79C3C34C52B45572883A05D425EB0F82
Code of Ethics
https://dent.ksu.edu.sa/sites/dent.ksu.edu.sa/files/imce_images/code_of_ethics_compilation_nov_141-smh1.pdf
http://leaux.net/URLS/ConvertAPI Text Files/285728936C435108AA092A71DE4D2068.en.txt
Examining the file media/Synopses/285728936C435108AA092A71DE4D2068.html:
This file was generated: 2020-12-01 07:56:37
| 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.(None): 6.6 Types of Review
p.(None): 6.6.1 Minimal Risk.
p.(None): 6.6.2 Determining the Level of Review
p.(None): 6.6.2.1 Full Dental Ethical Board Review
p.(None): 6.6.2.2 Exempt from the full ethical board review
p.(None): 6.6.2.3 Expedited from the full ethical board review
p.(None): 6.8 Conflict of Interest
p.(None): 6.9 Informed Consent:
p.(None): 6.9.1 Re-consent
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.9.2 Waiver of consent
p.(None): 6.10 Submitting a Research Proposal
p.(None): 6.11 Electronic Submission of a Research proposal
p.(None): 6.12 Evaluation of submitted research proposals
p.(None): 6.13 Meeting Requirements
p.(None): 6.14 Decision-making
p.(None): 7.0 RESEARCH PARTICIPANTS REQUIRING ADDITIONAL ATTENTION
p.(None): 7.1 Research Involving Children and Adolescents
p.(None): 7.1.1 Approval of research involving children and adolescents
p.(None): 7.1.2 Consent for children or adolescents
p.(None): 7.2 Research involving pregnant women
p.(None): 7.3 Research involving a fetus
p.(None): 7.4 Research involving prisoners
p.(None): 7.4.1 Considerations regarding research involving prisoners
p.(None): 7.4.2 Approval of research involving prisoners
p.(None): 7.5 Research involving humans highly dependent on medical care
p.(None): 7.6 Other groups requiring additional attention
p.(None): 8.0 EPIDEMIOLOGICAL RESEARCH
p.(None): 9.0 HUMAN GENETIC RESEARCH
p.(None): 10.0 HUMAN TISSUE SAMPLES
p.(None): 11.0 REFERENCES
p.(None):
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p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 1.0 INTRODUCTION
p.(None): The College of Dentistry, King Saud University is the one of the dental colleges in the Kingdom of Saudi Arabia and
p.(None): the Gulf Countries that carries the responsibility of educating students, providing oral health services to the
p.(None): patients, conducting research and servicing the community. These responsibilities are conducted under the good ethical
p.(None): principles that guide the educational process in King Saud University.
p.(None):
p.(None): The Research Center within the College of Dentistry (CDRC) is the product of the University’s aspiration of bringing
p.(None): about a more research-oriented institution especially in the area of dentistry. Founded in 1981, its primary goal is
p.(None): the encouragement of viable research Potentials from among the dental professionals in the Kingdom. The Center
p.(None): realizes that this objective can be achieved by extending support to all kinds of research work and providing
p.(None): state-of-the- art equipment complemented by highly trained technical staff in all its laboratories. This report will
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p.(None): 1) The participant experiences no pain or physical danger.
p.(None): 2) The participant experiences no emotional arousal or psychological stress beyond the levels normally to be expected
p.(None): in everyday life.
p.(None): 3) The project neither includes nor attempts to induce long-term significant change in the participant's behavior
p.(None): (including attitude towards self and others).
p.(None): 4) The data would not embarrass or socially disadvantage the participant, were confidentiality to
p.(None): be violated.
p.(None): 5) If the investigator conceals information about specific purpose of the project, there is no reason to believe
p.(None): the subject would choose not to participate if he or she had known that information initially.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.7.2 Determining the Level of Review
p.(None): There are three levels of review for a research proposal depending on the risk expected to the human participating in
p.(None): the planned research. The three levels are:
p.(None): (1) Full Dental Ethical Board Review.
p.(None): (2) Exempt from the full dental ethical board review.
p.(None): (3) Expedited from the full dental ethical board review.
p.(None):
p.(None):
p.(None): 6.7.2.1 Full Dental Ethical Board Review
p.(None): Any protocol that uses a methodology that is sensitive and of higher probability for causing harm or
p.(None): distress to participants is subject to full board review. Additionally, any protocol using prisoners as
p.(None): participants or involving pregnant women, fetuses, and human in vitro fertilization will be reviewed by
p.(None): the full board. Research in which the risks versus the expected benefits are relatively high is also likely to be
p.(None): reviewed by the full board.
p.(None): Dental research proposals that require full dental ethical board review included, but are not necessarily limited to
p.(None): the following:
p.(None): 1) Clinical trials involving human participants
p.(None): 2) New treatments or interventions
p.(None): 3) Research involving human remains, cadavers, tissues, discarded tissue (e.g. placenta), biological
p.(None): fluids
p.(None): 4) Physiological studies
p.(None): 5) Comparing an established procedure, whether therapeutic, non-therapeutic or diagnostic, with other
p.(None): procedures which are not recognized as established by virtue of their recent development, discovery or use in a new or
p.(None): unfamiliar way
p.(None): 6) Innovative practices in health and disability services
p.(None): 7) Research conducted by students, which includes all activities that meet the definition of
p.(None): research with human participants (As supervised student research is conducted primarily for the purpose of
p.(None): educating students on research techniques and methodologies, DERB should review research protocols with
p.(None): a view to
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
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p.(None): may waive the requirement for informed consent in the following instances:
p.(None): a) When it is impractical to conduct research since confidentiality of personally identifiable
p.(None): information has to be maintained throughout the research.
p.(None): b) Research on publicly available information, documents, records, works, performances,
p.(None): reviews, quality assurance studies, archival materials or third party interviews, service programs for benefit
p.(None): of public having a bearing on public health programs, and consumer acceptance studies.
p.(None): c) Research on anonymised biological samples from left over samples after clinical investigation.
p.(None): d) In emergency situations when informed consent can be taken. Do you mean cannot be taken? (yes cannot, but I think
p.(None): we need to define the emergency situations)
p.(None):
p.(None): 7.0 Research Participants Requiring Additional Attention
p.(None): Humans with limited autonomy or in subordinate positions are considered participants that require additional
p.(None): attention and are in need of greater protection. These may include children, pregnant women and fetus, prisoners, and
p.(None): human highly dependent on medical care. Does this cover mentally impaired people?
p.(None):
p.(None): 7.1 Research involving children, adolescents and mentally impaired people
p.(None): Dental treatment and research on children, adolescents and mentally impaired person is part of the dental
p.(None): discipline. A child is a person who has not yet reached puberty
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): whereas an adolescent is a person who is reaching or has reached puberty. Mentally impaired person is a
p.(None): person who has impairment of intelligence and social functioning which appears to be permanent or temporary. Children,
p.(None): adolescents and mentally impaired person are considered participants who require additional attention because
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p.(None): be secured if the research has any risk to the fetus.
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None):
p.(None): 7.3 Research involving a fetus
p.(None): Dental research usually do not involve fetuses as participants, however, in research involve investigations on the
p.(None): craniofacial malformations such as cleft lip and palate the dental researcher may be involved as a member of a larger
p.(None): research group including medical researchers. The dental researcher must abide by the ethical codes and the regulatory
p.(None): procedures of the medical research team.
p.(None): The policy of the Research Center College of Dentistry for the dental research involving fetus is that; no fetus in
p.(None): utero may be involved as a participant in any dental research activity. The inclusion of any member of the college of
p.(None): dentistry in research activity involving fetuses as a member of larger team must be approved by the DERB. The approval
p.(None): of the DERB must be granted before the member start any research activity within the research team.
p.(None):
p.(None): 7.4 Research involving Prisoners
p.(None): A Prisoner is an individual involuntarily confined in a penal institution, including persons:
p.(None): (1) sentenced under a criminal or civil statute; (2) detained pending arraignment, trial, or sentencing; and (3)
p.(None): detained in other facilities such as treatment of addiction. The condition of imprisonment may make it difficult to
p.(None): ensure voluntary consent and confidentiality. There is a need for special consideration to provide protection to
p.(None): prisoner participating in research. The college of dentistry research center policy requires that all dental research
p.(None): involving prisoners should be reviewed by the full board.
p.(None):
p.(None): 7.4.1 Considerations regarding research involving prisoners
p.(None): The DERB will approve research proposals involving prisoners if:
p.(None): 1. Research will probably improve oral health or well‐being of the prisoners.
p.(None): 2. Minimal risk and no more than inconvenience caused and the research is a study of causes and effects.
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 3. Minimal risk and no more than inconvenience caused and research is a study of prisons as institutional structures
p.(None): or of prisoners as incarcerated persons.
p.(None): 4. Research on conditions affecting prisoners as a class.
p.(None):
p.(None):
p.(None): 7.4.2 Approval of research involving prisoners
p.(None): 1) Advantages through participation compared to their current situation.
p.(None): 2) Risk of participation is the same as those that would be accepted by non‐prisoners.
p.(None): 3) Procedure of selection is fair to all prisoners.
p.(None): 4) Language for obtaining informed consent must be understandable to prisoners.
p.(None): 5) When studies need follow‐up, the provision for follow‐up must include a consideration of the length of individual
p.(None): sentences, and prisoners must be informed about follow‐up.
p.(None):
p.(None): 7.5 Research involving humans highly dependent on medical care
p.(None): Dental research on humans who are highly dependent on medical care raises ethical issues that deserve special
p.(None): attention. Researchers need to acknowledge that informed consent may be compromised by the effect of the medical
p.(None): condition or fear of affecting the level of medical care in case of refusal to participate. The following conditions
p.(None): are considered for possible dental research activities.
p.(None): 1. Research activities on humans under emergency care
p.(None): 2. Research activities on humans in the intensive care unit
p.(None): 3. Research activities on neonatals in the intensive care unit
p.(None): 4. Research activities on humans in the terminal care unit
p.(None): 5. Research activities on decisionally impaired humans
p.(None): 6. Research activities on unconscious human
p.(None): The policy of the college of dentistry research center is that; no dental research should be carried out on the above
p.(None): mentioned conditions. However, The DERB, within its authority can approve dental research in the following conditions;
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): • The research is based on valid scientific hypotheses which support a reasonable possibility of benefit over
p.(None): standard care.
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Political / criminal
Searching for indicator criminal:
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p.(None): the protocol of the approved proposal must be re-submitted to the DERB chairman to determine further
p.(None): exempt status. The dental researcher must submit to the DERB secretary the full documentations required
p.(None): for the review by the DERB, including the research proposal, informed consent and the CV’s of the investigators.
p.(None):
p.(None): To determine exempt status, the research must qualify as one or more of the categories listed below. To qualify for a
p.(None): category, the research must meet all of the conditions of that category.
p.(None):
p.(None): 1. Research conducted in established or commonly accepted educational settings involving normal educational
p.(None): practices such as (a) regular and special education
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
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p.(None): instructional strategies, or (b) research on the effectiveness of or the comparison among instructional
p.(None): techniques, curricula, or classroom management methods.
p.(None): 2. Research involving use of educational tests, survey or interview procedures, or observation of public
p.(None): behavior unless information obtained from these sources is recorded in such a manner that subjects can
p.(None): be identified, and disclosure of the subject’s responses outside the research could reasonably place the subject
p.(None): at risk of criminal or civil liability or be damaging to his or her financial standing,
p.(None): employability, or reputation.
p.(None): 3. Research involving the use of education tests, survey procedures, interview procedures, or observation of
p.(None): public behavior if (a) the human subjects are elected or appointed public officials or candidates for
p.(None): public office; or (b) federal statutes require, without exception, that the confidentiality of the
p.(None): personally identifiable information will be maintained throughout the research and thereafter. Children may
p.(None): not be involved in this research.
p.(None): 4. Research involving the collection or study of existing data, documents, records, pathological
p.(None): specimens, or diagnostic specimens, (a) if these sources are publicly available, or (b) if the information is
p.(None): recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers
p.(None): linked to the subjects.
p.(None): 5. Research and demonstration projects that are designed to study, evaluate, or otherwise examine (a) public benefit
p.(None): or service programs; (b) procedures for obtaining benefits or services under these programs; (c) possible changes or
p.(None): alternatives to those programs or procedures; or (d) possible changes in methods or levels of payments for benefits or
p.(None): services under those programs.
p.(None): 6. Tests and food quality evaluation and consumer studies (a) if wholesome food without additives is consumed, or (b)
p.(None): if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or
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p.(None): chairman. Like the exempt review, the research must be of minimal risk or no more than minimal risk and all aspects of
p.(None): a protocol must fit within one or more expedited categories to be reviewed in this manner. The dental researcher must
p.(None): submit to the DERB secretary the full documentations required for the review by the DERB, including the
p.(None): research proposal, informed consent and the CV’s of the investigators.
p.(None):
p.(None): An expedited review process is available for research activities that present no more than minimal risk to
p.(None): human participants or that request a minor change in previously approved research that involves no additional risk and
p.(None): that involve only procedures in one or more of the categories listed below. Some of the categories overlap with those
p.(None): used to assess exempt status. The distinction between exempt and expedited review is based on the sensitivity of the
p.(None): data and/or the risk of compromised confidentiality (such as a relatively small sample size).
p.(None):
p.(None): The expedited review procedure may not be used where identification of the subjects and/or their responses would
p.(None): reasonably place them at risk of criminal or civil liability or be damaging to the subject’s financial standing,
p.(None): employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be
p.(None): implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
p.(None): Furthermore, the expedited review procedure may not be used for classified research involving human
p.(None): participants.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): To determine expedited status, the research must qualify as one or more of the categories listed below.
p.(None): To qualify for a category, the research must meet all of the conditions of that category.
p.(None):
p.(None): 1. Clinical studies of drugs and medical devices. (a) Research on drugs where the application for
p.(None): investigation of new drug is not required. (b) Research on medical devices where; (i) the application
p.(None): for investigation of new medical device is not required, (ii) the medical device is cleared/approved for
p.(None): marketing. Examples: Review of dental implant results to assess for indicators of successful outcome.
p.(None): 2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture. Example: (i)
p.(None): Measurement of CRP levels before and after treatment for gingivitis. Requires 10 mL of blood drawn twice over
p.(None): a 3-month period.
p.(None): 3. Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a)
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p.(None): be secured if the research has any risk to the fetus.
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None):
p.(None): 7.3 Research involving a fetus
p.(None): Dental research usually do not involve fetuses as participants, however, in research involve investigations on the
p.(None): craniofacial malformations such as cleft lip and palate the dental researcher may be involved as a member of a larger
p.(None): research group including medical researchers. The dental researcher must abide by the ethical codes and the regulatory
p.(None): procedures of the medical research team.
p.(None): The policy of the Research Center College of Dentistry for the dental research involving fetus is that; no fetus in
p.(None): utero may be involved as a participant in any dental research activity. The inclusion of any member of the college of
p.(None): dentistry in research activity involving fetuses as a member of larger team must be approved by the DERB. The approval
p.(None): of the DERB must be granted before the member start any research activity within the research team.
p.(None):
p.(None): 7.4 Research involving Prisoners
p.(None): A Prisoner is an individual involuntarily confined in a penal institution, including persons:
p.(None): (1) sentenced under a criminal or civil statute; (2) detained pending arraignment, trial, or sentencing; and (3)
p.(None): detained in other facilities such as treatment of addiction. The condition of imprisonment may make it difficult to
p.(None): ensure voluntary consent and confidentiality. There is a need for special consideration to provide protection to
p.(None): prisoner participating in research. The college of dentistry research center policy requires that all dental research
p.(None): involving prisoners should be reviewed by the full board.
p.(None):
p.(None): 7.4.1 Considerations regarding research involving prisoners
p.(None): The DERB will approve research proposals involving prisoners if:
p.(None): 1. Research will probably improve oral health or well‐being of the prisoners.
p.(None): 2. Minimal risk and no more than inconvenience caused and the research is a study of causes and effects.
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 3. Minimal risk and no more than inconvenience caused and research is a study of prisons as institutional structures
p.(None): or of prisoners as incarcerated persons.
...
Political / person in detention center
Searching for indicator detained:
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p.(None): be secured if the research has any risk to the fetus.
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None):
p.(None): 7.3 Research involving a fetus
p.(None): Dental research usually do not involve fetuses as participants, however, in research involve investigations on the
p.(None): craniofacial malformations such as cleft lip and palate the dental researcher may be involved as a member of a larger
p.(None): research group including medical researchers. The dental researcher must abide by the ethical codes and the regulatory
p.(None): procedures of the medical research team.
p.(None): The policy of the Research Center College of Dentistry for the dental research involving fetus is that; no fetus in
p.(None): utero may be involved as a participant in any dental research activity. The inclusion of any member of the college of
p.(None): dentistry in research activity involving fetuses as a member of larger team must be approved by the DERB. The approval
p.(None): of the DERB must be granted before the member start any research activity within the research team.
p.(None):
p.(None): 7.4 Research involving Prisoners
p.(None): A Prisoner is an individual involuntarily confined in a penal institution, including persons:
p.(None): (1) sentenced under a criminal or civil statute; (2) detained pending arraignment, trial, or sentencing; and (3)
p.(None): detained in other facilities such as treatment of addiction. The condition of imprisonment may make it difficult to
p.(None): ensure voluntary consent and confidentiality. There is a need for special consideration to provide protection to
p.(None): prisoner participating in research. The college of dentistry research center policy requires that all dental research
p.(None): involving prisoners should be reviewed by the full board.
p.(None):
p.(None): 7.4.1 Considerations regarding research involving prisoners
p.(None): The DERB will approve research proposals involving prisoners if:
p.(None): 1. Research will probably improve oral health or well‐being of the prisoners.
p.(None): 2. Minimal risk and no more than inconvenience caused and the research is a study of causes and effects.
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 3. Minimal risk and no more than inconvenience caused and research is a study of prisons as institutional structures
p.(None): or of prisoners as incarcerated persons.
p.(None): 4. Research on conditions affecting prisoners as a class.
p.(None):
p.(None):
p.(None): 7.4.2 Approval of research involving prisoners
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Political / political affiliation
Searching for indicator party:
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p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): The Dean of the College of Dentistry, King Saud University is responsible for establishing the Dental
p.(None): Ethics Review Board (DERB) to review, approve and monitor research that involves human participants. The DERB
p.(None): consists of a chairman and members from the different specialties within the College of Dentistry.
p.(None):
p.(None): 6.5 Authorities of the Dental Ethics Review Board (DERB)
p.(None): DERB has the obligation to ensure that dental research is designed and conducted in such a manner that the rights and
p.(None): welfare of participating human subjects is well protected. The authorities of the DERB are the following:
p.(None): • Determination of the level of review required for the presented research proposal. This is, the
p.(None): authority of the DERB chairman.
p.(None): • Review, approve, and request modifications of a research proposal
p.(None): • Restrict or omit steps or parts of a research proposal for participants’ protection.
p.(None): • Follow-up of the approved research by conducting continuing ethical review for ongoing research at an
p.(None): appropriate interval.
p.(None): • Inspect research facilities, equipment, and data and other relevant information relating to
p.(None): the use of human participants in dental research
p.(None): • Observe or have a third party observe the informed consent process.
p.(None): • Suspend or terminate previously approved research that is not being conducted in accordance
p.(None): with the DERB’s required standards
p.(None): • Suspend or terminate previously approved research that is associated with unexpected serious harm to
p.(None): participants.
p.(None): • Review, accept, and/or reject reports, including but not limited to reports of serious adverse events
p.(None): and unanticipated problems involving risks to subjects and others.
p.(None): • Disapprove a research proposal that is expected to cause serious harm to participants.
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): • Approve the inclusion of the college member in other research teams within or outside the premises of King
p.(None): Saud University.
p.(None): • Research that has been reviewed and approved by the DERB may be subject to disapproval by King Saud
p.(None): University officials or higher authorities.
p.(None): • King Saud University officials may not authorize or approve the conduct of dental research involving human
p.(None): participants that has not been approved by the DERB.
p.(None): • Research approved by the DERB may be subject, if requested by King Saud University officials or higher
p.(None): authorities, to further review and approval or disapproval by officials of the institution.
p.(None): • Members are expected to treat as confidential all applications, meeting deliberations, information
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p.(None): 6) Before publication if there is possibility of disclosure of identity through data presentation or
p.(None): photographs that should be camouflaged adequately.
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.9.2 Waiver of consent
p.(None): Voluntary informed consent is a requirement for any research proposal that involves human participation.
p.(None): However, there are situations when the requirements for informed consent can be waived. If it is
p.(None): justified that the research involves not more than minimal risk or when the participant and the researcher do not
p.(None): come into contact or when it is necessitated in emergency situations. If such studies have the appropriate protection
p.(None): for both privacy and confidentiality, and do not violate the rights of the participants then the DERB
p.(None): may waive the requirement for informed consent in the following instances:
p.(None): a) When it is impractical to conduct research since confidentiality of personally identifiable
p.(None): information has to be maintained throughout the research.
p.(None): b) Research on publicly available information, documents, records, works, performances,
p.(None): reviews, quality assurance studies, archival materials or third party interviews, service programs for benefit
p.(None): of public having a bearing on public health programs, and consumer acceptance studies.
p.(None): c) Research on anonymised biological samples from left over samples after clinical investigation.
p.(None): d) In emergency situations when informed consent can be taken. Do you mean cannot be taken? (yes cannot, but I think
p.(None): we need to define the emergency situations)
p.(None):
p.(None): 7.0 Research Participants Requiring Additional Attention
p.(None): Humans with limited autonomy or in subordinate positions are considered participants that require additional
p.(None): attention and are in need of greater protection. These may include children, pregnant women and fetus, prisoners, and
p.(None): human highly dependent on medical care. Does this cover mentally impaired people?
p.(None):
p.(None): 7.1 Research involving children, adolescents and mentally impaired people
...
Political / vulnerable
Searching for indicator vulnerable:
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p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.3 Code of ethics in Dental Research Involving Human Participants
p.(None): The codes of ethics in Dental Research Involving Human Participants are in addition to the general code of ethics in
p.(None): dental research stated in part 4.2, they are applicable but not limited to dental research conducted by
p.(None): students, interns, academic or clinical staff, or affiliated researcher of the College of Dentistry, King
p.(None): Saud University. This is true regardless of the location where the research is conducted. The codes of ethics in
p.(None): dental research involving humans are:
p.(None): 1) Respect for persons incorporates at least two fundamental ethical considerations, namely:
p.(None): a. Respect for autonomy which requires that those who are capable of self- determination about their choices
p.(None): should be treated with respect for their capacity of self-determination.
p.(None): b. Protection of persons with impaired or diminished autonomy, which requires that those who are dependent or
p.(None): vulnerable be afforded full security against harm or abuse.
p.(None): 2) Beneficence and non-maleficence refers to the ethical obligation to maximize benefits and to minimize harms.
p.(None): This gives rise to norms requiring the risks of research to be reasonable in the light of the expected benefits, that
p.(None): the research design be sound, and that the investigators be competent to conduct the research and to safeguard the
p.(None): welfare of the research subjects.
p.(None): 3) Justice refers to the ethical obligation to treat each person in accordance with what is morally right and
p.(None): proper; to give each person what is due to him or her. In the ethics of research involving human participants, the
p.(None): principle refers primarily to distributive justice, which requires equitable distribution of both the burdens and the
p.(None): benefits of participation in research.
p.(None):
p.(None):
p.(None):
p.(None): 6.4 Establishment of the Dental Ethics Review Board (DERB)
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): The Dean of the College of Dentistry, King Saud University is responsible for establishing the Dental
p.(None): Ethics Review Board (DERB) to review, approve and monitor research that involves human participants. The DERB
...
Health / Cadavers
Searching for indicator cadavers:
(return to top)
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.7.2 Determining the Level of Review
p.(None): There are three levels of review for a research proposal depending on the risk expected to the human participating in
p.(None): the planned research. The three levels are:
p.(None): (1) Full Dental Ethical Board Review.
p.(None): (2) Exempt from the full dental ethical board review.
p.(None): (3) Expedited from the full dental ethical board review.
p.(None):
p.(None):
p.(None): 6.7.2.1 Full Dental Ethical Board Review
p.(None): Any protocol that uses a methodology that is sensitive and of higher probability for causing harm or
p.(None): distress to participants is subject to full board review. Additionally, any protocol using prisoners as
p.(None): participants or involving pregnant women, fetuses, and human in vitro fertilization will be reviewed by
p.(None): the full board. Research in which the risks versus the expected benefits are relatively high is also likely to be
p.(None): reviewed by the full board.
p.(None): Dental research proposals that require full dental ethical board review included, but are not necessarily limited to
p.(None): the following:
p.(None): 1) Clinical trials involving human participants
p.(None): 2) New treatments or interventions
p.(None): 3) Research involving human remains, cadavers, tissues, discarded tissue (e.g. placenta), biological
p.(None): fluids
p.(None): 4) Physiological studies
p.(None): 5) Comparing an established procedure, whether therapeutic, non-therapeutic or diagnostic, with other
p.(None): procedures which are not recognized as established by virtue of their recent development, discovery or use in a new or
p.(None): unfamiliar way
p.(None): 6) Innovative practices in health and disability services
p.(None): 7) Research conducted by students, which includes all activities that meet the definition of
p.(None): research with human participants (As supervised student research is conducted primarily for the purpose of
p.(None): educating students on research techniques and methodologies, DERB should review research protocols with
p.(None): a view to
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): contributing to the students’ education concerning scientific and ethical principles governing research).
p.(None): 8) Observational clinical research
p.(None): 9) Access to personal information by means of questionnaires, interviews or other techniques of information
p.(None): gathering
p.(None): 10) Research involving the secondary use of data (use of data not collected for that research purpose), if
p.(None): any form of identifier is involved and/or if health information pertaining to individuals is involved
p.(None): 11) Case studies, when a series of subject observations allow possible extrapolation of generalization of the
...
Health / Cognitive Impairment
Searching for indicator impaired:
(return to top)
p.(None): rights of research participants, and reflect the basic ethical values of respect, beneficence and justice for human.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.3 Code of ethics in Dental Research Involving Human Participants
p.(None): The codes of ethics in Dental Research Involving Human Participants are in addition to the general code of ethics in
p.(None): dental research stated in part 4.2, they are applicable but not limited to dental research conducted by
p.(None): students, interns, academic or clinical staff, or affiliated researcher of the College of Dentistry, King
p.(None): Saud University. This is true regardless of the location where the research is conducted. The codes of ethics in
p.(None): dental research involving humans are:
p.(None): 1) Respect for persons incorporates at least two fundamental ethical considerations, namely:
p.(None): a. Respect for autonomy which requires that those who are capable of self- determination about their choices
p.(None): should be treated with respect for their capacity of self-determination.
p.(None): b. Protection of persons with impaired or diminished autonomy, which requires that those who are dependent or
p.(None): vulnerable be afforded full security against harm or abuse.
p.(None): 2) Beneficence and non-maleficence refers to the ethical obligation to maximize benefits and to minimize harms.
p.(None): This gives rise to norms requiring the risks of research to be reasonable in the light of the expected benefits, that
p.(None): the research design be sound, and that the investigators be competent to conduct the research and to safeguard the
p.(None): welfare of the research subjects.
p.(None): 3) Justice refers to the ethical obligation to treat each person in accordance with what is morally right and
p.(None): proper; to give each person what is due to him or her. In the ethics of research involving human participants, the
p.(None): principle refers primarily to distributive justice, which requires equitable distribution of both the burdens and the
p.(None): benefits of participation in research.
p.(None):
p.(None):
p.(None):
p.(None): 6.4 Establishment of the Dental Ethics Review Board (DERB)
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
...
p.(None): information has to be maintained throughout the research.
p.(None): b) Research on publicly available information, documents, records, works, performances,
p.(None): reviews, quality assurance studies, archival materials or third party interviews, service programs for benefit
p.(None): of public having a bearing on public health programs, and consumer acceptance studies.
p.(None): c) Research on anonymised biological samples from left over samples after clinical investigation.
p.(None): d) In emergency situations when informed consent can be taken. Do you mean cannot be taken? (yes cannot, but I think
p.(None): we need to define the emergency situations)
p.(None):
p.(None): 7.0 Research Participants Requiring Additional Attention
p.(None): Humans with limited autonomy or in subordinate positions are considered participants that require additional
p.(None): attention and are in need of greater protection. These may include children, pregnant women and fetus, prisoners, and
p.(None): human highly dependent on medical care. Does this cover mentally impaired people?
p.(None):
p.(None): 7.1 Research involving children, adolescents and mentally impaired people
p.(None): Dental treatment and research on children, adolescents and mentally impaired person is part of the dental
p.(None): discipline. A child is a person who has not yet reached puberty
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): whereas an adolescent is a person who is reaching or has reached puberty. Mentally impaired person is a
p.(None): person who has impairment of intelligence and social functioning which appears to be permanent or temporary. Children,
p.(None): adolescents and mentally impaired person are considered participants who require additional attention because
p.(None): of their limited intellectual and emotional capacities. They cannot give a legal consent; therefore
p.(None): permission from the parent(s) is essential. Children, adolescents and mentally impaired person should
p.(None): participate in research only where their participation is indispensable to the research and where participation is
p.(None): not contrary to the individual's best interests. The research proposal must provide sufficient
p.(None): information to justify clearly why children, adolescents or mentally impaired person should be included
p.(None): as participants. Refusal of a child, adolescent or mentally impaired person to participate in the research must be
p.(None): respected.
p.(None):
p.(None): 7.1.1 Approval of research involving children and adolescents
p.(None): Research involving a child, adolescent or mentally impaired person should be approved only if:
p.(None): 1) The research, including observational research, places the child , adolescent or mentally impaired person at no
p.(None): more than minimal risk (that is, the risk commensurate with daily life or routine dental examinations – referred to as
p.(None): 'negligible risk' in some guidelines).
p.(None): 2) The research involves more than minimal risk but provides possible benefit for the child, adolescent or mentally
p.(None): impaired person participant. The degree of risk must be justified by the potential benefit.
p.(None): 3) The research involves greater than minimal risk, with no prospect of direct benefit to the child, adolescent or
p.(None): mentally impaired person, but has a high probability of providing significant knowledge. The risk should be justified
p.(None): by the risk-knowledge ratio and the risk must represent no more than a minor increase over minimal risk.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 7.1.2 Consent for children or adolescents
p.(None): Consent for children, adolescents or mentally impaired person to participate in research must be obtained from:
p.(None): a) The parents or legal guardian in all but exceptional circumstances such as emergencies.
p.(None): b) The child or adolescent that is competent to make the decision.
p.(None): c) Any organization or person required by authorization.
p.(None): d) No other caregiver can act on behalf of a child in providing consent to participate.
p.(None):
p.(None):
p.(None): 7.2 Research involving pregnant women
p.(None): The DERB must give extra attention to research that involves pregnant women or those who may become pregnant, because
p.(None): of the additional health concerns during pregnancy and the need to avoid unnecessary risk to the fetus. The policy of
p.(None): the college of dentistry research center is that; no pregnant woman may be involved as a participant in any dental
p.(None): research activity unless:
p.(None): • The purpose of the research is to meet the health needs of the mother and the fetus will be placed at no
p.(None): risk, or
...
Searching for indicator impairment:
(return to top)
p.(None): human highly dependent on medical care. Does this cover mentally impaired people?
p.(None):
p.(None): 7.1 Research involving children, adolescents and mentally impaired people
p.(None): Dental treatment and research on children, adolescents and mentally impaired person is part of the dental
p.(None): discipline. A child is a person who has not yet reached puberty
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): whereas an adolescent is a person who is reaching or has reached puberty. Mentally impaired person is a
p.(None): person who has impairment of intelligence and social functioning which appears to be permanent or temporary. Children,
p.(None): adolescents and mentally impaired person are considered participants who require additional attention because
p.(None): of their limited intellectual and emotional capacities. They cannot give a legal consent; therefore
p.(None): permission from the parent(s) is essential. Children, adolescents and mentally impaired person should
p.(None): participate in research only where their participation is indispensable to the research and where participation is
p.(None): not contrary to the individual's best interests. The research proposal must provide sufficient
p.(None): information to justify clearly why children, adolescents or mentally impaired person should be included
...
Health / Comatose
Searching for indicator comatose:
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p.(None): are considered for possible dental research activities.
p.(None): 1. Research activities on humans under emergency care
p.(None): 2. Research activities on humans in the intensive care unit
p.(None): 3. Research activities on neonatals in the intensive care unit
p.(None): 4. Research activities on humans in the terminal care unit
p.(None): 5. Research activities on decisionally impaired humans
p.(None): 6. Research activities on unconscious human
p.(None): The policy of the college of dentistry research center is that; no dental research should be carried out on the above
p.(None): mentioned conditions. However, The DERB, within its authority can approve dental research in the following conditions;
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): • The research is based on valid scientific hypotheses which support a reasonable possibility of benefit over
p.(None): standard care.
p.(None): • The research is intended to be therapeutic and the research intervention poses no more than a risk that is
p.(None): expected in alternative methods of treatment.
p.(None):
p.(None): 7.6 Other groups requiring additional attention
p.(None): The discussion of the dental research participants requiring additional attention should not be limited to those
p.(None): already mentioned. Other groups that require additional attention include: traumatized and comatose patients,
p.(None): terminally ill patients, elderly or aged patients, minorities, students, and employees. The DERB must ensure that
p.(None): special consideration is given to all these groups, especially with regard to the risks, benefits and obtaining
p.(None): informed consent.
p.(None):
p.(None): 8.0 EPIDEMIOLOGICAL RESEARCH
p.(None):
p.(None): Epidemiological research describes the health status in a population or subgroup of the population. Epidemiological
p.(None): research studies the distribution and determinants of health related problems in populations, and the application of
p.(None): the research results to prevent, control or eliminate such health problems. It is concerned with improvement of the
p.(None): health status and welfare in human populations and with the improvement in the efficiency and performance of health
p.(None): services. Epidemiological research is carried out with human participants, or data or biological samples from them,
p.(None): and such research provides important new knowledge that is not readily obtainable in other ways. Perhaps the second
p.(None): most significant dental discoveries, after local anesthesia, were the effects of naturally occurring fluoride on
p.(None): reducing the incidence of dental caries as revealed by epidemiological research. Such epidemiological studies provided
p.(None): the motive for several clinical and laboratory research studies on the relationships between fluoride and dental
p.(None): caries. The findings from these researches laid the ground for the current understanding of the relationship between
...
Health / Drug Usage
Searching for indicator drug:
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p.(None): occur to the human resulted from
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): participating in the planned dental research. The probability of risk may vary from no or minimal risk to significant.
p.(None):
p.(None): 6.7.1 Minimal Risk
p.(None): Minimal risk is defined as follows: "The probability and magnitude of harm or discomfort
p.(None): anticipated in the research are not greater than those ordinarily encountered in daily life or during
p.(None): the performance of routine physical or psychological examinations or tests." For example, the risk of bleeding
p.(None): during the examination of gingival pocket depth in a healthy human participating in dental research is not greater
p.(None): than the risk of bleeding in a routine gingival examination of a healthy human. The risks of psychological, social,
p.(None): or economic harm are difficult to assess in dental research. However, unethical breaches of confidentiality
p.(None): such as HIV infection status or drug and alcohol intake can place the human participating in dental research
p.(None): at the risk of damage to their employability, or reputation. Many risks can be minimized considerably with careful
p.(None): planning.
p.(None):
p.(None): In broad terms, a project involves minimal risk if:
p.(None): 1) The participant experiences no pain or physical danger.
p.(None): 2) The participant experiences no emotional arousal or psychological stress beyond the levels normally to be expected
p.(None): in everyday life.
p.(None): 3) The project neither includes nor attempts to induce long-term significant change in the participant's behavior
p.(None): (including attitude towards self and others).
p.(None): 4) The data would not embarrass or socially disadvantage the participant, were confidentiality to
p.(None): be violated.
p.(None): 5) If the investigator conceals information about specific purpose of the project, there is no reason to believe
p.(None): the subject would choose not to participate if he or she had known that information initially.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.7.2 Determining the Level of Review
p.(None): There are three levels of review for a research proposal depending on the risk expected to the human participating in
p.(None): the planned research. The three levels are:
p.(None): (1) Full Dental Ethical Board Review.
p.(None): (2) Exempt from the full dental ethical board review.
p.(None): (3) Expedited from the full dental ethical board review.
p.(None):
p.(None):
p.(None): 6.7.2.1 Full Dental Ethical Board Review
...
p.(None): that involve only procedures in one or more of the categories listed below. Some of the categories overlap with those
p.(None): used to assess exempt status. The distinction between exempt and expedited review is based on the sensitivity of the
p.(None): data and/or the risk of compromised confidentiality (such as a relatively small sample size).
p.(None):
p.(None): The expedited review procedure may not be used where identification of the subjects and/or their responses would
p.(None): reasonably place them at risk of criminal or civil liability or be damaging to the subject’s financial standing,
p.(None): employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be
p.(None): implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
p.(None): Furthermore, the expedited review procedure may not be used for classified research involving human
p.(None): participants.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): To determine expedited status, the research must qualify as one or more of the categories listed below.
p.(None): To qualify for a category, the research must meet all of the conditions of that category.
p.(None):
p.(None): 1. Clinical studies of drugs and medical devices. (a) Research on drugs where the application for
p.(None): investigation of new drug is not required. (b) Research on medical devices where; (i) the application
p.(None): for investigation of new medical device is not required, (ii) the medical device is cleared/approved for
p.(None): marketing. Examples: Review of dental implant results to assess for indicators of successful outcome.
p.(None): 2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture. Example: (i)
p.(None): Measurement of CRP levels before and after treatment for gingivitis. Requires 10 mL of blood drawn twice over
p.(None): a 3-month period.
p.(None): 3. Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a)
p.(None): deciduous and permanent teeth if routine patient care indicates a need for extraction; (b)
p.(None): uncannulated saliva collected either in an un- stimulated fashion or stimulated by chewing gum base or wax or by
p.(None): applying a dilute citric solution to the tongue; (c) supra- and sub-gingival dental plaque and calculus, provided the
p.(None): collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process
p.(None): is accomplished in accordance with accepted prophylactic techniques; (d) mucosal and skin cells collected by
p.(None): buccal scraping or swab, skin swab, or mouth washings; (e) sputum collected after saline mist
p.(None): nebulization.
p.(None): 4. Collection of data through noninvasive procedures routinely employed in dental clinical practice,
p.(None): excluding procedures involving x-rays. The medical/dental devices employed must be cleared/approved
p.(None): for marketing. Example: Analysis of measurements of blood pressure and heart rate using an automated blood
...
p.(None): will be collected solely for non-research purposes. Example: (i) Prospective review of dental records
p.(None): to determine the outcome of standard treatment of oral ulcers in HIV-positive patients. (ii) Review of
p.(None): medical records and pathology samples of patients with parotid tumors to determine predictors of malignancy.
p.(None): 6. Collection of data from voice, video, digital, or image recordings made for research purposes.
p.(None): 7. Research on individual or group characteristics or behavior employing survey, interview, oral history,
p.(None): focus group, program evaluation, human factors evaluation, or quality assurance methodologies. Examples: (i) Survey of
p.(None): children in a Headstart program to determine knowledge about dental care. (ii) Focus group of multiple
p.(None): ethnic groups to determine attitudes and practices about oral health.
p.(None): 8. Continuing review of research previously approved by the full DERB review as follows: (a) where (i) the
p.(None): research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related
p.(None): interventions; and (iii) the research remains active only for long-term follow-up of subjects; or (b) where no subjects
p.(None): have been enrolled and no additional risks have been identified; or (c) where the remaining research
p.(None): activities are limited to data analysis.
p.(None): 9. Continuing review of research, not conducted under an investigational new drug application or
p.(None): investigational device exemption where categories two (2) through eight (8) do not apply but the DERB has
p.(None): determined and documented at a convened meeting that the research involves no greater than minimal risk and no
p.(None): additional risks have been identified.
p.(None):
p.(None): 6.8 Conflict of Interest
p.(None): Dental researchers hold trustful relationships with research participants, research sponsors, their
p.(None): institution, professional bodies and society. This trust can be put at risk by a conflict of interest that
p.(None): influences their independent and objective judgment.
