: • Major surveys or epidemiological studies involving extensive data collection from patients.
p.000029: • Research involving sensitive, personal or psychologically intrusive interview questions or questionnaires.
p.000029: • Studies involving the extraction of personally-identifiable information from health records.
p.000029: • Research using administrative or secure
p.000029: CLINICAL RESEARCH (Interventional)
p.000029:
p.000029: ‘Clinical’ research (unsponsored or sponsored) includes:
p.000029: • Interventional studies involving use of: drugs, therapeutic devices, surgical techniques or devices, diagnostic
p.000029: procedures or devices, dietary interventions, new indications for approved products. These also include randomization,
p.000029: withdrawal of treatment/services, or use of placebo.
p.000029: • Genetic research, human stem cells research
p.000029: • Interventional research involving vulnerable subjects (minorities, children, elderly, pregnant women, human
p.000029: foetuses, illiterate persons, prisoners or mentally-challenged subjects).
p.000029: • Interventional research that involves offering participants incentives to take part (which exceed reimbursement
p.000029: of travel costs, payment to compensate for work, etc).
p.000029:
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p.000029: Page 11 of 31
p.000029:
p.000029:
p.000029:
p.000029: data. Example: HID confidential databases
p.000029: • Research involving invasive procedures, Example: collection of body samples, medical procedures.
p.000029: • Research involving vulnerable subjects (minorities, children, elderly, pregnant women, human foetuses, illiterate
p.000029: persons, prisoners or mentally-challenged subjects).
p.000029: • Research that involves offering participants incentives to take part (which exceed reimbursement of travel costs,
p.000029: payment to compensate for work, etc).
p.000029: Version 2
p.000029: Final draft 2
p.000029:
p.000029: Applications for approval of all observational research studies will be reviewed by the RTST, PHCRC, or SHCRC. For
p.000029: clinical research studies, applications will be reviewed by the HRC after National Health Regulatory Authority ,
p.000029: authorization letter.
p.000029: 3. SCOPE FOR REVIEW
p.000029: The following types of submissions are in scope for review:
p.000029: a. Submission of Research Application for initial review
p.000029: b. Resubmission of Research Application with corrections
p.000029: c. Post-approval submissions (Protocol amendments, progress reports, study completion report, adverse event reports,
p.000029: and renewal of approval)
p.000029: 4. SUBMISSION
p.000029: Submissions to the MOH Research Committees are reviewed on a first-come, first-served basis. Research committee
p.000029: meetings for review of new research are
p.000029: usually scheduled once a week (or less, depending on the number of submissions).
p.000029: The Review Meeting dates and submission deadlines for each month will be posted separately on the MOH intranet and
p.000029: internet websites. These dates will be updates regularly. The first 5 submissions received by the deadline will be
p.000029: included on the Research Committee’s agenda, if complete and ready for research committee review. The remaining
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p.000029:
p.000029:
p.000029:
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p.000029: Page 20 of 31
p.000029:
p.000029: Version 2
p.000029: Final draft 2
p.000029: - Details of the decision you received from the original reviewing committee and how you addressed the points
p.000029: raised.
p.000029: - Justification for raising the appeal.
p.000029: - Signed paper copy of your Application Form including any amendments/revisions already made, and all supporting
p.000029: documents.
p.000029: - A letter from the Research supervisor/Head of medical staff supporting your appeal (desirable but optional).
p.000029: c. Please submit the Letter of Appeal and the full set of appeal documents to the Research Coordinator by email.
p.000029: 7.2. NOTIFICATION OF THE APPEAL PANEL’S DECISION
p.000029: During the appeal hearing, the panel may invite the appellant to meet with them to clarify points where there is a
p.000029: disagreement, or a lack of clarity. If additional expertise is required, the Chair may invite up to two members of
p.000029: staff with relevant expertise but who have not been involved in the initial decision to join the appeal hearing. After
p.000029: the hearing, the appeal panel will determine whether the applicant is successful.
p.000029: A letter from the Chair of the RTST will be sent to the appellant within a week after the hearing, notifying them as to
p.000029: whether the decision of the original reviewing committee has been upheld or not. The appeal panel’s decision is final.
p.000029: 8. RESEARCH FUNDING
p.000029: 8.1. ELIGIBILITY
p.000029: The HRC will fund research projects that require financial support, provided that the general instructions (Section 1)
p.000029: and the following eligibility criteria are met. Funding is restricted to full-time MOH staff and will be in the form of
p.000029: in-kind contributions such as technical support and bearing of indirect costs. The researcher should:
p.000029: a. Ensure that the research is related to, and will focus on the identified health research priorities for Bahrain
p.000029: and the 6 strategic goals of the Bahrain Healthcare Agenda – Health Improvement Strategy, 2015-2018.
p.000029: b. Ensure the potential of introduction of the research findings into policy and practice in the Bahrain healthcare
p.000029: system, and
p.000029: c. Ensure scientific soundness of the project.
p.000029:
p.000029:
p.000029:
p.000029:
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p.000029:
p.000029: Version 2
p.000029: Final draft 2
p.000029: 8.2. EXCLUSION CRITERIA DURING PRELIMINARY SCREENING OF APPLICANTS FOR RESEARCH GRANTS
p.000029: The following applicants may not be eligible for a research funding request:
p.000029: a. Principal investigators with an ongoing research project funded by the MOH (Such applicants are eligible to apply
p.000029: for grants after the submission of their previous research reports).
p.000029: b. Applicants who have sought funding from other agencies.
p.000029: For research requiring funding, copies of approval letters are forwarded to the HRC, at which point the applications
p.000029: are reviewed for the awarding of research grants.
p.000029: 9. POST-APPROVAL REPORTING REQUIREMENTS
p.000029: The following sections detail instructions for notification of amendments, adverse events or study completion following
p.000029: MOH Research Committee approval.
p.000029: 9.1. AMENDMENTS (Form 3)
p.000029: Any changes made to either the research protocol (including changes to the study design recruitment method, study
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Searching for indicator illiterate:

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p.000029: - Coded (potentially identifiable) questionnaires or surveys
p.000029: - Identifiable surveys or questionnaires
p.000029: - Interviews (structured or unstructured), whether in person or by telephone
p.000029: - Web-based surveys
p.000029: The following studies will require in-depth review:
p.000029: • Major surveys or epidemiological studies involving extensive data collection from patients.
p.000029: • Research involving sensitive, personal or psychologically intrusive interview questions or questionnaires.
p.000029: • Studies involving the extraction of personally-identifiable information from health records.
p.000029: • Research using administrative or secure
p.000029: CLINICAL RESEARCH (Interventional)
p.000029:
p.000029: ‘Clinical’ research (unsponsored or sponsored) includes:
p.000029: • Interventional studies involving use of: drugs, therapeutic devices, surgical techniques or devices, diagnostic
p.000029: procedures or devices, dietary interventions, new indications for approved products. These also include randomization,
p.000029: withdrawal of treatment/services, or use of placebo.
p.000029: • Genetic research, human stem cells research
p.000029: • Interventional research involving vulnerable subjects (minorities, children, elderly, pregnant women, human
p.000029: foetuses, illiterate persons, prisoners or mentally-challenged subjects).
p.000029: • Interventional research that involves offering participants incentives to take part (which exceed reimbursement
p.000029: of travel costs, payment to compensate for work, etc).
p.000029:
p.000029: 19 June 2012
p.000029: Page 11 of 31
p.000029:
p.000029:
p.000029:
p.000029: data. Example: HID confidential databases
p.000029: • Research involving invasive procedures, Example: collection of body samples, medical procedures.
p.000029: • Research involving vulnerable subjects (minorities, children, elderly, pregnant women, human foetuses, illiterate
p.000029: persons, prisoners or mentally-challenged subjects).
p.000029: • Research that involves offering participants incentives to take part (which exceed reimbursement of travel costs,
p.000029: payment to compensate for work, etc).
p.000029: Version 2
p.000029: Final draft 2
p.000029:
p.000029: Applications for approval of all observational research studies will be reviewed by the RTST, PHCRC, or SHCRC. For
p.000029: clinical research studies, applications will be reviewed by the HRC after National Health Regulatory Authority ,
p.000029: authorization letter.
p.000029: 3. SCOPE FOR REVIEW
p.000029: The following types of submissions are in scope for review:
p.000029: a. Submission of Research Application for initial review
p.000029: b. Resubmission of Research Application with corrections
p.000029: c. Post-approval submissions (Protocol amendments, progress reports, study completion report, adverse event reports,
p.000029: and renewal of approval)
p.000029: 4. SUBMISSION
p.000029: Submissions to the MOH Research Committees are reviewed on a first-come, first-served basis. Research committee
p.000029: meetings for review of new research are
p.000029: usually scheduled once a week (or less, depending on the number of submissions).
p.000029: The Review Meeting dates and submission deadlines for each month will be posted separately on the MOH intranet and
p.000029: internet websites. These dates will be updates regularly. The first 5 submissions received by the deadline will be
p.000029: included on the Research Committee’s agenda, if complete and ready for research committee review. The remaining
p.000029: submissions will be placed on the next agenda.
p.000029: 4.1. DOCUMENTATION REQUIRED
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p.000029: 3. A consent can be waived
p.000029: 10.2.3. Disclosing results of laboratory tests to research participants
p.000029: Research participants have a right to know individual research results that affect their interests. Researchers must
p.000029: decide at the beginning of a project what information about the results of laboratory tests done on samples should be
p.000029: made available to the participants or their clinicians, and share these plans with the MOH Research Committee. If
p.000029: research results have immediate clinical relevance, there is a clear duty of care to ensure the participant or his/her
p.000029: clinician is informed.
p.000029:
p.000029:
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p.000029:
p.000029: Version 2
p.000029: Final draft 2
p.000029: 10.3. ACCESS TO PATIENT MEDICAL RECORDS AND IDENTIFIABLE INFORMATION FROM THE MOH
p.000029: No more information than that needed to accomplish the study must be recorded. The datasheet which contains the
p.000029: information to be recorded must be submitted with the protocol for MOH Research Committee approval.
p.000029: Following MOH Research Committee approval, access to paper or electronic medical records require authorization from the
p.000029: official data custodian of the records (e.g. Health Information Directorate, head of the medical record department of
p.000029: the appropriate health centre or hospital, or the patients’ clinician).
p.000029: 10.4. PARTICIPANT COMPENSATION
p.000029: The HRC believes that no amount of compensation or payment must be provided which will serve to coerce an informed
p.000029: subject to consent to participate. The principal investigator may be allowed to reimburse participants for:
p.000029: a) Out-of-pocket expenses borne by the subject for travel, meals, etc
p.000029: b) Degree of anticipated discomfort or inconvenience
p.000029: c) Duration of the study and impact on work-related income and time lost from work.
p.000029: The MOH Research Committee will review the compensation offered and ascertain the reasonableness of the compensation
p.000029: detailed by the researcher in the application. Additionally, the investigator must indicate the amount of compensation
p.000029: in the informed consent form.
p.000029: 11. FREQUENTLY ASKED QUESTIONS
p.000029: A list of common queries will be posted on the MOH website with our responses. Researchers may refer to this to
p.000029: eliminate any doubts they may have on the Research submission and review process. For any further questions, you may
p.000029: contact the RTST Research Coordinator at +973-17286052
p.000029:
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p.000029:
p.000029:
p.000029:
p.000029: suggested reading
p.000029: Version 2
p.000029: Final draft 2
p.000029:
p.000029: • Bahrain’s Healthcare Agenda – Health Improvement Strategy 2011-2016; Ministry of Health, Kingdom of Bahrain, 2011.
p.000029: • MOH Ethical Guidelines for Health Research, 2008.
p.000029: http://www.moh.gov.bh/PDF/Health%20Research%20Structure%20and%20Pr ocedures%20%20DRAFT.pdf
p.000029: • ICH Harmonized Tripartite Guideline for Good Clinical Practice ICH Topic E6), Good Clin Pract J 3:S3–S27.
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p.000029: message) that is directed to potential subjects for the purpose of recruitment. The purpose of submitting this
p.000029: documentation is to ensure that recruitment messages are appropriate and not coercive.
p.000029:
p.000029: Protocol: A document that describes the brief literature review,
p.000029: background, rationale, objective(s), design, methodology, statistical considerations and organization of a study.
p.000029:
p.000029:
p.000029: Product monograph:
p.000029: A factual, scientific document on a product that, devoid of promotional material, describes the properties, claims,
p.000029: indications, and conditions of use for the product, and that contains any other information that may be required for
p.000029: optimal, safe, and effective use of the product.
p.000029: This document is usually submitted for Research approval in cases of research studies involving the use of a marketed
p.000029: and licensed product/device.
p.000029:
p.000029:
p.000029:
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p.000029:
p.000029: Version 2
p.000029: Final draft 2
p.000029: INTRODUCTION
p.000029:
p.000029: Health research, whether data obtained by questionnaires, or by means of a physical intervention on patients
p.000029: or health volunteers, seeks to diminish existing uncertainties and improve our understanding of health and disease.
p.000029: Ultimately, the results obtained in such research contribute to appropriate and improved healthcare
p.000029: directed at meeting patients’ needs.
p.000029: The Ministry of Health, Bahrain (MOH) wishes to encourage research related to fundamental biological processes,
p.000029: diseases of national priority and quality of healthcare management, in the belief that a collaborative
p.000029: research effort can accelerate the acquisition of knowledge more effectively than a simple aggregate of research
p.000029: projects that have no interaction or thematic integration. These projects are also viewed as an effective
p.000029: instrument in capacity building of a cadre of scientists and clinicians of the highest calibre.
p.000029: The Health Research Committee (HRC) at the MOH plays a central role in the research process. As well as
p.000029: upholding the rights of research participants, the HRC is tasked with assessing the risk-benefit profile and
p.000029: methodology of research, ensuring consent is valid, protecting confidentiality and privacy of subjects,
p.000029: providing research grants and more recently with the monitoring of ongoing research. The scientific and
p.000029: ethical evaluation of a research protocol is not to be considered as an administrative obstacle but rather as
p.000029: an integral part of the research process.
p.000029: This Guidance manual accompanies the Online MOH Research Application System developed for the approval
p.000029: of health-related research studies conducted within MOH healthcare facilities. It is a reference document that
p.000029: provides detailed context for the questions asked and directs applicants to other related sources of information.
p.000029: Undoubtedly, this document will significantly contribute to a more streamlined approach that should facilitate
p.000029: efficient ethical review of health research studies, and should improve the calibre of applications completed
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p.000029: maintained in research projects to protect the interests of research participants, investigators and the MOH.
p.000029: Figure 1 Health Research Structure, MOH
p.000029:
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p.000029:
p.000029: Version 2
p.000029: Final draft 2
p.000029:
p.000029: INSTRUCTIONS FOR THE ETHICAL APPROVAL OF HEALTH RESEARCH
p.000029: This guidance details the procedure for application to the RTST and the peripheral research sub-committees. For ease,
p.000029: the general term ‘MOH Research Committee’ has been applied to refer to the above mentioned committees throughout the
p.000029: document.
p.000029: 1. GENERAL
p.000029: a. Health-related research may be conducted within MOH hospitals/health centres only after official approval has been
p.000029: sought and obtained from an MOH Research Committee.
p.000029: b. To ensure that the participants in research studies are not unduly exposed to unreasonable or unnecessary research
p.000029: risks, researchers must confirm that they have read the “MOH Ethical Guidelines for Health Research”, the Declaration
p.000029: of Helsinki, and Good Clinical Practice (GCP), and ensure that their research is compliant with these guidelines.
p.000029: c. The ‘applicant’ for review and approval of a research project must be the Principal Investigator of the study (a
p.000029: student/ staff who is professionally based in Bahrain). The MOH Online Research Application System is accessible via
