79C3C34C52B45572883A05D425EB0F82
Faculty of Medicine- Cairo University Ethical Review Board Policies & Procedures Manual
http://medicine.cu.edu.eg/images/stories/docs/research/fp7/cairo-procedure-manual.pdf
http://leaux.net/URLS/ConvertAPI Text Files/16491AA0275E738A62FEF27C931B7AD4.en.txt
Examining the file media/Synopses/16491AA0275E738A62FEF27C931B7AD4.html:
This file was generated: 2021-02-07 08:40:45
| 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:
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p.000003: Outside scientist could be invited by the IRB to review proposals that is in a field in which there is no expertise
p.000003: within the review committee membership.
p.000003:
p.000003: Functions of the ethical committee:
p.000003: 1. Primary review of research protocols: IRB must ensure that:
p.000003: 1.1. Research topic is important and will add to scientific knowledge.
p.000003: 1.2. Research topic is relevant to institutional and community interests.
p.000003: 1.3. Research design is appropriate, able to test the research hypothesis and study instruments are acceptable.
p.000003: 1.4. Adequacy of toxicological and pharmacological data for the drug or instrument to be used.
p.000003: 1.5. Training and experience of clinical staff.
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: 1.6. Adequacy of clinical research facilities at study site.
p.000004: 1.7. Benefit gain from research is outweighing expected risk by a considerable amount, according to IRB judgment.
p.000004: Such benefits should be sensed on both individual and society levels.
p.000004: 1.8. Necessary measures are taken to minimize any anticipated risks and boost benefits.
p.000004: 1.9. Selection of subjects is equitable, and there is a fair distribution of benefits and burdens at individual and
p.000004: society levels.
p.000004: 1.10. Appropriate safeguards to protect the rights and welfare of vulnerable subjects as children, women and prisoners.
p.000004: 1.11. Informed consent is sought in a written form from all research subjects, in language understandable to the
p.000004: subject and under conditions that minimize the possibility of coercion or undue influence.
p.000004: 1.12. Assurance that the budget for the project does not include undue inducement for subject participation, apart from
p.000004: legitimate compensation for travel and lost earnings.
p.000004: 1.13. Privacy of individuals and confidentiality of data is protected and maintained.
p.000004: 1.14. Any additional issues according to type, design and setting of the research.
p.000004: 2. Further review of any notification to IRB by researchers regarding changes in protocol, consent form, recruitment
p.000004: procedures or unanticipated adverse events to participants.
p.000004: 3. Follow-up, monitoring and continued review of approved research protocols to ensure compliance with approved
p.000004: protocols. This review would be annually for projects encountering minimal risks and every 6 months for projects with
p.000004: greater than minimal risks.
p.000004: 4. Supervising publication coming out of the project to ensure confidentiality is maintained.
p.000004:
p.000004: Types of reviews:
p.000004: Full Board Review
p.000004: Protocols are circulated to all Board members for review and comment. Issues of clarification often emerge during the
p.000004: review.
p.000004: Facilitated Review
p.000004: The review process is carried out as a full IRB review. Materials are assigned first to the Chair of the IRB who acts
...
Political / vulnerable
Searching for indicator vulnerable:
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p.000001: facilitates project monitoring and avoids repetitive discussions of the same issues.
p.000001:
p.000001:
p.000002: 2
p.000002:
p.000002: The mission, goal and objectives of Faculty of Medicine, Cairo University IRB are as follow:
p.000002: Mission:
p.000002: Improving scientific knowledge by ensuring proper conduct of medical, social and behavioral research.
p.000002:
p.000002: Goal:
p.000002:
p.000002: Protecting the rights and welfare of human subjects; participating in medical, social and behavioral research.
p.000002: Objectives:
p.000002: IRB review is grounded on the following ethical principles:
p.000002: • Respect for person;
p.000002: • Beneficence &
p.000002: • Justice/equity
p.000002: So, IRB will work to:
p.000002: 1. Ensure that research is relevant to community and is not providing benefit to other communities
p.000002: disproportionately.
p.000002: 2. Ensure absence of harm to individuals and/or societies for being participating in research.
p.000002: 3. Guarantee that individuals and/or societies participating in research will get a benefit out of such research.
p.000002: 4. Ensure respect for individuals and/or societies participating in research regarding their values, culture &
p.000002: privacy.
p.000002: 5. Make sure that every individual is fully informed before being enrolled in the research to be able to make an
p.000002: independent decision whether to participate or not.
p.000002: 6. Justice by fair distribution of burdens and benefits both on individual and community levels.
p.000002: 7. Prevent use of vulnerable populations disproportionately.
p.000002:
p.000002: What is " research?"
p.000002: Means systematic investigation designed to develop or contribute to generalizable knowledge, whether or not it is
p.000002: supported or funded under a program, which is considered research for other purposes.
p.000002: Who are " human subjects?"
p.000002: Means living individuals about whom an investigator (whether professional or student) conducting research obtains:
p.000002: (1) data through intervention or interaction, or
p.000002: (2) identifiable human materials,
p.000002: (3) identifiable private information.
p.000002:
p.000002: Authority of IRB:
p.000002: The IRB has the authority to approve, to require modification as a condition of approval, and to disapprove proposed
p.000002: activities that are with the scope of its authority. In addition, the IRB has the authority to verify that ongoing
p.000002: studies comply with regulations, and it may suspend or terminate approval for ongoing studies under its jurisdiction.
p.000002: Furthermore, the IRB has the authority to determine whether or not any activity requires review by the IRB.
p.000002: Failure to observe the policies and procedures described here will be considered serious misconduct, which is
p.000002: potentially harming human subjects participating in such research.
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: Approval of a Protocol by officials at any level at the Cairo University is not a substitute for IRB approval.
...
p.000003: The principal investigator has the right and is encouraged to attend the review meeting of his/her protocol but should
p.000003: absent themselves from confidential discussions and final assessment of the proposal.
p.000003: Outside scientist could be invited by the IRB to review proposals that is in a field in which there is no expertise
p.000003: within the review committee membership.
p.000003:
p.000003: Functions of the ethical committee:
p.000003: 1. Primary review of research protocols: IRB must ensure that:
p.000003: 1.1. Research topic is important and will add to scientific knowledge.
p.000003: 1.2. Research topic is relevant to institutional and community interests.
p.000003: 1.3. Research design is appropriate, able to test the research hypothesis and study instruments are acceptable.
p.000003: 1.4. Adequacy of toxicological and pharmacological data for the drug or instrument to be used.
p.000003: 1.5. Training and experience of clinical staff.