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): Conflict of Interest is when the professional judgment concerning research is influenced by a secondary interest such
p.(None): as personal or financial gain. The dental researchers and DERB members should disclose any actual, perceived or
p.(None): potential conflicts of interest to the DERB. The DERB should develop mechanisms to address and manage such conflicts of
p.(None): interest.
p.(None):
p.(None): 6.9 Informed Consent
p.(None): Informed consent means that a participant has been informed about the risks and benefits of the research,
p.(None): understands such risks and benefits and is able to give consent to participation, without coercion, undue
...
Searching for indicator influence:
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p.(None): investigational device exemption where categories two (2) through eight (8) do not apply but the DERB has
p.(None): determined and documented at a convened meeting that the research involves no greater than minimal risk and no
p.(None): additional risks have been identified.
p.(None):
p.(None): 6.8 Conflict of Interest
p.(None): Dental researchers hold trustful relationships with research participants, research sponsors, their
p.(None): institution, professional bodies and society. This trust can be put at risk by a conflict of interest that
p.(None): influences their independent and objective judgment.
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): Conflict of Interest is when the professional judgment concerning research is influenced by a secondary interest such
p.(None): as personal or financial gain. The dental researchers and DERB members should disclose any actual, perceived or
p.(None): potential conflicts of interest to the DERB. The DERB should develop mechanisms to address and manage such conflicts of
p.(None): interest.
p.(None):
p.(None): 6.9 Informed Consent
p.(None): Informed consent means that a participant has been informed about the risks and benefits of the research,
p.(None): understands such risks and benefits and is able to give consent to participation, without coercion, undue
p.(None): influence or inappropriate incentives. It represents a signed agreement between the dental researcher
p.(None): and the human participant or their legally authorized representative to participate in the research
p.(None): before the start of the research. The informed consent process should provide the necessary information to
p.(None): the participants in simple, clear language that they understand and in terms they comprehend. It should provide the
p.(None): freedom of choice, the respect of participant’s autonomy, the voluntariness to participate and the protection
p.(None): of privacy and confidentiality. The information is given in a document known as the Informed Consent
p.(None): Form.
p.(None):
p.(None): The informed consent form should have the following as may be applicable:
p.(None): 1) Nature and purpose of study, stating it as research.
p.(None): 2) Duration of participation with number of participants.
p.(None): 3) Procedures to be followed.
p.(None): 4) Investigations, if any, to be performed.
p.(None): 5) Foreseeable risks and discomforts adequately described and whether the project involves more than minimal
p.(None): risk.
p.(None): 6) Benefits to participants, community or the dental profession as may be applicable.
p.(None): 7) Policy on compensation.
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
...
p.(None): occurrence of disease, and to suggest hypotheses that may be tested later through other research. Dental health
p.(None): problems suitable for epidemiological research include
p.(None):
p.(None): The measurement of dental disease prevalence and incidence within the population of Saudi Arabia,
p.(None):
p.(None): The identification of oral health care needs within the population of Saudi Arabia,
p.(None): The establishment of baseline information regarding the Saudi’s oral health and disease status, and
p.(None):
p.(None): The development and evaluation of various disease control procedures within the population of Saudi Arabia.
p.(None):
p.(None): The policy of the College of Dentistry Research Center is to encourage such epidemiological research that is expected
p.(None): to results in the prevention, control or elimination of dental diseases and oral health problems, such as caries,
p.(None): malocclusions, TMJ problems, oral cancer and other oral health related problems. Such research usually has priority in
p.(None): support and funding because of the expected local and national impact. The DERB should approve research proposal of
p.(None): dental epidemiological research provided that the ethical principles of respect, informed consent, confidentiality, and
p.(None): publication of the information are well covered.
p.(None):
p.(None): 9.0 Human genetic research
p.(None): Dental researches on human genetics involve the study of the inheritance pattern of the dento- facial trait and
p.(None): characteristics. Participation of families rather than individuals is required for genetic research studies.
p.(None): Genetic research enhances our understanding of how genes and environmental factors interact to influence the
p.(None): health of individuals and communities. Genetic research can reveal information about an individual's
p.(None): susceptibility to disease and future
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): health. Such information may be of interest and benefit to research participants, especially where
p.(None): preventive strategies exist.
p.(None):
p.(None): In addition to ethical considerations applied to all research involving humans, there are ethical issues unique to
p.(None): genetic research. They arise from the nature of the information which may be shared with other family members and with
p.(None): unrelated individuals in the population. Research results may be of significance to the health of blood relatives and
p.(None): others not participating in the research. Individuals may have an interest in the genetic information that
p.(None): may create new options for life decisions. Participants may be at risk of harm, including unfair discrimination or
p.(None): exclusion. The results of genetic information about future health could be used, potentially, by third parties such as
p.(None): insurance companies and employers.
p.(None):
p.(None): Researcher must recognize that obtaining informed consent and the collection of genetic information from
p.(None): families require specific attention. The researcher must abide by the policy to protect the privacy, confidentiality,
...
Health / HIV/AIDS
Searching for indicator HIV:
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p.(None): magnitude of expected risk to the human. Risk is defined as the harm or injury that is expected to
p.(None): occur to the human resulted from
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): participating in the planned dental research. The probability of risk may vary from no or minimal risk to significant.
p.(None):
p.(None): 6.7.1 Minimal Risk
p.(None): Minimal risk is defined as follows: "The probability and magnitude of harm or discomfort
p.(None): anticipated in the research are not greater than those ordinarily encountered in daily life or during
p.(None): the performance of routine physical or psychological examinations or tests." For example, the risk of bleeding
p.(None): during the examination of gingival pocket depth in a healthy human participating in dental research is not greater
p.(None): than the risk of bleeding in a routine gingival examination of a healthy human. The risks of psychological, social,
p.(None): or economic harm are difficult to assess in dental research. However, unethical breaches of confidentiality
p.(None): such as HIV infection status or drug and alcohol intake can place the human participating in dental research
p.(None): at the risk of damage to their employability, or reputation. Many risks can be minimized considerably with careful
p.(None): planning.
p.(None):
p.(None): In broad terms, a project involves minimal risk if:
p.(None): 1) The participant experiences no pain or physical danger.
p.(None): 2) The participant experiences no emotional arousal or psychological stress beyond the levels normally to be expected
p.(None): in everyday life.
p.(None): 3) The project neither includes nor attempts to induce long-term significant change in the participant's behavior
p.(None): (including attitude towards self and others).
p.(None): 4) The data would not embarrass or socially disadvantage the participant, were confidentiality to
p.(None): be violated.
p.(None): 5) If the investigator conceals information about specific purpose of the project, there is no reason to believe
p.(None): the subject would choose not to participate if he or she had known that information initially.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.7.2 Determining the Level of Review
p.(None): There are three levels of review for a research proposal depending on the risk expected to the human participating in
p.(None): the planned research. The three levels are:
p.(None): (1) Full Dental Ethical Board Review.
p.(None): (2) Exempt from the full dental ethical board review.
p.(None): (3) Expedited from the full dental ethical board review.
p.(None):
p.(None):
...
p.(None): deciduous and permanent teeth if routine patient care indicates a need for extraction; (b)
p.(None): uncannulated saliva collected either in an un- stimulated fashion or stimulated by chewing gum base or wax or by
p.(None): applying a dilute citric solution to the tongue; (c) supra- and sub-gingival dental plaque and calculus, provided the
p.(None): collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process
p.(None): is accomplished in accordance with accepted prophylactic techniques; (d) mucosal and skin cells collected by
p.(None): buccal scraping or swab, skin swab, or mouth washings; (e) sputum collected after saline mist
p.(None): nebulization.
p.(None): 4. Collection of data through noninvasive procedures routinely employed in dental clinical practice,
p.(None): excluding procedures involving x-rays. The medical/dental devices employed must be cleared/approved
p.(None): for marketing. Example: Analysis of measurements of blood pressure and heart rate using an automated blood
p.(None): pressure monitor every 10 minutes during tooth extraction, a comparison between routine local anesthesia and
p.(None): routine local anesthesia with hypnosis.
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 5. Research involving materials (data, documents, records, or specimens) that have been collected, or
p.(None): will be collected solely for non-research purposes. Example: (i) Prospective review of dental records
p.(None): to determine the outcome of standard treatment of oral ulcers in HIV-positive patients. (ii) Review of
p.(None): medical records and pathology samples of patients with parotid tumors to determine predictors of malignancy.
p.(None): 6. Collection of data from voice, video, digital, or image recordings made for research purposes.
p.(None): 7. Research on individual or group characteristics or behavior employing survey, interview, oral history,
p.(None): focus group, program evaluation, human factors evaluation, or quality assurance methodologies. Examples: (i) Survey of
p.(None): children in a Headstart program to determine knowledge about dental care. (ii) Focus group of multiple
p.(None): ethnic groups to determine attitudes and practices about oral health.
p.(None): 8. Continuing review of research previously approved by the full DERB review as follows: (a) where (i) the
p.(None): research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related
p.(None): interventions; and (iii) the research remains active only for long-term follow-up of subjects; or (b) where no subjects
p.(None): have been enrolled and no additional risks have been identified; or (c) where the remaining research
p.(None): activities are limited to data analysis.
p.(None): 9. Continuing review of research, not conducted under an investigational new drug application or
p.(None): investigational device exemption where categories two (2) through eight (8) do not apply but the DERB has
p.(None): determined and documented at a convened meeting that the research involves no greater than minimal risk and no
p.(None): additional risks have been identified.
p.(None):
...
p.(None): freedom of choice, the respect of participant’s autonomy, the voluntariness to participate and the protection
p.(None): of privacy and confidentiality. The information is given in a document known as the Informed Consent
p.(None): Form.
p.(None):
p.(None): The informed consent form should have the following as may be applicable:
p.(None): 1) Nature and purpose of study, stating it as research.
p.(None): 2) Duration of participation with number of participants.
p.(None): 3) Procedures to be followed.
p.(None): 4) Investigations, if any, to be performed.
p.(None): 5) Foreseeable risks and discomforts adequately described and whether the project involves more than minimal
p.(None): risk.
p.(None): 6) Benefits to participants, community or the dental profession as may be applicable.
p.(None): 7) Policy on compensation.
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 8) Availability of dental or alternative treatments if available for injuries or risk management.
p.(None): 9) Steps taken for ensuring confidentiality.
p.(None): 10) Freedom to withdraw without any consequences or loss of benefits.
p.(None): 11) Contact details of researchers for seeking more information related to the research or in case of injury.
p.(None): 12) Contact details for appeal against violation of rights.
p.(None): 13) Voluntary participation.
p.(None): 14) If test for genetics and HIV is to be done, counseling for consent for testing must be given as per Kingdom of
p.(None): Saudi Arabia guidelines.
p.(None): 15) Storage period of biological sample and related data with choice offered to participant
p.(None): regarding future use of samples, refusal for storage and receipt of its results.
p.(None):
p.(None): A copy of the informed consent form should be given to the participant for personal record. Note; in the
p.(None): UK we call the above ‘the patient information leaflet’ the last page of which being where the signatures of patient and
p.(None): consent taker are required
p.(None):
p.(None): 6.9.1 Re-consent
p.(None): Re-consent is taken in following conditions:
p.(None): 1) Availability of new information that necessitate changes in the research protocol.
p.(None): 2) When a research participant regains consciousness from an unconscious state or become mentally competent
p.(None): to understand the study.
p.(None): 3) Follow-up of the results of previous research.
p.(None): 4) Not finished research that requires extension of the allowed time.
p.(None): 5) When there is a change in treatment modality, procedures and site visits.
p.(None): 6) Before publication if there is possibility of disclosure of identity through data presentation or
p.(None): photographs that should be camouflaged adequately.
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
...
Health / Healthy People
Searching for indicator volunteers:
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p.(None): • Suspend or terminate previously approved research that is not being conducted in accordance
p.(None): with the DERB’s required standards
p.(None): • Suspend or terminate previously approved research that is associated with unexpected serious harm to
p.(None): participants.
p.(None): • Review, accept, and/or reject reports, including but not limited to reports of serious adverse events
p.(None): and unanticipated problems involving risks to subjects and others.
p.(None): • Disapprove a research proposal that is expected to cause serious harm to participants.
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): • Approve the inclusion of the college member in other research teams within or outside the premises of King
p.(None): Saud University.
p.(None): • Research that has been reviewed and approved by the DERB may be subject to disapproval by King Saud
p.(None): University officials or higher authorities.
p.(None): • King Saud University officials may not authorize or approve the conduct of dental research involving human
p.(None): participants that has not been approved by the DERB.
p.(None): • Research approved by the DERB may be subject, if requested by King Saud University officials or higher
p.(None): authorities, to further review and approval or disapproval by officials of the institution.
p.(None): • Members are expected to treat as confidential all applications, meeting deliberations, information
p.(None): on research participants/volunteers and related matters.
p.(None): • When a committee member believe that he/she has a conflict of interest on a subject which will compromise
p.(None): his/her ability to make a decision, he/she should declare that conflict of interest and withdraw him/herself from the
p.(None): discussion and/or decision making.
p.(None):
p.(None): The DERB has the mandate to act as an independent entity within the College of Dentistry, King Saud
p.(None): University. As such, the DERB is the final authority for all decisions regarding safeguarding the rights and
p.(None): welfare of humans who are subjects of dental research conducted under the auspices of the University.
p.(None):
p.(None): 6.7 Types of Review
p.(None): A dental research proposal involving human participation is reviewed initially by the DERB chairman to
p.(None): determine the appropriate level of review. The level of review is determined by the probability and
p.(None): magnitude of expected risk to the human. Risk is defined as the harm or injury that is expected to
p.(None): occur to the human resulted from
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): participating in the planned dental research. The probability of risk may vary from no or minimal risk to significant.
p.(None):
p.(None): 6.7.1 Minimal Risk
...
Health / Mentally Disabled
Searching for indicator disabled:
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p.(None): –decision. A dentist must get valid consent before starting treatment or physical investigation, or providing personal
p.(None): care, for a patient. Dentists must provide all the information patients need to make their decisions. This involve
p.(None): explaining complex dental diagnosis, prognoses and treatment regimes in simple language, confirming or correcting
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): information that the patients may have obtained elsewhere (e.g., from another health practitioner, magazines or the
p.(None): internet), ensuring that patients understand the treatment options (including the option of no treatment) advantages
p.(None): and disadvantages of each, answering any questions they may have, and understanding whatever decision the patient has
p.(None): reached and, if possible, the reasons for it.
p.(None): Any competent mature adult person may fully consent to treatment. A person is considered competent if he/she has
p.(None): sufficient understanding and capacity to make and communicate reasonable decisions. A legally appointed guardian may
p.(None): consent to the treatment for an incompetent adult.
p.(None): A parent or legally appointed guardian must consent to the treatment for young children and mentally disabled adults.
p.(None): Parents or legal guardians have a right to an explanation regarding the options for behavioral management of children,
p.(None): and are responsible to ask for additional information if they do not understand explanations. Siblings, friends, or any
p.(None): person other than a parent or legal guardian cannot provide consent.
p.(None): Confidentiality
p.(None):
p.(None): Dentists are obliged to safeguard the confidentiality of patient records. Dentists shall maintain patient records in a
p.(None): manner consistent with the protection of the welfare of the patient. Upon request of a patient or another dental
p.(None): practitioner, dentists shall provide any information in accordance with applicable law that will be beneficial for the
p.(None): future treatment of that patient.
p.(None): Refuse of patient treatment
p.(None): The Dentist may, in non-emergency cases, refuse to treat a patient for justified personal or professional reasons which
p.(None): might compromise the quality of the service rendered to the patient. Provided that such refusal should not cause harm
p.(None): to the patient's health, and that there is another Dentist who could perform the treatment. The justification of such
p.(None): action must be documented and authorized by the higher clinical authority.
p.(None):
p.(None): Patient referral
p.(None):
...
Searching for indicator mentally:
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p.(None): –decision. A dentist must get valid consent before starting treatment or physical investigation, or providing personal
p.(None): care, for a patient. Dentists must provide all the information patients need to make their decisions. This involve
p.(None): explaining complex dental diagnosis, prognoses and treatment regimes in simple language, confirming or correcting
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): information that the patients may have obtained elsewhere (e.g., from another health practitioner, magazines or the
p.(None): internet), ensuring that patients understand the treatment options (including the option of no treatment) advantages
p.(None): and disadvantages of each, answering any questions they may have, and understanding whatever decision the patient has
p.(None): reached and, if possible, the reasons for it.
p.(None): Any competent mature adult person may fully consent to treatment. A person is considered competent if he/she has
p.(None): sufficient understanding and capacity to make and communicate reasonable decisions. A legally appointed guardian may
p.(None): consent to the treatment for an incompetent adult.
p.(None): A parent or legally appointed guardian must consent to the treatment for young children and mentally disabled adults.
p.(None): Parents or legal guardians have a right to an explanation regarding the options for behavioral management of children,
p.(None): and are responsible to ask for additional information if they do not understand explanations. Siblings, friends, or any
p.(None): person other than a parent or legal guardian cannot provide consent.
p.(None): Confidentiality
p.(None):
p.(None): Dentists are obliged to safeguard the confidentiality of patient records. Dentists shall maintain patient records in a
p.(None): manner consistent with the protection of the welfare of the patient. Upon request of a patient or another dental
p.(None): practitioner, dentists shall provide any information in accordance with applicable law that will be beneficial for the
p.(None): future treatment of that patient.
p.(None): Refuse of patient treatment
p.(None): The Dentist may, in non-emergency cases, refuse to treat a patient for justified personal or professional reasons which
p.(None): might compromise the quality of the service rendered to the patient. Provided that such refusal should not cause harm
p.(None): to the patient's health, and that there is another Dentist who could perform the treatment. The justification of such
p.(None): action must be documented and authorized by the higher clinical authority.
...
p.(None): 9) Steps taken for ensuring confidentiality.
p.(None): 10) Freedom to withdraw without any consequences or loss of benefits.
p.(None): 11) Contact details of researchers for seeking more information related to the research or in case of injury.
p.(None): 12) Contact details for appeal against violation of rights.
p.(None): 13) Voluntary participation.
p.(None): 14) If test for genetics and HIV is to be done, counseling for consent for testing must be given as per Kingdom of
p.(None): Saudi Arabia guidelines.
p.(None): 15) Storage period of biological sample and related data with choice offered to participant
p.(None): regarding future use of samples, refusal for storage and receipt of its results.
p.(None):
p.(None): A copy of the informed consent form should be given to the participant for personal record. Note; in the
p.(None): UK we call the above ‘the patient information leaflet’ the last page of which being where the signatures of patient and
p.(None): consent taker are required
p.(None):
p.(None): 6.9.1 Re-consent
p.(None): Re-consent is taken in following conditions:
p.(None): 1) Availability of new information that necessitate changes in the research protocol.
p.(None): 2) When a research participant regains consciousness from an unconscious state or become mentally competent
p.(None): to understand the study.
p.(None): 3) Follow-up of the results of previous research.
p.(None): 4) Not finished research that requires extension of the allowed time.
p.(None): 5) When there is a change in treatment modality, procedures and site visits.
p.(None): 6) Before publication if there is possibility of disclosure of identity through data presentation or
p.(None): photographs that should be camouflaged adequately.
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.9.2 Waiver of consent
p.(None): Voluntary informed consent is a requirement for any research proposal that involves human participation.
p.(None): However, there are situations when the requirements for informed consent can be waived. If it is
p.(None): justified that the research involves not more than minimal risk or when the participant and the researcher do not
p.(None): come into contact or when it is necessitated in emergency situations. If such studies have the appropriate protection
p.(None): for both privacy and confidentiality, and do not violate the rights of the participants then the DERB
p.(None): may waive the requirement for informed consent in the following instances:
p.(None): a) When it is impractical to conduct research since confidentiality of personally identifiable
p.(None): information has to be maintained throughout the research.
p.(None): b) Research on publicly available information, documents, records, works, performances,
p.(None): reviews, quality assurance studies, archival materials or third party interviews, service programs for benefit
p.(None): of public having a bearing on public health programs, and consumer acceptance studies.
p.(None): c) Research on anonymised biological samples from left over samples after clinical investigation.
p.(None): d) In emergency situations when informed consent can be taken. Do you mean cannot be taken? (yes cannot, but I think
p.(None): we need to define the emergency situations)
p.(None):
p.(None): 7.0 Research Participants Requiring Additional Attention
p.(None): Humans with limited autonomy or in subordinate positions are considered participants that require additional
p.(None): attention and are in need of greater protection. These may include children, pregnant women and fetus, prisoners, and
p.(None): human highly dependent on medical care. Does this cover mentally impaired people?
p.(None):
p.(None): 7.1 Research involving children, adolescents and mentally impaired people
p.(None): Dental treatment and research on children, adolescents and mentally impaired person is part of the dental
p.(None): discipline. A child is a person who has not yet reached puberty
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): whereas an adolescent is a person who is reaching or has reached puberty. Mentally impaired person is a
p.(None): person who has impairment of intelligence and social functioning which appears to be permanent or temporary. Children,
p.(None): adolescents and mentally impaired person are considered participants who require additional attention because
p.(None): of their limited intellectual and emotional capacities. They cannot give a legal consent; therefore
p.(None): permission from the parent(s) is essential. Children, adolescents and mentally impaired person should
p.(None): participate in research only where their participation is indispensable to the research and where participation is
p.(None): not contrary to the individual's best interests. The research proposal must provide sufficient
p.(None): information to justify clearly why children, adolescents or mentally impaired person should be included
p.(None): as participants. Refusal of a child, adolescent or mentally impaired person to participate in the research must be
p.(None): respected.
p.(None):
p.(None): 7.1.1 Approval of research involving children and adolescents
p.(None): Research involving a child, adolescent or mentally impaired person should be approved only if:
p.(None): 1) The research, including observational research, places the child , adolescent or mentally impaired person at no
p.(None): more than minimal risk (that is, the risk commensurate with daily life or routine dental examinations – referred to as
p.(None): 'negligible risk' in some guidelines).
p.(None): 2) The research involves more than minimal risk but provides possible benefit for the child, adolescent or mentally
p.(None): impaired person participant. The degree of risk must be justified by the potential benefit.
p.(None): 3) The research involves greater than minimal risk, with no prospect of direct benefit to the child, adolescent or
p.(None): mentally impaired person, but has a high probability of providing significant knowledge. The risk should be justified
p.(None): by the risk-knowledge ratio and the risk must represent no more than a minor increase over minimal risk.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 7.1.2 Consent for children or adolescents
p.(None): Consent for children, adolescents or mentally impaired person to participate in research must be obtained from:
p.(None): a) The parents or legal guardian in all but exceptional circumstances such as emergencies.
p.(None): b) The child or adolescent that is competent to make the decision.
p.(None): c) Any organization or person required by authorization.
p.(None): d) No other caregiver can act on behalf of a child in providing consent to participate.
p.(None):
p.(None):
p.(None): 7.2 Research involving pregnant women
p.(None): The DERB must give extra attention to research that involves pregnant women or those who may become pregnant, because
p.(None): of the additional health concerns during pregnancy and the need to avoid unnecessary risk to the fetus. The policy of
p.(None): the college of dentistry research center is that; no pregnant woman may be involved as a participant in any dental
p.(None): research activity unless:
p.(None): • The purpose of the research is to meet the health needs of the mother and the fetus will be placed at no
...
Searching for indicator disability:
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p.(None): (3) Expedited from the full dental ethical board review.
p.(None):
p.(None):
p.(None): 6.7.2.1 Full Dental Ethical Board Review
p.(None): Any protocol that uses a methodology that is sensitive and of higher probability for causing harm or
p.(None): distress to participants is subject to full board review. Additionally, any protocol using prisoners as
p.(None): participants or involving pregnant women, fetuses, and human in vitro fertilization will be reviewed by
p.(None): the full board. Research in which the risks versus the expected benefits are relatively high is also likely to be
p.(None): reviewed by the full board.
p.(None): Dental research proposals that require full dental ethical board review included, but are not necessarily limited to
p.(None): the following:
p.(None): 1) Clinical trials involving human participants
p.(None): 2) New treatments or interventions
p.(None): 3) Research involving human remains, cadavers, tissues, discarded tissue (e.g. placenta), biological
p.(None): fluids
p.(None): 4) Physiological studies
p.(None): 5) Comparing an established procedure, whether therapeutic, non-therapeutic or diagnostic, with other
p.(None): procedures which are not recognized as established by virtue of their recent development, discovery or use in a new or
p.(None): unfamiliar way
p.(None): 6) Innovative practices in health and disability services
p.(None): 7) Research conducted by students, which includes all activities that meet the definition of
p.(None): research with human participants (As supervised student research is conducted primarily for the purpose of
p.(None): educating students on research techniques and methodologies, DERB should review research protocols with
p.(None): a view to
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): contributing to the students’ education concerning scientific and ethical principles governing research).
p.(None): 8) Observational clinical research
p.(None): 9) Access to personal information by means of questionnaires, interviews or other techniques of information
p.(None): gathering
p.(None): 10) Research involving the secondary use of data (use of data not collected for that research purpose), if
p.(None): any form of identifier is involved and/or if health information pertaining to individuals is involved
p.(None): 11) Case studies, when a series of subject observations allow possible extrapolation of generalization of the
p.(None): results from the reported cases and when there is intent to publish or disseminate the data.
p.(None):
p.(None): 6.7.2.2 Exempt from the full ethical board review
p.(None): The determination of which proposals will be exempt from the full ethical board review is the sole authority of the
p.(None): DERB chairman. The exempt status of a research proposal means that the proposed protocol for the dental research is
...
Health / Motherhood/Family
Searching for indicator family:
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p.(None): to results in the prevention, control or elimination of dental diseases and oral health problems, such as caries,
p.(None): malocclusions, TMJ problems, oral cancer and other oral health related problems. Such research usually has priority in
p.(None): support and funding because of the expected local and national impact. The DERB should approve research proposal of
p.(None): dental epidemiological research provided that the ethical principles of respect, informed consent, confidentiality, and
p.(None): publication of the information are well covered.
p.(None):
p.(None): 9.0 Human genetic research
p.(None): Dental researches on human genetics involve the study of the inheritance pattern of the dento- facial trait and
p.(None): characteristics. Participation of families rather than individuals is required for genetic research studies.
p.(None): Genetic research enhances our understanding of how genes and environmental factors interact to influence the
p.(None): health of individuals and communities. Genetic research can reveal information about an individual's
p.(None): susceptibility to disease and future
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): health. Such information may be of interest and benefit to research participants, especially where
p.(None): preventive strategies exist.
p.(None):
p.(None): In addition to ethical considerations applied to all research involving humans, there are ethical issues unique to
p.(None): genetic research. They arise from the nature of the information which may be shared with other family members and with
p.(None): unrelated individuals in the population. Research results may be of significance to the health of blood relatives and
p.(None): others not participating in the research. Individuals may have an interest in the genetic information that
p.(None): may create new options for life decisions. Participants may be at risk of harm, including unfair discrimination or
p.(None): exclusion. The results of genetic information about future health could be used, potentially, by third parties such as
p.(None): insurance companies and employers.
p.(None):
p.(None): Researcher must recognize that obtaining informed consent and the collection of genetic information from
p.(None): families require specific attention. The researcher must abide by the policy to protect the privacy, confidentiality,
p.(None): storage and publication of genetic information. The DERB within its authority should not approve any proposal for
p.(None): dental research study if it might lead to a potential harm to participants, and if the competence and qualification of
p.(None): the researcher or any member of the research team is in doubt.
p.(None):
p.(None): 10.0 Human tissue samples
p.(None): Dental research on human tissue sample, blood and saliva include research on the various aspects of oral health such as
p.(None): oral cancer and the effect of smoking to the oral tissue. The CDRC Histopathology laboratory receives biopsies from
p.(None): dental clinics and other research centers for processing of the specimens. The histopathology laboratory collected over
...
p.(None): Research Natural Sciences and Engineering Research Council of Canada Social Sciences and Humanities Research
p.(None): Council of Canada. August (1998).
p.(None):
p.(None): 20) Operational Procedures for Research Ethics Committees Guidance. The Irish Council for Bioethics, Academy House, 19
p.(None): Dawson St, Dublin 2 (2004).
p.(None):
p.(None): 21) Handbook for the Protection of Human Subjects in Research. Institutional Review Board. University of Oklahoma. June
p.(None): (2008).
p.(None):
p.(None): 22) Institutional Review Board Procedures and Guidelines for the Protection of Human Subjects. Texas A&M
p.(None): University Commerce Institutional Review Board. November (2009).
p.(None):
p.(None): 23) Research Subjects Review Board (RSRB) Investigator Guidance, University of Rochester. February (2010).
p.(None):
p.(None): 24) Ethical and Policy Issues in Research Involving Human Participants. Volume I. Report and Recommendations of the
p.(None): National Bioethics Advisory Commission. Bethesda, Maryland. August (2001).
p.(None):
p.(None): 25) Research animals for scientific purposes in Thailand: Ethics & policies, The National Research Council
p.(None): of Thailand. AATEX 14, Special Issue, 189-191. Proc. 6th World Congress on Alternatives & Animal Use in the
p.(None): Life Sciences. Tokyo, Japan. August (2007).
p.(None):
p.(None): 26) Use of Animals in Scientific Research, Indian Council of Medical Research Ministry of Health & Family
p.(None): Welfare. New Delhi. May (2000).
p.(None):
p.(None): 27) Ethics in Health Research: Principles, Structures and Processes Research Ethics Guidelines,
p.(None): Department of Health, South Africa. (2004).
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None):
p.(None): 28) Universal Declaration on the Human Genome and Human Rights. UNESCO, United Nations Educational,
p.(None): Scientific, Cultural Organization. (1997).
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):
p.(None):
p.(None):
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Health / Pregnant
Searching for indicator pregnant:
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p.(None): 6.4 Establishment of the Dental Ethics Review Board (DERB)
p.(None): 6.5 Authority of the Dental Ethics Review Board
p.(None): 6.6 Types of Review
p.(None): 6.6.1 Minimal Risk.
p.(None): 6.6.2 Determining the Level of Review
p.(None): 6.6.2.1 Full Dental Ethical Board Review
p.(None): 6.6.2.2 Exempt from the full ethical board review
p.(None): 6.6.2.3 Expedited from the full ethical board review
p.(None): 6.8 Conflict of Interest
p.(None): 6.9 Informed Consent:
p.(None): 6.9.1 Re-consent
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.9.2 Waiver of consent
p.(None): 6.10 Submitting a Research Proposal
p.(None): 6.11 Electronic Submission of a Research proposal
p.(None): 6.12 Evaluation of submitted research proposals
p.(None): 6.13 Meeting Requirements
p.(None): 6.14 Decision-making
p.(None): 7.0 RESEARCH PARTICIPANTS REQUIRING ADDITIONAL ATTENTION
p.(None): 7.1 Research Involving Children and Adolescents
p.(None): 7.1.1 Approval of research involving children and adolescents
p.(None): 7.1.2 Consent for children or adolescents
p.(None): 7.2 Research involving pregnant women
p.(None): 7.3 Research involving a fetus
p.(None): 7.4 Research involving prisoners
p.(None): 7.4.1 Considerations regarding research involving prisoners
p.(None): 7.4.2 Approval of research involving prisoners
p.(None): 7.5 Research involving humans highly dependent on medical care
p.(None): 7.6 Other groups requiring additional attention
p.(None): 8.0 EPIDEMIOLOGICAL RESEARCH
p.(None): 9.0 HUMAN GENETIC RESEARCH
p.(None): 10.0 HUMAN TISSUE SAMPLES
p.(None): 11.0 REFERENCES
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): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 1.0 INTRODUCTION
p.(None): The College of Dentistry, King Saud University is the one of the dental colleges in the Kingdom of Saudi Arabia and
p.(None): the Gulf Countries that carries the responsibility of educating students, providing oral health services to the
p.(None): patients, conducting research and servicing the community. These responsibilities are conducted under the good ethical
p.(None): principles that guide the educational process in King Saud University.
p.(None):
p.(None): The Research Center within the College of Dentistry (CDRC) is the product of the University’s aspiration of bringing
...
p.(None): 2) The participant experiences no emotional arousal or psychological stress beyond the levels normally to be expected
p.(None): in everyday life.
p.(None): 3) The project neither includes nor attempts to induce long-term significant change in the participant's behavior
p.(None): (including attitude towards self and others).
p.(None): 4) The data would not embarrass or socially disadvantage the participant, were confidentiality to
p.(None): be violated.
p.(None): 5) If the investigator conceals information about specific purpose of the project, there is no reason to believe
p.(None): the subject would choose not to participate if he or she had known that information initially.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.7.2 Determining the Level of Review
p.(None): There are three levels of review for a research proposal depending on the risk expected to the human participating in
p.(None): the planned research. The three levels are:
p.(None): (1) Full Dental Ethical Board Review.
p.(None): (2) Exempt from the full dental ethical board review.
p.(None): (3) Expedited from the full dental ethical board review.
p.(None):
p.(None):
p.(None): 6.7.2.1 Full Dental Ethical Board Review
p.(None): Any protocol that uses a methodology that is sensitive and of higher probability for causing harm or
p.(None): distress to participants is subject to full board review. Additionally, any protocol using prisoners as
p.(None): participants or involving pregnant women, fetuses, and human in vitro fertilization will be reviewed by
p.(None): the full board. Research in which the risks versus the expected benefits are relatively high is also likely to be
p.(None): reviewed by the full board.
p.(None): Dental research proposals that require full dental ethical board review included, but are not necessarily limited to
p.(None): the following:
p.(None): 1) Clinical trials involving human participants
p.(None): 2) New treatments or interventions
p.(None): 3) Research involving human remains, cadavers, tissues, discarded tissue (e.g. placenta), biological
p.(None): fluids
p.(None): 4) Physiological studies
p.(None): 5) Comparing an established procedure, whether therapeutic, non-therapeutic or diagnostic, with other
p.(None): procedures which are not recognized as established by virtue of their recent development, discovery or use in a new or
p.(None): unfamiliar way
p.(None): 6) Innovative practices in health and disability services
p.(None): 7) Research conducted by students, which includes all activities that meet the definition of
p.(None): research with human participants (As supervised student research is conducted primarily for the purpose of
p.(None): educating students on research techniques and methodologies, DERB should review research protocols with
p.(None): a view to
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
...
p.(None): for both privacy and confidentiality, and do not violate the rights of the participants then the DERB
p.(None): may waive the requirement for informed consent in the following instances:
p.(None): a) When it is impractical to conduct research since confidentiality of personally identifiable
p.(None): information has to be maintained throughout the research.
p.(None): b) Research on publicly available information, documents, records, works, performances,
p.(None): reviews, quality assurance studies, archival materials or third party interviews, service programs for benefit
p.(None): of public having a bearing on public health programs, and consumer acceptance studies.
p.(None): c) Research on anonymised biological samples from left over samples after clinical investigation.
p.(None): d) In emergency situations when informed consent can be taken. Do you mean cannot be taken? (yes cannot, but I think
p.(None): we need to define the emergency situations)
p.(None):
p.(None): 7.0 Research Participants Requiring Additional Attention
p.(None): Humans with limited autonomy or in subordinate positions are considered participants that require additional
p.(None): attention and are in need of greater protection. These may include children, pregnant women and fetus, prisoners, and
p.(None): human highly dependent on medical care. Does this cover mentally impaired people?
p.(None):
p.(None): 7.1 Research involving children, adolescents and mentally impaired people
p.(None): Dental treatment and research on children, adolescents and mentally impaired person is part of the dental
p.(None): discipline. A child is a person who has not yet reached puberty
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): whereas an adolescent is a person who is reaching or has reached puberty. Mentally impaired person is a
p.(None): person who has impairment of intelligence and social functioning which appears to be permanent or temporary. Children,
...
p.(None): by the risk-knowledge ratio and the risk must represent no more than a minor increase over minimal risk.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 7.1.2 Consent for children or adolescents
p.(None): Consent for children, adolescents or mentally impaired person to participate in research must be obtained from:
p.(None): a) The parents or legal guardian in all but exceptional circumstances such as emergencies.
p.(None): b) The child or adolescent that is competent to make the decision.
p.(None): c) Any organization or person required by authorization.
p.(None): d) No other caregiver can act on behalf of a child in providing consent to participate.
p.(None):
p.(None):
p.(None): 7.2 Research involving pregnant women
p.(None): The DERB must give extra attention to research that involves pregnant women or those who may become pregnant, because
p.(None): of the additional health concerns during pregnancy and the need to avoid unnecessary risk to the fetus. The policy of
p.(None): the college of dentistry research center is that; no pregnant woman may be involved as a participant in any dental
p.(None): research activity unless:
p.(None): • The purpose of the research is to meet the health needs of the mother and the fetus will be placed at no
p.(None): risk, or
p.(None): • The risk to the fetus is minimal.
p.(None): The DERB should consider the following regulatory protections before approval of the research proposal.
p.(None): • Appropriate studies conducted on animals and non-pregnant women have provided data for assessing potential risks.
p.(None): • Risks and prospects of benefit to the fetus and mother (separately or together) and the purpose of the research
p.(None): have been determined.
p.(None): • Any risk is the least possible for achieving the objectives of the research.
p.(None): The research activity may be permitted to be conducted only if the mother is legally competent and has given informed
p.(None): consent after having been fully informed about the possible impact on the fetus. The father's informed consent needs to
p.(None): be secured if the research has any risk to the fetus.