p.000029: the MOH intranet and internet websites.
p.000029: d. Completing the application in accordance with the following recommended guidelines will speed up the process of
p.000029: approval and minimize any delays that could otherwise occur. Applicants can use the Documentation Checklists (Appendix
p.000029: B) for help with the completion and collation of the requisite supporting documents.
p.000029: e. Only an application that satisfies all of the necessary information and documentation will be considered a
p.000029: ‘complete’ application and will be scheduled for a review. Incorrect or incomplete applications will not be reviewed
p.000029: until all corrections / necessary documents are in place.
p.000029: f. Researchers must conduct a feasibility assessment of the proposed sites for carrying out their research, ahead of
p.000029: submitting an application to the MOH Research Committees – to ensure that the facilities/departments can spare the
p.000029: required staff, supplies or equipment required.
p.000029: g. Approval from an MOH Research Committee does not automatically imply that the researcher is granted access to
p.000029: data, medical records or biological samples from MOH healthcare facilities. Researchers must seek permission and follow
p.000029: procedures as dictated by the concerned departments after presenting them with a valid MOH approval letter.
p.000029:
p.000029:
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p.000029:
p.000029:
p.000029: 2. RISK ASSESSMENT OF RESEARCH
p.000029: Version 2
p.000029: Final draft 2
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p.000029: The Review Meeting dates and submission deadlines for each month will be posted separately on the MOH intranet and
p.000029: internet websites. These dates will be updates regularly. The first 5 submissions received by the deadline will be
p.000029: included on the Research Committee’s agenda, if complete and ready for research committee review. The remaining
p.000029: submissions will be placed on the next agenda.
p.000029: 4.1. DOCUMENTATION REQUIRED
p.000029: The following documents are required to be included in the submission package. The Documentation Checklist in Appendix
p.000029: B serves as a quick guide to ensure that there are no missing documents.
p.000029:
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p.000029: 4.1.1. ‘Observational’ (non-interventional) research
p.000029: Version 2
p.000029: Final draft 2
p.000029:
p.000029: a. A signed covering letter from the principal investigator to the chairperson of the relevant research committee
p.000029: (with the signature of the Department Head/Chairperson/head of the research body).
p.000029: b. Completed, signed and dated Research Application Form.
p.000029: c. Curriculum vitae of the Principal Investigator (applicant)and co- investigator(s)
p.000029: d. Detailed Research proposal
p.000029: e. Participant recruitment material: advertisements, information letters
p.000029: f. Informed consent form on the principal investigator’s/Institution’s letterhead (Arabic and English).
p.000029: g. Data collection tools (e.g. questionnaires, data collection forms, etc.)
p.000029: h. Number of centres and sample size for each centre (for multi-centre studies)
p.000029: i. Project timeline
p.000029: For student research, please also include:
p.000029: j. Supporting letter from the Research Supervisor/Administration-in- charge/Head of the research body (on official
p.000029: letterhead).
p.000029: k. Approval letter from the Ethics Review Board of the institution (on official letterhead).
p.000029: 4.1.2. ‘Clinical’ (interventional) research
p.000029: a. Authorization letter from National Health Regulatory Authority
p.000029: b. A covering letter from the principal investigator to the chairperson of the Health Research Committee (with the
p.000029: researcher’s Department
p.000029: Head/Chairperson’s signature/Head of Research).
p.000029: c. Completed, signed and dated Research Application Form.
p.000029: d. Curriculum vitae of the Principal Investigator (applicant)and co-investigator(s)
p.000029: e. Detailed Protocol, including amendments to the protocol, if any
p.000029: f. Investigator’s brochure/Product monograph (for clinical studies involving a pharmaceutical/ biological/device
p.000029: product)
p.000029: g. Participant recruitment material: advertisement, information letters
p.000029: h. Informed consent/Informed assent form in English
p.000029: i. Informed consent/assent form in Arabic (with signature and seal by a certified translator/translation service)
p.000029: j. Data collection tools: Case Report Form, questionnaire, etc.
p.000029:
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p.000029:
p.000029:
p.000029:
p.000029: k. Patient instruction card, identity card, diary, etc.
p.000029: Version 2
p.000029: Final draft 2
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p.000029: ICF Informed consent form
p.000029: ICH International Conference on Harmonization
p.000029: GCP Good Clinical Practice
p.000029: HRC Health Research Committee
p.000029: MOH Ministry of Health
p.000029: NOC No-Objection Certificate
p.000029: PHCRC Primary Health Care Research Sub-Committee
p.000029: REB Research Ethics Board
p.000029: RTST Research Technical Support Team
p.000029: SHCRC Secondary Health Care Research Sub-Committee
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p.000029:
p.000029:
p.000029:
p.000029: GLOSSARY OF TERMS
p.000029: Version 2
p.000029: Final draft 2
p.000029:
p.000029: Adverse event: An adverse event is any unfavourable and unintended
p.000029: sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with
p.000029: the use of a medicinal product or research procedure. For marketed medicinal products, this also includes failure to
p.000029: produce expected benefits (i.e. lack of efficacy), abuse or misuse.
p.000029: Case Report Form: A printed or electronic document designed to record all of the protocol-required information to be
p.000029: reported to the sponsor on each research participant.
p.000029:
p.000029:
p.000029: Good Clinical Practice:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: Greater than minimal risk research:
p.000029: A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical
p.000029: trials that provides assurance that the data and reported results are credible and accurate, and that the rights,
p.000029: integrity, and confidentiality of research subjects are protected (a guideline developed by the ICH).
p.000029: Research procedures that may include risk beyond that ordinarily encountered by participants. This research requires
p.000029: full review by the research committee.
p.000029:
p.000029: Informed consent: ICH GCP defines informed consent as a process by
p.000029: which a subject voluntarily confirms his or her willingness to participate in a particular research study, after having
p.000029: been informed of all aspects of the research that are relevant to the subject’s decision to participate. Informed
p.000029: consent is documented by means of a written, signed and dated informed consent form.
p.000029: Informed assent: “Assent” is a term used to express willingness to
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p.000029: weeks (14 working days) for observational research, stretching to a maximum of 3 months (90 working days) in cases of
p.000029: clinical research projects.
p.000029: a. Following the receipt of a complete submission package, the Research Coordinator creates an application reference
p.000029: number, assigns a review meeting date and distributes the package to the MOH Research Committee members for review.
p.000029: b. Based on the risk-level of the research study, submissions are assigned for either a full or expedited review.
p.000029: - Protocols under expedited review undergo faster approvals (2 weeks for approval).
p.000029: - Protocols under a full review require longer review periods (4 weeks for approval).
p.000029: c. The MOH Research Committee may invite an applicant to a review meeting to present his/her project and to clarify
p.000029: points where there is lack of clarity.
p.000029: d. For cases requiring further consultation, a subject expert may be requested to act as referee and provide
p.000029: scientific/ethical opinion.
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p.000029: Version 2
p.000029: Final draft 2
p.000029: e. Shortly after the protocol has been reviewed, any required revisions or requests for clarifications will be
p.000029: forwarded in writing to the applicant. Most protocols undergo at least 1 round of revision prior to approval being
p.000029: granted.
p.000029: 6. APPROVAL
p.000029: The MOH Research Committee review may have one of the following outcomes:
p.000029: a. Full approval: No concerns with the protocol or supporting documents. The researcher may proceed with the
p.000029: research.
p.000029: b. Conditional approval (Minor revisions required): Overall, the research project is satisfactory with minor
p.000029: modifications to be made. The researcher may proceed with the research only after making the requested changes. In this
p.000029: case, the researcher must submit an acknowledgement letter confirming that the committee’s comments have been taken
p.000029: into account.
p.000029: c. Re-submission (Major revisions required): Major methodological or ethical questions exist. Recommended revisions
p.000029: must be incorporated and the application re-submitted to the MOH Research Committee for a second round of review.
p.000029: d. Rejection: The committee may reject the application if:
p.000029: - The project is found to be too ethically controversial;
p.000029: - If the research methodology is scientifically flawed;
p.000029: - If the potential harm to the patients outweighs the benefits; or
p.000029: - If the researchers are not adequately qualified.
p.000029: The research committee shall provide the researcher with a letter stating the reasons for rejection.
p.000029: 6.1. APPROVAL LETTERS
p.000029: Following approval of the research project, researchers will be notified of approval by email, followed by a signed
p.000029: approval letter specifying the terms and conditions that apply to the approval.
p.000029: Once obtained, researchers should retain their approval letters, as these specify the effective date of approval and
p.000029: the terms and conditions of the approval. Approved research projects must begin within 6 months of the date of
p.000029: approval.
p.000029: For greater-than-minimal-risk research projects, approvals are issued for a period of 12 months only. For projects
p.000029: ongoing for longer than one year, researchers must submit an Annual Renewal Report (Section 9.3) prior to the expiry of
p.000029: approval in order to have their approval extended.
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p.000029:
p.000029: Version 2
p.000029: Final draft 2
p.000029: 8.2. EXCLUSION CRITERIA DURING PRELIMINARY SCREENING OF APPLICANTS FOR RESEARCH GRANTS
p.000029: The following applicants may not be eligible for a research funding request:
p.000029: a. Principal investigators with an ongoing research project funded by the MOH (Such applicants are eligible to apply
p.000029: for grants after the submission of their previous research reports).
p.000029: b. Applicants who have sought funding from other agencies.
p.000029: For research requiring funding, copies of approval letters are forwarded to the HRC, at which point the applications
p.000029: are reviewed for the awarding of research grants.
p.000029: 9. POST-APPROVAL REPORTING REQUIREMENTS
p.000029: The following sections detail instructions for notification of amendments, adverse events or study completion following