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: 1.6. Adequacy of clinical research facilities at study site.
p.000004: 1.7. Benefit gain from research is outweighing expected risk by a considerable amount, according to IRB judgment.
p.000004: Such benefits should be sensed on both individual and society levels.
p.000004: 1.8. Necessary measures are taken to minimize any anticipated risks and boost benefits.
p.000004: 1.9. Selection of subjects is equitable, and there is a fair distribution of benefits and burdens at individual and
p.000004: society levels.
p.000004: 1.10. Appropriate safeguards to protect the rights and welfare of vulnerable subjects as children, women and prisoners.
p.000004: 1.11. Informed consent is sought in a written form from all research subjects, in language understandable to the
p.000004: subject and under conditions that minimize the possibility of coercion or undue influence.
p.000004: 1.12. Assurance that the budget for the project does not include undue inducement for subject participation, apart from
p.000004: legitimate compensation for travel and lost earnings.
p.000004: 1.13. Privacy of individuals and confidentiality of data is protected and maintained.
p.000004: 1.14. Any additional issues according to type, design and setting of the research.
p.000004: 2. Further review of any notification to IRB by researchers regarding changes in protocol, consent form, recruitment
p.000004: procedures or unanticipated adverse events to participants.
p.000004: 3. Follow-up, monitoring and continued review of approved research protocols to ensure compliance with approved
p.000004: protocols. This review would be annually for projects encountering minimal risks and every 6 months for projects with
p.000004: greater than minimal risks.
p.000004: 4. Supervising publication coming out of the project to ensure confidentiality is maintained.
p.000004:
p.000004: Types of reviews:
p.000004: Full Board Review
p.000004: Protocols are circulated to all Board members for review and comment. Issues of clarification often emerge during the
p.000004: review.
p.000004: Facilitated Review
...
Health / Drug Usage
Searching for indicator drug:
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p.000003: human subjects, regardless of the level of risk foreseen, require IRB review and approval or exemption, prior to the
p.000003: initiation of the activity.
p.000003:
p.000003: Conflict of interest:
p.000003: The IRB will make sure of the independence of the committee from investigators and will exclude any member/s with a
p.000003: direct interest in a proposal from participating in its review and assessment.
p.000003:
p.000003: IRB meetings:
p.000003: Time:
p.000003: One of the four committees will meet regularly; once every week (every Thursday). If is happen to be a holiday then,
p.000003: IRB will meet next week.
p.000003: Dates and times of meetings will be advertised to help investigators to determine time to submit their proposals.
p.000003: Who could attend the meetings?
p.000003: Meeting is valid if at least 5 members of the committee attend the review process.
p.000003: The principal investigator has the right and is encouraged to attend the review meeting of his/her protocol but should
p.000003: absent themselves from confidential discussions and final assessment of the proposal.
p.000003: Outside scientist could be invited by the IRB to review proposals that is in a field in which there is no expertise
p.000003: within the review committee membership.
p.000003:
p.000003: Functions of the ethical committee:
p.000003: 1. Primary review of research protocols: IRB must ensure that:
p.000003: 1.1. Research topic is important and will add to scientific knowledge.
p.000003: 1.2. Research topic is relevant to institutional and community interests.
p.000003: 1.3. Research design is appropriate, able to test the research hypothesis and study instruments are acceptable.
p.000003: 1.4. Adequacy of toxicological and pharmacological data for the drug or instrument to be used.
p.000003: 1.5. Training and experience of clinical staff.
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: 1.6. Adequacy of clinical research facilities at study site.
p.000004: 1.7. Benefit gain from research is outweighing expected risk by a considerable amount, according to IRB judgment.
p.000004: Such benefits should be sensed on both individual and society levels.
p.000004: 1.8. Necessary measures are taken to minimize any anticipated risks and boost benefits.
p.000004: 1.9. Selection of subjects is equitable, and there is a fair distribution of benefits and burdens at individual and
p.000004: society levels.
p.000004: 1.10. Appropriate safeguards to protect the rights and welfare of vulnerable subjects as children, women and prisoners.
p.000004: 1.11. Informed consent is sought in a written form from all research subjects, in language understandable to the
p.000004: subject and under conditions that minimize the possibility of coercion or undue influence.
p.000004: 1.12. Assurance that the budget for the project does not include undue inducement for subject participation, apart from
p.000004: legitimate compensation for travel and lost earnings.
p.000004: 1.13. Privacy of individuals and confidentiality of data is protected and maintained.
...
Social / Child
Searching for indicator children:
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p.000003: absent themselves from confidential discussions and final assessment of the proposal.
p.000003: Outside scientist could be invited by the IRB to review proposals that is in a field in which there is no expertise
p.000003: within the review committee membership.
p.000003:
p.000003: Functions of the ethical committee:
p.000003: 1. Primary review of research protocols: IRB must ensure that:
p.000003: 1.1. Research topic is important and will add to scientific knowledge.
p.000003: 1.2. Research topic is relevant to institutional and community interests.
p.000003: 1.3. Research design is appropriate, able to test the research hypothesis and study instruments are acceptable.
p.000003: 1.4. Adequacy of toxicological and pharmacological data for the drug or instrument to be used.
p.000003: 1.5. Training and experience of clinical staff.