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None):
p.(None): 7.3 Research involving a fetus
p.(None): Dental research usually do not involve fetuses as participants, however, in research involve investigations on the
p.(None): craniofacial malformations such as cleft lip and palate the dental researcher may be involved as a member of a larger
p.(None): research group including medical researchers. The dental researcher must abide by the ethical codes and the regulatory
p.(None): procedures of the medical research team.
...
Health / Terminally Ill
Searching for indicator terminally:
(return to top)
p.(None): 1. Research activities on humans under emergency care
p.(None): 2. Research activities on humans in the intensive care unit
p.(None): 3. Research activities on neonatals in the intensive care unit
p.(None): 4. Research activities on humans in the terminal care unit
p.(None): 5. Research activities on decisionally impaired humans
p.(None): 6. Research activities on unconscious human
p.(None): The policy of the college of dentistry research center is that; no dental research should be carried out on the above
p.(None): mentioned conditions. However, The DERB, within its authority can approve dental research in the following conditions;
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): • The research is based on valid scientific hypotheses which support a reasonable possibility of benefit over
p.(None): standard care.
p.(None): • The research is intended to be therapeutic and the research intervention poses no more than a risk that is
p.(None): expected in alternative methods of treatment.
p.(None):
p.(None): 7.6 Other groups requiring additional attention
p.(None): The discussion of the dental research participants requiring additional attention should not be limited to those
p.(None): already mentioned. Other groups that require additional attention include: traumatized and comatose patients,
p.(None): terminally ill patients, elderly or aged patients, minorities, students, and employees. The DERB must ensure that
p.(None): special consideration is given to all these groups, especially with regard to the risks, benefits and obtaining
p.(None): informed consent.
p.(None):
p.(None): 8.0 EPIDEMIOLOGICAL RESEARCH
p.(None):
p.(None): Epidemiological research describes the health status in a population or subgroup of the population. Epidemiological
p.(None): research studies the distribution and determinants of health related problems in populations, and the application of
p.(None): the research results to prevent, control or eliminate such health problems. It is concerned with improvement of the
p.(None): health status and welfare in human populations and with the improvement in the efficiency and performance of health
p.(None): services. Epidemiological research is carried out with human participants, or data or biological samples from them,
p.(None): and such research provides important new knowledge that is not readily obtainable in other ways. Perhaps the second
p.(None): most significant dental discoveries, after local anesthesia, were the effects of naturally occurring fluoride on
p.(None): reducing the incidence of dental caries as revealed by epidemiological research. Such epidemiological studies provided
p.(None): the motive for several clinical and laboratory research studies on the relationships between fluoride and dental
p.(None): caries. The findings from these researches laid the ground for the current understanding of the relationship between
p.(None): fluoride and oral disease.
p.(None):
p.(None):
p.(None):
...
Searching for indicator terminal:
(return to top)
p.(None): 2) Risk of participation is the same as those that would be accepted by non‐prisoners.
p.(None): 3) Procedure of selection is fair to all prisoners.
p.(None): 4) Language for obtaining informed consent must be understandable to prisoners.
p.(None): 5) When studies need follow‐up, the provision for follow‐up must include a consideration of the length of individual
p.(None): sentences, and prisoners must be informed about follow‐up.
p.(None):
p.(None): 7.5 Research involving humans highly dependent on medical care
p.(None): Dental research on humans who are highly dependent on medical care raises ethical issues that deserve special
p.(None): attention. Researchers need to acknowledge that informed consent may be compromised by the effect of the medical
p.(None): condition or fear of affecting the level of medical care in case of refusal to participate. The following conditions
p.(None): are considered for possible dental research activities.
p.(None): 1. Research activities on humans under emergency care
p.(None): 2. Research activities on humans in the intensive care unit
p.(None): 3. Research activities on neonatals in the intensive care unit
p.(None): 4. Research activities on humans in the terminal care unit
p.(None): 5. Research activities on decisionally impaired humans
p.(None): 6. Research activities on unconscious human
p.(None): The policy of the college of dentistry research center is that; no dental research should be carried out on the above
p.(None): mentioned conditions. However, The DERB, within its authority can approve dental research in the following conditions;
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): • The research is based on valid scientific hypotheses which support a reasonable possibility of benefit over
p.(None): standard care.
p.(None): • The research is intended to be therapeutic and the research intervention poses no more than a risk that is
p.(None): expected in alternative methods of treatment.
p.(None):
p.(None): 7.6 Other groups requiring additional attention
p.(None): The discussion of the dental research participants requiring additional attention should not be limited to those
p.(None): already mentioned. Other groups that require additional attention include: traumatized and comatose patients,
p.(None): terminally ill patients, elderly or aged patients, minorities, students, and employees. The DERB must ensure that
...
Health / Unconscious People
Searching for indicator unconscious:
(return to top)
p.(None):
p.(None): 8) Availability of dental or alternative treatments if available for injuries or risk management.
p.(None): 9) Steps taken for ensuring confidentiality.
p.(None): 10) Freedom to withdraw without any consequences or loss of benefits.
p.(None): 11) Contact details of researchers for seeking more information related to the research or in case of injury.
p.(None): 12) Contact details for appeal against violation of rights.
p.(None): 13) Voluntary participation.
p.(None): 14) If test for genetics and HIV is to be done, counseling for consent for testing must be given as per Kingdom of
p.(None): Saudi Arabia guidelines.
p.(None): 15) Storage period of biological sample and related data with choice offered to participant
p.(None): regarding future use of samples, refusal for storage and receipt of its results.
p.(None):
p.(None): A copy of the informed consent form should be given to the participant for personal record. Note; in the
p.(None): UK we call the above ‘the patient information leaflet’ the last page of which being where the signatures of patient and
p.(None): consent taker are required
p.(None):
p.(None): 6.9.1 Re-consent
p.(None): Re-consent is taken in following conditions:
p.(None): 1) Availability of new information that necessitate changes in the research protocol.
p.(None): 2) When a research participant regains consciousness from an unconscious state or become mentally competent
p.(None): to understand the study.
p.(None): 3) Follow-up of the results of previous research.
p.(None): 4) Not finished research that requires extension of the allowed time.
p.(None): 5) When there is a change in treatment modality, procedures and site visits.
p.(None): 6) Before publication if there is possibility of disclosure of identity through data presentation or
p.(None): photographs that should be camouflaged adequately.
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.9.2 Waiver of consent
p.(None): Voluntary informed consent is a requirement for any research proposal that involves human participation.
p.(None): However, there are situations when the requirements for informed consent can be waived. If it is
p.(None): justified that the research involves not more than minimal risk or when the participant and the researcher do not
p.(None): come into contact or when it is necessitated in emergency situations. If such studies have the appropriate protection
p.(None): for both privacy and confidentiality, and do not violate the rights of the participants then the DERB
p.(None): may waive the requirement for informed consent in the following instances:
...
p.(None): 3) Procedure of selection is fair to all prisoners.
p.(None): 4) Language for obtaining informed consent must be understandable to prisoners.
p.(None): 5) When studies need follow‐up, the provision for follow‐up must include a consideration of the length of individual
p.(None): sentences, and prisoners must be informed about follow‐up.
p.(None):
p.(None): 7.5 Research involving humans highly dependent on medical care
p.(None): Dental research on humans who are highly dependent on medical care raises ethical issues that deserve special
p.(None): attention. Researchers need to acknowledge that informed consent may be compromised by the effect of the medical
p.(None): condition or fear of affecting the level of medical care in case of refusal to participate. The following conditions
p.(None): are considered for possible dental research activities.
p.(None): 1. Research activities on humans under emergency care
p.(None): 2. Research activities on humans in the intensive care unit
p.(None): 3. Research activities on neonatals in the intensive care unit
p.(None): 4. Research activities on humans in the terminal care unit
p.(None): 5. Research activities on decisionally impaired humans
p.(None): 6. Research activities on unconscious human
p.(None): The policy of the college of dentistry research center is that; no dental research should be carried out on the above
p.(None): mentioned conditions. However, The DERB, within its authority can approve dental research in the following conditions;
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): • The research is based on valid scientific hypotheses which support a reasonable possibility of benefit over
p.(None): standard care.
p.(None): • The research is intended to be therapeutic and the research intervention poses no more than a risk that is
p.(None): expected in alternative methods of treatment.
p.(None):
p.(None): 7.6 Other groups requiring additional attention
p.(None): The discussion of the dental research participants requiring additional attention should not be limited to those
p.(None): already mentioned. Other groups that require additional attention include: traumatized and comatose patients,
p.(None): terminally ill patients, elderly or aged patients, minorities, students, and employees. The DERB must ensure that
p.(None): special consideration is given to all these groups, especially with regard to the risks, benefits and obtaining
p.(None): informed consent.
p.(None):
p.(None): 8.0 EPIDEMIOLOGICAL RESEARCH
p.(None):
p.(None): Epidemiological research describes the health status in a population or subgroup of the population. Epidemiological
...
Health / ill
Searching for indicator ill:
(return to top)
p.(None): 2. Research activities on humans in the intensive care unit
p.(None): 3. Research activities on neonatals in the intensive care unit
p.(None): 4. Research activities on humans in the terminal care unit
p.(None): 5. Research activities on decisionally impaired humans
p.(None): 6. Research activities on unconscious human
p.(None): The policy of the college of dentistry research center is that; no dental research should be carried out on the above
p.(None): mentioned conditions. However, The DERB, within its authority can approve dental research in the following conditions;
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): • The research is based on valid scientific hypotheses which support a reasonable possibility of benefit over
p.(None): standard care.
p.(None): • The research is intended to be therapeutic and the research intervention poses no more than a risk that is
p.(None): expected in alternative methods of treatment.
p.(None):
p.(None): 7.6 Other groups requiring additional attention
p.(None): The discussion of the dental research participants requiring additional attention should not be limited to those
p.(None): already mentioned. Other groups that require additional attention include: traumatized and comatose patients,
p.(None): terminally ill patients, elderly or aged patients, minorities, students, and employees. The DERB must ensure that
p.(None): special consideration is given to all these groups, especially with regard to the risks, benefits and obtaining
p.(None): informed consent.
p.(None):
p.(None): 8.0 EPIDEMIOLOGICAL RESEARCH
p.(None):
p.(None): Epidemiological research describes the health status in a population or subgroup of the population. Epidemiological
p.(None): research studies the distribution and determinants of health related problems in populations, and the application of
p.(None): the research results to prevent, control or eliminate such health problems. It is concerned with improvement of the
p.(None): health status and welfare in human populations and with the improvement in the efficiency and performance of health
p.(None): services. Epidemiological research is carried out with human participants, or data or biological samples from them,
p.(None): and such research provides important new knowledge that is not readily obtainable in other ways. Perhaps the second
p.(None): most significant dental discoveries, after local anesthesia, were the effects of naturally occurring fluoride on
p.(None): reducing the incidence of dental caries as revealed by epidemiological research. Such epidemiological studies provided
p.(None): the motive for several clinical and laboratory research studies on the relationships between fluoride and dental
p.(None): caries. The findings from these researches laid the ground for the current understanding of the relationship between
p.(None): fluoride and oral disease.
p.(None):
p.(None):
p.(None):
...
Health / patients in emergency situations
Searching for indicator emergencies:
(return to top)
p.(None): 3) The research involves greater than minimal risk, with no prospect of direct benefit to the child, adolescent or
p.(None): mentally impaired person, but has a high probability of providing significant knowledge. The risk should be justified
p.(None): by the risk-knowledge ratio and the risk must represent no more than a minor increase over minimal risk.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 7.1.2 Consent for children or adolescents
p.(None): Consent for children, adolescents or mentally impaired person to participate in research must be obtained from:
p.(None): a) The parents or legal guardian in all but exceptional circumstances such as emergencies.
p.(None): b) The child or adolescent that is competent to make the decision.
p.(None): c) Any organization or person required by authorization.
p.(None): d) No other caregiver can act on behalf of a child in providing consent to participate.
p.(None):
p.(None):
p.(None): 7.2 Research involving pregnant women
p.(None): The DERB must give extra attention to research that involves pregnant women or those who may become pregnant, because
p.(None): of the additional health concerns during pregnancy and the need to avoid unnecessary risk to the fetus. The policy of
p.(None): the college of dentistry research center is that; no pregnant woman may be involved as a participant in any dental
p.(None): research activity unless:
p.(None): • The purpose of the research is to meet the health needs of the mother and the fetus will be placed at no
p.(None): risk, or
p.(None): • The risk to the fetus is minimal.
p.(None): The DERB should consider the following regulatory protections before approval of the research proposal.
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.(None): reviewed by the full board.
p.(None): Dental research proposals that require full dental ethical board review included, but are not necessarily limited to
p.(None): the following:
p.(None): 1) Clinical trials involving human participants
p.(None): 2) New treatments or interventions
p.(None): 3) Research involving human remains, cadavers, tissues, discarded tissue (e.g. placenta), biological
p.(None): fluids
p.(None): 4) Physiological studies
p.(None): 5) Comparing an established procedure, whether therapeutic, non-therapeutic or diagnostic, with other
p.(None): procedures which are not recognized as established by virtue of their recent development, discovery or use in a new or
p.(None): unfamiliar way
p.(None): 6) Innovative practices in health and disability services
p.(None): 7) Research conducted by students, which includes all activities that meet the definition of
p.(None): research with human participants (As supervised student research is conducted primarily for the purpose of
p.(None): educating students on research techniques and methodologies, DERB should review research protocols with
p.(None): a view to
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): contributing to the students’ education concerning scientific and ethical principles governing research).
p.(None): 8) Observational clinical research
p.(None): 9) Access to personal information by means of questionnaires, interviews or other techniques of information
p.(None): gathering
p.(None): 10) Research involving the secondary use of data (use of data not collected for that research purpose), if
p.(None): any form of identifier is involved and/or if health information pertaining to individuals is involved
p.(None): 11) Case studies, when a series of subject observations allow possible extrapolation of generalization of the
p.(None): results from the reported cases and when there is intent to publish or disseminate the data.
p.(None):
p.(None): 6.7.2.2 Exempt from the full ethical board review
p.(None): The determination of which proposals will be exempt from the full ethical board review is the sole authority of the
p.(None): DERB chairman. The exempt status of a research proposal means that the proposed protocol for the dental research is
p.(None): exempt from full authority of the DERB in research involving the participation of the human. Any change in
p.(None): the protocol of the approved proposal must be re-submitted to the DERB chairman to determine further
p.(None): exempt status. The dental researcher must submit to the DERB secretary the full documentations required
p.(None): for the review by the DERB, including the research proposal, informed consent and the CV’s of the investigators.
p.(None):
p.(None): To determine exempt status, the research must qualify as one or more of the categories listed below. To qualify for a
p.(None): category, the research must meet all of the conditions of that category.
p.(None):
...
Social / Child
Searching for indicator child:
(return to top)
p.(None): we need to define the emergency situations)
p.(None):
p.(None): 7.0 Research Participants Requiring Additional Attention
p.(None): Humans with limited autonomy or in subordinate positions are considered participants that require additional
p.(None): attention and are in need of greater protection. These may include children, pregnant women and fetus, prisoners, and
p.(None): human highly dependent on medical care. Does this cover mentally impaired people?
p.(None):
p.(None): 7.1 Research involving children, adolescents and mentally impaired people
p.(None): Dental treatment and research on children, adolescents and mentally impaired person is part of the dental
p.(None): discipline. A child is a person who has not yet reached puberty
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): whereas an adolescent is a person who is reaching or has reached puberty. Mentally impaired person is a
p.(None): person who has impairment of intelligence and social functioning which appears to be permanent or temporary. Children,
p.(None): adolescents and mentally impaired person are considered participants who require additional attention because
p.(None): of their limited intellectual and emotional capacities. They cannot give a legal consent; therefore
p.(None): permission from the parent(s) is essential. Children, adolescents and mentally impaired person should
p.(None): participate in research only where their participation is indispensable to the research and where participation is
p.(None): not contrary to the individual's best interests. The research proposal must provide sufficient
p.(None): information to justify clearly why children, adolescents or mentally impaired person should be included
p.(None): as participants. Refusal of a child, adolescent or mentally impaired person to participate in the research must be
p.(None): respected.
p.(None):
p.(None): 7.1.1 Approval of research involving children and adolescents
p.(None): Research involving a child, adolescent or mentally impaired person should be approved only if:
p.(None): 1) The research, including observational research, places the child , adolescent or mentally impaired person at no
p.(None): more than minimal risk (that is, the risk commensurate with daily life or routine dental examinations – referred to as
p.(None): 'negligible risk' in some guidelines).
p.(None): 2) The research involves more than minimal risk but provides possible benefit for the child, adolescent or mentally
p.(None): impaired person participant. The degree of risk must be justified by the potential benefit.
p.(None): 3) The research involves greater than minimal risk, with no prospect of direct benefit to the child, adolescent or
p.(None): mentally impaired person, but has a high probability of providing significant knowledge. The risk should be justified
p.(None): by the risk-knowledge ratio and the risk must represent no more than a minor increase over minimal risk.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 7.1.2 Consent for children or adolescents
p.(None): Consent for children, adolescents or mentally impaired person to participate in research must be obtained from:
p.(None): a) The parents or legal guardian in all but exceptional circumstances such as emergencies.
p.(None): b) The child or adolescent that is competent to make the decision.
p.(None): c) Any organization or person required by authorization.
p.(None): d) No other caregiver can act on behalf of a child in providing consent to participate.
p.(None):
p.(None):
p.(None): 7.2 Research involving pregnant women
p.(None): The DERB must give extra attention to research that involves pregnant women or those who may become pregnant, because
p.(None): of the additional health concerns during pregnancy and the need to avoid unnecessary risk to the fetus. The policy of
p.(None): the college of dentistry research center is that; no pregnant woman may be involved as a participant in any dental
p.(None): research activity unless:
p.(None): • The purpose of the research is to meet the health needs of the mother and the fetus will be placed at no
p.(None): risk, or
p.(None): • The risk to the fetus is minimal.
p.(None): The DERB should consider the following regulatory protections before approval of the research proposal.
p.(None): • Appropriate studies conducted on animals and non-pregnant women have provided data for assessing potential risks.
...
Searching for indicator children:
(return to top)
p.(None): Fully informed consent is essential to the ethical practice of dentistry and reflects the patient’s right of self
p.(None): –decision. A dentist must get valid consent before starting treatment or physical investigation, or providing personal
p.(None): care, for a patient. Dentists must provide all the information patients need to make their decisions. This involve
p.(None): explaining complex dental diagnosis, prognoses and treatment regimes in simple language, confirming or correcting
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): information that the patients may have obtained elsewhere (e.g., from another health practitioner, magazines or the
p.(None): internet), ensuring that patients understand the treatment options (including the option of no treatment) advantages
p.(None): and disadvantages of each, answering any questions they may have, and understanding whatever decision the patient has
p.(None): reached and, if possible, the reasons for it.
p.(None): Any competent mature adult person may fully consent to treatment. A person is considered competent if he/she has
p.(None): sufficient understanding and capacity to make and communicate reasonable decisions. A legally appointed guardian may
p.(None): consent to the treatment for an incompetent adult.
p.(None): A parent or legally appointed guardian must consent to the treatment for young children and mentally disabled adults.
p.(None): Parents or legal guardians have a right to an explanation regarding the options for behavioral management of children,
p.(None): and are responsible to ask for additional information if they do not understand explanations. Siblings, friends, or any
p.(None): person other than a parent or legal guardian cannot provide consent.
p.(None): Confidentiality
p.(None):
p.(None): Dentists are obliged to safeguard the confidentiality of patient records. Dentists shall maintain patient records in a
p.(None): manner consistent with the protection of the welfare of the patient. Upon request of a patient or another dental
p.(None): practitioner, dentists shall provide any information in accordance with applicable law that will be beneficial for the
p.(None): future treatment of that patient.
p.(None): Refuse of patient treatment
p.(None): The Dentist may, in non-emergency cases, refuse to treat a patient for justified personal or professional reasons which
p.(None): might compromise the quality of the service rendered to the patient. Provided that such refusal should not cause harm
p.(None): to the patient's health, and that there is another Dentist who could perform the treatment. The justification of such
p.(None): action must be documented and authorized by the higher clinical authority.
p.(None):
p.(None): Patient referral
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): When deemed necessary, a dentist having undertaken the care of a patient shall not discontinue that care without
...
p.(None): 5.5 Electronic Submission of a Research Proposal
p.(None): 5.6 Evaluation of Submitted Research Proposals
p.(None): 6.0 RESEARCH INVOLVING HUMAN PARTICIPANTS
p.(None): 6.1 Definition
p.(None): 6.2 Ethics in Dental Research Involving Human Participants
p.(None): 6.3 Code of Ethics in Dental Research Involving Human Participants
p.(None): 6.4 Establishment of the Dental Ethics Review Board (DERB)
p.(None): 6.5 Authority of the Dental Ethics Review Board
p.(None): 6.6 Types of Review
p.(None): 6.6.1 Minimal Risk.
p.(None): 6.6.2 Determining the Level of Review
p.(None): 6.6.2.1 Full Dental Ethical Board Review
p.(None): 6.6.2.2 Exempt from the full ethical board review
p.(None): 6.6.2.3 Expedited from the full ethical board review
p.(None): 6.8 Conflict of Interest
p.(None): 6.9 Informed Consent:
p.(None): 6.9.1 Re-consent
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.9.2 Waiver of consent
p.(None): 6.10 Submitting a Research Proposal
p.(None): 6.11 Electronic Submission of a Research proposal
p.(None): 6.12 Evaluation of submitted research proposals
p.(None): 6.13 Meeting Requirements
p.(None): 6.14 Decision-making
p.(None): 7.0 RESEARCH PARTICIPANTS REQUIRING ADDITIONAL ATTENTION
p.(None): 7.1 Research Involving Children and Adolescents
p.(None): 7.1.1 Approval of research involving children and adolescents
p.(None): 7.1.2 Consent for children or adolescents
p.(None): 7.2 Research involving pregnant women
p.(None): 7.3 Research involving a fetus
p.(None): 7.4 Research involving prisoners
p.(None): 7.4.1 Considerations regarding research involving prisoners
p.(None): 7.4.2 Approval of research involving prisoners
p.(None): 7.5 Research involving humans highly dependent on medical care
p.(None): 7.6 Other groups requiring additional attention
p.(None): 8.0 EPIDEMIOLOGICAL RESEARCH
p.(None): 9.0 HUMAN GENETIC RESEARCH
p.(None): 10.0 HUMAN TISSUE SAMPLES
p.(None): 11.0 REFERENCES
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): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 1.0 INTRODUCTION
p.(None): The College of Dentistry, King Saud University is the one of the dental colleges in the Kingdom of Saudi Arabia and
p.(None): the Gulf Countries that carries the responsibility of educating students, providing oral health services to the
p.(None): patients, conducting research and servicing the community. These responsibilities are conducted under the good ethical
p.(None): principles that guide the educational process in King Saud University.
p.(None):
...
p.(None): practices such as (a) regular and special education
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): instructional strategies, or (b) research on the effectiveness of or the comparison among instructional
p.(None): techniques, curricula, or classroom management methods.
p.(None): 2. Research involving use of educational tests, survey or interview procedures, or observation of public
p.(None): behavior unless information obtained from these sources is recorded in such a manner that subjects can
p.(None): be identified, and disclosure of the subject’s responses outside the research could reasonably place the subject
p.(None): at risk of criminal or civil liability or be damaging to his or her financial standing,
p.(None): employability, or reputation.
p.(None): 3. Research involving the use of education tests, survey procedures, interview procedures, or observation of
p.(None): public behavior if (a) the human subjects are elected or appointed public officials or candidates for
p.(None): public office; or (b) federal statutes require, without exception, that the confidentiality of the
p.(None): personally identifiable information will be maintained throughout the research and thereafter. Children may
p.(None): not be involved in this research.
p.(None): 4. Research involving the collection or study of existing data, documents, records, pathological
p.(None): specimens, or diagnostic specimens, (a) if these sources are publicly available, or (b) if the information is
p.(None): recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers
p.(None): linked to the subjects.
p.(None): 5. Research and demonstration projects that are designed to study, evaluate, or otherwise examine (a) public benefit
p.(None): or service programs; (b) procedures for obtaining benefits or services under these programs; (c) possible changes or
p.(None): alternatives to those programs or procedures; or (d) possible changes in methods or levels of payments for benefits or
p.(None): services under those programs.
p.(None): 6. Tests and food quality evaluation and consumer studies (a) if wholesome food without additives is consumed, or (b)
p.(None): if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or
p.(None): agricultural chemical or environmental contaminant at or below the level found to be safe.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.7.2.3 Expedited from the full ethical board review
p.(None): The determination of the expedited status for any research proposal is the authority of the DERB chairman. A dental
p.(None): research proposal eligible expedited from the full ethical board review means that the proposed dental research
...
p.(None): buccal scraping or swab, skin swab, or mouth washings; (e) sputum collected after saline mist
p.(None): nebulization.
p.(None): 4. Collection of data through noninvasive procedures routinely employed in dental clinical practice,
p.(None): excluding procedures involving x-rays. The medical/dental devices employed must be cleared/approved
p.(None): for marketing. Example: Analysis of measurements of blood pressure and heart rate using an automated blood
p.(None): pressure monitor every 10 minutes during tooth extraction, a comparison between routine local anesthesia and
p.(None): routine local anesthesia with hypnosis.
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 5. Research involving materials (data, documents, records, or specimens) that have been collected, or
p.(None): will be collected solely for non-research purposes. Example: (i) Prospective review of dental records
p.(None): to determine the outcome of standard treatment of oral ulcers in HIV-positive patients. (ii) Review of
p.(None): medical records and pathology samples of patients with parotid tumors to determine predictors of malignancy.
p.(None): 6. Collection of data from voice, video, digital, or image recordings made for research purposes.
p.(None): 7. Research on individual or group characteristics or behavior employing survey, interview, oral history,
p.(None): focus group, program evaluation, human factors evaluation, or quality assurance methodologies. Examples: (i) Survey of
p.(None): children in a Headstart program to determine knowledge about dental care. (ii) Focus group of multiple
p.(None): ethnic groups to determine attitudes and practices about oral health.
p.(None): 8. Continuing review of research previously approved by the full DERB review as follows: (a) where (i) the
p.(None): research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related
p.(None): interventions; and (iii) the research remains active only for long-term follow-up of subjects; or (b) where no subjects
p.(None): have been enrolled and no additional risks have been identified; or (c) where the remaining research
p.(None): activities are limited to data analysis.
p.(None): 9. Continuing review of research, not conducted under an investigational new drug application or
p.(None): investigational device exemption where categories two (2) through eight (8) do not apply but the DERB has
p.(None): determined and documented at a convened meeting that the research involves no greater than minimal risk and no
p.(None): additional risks have been identified.
p.(None):
p.(None): 6.8 Conflict of Interest
p.(None): Dental researchers hold trustful relationships with research participants, research sponsors, their
p.(None): institution, professional bodies and society. This trust can be put at risk by a conflict of interest that
p.(None): influences their independent and objective judgment.
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
...
p.(None): for both privacy and confidentiality, and do not violate the rights of the participants then the DERB
p.(None): may waive the requirement for informed consent in the following instances:
p.(None): a) When it is impractical to conduct research since confidentiality of personally identifiable
p.(None): information has to be maintained throughout the research.
p.(None): b) Research on publicly available information, documents, records, works, performances,
p.(None): reviews, quality assurance studies, archival materials or third party interviews, service programs for benefit
p.(None): of public having a bearing on public health programs, and consumer acceptance studies.
p.(None): c) Research on anonymised biological samples from left over samples after clinical investigation.
p.(None): d) In emergency situations when informed consent can be taken. Do you mean cannot be taken? (yes cannot, but I think
p.(None): we need to define the emergency situations)
p.(None):
p.(None): 7.0 Research Participants Requiring Additional Attention
p.(None): Humans with limited autonomy or in subordinate positions are considered participants that require additional
p.(None): attention and are in need of greater protection. These may include children, pregnant women and fetus, prisoners, and
p.(None): human highly dependent on medical care. Does this cover mentally impaired people?
p.(None):
p.(None): 7.1 Research involving children, adolescents and mentally impaired people
p.(None): Dental treatment and research on children, adolescents and mentally impaired person is part of the dental
p.(None): discipline. A child is a person who has not yet reached puberty
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): whereas an adolescent is a person who is reaching or has reached puberty. Mentally impaired person is a
p.(None): person who has impairment of intelligence and social functioning which appears to be permanent or temporary. Children,
p.(None): adolescents and mentally impaired person are considered participants who require additional attention because
p.(None): of their limited intellectual and emotional capacities. They cannot give a legal consent; therefore
p.(None): permission from the parent(s) is essential. Children, adolescents and mentally impaired person should
p.(None): participate in research only where their participation is indispensable to the research and where participation is
p.(None): not contrary to the individual's best interests. The research proposal must provide sufficient
p.(None): information to justify clearly why children, adolescents or mentally impaired person should be included
p.(None): as participants. Refusal of a child, adolescent or mentally impaired person to participate in the research must be
p.(None): respected.
p.(None):
p.(None): 7.1.1 Approval of research involving children and adolescents
p.(None): Research involving a child, adolescent or mentally impaired person should be approved only if:
p.(None): 1) The research, including observational research, places the child , adolescent or mentally impaired person at no
p.(None): more than minimal risk (that is, the risk commensurate with daily life or routine dental examinations – referred to as
p.(None): 'negligible risk' in some guidelines).
p.(None): 2) The research involves more than minimal risk but provides possible benefit for the child, adolescent or mentally
p.(None): impaired person participant. The degree of risk must be justified by the potential benefit.
p.(None): 3) The research involves greater than minimal risk, with no prospect of direct benefit to the child, adolescent or
p.(None): mentally impaired person, but has a high probability of providing significant knowledge. The risk should be justified
p.(None): by the risk-knowledge ratio and the risk must represent no more than a minor increase over minimal risk.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 7.1.2 Consent for children or adolescents
p.(None): Consent for children, adolescents or mentally impaired person to participate in research must be obtained from:
p.(None): a) The parents or legal guardian in all but exceptional circumstances such as emergencies.
p.(None): b) The child or adolescent that is competent to make the decision.
p.(None): c) Any organization or person required by authorization.
p.(None): d) No other caregiver can act on behalf of a child in providing consent to participate.
p.(None):
p.(None):
p.(None): 7.2 Research involving pregnant women
p.(None): The DERB must give extra attention to research that involves pregnant women or those who may become pregnant, because
p.(None): of the additional health concerns during pregnancy and the need to avoid unnecessary risk to the fetus. The policy of
p.(None): the college of dentistry research center is that; no pregnant woman may be involved as a participant in any dental
p.(None): research activity unless:
...
Social / Elderly
Searching for indicator elderly:
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p.(None): 2. Research activities on humans in the intensive care unit
p.(None): 3. Research activities on neonatals in the intensive care unit
p.(None): 4. Research activities on humans in the terminal care unit
p.(None): 5. Research activities on decisionally impaired humans
p.(None): 6. Research activities on unconscious human
p.(None): The policy of the college of dentistry research center is that; no dental research should be carried out on the above
p.(None): mentioned conditions. However, The DERB, within its authority can approve dental research in the following conditions;
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): • The research is based on valid scientific hypotheses which support a reasonable possibility of benefit over
p.(None): standard care.
p.(None): • The research is intended to be therapeutic and the research intervention poses no more than a risk that is
p.(None): expected in alternative methods of treatment.
p.(None):
p.(None): 7.6 Other groups requiring additional attention
p.(None): The discussion of the dental research participants requiring additional attention should not be limited to those
p.(None): already mentioned. Other groups that require additional attention include: traumatized and comatose patients,
p.(None): terminally ill patients, elderly or aged patients, minorities, students, and employees. The DERB must ensure that
p.(None): special consideration is given to all these groups, especially with regard to the risks, benefits and obtaining
p.(None): informed consent.
p.(None):
p.(None): 8.0 EPIDEMIOLOGICAL RESEARCH
p.(None):
p.(None): Epidemiological research describes the health status in a population or subgroup of the population. Epidemiological
p.(None): research studies the distribution and determinants of health related problems in populations, and the application of
p.(None): the research results to prevent, control or eliminate such health problems. It is concerned with improvement of the
p.(None): health status and welfare in human populations and with the improvement in the efficiency and performance of health
p.(None): services. Epidemiological research is carried out with human participants, or data or biological samples from them,
p.(None): and such research provides important new knowledge that is not readily obtainable in other ways. Perhaps the second
p.(None): most significant dental discoveries, after local anesthesia, were the effects of naturally occurring fluoride on
p.(None): reducing the incidence of dental caries as revealed by epidemiological research. Such epidemiological studies provided
p.(None): the motive for several clinical and laboratory research studies on the relationships between fluoride and dental
p.(None): caries. The findings from these researches laid the ground for the current understanding of the relationship between
p.(None): fluoride and oral disease.
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
...
Social / Ethnicity
Searching for indicator ethnic:
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p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
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): King Saud University College of Dentistry
p.(None):
p.(None):
p.(None):
p.(None): ETHICS IN DENTAL PRACTICE
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 2011-2012
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): INTRODUCTION
p.(None):
p.(None): Dentists should follow high ethical standards considering the benefits of the patient as their primary goal. The
p.(None): privilege of being a dentist comes with a responsibility to society and to fellow members of the profession to conduct
p.(None): ones professional activities in a highly ethical manner. The dentist –patient relationship is the cornerstone of dental
p.(None): ethics.
p.(None): This document is supplementary to the ethics in medical profession document by the Saudi Commission for
p.(None): health specialties which is the reference for ethics in medical profession.
p.(None):
p.(None):
p.(None): Respect and Equal Treatment
p.(None):
p.(None): Dental treatment should be provided without discrimination based on the basis of on patient’s gender, racial,
p.(None): religious, or ethnic characteristic. Service to the public includes the delivery of quality, component, and timely care
p.(None): within the bounds of the clinical circumstances presented by the patient.
p.(None): Professional Esteem
p.(None):
p.(None): While serving the public, a dentist has the obligation to act in a manner that maintains or elevate the esteem of the
p.(None): profession.
p.(None): Standard of care
p.(None):
p.(None): It is unethical for a dentist to render, or cause to be rendered, dental treatment of a quality that falls short of
p.(None): best available scientific evidence.
p.(None): Informed Consent
p.(None): Fully informed consent is essential to the ethical practice of dentistry and reflects the patient’s right of self
p.(None): –decision. A dentist must get valid consent before starting treatment or physical investigation, or providing personal
p.(None): care, for a patient. Dentists must provide all the information patients need to make their decisions. This involve
p.(None): explaining complex dental diagnosis, prognoses and treatment regimes in simple language, confirming or correcting
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): information that the patients may have obtained elsewhere (e.g., from another health practitioner, magazines or the
p.(None): internet), ensuring that patients understand the treatment options (including the option of no treatment) advantages
p.(None): and disadvantages of each, answering any questions they may have, and understanding whatever decision the patient has
p.(None): reached and, if possible, the reasons for it.
