79C3C34C52B45572883A05D425EB0F82
DHCR Conducting Research in DHCC- Policy and Procedures
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Examining the file media/Synopses/961F41C9FEDD6CA848F0271C25AC1BE8.html:
This file was generated: 2021-02-09 23:48:52
| 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
Political / Criminal Convictions
Searching for indicator prisoners:
(return to top)
p.(None):
p.(None): Subject’s representative, as applicable, before any Research related procedure, in accordance with DHCR Regulations and
p.(None): applicable Standards and Policies.
p.(None): 5.3.2.5 Informed consent must be appropriately documented, in accordance with evidence based best practices and using
p.(None): an approved form and patient information sheet. Arabic translation of the informed consent, patient information sheet,
p.(None): and any other material that is to be viewed and used by study Subjects is mandatory.
p.(None): 5.3.2.6 The Protocol includes adequate provision for Monitoring the data collected to ensure the safety of Human
p.(None): Subjects.
p.(None): 5.3.2.7 There are adequate provisions to protect the subject’s privacy and maintain
p.(None): confidentiality of research data.
p.(None): 5.3.2.8 There are appropriate provisions for compensation for Human Subjects.
p.(None): 5.3.2.9 When some or all of the Human Subjects are likely to be susceptible to coercion or undue influence, there must
p.(None): be additional safeguards to ensure protection of the rights and welfare of these Subjects.
p.(None):
p.(None): 6- Research involving Children, Vulnerable Adults, Dependents, Pregnant Women, Prisoners, and Others
p.(None):
p.(None): 6.1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 6.2
p.(None):
p.(None):
p.(None):
p.(None): 6.3
p.(None): Children, vulnerable adults, pregnant women, fetuses, neonates, prisoners, students, employees, elderly,
p.(None): refugees, prisoners, disabled subjects or anyone who is economically, socially or educationally
p.(None): disadvantaged are all considered special population and any research involving these groups would require additional
p.(None): protections and institution oversight. DHCR is committed to the protection of the rights of these vulnerable
p.(None): populations as participants in research studies and special care has to be taken as these subjects may be more
p.(None): vulnerable to coercion and inappropriate influence such that their voluntary participation or informed consent could be
p.(None): compromised.
p.(None): In cases where the participant is legally incapable of providing consent or is a minor, the researchers
p.(None): must obtain approval from the participants’ parent(s) or legal guardian(s), in addition to seeking the
p.(None): participant’s agreement, explaining the research project and the role of the participant, while ensuring the
p.(None): participant’s best interests are served.
p.(None): Any research involving children should comply with Articles 3 and 12 of the United Nations Convention on the Rights of
...
p.(None): acceptable if the research holds direct benefits to both the mother and the fetus or has no Risk or minimal Risk to
p.(None): either. In addition, the research should result in research findings/data that cannot be obtained by other
p.(None): means. Moreover, consent should be obtained from both partners except in special circumstances. For underage children
p.(None): who might be pregnant, both assent and parental permission need to be obtained for their participation in any research
p.(None): study. No monetary or other inducements may be offered to a pregnant woman to terminate her pregnancy for
p.(None): research purposes. Researchers involved in the research project are not allowed to make any decisions pertaining to
p.(None): the pregnancy or the viability of the fetus.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 10 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None):
p.(None): 6.6
p.(None): Any research involving prisoners should abide by the relevant UAE laws and it should ensure the safety and rights of
p.(None): prisoners. Therefore, as general guidelines, research on prisoners is only acceptable if the research project addresses
p.(None): the possible causes, effects, and processes of incarceration, and of criminal behavior, or focuses on prisons as
p.(None): institutional structures or on prisoners as incarcerated persons provided that the research presents no more
p.(None): than minimal Risk or inconvenience to the participants. In addition, if the research project investigates
p.(None): the conditions affecting prisoners (for example, vaccine trials or any other research that tends to be more
p.(None): prevalent among prisoners, such as on hepatitis, or research on social and psychological problems like alcoholism, drug
p.(None): addiction, and sexual assaults, etc.), then appropriate experts should be adequately consulted prior to the
p.(None): study. This kind of research may also require additional approvals from other UAE agencies.
p.(None):
p.(None): 7- Responsibilities of the Principal Investigator (PI)
p.(None): The research study PI must fulfill the following duties and responsibilities:
p.(None):
p.(None): 7.1
p.(None):
p.(None):
p.(None): 7.2
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 7.3
p.(None):
p.(None):
p.(None): 7.4
p.(None):
p.(None):
p.(None):
p.(None): 7.5
p.(None): To ensure that all research studies have obtained ethical approval by the DHCR REC and that the research is carried out
p.(None): in accordance with the DHCR Ethics Policies and Procedures, and in compliance with UAE laws on individual and public
p.(None): safety and Good Clinical Practice.
p.(None): As the DHCR REC relies on the information provided in the application form(s), it is expected that all information is
p.(None): complete, truthful, and accurate including declaration of Significant Financial Interest and/or Conflict of Interest
p.(None): pertaining to the PI or any other member of the research team. Failure to do so could be considered research misconduct
p.(None): and may result in Penalty.
p.(None): It is important to understand that regardless of the decision by the DHCR REC on a specific research study, it is
p.(None): ultimately the responsibility of the PI and the research team themselves to make sure that the research study is
p.(None): carried out at the highest ethical standard.
...
Political / criminal
Searching for indicator criminal:
(return to top)
p.(None): means. Moreover, consent should be obtained from both partners except in special circumstances. For underage children
p.(None): who might be pregnant, both assent and parental permission need to be obtained for their participation in any research
p.(None): study. No monetary or other inducements may be offered to a pregnant woman to terminate her pregnancy for
p.(None): research purposes. Researchers involved in the research project are not allowed to make any decisions pertaining to
p.(None): the pregnancy or the viability of the fetus.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 10 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None):
p.(None): 6.6
p.(None): Any research involving prisoners should abide by the relevant UAE laws and it should ensure the safety and rights of
p.(None): prisoners. Therefore, as general guidelines, research on prisoners is only acceptable if the research project addresses
p.(None): the possible causes, effects, and processes of incarceration, and of criminal behavior, or focuses on prisons as
p.(None): institutional structures or on prisoners as incarcerated persons provided that the research presents no more
p.(None): than minimal Risk or inconvenience to the participants. In addition, if the research project investigates
p.(None): the conditions affecting prisoners (for example, vaccine trials or any other research that tends to be more
p.(None): prevalent among prisoners, such as on hepatitis, or research on social and psychological problems like alcoholism, drug
p.(None): addiction, and sexual assaults, etc.), then appropriate experts should be adequately consulted prior to the
p.(None): study. This kind of research may also require additional approvals from other UAE agencies.
p.(None):
p.(None): 7- Responsibilities of the Principal Investigator (PI)
p.(None): The research study PI must fulfill the following duties and responsibilities:
p.(None):
p.(None): 7.1
p.(None):
p.(None):
p.(None): 7.2
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 7.3
p.(None):
p.(None):
p.(None): 7.4
p.(None):
p.(None):
p.(None):
p.(None): 7.5
p.(None): To ensure that all research studies have obtained ethical approval by the DHCR REC and that the research is carried out
p.(None): in accordance with the DHCR Ethics Policies and Procedures, and in compliance with UAE laws on individual and public
p.(None): safety and Good Clinical Practice.
...
Political / vulnerable
Searching for indicator vulnerable:
(return to top)
p.(None): of all those involved in the research project, ensuring confidentiality of information about human subjects, cultural
p.(None): sensitivities in the UAE, and the reputation of DHCC, Dubai and the UAE.
p.(None): 4.12.2 Human subjects must be adequately protected during any research project conducted within or in connection with
p.(None): DHCC. Procedures must also be aligned and implemented with due care to follow all DHCR Policies and applicable UAE
p.(None): laws (such as the UAE Medical Liability Law No 4, 2016).
p.(None): 4.12.3 In cases where there is potential conflict between the freedom that the researcher has, within the law, to carry
p.(None): out the research project and the rights of the participants involved in the research project, the researcher must
p.(None): ensure that the participants’ interests and rights in the study come first.
p.(None): 4.12.4 The DHCR REC will review all research proposals that involve human subjects to ensure that the principles of the
p.(None): Belmont report that revolve around respect for persons, non- maleficence, beneficence, and justice are met. Hence, the
p.(None): research must
p.(None): 4.12.4.1 ensure the voluntary participation of human participants free from undue influence
p.(None): or coercion;
p.(None): 4.12.4.2 clearly outline the informed consent process;
p.(None): 4.12.4.3 emphasize the fair and non-discriminatory recruitment of human participants especially if recruitment entails
p.(None): vulnerable populations;
p.(None): 4.12.4.4 outline how the risks associated with the research are reasonable and justify them
p.(None): by the expected benefits;
p.(None): 4.7.4.5 have a clear and adequate monitoring plan to ensure the safety of participants as well as indicate how
p.(None): additional protection and safeguards will be applied when vulnerable subject populations are included; and
p.(None): 4.7.4.6 adequately outline how matters of confidentiality of all Patient Health Information are
p.(None): respected and that data storage and quality control are adequately maintained and in compliance with DHCR Health Data
p.(None): Protection Regulation.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 3 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None):
p.(None): 5- Procedure Sequence
p.(None): 5.1 New/Renewed Research Permit Submission Procedure
p.(None): 5.1.1 Submitting the Application
p.(None): Upon receiving notification of an Operator’s intent to conduct/ continue to conduct Research activities
p.(None): within DHCC, the Research Department will provide guidance on the correct application form(s) and supporting
p.(None): documents required to obtain/renew a DHCR Research Permit. The applicant will also be advised on the associated
p.(None): fees which will be in accordance with the current DHCR service fees structure
p.(None): (https://www.dhcr.gov.ae/en/E-Services/services-fees).
p.(None): Once documents as per the requirements stated in the applicable checklist
p.(None): (https://www.dhcr.gov.ae/en/AboutDHCR/regulatory-functions#ClinicalResearch) are ready to be submitted, the
p.(None): applicant will send them to the Research Department via email.
p.(None):
p.(None): 5.1.2 Administrative Review: Acknowledging receipt of documents and validating an application for review by the ARC
p.(None): The Research Department will commence validation of the application on receipt of documents upon which an invoice for
...
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 8 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): Subject’s representative, as applicable, before any Research related procedure, in accordance with DHCR Regulations and
p.(None): applicable Standards and Policies.
p.(None): 5.3.2.5 Informed consent must be appropriately documented, in accordance with evidence based best practices and using
p.(None): an approved form and patient information sheet. Arabic translation of the informed consent, patient information sheet,
p.(None): and any other material that is to be viewed and used by study Subjects is mandatory.
p.(None): 5.3.2.6 The Protocol includes adequate provision for Monitoring the data collected to ensure the safety of Human
p.(None): Subjects.
p.(None): 5.3.2.7 There are adequate provisions to protect the subject’s privacy and maintain
p.(None): confidentiality of research data.
p.(None): 5.3.2.8 There are appropriate provisions for compensation for Human Subjects.
p.(None): 5.3.2.9 When some or all of the Human Subjects are likely to be susceptible to coercion or undue influence, there must
p.(None): be additional safeguards to ensure protection of the rights and welfare of these Subjects.
p.(None):
p.(None): 6- Research involving Children, Vulnerable Adults, Dependents, Pregnant Women, Prisoners, and Others
p.(None):
p.(None): 6.1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 6.2
p.(None):
p.(None):
p.(None):
p.(None): 6.3
p.(None): Children, vulnerable adults, pregnant women, fetuses, neonates, prisoners, students, employees, elderly,
p.(None): refugees, prisoners, disabled subjects or anyone who is economically, socially or educationally
p.(None): disadvantaged are all considered special population and any research involving these groups would require additional
p.(None): protections and institution oversight. DHCR is committed to the protection of the rights of these vulnerable
p.(None): populations as participants in research studies and special care has to be taken as these subjects may be more
p.(None): vulnerable to coercion and inappropriate influence such that their voluntary participation or informed consent could be
p.(None): compromised.
p.(None): In cases where the participant is legally incapable of providing consent or is a minor, the researchers
p.(None): must obtain approval from the participants’ parent(s) or legal guardian(s), in addition to seeking the
p.(None): participant’s agreement, explaining the research project and the role of the participant, while ensuring the
p.(None): participant’s best interests are served.
p.(None): Any research involving children should comply with Articles 3 and 12 of the United Nations Convention on the Rights of
p.(None): the Child and UAE laws on protection of children. UN Convention Article 3 stipulates that the best interest of the
p.(None): child must be the primary consideration in all
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 9 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): actions concerning children and UN Convention Article 12 stipulates that children who are capable of forming their own
p.(None): views should be granted the right to do so freely in all matters affecting them, appropriate with their age and
p.(None): maturity. Research involving children should also abide by relevant UAE laws on protection of the rights of children -
p.(None): including but not limited to Federal Law No. 3 of 2016 concerning child rights, also known as Wadeema’s Law - and
p.(None): ensure that no potential Risk(s) to the participants are associated with the research study. Following evaluation of
p.(None): the age, maturity, and psychological state of the child, assent from the child and parental permission (parallel to
p.(None): informed consent) should be obtained.
p.(None):
p.(None): 6.4
p.(None):
p.(None):
p.(None):
p.(None): 6.5
p.(None): Any research involving a vulnerable adult (who is incapacitated or dependent due to cognitive, medical, economic,
p.(None): social, or situational factors) should take the appropriate precautions to ensure that they have not been
p.(None): subjected to undue influence to participate by either the dependents, the research team, or anyone else.
p.(None): Any research involving pregnant women should abide by relevant UAE laws and ensure the safety and health of the
p.(None): mother and the fetus first and foremost. Therefore, as general guidelines, research on pregnant women is only
p.(None): acceptable if the research holds direct benefits to both the mother and the fetus or has no Risk or minimal Risk to
p.(None): either. In addition, the research should result in research findings/data that cannot be obtained by other
p.(None): means. Moreover, consent should be obtained from both partners except in special circumstances. For underage children
p.(None): who might be pregnant, both assent and parental permission need to be obtained for their participation in any research
...
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): 10.10 DHCR: Dubai Healthcare City Authority – Regulatory the independent regulatory arm of Dubai Healthcare City
p.(None): Authority (DHCA), the governing body of Dubai Healthcare City (DHCC) free zone - a health and wellness destination.
p.(None): 10.11 Document and Documentation: information stored in any form of writing, code, or visual depiction and the
p.(None): manner in which such information is stored is irrelevant for the purpose of deeming the information to constitute a
p.(None): “document” for the purpose of this definition.
p.(None): 10.12 Entity: an organization, institution, or corporation other than a natural person.
p.(None): 10.13 Human Biomedical Research: any systematic investigation, including research development, testing and
p.(None): evaluation that involves the use of either an investigational product in human subjects, the use of
p.(None): identifiable human tissue or Patient Health Information, with the objective of developing or contributing to
p.(None): generalizable knowledge.
p.(None): 10.14 Human Subject: a living individual about whom an Investigator conducting an Approved Research
p.(None): Activity obtains either data through intervention and/or interaction with the individual or by obtaining that person’s
p.(None): patient health information.
p.(None): 10.15 Informed Consent: a process by which a Human Subject’s, or where that person is a Vulnerable Subject, that
p.(None): person’s Representative, voluntary confirmation of his willingness to participate in a particular research study, after
p.(None): having been informed of all aspects of the study procedures that are relevant to such Human or Vulnerable Subject’s
p.(None): decision to participate.
p.(None): 10.16 Interventional Study: Human Biomedical Research in which Human Subjects are assigned to receive specific
p.(None): diagnostic, therapeutic, or other types of biomedical or behavioral intervention.
p.(None): 10.17 Investigational Product: any investigational drug, biologic or medical device being tested or used as a
p.(None): reference in Human Biomedical Research, including a product with a Marketing Authorization when
p.(None): used or assembled (formulated or packaged) in a way different from the Approved Use, or when used for an
p.(None): indication that is not an Approved Use, or when used to gain further information about an Approved Use.
p.(None): 10.18 Investigators: the Principal Investigator and co-investigators collectively. The Principal
p.(None): Investigator is the individual responsible and accountable for designing a Protocol, and
p.(None): conducting and Monitoring of an Approved Research Activity in accordance with the Protocol. The co-investigator is
p.(None): an individual member of a research team, qualified by training and experience, designated and supervised by
p.(None): the Principal Investigator to perform critical research- related procedures and/or to make important research-related
p.(None): decisions.