p.000029: MOH Research Committee approval.
p.000029: 9.1. AMENDMENTS (Form 3)
p.000029: Any changes made to either the research protocol (including changes to the study design recruitment method, study
p.000029: population, surveys, questionnaires, or interview formats), or the consent form must be submitted for review.
p.000029: Researchers seeking an amendment should:
p.000029: 1. Complete the Amendment Request Form (Form 3), indicating request for approval of changes to an approved protocol.
p.000029: 2. Attach copies of any revised study documentation e.g., modified recruitment documents or altered protocol, as
p.000029: described in the form.
p.000029: 3. Submit the above to the concerned research committee for review.
p.000029: Amendments can be minor (in which case the Chairperson of the Research committee can authorize their approval) or more
p.000029: substantial (in which case they are sent to one/more of the original reviewers of the protocol for assessment and
p.000029: approval). If the proposed amendment requires revision, or further information is needed, the researcher will be
p.000029: notified in writing. Once the amendment is approved, the researcher is provided with an amendment approval letter. Only
p.000029: after the amendment has been approved can the changes be implemented.
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
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p.000029:
p.000029:
p.000029:
p.000029: 9.2. UNANTICIPATED/SERIOUS EVENT REPORTS
p.000029: Version 2
p.000029: Final draft 2
p.000029: (Greater-than-minimal-risk research only) (Form 4)
p.000029: An unanticipated adverse event is defined as any adverse event or outcome experienced by any participant, which exceeds
p.000029: the risk that the participants were informed of during the consent process.
p.000029: A serious adverse event (SAE) is an adverse event that:
p.000029: • Results in death; or
p.000029: • Is life-threatening; or
p.000029: • Requires in-patient hospitalisation or prolongation of existing hospitalisation; or
p.000029: • Results in persistent or significant disability or incapacity; or
p.000029: • Causes congenital malformation/birth defect.
p.000029: Should any unanticipated/serious adverse events occur in relation to a research project involving human participants,
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p.000029: required staff, supplies or equipment required.
p.000029: g. Approval from an MOH Research Committee does not automatically imply that the researcher is granted access to
p.000029: data, medical records or biological samples from MOH healthcare facilities. Researchers must seek permission and follow
p.000029: procedures as dictated by the concerned departments after presenting them with a valid MOH approval letter.
p.000029:
p.000029:
p.000029:
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p.000029:
p.000029:
p.000029: 2. RISK ASSESSMENT OF RESEARCH
p.000029: Version 2
p.000029: Final draft 2
p.000029: Ethical approval should be considered for any research which involves human beings. Such studies may be of either a
p.000029: quantitative or qualitative nature.
p.000029: Currently, the MOH Research Committees reviews applications of all forms; however, the type of review depends on the
p.000029: type of research study, i.e., observational or interventional.
p.000029: Please consider the following information to determine which category your research belongs to:
p.000029:
p.000029: OBSERVATIONAL STUDIES
p.000029: (Non-interventional)
p.000029: ‘Observational’ research includes:
p.000029: • Most projects involving data collection from a small number of patients.
p.000029: • Almost all projects conducted with previously collected publicly available data.
p.000029: • Non-interventional studies. Example: case- control studies, cohort studies, cross- sectional studies, case
p.000029: reports, case series, descriptive studies.
p.000029: • Projects involving simple non-invasive clinical examinations or educational tests. Example: Blood pressure
p.000029: testing, educational tests (cognitive, diagnostic, aptitude etc).
p.000029: • Research procedures using the following techniques:
p.000029: - Anonymous questionnaires (where identities cannot be traced in any way)
p.000029: - Coded (potentially identifiable) questionnaires or surveys
p.000029: - Identifiable surveys or questionnaires
p.000029: - Interviews (structured or unstructured), whether in person or by telephone
p.000029: - Web-based surveys
p.000029: The following studies will require in-depth review:
p.000029: • Major surveys or epidemiological studies involving extensive data collection from patients.
p.000029: • Research involving sensitive, personal or psychologically intrusive interview questions or questionnaires.
p.000029: • Studies involving the extraction of personally-identifiable information from health records.
p.000029: • Research using administrative or secure
p.000029: CLINICAL RESEARCH (Interventional)
p.000029:
p.000029: ‘Clinical’ research (unsponsored or sponsored) includes:
p.000029: • Interventional studies involving use of: drugs, therapeutic devices, surgical techniques or devices, diagnostic
p.000029: procedures or devices, dietary interventions, new indications for approved products. These also include randomization,
p.000029: withdrawal of treatment/services, or use of placebo.
p.000029: • Genetic research, human stem cells research
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p.000029: A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical
p.000029: trials that provides assurance that the data and reported results are credible and accurate, and that the rights,
p.000029: integrity, and confidentiality of research subjects are protected (a guideline developed by the ICH).
p.000029: Research procedures that may include risk beyond that ordinarily encountered by participants. This research requires
p.000029: full review by the research committee.
p.000029:
p.000029: Informed consent: ICH GCP defines informed consent as a process by
p.000029: which a subject voluntarily confirms his or her willingness to participate in a particular research study, after having
p.000029: been informed of all aspects of the research that are relevant to the subject’s decision to participate. Informed
p.000029: consent is documented by means of a written, signed and dated informed consent form.
p.000029: Informed assent: “Assent” is a term used to express willingness to
p.000029: participate in research by persons who are by definition too young to give informed consent but who are old enough to
p.000029: understand the proposed research in general, its expected risks and possible benefits, and the activities expected of
p.000029: them as subjects. Assent by itself, however, is not sufficient. If assent is given, informed consent must still be
p.000029: obtained from the subject's parents or guardian.
p.000029:
p.000029:
p.000029:
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p.000029: Page 6 of 31
p.000029:
p.000029:
p.000029:
p.000029: Informed consent form:
p.000029:
p.000029: Investigational product:
p.000029:
p.000029:
p.000029:
p.000029: Investigator’s brochure:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: Low-risk / Minimal risk:
p.000029: Participant recruitment material:
p.000029: Version 2
p.000029: Final draft 2
p.000029: Signed approval form by which the subject confirms his or her willingness to participate in a particular research
p.000029: study.
p.000029: A form of an active ingredient being tested in a research study, including a marketed product when used in a way
p.000029: different from the approved form, or when used for an unapproved indication, or when used to gain further information
p.000029: about an approved use.
p.000029: A compilation of the clinical and non-clinical data on an investigational product(s), which is relevant to the study of
p.000029: investigational product(s) in human subjects.
p.000029: This document is usually submitted for Research approval in cases of clinical trials involving the use of an unapproved
p.000029: product/device.
p.000029: Research in which the only foreseeable risk to the participant is one of discomfort.
p.000029: This includes any type of communication (e.g. flyer, radio/television script, poster, newspaper advertisement, Internet
p.000029: message) that is directed to potential subjects for the purpose of recruitment. The purpose of submitting this
p.000029: documentation is to ensure that recruitment messages are appropriate and not coercive.
p.000029:
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p.000029:
p.000029: 19 June 2012
p.000029: Page 13 of 31
p.000029:
p.000029:
p.000029:
p.000029: k. Patient instruction card, identity card, diary, etc.
p.000029: Version 2
p.000029: Final draft 2
p.000029: l. Regulatory permissions (approvals from other Ethics Review Boards, FDA, EMA, etc.)
p.000029: m. Signed agreements/contracts between different parties:
p.000029: - Investigator / institution and sponsor
p.000029: - Investigator / institution and CRO
p.000029: - Sponsor and CRO
p.000029: n. No. of centres & sample size for each centre (for multi-centre studies)
p.000029: 4.2. DIRECTING YOUR RESEARCH APPLICATION
p.000029: Research applicants must direct their applications to the relevant MOH Research Committees according to the guidelines
p.000029: below:
p.000029: Observational Research
p.000029: a. MOH Primary Healthcare staff and Family Practice Residency Program (FPRP) residents who intend to conduct research
p.000029: within a primary health care centre must submit their applications to the PHCRC.
p.000029: b. Staff from MOH secondary healthcare facilities and Salmaniya Medical Complex (SMC) staff who intend to conduct
p.000029: research within SMC or any of the secondary healthcare centres must submit their applications to the SHCRC.
p.000029: c. Applications from other MOH staff, faculty/students of academic institutions, government and non-government staff,
p.000029: and from external sponsors (e.g., pharmaceuticals) must be submitted to the RTST.
p.000029: d. Applications for national surveys from any applicant must be submitted to the RTST.
p.000029: Following review, the PHCRC and SHCRC may forward applications requiring further scientific / ethical opinion and/or
p.000029: research funding to the RTST. Projects that need funding are assessed by the RTST for priority and validity, and
p.000029: subsequently recommendations will be raised to the HRC.
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: 19 June 2012
p.000029: Page 14 of 31
p.000029:
p.000029: Version 2
p.000029: Final draft 2
p.000029: Figure 2 Flowchart (Observational Research): Where should you direct your Research Application?
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: Clinical Research
p.000029: Any applicant (MOH staff or external researchers) who intends to conduct clinical trials within an MOH health care
p.000029: facility must first direct their application to the National Health Regulatory Authority (NHRA). The NHRA is the legal
p.000029: and national regulatory body responsible for approval of clinical trials. Following NHRA autherization, the applicant
p.000029: must prepare an application to the HRC for MOH authorization. The ethical, legal, and financial aspects of the clinical
p.000029: trial will be reviewed extensively by the HRC prior to granting approval.
p.000029: If you have questions on where to direct your research, please send in your queries to the RTST Research Coordinator,
p.000029: Manal Hassan at RTST@health.gov.bh / or call on +973-17286052.
p.000029: 4.3. CONTACT DETAILS FOR SUBMISSION
p.000029: One electronic copy of research applications (including all supporting documents as mentioned in Section 4) can be
...