...
p.(None): nebulization.
p.(None): 4. Collection of data through noninvasive procedures routinely employed in dental clinical practice,
p.(None): excluding procedures involving x-rays. The medical/dental devices employed must be cleared/approved
p.(None): for marketing. Example: Analysis of measurements of blood pressure and heart rate using an automated blood
p.(None): pressure monitor every 10 minutes during tooth extraction, a comparison between routine local anesthesia and
p.(None): routine local anesthesia with hypnosis.
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 5. Research involving materials (data, documents, records, or specimens) that have been collected, or
p.(None): will be collected solely for non-research purposes. Example: (i) Prospective review of dental records
p.(None): to determine the outcome of standard treatment of oral ulcers in HIV-positive patients. (ii) Review of
p.(None): medical records and pathology samples of patients with parotid tumors to determine predictors of malignancy.
p.(None): 6. Collection of data from voice, video, digital, or image recordings made for research purposes.
p.(None): 7. Research on individual or group characteristics or behavior employing survey, interview, oral history,
p.(None): focus group, program evaluation, human factors evaluation, or quality assurance methodologies. Examples: (i) Survey of
p.(None): children in a Headstart program to determine knowledge about dental care. (ii) Focus group of multiple
p.(None): ethnic groups to determine attitudes and practices about oral health.
p.(None): 8. Continuing review of research previously approved by the full DERB review as follows: (a) where (i) the
p.(None): research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related
p.(None): interventions; and (iii) the research remains active only for long-term follow-up of subjects; or (b) where no subjects
p.(None): have been enrolled and no additional risks have been identified; or (c) where the remaining research
p.(None): activities are limited to data analysis.
p.(None): 9. Continuing review of research, not conducted under an investigational new drug application or
p.(None): investigational device exemption where categories two (2) through eight (8) do not apply but the DERB has
p.(None): determined and documented at a convened meeting that the research involves no greater than minimal risk and no
p.(None): additional risks have been identified.
p.(None):
p.(None): 6.8 Conflict of Interest
p.(None): Dental researchers hold trustful relationships with research participants, research sponsors, their
p.(None): institution, professional bodies and society. This trust can be put at risk by a conflict of interest that
p.(None): influences their independent and objective judgment.
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): Conflict of Interest is when the professional judgment concerning research is influenced by a secondary interest such
p.(None): as personal or financial gain. The dental researchers and DERB members should disclose any actual, perceived or
...
Social / Fetus/Neonate
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p.(None): 6.5 Authority of the Dental Ethics Review Board
p.(None): 6.6 Types of Review
p.(None): 6.6.1 Minimal Risk.
p.(None): 6.6.2 Determining the Level of Review
p.(None): 6.6.2.1 Full Dental Ethical Board Review
p.(None): 6.6.2.2 Exempt from the full ethical board review
p.(None): 6.6.2.3 Expedited from the full ethical board review
p.(None): 6.8 Conflict of Interest
p.(None): 6.9 Informed Consent:
p.(None): 6.9.1 Re-consent
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.9.2 Waiver of consent
p.(None): 6.10 Submitting a Research Proposal
p.(None): 6.11 Electronic Submission of a Research proposal
p.(None): 6.12 Evaluation of submitted research proposals
p.(None): 6.13 Meeting Requirements
p.(None): 6.14 Decision-making
p.(None): 7.0 RESEARCH PARTICIPANTS REQUIRING ADDITIONAL ATTENTION
p.(None): 7.1 Research Involving Children and Adolescents
p.(None): 7.1.1 Approval of research involving children and adolescents
p.(None): 7.1.2 Consent for children or adolescents
p.(None): 7.2 Research involving pregnant women
p.(None): 7.3 Research involving a fetus
p.(None): 7.4 Research involving prisoners
p.(None): 7.4.1 Considerations regarding research involving prisoners
p.(None): 7.4.2 Approval of research involving prisoners
p.(None): 7.5 Research involving humans highly dependent on medical care
p.(None): 7.6 Other groups requiring additional attention
p.(None): 8.0 EPIDEMIOLOGICAL RESEARCH
p.(None): 9.0 HUMAN GENETIC RESEARCH
p.(None): 10.0 HUMAN TISSUE SAMPLES
p.(None): 11.0 REFERENCES
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): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 1.0 INTRODUCTION
p.(None): The College of Dentistry, King Saud University is the one of the dental colleges in the Kingdom of Saudi Arabia and
p.(None): the Gulf Countries that carries the responsibility of educating students, providing oral health services to the
p.(None): patients, conducting research and servicing the community. These responsibilities are conducted under the good ethical
p.(None): principles that guide the educational process in King Saud University.
p.(None):
p.(None): The Research Center within the College of Dentistry (CDRC) is the product of the University’s aspiration of bringing
p.(None): about a more research-oriented institution especially in the area of dentistry. Founded in 1981, its primary goal is
...
p.(None): may waive the requirement for informed consent in the following instances:
p.(None): a) When it is impractical to conduct research since confidentiality of personally identifiable
p.(None): information has to be maintained throughout the research.
p.(None): b) Research on publicly available information, documents, records, works, performances,
p.(None): reviews, quality assurance studies, archival materials or third party interviews, service programs for benefit
p.(None): of public having a bearing on public health programs, and consumer acceptance studies.
p.(None): c) Research on anonymised biological samples from left over samples after clinical investigation.
p.(None): d) In emergency situations when informed consent can be taken. Do you mean cannot be taken? (yes cannot, but I think
p.(None): we need to define the emergency situations)
p.(None):
p.(None): 7.0 Research Participants Requiring Additional Attention
p.(None): Humans with limited autonomy or in subordinate positions are considered participants that require additional
p.(None): attention and are in need of greater protection. These may include children, pregnant women and fetus, prisoners, and
p.(None): human highly dependent on medical care. Does this cover mentally impaired people?
p.(None):
p.(None): 7.1 Research involving children, adolescents and mentally impaired people
p.(None): Dental treatment and research on children, adolescents and mentally impaired person is part of the dental
p.(None): discipline. A child is a person who has not yet reached puberty
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): whereas an adolescent is a person who is reaching or has reached puberty. Mentally impaired person is a
p.(None): person who has impairment of intelligence and social functioning which appears to be permanent or temporary. Children,
p.(None): adolescents and mentally impaired person are considered participants who require additional attention because
...
p.(None):
p.(None): 7.1.2 Consent for children or adolescents
p.(None): Consent for children, adolescents or mentally impaired person to participate in research must be obtained from:
p.(None): a) The parents or legal guardian in all but exceptional circumstances such as emergencies.
p.(None): b) The child or adolescent that is competent to make the decision.
p.(None): c) Any organization or person required by authorization.
p.(None): d) No other caregiver can act on behalf of a child in providing consent to participate.
p.(None):
p.(None):
p.(None): 7.2 Research involving pregnant women
p.(None): The DERB must give extra attention to research that involves pregnant women or those who may become pregnant, because
p.(None): of the additional health concerns during pregnancy and the need to avoid unnecessary risk to the fetus. The policy of
p.(None): the college of dentistry research center is that; no pregnant woman may be involved as a participant in any dental
p.(None): research activity unless:
p.(None): • The purpose of the research is to meet the health needs of the mother and the fetus will be placed at no
p.(None): risk, or
p.(None): • The risk to the fetus is minimal.
p.(None): The DERB should consider the following regulatory protections before approval of the research proposal.
p.(None): • Appropriate studies conducted on animals and non-pregnant women have provided data for assessing potential risks.
p.(None): • Risks and prospects of benefit to the fetus and mother (separately or together) and the purpose of the research
p.(None): have been determined.
p.(None): • Any risk is the least possible for achieving the objectives of the research.
p.(None): The research activity may be permitted to be conducted only if the mother is legally competent and has given informed
p.(None): consent after having been fully informed about the possible impact on the fetus. The father's informed consent needs to
p.(None): be secured if the research has any risk to the fetus.
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None):
p.(None): 7.3 Research involving a fetus
p.(None): Dental research usually do not involve fetuses as participants, however, in research involve investigations on the
p.(None): craniofacial malformations such as cleft lip and palate the dental researcher may be involved as a member of a larger
p.(None): research group including medical researchers. The dental researcher must abide by the ethical codes and the regulatory
p.(None): procedures of the medical research team.
p.(None): The policy of the Research Center College of Dentistry for the dental research involving fetus is that; no fetus in
p.(None): utero may be involved as a participant in any dental research activity. The inclusion of any member of the college of
p.(None): dentistry in research activity involving fetuses as a member of larger team must be approved by the DERB. The approval
p.(None): of the DERB must be granted before the member start any research activity within the research team.
p.(None):
p.(None): 7.4 Research involving Prisoners
p.(None): A Prisoner is an individual involuntarily confined in a penal institution, including persons:
p.(None): (1) sentenced under a criminal or civil statute; (2) detained pending arraignment, trial, or sentencing; and (3)
p.(None): detained in other facilities such as treatment of addiction. The condition of imprisonment may make it difficult to
p.(None): ensure voluntary consent and confidentiality. There is a need for special consideration to provide protection to
p.(None): prisoner participating in research. The college of dentistry research center policy requires that all dental research
p.(None): involving prisoners should be reviewed by the full board.
p.(None):
p.(None): 7.4.1 Considerations regarding research involving prisoners
p.(None): The DERB will approve research proposals involving prisoners if:
...
Searching for indicator fetuses:
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p.(None): in everyday life.
p.(None): 3) The project neither includes nor attempts to induce long-term significant change in the participant's behavior
p.(None): (including attitude towards self and others).
p.(None): 4) The data would not embarrass or socially disadvantage the participant, were confidentiality to
p.(None): be violated.
p.(None): 5) If the investigator conceals information about specific purpose of the project, there is no reason to believe
p.(None): the subject would choose not to participate if he or she had known that information initially.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.7.2 Determining the Level of Review
p.(None): There are three levels of review for a research proposal depending on the risk expected to the human participating in
p.(None): the planned research. The three levels are:
p.(None): (1) Full Dental Ethical Board Review.
p.(None): (2) Exempt from the full dental ethical board review.
p.(None): (3) Expedited from the full dental ethical board review.
p.(None):
p.(None):
p.(None): 6.7.2.1 Full Dental Ethical Board Review
p.(None): Any protocol that uses a methodology that is sensitive and of higher probability for causing harm or
p.(None): distress to participants is subject to full board review. Additionally, any protocol using prisoners as
p.(None): participants or involving pregnant women, fetuses, and human in vitro fertilization will be reviewed by
p.(None): the full board. Research in which the risks versus the expected benefits are relatively high is also likely to be
p.(None): reviewed by the full board.
p.(None): Dental research proposals that require full dental ethical board review included, but are not necessarily limited to
p.(None): the following:
p.(None): 1) Clinical trials involving human participants
p.(None): 2) New treatments or interventions
p.(None): 3) Research involving human remains, cadavers, tissues, discarded tissue (e.g. placenta), biological
p.(None): fluids
p.(None): 4) Physiological studies
p.(None): 5) Comparing an established procedure, whether therapeutic, non-therapeutic or diagnostic, with other
p.(None): procedures which are not recognized as established by virtue of their recent development, discovery or use in a new or
p.(None): unfamiliar way
p.(None): 6) Innovative practices in health and disability services
p.(None): 7) Research conducted by students, which includes all activities that meet the definition of
p.(None): research with human participants (As supervised student research is conducted primarily for the purpose of
p.(None): educating students on research techniques and methodologies, DERB should review research protocols with
p.(None): a view to
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): contributing to the students’ education concerning scientific and ethical principles governing research).
p.(None): 8) Observational clinical research
...
p.(None): The DERB should consider the following regulatory protections before approval of the research proposal.
p.(None): • Appropriate studies conducted on animals and non-pregnant women have provided data for assessing potential risks.
p.(None): • Risks and prospects of benefit to the fetus and mother (separately or together) and the purpose of the research
p.(None): have been determined.
p.(None): • Any risk is the least possible for achieving the objectives of the research.
p.(None): The research activity may be permitted to be conducted only if the mother is legally competent and has given informed
p.(None): consent after having been fully informed about the possible impact on the fetus. The father's informed consent needs to
p.(None): be secured if the research has any risk to the fetus.
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None):
p.(None): 7.3 Research involving a fetus
p.(None): Dental research usually do not involve fetuses as participants, however, in research involve investigations on the
p.(None): craniofacial malformations such as cleft lip and palate the dental researcher may be involved as a member of a larger
p.(None): research group including medical researchers. The dental researcher must abide by the ethical codes and the regulatory
p.(None): procedures of the medical research team.
p.(None): The policy of the Research Center College of Dentistry for the dental research involving fetus is that; no fetus in
p.(None): utero may be involved as a participant in any dental research activity. The inclusion of any member of the college of
p.(None): dentistry in research activity involving fetuses as a member of larger team must be approved by the DERB. The approval
p.(None): of the DERB must be granted before the member start any research activity within the research team.
p.(None):
p.(None): 7.4 Research involving Prisoners
p.(None): A Prisoner is an individual involuntarily confined in a penal institution, including persons:
p.(None): (1) sentenced under a criminal or civil statute; (2) detained pending arraignment, trial, or sentencing; and (3)
p.(None): detained in other facilities such as treatment of addiction. The condition of imprisonment may make it difficult to
p.(None): ensure voluntary consent and confidentiality. There is a need for special consideration to provide protection to
p.(None): prisoner participating in research. The college of dentistry research center policy requires that all dental research
p.(None): involving prisoners should be reviewed by the full board.
p.(None):
p.(None): 7.4.1 Considerations regarding research involving prisoners
p.(None): The DERB will approve research proposals involving prisoners if:
p.(None): 1. Research will probably improve oral health or well‐being of the prisoners.
p.(None): 2. Minimal risk and no more than inconvenience caused and the research is a study of causes and effects.
p.(None):
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Social / Incarcerated
Searching for indicator incarcerated:
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p.(None): (1) sentenced under a criminal or civil statute; (2) detained pending arraignment, trial, or sentencing; and (3)
p.(None): detained in other facilities such as treatment of addiction. The condition of imprisonment may make it difficult to
p.(None): ensure voluntary consent and confidentiality. There is a need for special consideration to provide protection to
p.(None): prisoner participating in research. The college of dentistry research center policy requires that all dental research
p.(None): involving prisoners should be reviewed by the full board.
p.(None):
p.(None): 7.4.1 Considerations regarding research involving prisoners
p.(None): The DERB will approve research proposals involving prisoners if:
p.(None): 1. Research will probably improve oral health or well‐being of the prisoners.
p.(None): 2. Minimal risk and no more than inconvenience caused and the research is a study of causes and effects.
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 3. Minimal risk and no more than inconvenience caused and research is a study of prisons as institutional structures
p.(None): or of prisoners as incarcerated persons.
p.(None): 4. Research on conditions affecting prisoners as a class.
p.(None):
p.(None):
p.(None): 7.4.2 Approval of research involving prisoners
p.(None): 1) Advantages through participation compared to their current situation.
p.(None): 2) Risk of participation is the same as those that would be accepted by non‐prisoners.
p.(None): 3) Procedure of selection is fair to all prisoners.
p.(None): 4) Language for obtaining informed consent must be understandable to prisoners.
p.(None): 5) When studies need follow‐up, the provision for follow‐up must include a consideration of the length of individual
p.(None): sentences, and prisoners must be informed about follow‐up.
p.(None):
p.(None): 7.5 Research involving humans highly dependent on medical care
p.(None): Dental research on humans who are highly dependent on medical care raises ethical issues that deserve special
p.(None): attention. Researchers need to acknowledge that informed consent may be compromised by the effect of the medical
p.(None): condition or fear of affecting the level of medical care in case of refusal to participate. The following conditions
p.(None): are considered for possible dental research activities.
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Social / Linguistic Proficiency
Searching for indicator language:
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p.(None): regulations pertaining to the education of students and patient care.
p.(None):
p.(None): 10. Ethics on education on patients
p.(None):
p.(None): Dental education is based on practical clinical training that relies heavily on interaction with patients.
p.(None): There are sets of ethical principles related to training on patients that faculty members should observe
p.(None): which include:
p.(None):
p.(None): 1. The faculty member must respect patient's privacy thereby should avoid discuss issues infringing on
p.(None): the patient’s privacy in front of a group of trainees to ensure respecting patient’s right to privacy and
p.(None): confidentiality
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 2. The faculty member should be committed to prevent harm to the patient of any sort during the education of trainees.
p.(None):
p.(None): 3. The faculty member should avoid approaching the patient with a large number of students or multiple physical
p.(None): examinations by students in a short time period.
p.(None):
p.(None): 4. The faculty member should avoid blaming or reprimanding a trainee in front of the patient, in order to preserve
p.(None): the dignity of the trainee on one hand, and not to confuse the patient on the other hand, especially if all spoke a
p.(None): language not understood by the patient.
p.(None):
p.(None): 5. The faculty member should respect gradual progression in patient care assignments to the trainees. In
p.(None): addition, the supervising faculty member remains responsible for providing adequate supervision to
p.(None): ensure that the patient will receive appropriate care.
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): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): REFERENCES
p.(None): • Ethical Principles in College Teaching.Published by: Society for Teaching and Learning in Higher
p.(None): Education(STLHE)/ La Societe pour l'avancement de la
p.(None): pedagogiedansl'enseignementsuperieur (SAPES). 1996. http://www.stlhe.ca/en/stlhe/
p.(None):
p.(None): • Code of Conduct for All Staff.Australian Catholic College (AUC). November 2006
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 specialties which is the reference for ethics in medical profession.
p.(None):
p.(None):
p.(None): Respect and Equal Treatment
p.(None):
p.(None): Dental treatment should be provided without discrimination based on the basis of on patient’s gender, racial,
p.(None): religious, or ethnic characteristic. Service to the public includes the delivery of quality, component, and timely care
p.(None): within the bounds of the clinical circumstances presented by the patient.
p.(None): Professional Esteem
p.(None):
p.(None): While serving the public, a dentist has the obligation to act in a manner that maintains or elevate the esteem of the
p.(None): profession.
p.(None): Standard of care
p.(None):
p.(None): It is unethical for a dentist to render, or cause to be rendered, dental treatment of a quality that falls short of
p.(None): best available scientific evidence.
p.(None): Informed Consent
p.(None): Fully informed consent is essential to the ethical practice of dentistry and reflects the patient’s right of self
p.(None): –decision. A dentist must get valid consent before starting treatment or physical investigation, or providing personal
p.(None): care, for a patient. Dentists must provide all the information patients need to make their decisions. This involve
p.(None): explaining complex dental diagnosis, prognoses and treatment regimes in simple language, confirming or correcting
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): information that the patients may have obtained elsewhere (e.g., from another health practitioner, magazines or the
p.(None): internet), ensuring that patients understand the treatment options (including the option of no treatment) advantages
p.(None): and disadvantages of each, answering any questions they may have, and understanding whatever decision the patient has
p.(None): reached and, if possible, the reasons for it.
p.(None): Any competent mature adult person may fully consent to treatment. A person is considered competent if he/she has
p.(None): sufficient understanding and capacity to make and communicate reasonable decisions. A legally appointed guardian may
p.(None): consent to the treatment for an incompetent adult.
p.(None): A parent or legally appointed guardian must consent to the treatment for young children and mentally disabled adults.
p.(None): Parents or legal guardians have a right to an explanation regarding the options for behavioral management of children,
p.(None): and are responsible to ask for additional information if they do not understand explanations. Siblings, friends, or any
...
p.(None): institution, professional bodies and society. This trust can be put at risk by a conflict of interest that
p.(None): influences their independent and objective judgment.
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): Conflict of Interest is when the professional judgment concerning research is influenced by a secondary interest such
p.(None): as personal or financial gain. The dental researchers and DERB members should disclose any actual, perceived or
p.(None): potential conflicts of interest to the DERB. The DERB should develop mechanisms to address and manage such conflicts of
p.(None): interest.
p.(None):
p.(None): 6.9 Informed Consent
p.(None): Informed consent means that a participant has been informed about the risks and benefits of the research,
p.(None): understands such risks and benefits and is able to give consent to participation, without coercion, undue
p.(None): influence or inappropriate incentives. It represents a signed agreement between the dental researcher
p.(None): and the human participant or their legally authorized representative to participate in the research
p.(None): before the start of the research. The informed consent process should provide the necessary information to
p.(None): the participants in simple, clear language that they understand and in terms they comprehend. It should provide the
p.(None): freedom of choice, the respect of participant’s autonomy, the voluntariness to participate and the protection
p.(None): of privacy and confidentiality. The information is given in a document known as the Informed Consent
p.(None): Form.
p.(None):
p.(None): The informed consent form should have the following as may be applicable:
p.(None): 1) Nature and purpose of study, stating it as research.
p.(None): 2) Duration of participation with number of participants.
p.(None): 3) Procedures to be followed.
p.(None): 4) Investigations, if any, to be performed.
p.(None): 5) Foreseeable risks and discomforts adequately described and whether the project involves more than minimal
p.(None): risk.
p.(None): 6) Benefits to participants, community or the dental profession as may be applicable.
p.(None): 7) Policy on compensation.
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 8) Availability of dental or alternative treatments if available for injuries or risk management.
p.(None): 9) Steps taken for ensuring confidentiality.
p.(None): 10) Freedom to withdraw without any consequences or loss of benefits.
p.(None): 11) Contact details of researchers for seeking more information related to the research or in case of injury.
p.(None): 12) Contact details for appeal against violation of rights.
p.(None): 13) Voluntary participation.
...
p.(None): involving prisoners should be reviewed by the full board.
p.(None):
p.(None): 7.4.1 Considerations regarding research involving prisoners
p.(None): The DERB will approve research proposals involving prisoners if:
p.(None): 1. Research will probably improve oral health or well‐being of the prisoners.
p.(None): 2. Minimal risk and no more than inconvenience caused and the research is a study of causes and effects.
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 3. Minimal risk and no more than inconvenience caused and research is a study of prisons as institutional structures
p.(None): or of prisoners as incarcerated persons.
p.(None): 4. Research on conditions affecting prisoners as a class.
p.(None):
p.(None):
p.(None): 7.4.2 Approval of research involving prisoners
p.(None): 1) Advantages through participation compared to their current situation.
p.(None): 2) Risk of participation is the same as those that would be accepted by non‐prisoners.
p.(None): 3) Procedure of selection is fair to all prisoners.
p.(None): 4) Language for obtaining informed consent must be understandable to prisoners.
p.(None): 5) When studies need follow‐up, the provision for follow‐up must include a consideration of the length of individual
p.(None): sentences, and prisoners must be informed about follow‐up.
p.(None):
p.(None): 7.5 Research involving humans highly dependent on medical care
p.(None): Dental research on humans who are highly dependent on medical care raises ethical issues that deserve special
p.(None): attention. Researchers need to acknowledge that informed consent may be compromised by the effect of the medical
p.(None): condition or fear of affecting the level of medical care in case of refusal to participate. The following conditions
p.(None): are considered for possible dental research activities.
p.(None): 1. Research activities on humans under emergency care
p.(None): 2. Research activities on humans in the intensive care unit
p.(None): 3. Research activities on neonatals in the intensive care unit
p.(None): 4. Research activities on humans in the terminal care unit
p.(None): 5. Research activities on decisionally impaired humans
p.(None): 6. Research activities on unconscious human
p.(None): The policy of the college of dentistry research center is that; no dental research should be carried out on the above
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Social / Marital Status
Searching for indicator single:
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p.(None): not be involved in this research.
p.(None): 4. Research involving the collection or study of existing data, documents, records, pathological
p.(None): specimens, or diagnostic specimens, (a) if these sources are publicly available, or (b) if the information is
p.(None): recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers
p.(None): linked to the subjects.
p.(None): 5. Research and demonstration projects that are designed to study, evaluate, or otherwise examine (a) public benefit
p.(None): or service programs; (b) procedures for obtaining benefits or services under these programs; (c) possible changes or
p.(None): alternatives to those programs or procedures; or (d) possible changes in methods or levels of payments for benefits or
p.(None): services under those programs.
p.(None): 6. Tests and food quality evaluation and consumer studies (a) if wholesome food without additives is consumed, or (b)
p.(None): if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or
p.(None): agricultural chemical or environmental contaminant at or below the level found to be safe.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.7.2.3 Expedited from the full ethical board review
p.(None): The determination of the expedited status for any research proposal is the authority of the DERB chairman. A dental
p.(None): research proposal eligible expedited from the full ethical board review means that the proposed dental research
p.(None): is to be reviewed by a single member of the DERB panel. The single member is designated by the DERB
p.(None): chairman. Like the exempt review, the research must be of minimal risk or no more than minimal risk and all aspects of
p.(None): a protocol must fit within one or more expedited categories to be reviewed in this manner. The dental researcher must
p.(None): submit to the DERB secretary the full documentations required for the review by the DERB, including the
p.(None): research proposal, informed consent and the CV’s of the investigators.
p.(None):
p.(None): An expedited review process is available for research activities that present no more than minimal risk to
p.(None): human participants or that request a minor change in previously approved research that involves no additional risk and
p.(None): that involve only procedures in one or more of the categories listed below. Some of the categories overlap with those
p.(None): used to assess exempt status. The distinction between exempt and expedited review is based on the sensitivity of the
p.(None): data and/or the risk of compromised confidentiality (such as a relatively small sample size).
p.(None):
p.(None): The expedited review procedure may not be used where identification of the subjects and/or their responses would
p.(None): reasonably place them at risk of criminal or civil liability or be damaging to the subject’s financial standing,
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Social / Property Ownership
Searching for indicator property:
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p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): professional standard, guided by legal and ethical principles. Research ethics is the application of ethical codes or
p.(None): principles in scientific investigation.
p.(None):
p.(None): 2.2 Importance of the code of ethics in dental research
p.(None): Researchers should be familiar with the code of ethics designed to ensure good conduct and prevent sloppy or
p.(None): irresponsible research. There are several reasons why it is important to adhere to the code of ethics in dental
p.(None): research.
p.(None): 1) The code of ethics promotes the aims of research, such as knowledge, the truth, and avoidance of
p.(None): error. For example, prohibitions against fabricating, falsifying, or misrepresenting research data promote the
p.(None): truth and avoid error.
p.(None): 2) Research often involves a great deal of cooperation and coordination among many different people in different
p.(None): disciplines and institutions, the code of ethics promote the values that are essential to collaborative
p.(None): work, such as respect, trust, accountability, and fairness.
p.(None): 3) The code of ethics in research for authorship, copyright and patenting, data monitoring, and
p.(None): confidentiality protects the intellectual property interests and encourages collaboration. Researchers want to
p.(None): receive credit for their contributions and protect their intellectual property.
p.(None): 4) The code of ethics in research enhances the concept of confidentiality that most researchers want to
p.(None): receive credit and do not want to have their ideas stolen or disclosed prematurely.
p.(None): 5) The ethical codes ensure that the dental researcher is accountable to the public. For instance research
p.(None): misconduct, conflicts of interest, human participant protections, and animal care and use are necessary in order
p.(None): to make sure that the researcher can be held accountable to the public.
p.(None): 6) The code of ethics in research builds the public support for research. The public are more likely to support
p.(None): and participate in research projects if they can trust the quality and integrity of the research.
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 7) Finally, the code of ethics in research promotes a variety of other important moral and social values, such as
p.(None): social responsibility, human rights, and animal welfare, compliance with the law, and health and safety.
p.(None):
p.(None): 3.0 TYPES of RESEARCH
p.(None): The custodian of the two Holy Mosques, King Abdullah Bin Abdulaziz Al-Saud gave his royal order numbered
p.(None): 59/M dated 14-9-1431H to implement the system for the ethics of research involving living objects. In accordance
p.(None): with this, the research center College of Dentistry adopted two categories of research:
p.(None): 1) The non-living objects category
...
p.(None):
p.(None): 4.1 Ethics in Dental Research Involving non-living objects
p.(None): The dental researchers working in research involving non-living objects will spend most of their time in the
p.(None): laboratories. The dental researcher should be familiar with the basic principles regarding the safety procedures in
p.(None): each laboratory. The dental researcher will use some equipment and machines to perform the research so it is
p.(None): necessary to understand their operation and the safety procedures regarding the hazardous
p.(None): materials. He should learn how to deal with the personnel and technicians he will meet on a daily basis and
p.(None): learn how to fit his time with their schedule and respect arrangements made by others.
p.(None):
p.(None): 4.2 Code of ethics in Dental Research Involving non-living objects.
p.(None): The code of ethics adopted by the College of Dentistry Research Center for the dental research are applicable to
p.(None): the dental research conducted by students, interns, academic or clinical staff, or affiliated researcher
p.(None): of the College of Dentistry, King Saud University. This is true regardless of the location where the research is
p.(None): conducted. The general code of ethics in dental research includes and is not limited to the following:
p.(None): 1. Legality: Legal, scientifically sound and ethical conduct of dental research.
p.(None): 2. Honesty: Honest thinking and conduct of dental research from start to finish.
p.(None): 3. Respect: Self-respect and respect to individuals, property and agreements.
p.(None): 4. Responsible: Responsible person and responsible conduct in dental research.
p.(None): 5. Competence: Professional competence in conducting, promoting and mentoring dental research.
p.(None): 6. Objectivity: Objective, unbiased, clear interests in dental research.
p.(None): 7. Carefulness: Careful performance, avoid careless errors and negligence.
p.(None): 8. Confidentiality: Protect the requirements of confidential communications.
p.(None): 9. Openness: Open attitude and openness to criticism and new ideas.
p.(None): 10. Integrity: Act with sincerity and consistency of thought and action.
p.(None): 11. Safety: Proper and safe procedures in dental research and disposal of waste products.
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): These general codes are required for the good conduct of research, however conducting research on living objects
p.(None): require additional codes of ethics that are specified for each category.
p.(None):
p.(None): 5.0 RESEARCH INVOLVING NON-LIVING OBJECTS, PLANTS or ANIMALS
p.(None): The use of plants in dental health is related to the beginning of human beings. Plant material was used for the relief
p.(None): of pain and symptoms from orofacial structure. The use of plants, utilizing scientific method and planned research, in
p.(None): dentistry resulted in the development of known medications and anesthesia.
p.(None):
p.(None): The use of animal in scientific research formed a lifeline for medical and dental research and played a vital role in
p.(None): the development of human health sciences. The use of laboratory animals in Scientific Research began about 100 years
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Social / Racial Minority
Searching for indicator racial:
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p.(None):
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
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): King Saud University College of Dentistry
p.(None):
p.(None):
p.(None):
p.(None): ETHICS IN DENTAL PRACTICE
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 2011-2012
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): INTRODUCTION
p.(None):
p.(None): Dentists should follow high ethical standards considering the benefits of the patient as their primary goal. The
p.(None): privilege of being a dentist comes with a responsibility to society and to fellow members of the profession to conduct
p.(None): ones professional activities in a highly ethical manner. The dentist –patient relationship is the cornerstone of dental
p.(None): ethics.
p.(None): This document is supplementary to the ethics in medical profession document by the Saudi Commission for
p.(None): health specialties which is the reference for ethics in medical profession.
p.(None):
p.(None):
p.(None): Respect and Equal Treatment
p.(None):
p.(None): Dental treatment should be provided without discrimination based on the basis of on patient’s gender, racial,
p.(None): religious, or ethnic characteristic. Service to the public includes the delivery of quality, component, and timely care
p.(None): within the bounds of the clinical circumstances presented by the patient.
p.(None): Professional Esteem
p.(None):
p.(None): While serving the public, a dentist has the obligation to act in a manner that maintains or elevate the esteem of the
p.(None): profession.
p.(None): Standard of care
p.(None):
p.(None): It is unethical for a dentist to render, or cause to be rendered, dental treatment of a quality that falls short of
p.(None): best available scientific evidence.
p.(None): Informed Consent
p.(None): Fully informed consent is essential to the ethical practice of dentistry and reflects the patient’s right of self
p.(None): –decision. A dentist must get valid consent before starting treatment or physical investigation, or providing personal
p.(None): care, for a patient. Dentists must provide all the information patients need to make their decisions. This involve
p.(None): explaining complex dental diagnosis, prognoses and treatment regimes in simple language, confirming or correcting
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): information that the patients may have obtained elsewhere (e.g., from another health practitioner, magazines or the
p.(None): internet), ensuring that patients understand the treatment options (including the option of no treatment) advantages
...
Social / Religion
Searching for indicator religious:
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
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p.(None): King Saud University College of Dentistry
p.(None):
p.(None):
p.(None):
p.(None): ETHICS IN DENTAL PRACTICE
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 2011-2012
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): INTRODUCTION
p.(None):
p.(None): Dentists should follow high ethical standards considering the benefits of the patient as their primary goal. The
p.(None): privilege of being a dentist comes with a responsibility to society and to fellow members of the profession to conduct
p.(None): ones professional activities in a highly ethical manner. The dentist –patient relationship is the cornerstone of dental
p.(None): ethics.
p.(None): This document is supplementary to the ethics in medical profession document by the Saudi Commission for
p.(None): health specialties which is the reference for ethics in medical profession.
p.(None):
p.(None):
p.(None): Respect and Equal Treatment
p.(None):
p.(None): Dental treatment should be provided without discrimination based on the basis of on patient’s gender, racial,
p.(None): religious, or ethnic characteristic. Service to the public includes the delivery of quality, component, and timely care
p.(None): within the bounds of the clinical circumstances presented by the patient.
p.(None): Professional Esteem
p.(None):
p.(None): While serving the public, a dentist has the obligation to act in a manner that maintains or elevate the esteem of the
p.(None): profession.
p.(None): Standard of care
p.(None):
p.(None): It is unethical for a dentist to render, or cause to be rendered, dental treatment of a quality that falls short of
p.(None): best available scientific evidence.
p.(None): Informed Consent
p.(None): Fully informed consent is essential to the ethical practice of dentistry and reflects the patient’s right of self
p.(None): –decision. A dentist must get valid consent before starting treatment or physical investigation, or providing personal
p.(None): care, for a patient. Dentists must provide all the information patients need to make their decisions. This involve
p.(None): explaining complex dental diagnosis, prognoses and treatment regimes in simple language, confirming or correcting
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): information that the patients may have obtained elsewhere (e.g., from another health practitioner, magazines or the
p.(None): internet), ensuring that patients understand the treatment options (including the option of no treatment) advantages
p.(None): and disadvantages of each, answering any questions they may have, and understanding whatever decision the patient has
p.(None): reached and, if possible, the reasons for it.
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Social / Soldier
Searching for indicator military:
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p.(None): 165-170; (2007).
p.(None):
p.(None): 4) Newbrun E. Professional Ethics and Professional Etiquette in Dentistry: Are they Compatible?
p.(None): Journal of the History of Dentistry, 55: 119-124; (2007).
p.(None):
p.(None): 5) Porter, D.G. Ethical scores for animal experiments. Nature, 356: 101-102; (1992).
p.(None):
p.(None): 6) Koski, G. Research Involving Human Subjects in Developing Countries, Editorials; N Engl J Med, 345: 136-138;
p.(None): (2001).
p.(None):
p.(None): 7) Young, S. Risk in Research – from the Nuremberg Code to the Tri-Council Code: Implications for
p.(None): Clinical Trials of Psychotropic Drugs. Journal of Psychiatry and Neuroscience, 23: 149-155; (1998).
p.(None):
p.(None): 8) The Principles of Ethics and Code of Professional Conduct. The University of Washington School of Dentistry,
p.(None): revised (2002).
p.(None):
p.(None): 9) Code of Ethics and Professional Conduct. New York University College of Dentistry. Approved EMC 080405; (2009).
p.(None):
p.(None): 10) California Dental Association Code of Ethics. Adopted by the California Dental Association
p.(None): House of Delegates; (2005).
p.(None):
p.(None): 11) Guidelines for Conduct of Research and Scholarly Activities. University of Medicine and Dentistry of New Jersey;
p.(None): Revised August (2009).
p.(None):
p.(None): 12) The Nuremberg Code. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law.
p.(None): Washington DC : US Government Printing Office. No. 10, Vol. 2, pp. 181-182. (1947).
p.(None):
p.(None): 13) Belmont report: ethical principles and guidelines for the protection of human subjects of research (1979).
p.(None):
p.(None): 14) Declaration of Helsinki: World Medical Association. Recommendations Guiding Physicians in
p.(None): Biomedical Research Involving Subjects (2000).
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None):
p.(None): 15) Ethical Guidelines for Research in Animal Science; Research Animals Department, Royal Society for the Prevention of
p.(None): Cruelty to Animals (RSPCA), UK. (2003).
p.(None):
p.(None): 16) International Ethical Guidelines for Biomedical Research Involving Human Subjects. Prepared by the Council
p.(None): for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO)
p.(None): Geneva (2002).
p.(None):
p.(None): 17) International Guiding Principles for Biomedical Research Involving Animals. The Council for International
p.(None): Organizations of Medical Sciences (CIOMS), Geneva (1985).
p.(None):
p.(None): 18) Ethical Guidelines for Biomedical Research on Human Participants. Indian Council of Medical Research. New
p.(None): Delhi. (2006).
p.(None):
p.(None): 19) Ethical Conduct for Research Involving Humans, Tri-Council Policy Statement. Canadian Institutes of Health
...