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 17 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None):
p.(None): 10.19
p.(None):
p.(None): 10.20
p.(None):
p.(None):
p.(None): 10.21
p.(None): 10.22
p.(None):
p.(None):
p.(None):
p.(None): 10.23
p.(None): 10.24
p.(None):
p.(None): 10.25
p.(None):
p.(None):
p.(None): 10.26
p.(None):
p.(None):
p.(None): 10.27
p.(None): 10.28
p.(None):
p.(None): 10.29
p.(None):
p.(None): 10.30
p.(None):
p.(None): 10.31
p.(None): Investigator’s Brochure: a compilation of the clinical and pre-clinical data on an Investigational Product that is
p.(None): relevant to the study of the Investigational Product in Human Subjects
p.(None): Monitoring: the act of overseeing the progress of Approved Research Activities, and of ensuring that it is conducted,
p.(None): recorded and reported in accordance with the approved Protocol, the Research Regulation and any applicable Rules,
p.(None): Standards and Policies;
p.(None): NOC: No Objection Certificate.
p.(None): Patient Health Information: information about a patient, whether spoken, written, or in the form of an
p.(None): Electronic Record, that is created or received by any licensee, that relates to the physical or mental
p.(None): health or condition of the patient, including the reports from any diagnostic procedures and information related to the
p.(None): payment for services.
p.(None): Penalty: the penalty imposed by DHCR in accordance with the applicable regulations.
p.(None): Protocol: the document that describes the objective(s), design, methodology, statistical
p.(None): considerations and organization of the research activity.
p.(None): Records: all papers, records, recorded tapes, photographs, statistical tabulations or other documentary
p.(None): materials or data, regardless of physical form or characteristics, including in written or electronic form
p.(None): Representative: the Human Subject’s legal or personal representative who is authorized to act on behalf of a
p.(None): prospective Vulnerable Subject, with regard to the Human Subject’s participation in research.
...
...
Health / Cognitive Impairment
Searching for indicator cognitive:
(return to top)
p.(None):
p.(None): actions concerning children and UN Convention Article 12 stipulates that children who are capable of forming their own
p.(None): views should be granted the right to do so freely in all matters affecting them, appropriate with their age and
p.(None): maturity. Research involving children should also abide by relevant UAE laws on protection of the rights of children -
p.(None): including but not limited to Federal Law No. 3 of 2016 concerning child rights, also known as Wadeema’s Law - and
p.(None): ensure that no potential Risk(s) to the participants are associated with the research study. Following evaluation of
p.(None): the age, maturity, and psychological state of the child, assent from the child and parental permission (parallel to
p.(None): informed consent) should be obtained.
p.(None):
p.(None): 6.4
p.(None):
p.(None):
p.(None):
p.(None): 6.5
p.(None): Any research involving a vulnerable adult (who is incapacitated or dependent due to cognitive, medical, economic,
p.(None): social, or situational factors) should take the appropriate precautions to ensure that they have not been
p.(None): subjected to undue influence to participate by either the dependents, the research team, or anyone else.
p.(None): Any research involving pregnant women should abide by relevant UAE laws and ensure the safety and health of the
p.(None): mother and the fetus first and foremost. Therefore, as general guidelines, research on pregnant women is only
p.(None): acceptable if the research holds direct benefits to both the mother and the fetus or has no Risk or minimal Risk to
p.(None): either. In addition, the research should result in research findings/data that cannot be obtained by other
p.(None): means. Moreover, consent should be obtained from both partners except in special circumstances. For underage children
p.(None): who might be pregnant, both assent and parental permission need to be obtained for their participation in any research
p.(None): study. No monetary or other inducements may be offered to a pregnant woman to terminate her pregnancy for
...
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 10 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None):
p.(None): 6.6
p.(None): Any research involving prisoners should abide by the relevant UAE laws and it should ensure the safety and rights of
p.(None): prisoners. Therefore, as general guidelines, research on prisoners is only acceptable if the research project addresses
p.(None): the possible causes, effects, and processes of incarceration, and of criminal behavior, or focuses on prisons as
p.(None): institutional structures or on prisoners as incarcerated persons provided that the research presents no more
p.(None): than minimal Risk or inconvenience to the participants. In addition, if the research project investigates
p.(None): the conditions affecting prisoners (for example, vaccine trials or any other research that tends to be more
p.(None): prevalent among prisoners, such as on hepatitis, or research on social and psychological problems like alcoholism, drug
p.(None): addiction, and sexual assaults, etc.), then appropriate experts should be adequately consulted prior to the
p.(None): study. This kind of research may also require additional approvals from other UAE agencies.
p.(None):
p.(None): 7- Responsibilities of the Principal Investigator (PI)
p.(None): The research study PI must fulfill the following duties and responsibilities:
p.(None):
p.(None): 7.1
p.(None):
p.(None):
p.(None): 7.2
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 7.3
p.(None):
p.(None):
p.(None): 7.4
p.(None):
p.(None):
p.(None):
p.(None): 7.5
p.(None): To ensure that all research studies have obtained ethical approval by the DHCR REC and that the research is carried out
p.(None): in accordance with the DHCR Ethics Policies and Procedures, and in compliance with UAE laws on individual and public
p.(None): safety and Good Clinical Practice.
p.(None): As the DHCR REC relies on the information provided in the application form(s), it is expected that all information is
p.(None): complete, truthful, and accurate including declaration of Significant Financial Interest and/or Conflict of Interest
p.(None): pertaining to the PI or any other member of the research team. Failure to do so could be considered research misconduct
p.(None): and may result in Penalty.
p.(None): It is important to understand that regardless of the decision by the DHCR REC on a specific research study, it is
p.(None): ultimately the responsibility of the PI and the research team themselves to make sure that the research study is
p.(None): carried out at the highest ethical standard.
p.(None): Where a DHCA-licensed Healthcare Professional is engaged in joint research projects with other universities or
p.(None): institutions outside of DHCC ethical approval must be sought from all joint institutions as necessary.
...
p.(None): Ensuring the integrity of the data;
p.(None): Allocation of responsibilities by defining, establishing, and assigning all trial-related duties and functions;
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 13 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): 8.11 Compensation to subjects and investigators whereby the sponsor should provide insurance or should indemnify
p.(None): (legal and financial coverage) the investigator/the ARO against claims arising from the trial except for claims that
p.(None): arise from malpractice and/or negligence.
p.(None): In addition, the sponsor’s policies and procedures should address the costs of treatment of trial subjects in the event
p.(None): of trial-related injuries, as well as untoward side-effects, and the method and manner of compensation when trial
p.(None): subjects receive the same;
p.(None): 8.12 Financing of the study whereby the financial aspects of the trial should be documented in an agreement between
p.(None): the sponsor and the investigator/ARO and a signed copy provided to DHCR REC for review.
p.(None): 8.13 Notifying DHCR and any other relevant regulatory authorities of study commencement, amendments, close out,
p.(None): premature termination, suspension, adverse events or any deviation from/noncompliance with the REC-approved
p.(None): protocol/Good Clinical Practice or any material findings that may alter the REC’s approval to continue the trial;
p.(None): 8.14 Ensuring secure record access for monitoring, audits, REC reviews, and regulatory inspection;
p.(None): 8.15 Safety evaluation of the study and associated investigational products. All adverse drug reactions (ADRs) that
p.(None): are both serious and/or unexpected must be reported to DHCR REC in compliance with DHCR requirements and ICH Guideline
p.(None): for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting;
p.(None): 8.16 Research study monitoring and audit including selection of qualified monitors/auditors, establishing a
p.(None): monitoring/audit plan;
p.(None): 8.17 Preparing and providing DHCR with research study reports whether the study is completed or prematurely
p.(None): terminated;
p.(None): 8.18 It is the responsibility of the Sponsor to ensure that the Investigator as well as all research team members
p.(None): maintain valid Good Clinical Practice certification for the duration of the research study. (N.B. Good Clinical
p.(None): Practice certification is valid for two (2) years from date of issuance.)
p.(None):
p.(None):
p.(None): 9- Human Genetic Research
p.(None): The study of the human genome is the key to understanding the blueprint of human diseases and the advancement of
p.(None): medicine and any human genome research studies taking place in DHCC must abide by the following:
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 14 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): 9.1 Human genome, exome, and/or RNA sequencing and/or analysis must be documented in an agreement
p.(None): between the Investigator/ARO and the sequencing facility; and a signed copy provided to DHCR REC for review. Whenever
p.(None): feasible, genetic samples are to be analyzed by facilities/labs within the UAE. If the required service is not
p.(None): available within the UAE then the samples may be sent abroad with precautions taken to safeguard the safety, security,
...
p.(None): is stated in the agreement; and
p.(None): 9.2.16 The cost of the service.
p.(None): 9.3 The Investigator and the ARO must abide by all UAE federal and local laws, policies, and regulations.
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 15 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): 9.4 Genetic studies and their subsequent results must not be used in any manner that may be harmful or contrary to
p.(None): UAE federal and local laws or the UNESCO Genome Declaration of 1997.
p.(None): 9.5 Samples and/or parts of samples, as well as data from previously approved research studies must not be used for
p.(None): any further research or analysis without prior approval from DHCR REC.
p.(None): 9.6 The genetic sequencing facility credentials including but not limited to license, registration, and
p.(None): accreditation must be submitted as part of the genetic research study application for review by the DHCR Research
p.(None): Department and the DHCR REC.
p.(None):
p.(None):
p.(None): 10- Definitions:
p.(None): 10.1 Approved Research Activity: a research activity for which a Research Permit has been granted.
p.(None): 10.2 Approved Research Operator: an Entity that holds a valid Research Permit issued by DHCR to conduct research
p.(None): activities in accordance with the applicable DHCR Rules, Standards and Policies.
p.(None): 10.3 Approved Research Site: site or location within DHCC, including the physical facility or facilities
p.(None): associated therewith, at which an Approved Research Operator is permitted to conduct Approved Research Activities under
p.(None): its Research Permit.
p.(None): 10.4 Approved Use: the use of a drug, biologic or medical device that has been approved for one or more specific
p.(None): indications by a duly constituted regulatory agency in a jurisdiction recognized for this purpose by DHCR.
p.(None): 10.5 Audit: a systematic and independent evaluation of a research and documents to determine whether
p.(None): the research was conducted in accordance with the requirements of the Research Regulation, any applicable
p.(None): Rules, Standards and Policies, and the Protocol approved for such research.
p.(None): 10.6 ARC: Academic and Research Council.
p.(None): 10.7 CEO: Chief Executive Officer of DHCR.
p.(None): 10.8 Conflict of Interest: a divergence between an individual’s private interest and his professional obligations.
p.(None): A potential or actual Conflict of Interest, either financial or non-financial, exists when a significant interest could
p.(None): affect the design, conduct, or reporting of research or educational activities
p.(None): 10.9 DHCC: Dubai Healthcare City.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 16 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): 10.10 DHCR: Dubai Healthcare City Authority – Regulatory the independent regulatory arm of Dubai Healthcare City
p.(None): Authority (DHCA), the governing body of Dubai Healthcare City (DHCC) free zone - a health and wellness destination.
p.(None): 10.11 Document and Documentation: information stored in any form of writing, code, or visual depiction and the
p.(None): manner in which such information is stored is irrelevant for the purpose of deeming the information to constitute a
p.(None): “document” for the purpose of this definition.
p.(None): 10.12 Entity: an organization, institution, or corporation other than a natural person.
p.(None): 10.13 Human Biomedical Research: any systematic investigation, including research development, testing and
p.(None): evaluation that involves the use of either an investigational product in human subjects, the use of
p.(None): identifiable human tissue or Patient Health Information, with the objective of developing or contributing to
p.(None): generalizable knowledge.
p.(None): 10.14 Human Subject: a living individual about whom an Investigator conducting an Approved Research
p.(None): Activity obtains either data through intervention and/or interaction with the individual or by obtaining that person’s
p.(None): patient health information.
p.(None): 10.15 Informed Consent: a process by which a Human Subject’s, or where that person is a Vulnerable Subject, that
p.(None): person’s Representative, voluntary confirmation of his willingness to participate in a particular research study, after
p.(None): having been informed of all aspects of the study procedures that are relevant to such Human or Vulnerable Subject’s
p.(None): decision to participate.
p.(None): 10.16 Interventional Study: Human Biomedical Research in which Human Subjects are assigned to receive specific
p.(None): diagnostic, therapeutic, or other types of biomedical or behavioral intervention.
p.(None): 10.17 Investigational Product: any investigational drug, biologic or medical device being tested or used as a
p.(None): reference in Human Biomedical Research, including a product with a Marketing Authorization when
p.(None): used or assembled (formulated or packaged) in a way different from the Approved Use, or when used for an
p.(None): indication that is not an Approved Use, or when used to gain further information about an Approved Use.
p.(None): 10.18 Investigators: the Principal Investigator and co-investigators collectively. The Principal
p.(None): Investigator is the individual responsible and accountable for designing a Protocol, and
p.(None): conducting and Monitoring of an Approved Research Activity in accordance with the Protocol. The co-investigator is
p.(None): an individual member of a research team, qualified by training and experience, designated and supervised by
p.(None): the Principal Investigator to perform critical research- related procedures and/or to make important research-related
p.(None): decisions.
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 17 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None):
p.(None): 10.19
p.(None):
p.(None): 10.20
p.(None):
p.(None):
p.(None): 10.21
p.(None): 10.22
p.(None):
p.(None):
p.(None):
p.(None): 10.23
p.(None): 10.24
p.(None):
p.(None): 10.25
p.(None):
p.(None):
p.(None): 10.26
p.(None):
p.(None):
p.(None): 10.27
p.(None): 10.28
p.(None):
p.(None): 10.29
p.(None):
p.(None): 10.30
p.(None):
p.(None): 10.31
p.(None): Investigator’s Brochure: a compilation of the clinical and pre-clinical data on an Investigational Product that is
p.(None): relevant to the study of the Investigational Product in Human Subjects
...
