0A4F4F9BD490A749D5437F821CF06DF1
Ethical Guidelines for Biomedical Research
http://www.hsc.edu.kw/EC/EnglishForm/ETHICS.COMMITTEE.GUIDELINES-new2013.pdf
http://leaux.net/URLS/ConvertAPI Text Files/CD044F1FC26D1068497553D1A2093F28.en.txt
Examining the file media/Synopses/CD044F1FC26D1068497553D1A2093F28.html:
This file was generated: 2020-07-14 10:39:59
| 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
Social / Child
Searching for indicator children:
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p.(None): acceptable relative and if necessary a legal representatives.
p.(None): h. To check documents of “informed consent” which include the following:
p.(None): 1. A fair explanation of the procedures to be followed.
p.(None): 2. A description of attendant discomfort and risks.
p.(None): 3. A description of the benefits to be expected.
p.(None): 4. An offer to answer any inquiries concerning the procedure.
p.(None): 5. An undertaking that the subject is free to withdraw consent and to discontinue participation in the project at
p.(None): any time.
p.(None): 6. An assurance that measures would be taken for the confidentiality of data.
p.(None):
p.(None):
p.(None): The Committee shall consider any other matters referred to it by the Deans of the Health Sciences Centre (HSC), Kuwait
p.(None): University.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ÷i9²²ا 13110 :يli9ş²ا ýa9²ا ،ة¹ a²ا 24923 ب.ص - 25318455 :ç²¹ – (965) 25319481 :ن9 ²ä
p.(None): Tel. (965) 25319481 – Fax. 25318455 – P.O.Box: 24923 Safat, Code No. 13110, Kuwait
p.(None):
p.(None):
p.(None): KUWAIT UNIVERSITY HEALTH SCIENCES CENTRE
p.(None): HEALTH SCIENCES CENTRE ETHICAL COMMITTEE
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Procedures
p.(None):
p.(None): a. Principal Investigator(PI) should submit the research proposal/protocol attached with the special the COMMITTEE
p.(None): Forms to the Committee secretary.
p.(None): b. The PI should submit the COMMITTEE forms according to his/her research, and to fill the appropriate set of
p.(None): forms concerning the research, and whether the research involves adults or children or both.
p.(None): c. To submit both Arabic and English forms.
p.(None): d. The PI can submit only the Cover form (without the Informed Consent Forms) if the research involves
p.(None): only:
p.(None): - Pre-collected samples
p.(None): - Collecting data from records (patients’ medical history records)
p.(None): - Collecting data through distributing a questionnaire sheet, in such case, however, PI should enclose a copy of the
p.(None): questionnaire in both Arabic and English languages.
p.(None): e. The Committee’s deliberations shall be confidential and the decisions taken shall be communicated
p.(None): directly to the investigator(s).
p.(None):
p.(None):
p.(None): Any proposal involving change of the membership or functions of the Committee shall be referred to the Health Sciences
p.(None): Centre Deans Council.
p.(None):
p.(None):
p.(None): The Consent Form
p.(None):
p.(None): The subject’s consent must be confirmed at the time of consent and the signature of both the subject and the person
p.(None): conducting the informed consent must be dated. If the subject is unable to read, oral presentation and explanation of
p.(None): the written informed consent form and information to be supplied to the subject must take place in the
p.(None): presence of an impartial witness. Consent must be confirmed at the time of the oral consent by the
...
Social / Linguistic Proficiency
Searching for indicator language:
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p.(None):
p.(None): Functions
p.(None):
p.(None): a. To establish mechanisms for the ethical review of all research activities involving human subjects.
p.(None): b. To ensure that the study is conducted according to globally accepted standards of good clinical
p.(None): practice (as defined in the ICH E6 Guideline for Good Clinical Practice, July 2002 (please see the link
p.(None): on left side menu)), in agreement with the latest revision of the World Medical Association Declaration
p.(None): of Helsinki –
p.(None):
p.(None):
p.(None):
p.(None): ÷i9²²ا 13110 :يli9ş²ا ýa9²ا ،ة¹ a²ا 24923 ب.ص - 25318455 :ç²¹ – (965) 25319481 :ن9 ²ä
p.(None): Tel. (965) 25319481 – Fax. 25318455 – P.O.Box: 24923 Safat, Code No. 13110, Kuwait
p.(None):
p.(None):
p.(None): KUWAIT UNIVERSITY HEALTH SCIENCES CENTRE
p.(None): HEALTH SCIENCES CENTRE ETHICAL COMMITTEE
p.(None):
p.(None):
p.(None):
p.(None): Ethical Principles for Medical Research Involving Human Subjects, 59th WMA General Assembly, Seoul, October 2008
p.(None): (please see the link on left side menu) and in keeping with local regulations and moral values.