Social / Student
Searching for indicator student:
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): There are three distinct ethical codes within this manuscript namely:
p.(None):
p.(None):
p.(None): o ETHICS IN TEACHING AND LEARNING
p.(None):
p.(None): o ETHICS IN DENTAL PRACTICE
p.(None):
p.(None): o ETHICS FOR RESEARCH IN THE COLLEGE OF DENTISTRY
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): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
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): King Saud University College of Dentistry
p.(None):
p.(None):
p.(None):
p.(None): ETHICS IN TEACHING AND LEARNING
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 2011-2012
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): CONTENTS
p.(None):
p.(None): INTRODUCTION
p.(None): 1.0 Content Competence
p.(None): 2.0 Pedagogical Competence
p.(None): 3.0 Dealing with Sensitive Topics
p.(None): 4.0 Student Development
p.(None): 5.0 Dual Relationships with Students
p.(None): 6.0 Confidentiality
p.(None): 7.0 Respect for Colleagues
p.(None): 8.0 Valid Assessment of Students
p.(None): 9.0 Respect for Institution
p.(None): 10.0 Ethics on education on patients
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): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None):
p.(None): INTRODUCTION
p.(None): Ethical principles are conceptualized here as general guidelines, ideals or expectations that need to be
p.(None): taken into account, along with other relevant conditions and circumstances, in the design and analysis of university
p.(None): teaching.
p.(None):
p.(None): Implementation of this ethical code will be advantageous to university teachers in removing ambiguity
p.(None): concerning teaching responsibilities and will contribute significantly to improvement of teaching.
p.(None):
p.(None): The following nine ethical principles for teaching and learning were adopted from The Society for Teaching and Learning
p.(None): in Higher Education (STLHE) with minor modifications.
p.(None):
p.(None): 1. Content Competence
p.(None): A college teacher maintains a high level of subject matter knowledge and ensures that course content is current,
p.(None): accurate, representative, and appropriate to the position of the course within the student's program of
p.(None): studies.
p.(None):
p.(None): Achievement of content competence requires that the teacher take active steps to be up-to- date in content areas
p.(None): relevant to his/her courses; to be informed of the content of prerequisite courses and of courses for which the
p.(None): teacher's course is prerequisite; and to provide adequate representation of important topic areas and points of view.
p.(None):
p.(None): An Academic staff member should appreciate the nature of evaluation and utilizes effective evaluation
p.(None): techniques in relation to curriculum teaching and learning.
p.(None):
p.(None): 2. Pedagogical Competence
p.(None): A pedagogically competent teacher communicates the objectives of the course to students, is aware of alternative
p.(None): instructional methods or strategies, and selects methods of instruction
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): that, according to research evidence (including personal or self-reflective research), are
p.(None): effective in helping students to achieve the course objectives.
p.(None):
p.(None): An Academic staff member should understand a variety of teaching and learning approaches and strategies, and
p.(None): endeavors to maintain awareness of pedagogical advances.
p.(None): This principle implies that, in addition to knowing the subject matter, a teacher has adequate pedagogical knowledge
p.(None): and skills, including communication of objectives, selection of effective instructional methods, provision of
p.(None): practice and feedback opportunities, and accommodation of student diversity. If mastery of a certain
p.(None): skill (Example: critical analysis, design of experiments) is part of the course objectives and will be
p.(None): considered in evaluation and grading of students, the teacher provides students with adequate opportunity to
p.(None): practice and receive feedback on that skill during the course.
p.(None):
p.(None): Learning styles differ significantly for different students. Therefore, the teacher should be aware of these
p.(None): differences and, if feasible, modifies his/her style of teaching accordingly.
p.(None): To maintain pedagogical competence, and instructor takes active steps to stay current regarding
p.(None): teaching strategies that will help students learn relevant knowledge and skills and will provide equal educational
p.(None): opportunity for diverse groups. This might involve reading general or discipline-specific educational literature,
p.(None): attending workshops and conferences, or experimentation with alternative methods of teaching a
p.(None): given course or a specific group of students.
p.(None):
p.(None): 3. Dealing with Sensitive Topics
p.(None): Topics that students are likely to find sensitive or discomforting are dealt with in an open, honest,
p.(None): and positive way respecting cultural principles and values.
p.(None):
p.(None): The teacher should invite all students to state their position on the issue, sets ground rules for discussion, is
p.(None): respectful of students even when it is necessary to disagree, and encourages students to be respectful of
p.(None): one another.
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None):
p.(None): 4. Student Development
p.(None): The overriding responsibility of the teacher is to contribute to the intellectual development of the student, at least
p.(None): in the context of the teacher's own area of expertise, and to avoid actions such as exploitation and discrimination
p.(None): that detract from student development.
p.(None): According to this principle, the teacher's most basic responsibility is to design instruction that facilitates
p.(None): learning and encourages autonomy and independent thinking of students, to treat students with respect and
p.(None): dignity, and to avoid actions that detract unjustifiably from student development.
p.(None):
p.(None): 5. Dual Relationships with Students
p.(None): To avoid conflict of interest, a teacher does not enter into dual-role relationships with students that are likely to
p.(None): detract from student development or lead to actual or perceived favoritism on the part of the teacher.
p.(None):
p.(None): This principle means that it is the responsibility of the teacher to keep relationships with students
p.(None): focused on pedagogical goals and academic requirements. Even if the teacher believes that she or he is maintaining
p.(None): objectivity, the perception of favoritism on the part of other students is as educationally disastrous
p.(None): as actual favoritism or unfairness. If a teacher does become involved in a dual relationship with
p.(None): a student, such as business or financial relationships, blood or marital relatedness, it is the
p.(None): responsibility of the teacher to notify his or her supervisor of the situation as soon as possible, so that
p.(None): alternative arrangements can be made for supervision or evaluation of the student.
p.(None):
p.(None): Although there are definite pedagogical benefits to establishing good rapport with students and interacting with
p.(None): students both inside and outside the classroom, there are also serious risks of exploitation, compromise of academic
p.(None): standards, and harm to student development. It is the responsibility of the teacher to prevent these risks from
p.(None): materializing into real or perceived conflicts of interest.
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None):
p.(None): 6. Confidentiality
p.(None): Student grades, attendance records, and private communications are treated as confidential materials, and are
p.(None): released only with student consent, or for legitimate academic purposes, or if there are reasonable grounds for
p.(None): believing that releasing such information will be beneficial to the student or will prevent harm to others.
p.(None): This principle suggests that students are entitled to the same level of confidentiality in their
p.(None): relationships with teachers as would exist in a lawyer-client or doctor-patient relationship. Violation of
p.(None): confidentiality in the teacher-student relationship can cause students to distrust teachers and to show
p.(None): decreased academic motivation. Whatever rules or policies are followed with respect to confidentiality of student
p.(None): records, these should be disclosed in full to students at the beginning of the academic term.
p.(None):
p.(None): 7. Respect for Colleagues
p.(None): A college teacher respects the dignity of her or his colleagues and works cooperatively with colleagues
p.(None): in the interest of fostering student development.
p.(None):
p.(None): This principle means that in interactions among colleagues with respect to teaching, the overriding concern
p.(None): is the development of students. Disagreements between colleagues relating to teaching are settled privately, if
p.(None): possible, with no harm to student development. If a teacher suspects that a colleague has shown incompetence or ethical
p.(None): violations in teaching, the teacher takes responsibility for raising the matter to higher authority.
p.(None):
p.(None): 8. Valid Assessment of Students
p.(None): Given the importance of assessment of student performance in college teaching and in students' lives and
p.(None): careers, instructors are responsible for taking adequate steps to ensure that assessment of students is valid, open,
p.(None): fair, and congruent with course objectives.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): This principle means that the teacher is aware of research (including personal or self-reflective research) on the
p.(None): advantages and disadvantages of alternative methods of assessment, and based on this knowledge, the teacher
p.(None): selects assessment techniques that are consistent with the objectives of the course and at the same time are
p.(None): as reliable and valid as possible. Furthermore, assessment procedures and grading standards are
p.(None): communicated clearly to students at the beginning of the course, and except in rare circumstances, there is no
p.(None): deviation from the announced procedures. Student exams, papers, and assignments are graded carefully and fairly through
p.(None): the use of a rational marking system that can be communicated to students. By means appropriate for the size of the
p.(None): class, students are provided with prompt and accurate feedback on their performance at regular intervals throughout the
p.(None): course, plus an explanation as to how their work was graded, and constructive suggestions as to how to
p.(None): improve their standing in the course. In a similar vein, teachers are fair and objective in writing
p.(None): letters of reference for students.
p.(None):
p.(None): 9. Respect for Institution
p.(None): In the interests of student development, a college teacher is aware of and respects the educational
p.(None): goals, policies, and standards of the institution in which he or she teaches.
p.(None): This principle implies that a teacher shares a collective responsibility to work for the good of the college as a
p.(None): whole, to uphold the educational goals and standards of the college, and to abide by college policies and
p.(None): regulations pertaining to the education of students and patient care.
p.(None):
p.(None): 10. Ethics on education on patients
p.(None):
p.(None): Dental education is based on practical clinical training that relies heavily on interaction with patients.
p.(None): There are sets of ethical principles related to training on patients that faculty members should observe
p.(None): which include:
p.(None):
p.(None): 1. The faculty member must respect patient's privacy thereby should avoid discuss issues infringing on
p.(None): the patient’s privacy in front of a group of trainees to ensure respecting patient’s right to privacy and
p.(None): confidentiality
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 2. The faculty member should be committed to prevent harm to the patient of any sort during the education of trainees.
p.(None):
...
p.(None): about a more research-oriented institution especially in the area of dentistry. Founded in 1981, its primary goal is
p.(None): the encouragement of viable research Potentials from among the dental professionals in the Kingdom. The Center
p.(None): realizes that this objective can be achieved by extending support to all kinds of research work and providing
p.(None): state-of-the- art equipment complemented by highly trained technical staff in all its laboratories. This report will
p.(None): explain the code of ethics for dental research.
p.(None):
p.(None): 2.0 RESEARCH and ETHICS
p.(None): The relationship between research and ethics is unique. The practice of research requires ethical principles at the
p.(None): same time ethical principles are needed to guide the good conduct of research.
p.(None):
p.(None): Research is systematic investigation designed to develop or contribute to generalizable knowledge.
p.(None): Systematic investigation means that there is intention, plan and procedures to be followed in predetermined steps.
p.(None): Contributing to generalizable knowledge means that the results and conclusions will be published and made
p.(None): available to the others to benefit from these results.
p.(None):
p.(None): 2.1 Purpose of the Code of Ethics
p.(None): The purpose of the code of ethics in dental research is to establish a set of codes or principles that should help the
p.(None): dental student, intern staff or researcher to reach a
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): professional standard, guided by legal and ethical principles. Research ethics is the application of ethical codes or
p.(None): principles in scientific investigation.
p.(None):
p.(None): 2.2 Importance of the code of ethics in dental research
p.(None): Researchers should be familiar with the code of ethics designed to ensure good conduct and prevent sloppy or
p.(None): irresponsible research. There are several reasons why it is important to adhere to the code of ethics in dental
p.(None): research.
p.(None): 1) The code of ethics promotes the aims of research, such as knowledge, the truth, and avoidance of
p.(None): error. For example, prohibitions against fabricating, falsifying, or misrepresenting research data promote the
p.(None): truth and avoid error.
p.(None): 2) Research often involves a great deal of cooperation and coordination among many different people in different
p.(None): disciplines and institutions, the code of ethics promote the values that are essential to collaborative
p.(None): work, such as respect, trust, accountability, and fairness.
p.(None): 3) The code of ethics in research for authorship, copyright and patenting, data monitoring, and
...
p.(None): distress to participants is subject to full board review. Additionally, any protocol using prisoners as
p.(None): participants or involving pregnant women, fetuses, and human in vitro fertilization will be reviewed by
p.(None): the full board. Research in which the risks versus the expected benefits are relatively high is also likely to be
p.(None): reviewed by the full board.
p.(None): Dental research proposals that require full dental ethical board review included, but are not necessarily limited to
p.(None): the following:
p.(None): 1) Clinical trials involving human participants
p.(None): 2) New treatments or interventions
p.(None): 3) Research involving human remains, cadavers, tissues, discarded tissue (e.g. placenta), biological
p.(None): fluids
p.(None): 4) Physiological studies
p.(None): 5) Comparing an established procedure, whether therapeutic, non-therapeutic or diagnostic, with other
p.(None): procedures which are not recognized as established by virtue of their recent development, discovery or use in a new or
p.(None): unfamiliar way
p.(None): 6) Innovative practices in health and disability services
p.(None): 7) Research conducted by students, which includes all activities that meet the definition of
p.(None): research with human participants (As supervised student research is conducted primarily for the purpose of
p.(None): educating students on research techniques and methodologies, DERB should review research protocols with
p.(None): a view to
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): contributing to the students’ education concerning scientific and ethical principles governing research).
p.(None): 8) Observational clinical research
p.(None): 9) Access to personal information by means of questionnaires, interviews or other techniques of information
p.(None): gathering
p.(None): 10) Research involving the secondary use of data (use of data not collected for that research purpose), if
p.(None): any form of identifier is involved and/or if health information pertaining to individuals is involved
p.(None): 11) Case studies, when a series of subject observations allow possible extrapolation of generalization of the
p.(None): results from the reported cases and when there is intent to publish or disseminate the data.
p.(None):
p.(None): 6.7.2.2 Exempt from the full ethical board review
p.(None): The determination of which proposals will be exempt from the full ethical board review is the sole authority of the
p.(None): DERB chairman. The exempt status of a research proposal means that the proposed protocol for the dental research is
p.(None): exempt from full authority of the DERB in research involving the participation of the human. Any change in
p.(None): the protocol of the approved proposal must be re-submitted to the DERB chairman to determine further
...
Social / Victim of Abuse
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p.(None): The codes of ethics in Dental Research Involving Human Participants are in addition to the general code of ethics in
p.(None): dental research stated in part 4.2, they are applicable but not limited to dental research conducted by
p.(None): students, interns, academic or clinical staff, or affiliated researcher of the College of Dentistry, King
p.(None): Saud University. This is true regardless of the location where the research is conducted. The codes of ethics in
p.(None): dental research involving humans are:
p.(None): 1) Respect for persons incorporates at least two fundamental ethical considerations, namely:
p.(None): a. Respect for autonomy which requires that those who are capable of self- determination about their choices
p.(None): should be treated with respect for their capacity of self-determination.
p.(None): b. Protection of persons with impaired or diminished autonomy, which requires that those who are dependent or
p.(None): vulnerable be afforded full security against harm or abuse.
p.(None): 2) Beneficence and non-maleficence refers to the ethical obligation to maximize benefits and to minimize harms.
p.(None): This gives rise to norms requiring the risks of research to be reasonable in the light of the expected benefits, that
p.(None): the research design be sound, and that the investigators be competent to conduct the research and to safeguard the
p.(None): welfare of the research subjects.
p.(None): 3) Justice refers to the ethical obligation to treat each person in accordance with what is morally right and
p.(None): proper; to give each person what is due to him or her. In the ethics of research involving human participants, the
p.(None): principle refers primarily to distributive justice, which requires equitable distribution of both the burdens and the
p.(None): benefits of participation in research.
p.(None):
p.(None):
p.(None):
p.(None): 6.4 Establishment of the Dental Ethics Review Board (DERB)
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): The Dean of the College of Dentistry, King Saud University is responsible for establishing the Dental
p.(None): Ethics Review Board (DERB) to review, approve and monitor research that involves human participants. The DERB
p.(None): consists of a chairman and members from the different specialties within the College of Dentistry.
p.(None):
p.(None): 6.5 Authorities of the Dental Ethics Review Board (DERB)
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Social / Women
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p.(None): 6.4 Establishment of the Dental Ethics Review Board (DERB)
p.(None): 6.5 Authority of the Dental Ethics Review Board
p.(None): 6.6 Types of Review
p.(None): 6.6.1 Minimal Risk.
p.(None): 6.6.2 Determining the Level of Review
p.(None): 6.6.2.1 Full Dental Ethical Board Review
p.(None): 6.6.2.2 Exempt from the full ethical board review
p.(None): 6.6.2.3 Expedited from the full ethical board review
p.(None): 6.8 Conflict of Interest
p.(None): 6.9 Informed Consent:
p.(None): 6.9.1 Re-consent
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.9.2 Waiver of consent
p.(None): 6.10 Submitting a Research Proposal
p.(None): 6.11 Electronic Submission of a Research proposal
p.(None): 6.12 Evaluation of submitted research proposals
p.(None): 6.13 Meeting Requirements
p.(None): 6.14 Decision-making
p.(None): 7.0 RESEARCH PARTICIPANTS REQUIRING ADDITIONAL ATTENTION
p.(None): 7.1 Research Involving Children and Adolescents
p.(None): 7.1.1 Approval of research involving children and adolescents
p.(None): 7.1.2 Consent for children or adolescents
p.(None): 7.2 Research involving pregnant women
p.(None): 7.3 Research involving a fetus
p.(None): 7.4 Research involving prisoners
p.(None): 7.4.1 Considerations regarding research involving prisoners
p.(None): 7.4.2 Approval of research involving prisoners
p.(None): 7.5 Research involving humans highly dependent on medical care
p.(None): 7.6 Other groups requiring additional attention
p.(None): 8.0 EPIDEMIOLOGICAL RESEARCH
p.(None): 9.0 HUMAN GENETIC RESEARCH
p.(None): 10.0 HUMAN TISSUE SAMPLES
p.(None): 11.0 REFERENCES
p.(None):
p.(None):
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 1.0 INTRODUCTION
p.(None): The College of Dentistry, King Saud University is the one of the dental colleges in the Kingdom of Saudi Arabia and
p.(None): the Gulf Countries that carries the responsibility of educating students, providing oral health services to the
p.(None): patients, conducting research and servicing the community. These responsibilities are conducted under the good ethical
p.(None): principles that guide the educational process in King Saud University.
p.(None):
p.(None): The Research Center within the College of Dentistry (CDRC) is the product of the University’s aspiration of bringing
...
p.(None): in everyday life.
p.(None): 3) The project neither includes nor attempts to induce long-term significant change in the participant's behavior
p.(None): (including attitude towards self and others).
p.(None): 4) The data would not embarrass or socially disadvantage the participant, were confidentiality to
p.(None): be violated.
p.(None): 5) If the investigator conceals information about specific purpose of the project, there is no reason to believe
p.(None): the subject would choose not to participate if he or she had known that information initially.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.7.2 Determining the Level of Review
p.(None): There are three levels of review for a research proposal depending on the risk expected to the human participating in
p.(None): the planned research. The three levels are:
p.(None): (1) Full Dental Ethical Board Review.
p.(None): (2) Exempt from the full dental ethical board review.
p.(None): (3) Expedited from the full dental ethical board review.
p.(None):
p.(None):
p.(None): 6.7.2.1 Full Dental Ethical Board Review
p.(None): Any protocol that uses a methodology that is sensitive and of higher probability for causing harm or
p.(None): distress to participants is subject to full board review. Additionally, any protocol using prisoners as
p.(None): participants or involving pregnant women, fetuses, and human in vitro fertilization will be reviewed by
p.(None): the full board. Research in which the risks versus the expected benefits are relatively high is also likely to be
p.(None): reviewed by the full board.
p.(None): Dental research proposals that require full dental ethical board review included, but are not necessarily limited to
p.(None): the following:
p.(None): 1) Clinical trials involving human participants
p.(None): 2) New treatments or interventions
p.(None): 3) Research involving human remains, cadavers, tissues, discarded tissue (e.g. placenta), biological
p.(None): fluids
p.(None): 4) Physiological studies
p.(None): 5) Comparing an established procedure, whether therapeutic, non-therapeutic or diagnostic, with other
p.(None): procedures which are not recognized as established by virtue of their recent development, discovery or use in a new or
p.(None): unfamiliar way
p.(None): 6) Innovative practices in health and disability services
p.(None): 7) Research conducted by students, which includes all activities that meet the definition of
p.(None): research with human participants (As supervised student research is conducted primarily for the purpose of
p.(None): educating students on research techniques and methodologies, DERB should review research protocols with
p.(None): a view to
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
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p.(None): for both privacy and confidentiality, and do not violate the rights of the participants then the DERB
p.(None): may waive the requirement for informed consent in the following instances:
p.(None): a) When it is impractical to conduct research since confidentiality of personally identifiable
p.(None): information has to be maintained throughout the research.
p.(None): b) Research on publicly available information, documents, records, works, performances,
p.(None): reviews, quality assurance studies, archival materials or third party interviews, service programs for benefit
p.(None): of public having a bearing on public health programs, and consumer acceptance studies.
p.(None): c) Research on anonymised biological samples from left over samples after clinical investigation.
p.(None): d) In emergency situations when informed consent can be taken. Do you mean cannot be taken? (yes cannot, but I think
p.(None): we need to define the emergency situations)
p.(None):
p.(None): 7.0 Research Participants Requiring Additional Attention
p.(None): Humans with limited autonomy or in subordinate positions are considered participants that require additional
p.(None): attention and are in need of greater protection. These may include children, pregnant women and fetus, prisoners, and
p.(None): human highly dependent on medical care. Does this cover mentally impaired people?
p.(None):
p.(None): 7.1 Research involving children, adolescents and mentally impaired people
p.(None): Dental treatment and research on children, adolescents and mentally impaired person is part of the dental
p.(None): discipline. A child is a person who has not yet reached puberty
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): whereas an adolescent is a person who is reaching or has reached puberty. Mentally impaired person is a
p.(None): person who has impairment of intelligence and social functioning which appears to be permanent or temporary. Children,
p.(None): adolescents and mentally impaired person are considered participants who require additional attention because
...
p.(None): by the risk-knowledge ratio and the risk must represent no more than a minor increase over minimal risk.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 7.1.2 Consent for children or adolescents
p.(None): Consent for children, adolescents or mentally impaired person to participate in research must be obtained from:
p.(None): a) The parents or legal guardian in all but exceptional circumstances such as emergencies.
p.(None): b) The child or adolescent that is competent to make the decision.
p.(None): c) Any organization or person required by authorization.
p.(None): d) No other caregiver can act on behalf of a child in providing consent to participate.
p.(None):
p.(None):
p.(None): 7.2 Research involving pregnant women
p.(None): The DERB must give extra attention to research that involves pregnant women or those who may become pregnant, because
p.(None): of the additional health concerns during pregnancy and the need to avoid unnecessary risk to the fetus. The policy of
p.(None): the college of dentistry research center is that; no pregnant woman may be involved as a participant in any dental
p.(None): research activity unless:
p.(None): • The purpose of the research is to meet the health needs of the mother and the fetus will be placed at no
p.(None): risk, or
p.(None): • The risk to the fetus is minimal.
p.(None): The DERB should consider the following regulatory protections before approval of the research proposal.
p.(None): • Appropriate studies conducted on animals and non-pregnant women have provided data for assessing potential risks.
p.(None): • Risks and prospects of benefit to the fetus and mother (separately or together) and the purpose of the research
p.(None): have been determined.
p.(None): • Any risk is the least possible for achieving the objectives of the research.
p.(None): The research activity may be permitted to be conducted only if the mother is legally competent and has given informed
p.(None): consent after having been fully informed about the possible impact on the fetus. The father's informed consent needs to
p.(None): be secured if the research has any risk to the fetus.
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None):
p.(None): 7.3 Research involving a fetus
p.(None): Dental research usually do not involve fetuses as participants, however, in research involve investigations on the
p.(None): craniofacial malformations such as cleft lip and palate the dental researcher may be involved as a member of a larger
p.(None): research group including medical researchers. The dental researcher must abide by the ethical codes and the regulatory
p.(None): procedures of the medical research team.
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Social / Youth/Minors
Searching for indicator minor:
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p.(None): 2.0 Pedagogical Competence
p.(None): 3.0 Dealing with Sensitive Topics
p.(None): 4.0 Student Development
p.(None): 5.0 Dual Relationships with Students
p.(None): 6.0 Confidentiality
p.(None): 7.0 Respect for Colleagues
p.(None): 8.0 Valid Assessment of Students
p.(None): 9.0 Respect for Institution
p.(None): 10.0 Ethics on education on patients
p.(None):
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None):
p.(None): INTRODUCTION
p.(None): Ethical principles are conceptualized here as general guidelines, ideals or expectations that need to be
p.(None): taken into account, along with other relevant conditions and circumstances, in the design and analysis of university
p.(None): teaching.
p.(None):
p.(None): Implementation of this ethical code will be advantageous to university teachers in removing ambiguity
p.(None): concerning teaching responsibilities and will contribute significantly to improvement of teaching.
p.(None):
p.(None): The following nine ethical principles for teaching and learning were adopted from The Society for Teaching and Learning
p.(None): in Higher Education (STLHE) with minor modifications.
p.(None):
p.(None): 1. Content Competence
p.(None): A college teacher maintains a high level of subject matter knowledge and ensures that course content is current,
p.(None): accurate, representative, and appropriate to the position of the course within the student's program of
p.(None): studies.
p.(None):
p.(None): Achievement of content competence requires that the teacher take active steps to be up-to- date in content areas
p.(None): relevant to his/her courses; to be informed of the content of prerequisite courses and of courses for which the
p.(None): teacher's course is prerequisite; and to provide adequate representation of important topic areas and points of view.
p.(None):
p.(None): An Academic staff member should appreciate the nature of evaluation and utilizes effective evaluation
p.(None): techniques in relation to curriculum teaching and learning.
p.(None):
p.(None): 2. Pedagogical Competence
p.(None): A pedagogically competent teacher communicates the objectives of the course to students, is aware of alternative
p.(None): instructional methods or strategies, and selects methods of instruction
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): that, according to research evidence (including personal or self-reflective research), are
p.(None): effective in helping students to achieve the course objectives.
p.(None):
p.(None): An Academic staff member should understand a variety of teaching and learning approaches and strategies, and
p.(None): endeavors to maintain awareness of pedagogical advances.
p.(None): This principle implies that, in addition to knowing the subject matter, a teacher has adequate pedagogical knowledge
...
p.(None): if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or
p.(None): agricultural chemical or environmental contaminant at or below the level found to be safe.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.7.2.3 Expedited from the full ethical board review
p.(None): The determination of the expedited status for any research proposal is the authority of the DERB chairman. A dental
p.(None): research proposal eligible expedited from the full ethical board review means that the proposed dental research
p.(None): is to be reviewed by a single member of the DERB panel. The single member is designated by the DERB
p.(None): chairman. Like the exempt review, the research must be of minimal risk or no more than minimal risk and all aspects of
p.(None): a protocol must fit within one or more expedited categories to be reviewed in this manner. The dental researcher must
p.(None): submit to the DERB secretary the full documentations required for the review by the DERB, including the
p.(None): research proposal, informed consent and the CV’s of the investigators.
p.(None):
p.(None): An expedited review process is available for research activities that present no more than minimal risk to
p.(None): human participants or that request a minor change in previously approved research that involves no additional risk and
p.(None): that involve only procedures in one or more of the categories listed below. Some of the categories overlap with those
p.(None): used to assess exempt status. The distinction between exempt and expedited review is based on the sensitivity of the
p.(None): data and/or the risk of compromised confidentiality (such as a relatively small sample size).
p.(None):
p.(None): The expedited review procedure may not be used where identification of the subjects and/or their responses would
p.(None): reasonably place them at risk of criminal or civil liability or be damaging to the subject’s financial standing,
p.(None): employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be
p.(None): implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
p.(None): Furthermore, the expedited review procedure may not be used for classified research involving human
p.(None): participants.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): To determine expedited status, the research must qualify as one or more of the categories listed below.
p.(None): To qualify for a category, the research must meet all of the conditions of that category.
p.(None):
p.(None): 1. Clinical studies of drugs and medical devices. (a) Research on drugs where the application for
...
p.(None): 1) The research, including observational research, places the child , adolescent or mentally impaired person at no
p.(None): more than minimal risk (that is, the risk commensurate with daily life or routine dental examinations – referred to as
p.(None): 'negligible risk' in some guidelines).
p.(None): 2) The research involves more than minimal risk but provides possible benefit for the child, adolescent or mentally
p.(None): impaired person participant. The degree of risk must be justified by the potential benefit.
p.(None): 3) The research involves greater than minimal risk, with no prospect of direct benefit to the child, adolescent or
p.(None): mentally impaired person, but has a high probability of providing significant knowledge. The risk should be justified
p.(None): by the risk-knowledge ratio and the risk must represent no more than a minor increase over minimal risk.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 7.1.2 Consent for children or adolescents
p.(None): Consent for children, adolescents or mentally impaired person to participate in research must be obtained from:
p.(None): a) The parents or legal guardian in all but exceptional circumstances such as emergencies.
p.(None): b) The child or adolescent that is competent to make the decision.
p.(None): c) Any organization or person required by authorization.
p.(None): d) No other caregiver can act on behalf of a child in providing consent to participate.
p.(None):
p.(None):
p.(None): 7.2 Research involving pregnant women
p.(None): The DERB must give extra attention to research that involves pregnant women or those who may become pregnant, because
...
Social / education
Searching for indicator education:
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p.(None):
p.(None):
p.(None): o ETHICS IN TEACHING AND LEARNING
p.(None):
p.(None): o ETHICS IN DENTAL PRACTICE
p.(None):
p.(None): o ETHICS FOR RESEARCH IN THE COLLEGE OF DENTISTRY
p.(None):
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
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): King Saud University College of Dentistry
p.(None):
p.(None):
p.(None):
p.(None): ETHICS IN TEACHING AND LEARNING
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 2011-2012
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): CONTENTS
p.(None):
p.(None): INTRODUCTION
p.(None): 1.0 Content Competence
p.(None): 2.0 Pedagogical Competence
p.(None): 3.0 Dealing with Sensitive Topics
p.(None): 4.0 Student Development
p.(None): 5.0 Dual Relationships with Students
p.(None): 6.0 Confidentiality
p.(None): 7.0 Respect for Colleagues
p.(None): 8.0 Valid Assessment of Students
p.(None): 9.0 Respect for Institution
p.(None): 10.0 Ethics on education on patients
p.(None):
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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): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None):
p.(None): INTRODUCTION
p.(None): Ethical principles are conceptualized here as general guidelines, ideals or expectations that need to be
p.(None): taken into account, along with other relevant conditions and circumstances, in the design and analysis of university
p.(None): teaching.
p.(None):
p.(None): Implementation of this ethical code will be advantageous to university teachers in removing ambiguity
p.(None): concerning teaching responsibilities and will contribute significantly to improvement of teaching.
p.(None):
p.(None): The following nine ethical principles for teaching and learning were adopted from The Society for Teaching and Learning
p.(None): in Higher Education (STLHE) with minor modifications.
p.(None):
p.(None): 1. Content Competence
p.(None): A college teacher maintains a high level of subject matter knowledge and ensures that course content is current,
p.(None): accurate, representative, and appropriate to the position of the course within the student's program of
p.(None): studies.
p.(None):
p.(None): Achievement of content competence requires that the teacher take active steps to be up-to- date in content areas
p.(None): relevant to his/her courses; to be informed of the content of prerequisite courses and of courses for which the
p.(None): teacher's course is prerequisite; and to provide adequate representation of important topic areas and points of view.
p.(None):
p.(None): An Academic staff member should appreciate the nature of evaluation and utilizes effective evaluation
p.(None): techniques in relation to curriculum teaching and learning.
p.(None):
p.(None): 2. Pedagogical Competence
p.(None): A pedagogically competent teacher communicates the objectives of the course to students, is aware of alternative
p.(None): instructional methods or strategies, and selects methods of instruction
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): that, according to research evidence (including personal or self-reflective research), are
p.(None): effective in helping students to achieve the course objectives.
p.(None):
p.(None): An Academic staff member should understand a variety of teaching and learning approaches and strategies, and
p.(None): endeavors to maintain awareness of pedagogical advances.
...
p.(None): as reliable and valid as possible. Furthermore, assessment procedures and grading standards are
p.(None): communicated clearly to students at the beginning of the course, and except in rare circumstances, there is no
p.(None): deviation from the announced procedures. Student exams, papers, and assignments are graded carefully and fairly through
p.(None): the use of a rational marking system that can be communicated to students. By means appropriate for the size of the
p.(None): class, students are provided with prompt and accurate feedback on their performance at regular intervals throughout the
p.(None): course, plus an explanation as to how their work was graded, and constructive suggestions as to how to
p.(None): improve their standing in the course. In a similar vein, teachers are fair and objective in writing
p.(None): letters of reference for students.
p.(None):
p.(None): 9. Respect for Institution
p.(None): In the interests of student development, a college teacher is aware of and respects the educational
p.(None): goals, policies, and standards of the institution in which he or she teaches.
p.(None): This principle implies that a teacher shares a collective responsibility to work for the good of the college as a
p.(None): whole, to uphold the educational goals and standards of the college, and to abide by college policies and
p.(None): regulations pertaining to the education of students and patient care.
p.(None):
p.(None): 10. Ethics on education on patients
p.(None):
p.(None): Dental education is based on practical clinical training that relies heavily on interaction with patients.
p.(None): There are sets of ethical principles related to training on patients that faculty members should observe
p.(None): which include:
p.(None):
p.(None): 1. The faculty member must respect patient's privacy thereby should avoid discuss issues infringing on
p.(None): the patient’s privacy in front of a group of trainees to ensure respecting patient’s right to privacy and
p.(None): confidentiality
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 2. The faculty member should be committed to prevent harm to the patient of any sort during the education of trainees.
p.(None):
p.(None): 3. The faculty member should avoid approaching the patient with a large number of students or multiple physical
p.(None): examinations by students in a short time period.
p.(None):
p.(None): 4. The faculty member should avoid blaming or reprimanding a trainee in front of the patient, in order to preserve
p.(None): the dignity of the trainee on one hand, and not to confuse the patient on the other hand, especially if all spoke a
p.(None): language not understood by the patient.
p.(None):
p.(None): 5. The faculty member should respect gradual progression in patient care assignments to the trainees. In
p.(None): addition, the supervising faculty member remains responsible for providing adequate supervision to
p.(None): ensure that the patient will receive appropriate care.
p.(None):
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): REFERENCES
p.(None): • Ethical Principles in College Teaching.Published by: Society for Teaching and Learning in Higher
p.(None): Education(STLHE)/ La Societe pour l'avancement de la
p.(None): pedagogiedansl'enseignementsuperieur (SAPES). 1996. http://www.stlhe.ca/en/stlhe/
p.(None):
p.(None): • Code of Conduct for All Staff.Australian Catholic College (AUC). November 2006
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p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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p.(None):
p.(None): King Saud University College of Dentistry
p.(None):
p.(None):
p.(None):
p.(None): ETHICS IN DENTAL PRACTICE
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 2011-2012
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): INTRODUCTION
p.(None):
p.(None): Dentists should follow high ethical standards considering the benefits of the patient as their primary goal. The
p.(None): privilege of being a dentist comes with a responsibility to society and to fellow members of the profession to conduct
p.(None): ones professional activities in a highly ethical manner. The dentist –patient relationship is the cornerstone of dental
...
p.(None): the full board. Research in which the risks versus the expected benefits are relatively high is also likely to be
p.(None): reviewed by the full board.
p.(None): Dental research proposals that require full dental ethical board review included, but are not necessarily limited to
p.(None): the following:
p.(None): 1) Clinical trials involving human participants
p.(None): 2) New treatments or interventions
p.(None): 3) Research involving human remains, cadavers, tissues, discarded tissue (e.g. placenta), biological
p.(None): fluids
p.(None): 4) Physiological studies
p.(None): 5) Comparing an established procedure, whether therapeutic, non-therapeutic or diagnostic, with other
p.(None): procedures which are not recognized as established by virtue of their recent development, discovery or use in a new or
p.(None): unfamiliar way
p.(None): 6) Innovative practices in health and disability services
p.(None): 7) Research conducted by students, which includes all activities that meet the definition of
p.(None): research with human participants (As supervised student research is conducted primarily for the purpose of
p.(None): educating students on research techniques and methodologies, DERB should review research protocols with
p.(None): a view to
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): contributing to the students’ education concerning scientific and ethical principles governing research).
p.(None): 8) Observational clinical research
p.(None): 9) Access to personal information by means of questionnaires, interviews or other techniques of information
p.(None): gathering
p.(None): 10) Research involving the secondary use of data (use of data not collected for that research purpose), if
p.(None): any form of identifier is involved and/or if health information pertaining to individuals is involved
p.(None): 11) Case studies, when a series of subject observations allow possible extrapolation of generalization of the
p.(None): results from the reported cases and when there is intent to publish or disseminate the data.
p.(None):
p.(None): 6.7.2.2 Exempt from the full ethical board review
p.(None): The determination of which proposals will be exempt from the full ethical board review is the sole authority of the
p.(None): DERB chairman. The exempt status of a research proposal means that the proposed protocol for the dental research is
p.(None): exempt from full authority of the DERB in research involving the participation of the human. Any change in
p.(None): the protocol of the approved proposal must be re-submitted to the DERB chairman to determine further
p.(None): exempt status. The dental researcher must submit to the DERB secretary the full documentations required
p.(None): for the review by the DERB, including the research proposal, informed consent and the CV’s of the investigators.
p.(None):
p.(None): To determine exempt status, the research must qualify as one or more of the categories listed below. To qualify for a
p.(None): category, the research must meet all of the conditions of that category.
p.(None):
p.(None): 1. Research conducted in established or commonly accepted educational settings involving normal educational
p.(None): practices such as (a) regular and special education
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): instructional strategies, or (b) research on the effectiveness of or the comparison among instructional
p.(None): techniques, curricula, or classroom management methods.
p.(None): 2. Research involving use of educational tests, survey or interview procedures, or observation of public
p.(None): behavior unless information obtained from these sources is recorded in such a manner that subjects can
p.(None): be identified, and disclosure of the subject’s responses outside the research could reasonably place the subject
p.(None): at risk of criminal or civil liability or be damaging to his or her financial standing,
p.(None): employability, or reputation.
p.(None): 3. Research involving the use of education tests, survey procedures, interview procedures, or observation of
p.(None): public behavior if (a) the human subjects are elected or appointed public officials or candidates for
p.(None): public office; or (b) federal statutes require, without exception, that the confidentiality of the
p.(None): personally identifiable information will be maintained throughout the research and thereafter. Children may
p.(None): not be involved in this research.
p.(None): 4. Research involving the collection or study of existing data, documents, records, pathological
p.(None): specimens, or diagnostic specimens, (a) if these sources are publicly available, or (b) if the information is
p.(None): recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers
p.(None): linked to the subjects.
p.(None): 5. Research and demonstration projects that are designed to study, evaluate, or otherwise examine (a) public benefit
p.(None): or service programs; (b) procedures for obtaining benefits or services under these programs; (c) possible changes or
p.(None): alternatives to those programs or procedures; or (d) possible changes in methods or levels of payments for benefits or
p.(None): services under those programs.
p.(None): 6. Tests and food quality evaluation and consumer studies (a) if wholesome food without additives is consumed, or (b)
p.(None): if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or
p.(None): agricultural chemical or environmental contaminant at or below the level found to be safe.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
...