Searching for indicator influence:
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p.(None):
p.(None): 6.1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 6.2
p.(None):
p.(None):
p.(None):
p.(None): 6.3
p.(None): Children, vulnerable adults, pregnant women, fetuses, neonates, prisoners, students, employees, elderly,
p.(None): refugees, prisoners, disabled subjects or anyone who is economically, socially or educationally
p.(None): disadvantaged are all considered special population and any research involving these groups would require additional
p.(None): protections and institution oversight. DHCR is committed to the protection of the rights of these vulnerable
p.(None): populations as participants in research studies and special care has to be taken as these subjects may be more
p.(None): vulnerable to coercion and inappropriate influence such that their voluntary participation or informed consent could be
p.(None): compromised.
p.(None): In cases where the participant is legally incapable of providing consent or is a minor, the researchers
p.(None): must obtain approval from the participants’ parent(s) or legal guardian(s), in addition to seeking the
p.(None): participant’s agreement, explaining the research project and the role of the participant, while ensuring the
p.(None): participant’s best interests are served.
p.(None): Any research involving children should comply with Articles 3 and 12 of the United Nations Convention on the Rights of
p.(None): the Child and UAE laws on protection of children. UN Convention Article 3 stipulates that the best interest of the
p.(None): child must be the primary consideration in all
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 9 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): actions concerning children and UN Convention Article 12 stipulates that children who are capable of forming their own
p.(None): views should be granted the right to do so freely in all matters affecting them, appropriate with their age and
p.(None): maturity. Research involving children should also abide by relevant UAE laws on protection of the rights of children -
p.(None): including but not limited to Federal Law No. 3 of 2016 concerning child rights, also known as Wadeema’s Law - and
p.(None): ensure that no potential Risk(s) to the participants are associated with the research study. Following evaluation of
p.(None): the age, maturity, and psychological state of the child, assent from the child and parental permission (parallel to
p.(None): informed consent) should be obtained.
p.(None):
p.(None): 6.4
p.(None):
p.(None):
p.(None):
p.(None): 6.5
p.(None): Any research involving a vulnerable adult (who is incapacitated or dependent due to cognitive, medical, economic,
p.(None): social, or situational factors) should take the appropriate precautions to ensure that they have not been
p.(None): subjected to undue influence to participate by either the dependents, the research team, or anyone else.
p.(None): Any research involving pregnant women should abide by relevant UAE laws and ensure the safety and health of the
p.(None): mother and the fetus first and foremost. Therefore, as general guidelines, research on pregnant women is only
p.(None): acceptable if the research holds direct benefits to both the mother and the fetus or has no Risk or minimal Risk to
p.(None): either. In addition, the research should result in research findings/data that cannot be obtained by other
p.(None): means. Moreover, consent should be obtained from both partners except in special circumstances. For underage children
p.(None): who might be pregnant, both assent and parental permission need to be obtained for their participation in any research
p.(None): study. No monetary or other inducements may be offered to a pregnant woman to terminate her pregnancy for
p.(None): research purposes. Researchers involved in the research project are not allowed to make any decisions pertaining to
p.(None): the pregnancy or the viability of the fetus.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
Health / Mentally Disabled
Searching for indicator disabled:
(return to top)
p.(None): confidentiality of research data.
p.(None): 5.3.2.8 There are appropriate provisions for compensation for Human Subjects.
p.(None): 5.3.2.9 When some or all of the Human Subjects are likely to be susceptible to coercion or undue influence, there must
p.(None): be additional safeguards to ensure protection of the rights and welfare of these Subjects.
p.(None):
p.(None): 6- Research involving Children, Vulnerable Adults, Dependents, Pregnant Women, Prisoners, and Others
p.(None):
p.(None): 6.1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 6.2
p.(None):
p.(None):
p.(None):
p.(None): 6.3
p.(None): Children, vulnerable adults, pregnant women, fetuses, neonates, prisoners, students, employees, elderly,
p.(None): refugees, prisoners, disabled subjects or anyone who is economically, socially or educationally
p.(None): disadvantaged are all considered special population and any research involving these groups would require additional
p.(None): protections and institution oversight. DHCR is committed to the protection of the rights of these vulnerable
p.(None): populations as participants in research studies and special care has to be taken as these subjects may be more
p.(None): vulnerable to coercion and inappropriate influence such that their voluntary participation or informed consent could be
p.(None): compromised.
p.(None): In cases where the participant is legally incapable of providing consent or is a minor, the researchers
p.(None): must obtain approval from the participants’ parent(s) or legal guardian(s), in addition to seeking the
p.(None): participant’s agreement, explaining the research project and the role of the participant, while ensuring the
p.(None): participant’s best interests are served.
p.(None): Any research involving children should comply with Articles 3 and 12 of the United Nations Convention on the Rights of
...
Health / Mentally Incapacitated
Searching for indicator incapable:
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p.(None):
p.(None):
p.(None):
p.(None): 6.2
p.(None):
p.(None):
p.(None):
p.(None): 6.3
p.(None): Children, vulnerable adults, pregnant women, fetuses, neonates, prisoners, students, employees, elderly,
p.(None): refugees, prisoners, disabled subjects or anyone who is economically, socially or educationally
p.(None): disadvantaged are all considered special population and any research involving these groups would require additional
p.(None): protections and institution oversight. DHCR is committed to the protection of the rights of these vulnerable
p.(None): populations as participants in research studies and special care has to be taken as these subjects may be more
p.(None): vulnerable to coercion and inappropriate influence such that their voluntary participation or informed consent could be
p.(None): compromised.
p.(None): In cases where the participant is legally incapable of providing consent or is a minor, the researchers
p.(None): must obtain approval from the participants’ parent(s) or legal guardian(s), in addition to seeking the
p.(None): participant’s agreement, explaining the research project and the role of the participant, while ensuring the
p.(None): participant’s best interests are served.
p.(None): Any research involving children should comply with Articles 3 and 12 of the United Nations Convention on the Rights of
p.(None): the Child and UAE laws on protection of children. UN Convention Article 3 stipulates that the best interest of the
p.(None): child must be the primary consideration in all
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 9 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): actions concerning children and UN Convention Article 12 stipulates that children who are capable of forming their own
p.(None): views should be granted the right to do so freely in all matters affecting them, appropriate with their age and
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): Subject’s representative, as applicable, before any Research related procedure, in accordance with DHCR Regulations and
p.(None): applicable Standards and Policies.
p.(None): 5.3.2.5 Informed consent must be appropriately documented, in accordance with evidence based best practices and using
p.(None): an approved form and patient information sheet. Arabic translation of the informed consent, patient information sheet,
p.(None): and any other material that is to be viewed and used by study Subjects is mandatory.
p.(None): 5.3.2.6 The Protocol includes adequate provision for Monitoring the data collected to ensure the safety of Human
p.(None): Subjects.
p.(None): 5.3.2.7 There are adequate provisions to protect the subject’s privacy and maintain
p.(None): confidentiality of research data.
p.(None): 5.3.2.8 There are appropriate provisions for compensation for Human Subjects.
p.(None): 5.3.2.9 When some or all of the Human Subjects are likely to be susceptible to coercion or undue influence, there must
p.(None): be additional safeguards to ensure protection of the rights and welfare of these Subjects.
p.(None):
p.(None): 6- Research involving Children, Vulnerable Adults, Dependents, Pregnant Women, Prisoners, and Others
p.(None):
p.(None): 6.1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 6.2
p.(None):
p.(None):
p.(None):
p.(None): 6.3
p.(None): Children, vulnerable adults, pregnant women, fetuses, neonates, prisoners, students, employees, elderly,
p.(None): refugees, prisoners, disabled subjects or anyone who is economically, socially or educationally
p.(None): disadvantaged are all considered special population and any research involving these groups would require additional
p.(None): protections and institution oversight. DHCR is committed to the protection of the rights of these vulnerable
p.(None): populations as participants in research studies and special care has to be taken as these subjects may be more
p.(None): vulnerable to coercion and inappropriate influence such that their voluntary participation or informed consent could be
p.(None): compromised.
p.(None): In cases where the participant is legally incapable of providing consent or is a minor, the researchers
...
p.(None): maturity. Research involving children should also abide by relevant UAE laws on protection of the rights of children -
p.(None): including but not limited to Federal Law No. 3 of 2016 concerning child rights, also known as Wadeema’s Law - and
p.(None): ensure that no potential Risk(s) to the participants are associated with the research study. Following evaluation of
p.(None): the age, maturity, and psychological state of the child, assent from the child and parental permission (parallel to
p.(None): informed consent) should be obtained.
p.(None):
p.(None): 6.4
p.(None):
p.(None):
p.(None):
p.(None): 6.5
p.(None): Any research involving a vulnerable adult (who is incapacitated or dependent due to cognitive, medical, economic,
p.(None): social, or situational factors) should take the appropriate precautions to ensure that they have not been
p.(None): subjected to undue influence to participate by either the dependents, the research team, or anyone else.
p.(None): Any research involving pregnant women should abide by relevant UAE laws and ensure the safety and health of the
p.(None): mother and the fetus first and foremost. Therefore, as general guidelines, research on pregnant women is only
p.(None): acceptable if the research holds direct benefits to both the mother and the fetus or has no Risk or minimal Risk to
p.(None): either. In addition, the research should result in research findings/data that cannot be obtained by other
p.(None): means. Moreover, consent should be obtained from both partners except in special circumstances. For underage children
p.(None): who might be pregnant, both assent and parental permission need to be obtained for their participation in any research
p.(None): study. No monetary or other inducements may be offered to a pregnant woman to terminate her pregnancy for
p.(None): research purposes. Researchers involved in the research project are not allowed to make any decisions pertaining to
p.(None): the pregnancy or the viability of the fetus.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 10 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None):
p.(None): 6.6
p.(None): Any research involving prisoners should abide by the relevant UAE laws and it should ensure the safety and rights of
p.(None): prisoners. Therefore, as general guidelines, research on prisoners is only acceptable if the research project addresses
p.(None): the possible causes, effects, and processes of incarceration, and of criminal behavior, or focuses on prisons as
p.(None): institutional structures or on prisoners as incarcerated persons provided that the research presents no more
p.(None): than minimal Risk or inconvenience to the participants. In addition, if the research project investigates
p.(None): the conditions affecting prisoners (for example, vaccine trials or any other research that tends to be more
...
p.(None): prospective Vulnerable Subject, with regard to the Human Subject’s participation in research.
p.(None): REC: Research Ethics Committee.
p.(None): Research Permit: a permit issued by DHCR to an Entity authorizing it to conduct the Approved Research Activity.
p.(None): Risk: the probability of harm or injury, whether physical, psychological, social, or economic, occurring as
p.(None): a result of participating in Approved Research Activities.
p.(None): Serious Adverse Event: any unanticipated incident involving Risks or injury or death of Human Subjects that may present
p.(None): itself during the course of Approved Research Activities.
p.(None): Significant Financial Interest: anything of a monetary value or an Equity Interest in an Entity held by an Investigator
p.(None): during the time he is carrying out the research and for 1 year following completion of such investigation.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 18 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): 10.32 Sponsor: pharmaceutical company, academic institution or any other Entity that takes
p.(None): responsibility for the initiation of research and/or arranges for the payment, if any, of the research.
p.(None): 10.33 Special Population includes Vulnerable Subjects and others with special needs and includes pregnant
p.(None): women and their in utero fetuses
p.(None): 10.34 Vulnerable Subject: vulnerable Human Subject with diminished competence and/or decision making
p.(None): capacity due to age, physical or medical conditions, or social-economic status.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
Health / alcoholism
Searching for indicator alcoholism:
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 10 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None):
p.(None): 6.6
p.(None): Any research involving prisoners should abide by the relevant UAE laws and it should ensure the safety and rights of
p.(None): prisoners. Therefore, as general guidelines, research on prisoners is only acceptable if the research project addresses
p.(None): the possible causes, effects, and processes of incarceration, and of criminal behavior, or focuses on prisons as
p.(None): institutional structures or on prisoners as incarcerated persons provided that the research presents no more
p.(None): than minimal Risk or inconvenience to the participants. In addition, if the research project investigates
p.(None): the conditions affecting prisoners (for example, vaccine trials or any other research that tends to be more
p.(None): prevalent among prisoners, such as on hepatitis, or research on social and psychological problems like alcoholism, drug
p.(None): addiction, and sexual assaults, etc.), then appropriate experts should be adequately consulted prior to the
p.(None): study. This kind of research may also require additional approvals from other UAE agencies.
p.(None):
p.(None): 7- Responsibilities of the Principal Investigator (PI)
p.(None): The research study PI must fulfill the following duties and responsibilities:
p.(None):
p.(None): 7.1
p.(None):
p.(None):
p.(None): 7.2
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 7.3
p.(None):
p.(None):
p.(None): 7.4
p.(None):
p.(None):
p.(None):
p.(None): 7.5
p.(None): To ensure that all research studies have obtained ethical approval by the DHCR REC and that the research is carried out
p.(None): in accordance with the DHCR Ethics Policies and Procedures, and in compliance with UAE laws on individual and public
p.(None): safety and Good Clinical Practice.
p.(None): As the DHCR REC relies on the information provided in the application form(s), it is expected that all information is
p.(None): complete, truthful, and accurate including declaration of Significant Financial Interest and/or Conflict of Interest
p.(None): pertaining to the PI or any other member of the research team. Failure to do so could be considered research misconduct
p.(None): and may result in Penalty.
p.(None): It is important to understand that regardless of the decision by the DHCR REC on a specific research study, it is
p.(None): ultimately the responsibility of the PI and the research team themselves to make sure that the research study is
p.(None): carried out at the highest ethical standard.
p.(None): Where a DHCA-licensed Healthcare Professional is engaged in joint research projects with other universities or
...
Social / Access to Social Goods
Searching for indicator access:
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p.(None): 7.6.3 safeguard the privacy of research participants; and
p.(None): 7.6.4 ensure confidentiality of participant information/data. All personal information should be encoded or made
p.(None): anonymous from the beginning of the data collection and codes kept separately. In certain cases guarantees of privacy
p.(None): and confidentiality may be overruled in order to ensure protection of the research participants’ physical and
p.(None): psychological safety and well- being.
p.(None): 7.7 Once the research has been approved the PI must keep the DHCR Research Department and the REC updated on any
p.(None): issues that arise during the conduct of the study. This includes but is not limited to amendments, progress reports,
p.(None): and safety information reporting. The PI must report any Serious Adverse Event immediately to DHCR whether it occurs
p.(None): inside or outside DHCC.
p.(None): 7.8 If the research study is of an interventional nature in which there is potential harm to the research subjects
p.(None): the PI must allocate a part of the study budget to compensate affected subjects for research related injury (i.e.
p.(None): purchase liability insurance for such cases). In addition, the PI should address the method and manner of compensation
p.(None): when study subjects receive the same.
p.(None): 7.9 The PI must ensure the integrity of the data.
p.(None): 7.10 The PI must oversee all aspects of trial management, data handling, record keeping and ensuring protocol
p.(None): compliance.
p.(None): 7.11 The PI must allocate responsibilities by defining, establishing, and assigning all trial-related duties and
p.(None): functions.
p.(None): 7.12 The PI must ensure record access for monitoring, audits, REC reviews, and regulatory inspection.
p.(None): 7.13 The PI must prepare and provide DHCR with research study reports whether the study is completed or prematurely
p.(None): terminated.
p.(None): 7.14 The PI must establish systems of quality assurance and quality control with written Standard Operating
p.(None): Procedures (SOPs).
p.(None): 7.15 The PI must oversee regulatory requirements of the investigational product including safety and efficacy,
p.(None): updating the Investigator’s Brochure as required, compliance with Good Manufacturing Practice, and appropriate
p.(None): labelling, packaging, and coding of all investigational products.