p.(None): c. To ensure the potential risks involved in procedures involving human subjects relative to the benefits to be
p.(None): expected.
p.(None): d. To ensure that adequate safeguards for the relief of trauma or stress are included in the protocol.
p.(None): e. To ensure the suitability of the investigator(s) for the proposal in relation to his/her qualifications,
p.(None): experience, supporting staff and available facilities.
p.(None): f. To ensure that the “informed consent form (in both Arabic & English)” is in an understandable
p.(None): language and specifies the name and designation of the informing person.
p.(None): g. To review the adequacy and completeness of the written information given to the subjects or an
p.(None): acceptable relative and if necessary a legal representatives.
p.(None): h. To check documents of “informed consent” which include the following:
p.(None): 1. A fair explanation of the procedures to be followed.
p.(None): 2. A description of attendant discomfort and risks.
p.(None): 3. A description of the benefits to be expected.
p.(None): 4. An offer to answer any inquiries concerning the procedure.
p.(None): 5. An undertaking that the subject is free to withdraw consent and to discontinue participation in the project at
p.(None): any time.
p.(None): 6. An assurance that measures would be taken for the confidentiality of data.
p.(None):
p.(None):
p.(None): The Committee shall consider any other matters referred to it by the Deans of the Health Sciences Centre (HSC), Kuwait
p.(None): University.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ÷i9²²ا 13110 :يli9ş²ا ýa9²ا ،ة¹ a²ا 24923 ب.ص - 25318455 :ç²¹ – (965) 25319481 :ن9 ²ä
p.(None): Tel. (965) 25319481 – Fax. 25318455 – P.O.Box: 24923 Safat, Code No. 13110, Kuwait
p.(None):
p.(None):
p.(None): KUWAIT UNIVERSITY HEALTH SCIENCES CENTRE
p.(None): HEALTH SCIENCES CENTRE ETHICAL COMMITTEE
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Procedures
p.(None):
p.(None): a. Principal Investigator(PI) should submit the research proposal/protocol attached with the special the COMMITTEE
p.(None): Forms to the Committee secretary.
...
Social / Victim of Abuse
Searching for indicator trauma:
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p.(None): c. A member nominated from the Faculty of Dentistry.
p.(None): d. A member nominated from the Faculty of Pharmacy.
p.(None): e. A member nominated from the Faculty of Allied Health.
p.(None): f. Any other person with special knowledge or expertise may be invited to attend meetings of the
p.(None): Committee as appropriate.
p.(None):
p.(None):
p.(None):
p.(None): Functions
p.(None):
p.(None): a. To establish mechanisms for the ethical review of all research activities involving human subjects.
p.(None): b. To ensure that the study is conducted according to globally accepted standards of good clinical
p.(None): practice (as defined in the ICH E6 Guideline for Good Clinical Practice, July 2002 (please see the link
p.(None): on left side menu)), in agreement with the latest revision of the World Medical Association Declaration
p.(None): of Helsinki –
p.(None):
p.(None):
p.(None):
p.(None): ÷i9²²ا 13110 :يli9ş²ا ýa9²ا ،ة¹ a²ا 24923 ب.ص - 25318455 :ç²¹ – (965) 25319481 :ن9 ²ä
p.(None): Tel. (965) 25319481 – Fax. 25318455 – P.O.Box: 24923 Safat, Code No. 13110, Kuwait
p.(None):
p.(None):
p.(None): KUWAIT UNIVERSITY HEALTH SCIENCES CENTRE
p.(None): HEALTH SCIENCES CENTRE ETHICAL COMMITTEE
p.(None):
p.(None):
p.(None):
p.(None): Ethical Principles for Medical Research Involving Human Subjects, 59th WMA General Assembly, Seoul, October 2008
p.(None): (please see the link on left side menu) and in keeping with local regulations and moral values.
p.(None): c. To ensure the potential risks involved in procedures involving human subjects relative to the benefits to be
p.(None): expected.
p.(None): d. To ensure that adequate safeguards for the relief of trauma or stress are included in the protocol.
p.(None): e. To ensure the suitability of the investigator(s) for the proposal in relation to his/her qualifications,
p.(None): experience, supporting staff and available facilities.