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: 1.6. Adequacy of clinical research facilities at study site.
p.000004: 1.7. Benefit gain from research is outweighing expected risk by a considerable amount, according to IRB judgment.
p.000004: Such benefits should be sensed on both individual and society levels.
p.000004: 1.8. Necessary measures are taken to minimize any anticipated risks and boost benefits.
p.000004: 1.9. Selection of subjects is equitable, and there is a fair distribution of benefits and burdens at individual and
p.000004: society levels.
p.000004: 1.10. Appropriate safeguards to protect the rights and welfare of vulnerable subjects as children, women and prisoners.
p.000004: 1.11. Informed consent is sought in a written form from all research subjects, in language understandable to the
p.000004: subject and under conditions that minimize the possibility of coercion or undue influence.
p.000004: 1.12. Assurance that the budget for the project does not include undue inducement for subject participation, apart from
p.000004: legitimate compensation for travel and lost earnings.
p.000004: 1.13. Privacy of individuals and confidentiality of data is protected and maintained.
p.000004: 1.14. Any additional issues according to type, design and setting of the research.
p.000004: 2. Further review of any notification to IRB by researchers regarding changes in protocol, consent form, recruitment
p.000004: procedures or unanticipated adverse events to participants.
p.000004: 3. Follow-up, monitoring and continued review of approved research protocols to ensure compliance with approved
p.000004: protocols. This review would be annually for projects encountering minimal risks and every 6 months for projects with
p.000004: greater than minimal risks.
p.000004: 4. Supervising publication coming out of the project to ensure confidentiality is maintained.
p.000004:
p.000004: Types of reviews:
p.000004: Full Board Review
p.000004: Protocols are circulated to all Board members for review and comment. Issues of clarification often emerge during the
p.000004: review.
p.000004: Facilitated Review
...
Social / Linguistic Proficiency
Searching for indicator language:
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p.000003: Functions of the ethical committee:
p.000003: 1. Primary review of research protocols: IRB must ensure that:
p.000003: 1.1. Research topic is important and will add to scientific knowledge.
p.000003: 1.2. Research topic is relevant to institutional and community interests.
p.000003: 1.3. Research design is appropriate, able to test the research hypothesis and study instruments are acceptable.
p.000003: 1.4. Adequacy of toxicological and pharmacological data for the drug or instrument to be used.
p.000003: 1.5. Training and experience of clinical staff.
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: 1.6. Adequacy of clinical research facilities at study site.
p.000004: 1.7. Benefit gain from research is outweighing expected risk by a considerable amount, according to IRB judgment.
p.000004: Such benefits should be sensed on both individual and society levels.
p.000004: 1.8. Necessary measures are taken to minimize any anticipated risks and boost benefits.
p.000004: 1.9. Selection of subjects is equitable, and there is a fair distribution of benefits and burdens at individual and
p.000004: society levels.
p.000004: 1.10. Appropriate safeguards to protect the rights and welfare of vulnerable subjects as children, women and prisoners.
p.000004: 1.11. Informed consent is sought in a written form from all research subjects, in language understandable to the
p.000004: subject and under conditions that minimize the possibility of coercion or undue influence.
p.000004: 1.12. Assurance that the budget for the project does not include undue inducement for subject participation, apart from
p.000004: legitimate compensation for travel and lost earnings.
p.000004: 1.13. Privacy of individuals and confidentiality of data is protected and maintained.
p.000004: 1.14. Any additional issues according to type, design and setting of the research.
p.000004: 2. Further review of any notification to IRB by researchers regarding changes in protocol, consent form, recruitment
p.000004: procedures or unanticipated adverse events to participants.
p.000004: 3. Follow-up, monitoring and continued review of approved research protocols to ensure compliance with approved
p.000004: protocols. This review would be annually for projects encountering minimal risks and every 6 months for projects with
p.000004: greater than minimal risks.
p.000004: 4. Supervising publication coming out of the project to ensure confidentiality is maintained.
p.000004:
p.000004: Types of reviews:
p.000004: Full Board Review
p.000004: Protocols are circulated to all Board members for review and comment. Issues of clarification often emerge during the
p.000004: review.
p.000004: Facilitated Review
p.000004: The review process is carried out as a full IRB review. Materials are assigned first to the Chair of the IRB who acts
p.000004: as the Primary Reviewer for the protocol. Protocols are also provided to all IRB members. Protocols are not presented
p.000004: at length to the IRB and/or discussed by the full committee unless there is concern voiced by a member of the IRB.
p.000004: Expedited Review
...
Social / Occupation
Searching for indicator job:
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p.000001: Research Involving Human Subjects issued by the Council For International Organizations Of Medical Sciences (CIOMS).
p.000001: This committee will operates within the framework of the Egyptian policies and laws and the international guidelines
p.000001: will be explained and applied within the framework of the Egyptian laws.
p.000001:
p.000001: Construction of committee:
p.000001: The Faculty of Medicine, Cairo University Institutional Review Board (IRB) is a standing committee, constituted
p.000001: according to decision no for the year 2002 issued in 2002 by the Dean of Faculty of Medicine, Cairo
p.000001: University and the approval of the Faculty Council dated for the year 2002 and approval of the Cairo University
p.000001: Council dated 2003.
p.000001:
p.000001: Membership of the committee:
p.000001: The executive committee is formed of:
p.000001: 1. The Chair,
p.000001: 2. The Executive Director,
p.000001: 3. The Chairs of the Sub-Committees,
p.000001: 4. The Administrator.
p.000001:
p.000001: The Institutional Review Board (IRB) for Faculty of Medicine, Cairo University is comprised of 40 individuals to be
p.000001: divided over 4 subcommittees. The members are of varying medial specialties, disciplines, gender and expertise from the
p.000001: scientific and the non- scientific community.
p.000001: The responsibility for appointing the IRB Chair and some members of unique expertise rests with the Dean of Faculty of
p.000001: Medicine, Cairo University while the different departments will appoint the majority of the members in response to a
p.000001: written request from the IRB chair including the number of members to be appointed.
p.000001: Members of IRB are unpaid and they carry the job as part of the institutional commitment to Faculty of Medicine, Cairo
p.000001: University. Members from outside are also unpaid and it is considered as a volunteer work for them.
p.000001: There is a chair for the committee who is responsible of maintaining the scientific and logistic aspects of IRB work.
p.000001: The executive director helps the Chair especially with the logistic aspect. The administrator is responsible for
p.000001: secretary and administrative work.
p.000001: Membership will change periodically every three years where one third of the members being rotated off the committee at
p.000001: the end of each year. This mechanism provides an opportunity for a variety of individuals to participate in the work of
p.000001: the review committee, encourages the development of a collective memory in the review committee, educates new members,
p.000001: facilitates project monitoring and avoids repetitive discussions of the same issues.
p.000001:
p.000001:
p.000002: 2
p.000002:
p.000002: The mission, goal and objectives of Faculty of Medicine, Cairo University IRB are as follow:
p.000002: Mission:
p.000002: Improving scientific knowledge by ensuring proper conduct of medical, social and behavioral research.
p.000002:
p.000002: Goal:
p.000002:
p.000002: Protecting the rights and welfare of human subjects; participating in medical, social and behavioral research.
p.000002: Objectives:
p.000002: IRB review is grounded on the following ethical principles:
p.000002: • Respect for person;
p.000002: • Beneficence &
p.000002: • Justice/equity
p.000002: So, IRB will work to:
p.000002: 1. Ensure that research is relevant to community and is not providing benefit to other communities
p.000002: disproportionately.