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 12 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): 7.16 The PI must establish a system for ongoing research study monitoring.
p.(None): 7.17 The PI must ensure that he/she as well as all research team members maintain valid Good Clinical Practice
p.(None): certification for the duration of the research study. Good Clinical Practice certification is valid for two (2) years
p.(None): from date of issuance.
p.(None):
p.(None):
p.(None): 8- Responsibilities of the Sponsor
p.(None): Research study sponsors must fulfill the following duties and responsibilities:
p.(None):
p.(None): 8.1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 8.2
p.(None): 8.3
p.(None): 8.4
p.(None): 8.5
p.(None):
p.(None): 8.6
p.(None):
p.(None):
p.(None): 8.7
p.(None): 8.8
p.(None):
p.(None):
p.(None):
p.(None): 8.9
p.(None): 8.10
p.(None): Quality management and monitoring including: risk identification, evaluation, control, communication,
...
p.(None): questions or problems. Each investigator should be qualified by training and experience and should have adequate
p.(None): resources to properly conduct the trial for which the investigator is selected;
p.(None): Ensuring the integrity of the data;
p.(None): Allocation of responsibilities by defining, establishing, and assigning all trial-related duties and functions;
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 13 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): 8.11 Compensation to subjects and investigators whereby the sponsor should provide insurance or should indemnify
p.(None): (legal and financial coverage) the investigator/the ARO against claims arising from the trial except for claims that
p.(None): arise from malpractice and/or negligence.
p.(None): In addition, the sponsor’s policies and procedures should address the costs of treatment of trial subjects in the event
p.(None): of trial-related injuries, as well as untoward side-effects, and the method and manner of compensation when trial
p.(None): subjects receive the same;
p.(None): 8.12 Financing of the study whereby the financial aspects of the trial should be documented in an agreement between
p.(None): the sponsor and the investigator/ARO and a signed copy provided to DHCR REC for review.
p.(None): 8.13 Notifying DHCR and any other relevant regulatory authorities of study commencement, amendments, close out,
p.(None): premature termination, suspension, adverse events or any deviation from/noncompliance with the REC-approved
p.(None): protocol/Good Clinical Practice or any material findings that may alter the REC’s approval to continue the trial;
p.(None): 8.14 Ensuring secure record access for monitoring, audits, REC reviews, and regulatory inspection;
p.(None): 8.15 Safety evaluation of the study and associated investigational products. All adverse drug reactions (ADRs) that
p.(None): are both serious and/or unexpected must be reported to DHCR REC in compliance with DHCR requirements and ICH Guideline
p.(None): for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting;
p.(None): 8.16 Research study monitoring and audit including selection of qualified monitors/auditors, establishing a
p.(None): monitoring/audit plan;
p.(None): 8.17 Preparing and providing DHCR with research study reports whether the study is completed or prematurely
p.(None): terminated;
p.(None): 8.18 It is the responsibility of the Sponsor to ensure that the Investigator as well as all research team members
p.(None): maintain valid Good Clinical Practice certification for the duration of the research study. (N.B. Good Clinical
p.(None): Practice certification is valid for two (2) years from date of issuance.)
p.(None):
p.(None):
p.(None): 9- Human Genetic Research
p.(None): The study of the human genome is the key to understanding the blueprint of human diseases and the advancement of
p.(None): medicine and any human genome research studies taking place in DHCC must abide by the following:
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 14 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): 9.1 Human genome, exome, and/or RNA sequencing and/or analysis must be documented in an agreement
p.(None): between the Investigator/ARO and the sequencing facility; and a signed copy provided to DHCR REC for review. Whenever
...
Social / Age
Searching for indicator age:
(return to top)
p.(None): compromised.
p.(None): In cases where the participant is legally incapable of providing consent or is a minor, the researchers
p.(None): must obtain approval from the participants’ parent(s) or legal guardian(s), in addition to seeking the
p.(None): participant’s agreement, explaining the research project and the role of the participant, while ensuring the
p.(None): participant’s best interests are served.
p.(None): Any research involving children should comply with Articles 3 and 12 of the United Nations Convention on the Rights of
p.(None): the Child and UAE laws on protection of children. UN Convention Article 3 stipulates that the best interest of the
p.(None): child must be the primary consideration in all
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 9 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): actions concerning children and UN Convention Article 12 stipulates that children who are capable of forming their own
p.(None): views should be granted the right to do so freely in all matters affecting them, appropriate with their age and
p.(None): maturity. Research involving children should also abide by relevant UAE laws on protection of the rights of children -
p.(None): including but not limited to Federal Law No. 3 of 2016 concerning child rights, also known as Wadeema’s Law - and
p.(None): ensure that no potential Risk(s) to the participants are associated with the research study. Following evaluation of
p.(None): the age, maturity, and psychological state of the child, assent from the child and parental permission (parallel to
p.(None): informed consent) should be obtained.
p.(None):
p.(None): 6.4
p.(None):
p.(None):
p.(None):
p.(None): 6.5
p.(None): Any research involving a vulnerable adult (who is incapacitated or dependent due to cognitive, medical, economic,
p.(None): social, or situational factors) should take the appropriate precautions to ensure that they have not been
p.(None): subjected to undue influence to participate by either the dependents, the research team, or anyone else.
p.(None): Any research involving pregnant women should abide by relevant UAE laws and ensure the safety and health of the
p.(None): mother and the fetus first and foremost. Therefore, as general guidelines, research on pregnant women is only
p.(None): acceptable if the research holds direct benefits to both the mother and the fetus or has no Risk or minimal Risk to
...
p.(None): a result of participating in Approved Research Activities.
p.(None): Serious Adverse Event: any unanticipated incident involving Risks or injury or death of Human Subjects that may present
p.(None): itself during the course of Approved Research Activities.
p.(None): Significant Financial Interest: anything of a monetary value or an Equity Interest in an Entity held by an Investigator
p.(None): during the time he is carrying out the research and for 1 year following completion of such investigation.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 18 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): 10.32 Sponsor: pharmaceutical company, academic institution or any other Entity that takes
p.(None): responsibility for the initiation of research and/or arranges for the payment, if any, of the research.
p.(None): 10.33 Special Population includes Vulnerable Subjects and others with special needs and includes pregnant
p.(None): women and their in utero fetuses
p.(None): 10.34 Vulnerable Subject: vulnerable Human Subject with diminished competence and/or decision making
p.(None): capacity due to age, physical or medical conditions, or social-economic status.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
Social / Child
Searching for indicator child:
(return to top)
p.(None): disadvantaged are all considered special population and any research involving these groups would require additional
p.(None): protections and institution oversight. DHCR is committed to the protection of the rights of these vulnerable
p.(None): populations as participants in research studies and special care has to be taken as these subjects may be more
p.(None): vulnerable to coercion and inappropriate influence such that their voluntary participation or informed consent could be
p.(None): compromised.
p.(None): In cases where the participant is legally incapable of providing consent or is a minor, the researchers
p.(None): must obtain approval from the participants’ parent(s) or legal guardian(s), in addition to seeking the
p.(None): participant’s agreement, explaining the research project and the role of the participant, while ensuring the
p.(None): participant’s best interests are served.
p.(None): Any research involving children should comply with Articles 3 and 12 of the United Nations Convention on the Rights of
p.(None): the Child and UAE laws on protection of children. UN Convention Article 3 stipulates that the best interest of the
p.(None): child must be the primary consideration in all
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 9 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): actions concerning children and UN Convention Article 12 stipulates that children who are capable of forming their own
p.(None): views should be granted the right to do so freely in all matters affecting them, appropriate with their age and
p.(None): maturity. Research involving children should also abide by relevant UAE laws on protection of the rights of children -
p.(None): including but not limited to Federal Law No. 3 of 2016 concerning child rights, also known as Wadeema’s Law - and
p.(None): ensure that no potential Risk(s) to the participants are associated with the research study. Following evaluation of
p.(None): the age, maturity, and psychological state of the child, assent from the child and parental permission (parallel to
p.(None): informed consent) should be obtained.
p.(None):
p.(None): 6.4
p.(None):
p.(None):
p.(None):
p.(None): 6.5
p.(None): Any research involving a vulnerable adult (who is incapacitated or dependent due to cognitive, medical, economic,
p.(None): social, or situational factors) should take the appropriate precautions to ensure that they have not been
p.(None): subjected to undue influence to participate by either the dependents, the research team, or anyone else.
p.(None): Any research involving pregnant women should abide by relevant UAE laws and ensure the safety and health of the
p.(None): mother and the fetus first and foremost. Therefore, as general guidelines, research on pregnant women is only
p.(None): acceptable if the research holds direct benefits to both the mother and the fetus or has no Risk or minimal Risk to
p.(None): either. In addition, the research should result in research findings/data that cannot be obtained by other
...
Searching for indicator children:
(return to top)
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 8 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): Subject’s representative, as applicable, before any Research related procedure, in accordance with DHCR Regulations and
p.(None): applicable Standards and Policies.
p.(None): 5.3.2.5 Informed consent must be appropriately documented, in accordance with evidence based best practices and using
p.(None): an approved form and patient information sheet. Arabic translation of the informed consent, patient information sheet,
p.(None): and any other material that is to be viewed and used by study Subjects is mandatory.
p.(None): 5.3.2.6 The Protocol includes adequate provision for Monitoring the data collected to ensure the safety of Human
p.(None): Subjects.
p.(None): 5.3.2.7 There are adequate provisions to protect the subject’s privacy and maintain
p.(None): confidentiality of research data.
p.(None): 5.3.2.8 There are appropriate provisions for compensation for Human Subjects.
p.(None): 5.3.2.9 When some or all of the Human Subjects are likely to be susceptible to coercion or undue influence, there must
p.(None): be additional safeguards to ensure protection of the rights and welfare of these Subjects.
p.(None):
p.(None): 6- Research involving Children, Vulnerable Adults, Dependents, Pregnant Women, Prisoners, and Others
p.(None):
p.(None): 6.1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 6.2
p.(None):
p.(None):
p.(None):
p.(None): 6.3
p.(None): Children, vulnerable adults, pregnant women, fetuses, neonates, prisoners, students, employees, elderly,
p.(None): refugees, prisoners, disabled subjects or anyone who is economically, socially or educationally
p.(None): disadvantaged are all considered special population and any research involving these groups would require additional
p.(None): protections and institution oversight. DHCR is committed to the protection of the rights of these vulnerable
p.(None): populations as participants in research studies and special care has to be taken as these subjects may be more
p.(None): vulnerable to coercion and inappropriate influence such that their voluntary participation or informed consent could be
p.(None): compromised.
p.(None): In cases where the participant is legally incapable of providing consent or is a minor, the researchers
p.(None): must obtain approval from the participants’ parent(s) or legal guardian(s), in addition to seeking the
p.(None): participant’s agreement, explaining the research project and the role of the participant, while ensuring the
p.(None): participant’s best interests are served.
p.(None): Any research involving children should comply with Articles 3 and 12 of the United Nations Convention on the Rights of
p.(None): the Child and UAE laws on protection of children. UN Convention Article 3 stipulates that the best interest of the
p.(None): child must be the primary consideration in all
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 9 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): actions concerning children and UN Convention Article 12 stipulates that children who are capable of forming their own
p.(None): views should be granted the right to do so freely in all matters affecting them, appropriate with their age and
p.(None): maturity. Research involving children should also abide by relevant UAE laws on protection of the rights of children -
p.(None): including but not limited to Federal Law No. 3 of 2016 concerning child rights, also known as Wadeema’s Law - and
p.(None): ensure that no potential Risk(s) to the participants are associated with the research study. Following evaluation of
p.(None): the age, maturity, and psychological state of the child, assent from the child and parental permission (parallel to
p.(None): informed consent) should be obtained.
p.(None):
p.(None): 6.4
p.(None):
p.(None):
p.(None):
p.(None): 6.5
p.(None): Any research involving a vulnerable adult (who is incapacitated or dependent due to cognitive, medical, economic,
p.(None): social, or situational factors) should take the appropriate precautions to ensure that they have not been
p.(None): subjected to undue influence to participate by either the dependents, the research team, or anyone else.
p.(None): Any research involving pregnant women should abide by relevant UAE laws and ensure the safety and health of the
p.(None): mother and the fetus first and foremost. Therefore, as general guidelines, research on pregnant women is only
p.(None): acceptable if the research holds direct benefits to both the mother and the fetus or has no Risk or minimal Risk to
p.(None): either. In addition, the research should result in research findings/data that cannot be obtained by other
p.(None): means. Moreover, consent should be obtained from both partners except in special circumstances. For underage children
p.(None): who might be pregnant, both assent and parental permission need to be obtained for their participation in any research
p.(None): study. No monetary or other inducements may be offered to a pregnant woman to terminate her pregnancy for
p.(None): research purposes. Researchers involved in the research project are not allowed to make any decisions pertaining to
p.(None): the pregnancy or the viability of the fetus.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 10 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None):
p.(None): 6.6
p.(None): Any research involving prisoners should abide by the relevant UAE laws and it should ensure the safety and rights of
p.(None): prisoners. Therefore, as general guidelines, research on prisoners is only acceptable if the research project addresses
p.(None): the possible causes, effects, and processes of incarceration, and of criminal behavior, or focuses on prisons as
p.(None): institutional structures or on prisoners as incarcerated persons provided that the research presents no more
...
Social / Elderly
Searching for indicator elderly:
(return to top)
p.(None): Subjects.
p.(None): 5.3.2.7 There are adequate provisions to protect the subject’s privacy and maintain
p.(None): confidentiality of research data.
p.(None): 5.3.2.8 There are appropriate provisions for compensation for Human Subjects.
p.(None): 5.3.2.9 When some or all of the Human Subjects are likely to be susceptible to coercion or undue influence, there must
p.(None): be additional safeguards to ensure protection of the rights and welfare of these Subjects.
p.(None):
p.(None): 6- Research involving Children, Vulnerable Adults, Dependents, Pregnant Women, Prisoners, and Others
p.(None):
p.(None): 6.1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 6.2
p.(None):
p.(None):
p.(None):
p.(None): 6.3
p.(None): Children, vulnerable adults, pregnant women, fetuses, neonates, prisoners, students, employees, elderly,
p.(None): refugees, prisoners, disabled subjects or anyone who is economically, socially or educationally
p.(None): disadvantaged are all considered special population and any research involving these groups would require additional
p.(None): protections and institution oversight. DHCR is committed to the protection of the rights of these vulnerable
p.(None): populations as participants in research studies and special care has to be taken as these subjects may be more
p.(None): vulnerable to coercion and inappropriate influence such that their voluntary participation or informed consent could be
p.(None): compromised.
p.(None): In cases where the participant is legally incapable of providing consent or is a minor, the researchers
p.(None): must obtain approval from the participants’ parent(s) or legal guardian(s), in addition to seeking the
p.(None): participant’s agreement, explaining the research project and the role of the participant, while ensuring the
p.(None): participant’s best interests are served.
p.(None): Any research involving children should comply with Articles 3 and 12 of the United Nations Convention on the Rights of
...