p.(None): f. To ensure that the “informed consent form (in both Arabic & English)” is in an understandable
p.(None): language and specifies the name and designation of the informing person.
p.(None): g. To review the adequacy and completeness of the written information given to the subjects or an
p.(None): acceptable relative and if necessary a legal representatives.
p.(None): h. To check documents of “informed consent” which include the following:
p.(None): 1. A fair explanation of the procedures to be followed.
p.(None): 2. A description of attendant discomfort and risks.
p.(None): 3. A description of the benefits to be expected.
p.(None): 4. An offer to answer any inquiries concerning the procedure.
p.(None): 5. An undertaking that the subject is free to withdraw consent and to discontinue participation in the project at
p.(None): any time.
p.(None): 6. An assurance that measures would be taken for the confidentiality of data.
p.(None):
p.(None):
p.(None): The Committee shall consider any other matters referred to it by the Deans of the Health Sciences Centre (HSC), Kuwait
p.(None): University.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ÷i9²²ا 13110 :يli9ş²ا ýa9²ا ،ة¹ a²ا 24923 ب.ص - 25318455 :ç²¹ – (965) 25319481 :ن9 ²ä
p.(None): Tel. (965) 25319481 – Fax. 25318455 – P.O.Box: 24923 Safat, Code No. 13110, Kuwait
p.(None):
...
Orphaned Trigger Words
p.(None): HEALTH SCIENCES CENTRE ETHICAL COMMITTEE
p.(None):
p.(None):
p.(None):
p.(None): Ethical Principles for Medical Research Involving Human Subjects, 59th WMA General Assembly, Seoul, October 2008
p.(None): (please see the link on left side menu) and in keeping with local regulations and moral values.
p.(None): c. To ensure the potential risks involved in procedures involving human subjects relative to the benefits to be
p.(None): expected.
p.(None): d. To ensure that adequate safeguards for the relief of trauma or stress are included in the protocol.
p.(None): e. To ensure the suitability of the investigator(s) for the proposal in relation to his/her qualifications,
p.(None): experience, supporting staff and available facilities.
p.(None): f. To ensure that the “informed consent form (in both Arabic & English)” is in an understandable
p.(None): language and specifies the name and designation of the informing person.
p.(None): g. To review the adequacy and completeness of the written information given to the subjects or an
p.(None): acceptable relative and if necessary a legal representatives.
p.(None): h. To check documents of “informed consent” which include the following:
p.(None): 1. A fair explanation of the procedures to be followed.
p.(None): 2. A description of attendant discomfort and risks.
p.(None): 3. A description of the benefits to be expected.
p.(None): 4. An offer to answer any inquiries concerning the procedure.
p.(None): 5. An undertaking that the subject is free to withdraw consent and to discontinue participation in the project at
p.(None): any time.
p.(None): 6. An assurance that measures would be taken for the confidentiality of data.
p.(None):
p.(None):
p.(None): The Committee shall consider any other matters referred to it by the Deans of the Health Sciences Centre (HSC), Kuwait
p.(None): University.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): ÷i9²²ا 13110 :يli9ş²ا ýa9²ا ،ة¹ a²ا 24923 ب.ص - 25318455 :ç²¹ – (965) 25319481 :ن9 ²ä
p.(None): Tel. (965) 25319481 – Fax. 25318455 – P.O.Box: 24923 Safat, Code No. 13110, Kuwait
p.(None):
p.(None):
p.(None): KUWAIT UNIVERSITY HEALTH SCIENCES CENTRE
p.(None): HEALTH SCIENCES CENTRE ETHICAL COMMITTEE
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Procedures
p.(None):
p.(None): a. Principal Investigator(PI) should submit the research proposal/protocol attached with the special the COMMITTEE
p.(None): Forms to the Committee secretary.
p.(None): b. The PI should submit the COMMITTEE forms according to his/her research, and to fill the appropriate set of
p.(None): forms concerning the research, and whether the research involves adults or children or both.
p.(None): c. To submit both Arabic and English forms.
p.(None): d. The PI can submit only the Cover form (without the Informed Consent Forms) if the research involves
p.(None): only:
p.(None): - Pre-collected samples
p.(None): - Collecting data from records (patients’ medical history records)
p.(None): - Collecting data through distributing a questionnaire sheet, in such case, however, PI should enclose a copy of the
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| children | Child |
| language | Linguistic Proficiency |
| trauma | Victim of Abuse |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
ethics
protection
Applicable Type / Vulnerability / Indicator Overlay for this Input