...
Social / Student
Searching for indicator student:
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p.000002: Objectives:
p.000002: IRB review is grounded on the following ethical principles:
p.000002: • Respect for person;
p.000002: • Beneficence &
p.000002: • Justice/equity
p.000002: So, IRB will work to:
p.000002: 1. Ensure that research is relevant to community and is not providing benefit to other communities
p.000002: disproportionately.
p.000002: 2. Ensure absence of harm to individuals and/or societies for being participating in research.
p.000002: 3. Guarantee that individuals and/or societies participating in research will get a benefit out of such research.
p.000002: 4. Ensure respect for individuals and/or societies participating in research regarding their values, culture &
p.000002: privacy.
p.000002: 5. Make sure that every individual is fully informed before being enrolled in the research to be able to make an
p.000002: independent decision whether to participate or not.
p.000002: 6. Justice by fair distribution of burdens and benefits both on individual and community levels.
p.000002: 7. Prevent use of vulnerable populations disproportionately.
p.000002:
p.000002: What is " research?"
p.000002: Means systematic investigation designed to develop or contribute to generalizable knowledge, whether or not it is
p.000002: supported or funded under a program, which is considered research for other purposes.
p.000002: Who are " human subjects?"
p.000002: Means living individuals about whom an investigator (whether professional or student) conducting research obtains:
p.000002: (1) data through intervention or interaction, or
p.000002: (2) identifiable human materials,
p.000002: (3) identifiable private information.
p.000002:
p.000002: Authority of IRB:
p.000002: The IRB has the authority to approve, to require modification as a condition of approval, and to disapprove proposed
p.000002: activities that are with the scope of its authority. In addition, the IRB has the authority to verify that ongoing
p.000002: studies comply with regulations, and it may suspend or terminate approval for ongoing studies under its jurisdiction.
p.000002: Furthermore, the IRB has the authority to determine whether or not any activity requires review by the IRB.
p.000002: Failure to observe the policies and procedures described here will be considered serious misconduct, which is
p.000002: potentially harming human subjects participating in such research.
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: Approval of a Protocol by officials at any level at the Cairo University is not a substitute for IRB approval.
p.000003: Effectively, therefore, there is no possibility of appeal of IRB disapproval to a higher institutional level.
p.000003: IRB decision is valid after being signed by the Dean of the Faculty and the Vice Dean for Higher Education and
p.000003: Research.
p.000003: All investigators considering research involving human subjects should contact the IRB Office for getting forms to be
p.000003: completed and may be personal assistance if requested.
p.000003:
...
p.000005: satisfactory to the committee. Clarifications must be sent within 60 days of notification to the investigator or the
p.000005: protocol will be closed and will require re-submission in its entirety to be reconsidered.
p.000005: 3. Protocol is approved after amendment(s), indicating that approval is conditioned on incorporation of the specified
p.000005: amendment(s).
p.000005: 4. Protocol is deferred indicating that it is not approved as submitted but it can be re- assessed after revision to
p.000005: address the specified reason(s) for deferment.
p.000005: 5. Protocol is disapproved.
p.000005:
p.000005: Time needed for action:
p.000005: All Protocols must be submitted to the IRB for review, regardless of the investigator’s perception of degree of risk
p.000005: involved.
p.000005: Full Board review is required for the majority of protocols submitted. Full Board review takes a minimum of 3 weeks
p.000005: from the date of submission before action may be recommended.
p.000005: Protocols that qualify for expedited review may receive action within 2 weeks of submission if no substantive issues
p.000005: are raised in the review.
p.000005: Exemption requests may receive action within several days of submission.
p.000005:
p.000005: Cost of ethical review of researches:
p.000005: Faculty of Medicine, Cairo University will provide the necessary supplies for IRB work including an office, stationary,
p.000005: administrative and technical support through its staff.
p.000005: The Faculty will pay the cost of review of researches conducted by its staff as long as the Faculty is the funding
p.000005: body. Also, researches for thesis of master and doctorate degrees for student registered at the faculty will be
p.000005: exempted.
p.000005: For researches funded by an external body, the Faculty will charge 1% of the total budget of the research with a
p.000005: maximum of 10000 LE to cover the administrative & technical cost.
p.000005:
p.000005: Documentation and archiving:
p.000005: The administrator will keep minutes of the meetings in general, an agreed written record decisions made at each
p.000005: meeting, research protocols, forms,…etc.
p.000005: The committee encourages researchers to prepare protocols in the standard format that facilitate its review. Also,
p.000005: forms are available for informed consent guidelines, request for modification, adverse event reporting, final report
p.000005: and expedited review.
p.000005:
p.000005: Publication:
p.000005: The committee will issue annual report to increase the understanding of the general public and foster the dialogue with
p.000005: the scientific community. Such report will not include confidential information not indicate individual project review
p.000005: but it would provide overview of the committee work as the number of proposal reviewed, the number approved,
p.000005: ..etc.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
...
Social / Women
Searching for indicator women:
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p.000003: absent themselves from confidential discussions and final assessment of the proposal.
p.000003: Outside scientist could be invited by the IRB to review proposals that is in a field in which there is no expertise
p.000003: within the review committee membership.
p.000003:
p.000003: Functions of the ethical committee:
p.000003: 1. Primary review of research protocols: IRB must ensure that:
p.000003: 1.1. Research topic is important and will add to scientific knowledge.
p.000003: 1.2. Research topic is relevant to institutional and community interests.
p.000003: 1.3. Research design is appropriate, able to test the research hypothesis and study instruments are acceptable.
p.000003: 1.4. Adequacy of toxicological and pharmacological data for the drug or instrument to be used.
p.000003: 1.5. Training and experience of clinical staff.