Searching for indicator educational:
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p.(None): instructional methods or strategies, and selects methods of instruction
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): that, according to research evidence (including personal or self-reflective research), are
p.(None): effective in helping students to achieve the course objectives.
p.(None):
p.(None): An Academic staff member should understand a variety of teaching and learning approaches and strategies, and
p.(None): endeavors to maintain awareness of pedagogical advances.
p.(None): This principle implies that, in addition to knowing the subject matter, a teacher has adequate pedagogical knowledge
p.(None): and skills, including communication of objectives, selection of effective instructional methods, provision of
p.(None): practice and feedback opportunities, and accommodation of student diversity. If mastery of a certain
p.(None): skill (Example: critical analysis, design of experiments) is part of the course objectives and will be
p.(None): considered in evaluation and grading of students, the teacher provides students with adequate opportunity to
p.(None): practice and receive feedback on that skill during the course.
p.(None):
p.(None): Learning styles differ significantly for different students. Therefore, the teacher should be aware of these
p.(None): differences and, if feasible, modifies his/her style of teaching accordingly.
p.(None): To maintain pedagogical competence, and instructor takes active steps to stay current regarding
p.(None): teaching strategies that will help students learn relevant knowledge and skills and will provide equal educational
p.(None): opportunity for diverse groups. This might involve reading general or discipline-specific educational literature,
p.(None): attending workshops and conferences, or experimentation with alternative methods of teaching a
p.(None): given course or a specific group of students.
p.(None):
p.(None): 3. Dealing with Sensitive Topics
p.(None): Topics that students are likely to find sensitive or discomforting are dealt with in an open, honest,
p.(None): and positive way respecting cultural principles and values.
p.(None):
p.(None): The teacher should invite all students to state their position on the issue, sets ground rules for discussion, is
p.(None): respectful of students even when it is necessary to disagree, and encourages students to be respectful of
p.(None): one another.
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None):
p.(None): 4. Student Development
p.(None): The overriding responsibility of the teacher is to contribute to the intellectual development of the student, at least
p.(None): in the context of the teacher's own area of expertise, and to avoid actions such as exploitation and discrimination
p.(None): that detract from student development.
p.(None): According to this principle, the teacher's most basic responsibility is to design instruction that facilitates
p.(None): learning and encourages autonomy and independent thinking of students, to treat students with respect and
...
p.(None): fair, and congruent with course objectives.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): This principle means that the teacher is aware of research (including personal or self-reflective research) on the
p.(None): advantages and disadvantages of alternative methods of assessment, and based on this knowledge, the teacher
p.(None): selects assessment techniques that are consistent with the objectives of the course and at the same time are
p.(None): as reliable and valid as possible. Furthermore, assessment procedures and grading standards are
p.(None): communicated clearly to students at the beginning of the course, and except in rare circumstances, there is no
p.(None): deviation from the announced procedures. Student exams, papers, and assignments are graded carefully and fairly through
p.(None): the use of a rational marking system that can be communicated to students. By means appropriate for the size of the
p.(None): class, students are provided with prompt and accurate feedback on their performance at regular intervals throughout the
p.(None): course, plus an explanation as to how their work was graded, and constructive suggestions as to how to
p.(None): improve their standing in the course. In a similar vein, teachers are fair and objective in writing
p.(None): letters of reference for students.
p.(None):
p.(None): 9. Respect for Institution
p.(None): In the interests of student development, a college teacher is aware of and respects the educational
p.(None): goals, policies, and standards of the institution in which he or she teaches.
p.(None): This principle implies that a teacher shares a collective responsibility to work for the good of the college as a
p.(None): whole, to uphold the educational goals and standards of the college, and to abide by college policies and
p.(None): regulations pertaining to the education of students and patient care.
p.(None):
p.(None): 10. Ethics on education on patients
p.(None):
p.(None): Dental education is based on practical clinical training that relies heavily on interaction with patients.
p.(None): There are sets of ethical principles related to training on patients that faculty members should observe
p.(None): which include:
p.(None):
p.(None): 1. The faculty member must respect patient's privacy thereby should avoid discuss issues infringing on
p.(None): the patient’s privacy in front of a group of trainees to ensure respecting patient’s right to privacy and
p.(None): confidentiality
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 2. The faculty member should be committed to prevent harm to the patient of any sort during the education of trainees.
p.(None):
p.(None): 3. The faculty member should avoid approaching the patient with a large number of students or multiple physical
p.(None): examinations by students in a short time period.
p.(None):
p.(None): 4. The faculty member should avoid blaming or reprimanding a trainee in front of the patient, in order to preserve
...
p.(None): 7.2 Research involving pregnant women
p.(None): 7.3 Research involving a fetus
p.(None): 7.4 Research involving prisoners
p.(None): 7.4.1 Considerations regarding research involving prisoners
p.(None): 7.4.2 Approval of research involving prisoners
p.(None): 7.5 Research involving humans highly dependent on medical care
p.(None): 7.6 Other groups requiring additional attention
p.(None): 8.0 EPIDEMIOLOGICAL RESEARCH
p.(None): 9.0 HUMAN GENETIC RESEARCH
p.(None): 10.0 HUMAN TISSUE SAMPLES
p.(None): 11.0 REFERENCES
p.(None):
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p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 1.0 INTRODUCTION
p.(None): The College of Dentistry, King Saud University is the one of the dental colleges in the Kingdom of Saudi Arabia and
p.(None): the Gulf Countries that carries the responsibility of educating students, providing oral health services to the
p.(None): patients, conducting research and servicing the community. These responsibilities are conducted under the good ethical
p.(None): principles that guide the educational process in King Saud University.
p.(None):
p.(None): The Research Center within the College of Dentistry (CDRC) is the product of the University’s aspiration of bringing
p.(None): about a more research-oriented institution especially in the area of dentistry. Founded in 1981, its primary goal is
p.(None): the encouragement of viable research Potentials from among the dental professionals in the Kingdom. The Center
p.(None): realizes that this objective can be achieved by extending support to all kinds of research work and providing
p.(None): state-of-the- art equipment complemented by highly trained technical staff in all its laboratories. This report will
p.(None): explain the code of ethics for dental research.
p.(None):
p.(None): 2.0 RESEARCH and ETHICS
p.(None): The relationship between research and ethics is unique. The practice of research requires ethical principles at the
p.(None): same time ethical principles are needed to guide the good conduct of research.
p.(None):
p.(None): Research is systematic investigation designed to develop or contribute to generalizable knowledge.
p.(None): Systematic investigation means that there is intention, plan and procedures to be followed in predetermined steps.
p.(None): Contributing to generalizable knowledge means that the results and conclusions will be published and made
p.(None): available to the others to benefit from these results.
p.(None):
p.(None): 2.1 Purpose of the Code of Ethics
p.(None): The purpose of the code of ethics in dental research is to establish a set of codes or principles that should help the
...
p.(None): gathering
p.(None): 10) Research involving the secondary use of data (use of data not collected for that research purpose), if
p.(None): any form of identifier is involved and/or if health information pertaining to individuals is involved
p.(None): 11) Case studies, when a series of subject observations allow possible extrapolation of generalization of the
p.(None): results from the reported cases and when there is intent to publish or disseminate the data.
p.(None):
p.(None): 6.7.2.2 Exempt from the full ethical board review
p.(None): The determination of which proposals will be exempt from the full ethical board review is the sole authority of the
p.(None): DERB chairman. The exempt status of a research proposal means that the proposed protocol for the dental research is
p.(None): exempt from full authority of the DERB in research involving the participation of the human. Any change in
p.(None): the protocol of the approved proposal must be re-submitted to the DERB chairman to determine further
p.(None): exempt status. The dental researcher must submit to the DERB secretary the full documentations required
p.(None): for the review by the DERB, including the research proposal, informed consent and the CV’s of the investigators.
p.(None):
p.(None): To determine exempt status, the research must qualify as one or more of the categories listed below. To qualify for a
p.(None): category, the research must meet all of the conditions of that category.
p.(None):
p.(None): 1. Research conducted in established or commonly accepted educational settings involving normal educational
p.(None): practices such as (a) regular and special education
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): instructional strategies, or (b) research on the effectiveness of or the comparison among instructional
p.(None): techniques, curricula, or classroom management methods.
p.(None): 2. Research involving use of educational tests, survey or interview procedures, or observation of public
p.(None): behavior unless information obtained from these sources is recorded in such a manner that subjects can
p.(None): be identified, and disclosure of the subject’s responses outside the research could reasonably place the subject
p.(None): at risk of criminal or civil liability or be damaging to his or her financial standing,
p.(None): employability, or reputation.
p.(None): 3. Research involving the use of education tests, survey procedures, interview procedures, or observation of
p.(None): public behavior if (a) the human subjects are elected or appointed public officials or candidates for
p.(None): public office; or (b) federal statutes require, without exception, that the confidentiality of the
p.(None): personally identifiable information will be maintained throughout the research and thereafter. Children may
p.(None): not be involved in this research.
p.(None): 4. Research involving the collection or study of existing data, documents, records, pathological
p.(None): specimens, or diagnostic specimens, (a) if these sources are publicly available, or (b) if the information is
p.(None): recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers
p.(None): linked to the subjects.
p.(None): 5. Research and demonstration projects that are designed to study, evaluate, or otherwise examine (a) public benefit
...
p.(None): (2008).
p.(None):
p.(None): 22) Institutional Review Board Procedures and Guidelines for the Protection of Human Subjects. Texas A&M
p.(None): University Commerce Institutional Review Board. November (2009).
p.(None):
p.(None): 23) Research Subjects Review Board (RSRB) Investigator Guidance, University of Rochester. February (2010).
p.(None):
p.(None): 24) Ethical and Policy Issues in Research Involving Human Participants. Volume I. Report and Recommendations of the
p.(None): National Bioethics Advisory Commission. Bethesda, Maryland. August (2001).
p.(None):
p.(None): 25) Research animals for scientific purposes in Thailand: Ethics & policies, The National Research Council
p.(None): of Thailand. AATEX 14, Special Issue, 189-191. Proc. 6th World Congress on Alternatives & Animal Use in the
p.(None): Life Sciences. Tokyo, Japan. August (2007).
p.(None):
p.(None): 26) Use of Animals in Scientific Research, Indian Council of Medical Research Ministry of Health & Family
p.(None): Welfare. New Delhi. May (2000).
p.(None):
p.(None): 27) Ethics in Health Research: Principles, Structures and Processes Research Ethics Guidelines,
p.(None): Department of Health, South Africa. (2004).
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None):
p.(None): 28) Universal Declaration on the Human Genome and Human Rights. UNESCO, United Nations Educational,
p.(None): Scientific, Cultural Organization. (1997).
p.(None):
p.(None):
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p.(None):
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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):
p.(None):
p.(None):
p.(None):
p.(None):
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Social / employees
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p.(None): 3. Research activities on neonatals in the intensive care unit
p.(None): 4. Research activities on humans in the terminal care unit
p.(None): 5. Research activities on decisionally impaired humans
p.(None): 6. Research activities on unconscious human
p.(None): The policy of the college of dentistry research center is that; no dental research should be carried out on the above
p.(None): mentioned conditions. However, The DERB, within its authority can approve dental research in the following conditions;
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): • The research is based on valid scientific hypotheses which support a reasonable possibility of benefit over
p.(None): standard care.
p.(None): • The research is intended to be therapeutic and the research intervention poses no more than a risk that is
p.(None): expected in alternative methods of treatment.
p.(None):
p.(None): 7.6 Other groups requiring additional attention
p.(None): The discussion of the dental research participants requiring additional attention should not be limited to those
p.(None): already mentioned. Other groups that require additional attention include: traumatized and comatose patients,
p.(None): terminally ill patients, elderly or aged patients, minorities, students, and employees. The DERB must ensure that
p.(None): special consideration is given to all these groups, especially with regard to the risks, benefits and obtaining
p.(None): informed consent.
p.(None):
p.(None): 8.0 EPIDEMIOLOGICAL RESEARCH
p.(None):
p.(None): Epidemiological research describes the health status in a population or subgroup of the population. Epidemiological
p.(None): research studies the distribution and determinants of health related problems in populations, and the application of
p.(None): the research results to prevent, control or eliminate such health problems. It is concerned with improvement of the
p.(None): health status and welfare in human populations and with the improvement in the efficiency and performance of health
p.(None): services. Epidemiological research is carried out with human participants, or data or biological samples from them,
p.(None): and such research provides important new knowledge that is not readily obtainable in other ways. Perhaps the second
p.(None): most significant dental discoveries, after local anesthesia, were the effects of naturally occurring fluoride on
p.(None): reducing the incidence of dental caries as revealed by epidemiological research. Such epidemiological studies provided
p.(None): the motive for several clinical and laboratory research studies on the relationships between fluoride and dental
p.(None): caries. The findings from these researches laid the ground for the current understanding of the relationship between
p.(None): fluoride and oral disease.
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): The main objective of epidemiological research is to collect information in order to throw light on the nature and
...
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p.(None):
p.(None):
p.(None):
p.(None):
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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): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
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p.(None):
p.(None): King Saud University College of Dentistry
p.(None):
p.(None):
p.(None):
p.(None): ETHICS IN DENTAL PRACTICE
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): 2011-2012
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): INTRODUCTION
p.(None):
p.(None): Dentists should follow high ethical standards considering the benefits of the patient as their primary goal. The
p.(None): privilege of being a dentist comes with a responsibility to society and to fellow members of the profession to conduct
p.(None): ones professional activities in a highly ethical manner. The dentist –patient relationship is the cornerstone of dental
p.(None): ethics.
p.(None): This document is supplementary to the ethics in medical profession document by the Saudi Commission for
p.(None): health specialties which is the reference for ethics in medical profession.
p.(None):
p.(None):
p.(None): Respect and Equal Treatment
p.(None):
p.(None): Dental treatment should be provided without discrimination based on the basis of on patient’s gender, racial,
p.(None): religious, or ethnic characteristic. Service to the public includes the delivery of quality, component, and timely care
p.(None): within the bounds of the clinical circumstances presented by the patient.
p.(None): Professional Esteem
p.(None):
p.(None): While serving the public, a dentist has the obligation to act in a manner that maintains or elevate the esteem of the
p.(None): profession.
p.(None): Standard of care
p.(None):
p.(None): It is unethical for a dentist to render, or cause to be rendered, dental treatment of a quality that falls short of
p.(None): best available scientific evidence.
p.(None): Informed Consent
p.(None): Fully informed consent is essential to the ethical practice of dentistry and reflects the patient’s right of self
p.(None): –decision. A dentist must get valid consent before starting treatment or physical investigation, or providing personal
p.(None): care, for a patient. Dentists must provide all the information patients need to make their decisions. This involve
p.(None): explaining complex dental diagnosis, prognoses and treatment regimes in simple language, confirming or correcting
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): information that the patients may have obtained elsewhere (e.g., from another health practitioner, magazines or the
p.(None): internet), ensuring that patients understand the treatment options (including the option of no treatment) advantages
...
Social / parents
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p.(None): best available scientific evidence.
p.(None): Informed Consent
p.(None): Fully informed consent is essential to the ethical practice of dentistry and reflects the patient’s right of self
p.(None): –decision. A dentist must get valid consent before starting treatment or physical investigation, or providing personal
p.(None): care, for a patient. Dentists must provide all the information patients need to make their decisions. This involve
p.(None): explaining complex dental diagnosis, prognoses and treatment regimes in simple language, confirming or correcting
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): information that the patients may have obtained elsewhere (e.g., from another health practitioner, magazines or the
p.(None): internet), ensuring that patients understand the treatment options (including the option of no treatment) advantages
p.(None): and disadvantages of each, answering any questions they may have, and understanding whatever decision the patient has
p.(None): reached and, if possible, the reasons for it.
p.(None): Any competent mature adult person may fully consent to treatment. A person is considered competent if he/she has
p.(None): sufficient understanding and capacity to make and communicate reasonable decisions. A legally appointed guardian may
p.(None): consent to the treatment for an incompetent adult.
p.(None): A parent or legally appointed guardian must consent to the treatment for young children and mentally disabled adults.
p.(None): Parents or legal guardians have a right to an explanation regarding the options for behavioral management of children,
p.(None): and are responsible to ask for additional information if they do not understand explanations. Siblings, friends, or any
p.(None): person other than a parent or legal guardian cannot provide consent.
p.(None): Confidentiality
p.(None):
p.(None): Dentists are obliged to safeguard the confidentiality of patient records. Dentists shall maintain patient records in a
p.(None): manner consistent with the protection of the welfare of the patient. Upon request of a patient or another dental
p.(None): practitioner, dentists shall provide any information in accordance with applicable law that will be beneficial for the
p.(None): future treatment of that patient.
p.(None): Refuse of patient treatment
p.(None): The Dentist may, in non-emergency cases, refuse to treat a patient for justified personal or professional reasons which
p.(None): might compromise the quality of the service rendered to the patient. Provided that such refusal should not cause harm
p.(None): to the patient's health, and that there is another Dentist who could perform the treatment. The justification of such
p.(None): action must be documented and authorized by the higher clinical authority.
p.(None):
p.(None): Patient referral
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): When deemed necessary, a dentist having undertaken the care of a patient shall not discontinue that care without
p.(None): notifying the patient and make proper arrangement for continuity of treatment. The dentist should refer the patient in
p.(None): any situation he/she can’t provide good quality type of treatment or when he/she feels that another dentist can provide
p.(None): a better service.
p.(None):
...
p.(None):
p.(None): 7.1 Research involving children, adolescents and mentally impaired people
p.(None): Dental treatment and research on children, adolescents and mentally impaired person is part of the dental
p.(None): discipline. A child is a person who has not yet reached puberty
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): whereas an adolescent is a person who is reaching or has reached puberty. Mentally impaired person is a
p.(None): person who has impairment of intelligence and social functioning which appears to be permanent or temporary. Children,
p.(None): adolescents and mentally impaired person are considered participants who require additional attention because
p.(None): of their limited intellectual and emotional capacities. They cannot give a legal consent; therefore
p.(None): permission from the parent(s) is essential. Children, adolescents and mentally impaired person should
p.(None): participate in research only where their participation is indispensable to the research and where participation is
p.(None): not contrary to the individual's best interests. The research proposal must provide sufficient
p.(None): information to justify clearly why children, adolescents or mentally impaired person should be included
p.(None): as participants. Refusal of a child, adolescent or mentally impaired person to participate in the research must be
p.(None): respected.
p.(None):
p.(None): 7.1.1 Approval of research involving children and adolescents
p.(None): Research involving a child, adolescent or mentally impaired person should be approved only if:
p.(None): 1) The research, including observational research, places the child , adolescent or mentally impaired person at no
...
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p.(None): care, for a patient. Dentists must provide all the information patients need to make their decisions. This involve
p.(None): explaining complex dental diagnosis, prognoses and treatment regimes in simple language, confirming or correcting
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): information that the patients may have obtained elsewhere (e.g., from another health practitioner, magazines or the
p.(None): internet), ensuring that patients understand the treatment options (including the option of no treatment) advantages
p.(None): and disadvantages of each, answering any questions they may have, and understanding whatever decision the patient has
p.(None): reached and, if possible, the reasons for it.
p.(None): Any competent mature adult person may fully consent to treatment. A person is considered competent if he/she has
p.(None): sufficient understanding and capacity to make and communicate reasonable decisions. A legally appointed guardian may
p.(None): consent to the treatment for an incompetent adult.
p.(None): A parent or legally appointed guardian must consent to the treatment for young children and mentally disabled adults.
p.(None): Parents or legal guardians have a right to an explanation regarding the options for behavioral management of children,
p.(None): and are responsible to ask for additional information if they do not understand explanations. Siblings, friends, or any
p.(None): person other than a parent or legal guardian cannot provide consent.
p.(None): Confidentiality
p.(None):
p.(None): Dentists are obliged to safeguard the confidentiality of patient records. Dentists shall maintain patient records in a
p.(None): manner consistent with the protection of the welfare of the patient. Upon request of a patient or another dental
p.(None): practitioner, dentists shall provide any information in accordance with applicable law that will be beneficial for the
p.(None): future treatment of that patient.
p.(None): Refuse of patient treatment
p.(None): The Dentist may, in non-emergency cases, refuse to treat a patient for justified personal or professional reasons which
p.(None): might compromise the quality of the service rendered to the patient. Provided that such refusal should not cause harm
p.(None): to the patient's health, and that there is another Dentist who could perform the treatment. The justification of such
p.(None): action must be documented and authorized by the higher clinical authority.
p.(None):
p.(None): Patient referral
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
...
p.(None): impaired person participant. The degree of risk must be justified by the potential benefit.
p.(None): 3) The research involves greater than minimal risk, with no prospect of direct benefit to the child, adolescent or
p.(None): mentally impaired person, but has a high probability of providing significant knowledge. The risk should be justified
p.(None): by the risk-knowledge ratio and the risk must represent no more than a minor increase over minimal risk.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 7.1.2 Consent for children or adolescents
p.(None): Consent for children, adolescents or mentally impaired person to participate in research must be obtained from:
p.(None): a) The parents or legal guardian in all but exceptional circumstances such as emergencies.
p.(None): b) The child or adolescent that is competent to make the decision.
p.(None): c) Any organization or person required by authorization.
p.(None): d) No other caregiver can act on behalf of a child in providing consent to participate.
p.(None):
p.(None):
p.(None): 7.2 Research involving pregnant women
p.(None): The DERB must give extra attention to research that involves pregnant women or those who may become pregnant, because
p.(None): of the additional health concerns during pregnancy and the need to avoid unnecessary risk to the fetus. The policy of
p.(None): the college of dentistry research center is that; no pregnant woman may be involved as a participant in any dental
p.(None): research activity unless:
p.(None): • The purpose of the research is to meet the health needs of the mother and the fetus will be placed at no
p.(None): risk, or
p.(None): • The risk to the fetus is minimal.
...
General/Other / Dependent
Searching for indicator dependent:
(return to top)
p.(None): 6.6.2.3 Expedited from the full ethical board review
p.(None): 6.8 Conflict of Interest
p.(None): 6.9 Informed Consent:
p.(None): 6.9.1 Re-consent
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.9.2 Waiver of consent
p.(None): 6.10 Submitting a Research Proposal
p.(None): 6.11 Electronic Submission of a Research proposal
p.(None): 6.12 Evaluation of submitted research proposals
p.(None): 6.13 Meeting Requirements
p.(None): 6.14 Decision-making
p.(None): 7.0 RESEARCH PARTICIPANTS REQUIRING ADDITIONAL ATTENTION
p.(None): 7.1 Research Involving Children and Adolescents
p.(None): 7.1.1 Approval of research involving children and adolescents
p.(None): 7.1.2 Consent for children or adolescents
p.(None): 7.2 Research involving pregnant women
p.(None): 7.3 Research involving a fetus
p.(None): 7.4 Research involving prisoners
p.(None): 7.4.1 Considerations regarding research involving prisoners
p.(None): 7.4.2 Approval of research involving prisoners
p.(None): 7.5 Research involving humans highly dependent on medical care
p.(None): 7.6 Other groups requiring additional attention
p.(None): 8.0 EPIDEMIOLOGICAL RESEARCH
p.(None): 9.0 HUMAN GENETIC RESEARCH
p.(None): 10.0 HUMAN TISSUE SAMPLES
p.(None): 11.0 REFERENCES
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): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 1.0 INTRODUCTION
p.(None): The College of Dentistry, King Saud University is the one of the dental colleges in the Kingdom of Saudi Arabia and
p.(None): the Gulf Countries that carries the responsibility of educating students, providing oral health services to the
p.(None): patients, conducting research and servicing the community. These responsibilities are conducted under the good ethical
p.(None): principles that guide the educational process in King Saud University.
p.(None):
p.(None): The Research Center within the College of Dentistry (CDRC) is the product of the University’s aspiration of bringing
p.(None): about a more research-oriented institution especially in the area of dentistry. Founded in 1981, its primary goal is
p.(None): the encouragement of viable research Potentials from among the dental professionals in the Kingdom. The Center
p.(None): realizes that this objective can be achieved by extending support to all kinds of research work and providing
p.(None): state-of-the- art equipment complemented by highly trained technical staff in all its laboratories. This report will
p.(None): explain the code of ethics for dental research.
p.(None):
...
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.3 Code of ethics in Dental Research Involving Human Participants
p.(None): The codes of ethics in Dental Research Involving Human Participants are in addition to the general code of ethics in
p.(None): dental research stated in part 4.2, they are applicable but not limited to dental research conducted by
p.(None): students, interns, academic or clinical staff, or affiliated researcher of the College of Dentistry, King
p.(None): Saud University. This is true regardless of the location where the research is conducted. The codes of ethics in
p.(None): dental research involving humans are:
p.(None): 1) Respect for persons incorporates at least two fundamental ethical considerations, namely:
p.(None): a. Respect for autonomy which requires that those who are capable of self- determination about their choices
p.(None): should be treated with respect for their capacity of self-determination.
p.(None): b. Protection of persons with impaired or diminished autonomy, which requires that those who are dependent or
p.(None): vulnerable be afforded full security against harm or abuse.
p.(None): 2) Beneficence and non-maleficence refers to the ethical obligation to maximize benefits and to minimize harms.
p.(None): This gives rise to norms requiring the risks of research to be reasonable in the light of the expected benefits, that
p.(None): the research design be sound, and that the investigators be competent to conduct the research and to safeguard the
p.(None): welfare of the research subjects.
p.(None): 3) Justice refers to the ethical obligation to treat each person in accordance with what is morally right and
p.(None): proper; to give each person what is due to him or her. In the ethics of research involving human participants, the
p.(None): principle refers primarily to distributive justice, which requires equitable distribution of both the burdens and the
p.(None): benefits of participation in research.
p.(None):
p.(None):
p.(None):
p.(None): 6.4 Establishment of the Dental Ethics Review Board (DERB)
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): The Dean of the College of Dentistry, King Saud University is responsible for establishing the Dental
p.(None): Ethics Review Board (DERB) to review, approve and monitor research that involves human participants. The DERB
...
p.(None): a) When it is impractical to conduct research since confidentiality of personally identifiable
p.(None): information has to be maintained throughout the research.
p.(None): b) Research on publicly available information, documents, records, works, performances,
p.(None): reviews, quality assurance studies, archival materials or third party interviews, service programs for benefit
p.(None): of public having a bearing on public health programs, and consumer acceptance studies.
p.(None): c) Research on anonymised biological samples from left over samples after clinical investigation.
p.(None): d) In emergency situations when informed consent can be taken. Do you mean cannot be taken? (yes cannot, but I think
p.(None): we need to define the emergency situations)
p.(None):
p.(None): 7.0 Research Participants Requiring Additional Attention
p.(None): Humans with limited autonomy or in subordinate positions are considered participants that require additional
p.(None): attention and are in need of greater protection. These may include children, pregnant women and fetus, prisoners, and
p.(None): human highly dependent on medical care. Does this cover mentally impaired people?
p.(None):
p.(None): 7.1 Research involving children, adolescents and mentally impaired people
p.(None): Dental treatment and research on children, adolescents and mentally impaired person is part of the dental
p.(None): discipline. A child is a person who has not yet reached puberty
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): whereas an adolescent is a person who is reaching or has reached puberty. Mentally impaired person is a
p.(None): person who has impairment of intelligence and social functioning which appears to be permanent or temporary. Children,
p.(None): adolescents and mentally impaired person are considered participants who require additional attention because
p.(None): of their limited intellectual and emotional capacities. They cannot give a legal consent; therefore
...
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 3. Minimal risk and no more than inconvenience caused and research is a study of prisons as institutional structures
p.(None): or of prisoners as incarcerated persons.
p.(None): 4. Research on conditions affecting prisoners as a class.
p.(None):
p.(None):
p.(None): 7.4.2 Approval of research involving prisoners
p.(None): 1) Advantages through participation compared to their current situation.
p.(None): 2) Risk of participation is the same as those that would be accepted by non‐prisoners.
p.(None): 3) Procedure of selection is fair to all prisoners.
p.(None): 4) Language for obtaining informed consent must be understandable to prisoners.
p.(None): 5) When studies need follow‐up, the provision for follow‐up must include a consideration of the length of individual
p.(None): sentences, and prisoners must be informed about follow‐up.
p.(None):
p.(None): 7.5 Research involving humans highly dependent on medical care
p.(None): Dental research on humans who are highly dependent on medical care raises ethical issues that deserve special
p.(None): attention. Researchers need to acknowledge that informed consent may be compromised by the effect of the medical
p.(None): condition or fear of affecting the level of medical care in case of refusal to participate. The following conditions
p.(None): are considered for possible dental research activities.
p.(None): 1. Research activities on humans under emergency care
p.(None): 2. Research activities on humans in the intensive care unit
p.(None): 3. Research activities on neonatals in the intensive care unit
p.(None): 4. Research activities on humans in the terminal care unit
p.(None): 5. Research activities on decisionally impaired humans
p.(None): 6. Research activities on unconscious human
p.(None): The policy of the college of dentistry research center is that; no dental research should be carried out on the above
p.(None): mentioned conditions. However, The DERB, within its authority can approve dental research in the following conditions;
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): • The research is based on valid scientific hypotheses which support a reasonable possibility of benefit over
p.(None): standard care.
p.(None): • The research is intended to be therapeutic and the research intervention poses no more than a risk that is
p.(None): expected in alternative methods of treatment.
p.(None):
...
General/Other / Diminished Autonomy
Searching for indicator diminished:
(return to top)
p.(None): rights of research participants, and reflect the basic ethical values of respect, beneficence and justice for human.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.3 Code of ethics in Dental Research Involving Human Participants
p.(None): The codes of ethics in Dental Research Involving Human Participants are in addition to the general code of ethics in
p.(None): dental research stated in part 4.2, they are applicable but not limited to dental research conducted by
p.(None): students, interns, academic or clinical staff, or affiliated researcher of the College of Dentistry, King
p.(None): Saud University. This is true regardless of the location where the research is conducted. The codes of ethics in
p.(None): dental research involving humans are:
p.(None): 1) Respect for persons incorporates at least two fundamental ethical considerations, namely:
p.(None): a. Respect for autonomy which requires that those who are capable of self- determination about their choices
p.(None): should be treated with respect for their capacity of self-determination.
p.(None): b. Protection of persons with impaired or diminished autonomy, which requires that those who are dependent or
p.(None): vulnerable be afforded full security against harm or abuse.
p.(None): 2) Beneficence and non-maleficence refers to the ethical obligation to maximize benefits and to minimize harms.
p.(None): This gives rise to norms requiring the risks of research to be reasonable in the light of the expected benefits, that
p.(None): the research design be sound, and that the investigators be competent to conduct the research and to safeguard the
p.(None): welfare of the research subjects.
p.(None): 3) Justice refers to the ethical obligation to treat each person in accordance with what is morally right and
p.(None): proper; to give each person what is due to him or her. In the ethics of research involving human participants, the
p.(None): principle refers primarily to distributive justice, which requires equitable distribution of both the burdens and the
p.(None): benefits of participation in research.
p.(None):
p.(None):
p.(None):
p.(None): 6.4 Establishment of the Dental Ethics Review Board (DERB)
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): The Dean of the College of Dentistry, King Saud University is responsible for establishing the Dental
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
(return to top)
p.(None): opportunity for diverse groups. This might involve reading general or discipline-specific educational literature,
p.(None): attending workshops and conferences, or experimentation with alternative methods of teaching a
p.(None): given course or a specific group of students.
p.(None):
p.(None): 3. Dealing with Sensitive Topics
p.(None): Topics that students are likely to find sensitive or discomforting are dealt with in an open, honest,
p.(None): and positive way respecting cultural principles and values.
p.(None):
p.(None): The teacher should invite all students to state their position on the issue, sets ground rules for discussion, is
p.(None): respectful of students even when it is necessary to disagree, and encourages students to be respectful of
p.(None): one another.
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None):
p.(None): 4. Student Development
p.(None): The overriding responsibility of the teacher is to contribute to the intellectual development of the student, at least
p.(None): in the context of the teacher's own area of expertise, and to avoid actions such as exploitation and discrimination
p.(None): that detract from student development.
p.(None): According to this principle, the teacher's most basic responsibility is to design instruction that facilitates
p.(None): learning and encourages autonomy and independent thinking of students, to treat students with respect and
p.(None): dignity, and to avoid actions that detract unjustifiably from student development.
p.(None):
p.(None): 5. Dual Relationships with Students
p.(None): To avoid conflict of interest, a teacher does not enter into dual-role relationships with students that are likely to
p.(None): detract from student development or lead to actual or perceived favoritism on the part of the teacher.
p.(None):
p.(None): This principle means that it is the responsibility of the teacher to keep relationships with students
p.(None): focused on pedagogical goals and academic requirements. Even if the teacher believes that she or he is maintaining
p.(None): objectivity, the perception of favoritism on the part of other students is as educationally disastrous
p.(None): as actual favoritism or unfairness. If a teacher does become involved in a dual relationship with
p.(None): a student, such as business or financial relationships, blood or marital relatedness, it is the
p.(None): responsibility of the teacher to notify his or her supervisor of the situation as soon as possible, so that
p.(None): alternative arrangements can be made for supervision or evaluation of the student.
p.(None):
p.(None): Although there are definite pedagogical benefits to establishing good rapport with students and interacting with
p.(None): students both inside and outside the classroom, there are also serious risks of exploitation, compromise of academic
...
p.(None):
p.(None): 6.2 Ethics in Dental Research Involving Human Participants
p.(None): The dental researcher should strive for the ethical principles that identify good, desirable and
p.(None): acceptable conduct of research involving human participant. The researcher should protect the welfare and
p.(None): rights of research participants, and reflect the basic ethical values of respect, beneficence and justice for human.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.3 Code of ethics in Dental Research Involving Human Participants
p.(None): The codes of ethics in Dental Research Involving Human Participants are in addition to the general code of ethics in
p.(None): dental research stated in part 4.2, they are applicable but not limited to dental research conducted by
p.(None): students, interns, academic or clinical staff, or affiliated researcher of the College of Dentistry, King
p.(None): Saud University. This is true regardless of the location where the research is conducted. The codes of ethics in
p.(None): dental research involving humans are:
p.(None): 1) Respect for persons incorporates at least two fundamental ethical considerations, namely:
p.(None): a. Respect for autonomy which requires that those who are capable of self- determination about their choices
p.(None): should be treated with respect for their capacity of self-determination.
p.(None): b. Protection of persons with impaired or diminished autonomy, which requires that those who are dependent or
p.(None): vulnerable be afforded full security against harm or abuse.
p.(None): 2) Beneficence and non-maleficence refers to the ethical obligation to maximize benefits and to minimize harms.
p.(None): This gives rise to norms requiring the risks of research to be reasonable in the light of the expected benefits, that
p.(None): the research design be sound, and that the investigators be competent to conduct the research and to safeguard the
p.(None): welfare of the research subjects.
p.(None): 3) Justice refers to the ethical obligation to treat each person in accordance with what is morally right and
p.(None): proper; to give each person what is due to him or her. In the ethics of research involving human participants, the
p.(None): principle refers primarily to distributive justice, which requires equitable distribution of both the burdens and the
p.(None): benefits of participation in research.
p.(None):
p.(None):
p.(None):
p.(None): 6.4 Establishment of the Dental Ethics Review Board (DERB)
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): The Dean of the College of Dentistry, King Saud University is responsible for establishing the Dental
...
p.(None): influences their independent and objective judgment.