p.000029: E-mail: RTST@health.gov.bh / Manal Hassan
p.000029: 4.4. SUBMISSION PROCESS
p.000029: Received submissions are subjected to a preliminary screening and are checked for completeness by the Research
p.000029: Coordinator. An email acknowledging receipt submission will be sent to the researcher as documentation, containing a
p.000029: list of documents received, date of submission and comments on missing documents
p.000029: /preliminary queries.
p.000029: 5. REVIEW TIMEFRAME & PROCEDURE
p.000029: The approximate target time between submission of a research application and final approval is estimated to be about 2
p.000029: weeks (14 working days) for observational research, stretching to a maximum of 3 months (90 working days) in cases of
p.000029: clinical research projects.
p.000029: a. Following the receipt of a complete submission package, the Research Coordinator creates an application reference
p.000029: number, assigns a review meeting date and distributes the package to the MOH Research Committee members for review.
p.000029: b. Based on the risk-level of the research study, submissions are assigned for either a full or expedited review.
p.000029: - Protocols under expedited review undergo faster approvals (2 weeks for approval).
p.000029: - Protocols under a full review require longer review periods (4 weeks for approval).
p.000029: c. The MOH Research Committee may invite an applicant to a review meeting to present his/her project and to clarify
p.000029: points where there is lack of clarity.
p.000029: d. For cases requiring further consultation, a subject expert may be requested to act as referee and provide
p.000029: scientific/ethical opinion.
p.000029:
p.000029:
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p.000029:
p.000029: Version 2
p.000029: Final draft 2
p.000029: e. Shortly after the protocol has been reviewed, any required revisions or requests for clarifications will be
p.000029: forwarded in writing to the applicant. Most protocols undergo at least 1 round of revision prior to approval being
p.000029: granted.
p.000029: 6. APPROVAL
p.000029: The MOH Research Committee review may have one of the following outcomes:
p.000029: a. Full approval: No concerns with the protocol or supporting documents. The researcher may proceed with the
p.000029: research.
p.000029: b. Conditional approval (Minor revisions required): Overall, the research project is satisfactory with minor
p.000029: modifications to be made. The researcher may proceed with the research only after making the requested changes. In this
p.000029: case, the researcher must submit an acknowledgement letter confirming that the committee’s comments have been taken
p.000029: into account.
p.000029: c. Re-submission (Major revisions required): Major methodological or ethical questions exist. Recommended revisions
p.000029: must be incorporated and the application re-submitted to the MOH Research Committee for a second round of review.
p.000029: d. Rejection: The committee may reject the application if:
p.000029: - The project is found to be too ethically controversial;
p.000029: - If the research methodology is scientifically flawed;
p.000029: - If the potential harm to the patients outweighs the benefits; or
p.000029: - If the researchers are not adequately qualified.
p.000029: The research committee shall provide the researcher with a letter stating the reasons for rejection.
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p.000029: • Interventional research that involves offering participants incentives to take part (which exceed reimbursement
p.000029: of travel costs, payment to compensate for work, etc).
p.000029:
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p.000029: Page 11 of 31
p.000029:
p.000029:
p.000029:
p.000029: data. Example: HID confidential databases
p.000029: • Research involving invasive procedures, Example: collection of body samples, medical procedures.
p.000029: • Research involving vulnerable subjects (minorities, children, elderly, pregnant women, human foetuses, illiterate
p.000029: persons, prisoners or mentally-challenged subjects).
p.000029: • Research that involves offering participants incentives to take part (which exceed reimbursement of travel costs,
p.000029: payment to compensate for work, etc).
p.000029: Version 2
p.000029: Final draft 2
p.000029:
p.000029: Applications for approval of all observational research studies will be reviewed by the RTST, PHCRC, or SHCRC. For
p.000029: clinical research studies, applications will be reviewed by the HRC after National Health Regulatory Authority ,
p.000029: authorization letter.
p.000029: 3. SCOPE FOR REVIEW
p.000029: The following types of submissions are in scope for review:
p.000029: a. Submission of Research Application for initial review
p.000029: b. Resubmission of Research Application with corrections
p.000029: c. Post-approval submissions (Protocol amendments, progress reports, study completion report, adverse event reports,
p.000029: and renewal of approval)
p.000029: 4. SUBMISSION
p.000029: Submissions to the MOH Research Committees are reviewed on a first-come, first-served basis. Research committee
p.000029: meetings for review of new research are
p.000029: usually scheduled once a week (or less, depending on the number of submissions).
p.000029: The Review Meeting dates and submission deadlines for each month will be posted separately on the MOH intranet and
p.000029: internet websites. These dates will be updates regularly. The first 5 submissions received by the deadline will be
p.000029: included on the Research Committee’s agenda, if complete and ready for research committee review. The remaining
p.000029: submissions will be placed on the next agenda.
p.000029: 4.1. DOCUMENTATION REQUIRED
p.000029: The following documents are required to be included in the submission package. The Documentation Checklist in Appendix
p.000029: B serves as a quick guide to ensure that there are no missing documents.
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
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p.000029:
p.000029:
p.000029:
p.000029: 4.1.1. ‘Observational’ (non-interventional) research
p.000029: Version 2
p.000029: Final draft 2
p.000029:
p.000029: a. A signed covering letter from the principal investigator to the chairperson of the relevant research committee
p.000029: (with the signature of the Department Head/Chairperson/head of the research body).
p.000029: b. Completed, signed and dated Research Application Form.
p.000029: c. Curriculum vitae of the Principal Investigator (applicant)and co- investigator(s)
p.000029: d. Detailed Research proposal
p.000029: e. Participant recruitment material: advertisements, information letters
p.000029: f. Informed consent form on the principal investigator’s/Institution’s letterhead (Arabic and English).
p.000029: g. Data collection tools (e.g. questionnaires, data collection forms, etc.)
p.000029: h. Number of centres and sample size for each centre (for multi-centre studies)
p.000029: i. Project timeline
p.000029: For student research, please also include:
p.000029: j. Supporting letter from the Research Supervisor/Administration-in- charge/Head of the research body (on official
p.000029: letterhead).
p.000029: k. Approval letter from the Ethics Review Board of the institution (on official letterhead).
p.000029: 4.1.2. ‘Clinical’ (interventional) research
p.000029: a. Authorization letter from National Health Regulatory Authority
p.000029: b. A covering letter from the principal investigator to the chairperson of the Health Research Committee (with the
p.000029: researcher’s Department
p.000029: Head/Chairperson’s signature/Head of Research).
p.000029: c. Completed, signed and dated Research Application Form.
p.000029: d. Curriculum vitae of the Principal Investigator (applicant)and co-investigator(s)
p.000029: e. Detailed Protocol, including amendments to the protocol, if any
p.000029: f. Investigator’s brochure/Product monograph (for clinical studies involving a pharmaceutical/ biological/device
p.000029: product)
p.000029: g. Participant recruitment material: advertisement, information letters
p.000029: h. Informed consent/Informed assent form in English
p.000029: i. Informed consent/assent form in Arabic (with signature and seal by a certified translator/translation service)
p.000029: j. Data collection tools: Case Report Form, questionnaire, etc.
p.000029:
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p.000029: Page 13 of 31
p.000029:
p.000029:
p.000029:
p.000029: k. Patient instruction card, identity card, diary, etc.
p.000029: Version 2
p.000029: Final draft 2
p.000029: l. Regulatory permissions (approvals from other Ethics Review Boards, FDA, EMA, etc.)
p.000029: m. Signed agreements/contracts between different parties:
p.000029: - Investigator / institution and sponsor
p.000029: - Investigator / institution and CRO
p.000029: - Sponsor and CRO
p.000029: n. No. of centres & sample size for each centre (for multi-centre studies)
p.000029: 4.2. DIRECTING YOUR RESEARCH APPLICATION
p.000029: Research applicants must direct their applications to the relevant MOH Research Committees according to the guidelines
p.000029: below:
...