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: 1.6. Adequacy of clinical research facilities at study site.
p.000004: 1.7. Benefit gain from research is outweighing expected risk by a considerable amount, according to IRB judgment.
p.000004: Such benefits should be sensed on both individual and society levels.
p.000004: 1.8. Necessary measures are taken to minimize any anticipated risks and boost benefits.
p.000004: 1.9. Selection of subjects is equitable, and there is a fair distribution of benefits and burdens at individual and
p.000004: society levels.
p.000004: 1.10. Appropriate safeguards to protect the rights and welfare of vulnerable subjects as children, women and prisoners.
p.000004: 1.11. Informed consent is sought in a written form from all research subjects, in language understandable to the
p.000004: subject and under conditions that minimize the possibility of coercion or undue influence.
p.000004: 1.12. Assurance that the budget for the project does not include undue inducement for subject participation, apart from
p.000004: legitimate compensation for travel and lost earnings.
p.000004: 1.13. Privacy of individuals and confidentiality of data is protected and maintained.
p.000004: 1.14. Any additional issues according to type, design and setting of the research.
p.000004: 2. Further review of any notification to IRB by researchers regarding changes in protocol, consent form, recruitment
p.000004: procedures or unanticipated adverse events to participants.
p.000004: 3. Follow-up, monitoring and continued review of approved research protocols to ensure compliance with approved
p.000004: protocols. This review would be annually for projects encountering minimal risks and every 6 months for projects with
p.000004: greater than minimal risks.
p.000004: 4. Supervising publication coming out of the project to ensure confidentiality is maintained.
p.000004:
p.000004: Types of reviews:
p.000004: Full Board Review
p.000004: Protocols are circulated to all Board members for review and comment. Issues of clarification often emerge during the
p.000004: review.
p.000004: Facilitated Review
p.000004: The review process is carried out as a full IRB review. Materials are assigned first to the Chair of the IRB who acts
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000004: legitimate compensation for travel and lost earnings.
p.000004: 1.13. Privacy of individuals and confidentiality of data is protected and maintained.
p.000004: 1.14. Any additional issues according to type, design and setting of the research.
p.000004: 2. Further review of any notification to IRB by researchers regarding changes in protocol, consent form, recruitment
p.000004: procedures or unanticipated adverse events to participants.
p.000004: 3. Follow-up, monitoring and continued review of approved research protocols to ensure compliance with approved
p.000004: protocols. This review would be annually for projects encountering minimal risks and every 6 months for projects with
p.000004: greater than minimal risks.
p.000004: 4. Supervising publication coming out of the project to ensure confidentiality is maintained.
p.000004:
p.000004: Types of reviews:
p.000004: Full Board Review
p.000004: Protocols are circulated to all Board members for review and comment. Issues of clarification often emerge during the
p.000004: review.
p.000004: Facilitated Review
p.000004: The review process is carried out as a full IRB review. Materials are assigned first to the Chair of the IRB who acts
p.000004: as the Primary Reviewer for the protocol. Protocols are also provided to all IRB members. Protocols are not presented
p.000004: at length to the IRB and/or discussed by the full committee unless there is concern voiced by a member of the IRB.
p.000004: Expedited Review
p.000004: The review is carried out by one member who informs other members with the approval decision. In case of disapproval,
p.000004: the whole committee should make the decision. It is applied for minimal risk studies or minor changes in approved
p.000004: protocols.
p.000004: Exemptions
p.000004: The IRB may determine that research is exempt from IRB approval. Members of the Executive Committee determine on behalf
p.000004: of the IRB whether exemptions will be granted. It is applicable for researches involving unidentifiable persons of for
p.000004: publicly available data.
p.000004:
p.000004: Categories of recommendation:
p.000004: The IRB may act on a protocol in one of the following ways:
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: 1. Protocol is approved;
p.000005: 2. Protocol is approved after clarification; indicating that the proposal is approved if clarifications requested are
p.000005: satisfactory to the committee. Clarifications must be sent within 60 days of notification to the investigator or the
p.000005: protocol will be closed and will require re-submission in its entirety to be reconsidered.
p.000005: 3. Protocol is approved after amendment(s), indicating that approval is conditioned on incorporation of the specified
p.000005: amendment(s).
p.000005: 4. Protocol is deferred indicating that it is not approved as submitted but it can be re- assessed after revision to
p.000005: address the specified reason(s) for deferment.
p.000005: 5. Protocol is disapproved.
p.000005:
p.000005: Time needed for action:
p.000005: All Protocols must be submitted to the IRB for review, regardless of the investigator’s perception of degree of risk
p.000005: involved.
p.000005: Full Board review is required for the majority of protocols submitted. Full Board review takes a minimum of 3 weeks
p.000005: from the date of submission before action may be recommended.
p.000005: Protocols that qualify for expedited review may receive action within 2 weeks of submission if no substantive issues
p.000005: are raised in the review.
...
Social / education
Searching for indicator education:
(return to top)
p.000002: supported or funded under a program, which is considered research for other purposes.
p.000002: Who are " human subjects?"
p.000002: Means living individuals about whom an investigator (whether professional or student) conducting research obtains:
p.000002: (1) data through intervention or interaction, or
p.000002: (2) identifiable human materials,
p.000002: (3) identifiable private information.
p.000002:
p.000002: Authority of IRB:
p.000002: The IRB has the authority to approve, to require modification as a condition of approval, and to disapprove proposed
p.000002: activities that are with the scope of its authority. In addition, the IRB has the authority to verify that ongoing
p.000002: studies comply with regulations, and it may suspend or terminate approval for ongoing studies under its jurisdiction.
p.000002: Furthermore, the IRB has the authority to determine whether or not any activity requires review by the IRB.
p.000002: Failure to observe the policies and procedures described here will be considered serious misconduct, which is
p.000002: potentially harming human subjects participating in such research.