Social / Fetus/Neonate
Searching for indicator fetus:
(return to top)
p.(None): including but not limited to Federal Law No. 3 of 2016 concerning child rights, also known as Wadeema’s Law - and
p.(None): ensure that no potential Risk(s) to the participants are associated with the research study. Following evaluation of
p.(None): the age, maturity, and psychological state of the child, assent from the child and parental permission (parallel to
p.(None): informed consent) should be obtained.
p.(None):
p.(None): 6.4
p.(None):
p.(None):
p.(None):
p.(None): 6.5
p.(None): Any research involving a vulnerable adult (who is incapacitated or dependent due to cognitive, medical, economic,
p.(None): social, or situational factors) should take the appropriate precautions to ensure that they have not been
p.(None): subjected to undue influence to participate by either the dependents, the research team, or anyone else.
p.(None): Any research involving pregnant women should abide by relevant UAE laws and ensure the safety and health of the
p.(None): mother and the fetus first and foremost. Therefore, as general guidelines, research on pregnant women is only
p.(None): acceptable if the research holds direct benefits to both the mother and the fetus or has no Risk or minimal Risk to
p.(None): either. In addition, the research should result in research findings/data that cannot be obtained by other
p.(None): means. Moreover, consent should be obtained from both partners except in special circumstances. For underage children
p.(None): who might be pregnant, both assent and parental permission need to be obtained for their participation in any research
p.(None): study. No monetary or other inducements may be offered to a pregnant woman to terminate her pregnancy for
p.(None): research purposes. Researchers involved in the research project are not allowed to make any decisions pertaining to
p.(None): the pregnancy or the viability of the fetus.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 10 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None):
p.(None): 6.6
p.(None): Any research involving prisoners should abide by the relevant UAE laws and it should ensure the safety and rights of
p.(None): prisoners. Therefore, as general guidelines, research on prisoners is only acceptable if the research project addresses
p.(None): the possible causes, effects, and processes of incarceration, and of criminal behavior, or focuses on prisons as
p.(None): institutional structures or on prisoners as incarcerated persons provided that the research presents no more
p.(None): than minimal Risk or inconvenience to the participants. In addition, if the research project investigates
p.(None): the conditions affecting prisoners (for example, vaccine trials or any other research that tends to be more
...
Searching for indicator fetuses:
(return to top)
p.(None): and any other material that is to be viewed and used by study Subjects is mandatory.
p.(None): 5.3.2.6 The Protocol includes adequate provision for Monitoring the data collected to ensure the safety of Human
p.(None): Subjects.
p.(None): 5.3.2.7 There are adequate provisions to protect the subject’s privacy and maintain
p.(None): confidentiality of research data.
p.(None): 5.3.2.8 There are appropriate provisions for compensation for Human Subjects.
p.(None): 5.3.2.9 When some or all of the Human Subjects are likely to be susceptible to coercion or undue influence, there must
p.(None): be additional safeguards to ensure protection of the rights and welfare of these Subjects.
p.(None):
p.(None): 6- Research involving Children, Vulnerable Adults, Dependents, Pregnant Women, Prisoners, and Others
p.(None):
p.(None): 6.1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 6.2
p.(None):
p.(None):
p.(None):
p.(None): 6.3
p.(None): Children, vulnerable adults, pregnant women, fetuses, neonates, prisoners, students, employees, elderly,
p.(None): refugees, prisoners, disabled subjects or anyone who is economically, socially or educationally
p.(None): disadvantaged are all considered special population and any research involving these groups would require additional
p.(None): protections and institution oversight. DHCR is committed to the protection of the rights of these vulnerable
p.(None): populations as participants in research studies and special care has to be taken as these subjects may be more
p.(None): vulnerable to coercion and inappropriate influence such that their voluntary participation or informed consent could be
p.(None): compromised.
p.(None): In cases where the participant is legally incapable of providing consent or is a minor, the researchers
p.(None): must obtain approval from the participants’ parent(s) or legal guardian(s), in addition to seeking the
...
p.(None): REC: Research Ethics Committee.
p.(None): Research Permit: a permit issued by DHCR to an Entity authorizing it to conduct the Approved Research Activity.
p.(None): Risk: the probability of harm or injury, whether physical, psychological, social, or economic, occurring as
p.(None): a result of participating in Approved Research Activities.
p.(None): Serious Adverse Event: any unanticipated incident involving Risks or injury or death of Human Subjects that may present
p.(None): itself during the course of Approved Research Activities.
p.(None): Significant Financial Interest: anything of a monetary value or an Equity Interest in an Entity held by an Investigator
p.(None): during the time he is carrying out the research and for 1 year following completion of such investigation.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 18 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): 10.32 Sponsor: pharmaceutical company, academic institution or any other Entity that takes
p.(None): responsibility for the initiation of research and/or arranges for the payment, if any, of the research.
p.(None): 10.33 Special Population includes Vulnerable Subjects and others with special needs and includes pregnant
p.(None): women and their in utero fetuses
p.(None): 10.34 Vulnerable Subject: vulnerable Human Subject with diminished competence and/or decision making
p.(None): capacity due to age, physical or medical conditions, or social-economic status.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
Searching for indicator neonates:
(return to top)
p.(None): 5.3.2.6 The Protocol includes adequate provision for Monitoring the data collected to ensure the safety of Human
p.(None): Subjects.
p.(None): 5.3.2.7 There are adequate provisions to protect the subject’s privacy and maintain
p.(None): confidentiality of research data.
p.(None): 5.3.2.8 There are appropriate provisions for compensation for Human Subjects.
p.(None): 5.3.2.9 When some or all of the Human Subjects are likely to be susceptible to coercion or undue influence, there must
p.(None): be additional safeguards to ensure protection of the rights and welfare of these Subjects.
p.(None):
p.(None): 6- Research involving Children, Vulnerable Adults, Dependents, Pregnant Women, Prisoners, and Others
p.(None):
p.(None): 6.1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 6.2
p.(None):
p.(None):
p.(None):
p.(None): 6.3
p.(None): Children, vulnerable adults, pregnant women, fetuses, neonates, prisoners, students, employees, elderly,
p.(None): refugees, prisoners, disabled subjects or anyone who is economically, socially or educationally
p.(None): disadvantaged are all considered special population and any research involving these groups would require additional
p.(None): protections and institution oversight. DHCR is committed to the protection of the rights of these vulnerable
p.(None): populations as participants in research studies and special care has to be taken as these subjects may be more
p.(None): vulnerable to coercion and inappropriate influence such that their voluntary participation or informed consent could be
p.(None): compromised.
p.(None): In cases where the participant is legally incapable of providing consent or is a minor, the researchers
p.(None): must obtain approval from the participants’ parent(s) or legal guardian(s), in addition to seeking the
p.(None): participant’s agreement, explaining the research project and the role of the participant, while ensuring the
...
Social / Incarcerated
Searching for indicator incarcerated:
(return to top)
p.(None): who might be pregnant, both assent and parental permission need to be obtained for their participation in any research
p.(None): study. No monetary or other inducements may be offered to a pregnant woman to terminate her pregnancy for
p.(None): research purposes. Researchers involved in the research project are not allowed to make any decisions pertaining to
p.(None): the pregnancy or the viability of the fetus.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 10 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None):
p.(None): 6.6
p.(None): Any research involving prisoners should abide by the relevant UAE laws and it should ensure the safety and rights of
p.(None): prisoners. Therefore, as general guidelines, research on prisoners is only acceptable if the research project addresses
p.(None): the possible causes, effects, and processes of incarceration, and of criminal behavior, or focuses on prisons as
p.(None): institutional structures or on prisoners as incarcerated persons provided that the research presents no more
p.(None): than minimal Risk or inconvenience to the participants. In addition, if the research project investigates
p.(None): the conditions affecting prisoners (for example, vaccine trials or any other research that tends to be more
p.(None): prevalent among prisoners, such as on hepatitis, or research on social and psychological problems like alcoholism, drug
p.(None): addiction, and sexual assaults, etc.), then appropriate experts should be adequately consulted prior to the
p.(None): study. This kind of research may also require additional approvals from other UAE agencies.
p.(None):
p.(None): 7- Responsibilities of the Principal Investigator (PI)
p.(None): The research study PI must fulfill the following duties and responsibilities:
p.(None):
p.(None): 7.1
p.(None):
p.(None):
p.(None): 7.2
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 7.3
p.(None):
p.(None):
p.(None): 7.4
p.(None):
p.(None):
p.(None):
p.(None): 7.5
p.(None): To ensure that all research studies have obtained ethical approval by the DHCR REC and that the research is carried out
p.(None): in accordance with the DHCR Ethics Policies and Procedures, and in compliance with UAE laws on individual and public
p.(None): safety and Good Clinical Practice.
p.(None): As the DHCR REC relies on the information provided in the application form(s), it is expected that all information is
...
Social / Police Officer
Searching for indicator officer:
(return to top)
p.(None): any further research or analysis without prior approval from DHCR REC.
p.(None): 9.6 The genetic sequencing facility credentials including but not limited to license, registration, and
p.(None): accreditation must be submitted as part of the genetic research study application for review by the DHCR Research
p.(None): Department and the DHCR REC.
p.(None):
p.(None):
p.(None): 10- Definitions:
p.(None): 10.1 Approved Research Activity: a research activity for which a Research Permit has been granted.
p.(None): 10.2 Approved Research Operator: an Entity that holds a valid Research Permit issued by DHCR to conduct research
p.(None): activities in accordance with the applicable DHCR Rules, Standards and Policies.
p.(None): 10.3 Approved Research Site: site or location within DHCC, including the physical facility or facilities
p.(None): associated therewith, at which an Approved Research Operator is permitted to conduct Approved Research Activities under
p.(None): its Research Permit.
p.(None): 10.4 Approved Use: the use of a drug, biologic or medical device that has been approved for one or more specific
p.(None): indications by a duly constituted regulatory agency in a jurisdiction recognized for this purpose by DHCR.
p.(None): 10.5 Audit: a systematic and independent evaluation of a research and documents to determine whether
p.(None): the research was conducted in accordance with the requirements of the Research Regulation, any applicable
p.(None): Rules, Standards and Policies, and the Protocol approved for such research.
p.(None): 10.6 ARC: Academic and Research Council.
p.(None): 10.7 CEO: Chief Executive Officer of DHCR.
p.(None): 10.8 Conflict of Interest: a divergence between an individual’s private interest and his professional obligations.
p.(None): A potential or actual Conflict of Interest, either financial or non-financial, exists when a significant interest could
p.(None): affect the design, conduct, or reporting of research or educational activities
p.(None): 10.9 DHCC: Dubai Healthcare City.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 16 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): 10.10 DHCR: Dubai Healthcare City Authority – Regulatory the independent regulatory arm of Dubai Healthcare City
p.(None): Authority (DHCA), the governing body of Dubai Healthcare City (DHCC) free zone - a health and wellness destination.
p.(None): 10.11 Document and Documentation: information stored in any form of writing, code, or visual depiction and the
p.(None): manner in which such information is stored is irrelevant for the purpose of deeming the information to constitute a
p.(None): “document” for the purpose of this definition.
p.(None): 10.12 Entity: an organization, institution, or corporation other than a natural person.
p.(None): 10.13 Human Biomedical Research: any systematic investigation, including research development, testing and
p.(None): evaluation that involves the use of either an investigational product in human subjects, the use of
p.(None): identifiable human tissue or Patient Health Information, with the objective of developing or contributing to
...
Social / Women
Searching for indicator women:
(return to top)
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): Subject’s representative, as applicable, before any Research related procedure, in accordance with DHCR Regulations and
p.(None): applicable Standards and Policies.
p.(None): 5.3.2.5 Informed consent must be appropriately documented, in accordance with evidence based best practices and using
p.(None): an approved form and patient information sheet. Arabic translation of the informed consent, patient information sheet,
p.(None): and any other material that is to be viewed and used by study Subjects is mandatory.
p.(None): 5.3.2.6 The Protocol includes adequate provision for Monitoring the data collected to ensure the safety of Human
p.(None): Subjects.
p.(None): 5.3.2.7 There are adequate provisions to protect the subject’s privacy and maintain
p.(None): confidentiality of research data.
p.(None): 5.3.2.8 There are appropriate provisions for compensation for Human Subjects.
p.(None): 5.3.2.9 When some or all of the Human Subjects are likely to be susceptible to coercion or undue influence, there must
p.(None): be additional safeguards to ensure protection of the rights and welfare of these Subjects.
p.(None):
p.(None): 6- Research involving Children, Vulnerable Adults, Dependents, Pregnant Women, Prisoners, and Others
p.(None):
p.(None): 6.1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 6.2
p.(None):
p.(None):
p.(None):
p.(None): 6.3
p.(None): Children, vulnerable adults, pregnant women, fetuses, neonates, prisoners, students, employees, elderly,
p.(None): refugees, prisoners, disabled subjects or anyone who is economically, socially or educationally
p.(None): disadvantaged are all considered special population and any research involving these groups would require additional
p.(None): protections and institution oversight. DHCR is committed to the protection of the rights of these vulnerable
p.(None): populations as participants in research studies and special care has to be taken as these subjects may be more
p.(None): vulnerable to coercion and inappropriate influence such that their voluntary participation or informed consent could be
p.(None): compromised.
p.(None): In cases where the participant is legally incapable of providing consent or is a minor, the researchers
p.(None): must obtain approval from the participants’ parent(s) or legal guardian(s), in addition to seeking the
...
p.(None): maturity. Research involving children should also abide by relevant UAE laws on protection of the rights of children -
p.(None): including but not limited to Federal Law No. 3 of 2016 concerning child rights, also known as Wadeema’s Law - and
p.(None): ensure that no potential Risk(s) to the participants are associated with the research study. Following evaluation of
p.(None): the age, maturity, and psychological state of the child, assent from the child and parental permission (parallel to
p.(None): informed consent) should be obtained.
p.(None):
p.(None): 6.4
p.(None):
p.(None):
p.(None):
p.(None): 6.5
p.(None): Any research involving a vulnerable adult (who is incapacitated or dependent due to cognitive, medical, economic,
p.(None): social, or situational factors) should take the appropriate precautions to ensure that they have not been
p.(None): subjected to undue influence to participate by either the dependents, the research team, or anyone else.
p.(None): Any research involving pregnant women should abide by relevant UAE laws and ensure the safety and health of the
p.(None): mother and the fetus first and foremost. Therefore, as general guidelines, research on pregnant women is only
p.(None): acceptable if the research holds direct benefits to both the mother and the fetus or has no Risk or minimal Risk to
p.(None): either. In addition, the research should result in research findings/data that cannot be obtained by other
p.(None): means. Moreover, consent should be obtained from both partners except in special circumstances. For underage children
p.(None): who might be pregnant, both assent and parental permission need to be obtained for their participation in any research
p.(None): study. No monetary or other inducements may be offered to a pregnant woman to terminate her pregnancy for
p.(None): research purposes. Researchers involved in the research project are not allowed to make any decisions pertaining to
p.(None): the pregnancy or the viability of the fetus.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 10 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None):
p.(None): 6.6
p.(None): Any research involving prisoners should abide by the relevant UAE laws and it should ensure the safety and rights of
...
p.(None): REC: Research Ethics Committee.
p.(None): Research Permit: a permit issued by DHCR to an Entity authorizing it to conduct the Approved Research Activity.
p.(None): Risk: the probability of harm or injury, whether physical, psychological, social, or economic, occurring as
p.(None): a result of participating in Approved Research Activities.