p.000029: within a primary health care centre must submit their applications to the PHCRC.
p.000029: b. Staff from MOH secondary healthcare facilities and Salmaniya Medical Complex (SMC) staff who intend to conduct
p.000029: research within SMC or any of the secondary healthcare centres must submit their applications to the SHCRC.
p.000029: c. Applications from other MOH staff, faculty/students of academic institutions, government and non-government staff,
p.000029: and from external sponsors (e.g., pharmaceuticals) must be submitted to the RTST.
p.000029: d. Applications for national surveys from any applicant must be submitted to the RTST.
p.000029: Following review, the PHCRC and SHCRC may forward applications requiring further scientific / ethical opinion and/or
p.000029: research funding to the RTST. Projects that need funding are assessed by the RTST for priority and validity, and
p.000029: subsequently recommendations will be raised to the HRC.
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
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p.000029: Page 14 of 31
p.000029:
p.000029: Version 2
p.000029: Final draft 2
p.000029: Figure 2 Flowchart (Observational Research): Where should you direct your Research Application?
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029: Clinical Research
p.000029: Any applicant (MOH staff or external researchers) who intends to conduct clinical trials within an MOH health care
p.000029: facility must first direct their application to the National Health Regulatory Authority (NHRA). The NHRA is the legal
p.000029: and national regulatory body responsible for approval of clinical trials. Following NHRA autherization, the applicant
p.000029: must prepare an application to the HRC for MOH authorization. The ethical, legal, and financial aspects of the clinical
p.000029: trial will be reviewed extensively by the HRC prior to granting approval.
p.000029: If you have questions on where to direct your research, please send in your queries to the RTST Research Coordinator,
p.000029: Manal Hassan at RTST@health.gov.bh / or call on +973-17286052.
p.000029: 4.3. CONTACT DETAILS FOR SUBMISSION
p.000029: One electronic copy of research applications (including all supporting documents as mentioned in Section 4) can be
p.000029: sent, email / fax to the relevant MOH Research Committee. The contact details for each of the MOH research committees
p.000029: are listed below.
p.000029:
p.000029:
p.000029:
p.000029:
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p.000029: Page 15 of 31
p.000029:
p.000029:
p.000029:
p.000029: Primary Healthcare Research Committee:
p.000029: Chairperson: Dr. Ebtisam Mohamed Fakhro
p.000029: Consultant Tutor, Directorate of Health Centres
p.000029: POSTAL ADDRESS PHYSICAL ADDRESS
p.000029: Version 2
p.000029: Final draft 2
p.000029:
p.000029: Amira Ali Hammad, Medical Secretary - FPRP, The Office of FPRP,
p.000029: P.O.Box-42, Ministry of Health, Manama, Kingdom of Bahrain.
p.000029: Amira Ali Hammad,
p.000029: Medical Secretary - FPRP, The Office of FPRP, Al-Naim Health Centre, Building 95,
p.000029: Lulu Road, Block 303, Kingdom of Bahrain.
p.000029: Contact hours: 8:00 a.m. to 1:00 p.m., Sunday to Thursday. Telephone: +973-17263597; Fax: +973-17251104
p.000029: E-mail: AHammad1@health.gov.bh Secondary Healthcare Research Committee: Chairperson: Dr Eman Fareed
p.000029: Consultant, Laboratory Department,
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p.000029: A list of common queries will be posted on the MOH website with our responses. Researchers may refer to this to
p.000029: eliminate any doubts they may have on the Research submission and review process. For any further questions, you may
p.000029: contact the RTST Research Coordinator at +973-17286052
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
p.000029:
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p.000029: Final draft 2
p.000029:
p.000029: • Bahrain’s Healthcare Agenda – Health Improvement Strategy 2011-2016; Ministry of Health, Kingdom of Bahrain, 2011.
p.000029: • MOH Ethical Guidelines for Health Research, 2008.
p.000029: http://www.moh.gov.bh/PDF/Health%20Research%20Structure%20and%20Pr ocedures%20%20DRAFT.pdf
p.000029: • ICH Harmonized Tripartite Guideline for Good Clinical Practice ICH Topic E6), Good Clin Pract J 3:S3–S27.
p.000029: • Protection of Human Subjects, Code of Federal Regulations, 21CFR50, Food and Drug Administration, USA.
p.000029: • World Medical Association, Declaration of Helsinki: Ethical Principles for Medical Research Involving Human
p.000029: Subjects: Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 and most recent amendments accepted at
p.000029: the 59th WMA General Assembly, Seoul, October 2008. http://www.wma.net/e/policy/b3.htm
p.000029: • Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for
p.000029: biomedical research involving human subjects. (Accessed November 10, 2011 at
p.000029: http://www.cioms.ch/publications/layout_guide2002.pdf)
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p.000029: Appendix A Health Research Application Forms
p.000029: Version 2
p.000029: Final draft 2
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p.000029: Form 1 Application for Approval of Minimal-Risk Research
p.000029: Form 2 Application for Approval of Greater-than-Minimal- Risk Research
p.000029: Appendix B Documentation Checklist for Submission Package
p.000029: Appendix C Sample Informed Consent Form Appendix D Post-Approval Forms/Reports Form 3 Amendment
p.000029: Request Form
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General/Other / declaration of helsinki