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: Approval of a Protocol by officials at any level at the Cairo University is not a substitute for IRB approval.
p.000003: Effectively, therefore, there is no possibility of appeal of IRB disapproval to a higher institutional level.
p.000003: IRB decision is valid after being signed by the Dean of the Faculty and the Vice Dean for Higher Education and
p.000003: Research.
p.000003: All investigators considering research involving human subjects should contact the IRB Office for getting forms to be
p.000003: completed and may be personal assistance if requested.
p.000003:
p.000003: The scope of authority of IRB policies:
p.000003: These policies and procedures apply to all research activities conducted under the auspices of Faculty of Medicine,
p.000003: Cairo University. Also it applies to all development, training, and improvement or other related activities containing
p.000003: a research and development component. Research is considered to be conducted under the auspices of Faculty of Medicine,
p.000003: Cairo University when it is supported financially or by in kind services of Faculty of Medicine, Cairo University, when
p.000003: the research will take place at Faculty of Medicine, Cairo University, when the research will involve participation by
p.000003: Faculty of Medicine, Cairo University employees, or when the use of a Faculty of Medicine, Cairo University affiliation
p.000003: is made in correspondence with research subjects or agreements with research sponsors.
p.000003: In accordance with system policy, all research activities within Faculty of Medicine, Cairo University, which involve
p.000003: human subjects, regardless of the level of risk foreseen, require IRB review and approval or exemption, prior to the
p.000003: initiation of the activity.
p.000003:
p.000003: Conflict of interest:
p.000003: The IRB will make sure of the independence of the committee from investigators and will exclude any member/s with a
p.000003: direct interest in a proposal from participating in its review and assessment.
p.000003:
p.000003: IRB meetings:
p.000003: Time:
...
Social / employees
Searching for indicator employees:
(return to top)
p.000002: Furthermore, the IRB has the authority to determine whether or not any activity requires review by the IRB.
p.000002: Failure to observe the policies and procedures described here will be considered serious misconduct, which is
p.000002: potentially harming human subjects participating in such research.
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: Approval of a Protocol by officials at any level at the Cairo University is not a substitute for IRB approval.
p.000003: Effectively, therefore, there is no possibility of appeal of IRB disapproval to a higher institutional level.
p.000003: IRB decision is valid after being signed by the Dean of the Faculty and the Vice Dean for Higher Education and
p.000003: Research.
p.000003: All investigators considering research involving human subjects should contact the IRB Office for getting forms to be
p.000003: completed and may be personal assistance if requested.
p.000003:
p.000003: The scope of authority of IRB policies:
p.000003: These policies and procedures apply to all research activities conducted under the auspices of Faculty of Medicine,
p.000003: Cairo University. Also it applies to all development, training, and improvement or other related activities containing
p.000003: a research and development component. Research is considered to be conducted under the auspices of Faculty of Medicine,
p.000003: Cairo University when it is supported financially or by in kind services of Faculty of Medicine, Cairo University, when
p.000003: the research will take place at Faculty of Medicine, Cairo University, when the research will involve participation by
p.000003: Faculty of Medicine, Cairo University employees, or when the use of a Faculty of Medicine, Cairo University affiliation
p.000003: is made in correspondence with research subjects or agreements with research sponsors.
p.000003: In accordance with system policy, all research activities within Faculty of Medicine, Cairo University, which involve
p.000003: human subjects, regardless of the level of risk foreseen, require IRB review and approval or exemption, prior to the
p.000003: initiation of the activity.
p.000003:
p.000003: Conflict of interest:
p.000003: The IRB will make sure of the independence of the committee from investigators and will exclude any member/s with a
p.000003: direct interest in a proposal from participating in its review and assessment.
p.000003:
p.000003: IRB meetings:
p.000003: Time:
p.000003: One of the four committees will meet regularly; once every week (every Thursday). If is happen to be a holiday then,
p.000003: IRB will meet next week.
p.000003: Dates and times of meetings will be advertised to help investigators to determine time to submit their proposals.
p.000003: Who could attend the meetings?
p.000003: Meeting is valid if at least 5 members of the committee attend the review process.
p.000003: The principal investigator has the right and is encouraged to attend the review meeting of his/her protocol but should
p.000003: absent themselves from confidential discussions and final assessment of the proposal.
p.000003: Outside scientist could be invited by the IRB to review proposals that is in a field in which there is no expertise
p.000003: within the review committee membership.
p.000003:
p.000003: Functions of the ethical committee:
p.000003: 1. Primary review of research protocols: IRB must ensure that:
p.000003: 1.1. Research topic is important and will add to scientific knowledge.
...
Social / gender
Searching for indicator gender:
(return to top)
p.000001: under the auspices of the institution with which it is affiliated.
p.000001:
p.000001: Guidelines:
p.000001: In the conduct of research and/or actions of this institution is guided by the principles set forth in the
p.000001: international reports and guidelines named Helsinki Declaration and the International Ethical Guidelines For Biomedical
p.000001: Research Involving Human Subjects issued by the Council For International Organizations Of Medical Sciences (CIOMS).
p.000001: This committee will operates within the framework of the Egyptian policies and laws and the international guidelines
p.000001: will be explained and applied within the framework of the Egyptian laws.
p.000001:
p.000001: Construction of committee:
p.000001: The Faculty of Medicine, Cairo University Institutional Review Board (IRB) is a standing committee, constituted
p.000001: according to decision no for the year 2002 issued in 2002 by the Dean of Faculty of Medicine, Cairo
p.000001: University and the approval of the Faculty Council dated for the year 2002 and approval of the Cairo University
p.000001: Council dated 2003.
p.000001:
p.000001: Membership of the committee:
p.000001: The executive committee is formed of:
p.000001: 1. The Chair,
p.000001: 2. The Executive Director,
p.000001: 3. The Chairs of the Sub-Committees,
p.000001: 4. The Administrator.
p.000001:
p.000001: The Institutional Review Board (IRB) for Faculty of Medicine, Cairo University is comprised of 40 individuals to be
p.000001: divided over 4 subcommittees. The members are of varying medial specialties, disciplines, gender and expertise from the
p.000001: scientific and the non- scientific community.
p.000001: The responsibility for appointing the IRB Chair and some members of unique expertise rests with the Dean of Faculty of
p.000001: Medicine, Cairo University while the different departments will appoint the majority of the members in response to a
p.000001: written request from the IRB chair including the number of members to be appointed.
p.000001: Members of IRB are unpaid and they carry the job as part of the institutional commitment to Faculty of Medicine, Cairo
p.000001: University. Members from outside are also unpaid and it is considered as a volunteer work for them.