p.(None): Serious Adverse Event: any unanticipated incident involving Risks or injury or death of Human Subjects that may present
p.(None): itself during the course of Approved Research Activities.
p.(None): Significant Financial Interest: anything of a monetary value or an Equity Interest in an Entity held by an Investigator
p.(None): during the time he is carrying out the research and for 1 year following completion of such investigation.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 18 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): 10.32 Sponsor: pharmaceutical company, academic institution or any other Entity that takes
p.(None): responsibility for the initiation of research and/or arranges for the payment, if any, of the research.
p.(None): 10.33 Special Population includes Vulnerable Subjects and others with special needs and includes pregnant
p.(None): women and their in utero fetuses
p.(None): 10.34 Vulnerable Subject: vulnerable Human Subject with diminished competence and/or decision making
p.(None): capacity due to age, physical or medical conditions, or social-economic status.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.(None): The cut-off point of resubmission of deficient documentation is 10 working days prior to meeting of the REC for
p.(None): standard review and 3-9 working days for urgent review. Applications requiring more than three
p.(None): administrative reviews due to noncompliance with Research Department’s comments will incur additional review
p.(None): fees. Submission of altered and/or additional documents following validation of a Research Proposal application by
p.(None): the Research Department and prior to review by the REC will incur additional review fees.
p.(None):
p.(None): At any time during the review of an Application and prior to the Research Department issuing a Research Proposal
p.(None): decision, the Applicant must promptly notify the Research Department of any modification or change to the information
p.(None): or documentation contained in its Application. Failure of an Applicant to notify the Research Department of any such
p.(None): changes will result in the Application being considered incomplete and withdrawn.
p.(None): If the notification of changes is received after the Research Department has completed its review of the Application,
p.(None): the Applicant will pay the applicable fee before the Research Department undertakes a further review of the revised
p.(None): Application.
p.(None):
p.(None): 5.2.3 Decisions by the REC
p.(None): The DHCR Research Ethics Committee (REC) is responsible for review of new Research Proposals, continuing research
p.(None): proposal applications, and any other proposals that require REC members’ decisions.
p.(None): REC decisions include:
p.(None): 5.2.3.1 approval;
p.(None): 5.2.3.2 approval with minor modifications/conditions;
p.(None): 5.2.3.3 decision deferral pending further information/major changes; or
p.(None): 5.2.3.4 denial.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 7 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): 5.2.4 Notification of Decision Regarding Research Proposal
p.(None): The DHCR Research Department will notify the ARO via email of the REC decisions within 5 working days of the decision.
p.(None): The notification email will include:
p.(None): 5.2.4.1 reasons for REC decisions;
p.(None): 5.2.4.2 committee requested changes to the protocol, informed consent forms and/or other documents; and
p.(None): 5.2.4.3 the frequency of continuing review to be determined by the REC members following
p.(None): review of each protocol. The frequency of continuing review is at least annual unless otherwise agreed upon and depends
p.(None): on the degree of risk, involvement of special population, if previous studies indicated high incidence of adverse
p.(None): events or if the REC believes that close monitoring is required.
p.(None): Resubmission of the Research Proposal application with relevant fees is required if the ARO fails to respond to the REC
p.(None): comments within 10 days of receiving said comments.
p.(None): In the event that the REC denies a certain Research Proposal application, the applicant has the right to appeal the
p.(None): denial decision with the DHCR Appeals Board.
p.(None): 5.3 REC Approval Criteria
p.(None): 5.3.1 The DHCR REC is governed by ethical principles described in the following documents:
p.(None): 5.3.1.1 Federal Laws of the UAE;
...
p.(None): refugees, prisoners, disabled subjects or anyone who is economically, socially or educationally
p.(None): disadvantaged are all considered special population and any research involving these groups would require additional
p.(None): protections and institution oversight. DHCR is committed to the protection of the rights of these vulnerable
p.(None): populations as participants in research studies and special care has to be taken as these subjects may be more
p.(None): vulnerable to coercion and inappropriate influence such that their voluntary participation or informed consent could be
p.(None): compromised.
p.(None): In cases where the participant is legally incapable of providing consent or is a minor, the researchers
p.(None): must obtain approval from the participants’ parent(s) or legal guardian(s), in addition to seeking the
p.(None): participant’s agreement, explaining the research project and the role of the participant, while ensuring the
p.(None): participant’s best interests are served.
p.(None): Any research involving children should comply with Articles 3 and 12 of the United Nations Convention on the Rights of
p.(None): the Child and UAE laws on protection of children. UN Convention Article 3 stipulates that the best interest of the
p.(None): child must be the primary consideration in all
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 9 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): actions concerning children and UN Convention Article 12 stipulates that children who are capable of forming their own
p.(None): views should be granted the right to do so freely in all matters affecting them, appropriate with their age and
p.(None): maturity. Research involving children should also abide by relevant UAE laws on protection of the rights of children -
...
Social / education
Searching for indicator education:
(return to top)
p.(None):
p.(None): DHC
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): CONDUCTING RESEARCH IN
p.(None): DUBAI HEALTHCARE CITY
p.(None): Policy and Procedure
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Department: Policy and Regulation
p.(None): Document Identifier: DHCR/PP/RO/001/02
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): INTRODUCTION
p.(None): Research is essential for the advancement of medical knowledge, development of new treatments, and delivery of
p.(None): efficient services for the health and wellbeing of patients, service users, and the wider society. The vision of DHCC
p.(None): is to be the internationally recognized location of choice for quality healthcare services and an integrated center of
p.(None): excellence for clinical and wellness services, medical education, and research. Dubai Healthcare City Authority –
p.(None): Regulatory (DHCR) is responsible for regulating all aspects of research within the free zone and it is mandatory to
p.(None): have a valid research permit to conduct research within Dubai Healthcare City (DHCC).
p.(None): The mission of the DHCR Research Department is to protect the rights of human subjects and welfare of animals involved
p.(None): in research conducted within DHCC as well as to guard the reputation of DHCC, Dubai, and the UAE. Supporting the DHCR
p.(None): Research Department in its role are the DHCR Academic and Research Council and the Research Ethics Committee.
p.(None): The ultimate responsibility to comply with the approval of ethical standards rests with the Investigator(s) carrying
p.(None): out the research project, the associated Approved Research Operator and the Study Sponsor where applicable.
p.(None): 1- Purpose:
p.(None): 1.1 Set out a strong and transparent governance framework for regulatory compliance, promoting
p.(None): principles of good practice, and issuing guidance which ensure that research is conducted with appropriate
p.(None): professional expertise and according to the highest ethical and scientific standards.
p.(None): 1.2 Provide guidance to Entities and Approved Research Operators conducting or intending to conduct research
p.(None): activities in DHCC. It includes policies, procedures, guidelines, as well as the necessary forms for researchers to
p.(None): prepare, submit, and seek ethical approval for their research studies.
p.(None):
p.(None): 2- Scope of application:
...
p.(None): Research Permit, the Entity becomes an Approved Research Operator (ARO) within DHCC.
p.(None): 4.4 All Approved Research Operators are required to obtain approval for individual Research Proposals prior to
p.(None): commencing research activities within DHCC. Review of Research Proposals is carried out by the DHCR Research Ethics
p.(None): Committee (REC).
p.(None): 4.5 All AROs are required to submit a minimum of one (1) Research Proposal for review by the DHCR REC during the
p.(None): duration of their active Research Permit. AROs with an ongoing research study must submit a progress
p.(None): report summarizing the study’s progress at the time of renewal of the Research Permit and as required by the
p.(None): REC.
p.(None): 4.6 AROs must begin the process of Research Permit renewal 60-30 days prior to the expiry date of the existing
p.(None): active Permit.
p.(None): 4.7 Prior to commencing the research activity, the ARO is responsible for obtaining all necessary
p.(None): approvals (such as ethics committee approvals) from within and outside of DHCC as applicable.
p.(None): 4.8 Research Proposals that have already obtained ethical approval from a recognized entity as defined by UAE
p.(None): Medical Liability Law No. 4 of 2016 is eligible for expedited review by DHCR.
p.(None): 4.9 A new Research Permit’s expiry date will be aligned with that of the Entity’s Commercial License with the
p.(None): relevant fees being prorated accordingly.
p.(None): 4.10 The Research Permit will be renewed automatically at the time of renewal of the Commercial
p.(None): License for AROs that have Research as a core activity such as hospitals, higher education institutes,
p.(None): and research and development centers.
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 2 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): 4.11 DHCR will seriously consider misconduct in research and/or breaches of ethical standards which will be referred
p.(None): to appropriate bodies for review, investigation, and penalties as applicable.
p.(None): 4.12 Research Involving Human Subjects/Tissue/Samples/Data
p.(None): 4.12.1 All research procedures and protocols conducted within DHCC involving human samples or participants must
p.(None): undergo appropriate ethical scrutiny leading to the protection of the rights, dignity, safety, and well-being
p.(None): of all those involved in the research project, ensuring confidentiality of information about human subjects, cultural
p.(None): sensitivities in the UAE, and the reputation of DHCC, Dubai and the UAE.
p.(None): 4.12.2 Human subjects must be adequately protected during any research project conducted within or in connection with
p.(None): DHCC. Procedures must also be aligned and implemented with due care to follow all DHCR Policies and applicable UAE
p.(None): laws (such as the UAE Medical Liability Law No 4, 2016).
p.(None): 4.12.3 In cases where there is potential conflict between the freedom that the researcher has, within the law, to carry
p.(None): out the research project and the rights of the participants involved in the research project, the researcher must
p.(None): ensure that the participants’ interests and rights in the study come first.
...
Searching for indicator educational:
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p.(None): Department and the DHCR REC.
p.(None):
p.(None):
p.(None): 10- Definitions:
p.(None): 10.1 Approved Research Activity: a research activity for which a Research Permit has been granted.
p.(None): 10.2 Approved Research Operator: an Entity that holds a valid Research Permit issued by DHCR to conduct research
p.(None): activities in accordance with the applicable DHCR Rules, Standards and Policies.
p.(None): 10.3 Approved Research Site: site or location within DHCC, including the physical facility or facilities
p.(None): associated therewith, at which an Approved Research Operator is permitted to conduct Approved Research Activities under
p.(None): its Research Permit.
p.(None): 10.4 Approved Use: the use of a drug, biologic or medical device that has been approved for one or more specific
p.(None): indications by a duly constituted regulatory agency in a jurisdiction recognized for this purpose by DHCR.
p.(None): 10.5 Audit: a systematic and independent evaluation of a research and documents to determine whether
p.(None): the research was conducted in accordance with the requirements of the Research Regulation, any applicable
p.(None): Rules, Standards and Policies, and the Protocol approved for such research.
p.(None): 10.6 ARC: Academic and Research Council.
p.(None): 10.7 CEO: Chief Executive Officer of DHCR.
p.(None): 10.8 Conflict of Interest: a divergence between an individual’s private interest and his professional obligations.
p.(None): A potential or actual Conflict of Interest, either financial or non-financial, exists when a significant interest could
p.(None): affect the design, conduct, or reporting of research or educational activities
p.(None): 10.9 DHCC: Dubai Healthcare City.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 16 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): 10.10 DHCR: Dubai Healthcare City Authority – Regulatory the independent regulatory arm of Dubai Healthcare City
p.(None): Authority (DHCA), the governing body of Dubai Healthcare City (DHCC) free zone - a health and wellness destination.
p.(None): 10.11 Document and Documentation: information stored in any form of writing, code, or visual depiction and the
p.(None): manner in which such information is stored is irrelevant for the purpose of deeming the information to constitute a
p.(None): “document” for the purpose of this definition.
p.(None): 10.12 Entity: an organization, institution, or corporation other than a natural person.
p.(None): 10.13 Human Biomedical Research: any systematic investigation, including research development, testing and
p.(None): evaluation that involves the use of either an investigational product in human subjects, the use of
p.(None): identifiable human tissue or Patient Health Information, with the objective of developing or contributing to
p.(None): generalizable knowledge.
p.(None): 10.14 Human Subject: a living individual about whom an Investigator conducting an Approved Research
p.(None): Activity obtains either data through intervention and/or interaction with the individual or by obtaining that person’s
p.(None): patient health information.
...
Social / employees
Searching for indicator employees:
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p.(None): Subjects.
p.(None): 5.3.2.7 There are adequate provisions to protect the subject’s privacy and maintain
p.(None): confidentiality of research data.
p.(None): 5.3.2.8 There are appropriate provisions for compensation for Human Subjects.
p.(None): 5.3.2.9 When some or all of the Human Subjects are likely to be susceptible to coercion or undue influence, there must
p.(None): be additional safeguards to ensure protection of the rights and welfare of these Subjects.
p.(None):
p.(None): 6- Research involving Children, Vulnerable Adults, Dependents, Pregnant Women, Prisoners, and Others
p.(None):
p.(None): 6.1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 6.2
p.(None):
p.(None):
p.(None):
p.(None): 6.3
p.(None): Children, vulnerable adults, pregnant women, fetuses, neonates, prisoners, students, employees, elderly,
p.(None): refugees, prisoners, disabled subjects or anyone who is economically, socially or educationally
p.(None): disadvantaged are all considered special population and any research involving these groups would require additional
p.(None): protections and institution oversight. DHCR is committed to the protection of the rights of these vulnerable
p.(None): populations as participants in research studies and special care has to be taken as these subjects may be more
p.(None): vulnerable to coercion and inappropriate influence such that their voluntary participation or informed consent could be
p.(None): compromised.
p.(None): In cases where the participant is legally incapable of providing consent or is a minor, the researchers
p.(None): must obtain approval from the participants’ parent(s) or legal guardian(s), in addition to seeking the
p.(None): participant’s agreement, explaining the research project and the role of the participant, while ensuring the
p.(None): participant’s best interests are served.
...
Social / parents
Searching for indicator parent:
(return to top)
p.(None): refugees, prisoners, disabled subjects or anyone who is economically, socially or educationally
p.(None): disadvantaged are all considered special population and any research involving these groups would require additional
p.(None): protections and institution oversight. DHCR is committed to the protection of the rights of these vulnerable
p.(None): populations as participants in research studies and special care has to be taken as these subjects may be more
p.(None): vulnerable to coercion and inappropriate influence such that their voluntary participation or informed consent could be
p.(None): compromised.
p.(None): In cases where the participant is legally incapable of providing consent or is a minor, the researchers
p.(None): must obtain approval from the participants’ parent(s) or legal guardian(s), in addition to seeking the
p.(None): participant’s agreement, explaining the research project and the role of the participant, while ensuring the
p.(None): participant’s best interests are served.
p.(None): Any research involving children should comply with Articles 3 and 12 of the United Nations Convention on the Rights of
p.(None): the Child and UAE laws on protection of children. UN Convention Article 3 stipulates that the best interest of the
p.(None): child must be the primary consideration in all
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 9 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): actions concerning children and UN Convention Article 12 stipulates that children who are capable of forming their own
p.(None): views should be granted the right to do so freely in all matters affecting them, appropriate with their age and
p.(None): maturity. Research involving children should also abide by relevant UAE laws on protection of the rights of children -
...