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): Conflict of Interest is when the professional judgment concerning research is influenced by a secondary interest such
p.(None): as personal or financial gain. The dental researchers and DERB members should disclose any actual, perceived or
p.(None): potential conflicts of interest to the DERB. The DERB should develop mechanisms to address and manage such conflicts of
p.(None): interest.
p.(None):
p.(None): 6.9 Informed Consent
p.(None): Informed consent means that a participant has been informed about the risks and benefits of the research,
p.(None): understands such risks and benefits and is able to give consent to participation, without coercion, undue
p.(None): influence or inappropriate incentives. It represents a signed agreement between the dental researcher
p.(None): and the human participant or their legally authorized representative to participate in the research
p.(None): before the start of the research. The informed consent process should provide the necessary information to
p.(None): the participants in simple, clear language that they understand and in terms they comprehend. It should provide the
p.(None): freedom of choice, the respect of participant’s autonomy, the voluntariness to participate and the protection
p.(None): of privacy and confidentiality. The information is given in a document known as the Informed Consent
p.(None): Form.
p.(None):
p.(None): The informed consent form should have the following as may be applicable:
p.(None): 1) Nature and purpose of study, stating it as research.
p.(None): 2) Duration of participation with number of participants.
p.(None): 3) Procedures to be followed.
p.(None): 4) Investigations, if any, to be performed.
p.(None): 5) Foreseeable risks and discomforts adequately described and whether the project involves more than minimal
p.(None): risk.
p.(None): 6) Benefits to participants, community or the dental profession as may be applicable.
p.(None): 7) Policy on compensation.
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 8) Availability of dental or alternative treatments if available for injuries or risk management.
p.(None): 9) Steps taken for ensuring confidentiality.
p.(None): 10) Freedom to withdraw without any consequences or loss of benefits.
p.(None): 11) Contact details of researchers for seeking more information related to the research or in case of injury.
p.(None): 12) Contact details for appeal against violation of rights.
p.(None): 13) Voluntary participation.
...
p.(None): justified that the research involves not more than minimal risk or when the participant and the researcher do not
p.(None): come into contact or when it is necessitated in emergency situations. If such studies have the appropriate protection
p.(None): for both privacy and confidentiality, and do not violate the rights of the participants then the DERB
p.(None): may waive the requirement for informed consent in the following instances:
p.(None): a) When it is impractical to conduct research since confidentiality of personally identifiable
p.(None): information has to be maintained throughout the research.
p.(None): b) Research on publicly available information, documents, records, works, performances,
p.(None): reviews, quality assurance studies, archival materials or third party interviews, service programs for benefit
p.(None): of public having a bearing on public health programs, and consumer acceptance studies.
p.(None): c) Research on anonymised biological samples from left over samples after clinical investigation.
p.(None): d) In emergency situations when informed consent can be taken. Do you mean cannot be taken? (yes cannot, but I think
p.(None): we need to define the emergency situations)
p.(None):
p.(None): 7.0 Research Participants Requiring Additional Attention
p.(None): Humans with limited autonomy or in subordinate positions are considered participants that require additional
p.(None): attention and are in need of greater protection. These may include children, pregnant women and fetus, prisoners, and
p.(None): human highly dependent on medical care. Does this cover mentally impaired people?
p.(None):
p.(None): 7.1 Research involving children, adolescents and mentally impaired people
p.(None): Dental treatment and research on children, adolescents and mentally impaired person is part of the dental
p.(None): discipline. A child is a person who has not yet reached puberty
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): whereas an adolescent is a person who is reaching or has reached puberty. Mentally impaired person is a
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.(None): consent to the treatment for an incompetent adult.
p.(None): A parent or legally appointed guardian must consent to the treatment for young children and mentally disabled adults.
p.(None): Parents or legal guardians have a right to an explanation regarding the options for behavioral management of children,
p.(None): and are responsible to ask for additional information if they do not understand explanations. Siblings, friends, or any
p.(None): person other than a parent or legal guardian cannot provide consent.
p.(None): Confidentiality
p.(None):
p.(None): Dentists are obliged to safeguard the confidentiality of patient records. Dentists shall maintain patient records in a
p.(None): manner consistent with the protection of the welfare of the patient. Upon request of a patient or another dental
p.(None): practitioner, dentists shall provide any information in accordance with applicable law that will be beneficial for the
p.(None): future treatment of that patient.
p.(None): Refuse of patient treatment
p.(None): The Dentist may, in non-emergency cases, refuse to treat a patient for justified personal or professional reasons which
p.(None): might compromise the quality of the service rendered to the patient. Provided that such refusal should not cause harm
p.(None): to the patient's health, and that there is another Dentist who could perform the treatment. The justification of such
p.(None): action must be documented and authorized by the higher clinical authority.
p.(None):
p.(None): Patient referral
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): When deemed necessary, a dentist having undertaken the care of a patient shall not discontinue that care without
p.(None): notifying the patient and make proper arrangement for continuity of treatment. The dentist should refer the patient in
p.(None): any situation he/she can’t provide good quality type of treatment or when he/she feels that another dentist can provide
p.(None): a better service.
p.(None):
p.(None): Patient should be referred to another dentist specialized in the treatment of the patient condition or to the dentist
p.(None): who has more advanced and effective means if the condition of the patient so requires. The dentist should not delay the
p.(None): referral, whenever such referral is in the best interest of the patient.
p.(None): - When referring the patient to another dentist, the information which he/she believes necessary for the treatment
p.(None): should be provided.
p.(None): - When a patient wishes to consult another dentist (in respect of the condition of his disease), the dentist should
p.(None): not refuse fulfilling such wish, but should rather facilitate furnishing the patient with the necessary dental reports
p.(None): and information for such consultation.
...
p.(None):
p.(None): 6.9.1 Re-consent
p.(None): Re-consent is taken in following conditions:
p.(None): 1) Availability of new information that necessitate changes in the research protocol.
p.(None): 2) When a research participant regains consciousness from an unconscious state or become mentally competent
p.(None): to understand the study.
p.(None): 3) Follow-up of the results of previous research.
p.(None): 4) Not finished research that requires extension of the allowed time.
p.(None): 5) When there is a change in treatment modality, procedures and site visits.
p.(None): 6) Before publication if there is possibility of disclosure of identity through data presentation or
p.(None): photographs that should be camouflaged adequately.
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.9.2 Waiver of consent
p.(None): Voluntary informed consent is a requirement for any research proposal that involves human participation.
p.(None): However, there are situations when the requirements for informed consent can be waived. If it is
p.(None): justified that the research involves not more than minimal risk or when the participant and the researcher do not
p.(None): come into contact or when it is necessitated in emergency situations. If such studies have the appropriate protection
p.(None): for both privacy and confidentiality, and do not violate the rights of the participants then the DERB
p.(None): may waive the requirement for informed consent in the following instances:
p.(None): a) When it is impractical to conduct research since confidentiality of personally identifiable
p.(None): information has to be maintained throughout the research.
p.(None): b) Research on publicly available information, documents, records, works, performances,
p.(None): reviews, quality assurance studies, archival materials or third party interviews, service programs for benefit
p.(None): of public having a bearing on public health programs, and consumer acceptance studies.
p.(None): c) Research on anonymised biological samples from left over samples after clinical investigation.
p.(None): d) In emergency situations when informed consent can be taken. Do you mean cannot be taken? (yes cannot, but I think
p.(None): we need to define the emergency situations)
p.(None):
p.(None): 7.0 Research Participants Requiring Additional Attention
p.(None): Humans with limited autonomy or in subordinate positions are considered participants that require additional
p.(None): attention and are in need of greater protection. These may include children, pregnant women and fetus, prisoners, and
p.(None): human highly dependent on medical care. Does this cover mentally impaired people?
p.(None):
p.(None): 7.1 Research involving children, adolescents and mentally impaired people
p.(None): Dental treatment and research on children, adolescents and mentally impaired person is part of the dental
p.(None): discipline. A child is a person who has not yet reached puberty
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
...
p.(None):
p.(None):
p.(None): 7.4.2 Approval of research involving prisoners
p.(None): 1) Advantages through participation compared to their current situation.
p.(None): 2) Risk of participation is the same as those that would be accepted by non‐prisoners.
p.(None): 3) Procedure of selection is fair to all prisoners.
p.(None): 4) Language for obtaining informed consent must be understandable to prisoners.
p.(None): 5) When studies need follow‐up, the provision for follow‐up must include a consideration of the length of individual
p.(None): sentences, and prisoners must be informed about follow‐up.
p.(None):
p.(None): 7.5 Research involving humans highly dependent on medical care
p.(None): Dental research on humans who are highly dependent on medical care raises ethical issues that deserve special
p.(None): attention. Researchers need to acknowledge that informed consent may be compromised by the effect of the medical
p.(None): condition or fear of affecting the level of medical care in case of refusal to participate. The following conditions
p.(None): are considered for possible dental research activities.
p.(None): 1. Research activities on humans under emergency care
p.(None): 2. Research activities on humans in the intensive care unit
p.(None): 3. Research activities on neonatals in the intensive care unit
p.(None): 4. Research activities on humans in the terminal care unit
p.(None): 5. Research activities on decisionally impaired humans
p.(None): 6. Research activities on unconscious human
p.(None): The policy of the college of dentistry research center is that; no dental research should be carried out on the above
p.(None): mentioned conditions. However, The DERB, within its authority can approve dental research in the following conditions;
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): • The research is based on valid scientific hypotheses which support a reasonable possibility of benefit over
p.(None): standard care.
p.(None): • The research is intended to be therapeutic and the research intervention poses no more than a risk that is
p.(None): expected in alternative methods of treatment.
p.(None):
p.(None): 7.6 Other groups requiring additional attention
p.(None): The discussion of the dental research participants requiring additional attention should not be limited to those
p.(None): already mentioned. Other groups that require additional attention include: traumatized and comatose patients,
...
General/Other / Relationship to Authority
Searching for indicator authority:
(return to top)
p.(None): believing that releasing such information will be beneficial to the student or will prevent harm to others.
p.(None): This principle suggests that students are entitled to the same level of confidentiality in their
p.(None): relationships with teachers as would exist in a lawyer-client or doctor-patient relationship. Violation of
p.(None): confidentiality in the teacher-student relationship can cause students to distrust teachers and to show
p.(None): decreased academic motivation. Whatever rules or policies are followed with respect to confidentiality of student
p.(None): records, these should be disclosed in full to students at the beginning of the academic term.
p.(None):
p.(None): 7. Respect for Colleagues
p.(None): A college teacher respects the dignity of her or his colleagues and works cooperatively with colleagues
p.(None): in the interest of fostering student development.
p.(None):
p.(None): This principle means that in interactions among colleagues with respect to teaching, the overriding concern
p.(None): is the development of students. Disagreements between colleagues relating to teaching are settled privately, if
p.(None): possible, with no harm to student development. If a teacher suspects that a colleague has shown incompetence or ethical
p.(None): violations in teaching, the teacher takes responsibility for raising the matter to higher authority.
p.(None):
p.(None): 8. Valid Assessment of Students
p.(None): Given the importance of assessment of student performance in college teaching and in students' lives and
p.(None): careers, instructors are responsible for taking adequate steps to ensure that assessment of students is valid, open,
p.(None): fair, and congruent with course objectives.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): This principle means that the teacher is aware of research (including personal or self-reflective research) on the
p.(None): advantages and disadvantages of alternative methods of assessment, and based on this knowledge, the teacher
p.(None): selects assessment techniques that are consistent with the objectives of the course and at the same time are
p.(None): as reliable and valid as possible. Furthermore, assessment procedures and grading standards are
p.(None): communicated clearly to students at the beginning of the course, and except in rare circumstances, there is no
p.(None): deviation from the announced procedures. Student exams, papers, and assignments are graded carefully and fairly through
p.(None): the use of a rational marking system that can be communicated to students. By means appropriate for the size of the
p.(None): class, students are provided with prompt and accurate feedback on their performance at regular intervals throughout the
p.(None): course, plus an explanation as to how their work was graded, and constructive suggestions as to how to
p.(None): improve their standing in the course. In a similar vein, teachers are fair and objective in writing
p.(None): letters of reference for students.
p.(None):
...
p.(None): Parents or legal guardians have a right to an explanation regarding the options for behavioral management of children,
p.(None): and are responsible to ask for additional information if they do not understand explanations. Siblings, friends, or any
p.(None): person other than a parent or legal guardian cannot provide consent.
p.(None): Confidentiality
p.(None):
p.(None): Dentists are obliged to safeguard the confidentiality of patient records. Dentists shall maintain patient records in a
p.(None): manner consistent with the protection of the welfare of the patient. Upon request of a patient or another dental
p.(None): practitioner, dentists shall provide any information in accordance with applicable law that will be beneficial for the
p.(None): future treatment of that patient.
p.(None): Refuse of patient treatment
p.(None): The Dentist may, in non-emergency cases, refuse to treat a patient for justified personal or professional reasons which
p.(None): might compromise the quality of the service rendered to the patient. Provided that such refusal should not cause harm
p.(None): to the patient's health, and that there is another Dentist who could perform the treatment. The justification of such
p.(None): action must be documented and authorized by the higher clinical authority.
p.(None):
p.(None): Patient referral
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): When deemed necessary, a dentist having undertaken the care of a patient shall not discontinue that care without
p.(None): notifying the patient and make proper arrangement for continuity of treatment. The dentist should refer the patient in
p.(None): any situation he/she can’t provide good quality type of treatment or when he/she feels that another dentist can provide
p.(None): a better service.
p.(None):
p.(None): Patient should be referred to another dentist specialized in the treatment of the patient condition or to the dentist
p.(None): who has more advanced and effective means if the condition of the patient so requires. The dentist should not delay the
p.(None): referral, whenever such referral is in the best interest of the patient.
p.(None): - When referring the patient to another dentist, the information which he/she believes necessary for the treatment
p.(None): should be provided.
p.(None): - When a patient wishes to consult another dentist (in respect of the condition of his disease), the dentist should
p.(None): not refuse fulfilling such wish, but should rather facilitate furnishing the patient with the necessary dental reports
p.(None): and information for such consultation.
p.(None): - To realize the fact that the patient is entitled for the right of consulting another
p.(None): dentist, and also for the right of obtaining the recorded information in his medical record or the necessary medical
p.(None): report describing the condition of his disease.
p.(None):
p.(None): REFERENCES
p.(None): 1- FDI World Dental Federation. Dental Ethics Manual, 2007.
...
p.(None): 2.1 Purpose of the Code of Ethics
p.(None): 2.2 Importance of the Code of Ethics in Dental Research
p.(None): 3.0 TYPES of RESEARCH
p.(None): 4.0 RESEARCH INVOLVING NON-LIVING OBJECTS
p.(None): 4.1 Ethics in Dental Research Involving Non-Living Objects
p.(None): 4.2 Code of Ethics in Dental Research Involving Non-living Objects
p.(None): 4.3 Research Proposal
p.(None): 4.4 Submitting a Research Proposal
p.(None): 4.5 Electronic Submission of a Research Proposal
p.(None): 4.6 Evaluation of Submitted Research Proposals
p.(None): 5.0 RESEARCH INVOLVING PLANTS or ANIMALS
p.(None): 5.1 Ethics in Dental Research Involving Plants or Animals
p.(None): 5.2 Code of Ethics in Dental Research Involving Plants or Animals
p.(None): 5.3 Consideration for the use of animals in dental research
p.(None): 5.4 Submitting a Research Proposal
p.(None): 5.5 Electronic Submission of a Research Proposal
p.(None): 5.6 Evaluation of Submitted Research Proposals
p.(None): 6.0 RESEARCH INVOLVING HUMAN PARTICIPANTS
p.(None): 6.1 Definition
p.(None): 6.2 Ethics in Dental Research Involving Human Participants
p.(None): 6.3 Code of Ethics in Dental Research Involving Human Participants
p.(None): 6.4 Establishment of the Dental Ethics Review Board (DERB)
p.(None): 6.5 Authority of the Dental Ethics Review Board
p.(None): 6.6 Types of Review
p.(None): 6.6.1 Minimal Risk.
p.(None): 6.6.2 Determining the Level of Review
p.(None): 6.6.2.1 Full Dental Ethical Board Review
p.(None): 6.6.2.2 Exempt from the full ethical board review
p.(None): 6.6.2.3 Expedited from the full ethical board review
p.(None): 6.8 Conflict of Interest
p.(None): 6.9 Informed Consent:
p.(None): 6.9.1 Re-consent
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.9.2 Waiver of consent
p.(None): 6.10 Submitting a Research Proposal
p.(None): 6.11 Electronic Submission of a Research proposal
p.(None): 6.12 Evaluation of submitted research proposals
p.(None): 6.13 Meeting Requirements
p.(None): 6.14 Decision-making
p.(None): 7.0 RESEARCH PARTICIPANTS REQUIRING ADDITIONAL ATTENTION
p.(None): 7.1 Research Involving Children and Adolescents
p.(None): 7.1.1 Approval of research involving children and adolescents
p.(None): 7.1.2 Consent for children or adolescents
p.(None): 7.2 Research involving pregnant women
p.(None): 7.3 Research involving a fetus
p.(None): 7.4 Research involving prisoners
...
p.(None): 3) Justice refers to the ethical obligation to treat each person in accordance with what is morally right and
p.(None): proper; to give each person what is due to him or her. In the ethics of research involving human participants, the
p.(None): principle refers primarily to distributive justice, which requires equitable distribution of both the burdens and the
p.(None): benefits of participation in research.
p.(None):
p.(None):
p.(None):
p.(None): 6.4 Establishment of the Dental Ethics Review Board (DERB)
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): The Dean of the College of Dentistry, King Saud University is responsible for establishing the Dental
p.(None): Ethics Review Board (DERB) to review, approve and monitor research that involves human participants. The DERB
p.(None): consists of a chairman and members from the different specialties within the College of Dentistry.
p.(None):
p.(None): 6.5 Authorities of the Dental Ethics Review Board (DERB)
p.(None): DERB has the obligation to ensure that dental research is designed and conducted in such a manner that the rights and
p.(None): welfare of participating human subjects is well protected. The authorities of the DERB are the following:
p.(None): • Determination of the level of review required for the presented research proposal. This is, the
p.(None): authority of the DERB chairman.
p.(None): • Review, approve, and request modifications of a research proposal
p.(None): • Restrict or omit steps or parts of a research proposal for participants’ protection.
p.(None): • Follow-up of the approved research by conducting continuing ethical review for ongoing research at an
p.(None): appropriate interval.
p.(None): • Inspect research facilities, equipment, and data and other relevant information relating to
p.(None): the use of human participants in dental research
p.(None): • Observe or have a third party observe the informed consent process.
p.(None): • Suspend or terminate previously approved research that is not being conducted in accordance
p.(None): with the DERB’s required standards
p.(None): • Suspend or terminate previously approved research that is associated with unexpected serious harm to
p.(None): participants.
p.(None): • Review, accept, and/or reject reports, including but not limited to reports of serious adverse events
p.(None): and unanticipated problems involving risks to subjects and others.
p.(None): • Disapprove a research proposal that is expected to cause serious harm to participants.
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): • Approve the inclusion of the college member in other research teams within or outside the premises of King
p.(None): Saud University.
p.(None): • Research that has been reviewed and approved by the DERB may be subject to disapproval by King Saud
p.(None): University officials or higher authorities.
p.(None): • King Saud University officials may not authorize or approve the conduct of dental research involving human
p.(None): participants that has not been approved by the DERB.
p.(None): • Research approved by the DERB may be subject, if requested by King Saud University officials or higher
p.(None): authorities, to further review and approval or disapproval by officials of the institution.
p.(None): • Members are expected to treat as confidential all applications, meeting deliberations, information
p.(None): on research participants/volunteers and related matters.
p.(None): • When a committee member believe that he/she has a conflict of interest on a subject which will compromise
p.(None): his/her ability to make a decision, he/she should declare that conflict of interest and withdraw him/herself from the
p.(None): discussion and/or decision making.
p.(None):
p.(None): The DERB has the mandate to act as an independent entity within the College of Dentistry, King Saud
p.(None): University. As such, the DERB is the final authority for all decisions regarding safeguarding the rights and
p.(None): welfare of humans who are subjects of dental research conducted under the auspices of the University.
p.(None):
p.(None): 6.7 Types of Review
p.(None): A dental research proposal involving human participation is reviewed initially by the DERB chairman to
p.(None): determine the appropriate level of review. The level of review is determined by the probability and
p.(None): magnitude of expected risk to the human. Risk is defined as the harm or injury that is expected to
p.(None): occur to the human resulted from
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): participating in the planned dental research. The probability of risk may vary from no or minimal risk to significant.
p.(None):
p.(None): 6.7.1 Minimal Risk
p.(None): Minimal risk is defined as follows: "The probability and magnitude of harm or discomfort
p.(None): anticipated in the research are not greater than those ordinarily encountered in daily life or during
p.(None): the performance of routine physical or psychological examinations or tests." For example, the risk of bleeding
...
p.(None): unfamiliar way
p.(None): 6) Innovative practices in health and disability services
p.(None): 7) Research conducted by students, which includes all activities that meet the definition of
p.(None): research with human participants (As supervised student research is conducted primarily for the purpose of
p.(None): educating students on research techniques and methodologies, DERB should review research protocols with
p.(None): a view to
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): contributing to the students’ education concerning scientific and ethical principles governing research).
p.(None): 8) Observational clinical research
p.(None): 9) Access to personal information by means of questionnaires, interviews or other techniques of information
p.(None): gathering
p.(None): 10) Research involving the secondary use of data (use of data not collected for that research purpose), if
p.(None): any form of identifier is involved and/or if health information pertaining to individuals is involved
p.(None): 11) Case studies, when a series of subject observations allow possible extrapolation of generalization of the
p.(None): results from the reported cases and when there is intent to publish or disseminate the data.
p.(None):
p.(None): 6.7.2.2 Exempt from the full ethical board review
p.(None): The determination of which proposals will be exempt from the full ethical board review is the sole authority of the
p.(None): DERB chairman. The exempt status of a research proposal means that the proposed protocol for the dental research is
p.(None): exempt from full authority of the DERB in research involving the participation of the human. Any change in
p.(None): the protocol of the approved proposal must be re-submitted to the DERB chairman to determine further
p.(None): exempt status. The dental researcher must submit to the DERB secretary the full documentations required
p.(None): for the review by the DERB, including the research proposal, informed consent and the CV’s of the investigators.
p.(None):
p.(None): To determine exempt status, the research must qualify as one or more of the categories listed below. To qualify for a
p.(None): category, the research must meet all of the conditions of that category.
p.(None):
p.(None): 1. Research conducted in established or commonly accepted educational settings involving normal educational
p.(None): practices such as (a) regular and special education
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): instructional strategies, or (b) research on the effectiveness of or the comparison among instructional
p.(None): techniques, curricula, or classroom management methods.
p.(None): 2. Research involving use of educational tests, survey or interview procedures, or observation of public
p.(None): behavior unless information obtained from these sources is recorded in such a manner that subjects can
p.(None): be identified, and disclosure of the subject’s responses outside the research could reasonably place the subject
...
p.(None): public office; or (b) federal statutes require, without exception, that the confidentiality of the
p.(None): personally identifiable information will be maintained throughout the research and thereafter. Children may
p.(None): not be involved in this research.
p.(None): 4. Research involving the collection or study of existing data, documents, records, pathological
p.(None): specimens, or diagnostic specimens, (a) if these sources are publicly available, or (b) if the information is
p.(None): recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers
p.(None): linked to the subjects.
p.(None): 5. Research and demonstration projects that are designed to study, evaluate, or otherwise examine (a) public benefit
p.(None): or service programs; (b) procedures for obtaining benefits or services under these programs; (c) possible changes or
p.(None): alternatives to those programs or procedures; or (d) possible changes in methods or levels of payments for benefits or
p.(None): services under those programs.
p.(None): 6. Tests and food quality evaluation and consumer studies (a) if wholesome food without additives is consumed, or (b)
p.(None): if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or
p.(None): agricultural chemical or environmental contaminant at or below the level found to be safe.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.7.2.3 Expedited from the full ethical board review
p.(None): The determination of the expedited status for any research proposal is the authority of the DERB chairman. A dental
p.(None): research proposal eligible expedited from the full ethical board review means that the proposed dental research
p.(None): is to be reviewed by a single member of the DERB panel. The single member is designated by the DERB
p.(None): chairman. Like the exempt review, the research must be of minimal risk or no more than minimal risk and all aspects of
p.(None): a protocol must fit within one or more expedited categories to be reviewed in this manner. The dental researcher must
p.(None): submit to the DERB secretary the full documentations required for the review by the DERB, including the
p.(None): research proposal, informed consent and the CV’s of the investigators.
p.(None):
p.(None): An expedited review process is available for research activities that present no more than minimal risk to
p.(None): human participants or that request a minor change in previously approved research that involves no additional risk and
p.(None): that involve only procedures in one or more of the categories listed below. Some of the categories overlap with those
p.(None): used to assess exempt status. The distinction between exempt and expedited review is based on the sensitivity of the
p.(None): data and/or the risk of compromised confidentiality (such as a relatively small sample size).
p.(None):
...
p.(None): 5) When studies need follow‐up, the provision for follow‐up must include a consideration of the length of individual
p.(None): sentences, and prisoners must be informed about follow‐up.
p.(None):
p.(None): 7.5 Research involving humans highly dependent on medical care
p.(None): Dental research on humans who are highly dependent on medical care raises ethical issues that deserve special
p.(None): attention. Researchers need to acknowledge that informed consent may be compromised by the effect of the medical
p.(None): condition or fear of affecting the level of medical care in case of refusal to participate. The following conditions
p.(None): are considered for possible dental research activities.
p.(None): 1. Research activities on humans under emergency care
p.(None): 2. Research activities on humans in the intensive care unit
p.(None): 3. Research activities on neonatals in the intensive care unit
p.(None): 4. Research activities on humans in the terminal care unit
p.(None): 5. Research activities on decisionally impaired humans
p.(None): 6. Research activities on unconscious human
p.(None): The policy of the college of dentistry research center is that; no dental research should be carried out on the above
p.(None): mentioned conditions. However, The DERB, within its authority can approve dental research in the following conditions;
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): • The research is based on valid scientific hypotheses which support a reasonable possibility of benefit over
p.(None): standard care.
p.(None): • The research is intended to be therapeutic and the research intervention poses no more than a risk that is
p.(None): expected in alternative methods of treatment.
p.(None):
p.(None): 7.6 Other groups requiring additional attention
p.(None): The discussion of the dental research participants requiring additional attention should not be limited to those
p.(None): already mentioned. Other groups that require additional attention include: traumatized and comatose patients,
p.(None): terminally ill patients, elderly or aged patients, minorities, students, and employees. The DERB must ensure that
p.(None): special consideration is given to all these groups, especially with regard to the risks, benefits and obtaining
p.(None): informed consent.
p.(None):
p.(None): 8.0 EPIDEMIOLOGICAL RESEARCH
p.(None):
p.(None): Epidemiological research describes the health status in a population or subgroup of the population. Epidemiological
p.(None): research studies the distribution and determinants of health related problems in populations, and the application of
p.(None): the research results to prevent, control or eliminate such health problems. It is concerned with improvement of the
...
p.(None): susceptibility to disease and future
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): health. Such information may be of interest and benefit to research participants, especially where
p.(None): preventive strategies exist.
p.(None):
p.(None): In addition to ethical considerations applied to all research involving humans, there are ethical issues unique to
p.(None): genetic research. They arise from the nature of the information which may be shared with other family members and with
p.(None): unrelated individuals in the population. Research results may be of significance to the health of blood relatives and
p.(None): others not participating in the research. Individuals may have an interest in the genetic information that
p.(None): may create new options for life decisions. Participants may be at risk of harm, including unfair discrimination or
p.(None): exclusion. The results of genetic information about future health could be used, potentially, by third parties such as
p.(None): insurance companies and employers.
p.(None):
p.(None): Researcher must recognize that obtaining informed consent and the collection of genetic information from
p.(None): families require specific attention. The researcher must abide by the policy to protect the privacy, confidentiality,
p.(None): storage and publication of genetic information. The DERB within its authority should not approve any proposal for
p.(None): dental research study if it might lead to a potential harm to participants, and if the competence and qualification of
p.(None): the researcher or any member of the research team is in doubt.
p.(None):
p.(None): 10.0 Human tissue samples
p.(None): Dental research on human tissue sample, blood and saliva include research on the various aspects of oral health such as
p.(None): oral cancer and the effect of smoking to the oral tissue. The CDRC Histopathology laboratory receives biopsies from
p.(None): dental clinics and other research centers for processing of the specimens. The histopathology laboratory collected over
p.(None): the last 26 years large numbers of biopsy specimens and research slides that is estimated around 25,000 human tissue
p.(None): samples. 50% of these human tissue samples are biopsy cases that come from the dental clinic at King Saud University
p.(None): and other clinics and hospitals. They are filed according to the histopathology laboratory number assigned for each
p.(None): biopsy case per year. The other 40% are research cases that come from researchers from the college and other provinces
p.(None): of Saudi
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): Arabia. Most of the research cases are animal research including soft tissue, hard tissue, teeth and bone. The
p.(None): remaining 10% of the human tissue samples are teaching slides and filed according to the microscopic diagnosis. The
p.(None): CDRC histopathology lab follows a very strict policy regarding receiving, processing, handling and storage of human
p.(None): tissue samples. The CDRC histopathology laboratory abides by very strict policy regarding the communication and
p.(None): dissemination of the information of human tissue samples.
p.(None):
...
General/Other / belmont
Searching for indicator belmont:
(return to top)
p.(None): severe pain, distress, discomfort, or disablement should be painlessly killed under anesthesia.
p.(None): 9. The care of animals should be under the supervision of a veterinarian or a person having adequate
p.(None): experience in laboratory animal care.
p.(None): 10. The best possible living condition should be provided to animals used for research purpose.
p.(None): 11. It is the responsibility of the investigator to ensure that personnel conducting experiments on
p.(None): animals possess appropriate qualifications or experience for conducting the required procedures.
p.(None): 12. Adequate opportunities have to be provided by the institution for in-service training for scientific and technical
p.(None): staff in this respect.
p.(None): 13. In-vitro systems to replace or reduce the number of animals should be used wherever possible.
p.(None):
p.(None): 6.0 RESEARCH INVOLVING HUMAN PARTICIPANTS
p.(None): The development of a code of ethics in research involving human participation is comparatively recent. The first
p.(None): international code of ethics for research involving human participants, the Nuremberg Code, was issued in 1947
p.(None): and laid down standards for carrying out human research, emphasizing the voluntary consent. In 1964 the World
p.(None): Medical Association adopted the Declaration of Helsinki, most recently revised in 2010, requiring that the proposed
p.(None): research on humans should be approved by a committee. The Belmont report published in 1979 forms the basis of all human
p.(None): research regulation. The report sets three basic ethical principles, respect for persons, beneficence, and justice.
p.(None): These principles are accepted internationally as the three essential requirements for ethical conduct of
p.(None): research involving human participants. Most
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): recently, the Council for International Organizations of Medical Sciences (CIOMS), working with the World Health
p.(None): Organization, issued the third edition of biomedical research ethical guidelines in 2002 which feature
p.(None): recommendations on ethical review committees and the issue of safeguarding confidentiality.
p.(None): 6.1 Definition
p.(None): Human participant is a living human being participating in a dental research project from which a
p.(None): researcher can obtain data through (1) intervention (2) interaction (3) private information. Intervention
p.(None): includes dental procedures and/or manipulations of the environment for research purposes. Interaction
p.(None): includes communication or interpersonal contact between the dental researcher and the human participant. Private
p.(None): information includes information that is individually identifiable and not expected to be made public. Private
p.(None): information is identifiable when the identity of the human participant must be exposed or
p.(None): associated with the collected information. Thus, an interaction with or an intervention involving a living human
...
p.(None):
p.(None): 5) Porter, D.G. Ethical scores for animal experiments. Nature, 356: 101-102; (1992).
p.(None):
p.(None): 6) Koski, G. Research Involving Human Subjects in Developing Countries, Editorials; N Engl J Med, 345: 136-138;
p.(None): (2001).
p.(None):
p.(None): 7) Young, S. Risk in Research – from the Nuremberg Code to the Tri-Council Code: Implications for
p.(None): Clinical Trials of Psychotropic Drugs. Journal of Psychiatry and Neuroscience, 23: 149-155; (1998).
p.(None):
p.(None): 8) The Principles of Ethics and Code of Professional Conduct. The University of Washington School of Dentistry,
p.(None): revised (2002).
p.(None):
p.(None): 9) Code of Ethics and Professional Conduct. New York University College of Dentistry. Approved EMC 080405; (2009).
p.(None):
p.(None): 10) California Dental Association Code of Ethics. Adopted by the California Dental Association
p.(None): House of Delegates; (2005).
p.(None):
p.(None): 11) Guidelines for Conduct of Research and Scholarly Activities. University of Medicine and Dentistry of New Jersey;
p.(None): Revised August (2009).
p.(None):
p.(None): 12) The Nuremberg Code. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law.
p.(None): Washington DC : US Government Printing Office. No. 10, Vol. 2, pp. 181-182. (1947).
p.(None):
p.(None): 13) Belmont report: ethical principles and guidelines for the protection of human subjects of research (1979).
p.(None):
p.(None): 14) Declaration of Helsinki: World Medical Association. Recommendations Guiding Physicians in
p.(None): Biomedical Research Involving Subjects (2000).
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None):
p.(None): 15) Ethical Guidelines for Research in Animal Science; Research Animals Department, Royal Society for the Prevention of
p.(None): Cruelty to Animals (RSPCA), UK. (2003).
p.(None):
p.(None): 16) International Ethical Guidelines for Biomedical Research Involving Human Subjects. Prepared by the Council
p.(None): for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO)
p.(None): Geneva (2002).
p.(None):
p.(None): 17) International Guiding Principles for Biomedical Research Involving Animals. The Council for International
p.(None): Organizations of Medical Sciences (CIOMS), Geneva (1985).
p.(None):
p.(None): 18) Ethical Guidelines for Biomedical Research on Human Participants. Indian Council of Medical Research. New
p.(None): Delhi. (2006).
p.(None):
p.(None): 19) Ethical Conduct for Research Involving Humans, Tri-Council Policy Statement. Canadian Institutes of Health
p.(None): Research Natural Sciences and Engineering Research Council of Canada Social Sciences and Humanities Research
p.(None): Council of Canada. August (1998).
p.(None):
...
General/Other / cioms guidelines
Searching for indicator cioms:
(return to top)
p.(None): 12. Adequate opportunities have to be provided by the institution for in-service training for scientific and technical
p.(None): staff in this respect.
p.(None): 13. In-vitro systems to replace or reduce the number of animals should be used wherever possible.
p.(None):
p.(None): 6.0 RESEARCH INVOLVING HUMAN PARTICIPANTS
p.(None): The development of a code of ethics in research involving human participation is comparatively recent. The first
p.(None): international code of ethics for research involving human participants, the Nuremberg Code, was issued in 1947
p.(None): and laid down standards for carrying out human research, emphasizing the voluntary consent. In 1964 the World
p.(None): Medical Association adopted the Declaration of Helsinki, most recently revised in 2010, requiring that the proposed
p.(None): research on humans should be approved by a committee. The Belmont report published in 1979 forms the basis of all human
p.(None): research regulation. The report sets three basic ethical principles, respect for persons, beneficence, and justice.
p.(None): These principles are accepted internationally as the three essential requirements for ethical conduct of
p.(None): research involving human participants. Most
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): recently, the Council for International Organizations of Medical Sciences (CIOMS), working with the World Health
p.(None): Organization, issued the third edition of biomedical research ethical guidelines in 2002 which feature
p.(None): recommendations on ethical review committees and the issue of safeguarding confidentiality.
p.(None): 6.1 Definition
p.(None): Human participant is a living human being participating in a dental research project from which a
p.(None): researcher can obtain data through (1) intervention (2) interaction (3) private information. Intervention
p.(None): includes dental procedures and/or manipulations of the environment for research purposes. Interaction
p.(None): includes communication or interpersonal contact between the dental researcher and the human participant. Private
p.(None): information includes information that is individually identifiable and not expected to be made public. Private
p.(None): information is identifiable when the identity of the human participant must be exposed or
p.(None): associated with the collected information. Thus, an interaction with or an intervention involving a living human
p.(None): being happening within the context of research experimentation must be in compliance with the ethical principles
p.(None): within the Kingdom of Saudi Arabia. The ethical principles that govern human subjects research apply no matter where,
p.(None): with what populations, and how the research is being conducted. All researchers should assure that their
p.(None): research methods maintain these principles and maximize human subjects’ protection. Beyond these ethical principles
p.(None): are rules and laws that govern research.
p.(None):
p.(None): 6.2 Ethics in Dental Research Involving Human Participants
...
p.(None):
p.(None): 9) Code of Ethics and Professional Conduct. New York University College of Dentistry. Approved EMC 080405; (2009).
p.(None):
p.(None): 10) California Dental Association Code of Ethics. Adopted by the California Dental Association
p.(None): House of Delegates; (2005).
p.(None):
p.(None): 11) Guidelines for Conduct of Research and Scholarly Activities. University of Medicine and Dentistry of New Jersey;
p.(None): Revised August (2009).
p.(None):
p.(None): 12) The Nuremberg Code. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law.
p.(None): Washington DC : US Government Printing Office. No. 10, Vol. 2, pp. 181-182. (1947).
p.(None):
p.(None): 13) Belmont report: ethical principles and guidelines for the protection of human subjects of research (1979).
p.(None):
p.(None): 14) Declaration of Helsinki: World Medical Association. Recommendations Guiding Physicians in
p.(None): Biomedical Research Involving Subjects (2000).