p.000001: There is a chair for the committee who is responsible of maintaining the scientific and logistic aspects of IRB work.
p.000001: The executive director helps the Chair especially with the logistic aspect. The administrator is responsible for
p.000001: secretary and administrative work.
p.000001: Membership will change periodically every three years where one third of the members being rotated off the committee at
p.000001: the end of each year. This mechanism provides an opportunity for a variety of individuals to participate in the work of
p.000001: the review committee, encourages the development of a collective memory in the review committee, educates new members,
p.000001: facilitates project monitoring and avoids repetitive discussions of the same issues.
p.000001:
p.000001:
p.000002: 2
p.000002:
p.000002: The mission, goal and objectives of Faculty of Medicine, Cairo University IRB are as follow:
p.000002: Mission:
p.000002: Improving scientific knowledge by ensuring proper conduct of medical, social and behavioral research.
p.000002:
p.000002: Goal:
p.000002:
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.000002: • Beneficence &
p.000002: • Justice/equity
p.000002: So, IRB will work to:
p.000002: 1. Ensure that research is relevant to community and is not providing benefit to other communities
p.000002: disproportionately.
p.000002: 2. Ensure absence of harm to individuals and/or societies for being participating in research.
p.000002: 3. Guarantee that individuals and/or societies participating in research will get a benefit out of such research.
p.000002: 4. Ensure respect for individuals and/or societies participating in research regarding their values, culture &
p.000002: privacy.
p.000002: 5. Make sure that every individual is fully informed before being enrolled in the research to be able to make an
p.000002: independent decision whether to participate or not.
p.000002: 6. Justice by fair distribution of burdens and benefits both on individual and community levels.
p.000002: 7. Prevent use of vulnerable populations disproportionately.
p.000002:
p.000002: What is " research?"
p.000002: Means systematic investigation designed to develop or contribute to generalizable knowledge, whether or not it is
p.000002: supported or funded under a program, which is considered research for other purposes.
p.000002: Who are " human subjects?"
p.000002: Means living individuals about whom an investigator (whether professional or student) conducting research obtains:
p.000002: (1) data through intervention or interaction, or
p.000002: (2) identifiable human materials,
p.000002: (3) identifiable private information.
p.000002:
p.000002: Authority of IRB:
p.000002: The IRB has the authority to approve, to require modification as a condition of approval, and to disapprove proposed
p.000002: activities that are with the scope of its authority. In addition, the IRB has the authority to verify that ongoing
p.000002: studies comply with regulations, and it may suspend or terminate approval for ongoing studies under its jurisdiction.
p.000002: Furthermore, the IRB has the authority to determine whether or not any activity requires review by the IRB.
p.000002: Failure to observe the policies and procedures described here will be considered serious misconduct, which is
p.000002: potentially harming human subjects participating in such research.
p.000002:
p.000002:
p.000002:
p.000003: 3
p.000003:
p.000003: Approval of a Protocol by officials at any level at the Cairo University is not a substitute for IRB approval.
p.000003: Effectively, therefore, there is no possibility of appeal of IRB disapproval to a higher institutional level.
p.000003: IRB decision is valid after being signed by the Dean of the Faculty and the Vice Dean for Higher Education and
p.000003: Research.
p.000003: All investigators considering research involving human subjects should contact the IRB Office for getting forms to be
p.000003: completed and may be personal assistance if requested.
p.000003:
p.000003: The scope of authority of IRB policies:
p.000003: These policies and procedures apply to all research activities conducted under the auspices of Faculty of Medicine,
p.000003: Cairo University. Also it applies to all development, training, and improvement or other related activities containing
p.000003: a research and development component. Research is considered to be conducted under the auspices of Faculty of Medicine,
p.000003: Cairo University when it is supported financially or by in kind services of Faculty of Medicine, Cairo University, when
p.000003: the research will take place at Faculty of Medicine, Cairo University, when the research will involve participation by
p.000003: Faculty of Medicine, Cairo University employees, or when the use of a Faculty of Medicine, Cairo University affiliation
p.000003: is made in correspondence with research subjects or agreements with research sponsors.
p.000003: In accordance with system policy, all research activities within Faculty of Medicine, Cairo University, which involve
p.000003: human subjects, regardless of the level of risk foreseen, require IRB review and approval or exemption, prior to the
p.000003: initiation of the activity.
p.000003:
p.000003: Conflict of interest:
p.000003: The IRB will make sure of the independence of the committee from investigators and will exclude any member/s with a
p.000003: direct interest in a proposal from participating in its review and assessment.
p.000003:
p.000003: IRB meetings:
p.000003: Time:
p.000003: One of the four committees will meet regularly; once every week (every Thursday). If is happen to be a holiday then,
p.000003: IRB will meet next week.
p.000003: Dates and times of meetings will be advertised to help investigators to determine time to submit their proposals.
p.000003: Who could attend the meetings?
...
General/Other / Undue Influence
Searching for indicator undue influence:
(return to top)
p.000003: 1.3. Research design is appropriate, able to test the research hypothesis and study instruments are acceptable.
p.000003: 1.4. Adequacy of toxicological and pharmacological data for the drug or instrument to be used.
p.000003: 1.5. Training and experience of clinical staff.
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: 1.6. Adequacy of clinical research facilities at study site.
p.000004: 1.7. Benefit gain from research is outweighing expected risk by a considerable amount, according to IRB judgment.
p.000004: Such benefits should be sensed on both individual and society levels.
p.000004: 1.8. Necessary measures are taken to minimize any anticipated risks and boost benefits.
p.000004: 1.9. Selection of subjects is equitable, and there is a fair distribution of benefits and burdens at individual and
p.000004: society levels.
p.000004: 1.10. Appropriate safeguards to protect the rights and welfare of vulnerable subjects as children, women and prisoners.
p.000004: 1.11. Informed consent is sought in a written form from all research subjects, in language understandable to the
p.000004: subject and under conditions that minimize the possibility of coercion or undue influence.
p.000004: 1.12. Assurance that the budget for the project does not include undue inducement for subject participation, apart from
p.000004: legitimate compensation for travel and lost earnings.