General/Other / Dependent
Searching for indicator dependent:
(return to top)
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): actions concerning children and UN Convention Article 12 stipulates that children who are capable of forming their own
p.(None): views should be granted the right to do so freely in all matters affecting them, appropriate with their age and
p.(None): maturity. Research involving children should also abide by relevant UAE laws on protection of the rights of children -
p.(None): including but not limited to Federal Law No. 3 of 2016 concerning child rights, also known as Wadeema’s Law - and
p.(None): ensure that no potential Risk(s) to the participants are associated with the research study. Following evaluation of
p.(None): the age, maturity, and psychological state of the child, assent from the child and parental permission (parallel to
p.(None): informed consent) should be obtained.
p.(None):
p.(None): 6.4
p.(None):
p.(None):
p.(None):
p.(None): 6.5
p.(None): Any research involving a vulnerable adult (who is incapacitated or dependent due to cognitive, medical, economic,
p.(None): social, or situational factors) should take the appropriate precautions to ensure that they have not been
p.(None): subjected to undue influence to participate by either the dependents, the research team, or anyone else.
p.(None): Any research involving pregnant women should abide by relevant UAE laws and ensure the safety and health of the
p.(None): mother and the fetus first and foremost. Therefore, as general guidelines, research on pregnant women is only
p.(None): acceptable if the research holds direct benefits to both the mother and the fetus or has no Risk or minimal Risk to
p.(None): either. In addition, the research should result in research findings/data that cannot be obtained by other
p.(None): means. Moreover, consent should be obtained from both partners except in special circumstances. For underage children
p.(None): who might be pregnant, both assent and parental permission need to be obtained for their participation in any research
...
General/Other / Diminished Autonomy
Searching for indicator diminished:
(return to top)
p.(None): Risk: the probability of harm or injury, whether physical, psychological, social, or economic, occurring as
p.(None): a result of participating in Approved Research Activities.
p.(None): Serious Adverse Event: any unanticipated incident involving Risks or injury or death of Human Subjects that may present
p.(None): itself during the course of Approved Research Activities.
p.(None): Significant Financial Interest: anything of a monetary value or an Equity Interest in an Entity held by an Investigator
p.(None): during the time he is carrying out the research and for 1 year following completion of such investigation.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 18 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): 10.32 Sponsor: pharmaceutical company, academic institution or any other Entity that takes
p.(None): responsibility for the initiation of research and/or arranges for the payment, if any, of the research.
p.(None): 10.33 Special Population includes Vulnerable Subjects and others with special needs and includes pregnant
p.(None): women and their in utero fetuses
p.(None): 10.34 Vulnerable Subject: vulnerable Human Subject with diminished competence and/or decision making
p.(None): capacity due to age, physical or medical conditions, or social-economic status.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
General/Other / Incapacitated
Searching for indicator incapacitated:
(return to top)
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): actions concerning children and UN Convention Article 12 stipulates that children who are capable of forming their own
p.(None): views should be granted the right to do so freely in all matters affecting them, appropriate with their age and
p.(None): maturity. Research involving children should also abide by relevant UAE laws on protection of the rights of children -
p.(None): including but not limited to Federal Law No. 3 of 2016 concerning child rights, also known as Wadeema’s Law - and
p.(None): ensure that no potential Risk(s) to the participants are associated with the research study. Following evaluation of
p.(None): the age, maturity, and psychological state of the child, assent from the child and parental permission (parallel to
p.(None): informed consent) should be obtained.
p.(None):
p.(None): 6.4
p.(None):
p.(None):
p.(None):
p.(None): 6.5
p.(None): Any research involving a vulnerable adult (who is incapacitated or dependent due to cognitive, medical, economic,
p.(None): social, or situational factors) should take the appropriate precautions to ensure that they have not been
p.(None): subjected to undue influence to participate by either the dependents, the research team, or anyone else.
p.(None): Any research involving pregnant women should abide by relevant UAE laws and ensure the safety and health of the
p.(None): mother and the fetus first and foremost. Therefore, as general guidelines, research on pregnant women is only
p.(None): acceptable if the research holds direct benefits to both the mother and the fetus or has no Risk or minimal Risk to
p.(None): either. In addition, the research should result in research findings/data that cannot be obtained by other
p.(None): means. Moreover, consent should be obtained from both partners except in special circumstances. For underage children
p.(None): who might be pregnant, both assent and parental permission need to be obtained for their participation in any research
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None):
p.(None): DHC
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): CONDUCTING RESEARCH IN
p.(None): DUBAI HEALTHCARE CITY
p.(None): Policy and Procedure
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Department: Policy and Regulation
p.(None): Document Identifier: DHCR/PP/RO/001/02
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): INTRODUCTION
p.(None): Research is essential for the advancement of medical knowledge, development of new treatments, and delivery of
p.(None): efficient services for the health and wellbeing of patients, service users, and the wider society. The vision of DHCC
p.(None): is to be the internationally recognized location of choice for quality healthcare services and an integrated center of
p.(None): excellence for clinical and wellness services, medical education, and research. Dubai Healthcare City Authority –
p.(None): Regulatory (DHCR) is responsible for regulating all aspects of research within the free zone and it is mandatory to
p.(None): have a valid research permit to conduct research within Dubai Healthcare City (DHCC).
p.(None): The mission of the DHCR Research Department is to protect the rights of human subjects and welfare of animals involved
p.(None): in research conducted within DHCC as well as to guard the reputation of DHCC, Dubai, and the UAE. Supporting the DHCR
p.(None): Research Department in its role are the DHCR Academic and Research Council and the Research Ethics Committee.
p.(None): The ultimate responsibility to comply with the approval of ethical standards rests with the Investigator(s) carrying
p.(None): out the research project, the associated Approved Research Operator and the Study Sponsor where applicable.
p.(None): 1- Purpose:
p.(None): 1.1 Set out a strong and transparent governance framework for regulatory compliance, promoting
p.(None): principles of good practice, and issuing guidance which ensure that research is conducted with appropriate
p.(None): professional expertise and according to the highest ethical and scientific standards.
p.(None): 1.2 Provide guidance to Entities and Approved Research Operators conducting or intending to conduct research
p.(None): activities in DHCC. It includes policies, procedures, guidelines, as well as the necessary forms for researchers to
p.(None): prepare, submit, and seek ethical approval for their research studies.
p.(None):
p.(None): 2- Scope of application:
p.(None): 2.1 Any and all research activities that may be carried out within DHCC.
p.(None):
p.(None):
p.(None): 3- Applicable To:
...
p.(None): 10.3 Approved Research Site: site or location within DHCC, including the physical facility or facilities
p.(None): associated therewith, at which an Approved Research Operator is permitted to conduct Approved Research Activities under
p.(None): its Research Permit.
p.(None): 10.4 Approved Use: the use of a drug, biologic or medical device that has been approved for one or more specific
p.(None): indications by a duly constituted regulatory agency in a jurisdiction recognized for this purpose by DHCR.
p.(None): 10.5 Audit: a systematic and independent evaluation of a research and documents to determine whether
p.(None): the research was conducted in accordance with the requirements of the Research Regulation, any applicable
p.(None): Rules, Standards and Policies, and the Protocol approved for such research.
p.(None): 10.6 ARC: Academic and Research Council.
p.(None): 10.7 CEO: Chief Executive Officer of DHCR.
p.(None): 10.8 Conflict of Interest: a divergence between an individual’s private interest and his professional obligations.
p.(None): A potential or actual Conflict of Interest, either financial or non-financial, exists when a significant interest could
p.(None): affect the design, conduct, or reporting of research or educational activities
p.(None): 10.9 DHCC: Dubai Healthcare City.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 16 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): 10.10 DHCR: Dubai Healthcare City Authority – Regulatory the independent regulatory arm of Dubai Healthcare City
p.(None): Authority (DHCA), the governing body of Dubai Healthcare City (DHCC) free zone - a health and wellness destination.
p.(None): 10.11 Document and Documentation: information stored in any form of writing, code, or visual depiction and the
p.(None): manner in which such information is stored is irrelevant for the purpose of deeming the information to constitute a
p.(None): “document” for the purpose of this definition.
p.(None): 10.12 Entity: an organization, institution, or corporation other than a natural person.
p.(None): 10.13 Human Biomedical Research: any systematic investigation, including research development, testing and
p.(None): evaluation that involves the use of either an investigational product in human subjects, the use of
p.(None): identifiable human tissue or Patient Health Information, with the objective of developing or contributing to
p.(None): generalizable knowledge.
p.(None): 10.14 Human Subject: a living individual about whom an Investigator conducting an Approved Research
p.(None): Activity obtains either data through intervention and/or interaction with the individual or by obtaining that person’s
p.(None): patient health information.
p.(None): 10.15 Informed Consent: a process by which a Human Subject’s, or where that person is a Vulnerable Subject, that
p.(None): person’s Representative, voluntary confirmation of his willingness to participate in a particular research study, after
p.(None): having been informed of all aspects of the study procedures that are relevant to such Human or Vulnerable Subject’s
p.(None): decision to participate.
...
General/Other / Undue Influence
Searching for indicator undue influence:
(return to top)
p.(None): to appropriate bodies for review, investigation, and penalties as applicable.
p.(None): 4.12 Research Involving Human Subjects/Tissue/Samples/Data
p.(None): 4.12.1 All research procedures and protocols conducted within DHCC involving human samples or participants must
p.(None): undergo appropriate ethical scrutiny leading to the protection of the rights, dignity, safety, and well-being
p.(None): of all those involved in the research project, ensuring confidentiality of information about human subjects, cultural
p.(None): sensitivities in the UAE, and the reputation of DHCC, Dubai and the UAE.
p.(None): 4.12.2 Human subjects must be adequately protected during any research project conducted within or in connection with
p.(None): DHCC. Procedures must also be aligned and implemented with due care to follow all DHCR Policies and applicable UAE
p.(None): laws (such as the UAE Medical Liability Law No 4, 2016).
p.(None): 4.12.3 In cases where there is potential conflict between the freedom that the researcher has, within the law, to carry
p.(None): out the research project and the rights of the participants involved in the research project, the researcher must
p.(None): ensure that the participants’ interests and rights in the study come first.
p.(None): 4.12.4 The DHCR REC will review all research proposals that involve human subjects to ensure that the principles of the
p.(None): Belmont report that revolve around respect for persons, non- maleficence, beneficence, and justice are met. Hence, the
p.(None): research must
p.(None): 4.12.4.1 ensure the voluntary participation of human participants free from undue influence
p.(None): or coercion;
p.(None): 4.12.4.2 clearly outline the informed consent process;
p.(None): 4.12.4.3 emphasize the fair and non-discriminatory recruitment of human participants especially if recruitment entails
p.(None): vulnerable populations;
p.(None): 4.12.4.4 outline how the risks associated with the research are reasonable and justify them
p.(None): by the expected benefits;
p.(None): 4.7.4.5 have a clear and adequate monitoring plan to ensure the safety of participants as well as indicate how
p.(None): additional protection and safeguards will be applied when vulnerable subject populations are included; and
p.(None): 4.7.4.6 adequately outline how matters of confidentiality of all Patient Health Information are
p.(None): respected and that data storage and quality control are adequately maintained and in compliance with DHCR Health Data
p.(None): Protection Regulation.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 3 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None):
p.(None): 5- Procedure Sequence
p.(None): 5.1 New/Renewed Research Permit Submission Procedure
p.(None): 5.1.1 Submitting the Application
p.(None): Upon receiving notification of an Operator’s intent to conduct/ continue to conduct Research activities
p.(None): within DHCC, the Research Department will provide guidance on the correct application form(s) and supporting
...
p.(None): importance of the knowledge that may reasonably be expected to result.
p.(None): 5.3.2.3 The selection of Subjects must be equitable.
p.(None): 5.3.2.4 Informed consent must be obtained from each prospective Human Subject or the
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 8 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): Subject’s representative, as applicable, before any Research related procedure, in accordance with DHCR Regulations and
p.(None): applicable Standards and Policies.
p.(None): 5.3.2.5 Informed consent must be appropriately documented, in accordance with evidence based best practices and using
p.(None): an approved form and patient information sheet. Arabic translation of the informed consent, patient information sheet,
p.(None): and any other material that is to be viewed and used by study Subjects is mandatory.
p.(None): 5.3.2.6 The Protocol includes adequate provision for Monitoring the data collected to ensure the safety of Human
p.(None): Subjects.
p.(None): 5.3.2.7 There are adequate provisions to protect the subject’s privacy and maintain
p.(None): confidentiality of research data.
p.(None): 5.3.2.8 There are appropriate provisions for compensation for Human Subjects.
p.(None): 5.3.2.9 When some or all of the Human Subjects are likely to be susceptible to coercion or undue influence, there must
p.(None): be additional safeguards to ensure protection of the rights and welfare of these Subjects.
p.(None):
p.(None): 6- Research involving Children, Vulnerable Adults, Dependents, Pregnant Women, Prisoners, and Others
p.(None):
p.(None): 6.1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 6.2
p.(None):
p.(None):
p.(None):
p.(None): 6.3
p.(None): Children, vulnerable adults, pregnant women, fetuses, neonates, prisoners, students, employees, elderly,
p.(None): refugees, prisoners, disabled subjects or anyone who is economically, socially or educationally
p.(None): disadvantaged are all considered special population and any research involving these groups would require additional
...