Searching for indicator helsinki:

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p.000029: (PHCRC), Secondary Health Care Research Sub-Committee (SHCRC) and College of Health Sciences Research
p.000029: Sub- Committee (CHSRC), were established. The aim of the RTST is to ensure that high ethical standards are
p.000029: maintained in research projects to protect the interests of research participants, investigators and the MOH.
p.000029: Figure 1 Health Research Structure, MOH
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p.000029: INSTRUCTIONS FOR THE ETHICAL APPROVAL OF HEALTH RESEARCH
p.000029: This guidance details the procedure for application to the RTST and the peripheral research sub-committees. For ease,
p.000029: the general term ‘MOH Research Committee’ has been applied to refer to the above mentioned committees throughout the
p.000029: document.
p.000029: 1. GENERAL
p.000029: a. Health-related research may be conducted within MOH hospitals/health centres only after official approval has been
p.000029: sought and obtained from an MOH Research Committee.
p.000029: b. To ensure that the participants in research studies are not unduly exposed to unreasonable or unnecessary research
p.000029: risks, researchers must confirm that they have read the “MOH Ethical Guidelines for Health Research”, the Declaration
p.000029: of Helsinki, and Good Clinical Practice (GCP), and ensure that their research is compliant with these guidelines.
p.000029: c. The ‘applicant’ for review and approval of a research project must be the Principal Investigator of the study (a
p.000029: student/ staff who is professionally based in Bahrain). The MOH Online Research Application System is accessible via
p.000029: the MOH intranet and internet websites.
p.000029: d. Completing the application in accordance with the following recommended guidelines will speed up the process of
p.000029: approval and minimize any delays that could otherwise occur. Applicants can use the Documentation Checklists (Appendix
p.000029: B) for help with the completion and collation of the requisite supporting documents.
p.000029: e. Only an application that satisfies all of the necessary information and documentation will be considered a
p.000029: ‘complete’ application and will be scheduled for a review. Incorrect or incomplete applications will not be reviewed
p.000029: until all corrections / necessary documents are in place.
p.000029: f. Researchers must conduct a feasibility assessment of the proposed sites for carrying out their research, ahead of
p.000029: submitting an application to the MOH Research Committees – to ensure that the facilities/departments can spare the
p.000029: required staff, supplies or equipment required.
p.000029: g. Approval from an MOH Research Committee does not automatically imply that the researcher is granted access to
p.000029: data, medical records or biological samples from MOH healthcare facilities. Researchers must seek permission and follow
p.000029: procedures as dictated by the concerned departments after presenting them with a valid MOH approval letter.
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p.000029: The MOH Research Committee will review the compensation offered and ascertain the reasonableness of the compensation
p.000029: detailed by the researcher in the application. Additionally, the investigator must indicate the amount of compensation
p.000029: in the informed consent form.
p.000029: 11. FREQUENTLY ASKED QUESTIONS
p.000029: A list of common queries will be posted on the MOH website with our responses. Researchers may refer to this to
p.000029: eliminate any doubts they may have on the Research submission and review process. For any further questions, you may
p.000029: contact the RTST Research Coordinator at +973-17286052
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p.000029: suggested reading
p.000029: Version 2
p.000029: Final draft 2
p.000029:
p.000029: • Bahrain’s Healthcare Agenda – Health Improvement Strategy 2011-2016; Ministry of Health, Kingdom of Bahrain, 2011.
p.000029: • MOH Ethical Guidelines for Health Research, 2008.
p.000029: http://www.moh.gov.bh/PDF/Health%20Research%20Structure%20and%20Pr ocedures%20%20DRAFT.pdf
p.000029: • ICH Harmonized Tripartite Guideline for Good Clinical Practice ICH Topic E6), Good Clin Pract J 3:S3–S27.
p.000029: • Protection of Human Subjects, Code of Federal Regulations, 21CFR50, Food and Drug Administration, USA.
p.000029: • World Medical Association, Declaration of Helsinki: Ethical Principles for Medical Research Involving Human
p.000029: Subjects: Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 and most recent amendments accepted at
p.000029: the 59th WMA General Assembly, Seoul, October 2008. http://www.wma.net/e/policy/b3.htm
p.000029: • Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for
p.000029: biomedical research involving human subjects. (Accessed November 10, 2011 at
p.000029: http://www.cioms.ch/publications/layout_guide2002.pdf)
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General/Other / participants in a control group