p.000004: 1.13. Privacy of individuals and confidentiality of data is protected and maintained.
p.000004: 1.14. Any additional issues according to type, design and setting of the research.
p.000004: 2. Further review of any notification to IRB by researchers regarding changes in protocol, consent form, recruitment
p.000004: procedures or unanticipated adverse events to participants.
p.000004: 3. Follow-up, monitoring and continued review of approved research protocols to ensure compliance with approved
p.000004: protocols. This review would be annually for projects encountering minimal risks and every 6 months for projects with
p.000004: greater than minimal risks.
p.000004: 4. Supervising publication coming out of the project to ensure confidentiality is maintained.
p.000004:
p.000004: Types of reviews:
p.000004: Full Board Review
p.000004: Protocols are circulated to all Board members for review and comment. Issues of clarification often emerge during the
p.000004: review.
p.000004: Facilitated Review
p.000004: The review process is carried out as a full IRB review. Materials are assigned first to the Chair of the IRB who acts
p.000004: as the Primary Reviewer for the protocol. Protocols are also provided to all IRB members. Protocols are not presented
p.000004: at length to the IRB and/or discussed by the full committee unless there is concern voiced by a member of the IRB.
p.000004: Expedited Review
p.000004: The review is carried out by one member who informs other members with the approval decision. In case of disapproval,
...
General/Other / cioms guidelines
Searching for indicator cioms:
(return to top)
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: 1
p.000001:
p.000001: Introduction;
p.000001: It is the policy of Faculty of Medicine, Cairo University to respect and protect the rights and welfare of individuals.
p.000001: Institutional Review Boards (IRB) at Faculty of Medicine, Cairo University is an ethical committee established to
p.000001: protect the rights and welfare of human research subjects recruited to participate in research activities conducted
p.000001: under the auspices of the institution with which it is affiliated.
p.000001:
p.000001: Guidelines:
p.000001: In the conduct of research and/or actions of this institution is guided by the principles set forth in the
p.000001: international reports and guidelines named Helsinki Declaration and the International Ethical Guidelines For Biomedical
p.000001: Research Involving Human Subjects issued by the Council For International Organizations Of Medical Sciences (CIOMS).
p.000001: This committee will operates within the framework of the Egyptian policies and laws and the international guidelines
p.000001: will be explained and applied within the framework of the Egyptian laws.
p.000001:
p.000001: Construction of committee:
p.000001: The Faculty of Medicine, Cairo University Institutional Review Board (IRB) is a standing committee, constituted
p.000001: according to decision no for the year 2002 issued in 2002 by the Dean of Faculty of Medicine, Cairo
p.000001: University and the approval of the Faculty Council dated for the year 2002 and approval of the Cairo University
p.000001: Council dated 2003.
p.000001:
p.000001: Membership of the committee:
p.000001: The executive committee is formed of:
p.000001: 1. The Chair,
p.000001: 2. The Executive Director,
p.000001: 3. The Chairs of the Sub-Committees,
p.000001: 4. The Administrator.
p.000001:
p.000001: The Institutional Review Board (IRB) for Faculty of Medicine, Cairo University is comprised of 40 individuals to be
p.000001: divided over 4 subcommittees. The members are of varying medial specialties, disciplines, gender and expertise from the
p.000001: scientific and the non- scientific community.
p.000001: The responsibility for appointing the IRB Chair and some members of unique expertise rests with the Dean of Faculty of
p.000001: Medicine, Cairo University while the different departments will appoint the majority of the members in response to a
p.000001: written request from the IRB chair including the number of members to be appointed.
p.000001: Members of IRB are unpaid and they carry the job as part of the institutional commitment to Faculty of Medicine, Cairo
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: 1
p.000001:
p.000001: Introduction;
p.000001: It is the policy of Faculty of Medicine, Cairo University to respect and protect the rights and welfare of individuals.
p.000001: Institutional Review Boards (IRB) at Faculty of Medicine, Cairo University is an ethical committee established to
p.000001: protect the rights and welfare of human research subjects recruited to participate in research activities conducted
p.000001: under the auspices of the institution with which it is affiliated.
p.000001:
p.000001: Guidelines:
p.000001: In the conduct of research and/or actions of this institution is guided by the principles set forth in the
p.000001: international reports and guidelines named Helsinki Declaration and the International Ethical Guidelines For Biomedical
p.000001: Research Involving Human Subjects issued by the Council For International Organizations Of Medical Sciences (CIOMS).
p.000001: This committee will operates within the framework of the Egyptian policies and laws and the international guidelines
p.000001: will be explained and applied within the framework of the Egyptian laws.
p.000001:
p.000001: Construction of committee:
p.000001: The Faculty of Medicine, Cairo University Institutional Review Board (IRB) is a standing committee, constituted
p.000001: according to decision no for the year 2002 issued in 2002 by the Dean of Faculty of Medicine, Cairo
p.000001: University and the approval of the Faculty Council dated for the year 2002 and approval of the Cairo University
p.000001: Council dated 2003.
p.000001:
p.000001: Membership of the committee:
p.000001: The executive committee is formed of:
p.000001: 1. The Chair,
p.000001: 2. The Executive Director,
p.000001: 3. The Chairs of the Sub-Committees,
p.000001: 4. The Administrator.
p.000001:
p.000001: The Institutional Review Board (IRB) for Faculty of Medicine, Cairo University is comprised of 40 individuals to be
p.000001: divided over 4 subcommittees. The members are of varying medial specialties, disciplines, gender and expertise from the
p.000001: scientific and the non- scientific community.
p.000001: The responsibility for appointing the IRB Chair and some members of unique expertise rests with the Dean of Faculty of
p.000001: Medicine, Cairo University while the different departments will appoint the majority of the members in response to a
p.000001: written request from the IRB chair including the number of members to be appointed.
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| authority | Relationship to Authority |
| children | Child |
| cioms | cioms guidelines |
| drug | Drug Usage |
| education | education |
| employees | employees |
| gender | gender |
| helsinki | declaration of helsinki |
| job | Occupation |
| language | Linguistic Proficiency |
| minor | Youth/Minors |
| prisoners | Criminal Convictions |
| student | Student |
| undue influence | Undue Influence |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
coercion
consent
harm
justice
protect
risk
volunteer
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input