General/Other / belmont
Searching for indicator belmont:
(return to top)
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 2 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): 4.11 DHCR will seriously consider misconduct in research and/or breaches of ethical standards which will be referred
p.(None): to appropriate bodies for review, investigation, and penalties as applicable.
p.(None): 4.12 Research Involving Human Subjects/Tissue/Samples/Data
p.(None): 4.12.1 All research procedures and protocols conducted within DHCC involving human samples or participants must
p.(None): undergo appropriate ethical scrutiny leading to the protection of the rights, dignity, safety, and well-being
p.(None): of all those involved in the research project, ensuring confidentiality of information about human subjects, cultural
p.(None): sensitivities in the UAE, and the reputation of DHCC, Dubai and the UAE.
p.(None): 4.12.2 Human subjects must be adequately protected during any research project conducted within or in connection with
p.(None): DHCC. Procedures must also be aligned and implemented with due care to follow all DHCR Policies and applicable UAE
p.(None): laws (such as the UAE Medical Liability Law No 4, 2016).
p.(None): 4.12.3 In cases where there is potential conflict between the freedom that the researcher has, within the law, to carry
p.(None): out the research project and the rights of the participants involved in the research project, the researcher must
p.(None): ensure that the participants’ interests and rights in the study come first.
p.(None): 4.12.4 The DHCR REC will review all research proposals that involve human subjects to ensure that the principles of the
p.(None): Belmont report that revolve around respect for persons, non- maleficence, beneficence, and justice are met. Hence, the
p.(None): research must
p.(None): 4.12.4.1 ensure the voluntary participation of human participants free from undue influence
p.(None): or coercion;
p.(None): 4.12.4.2 clearly outline the informed consent process;
p.(None): 4.12.4.3 emphasize the fair and non-discriminatory recruitment of human participants especially if recruitment entails
p.(None): vulnerable populations;
p.(None): 4.12.4.4 outline how the risks associated with the research are reasonable and justify them
p.(None): by the expected benefits;
p.(None): 4.7.4.5 have a clear and adequate monitoring plan to ensure the safety of participants as well as indicate how
p.(None): additional protection and safeguards will be applied when vulnerable subject populations are included; and
p.(None): 4.7.4.6 adequately outline how matters of confidentiality of all Patient Health Information are
p.(None): respected and that data storage and quality control are adequately maintained and in compliance with DHCR Health Data
p.(None): Protection Regulation.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 3 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None):
p.(None): 5- Procedure Sequence
...
p.(None): 5.2.4 Notification of Decision Regarding Research Proposal
p.(None): The DHCR Research Department will notify the ARO via email of the REC decisions within 5 working days of the decision.
p.(None): The notification email will include:
p.(None): 5.2.4.1 reasons for REC decisions;
p.(None): 5.2.4.2 committee requested changes to the protocol, informed consent forms and/or other documents; and
p.(None): 5.2.4.3 the frequency of continuing review to be determined by the REC members following
p.(None): review of each protocol. The frequency of continuing review is at least annual unless otherwise agreed upon and depends
p.(None): on the degree of risk, involvement of special population, if previous studies indicated high incidence of adverse
p.(None): events or if the REC believes that close monitoring is required.
p.(None): Resubmission of the Research Proposal application with relevant fees is required if the ARO fails to respond to the REC
p.(None): comments within 10 days of receiving said comments.
p.(None): In the event that the REC denies a certain Research Proposal application, the applicant has the right to appeal the
p.(None): denial decision with the DHCR Appeals Board.
p.(None): 5.3 REC Approval Criteria
p.(None): 5.3.1 The DHCR REC is governed by ethical principles described in the following documents:
p.(None): 5.3.1.1 Federal Laws of the UAE;
p.(None): 5.3.1.2 DHCR Regulations, Rules, Standards, and Policies;
p.(None): 5.3.1.3 World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human
p.(None): Subjects;
p.(None): 5.3.1.4 International Conference on Harmonization Good Clinical Practice;
p.(None): 5.3.1.5 The Belmont report that revolves around respect for persons, non- maleficence, beneficence, and justice.
p.(None):
p.(None): 5.3.2 Criteria for Review and Approval
p.(None): 5.3.2.1 Risks to the Subjects must be minimized by using procedures that are consistent with sound research design and
p.(None): that do not unnecessarily expose Human Subjects to Risk; and whenever appropriate, by using procedures already being
p.(None): performed on Human Subjects
p.(None): for diagnostic or treatment purposes.
p.(None): 5.3.2.2 Risks to a Human Subject must be reasonable in relation to the anticipated benefits to the Subject and the
p.(None): importance of the knowledge that may reasonably be expected to result.
p.(None): 5.3.2.3 The selection of Subjects must be equitable.
p.(None): 5.3.2.4 Informed consent must be obtained from each prospective Human Subject or the
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 8 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): Subject’s representative, as applicable, before any Research related procedure, in accordance with DHCR Regulations and
p.(None): applicable Standards and Policies.
p.(None): 5.3.2.5 Informed consent must be appropriately documented, in accordance with evidence based best practices and using
p.(None): an approved form and patient information sheet. Arabic translation of the informed consent, patient information sheet,
p.(None): and any other material that is to be viewed and used by study Subjects is mandatory.
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 7 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): 5.2.4 Notification of Decision Regarding Research Proposal
p.(None): The DHCR Research Department will notify the ARO via email of the REC decisions within 5 working days of the decision.
p.(None): The notification email will include:
p.(None): 5.2.4.1 reasons for REC decisions;
p.(None): 5.2.4.2 committee requested changes to the protocol, informed consent forms and/or other documents; and
p.(None): 5.2.4.3 the frequency of continuing review to be determined by the REC members following
p.(None): review of each protocol. The frequency of continuing review is at least annual unless otherwise agreed upon and depends
p.(None): on the degree of risk, involvement of special population, if previous studies indicated high incidence of adverse
p.(None): events or if the REC believes that close monitoring is required.
p.(None): Resubmission of the Research Proposal application with relevant fees is required if the ARO fails to respond to the REC
p.(None): comments within 10 days of receiving said comments.
p.(None): In the event that the REC denies a certain Research Proposal application, the applicant has the right to appeal the
p.(None): denial decision with the DHCR Appeals Board.
p.(None): 5.3 REC Approval Criteria
p.(None): 5.3.1 The DHCR REC is governed by ethical principles described in the following documents:
p.(None): 5.3.1.1 Federal Laws of the UAE;
p.(None): 5.3.1.2 DHCR Regulations, Rules, Standards, and Policies;
p.(None): 5.3.1.3 World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human
p.(None): Subjects;
p.(None): 5.3.1.4 International Conference on Harmonization Good Clinical Practice;
p.(None): 5.3.1.5 The Belmont report that revolves around respect for persons, non- maleficence, beneficence, and justice.
p.(None):
p.(None): 5.3.2 Criteria for Review and Approval
p.(None): 5.3.2.1 Risks to the Subjects must be minimized by using procedures that are consistent with sound research design and
p.(None): that do not unnecessarily expose Human Subjects to Risk; and whenever appropriate, by using procedures already being
p.(None): performed on Human Subjects
p.(None): for diagnostic or treatment purposes.
p.(None): 5.3.2.2 Risks to a Human Subject must be reasonable in relation to the anticipated benefits to the Subject and the
p.(None): importance of the knowledge that may reasonably be expected to result.
p.(None): 5.3.2.3 The selection of Subjects must be equitable.
p.(None): 5.3.2.4 Informed consent must be obtained from each prospective Human Subject or the
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 8 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): Subject’s representative, as applicable, before any Research related procedure, in accordance with DHCR Regulations and
p.(None): applicable Standards and Policies.
p.(None): 5.3.2.5 Informed consent must be appropriately documented, in accordance with evidence based best practices and using
...
Orphaned Trigger Words
p.(None): 1- Purpose:
p.(None): 1.1 Set out a strong and transparent governance framework for regulatory compliance, promoting
p.(None): principles of good practice, and issuing guidance which ensure that research is conducted with appropriate
p.(None): professional expertise and according to the highest ethical and scientific standards.
p.(None): 1.2 Provide guidance to Entities and Approved Research Operators conducting or intending to conduct research
p.(None): activities in DHCC. It includes policies, procedures, guidelines, as well as the necessary forms for researchers to
p.(None): prepare, submit, and seek ethical approval for their research studies.
p.(None):
p.(None): 2- Scope of application:
p.(None): 2.1 Any and all research activities that may be carried out within DHCC.
p.(None):
p.(None):
p.(None): 3- Applicable To:
p.(None): 3.1 All DHCC Entities and Approved Research Operators conducting or intending to conduct research activities in
p.(None): DHCC.
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 1 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): 4- Policy:
p.(None): 4.1 DHCR is committed to maintaining the highest ethical and scientific standards in all aspects of
p.(None): research carried out in DHCC by providing a framework for good research conduct and its governance.
p.(None): 4.2 All DHCC Entities and Approved Research Operators and associated researchers conducting or intending
p.(None): to conduct research activities in DHCC must act in accordance with all relevant UAE laws, DHCR rules, policies, and
p.(None): guidelines; and should abide with the cultural norms within the UAE.
p.(None): 4.3 Any DHCC Entity intending to conduct research activities in DHCC must first apply for and obtain a Research
p.(None): Permit. The application is initially reviewed by the DHCR Research Department and then by the DHCR Academic and
p.(None): Research Council (ARC) who then issue the permit once all the Permit requirements are met. Upon obtaining a
p.(None): Research Permit, the Entity becomes an Approved Research Operator (ARO) within DHCC.
p.(None): 4.4 All Approved Research Operators are required to obtain approval for individual Research Proposals prior to
p.(None): commencing research activities within DHCC. Review of Research Proposals is carried out by the DHCR Research Ethics
p.(None): Committee (REC).
p.(None): 4.5 All AROs are required to submit a minimum of one (1) Research Proposal for review by the DHCR REC during the
p.(None): duration of their active Research Permit. AROs with an ongoing research study must submit a progress
p.(None): report summarizing the study’s progress at the time of renewal of the Research Permit and as required by the
p.(None): REC.
p.(None): 4.6 AROs must begin the process of Research Permit renewal 60-30 days prior to the expiry date of the existing
p.(None): active Permit.
p.(None): 4.7 Prior to commencing the research activity, the ARO is responsible for obtaining all necessary
p.(None): approvals (such as ethics committee approvals) from within and outside of DHCC as applicable.
p.(None): 4.8 Research Proposals that have already obtained ethical approval from a recognized entity as defined by UAE
p.(None): Medical Liability Law No. 4 of 2016 is eligible for expedited review by DHCR.
...
p.(None): (documents can be accessed on the following link:
p.(None): https://www.dhcr.gov.ae/en/AboutDHCR/regulatory-functions#ClinicalResearch). The applicant will also be advised on the
p.(None): associated fees which will be in accordance with the current DHCR service fees structure
p.(None): (https://www.dhcr.gov.ae/en/E-Services/services-fees ).
p.(None): Once documents as per the requirements stated in the applicable checklist are ready to be submitted, the applicant will
p.(None): send them to the Research Department via email. Research Proposal submissions for REC review must be made at least 10
p.(None): working days prior to the upcoming REC meeting in order to be included on said meeting’s agenda. Submissions 3-9
p.(None): working days prior to the REC meeting will incur an urgent processing fee where urgent processing does not guarantee
p.(None): approval.
p.(None):
p.(None): 5.2.2 Administrative Review: Acknowledging receipt of documents and validating an application for review by the REC
p.(None): The Research Department will commence validation of the application on receipt of documents upon which an invoice for
p.(None): Initial Review will be issued by the DHCR Finance Department.
p.(None): Notification of validity is issued via email within ten (10) working days from receipt of documents. In general, an
p.(None): application should be accepted as valid if it meets the following criteria :
p.(None): 5.2.2.1 mandatory documents as per the specified checklist have been provided;
p.(None): 5.2.2.2 the correct application form has been completed and has been signed and dated by the authorized person on
p.(None): behalf of the Operator;
p.(None): 5.2.2.3 applicable supporting documents as required have been provided;
p.(None): 5.2.2.4 all text is in English, and the print is clearly legible;
p.(None): 5.2.2.5 Arabic translation of necessary documents (such as consent form, Patient Information Sheet, Questionnaires
p.(None): etc..) has been provided; and
p.(None): 5.2.2.5 receipt for payment of Initial Review Fee for Research Protocol is provided.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 6 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): It is the responsibility of the Entity submitting the Application to provide a completed application form and to ensure
p.(None): the accuracy of all information provided. In the case of incomplete Applications, the Research Department will notify
p.(None): the Entity identifying the information that has not been provided and the timeframe within which the Application may be
p.(None): resubmitted. The Entity will not be required to pay an additional fee for resubmitting the Application within the
p.(None): specified timeframe. If the Application is not resubmitted within the time specified, the Application will be
p.(None): considered to be withdrawn and the Applicant will need to submit a new Application together with the applicable fee.
p.(None): The cut-off point of resubmission of deficient documentation is 10 working days prior to meeting of the REC for
p.(None): standard review and 3-9 working days for urgent review. Applications requiring more than three
p.(None): administrative reviews due to noncompliance with Research Department’s comments will incur additional review
p.(None): fees. Submission of altered and/or additional documents following validation of a Research Proposal application by
p.(None): the Research Department and prior to review by the REC will incur additional review fees.
p.(None):
...
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): 7.16 The PI must establish a system for ongoing research study monitoring.
p.(None): 7.17 The PI must ensure that he/she as well as all research team members maintain valid Good Clinical Practice
p.(None): certification for the duration of the research study. Good Clinical Practice certification is valid for two (2) years
p.(None): from date of issuance.
p.(None):
p.(None):
p.(None): 8- Responsibilities of the Sponsor
p.(None): Research study sponsors must fulfill the following duties and responsibilities:
p.(None):
p.(None): 8.1
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 8.2
p.(None): 8.3
p.(None): 8.4
p.(None): 8.5
p.(None):
p.(None): 8.6
p.(None):
p.(None):
p.(None): 8.7
p.(None): 8.8
p.(None):
p.(None):
p.(None):
p.(None): 8.9
p.(None): 8.10
p.(None): Quality management and monitoring including: risk identification, evaluation, control, communication,
p.(None): and reporting. In addition to identification of critical processes and data. A sponsor may transfer any or all of
p.(None): the sponsor’s trial-related duties and functions to a Contract Research Organization (CRO), but the ultimate
p.(None): responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should
p.(None): implement quality assurance and quality control;
p.(None): Quality assurance and quality control with written Standard Operating Procedures (SOPs); Selection of reliable vendors
p.(None): and timely delivery of investigational products to the Investigator(s); Trial management, secure data handling, record
p.(None): keeping and ensuring protocol compliance; Submitting regulatory documents to both research ethics
p.(None): committees/institutional review boards (REC/IRBs) and regulatory/competent authorities;
p.(None): Overseeing regulatory requirements of any/all investigational product(s) including safety and efficacy, updating the
p.(None): Investigator’s Brochure as required, compliance with Good Manufacturing Practice, and appropriate labelling, packaging,
p.(None): and coding of all investigational products; Adequately training all study personnel, participants, and vendors as
p.(None): necessary;
p.(None): Appointment of appropriately qualified clinical personnel readily available to advise on trial related medical
p.(None): questions or problems. Each investigator should be qualified by training and experience and should have adequate
p.(None): resources to properly conduct the trial for which the investigator is selected;
p.(None): Ensuring the integrity of the data;
p.(None): Allocation of responsibilities by defining, establishing, and assigning all trial-related duties and functions;
p.(None):
p.(None):
p.(None):
p.(None): Identifier: DHCR/PP/RO/001/02 Issue Date: 30/08/2019 Review Date: 30/08/2022 Page Nu: 13 / 19
p.(None):
p.(None): Conducting Research in Dubai Healthcare City Policy and Procedure
p.(None):
p.(None): 8.11 Compensation to subjects and investigators whereby the sponsor should provide insurance or should indemnify
p.(None): (legal and financial coverage) the investigator/the ARO against claims arising from the trial except for claims that
p.(None): arise from malpractice and/or negligence.
p.(None): In addition, the sponsor’s policies and procedures should address the costs of treatment of trial subjects in the event
p.(None): of trial-related injuries, as well as untoward side-effects, and the method and manner of compensation when trial
p.(None): subjects receive the same;
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| alcoholism | alcoholism |
| authority | Relationship to Authority |
| belmont | belmont |
| child | Child |
| children | Child |
| cognitive | Cognitive Impairment |
| criminal | criminal |
| dependent | Dependent |
| diminished | Diminished Autonomy |
| disabled | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| educational | education |
| elderly | Elderly |
| employees | employees |
| fetus | Fetus/Neonate |
| fetuses | Fetus/Neonate |
| helsinki | declaration of helsinki |
| incapable | Mentally Incapacitated |
| incapacitated | Incapacitated |
| incarcerated | Incarcerated |
| influence | Drug Usage |
| minor | Youth/Minors |
| neonates | Fetus/Neonate |
| officer | Police Officer |
| parent | parents |
| pregnant | Pregnant |
| prisoners | Criminal Convictions |
| undue influence | Undue Influence |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| drug | ['influence'] |
| education | ['educational'] |
| educational | ['education'] |
| fetus | ['fetuses', 'neonates'] |
| fetuses | ['fetus', 'neonates'] |
| influence | ['drug'] |
| neonates | ['fetus', 'fetuses'] |
Trigger Words
capacity
coercion
consent
cultural
developing
ethics
harm
justice
protect
protection
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input