Searching for indicator placebo:

Orphaned Trigger Words

Appendix

Indicator List

Indicator	Vulnerability
abuse	Victim of Abuse
access	Access to Social Goods
authority	Relationship to Authority
belief	Religion
children	Child
cioms	cioms guidelines
coerce	Presence of Coercion
cognitive	Cognitive Impairment
criminal	criminal
disability	Mentally Disabled
drug	Drug Usage
educational	education
elderly	Elderly
family	Motherhood/Family
foetuses	Fetus/Neonate
helsinki	declaration of helsinki
illegal	Illegal Activity
illiterate	Literacy
incapacity	Incapacitated
mentally	Mentally Disabled
minor	Youth/Minors
opinion	philosophical differences/differences of opinion
parents	parents
placebo	participants in a control group
pregnant	Pregnant
prisoners	Criminal Convictions
restricted	Incarcerated
stem cells	stem cells
student	Student
volunteers	Healthy People
vulnerable	vulnerable
women	Women

Indicator Peers (Indicators in Same Vulnerability)

Indicator	Peers
disability	['mentally']
mentally	['disability']

Trigger Words

capacity

consent

ethics

harm

protect

protection

risk

sensitive

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	Criminal Convictions	prisoners	2
Political	Illegal Activity	illegal	1
Political	criminal	criminal	1
Political	vulnerable	vulnerable	2
Health	Cognitive Impairment	cognitive	1
Health	Drug Usage	drug	2
Health	Healthy People	volunteers	1
Health	Mentally Disabled	mentally	2
Health	Mentally Disabled	disability	1
Health	Motherhood/Family	family	1
Health	Pregnant	pregnant	2
Health	stem cells	stem cells	1
Social	Access to Social Goods	access	4
Social	Child	children	2
Social	Elderly	elderly	2
Social	Fetus/Neonate	foetuses	2
Social	Incarcerated	restricted	1
Social	Literacy	illiterate	2
Social	Presence of Coercion	coerce	1
Social	Religion	belief	1
Social	Student	student	2
Social	Victim of Abuse	abuse	1
Social	Women	women	2
Social	Youth/Minors	minor	3
Social	education	educational	2
Social	parents	parents	1
Social	philosophical differences/differences of opinion	opinion	2
General/Other	Incapacitated	incapacity	1
General/Other	Relationship to Authority	authority	3
General/Other	cioms guidelines	cioms	2
General/Other	declaration of helsinki	helsinki	3
General/Other	participants in a control group	placebo	1

Guidance to Applicants For the Approval of Health Research In Human Subjects

Applicable Type / Vulnerability / Indicator Overlay for this Input

Political / Criminal Convictions

Political / Illegal Activity

Political / criminal

Political / vulnerable

Health / Cognitive Impairment

Health / Drug Usage

Health / Healthy People

Health / Mentally Disabled

Health / Motherhood/Family

Health / Pregnant

Health / stem cells

Social / Access to Social Goods

Social / Child

Social / Elderly

Social / Fetus/Neonate

Social / Incarcerated

Social / Literacy

Social / Presence of Coercion

Social / Religion

Social / Student

Social / Victim of Abuse

Social / Women

Social / Youth/Minors

Social / education

Social / parents

Social / philosophical differences/differences of opinion

General/Other / Incapacitated

General/Other / Relationship to Authority

General/Other / cioms guidelines

General/Other / declaration of helsinki

General/Other / participants in a control group

Orphaned Trigger Words

Appendix

Indicator List

Indicator Peers (Indicators in Same Vulnerability)

Trigger Words

Applicable Type / Vulnerability / Indicator Overlay for this Input