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None):
p.(None): 15) Ethical Guidelines for Research in Animal Science; Research Animals Department, Royal Society for the Prevention of
p.(None): Cruelty to Animals (RSPCA), UK. (2003).
p.(None):
p.(None): 16) International Ethical Guidelines for Biomedical Research Involving Human Subjects. Prepared by the Council
p.(None): for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO)
p.(None): Geneva (2002).
p.(None):
p.(None): 17) International Guiding Principles for Biomedical Research Involving Animals. The Council for International
p.(None): Organizations of Medical Sciences (CIOMS), Geneva (1985).
p.(None):
p.(None): 18) Ethical Guidelines for Biomedical Research on Human Participants. Indian Council of Medical Research. New
p.(None): Delhi. (2006).
p.(None):
p.(None): 19) Ethical Conduct for Research Involving Humans, Tri-Council Policy Statement. Canadian Institutes of Health
p.(None): Research Natural Sciences and Engineering Research Council of Canada Social Sciences and Humanities Research
p.(None): Council of Canada. August (1998).
p.(None):
p.(None): 20) Operational Procedures for Research Ethics Committees Guidance. The Irish Council for Bioethics, Academy House, 19
p.(None): Dawson St, Dublin 2 (2004).
p.(None):
p.(None): 21) Handbook for the Protection of Human Subjects in Research. Institutional Review Board. University of Oklahoma. June
p.(None): (2008).
p.(None):
p.(None): 22) Institutional Review Board Procedures and Guidelines for the Protection of Human Subjects. Texas A&M
p.(None): University Commerce Institutional Review Board. November (2009).
p.(None):
p.(None): 23) Research Subjects Review Board (RSRB) Investigator Guidance, University of Rochester. February (2010).
p.(None):
p.(None): 24) Ethical and Policy Issues in Research Involving Human Participants. Volume I. Report and Recommendations of the
p.(None): National Bioethics Advisory Commission. Bethesda, Maryland. August (2001).
p.(None):
p.(None): 25) Research animals for scientific purposes in Thailand: Ethics & policies, The National Research Council
p.(None): of Thailand. AATEX 14, Special Issue, 189-191. Proc. 6th World Congress on Alternatives & Animal Use in the
...
General/Other / decisionally impaired
Searching for indicator decisionally impaired:
(return to top)
p.(None): 3) Procedure of selection is fair to all prisoners.
p.(None): 4) Language for obtaining informed consent must be understandable to prisoners.
p.(None): 5) When studies need follow‐up, the provision for follow‐up must include a consideration of the length of individual
p.(None): sentences, and prisoners must be informed about follow‐up.
p.(None):
p.(None): 7.5 Research involving humans highly dependent on medical care
p.(None): Dental research on humans who are highly dependent on medical care raises ethical issues that deserve special
p.(None): attention. Researchers need to acknowledge that informed consent may be compromised by the effect of the medical
p.(None): condition or fear of affecting the level of medical care in case of refusal to participate. The following conditions
p.(None): are considered for possible dental research activities.
p.(None): 1. Research activities on humans under emergency care
p.(None): 2. Research activities on humans in the intensive care unit
p.(None): 3. Research activities on neonatals in the intensive care unit
p.(None): 4. Research activities on humans in the terminal care unit
p.(None): 5. Research activities on decisionally impaired humans
p.(None): 6. Research activities on unconscious human
p.(None): The policy of the college of dentistry research center is that; no dental research should be carried out on the above
p.(None): mentioned conditions. However, The DERB, within its authority can approve dental research in the following conditions;
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): • The research is based on valid scientific hypotheses which support a reasonable possibility of benefit over
p.(None): standard care.
p.(None): • The research is intended to be therapeutic and the research intervention poses no more than a risk that is
p.(None): expected in alternative methods of treatment.
p.(None):
p.(None): 7.6 Other groups requiring additional attention
p.(None): The discussion of the dental research participants requiring additional attention should not be limited to those
p.(None): already mentioned. Other groups that require additional attention include: traumatized and comatose patients,
p.(None): terminally ill patients, elderly or aged patients, minorities, students, and employees. The DERB must ensure that
p.(None): special consideration is given to all these groups, especially with regard to the risks, benefits and obtaining
p.(None): informed consent.
p.(None):
p.(None): 8.0 EPIDEMIOLOGICAL RESEARCH
p.(None):
...
General/Other / declaration of helsinki
Searching for indicator helsinki:
(return to top)
p.(None): 7. Surgical or other painful procedures should be performed under anesthesia.
p.(None): 8. At the end of the experiment, or when appropriate during an experiment, the animal that would otherwise suffer
p.(None): severe pain, distress, discomfort, or disablement should be painlessly killed under anesthesia.
p.(None): 9. The care of animals should be under the supervision of a veterinarian or a person having adequate
p.(None): experience in laboratory animal care.
p.(None): 10. The best possible living condition should be provided to animals used for research purpose.
p.(None): 11. It is the responsibility of the investigator to ensure that personnel conducting experiments on
p.(None): animals possess appropriate qualifications or experience for conducting the required procedures.
p.(None): 12. Adequate opportunities have to be provided by the institution for in-service training for scientific and technical
p.(None): staff in this respect.
p.(None): 13. In-vitro systems to replace or reduce the number of animals should be used wherever possible.
p.(None):
p.(None): 6.0 RESEARCH INVOLVING HUMAN PARTICIPANTS
p.(None): The development of a code of ethics in research involving human participation is comparatively recent. The first
p.(None): international code of ethics for research involving human participants, the Nuremberg Code, was issued in 1947
p.(None): and laid down standards for carrying out human research, emphasizing the voluntary consent. In 1964 the World
p.(None): Medical Association adopted the Declaration of Helsinki, most recently revised in 2010, requiring that the proposed
p.(None): research on humans should be approved by a committee. The Belmont report published in 1979 forms the basis of all human
p.(None): research regulation. The report sets three basic ethical principles, respect for persons, beneficence, and justice.
p.(None): These principles are accepted internationally as the three essential requirements for ethical conduct of
p.(None): research involving human participants. Most
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): recently, the Council for International Organizations of Medical Sciences (CIOMS), working with the World Health
p.(None): Organization, issued the third edition of biomedical research ethical guidelines in 2002 which feature
p.(None): recommendations on ethical review committees and the issue of safeguarding confidentiality.
p.(None): 6.1 Definition
p.(None): Human participant is a living human being participating in a dental research project from which a
p.(None): researcher can obtain data through (1) intervention (2) interaction (3) private information. Intervention
p.(None): includes dental procedures and/or manipulations of the environment for research purposes. Interaction
p.(None): includes communication or interpersonal contact between the dental researcher and the human participant. Private
p.(None): information includes information that is individually identifiable and not expected to be made public. Private
p.(None): information is identifiable when the identity of the human participant must be exposed or
...
p.(None): (2001).
p.(None):
p.(None): 7) Young, S. Risk in Research – from the Nuremberg Code to the Tri-Council Code: Implications for
p.(None): Clinical Trials of Psychotropic Drugs. Journal of Psychiatry and Neuroscience, 23: 149-155; (1998).
p.(None):
p.(None): 8) The Principles of Ethics and Code of Professional Conduct. The University of Washington School of Dentistry,
p.(None): revised (2002).
p.(None):
p.(None): 9) Code of Ethics and Professional Conduct. New York University College of Dentistry. Approved EMC 080405; (2009).
p.(None):
p.(None): 10) California Dental Association Code of Ethics. Adopted by the California Dental Association
p.(None): House of Delegates; (2005).
p.(None):
p.(None): 11) Guidelines for Conduct of Research and Scholarly Activities. University of Medicine and Dentistry of New Jersey;
p.(None): Revised August (2009).
p.(None):
p.(None): 12) The Nuremberg Code. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law.
p.(None): Washington DC : US Government Printing Office. No. 10, Vol. 2, pp. 181-182. (1947).
p.(None):
p.(None): 13) Belmont report: ethical principles and guidelines for the protection of human subjects of research (1979).
p.(None):
p.(None): 14) Declaration of Helsinki: World Medical Association. Recommendations Guiding Physicians in
p.(None): Biomedical Research Involving Subjects (2000).
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None):
p.(None): 15) Ethical Guidelines for Research in Animal Science; Research Animals Department, Royal Society for the Prevention of
p.(None): Cruelty to Animals (RSPCA), UK. (2003).
p.(None):
p.(None): 16) International Ethical Guidelines for Biomedical Research Involving Human Subjects. Prepared by the Council
p.(None): for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO)
p.(None): Geneva (2002).
p.(None):
p.(None): 17) International Guiding Principles for Biomedical Research Involving Animals. The Council for International
p.(None): Organizations of Medical Sciences (CIOMS), Geneva (1985).
p.(None):
p.(None): 18) Ethical Guidelines for Biomedical Research on Human Participants. Indian Council of Medical Research. New
p.(None): Delhi. (2006).
p.(None):
p.(None): 19) Ethical Conduct for Research Involving Humans, Tri-Council Policy Statement. Canadian Institutes of Health
p.(None): Research Natural Sciences and Engineering Research Council of Canada Social Sciences and Humanities Research
p.(None): Council of Canada. August (1998).
p.(None):
p.(None): 20) Operational Procedures for Research Ethics Committees Guidance. The Irish Council for Bioethics, Academy House, 19
p.(None): Dawson St, Dublin 2 (2004).
p.(None):
...
General/Other / tri-council policy statement
Searching for indicator tri-council:
(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):
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): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): REFERENCES
p.(None): 1) Branson R. The Ethics of Dental Research: An Overview of Basic Principles. J Dent Res, 59: 1214-1220; (1980).
p.(None):
p.(None): 2) Shah R.M. Toward Developing a Code of Ethics. J Dent Res, 73: 1783-1787; (1994).
p.(None):
p.(None): 3) Baumrind S. Dental Ethics in a Larger Context: One Point of View. Journal of the History of Dentistry, 55:
p.(None): 165-170; (2007).
p.(None):
p.(None): 4) Newbrun E. Professional Ethics and Professional Etiquette in Dentistry: Are they Compatible?
p.(None): Journal of the History of Dentistry, 55: 119-124; (2007).
p.(None):
p.(None): 5) Porter, D.G. Ethical scores for animal experiments. Nature, 356: 101-102; (1992).
p.(None):
p.(None): 6) Koski, G. Research Involving Human Subjects in Developing Countries, Editorials; N Engl J Med, 345: 136-138;
p.(None): (2001).
p.(None):
p.(None): 7) Young, S. Risk in Research – from the Nuremberg Code to the Tri-Council Code: Implications for
p.(None): Clinical Trials of Psychotropic Drugs. Journal of Psychiatry and Neuroscience, 23: 149-155; (1998).
p.(None):
p.(None): 8) The Principles of Ethics and Code of Professional Conduct. The University of Washington School of Dentistry,
p.(None): revised (2002).
p.(None):
p.(None): 9) Code of Ethics and Professional Conduct. New York University College of Dentistry. Approved EMC 080405; (2009).
p.(None):
p.(None): 10) California Dental Association Code of Ethics. Adopted by the California Dental Association
p.(None): House of Delegates; (2005).
p.(None):
p.(None): 11) Guidelines for Conduct of Research and Scholarly Activities. University of Medicine and Dentistry of New Jersey;
p.(None): Revised August (2009).
p.(None):
p.(None): 12) The Nuremberg Code. Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law.
p.(None): Washington DC : US Government Printing Office. No. 10, Vol. 2, pp. 181-182. (1947).
p.(None):
p.(None): 13) Belmont report: ethical principles and guidelines for the protection of human subjects of research (1979).
p.(None):
p.(None): 14) Declaration of Helsinki: World Medical Association. Recommendations Guiding Physicians in
p.(None): Biomedical Research Involving Subjects (2000).
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None):
p.(None): 15) Ethical Guidelines for Research in Animal Science; Research Animals Department, Royal Society for the Prevention of
p.(None): Cruelty to Animals (RSPCA), UK. (2003).
p.(None):
p.(None): 16) International Ethical Guidelines for Biomedical Research Involving Human Subjects. Prepared by the Council
p.(None): for International Organizations of Medical Sciences (CIOMS) in collaboration with the World Health Organization (WHO)
p.(None): Geneva (2002).
p.(None):
p.(None): 17) International Guiding Principles for Biomedical Research Involving Animals. The Council for International
p.(None): Organizations of Medical Sciences (CIOMS), Geneva (1985).
p.(None):
p.(None): 18) Ethical Guidelines for Biomedical Research on Human Participants. Indian Council of Medical Research. New
p.(None): Delhi. (2006).
p.(None):
p.(None): 19) Ethical Conduct for Research Involving Humans, Tri-Council Policy Statement. Canadian Institutes of Health
p.(None): Research Natural Sciences and Engineering Research Council of Canada Social Sciences and Humanities Research
p.(None): Council of Canada. August (1998).
p.(None):
p.(None): 20) Operational Procedures for Research Ethics Committees Guidance. The Irish Council for Bioethics, Academy House, 19
p.(None): Dawson St, Dublin 2 (2004).
p.(None):
p.(None): 21) Handbook for the Protection of Human Subjects in Research. Institutional Review Board. University of Oklahoma. June
p.(None): (2008).
p.(None):
p.(None): 22) Institutional Review Board Procedures and Guidelines for the Protection of Human Subjects. Texas A&M
p.(None): University Commerce Institutional Review Board. November (2009).
p.(None):
p.(None): 23) Research Subjects Review Board (RSRB) Investigator Guidance, University of Rochester. February (2010).
p.(None):
p.(None): 24) Ethical and Policy Issues in Research Involving Human Participants. Volume I. Report and Recommendations of the
p.(None): National Bioethics Advisory Commission. Bethesda, Maryland. August (2001).
p.(None):
p.(None): 25) Research animals for scientific purposes in Thailand: Ethics & policies, The National Research Council
p.(None): of Thailand. AATEX 14, Special Issue, 189-191. Proc. 6th World Congress on Alternatives & Animal Use in the
p.(None): Life Sciences. Tokyo, Japan. August (2007).
p.(None):
p.(None): 26) Use of Animals in Scientific Research, Indian Council of Medical Research Ministry of Health & Family
...
Orphaned Trigger Words
p.(None): INTRODUCTION
p.(None): 1.0 Content Competence
p.(None): 2.0 Pedagogical Competence
p.(None): 3.0 Dealing with Sensitive Topics
p.(None): 4.0 Student Development
p.(None): 5.0 Dual Relationships with Students
p.(None): 6.0 Confidentiality
p.(None): 7.0 Respect for Colleagues
p.(None): 8.0 Valid Assessment of Students
p.(None): 9.0 Respect for Institution
p.(None): 10.0 Ethics on education on patients
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): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None):
p.(None): INTRODUCTION
p.(None): Ethical principles are conceptualized here as general guidelines, ideals or expectations that need to be
p.(None): taken into account, along with other relevant conditions and circumstances, in the design and analysis of university
p.(None): teaching.
p.(None):
p.(None): Implementation of this ethical code will be advantageous to university teachers in removing ambiguity
p.(None): concerning teaching responsibilities and will contribute significantly to improvement of teaching.
p.(None):
p.(None): The following nine ethical principles for teaching and learning were adopted from The Society for Teaching and Learning
p.(None): in Higher Education (STLHE) with minor modifications.
p.(None):
p.(None): 1. Content Competence
p.(None): A college teacher maintains a high level of subject matter knowledge and ensures that course content is current,
p.(None): accurate, representative, and appropriate to the position of the course within the student's program of
p.(None): studies.
p.(None):
p.(None): Achievement of content competence requires that the teacher take active steps to be up-to- date in content areas
p.(None): relevant to his/her courses; to be informed of the content of prerequisite courses and of courses for which the
p.(None): teacher's course is prerequisite; and to provide adequate representation of important topic areas and points of view.
p.(None):
p.(None): An Academic staff member should appreciate the nature of evaluation and utilizes effective evaluation
p.(None): techniques in relation to curriculum teaching and learning.
p.(None):
p.(None): 2. Pedagogical Competence
p.(None): A pedagogically competent teacher communicates the objectives of the course to students, is aware of alternative
p.(None): instructional methods or strategies, and selects methods of instruction
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): that, according to research evidence (including personal or self-reflective research), are
p.(None): effective in helping students to achieve the course objectives.
p.(None):
p.(None): An Academic staff member should understand a variety of teaching and learning approaches and strategies, and
p.(None): endeavors to maintain awareness of pedagogical advances.
p.(None): This principle implies that, in addition to knowing the subject matter, a teacher has adequate pedagogical knowledge
p.(None): and skills, including communication of objectives, selection of effective instructional methods, provision of
p.(None): practice and feedback opportunities, and accommodation of student diversity. If mastery of a certain
p.(None): skill (Example: critical analysis, design of experiments) is part of the course objectives and will be
p.(None): considered in evaluation and grading of students, the teacher provides students with adequate opportunity to
p.(None): practice and receive feedback on that skill during the course.
p.(None):
p.(None): Learning styles differ significantly for different students. Therefore, the teacher should be aware of these
p.(None): differences and, if feasible, modifies his/her style of teaching accordingly.
p.(None): To maintain pedagogical competence, and instructor takes active steps to stay current regarding
p.(None): teaching strategies that will help students learn relevant knowledge and skills and will provide equal educational
p.(None): opportunity for diverse groups. This might involve reading general or discipline-specific educational literature,
p.(None): attending workshops and conferences, or experimentation with alternative methods of teaching a
p.(None): given course or a specific group of students.
p.(None):
p.(None): 3. Dealing with Sensitive Topics
p.(None): Topics that students are likely to find sensitive or discomforting are dealt with in an open, honest,
p.(None): and positive way respecting cultural principles and values.
p.(None):
p.(None): The teacher should invite all students to state their position on the issue, sets ground rules for discussion, is
p.(None): respectful of students even when it is necessary to disagree, and encourages students to be respectful of
p.(None): one another.
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None):
p.(None): 4. Student Development
p.(None): The overriding responsibility of the teacher is to contribute to the intellectual development of the student, at least
p.(None): in the context of the teacher's own area of expertise, and to avoid actions such as exploitation and discrimination
p.(None): that detract from student development.
p.(None): According to this principle, the teacher's most basic responsibility is to design instruction that facilitates
p.(None): learning and encourages autonomy and independent thinking of students, to treat students with respect and
p.(None): dignity, and to avoid actions that detract unjustifiably from student development.
p.(None):
p.(None): 5. Dual Relationships with Students
p.(None): To avoid conflict of interest, a teacher does not enter into dual-role relationships with students that are likely to
p.(None): detract from student development or lead to actual or perceived favoritism on the part of the teacher.
p.(None):
p.(None): This principle means that it is the responsibility of the teacher to keep relationships with students
p.(None): focused on pedagogical goals and academic requirements. Even if the teacher believes that she or he is maintaining
p.(None): objectivity, the perception of favoritism on the part of other students is as educationally disastrous
p.(None): as actual favoritism or unfairness. If a teacher does become involved in a dual relationship with
p.(None): a student, such as business or financial relationships, blood or marital relatedness, it is the
p.(None): responsibility of the teacher to notify his or her supervisor of the situation as soon as possible, so that
p.(None): alternative arrangements can be made for supervision or evaluation of the student.
p.(None):
p.(None): Although there are definite pedagogical benefits to establishing good rapport with students and interacting with
p.(None): students both inside and outside the classroom, there are also serious risks of exploitation, compromise of academic
p.(None): standards, and harm to student development. It is the responsibility of the teacher to prevent these risks from
p.(None): materializing into real or perceived conflicts of interest.
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None):
p.(None): 6. Confidentiality
p.(None): Student grades, attendance records, and private communications are treated as confidential materials, and are
p.(None): released only with student consent, or for legitimate academic purposes, or if there are reasonable grounds for
p.(None): believing that releasing such information will be beneficial to the student or will prevent harm to others.
p.(None): This principle suggests that students are entitled to the same level of confidentiality in their
p.(None): relationships with teachers as would exist in a lawyer-client or doctor-patient relationship. Violation of
p.(None): confidentiality in the teacher-student relationship can cause students to distrust teachers and to show
p.(None): decreased academic motivation. Whatever rules or policies are followed with respect to confidentiality of student
p.(None): records, these should be disclosed in full to students at the beginning of the academic term.
p.(None):
p.(None): 7. Respect for Colleagues
p.(None): A college teacher respects the dignity of her or his colleagues and works cooperatively with colleagues
p.(None): in the interest of fostering student development.
p.(None):
p.(None): This principle means that in interactions among colleagues with respect to teaching, the overriding concern
p.(None): is the development of students. Disagreements between colleagues relating to teaching are settled privately, if
p.(None): possible, with no harm to student development. If a teacher suspects that a colleague has shown incompetence or ethical
p.(None): violations in teaching, the teacher takes responsibility for raising the matter to higher authority.
p.(None):
p.(None): 8. Valid Assessment of Students
p.(None): Given the importance of assessment of student performance in college teaching and in students' lives and
p.(None): careers, instructors are responsible for taking adequate steps to ensure that assessment of students is valid, open,
p.(None): fair, and congruent with course objectives.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): This principle means that the teacher is aware of research (including personal or self-reflective research) on the
p.(None): advantages and disadvantages of alternative methods of assessment, and based on this knowledge, the teacher
p.(None): selects assessment techniques that are consistent with the objectives of the course and at the same time are
p.(None): as reliable and valid as possible. Furthermore, assessment procedures and grading standards are
p.(None): communicated clearly to students at the beginning of the course, and except in rare circumstances, there is no
p.(None): deviation from the announced procedures. Student exams, papers, and assignments are graded carefully and fairly through
p.(None): the use of a rational marking system that can be communicated to students. By means appropriate for the size of the
p.(None): class, students are provided with prompt and accurate feedback on their performance at regular intervals throughout the
p.(None): course, plus an explanation as to how their work was graded, and constructive suggestions as to how to
p.(None): improve their standing in the course. In a similar vein, teachers are fair and objective in writing
p.(None): letters of reference for students.
p.(None):
p.(None): 9. Respect for Institution
p.(None): In the interests of student development, a college teacher is aware of and respects the educational
p.(None): goals, policies, and standards of the institution in which he or she teaches.
p.(None): This principle implies that a teacher shares a collective responsibility to work for the good of the college as a
p.(None): whole, to uphold the educational goals and standards of the college, and to abide by college policies and
p.(None): regulations pertaining to the education of students and patient care.
p.(None):
p.(None): 10. Ethics on education on patients
p.(None):
p.(None): Dental education is based on practical clinical training that relies heavily on interaction with patients.
p.(None): There are sets of ethical principles related to training on patients that faculty members should observe
p.(None): which include:
p.(None):
p.(None): 1. The faculty member must respect patient's privacy thereby should avoid discuss issues infringing on
p.(None): the patient’s privacy in front of a group of trainees to ensure respecting patient’s right to privacy and
p.(None): confidentiality
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 2. The faculty member should be committed to prevent harm to the patient of any sort during the education of trainees.
p.(None):
p.(None): 3. The faculty member should avoid approaching the patient with a large number of students or multiple physical
p.(None): examinations by students in a short time period.
p.(None):
p.(None): 4. The faculty member should avoid blaming or reprimanding a trainee in front of the patient, in order to preserve
p.(None): the dignity of the trainee on one hand, and not to confuse the patient on the other hand, especially if all spoke a
p.(None): language not understood by the patient.
p.(None):
p.(None): 5. The faculty member should respect gradual progression in patient care assignments to the trainees. In
p.(None): addition, the supervising faculty member remains responsible for providing adequate supervision to
p.(None): ensure that the patient will receive appropriate care.
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p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): REFERENCES
p.(None): • Ethical Principles in College Teaching.Published by: Society for Teaching and Learning in Higher
p.(None): Education(STLHE)/ La Societe pour l'avancement de la
p.(None): pedagogiedansl'enseignementsuperieur (SAPES). 1996. http://www.stlhe.ca/en/stlhe/
p.(None):
p.(None): • Code of Conduct for All Staff.Australian Catholic College (AUC). November 2006
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p.(None):
p.(None): King Saud University College of Dentistry
p.(None):
p.(None):
p.(None):
p.(None): ETHICS IN DENTAL PRACTICE
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p.(None):
p.(None):
p.(None): 2011-2012
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): INTRODUCTION
p.(None):
p.(None): Dentists should follow high ethical standards considering the benefits of the patient as their primary goal. The
p.(None): privilege of being a dentist comes with a responsibility to society and to fellow members of the profession to conduct
p.(None): ones professional activities in a highly ethical manner. The dentist –patient relationship is the cornerstone of dental
p.(None): ethics.
p.(None): This document is supplementary to the ethics in medical profession document by the Saudi Commission for
p.(None): health specialties which is the reference for ethics in medical profession.
p.(None):
p.(None):
p.(None): Respect and Equal Treatment
p.(None):
p.(None): Dental treatment should be provided without discrimination based on the basis of on patient’s gender, racial,
p.(None): religious, or ethnic characteristic. Service to the public includes the delivery of quality, component, and timely care
p.(None): within the bounds of the clinical circumstances presented by the patient.
p.(None): Professional Esteem
p.(None):
p.(None): While serving the public, a dentist has the obligation to act in a manner that maintains or elevate the esteem of the
p.(None): profession.
p.(None): Standard of care
p.(None):
p.(None): It is unethical for a dentist to render, or cause to be rendered, dental treatment of a quality that falls short of
p.(None): best available scientific evidence.
p.(None): Informed Consent
p.(None): Fully informed consent is essential to the ethical practice of dentistry and reflects the patient’s right of self
p.(None): –decision. A dentist must get valid consent before starting treatment or physical investigation, or providing personal
p.(None): care, for a patient. Dentists must provide all the information patients need to make their decisions. This involve
p.(None): explaining complex dental diagnosis, prognoses and treatment regimes in simple language, confirming or correcting
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): information that the patients may have obtained elsewhere (e.g., from another health practitioner, magazines or the
p.(None): internet), ensuring that patients understand the treatment options (including the option of no treatment) advantages
p.(None): and disadvantages of each, answering any questions they may have, and understanding whatever decision the patient has
p.(None): reached and, if possible, the reasons for it.
p.(None): Any competent mature adult person may fully consent to treatment. A person is considered competent if he/she has
p.(None): sufficient understanding and capacity to make and communicate reasonable decisions. A legally appointed guardian may
p.(None): consent to the treatment for an incompetent adult.
p.(None): A parent or legally appointed guardian must consent to the treatment for young children and mentally disabled adults.
p.(None): Parents or legal guardians have a right to an explanation regarding the options for behavioral management of children,
p.(None): and are responsible to ask for additional information if they do not understand explanations. Siblings, friends, or any
p.(None): person other than a parent or legal guardian cannot provide consent.
p.(None): Confidentiality
p.(None):
p.(None): Dentists are obliged to safeguard the confidentiality of patient records. Dentists shall maintain patient records in a
p.(None): manner consistent with the protection of the welfare of the patient. Upon request of a patient or another dental
p.(None): practitioner, dentists shall provide any information in accordance with applicable law that will be beneficial for the
p.(None): future treatment of that patient.
p.(None): Refuse of patient treatment
p.(None): The Dentist may, in non-emergency cases, refuse to treat a patient for justified personal or professional reasons which
p.(None): might compromise the quality of the service rendered to the patient. Provided that such refusal should not cause harm
p.(None): to the patient's health, and that there is another Dentist who could perform the treatment. The justification of such
p.(None): action must be documented and authorized by the higher clinical authority.
p.(None):
p.(None): Patient referral
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p.(None): 6.4 Establishment of the Dental Ethics Review Board (DERB)
p.(None): 6.5 Authority of the Dental Ethics Review Board
p.(None): 6.6 Types of Review
p.(None): 6.6.1 Minimal Risk.
p.(None): 6.6.2 Determining the Level of Review
p.(None): 6.6.2.1 Full Dental Ethical Board Review
p.(None): 6.6.2.2 Exempt from the full ethical board review
p.(None): 6.6.2.3 Expedited from the full ethical board review
p.(None): 6.8 Conflict of Interest
p.(None): 6.9 Informed Consent:
p.(None): 6.9.1 Re-consent
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.9.2 Waiver of consent
p.(None): 6.10 Submitting a Research Proposal
p.(None): 6.11 Electronic Submission of a Research proposal
p.(None): 6.12 Evaluation of submitted research proposals
p.(None): 6.13 Meeting Requirements
p.(None): 6.14 Decision-making
p.(None): 7.0 RESEARCH PARTICIPANTS REQUIRING ADDITIONAL ATTENTION
p.(None): 7.1 Research Involving Children and Adolescents
p.(None): 7.1.1 Approval of research involving children and adolescents
p.(None): 7.1.2 Consent for children or adolescents
p.(None): 7.2 Research involving pregnant women
p.(None): 7.3 Research involving a fetus
p.(None): 7.4 Research involving prisoners
p.(None): 7.4.1 Considerations regarding research involving prisoners
p.(None): 7.4.2 Approval of research involving prisoners
p.(None): 7.5 Research involving humans highly dependent on medical care
p.(None): 7.6 Other groups requiring additional attention
p.(None): 8.0 EPIDEMIOLOGICAL RESEARCH
p.(None): 9.0 HUMAN GENETIC RESEARCH
p.(None): 10.0 HUMAN TISSUE SAMPLES
p.(None): 11.0 REFERENCES
p.(None):
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p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 1.0 INTRODUCTION
p.(None): The College of Dentistry, King Saud University is the one of the dental colleges in the Kingdom of Saudi Arabia and
p.(None): the Gulf Countries that carries the responsibility of educating students, providing oral health services to the
p.(None): patients, conducting research and servicing the community. These responsibilities are conducted under the good ethical
p.(None): principles that guide the educational process in King Saud University.
p.(None):
p.(None): The Research Center within the College of Dentistry (CDRC) is the product of the University’s aspiration of bringing
p.(None): about a more research-oriented institution especially in the area of dentistry. Founded in 1981, its primary goal is
p.(None): the encouragement of viable research Potentials from among the dental professionals in the Kingdom. The Center
p.(None): realizes that this objective can be achieved by extending support to all kinds of research work and providing
p.(None): state-of-the- art equipment complemented by highly trained technical staff in all its laboratories. This report will
p.(None): explain the code of ethics for dental research.
p.(None):
p.(None): 2.0 RESEARCH and ETHICS
p.(None): The relationship between research and ethics is unique. The practice of research requires ethical principles at the
p.(None): same time ethical principles are needed to guide the good conduct of research.
p.(None):
p.(None): Research is systematic investigation designed to develop or contribute to generalizable knowledge.
p.(None): Systematic investigation means that there is intention, plan and procedures to be followed in predetermined steps.
p.(None): Contributing to generalizable knowledge means that the results and conclusions will be published and made
p.(None): available to the others to benefit from these results.
p.(None):
p.(None): 2.1 Purpose of the Code of Ethics
p.(None): The purpose of the code of ethics in dental research is to establish a set of codes or principles that should help the
p.(None): dental student, intern staff or researcher to reach a
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): professional standard, guided by legal and ethical principles. Research ethics is the application of ethical codes or
p.(None): principles in scientific investigation.
p.(None):
p.(None): 2.2 Importance of the code of ethics in dental research
p.(None): Researchers should be familiar with the code of ethics designed to ensure good conduct and prevent sloppy or
p.(None): irresponsible research. There are several reasons why it is important to adhere to the code of ethics in dental
p.(None): research.
p.(None): 1) The code of ethics promotes the aims of research, such as knowledge, the truth, and avoidance of
p.(None): error. For example, prohibitions against fabricating, falsifying, or misrepresenting research data promote the
p.(None): truth and avoid error.
p.(None): 2) Research often involves a great deal of cooperation and coordination among many different people in different
p.(None): disciplines and institutions, the code of ethics promote the values that are essential to collaborative
p.(None): work, such as respect, trust, accountability, and fairness.
p.(None): 3) The code of ethics in research for authorship, copyright and patenting, data monitoring, and
p.(None): confidentiality protects the intellectual property interests and encourages collaboration. Researchers want to
p.(None): receive credit for their contributions and protect their intellectual property.
p.(None): 4) The code of ethics in research enhances the concept of confidentiality that most researchers want to
p.(None): receive credit and do not want to have their ideas stolen or disclosed prematurely.
p.(None): 5) The ethical codes ensure that the dental researcher is accountable to the public. For instance research
p.(None): misconduct, conflicts of interest, human participant protections, and animal care and use are necessary in order
p.(None): to make sure that the researcher can be held accountable to the public.
p.(None): 6) The code of ethics in research builds the public support for research. The public are more likely to support
p.(None): and participate in research projects if they can trust the quality and integrity of the research.
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 7) Finally, the code of ethics in research promotes a variety of other important moral and social values, such as
p.(None): social responsibility, human rights, and animal welfare, compliance with the law, and health and safety.
p.(None):
p.(None): 3.0 TYPES of RESEARCH
p.(None): The custodian of the two Holy Mosques, King Abdullah Bin Abdulaziz Al-Saud gave his royal order numbered
p.(None): 59/M dated 14-9-1431H to implement the system for the ethics of research involving living objects. In accordance
p.(None): with this, the research center College of Dentistry adopted two categories of research:
p.(None): 1) The non-living objects category
p.(None): 2) The living objects category.
p.(None): Figure 2 describes these categories.
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p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): Fig. (2) Type of Dental Research
p.(None):
p.(None):
p.(None): College of Dentistry, King Saud University
p.(None):
p.(None):
p.(None):
p.(None): Type of Dental Research
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p.(None):
p.(None):
p.(None): Non-living object research Living object research
p.(None):
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p.(None): Plant or Animal Research Human Participation Research
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p.(None): Require Application of the General Ethical Principles in
p.(None): Dental Research
p.(None): Require Application of the Ethical Principles in Dental Research involving Plant or Animal
p.(None): Require Application of the Ethical Principles in Dental Research involving Participation of Human
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p.(None): Note: Each require should read ‘requires’
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p.(None):
p.(None): 4.0 RESEARCH INVOLVING NON-LIVING OBJECTS
p.(None):
p.(None): Non-living object research represents a large percentage of scientific research. It is used mainly to test materials
p.(None): and ranges from nano level to larger scale materials. Teaching institutions throughout the world now consider that it
p.(None): is essential for students in the universities and even at school level to perform laboratory research on non-living
p.(None): objects.
p.(None):
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p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 4.1 Ethics in Dental Research Involving non-living objects
p.(None): The dental researchers working in research involving non-living objects will spend most of their time in the
p.(None): laboratories. The dental researcher should be familiar with the basic principles regarding the safety procedures in
p.(None): each laboratory. The dental researcher will use some equipment and machines to perform the research so it is
p.(None): necessary to understand their operation and the safety procedures regarding the hazardous
p.(None): materials. He should learn how to deal with the personnel and technicians he will meet on a daily basis and
p.(None): learn how to fit his time with their schedule and respect arrangements made by others.
p.(None):
p.(None): 4.2 Code of ethics in Dental Research Involving non-living objects.
p.(None): The code of ethics adopted by the College of Dentistry Research Center for the dental research are applicable to
p.(None): the dental research conducted by students, interns, academic or clinical staff, or affiliated researcher
p.(None): of the College of Dentistry, King Saud University. This is true regardless of the location where the research is
p.(None): conducted. The general code of ethics in dental research includes and is not limited to the following:
p.(None): 1. Legality: Legal, scientifically sound and ethical conduct of dental research.
p.(None): 2. Honesty: Honest thinking and conduct of dental research from start to finish.
p.(None): 3. Respect: Self-respect and respect to individuals, property and agreements.
p.(None): 4. Responsible: Responsible person and responsible conduct in dental research.
p.(None): 5. Competence: Professional competence in conducting, promoting and mentoring dental research.
p.(None): 6. Objectivity: Objective, unbiased, clear interests in dental research.
...
p.(None): severe pain, distress, discomfort, or disablement should be painlessly killed under anesthesia.
p.(None): 9. The care of animals should be under the supervision of a veterinarian or a person having adequate
p.(None): experience in laboratory animal care.
p.(None): 10. The best possible living condition should be provided to animals used for research purpose.
p.(None): 11. It is the responsibility of the investigator to ensure that personnel conducting experiments on
p.(None): animals possess appropriate qualifications or experience for conducting the required procedures.
p.(None): 12. Adequate opportunities have to be provided by the institution for in-service training for scientific and technical
p.(None): staff in this respect.
p.(None): 13. In-vitro systems to replace or reduce the number of animals should be used wherever possible.
p.(None):
p.(None): 6.0 RESEARCH INVOLVING HUMAN PARTICIPANTS
p.(None): The development of a code of ethics in research involving human participation is comparatively recent. The first
p.(None): international code of ethics for research involving human participants, the Nuremberg Code, was issued in 1947
p.(None): and laid down standards for carrying out human research, emphasizing the voluntary consent. In 1964 the World
p.(None): Medical Association adopted the Declaration of Helsinki, most recently revised in 2010, requiring that the proposed
p.(None): research on humans should be approved by a committee. The Belmont report published in 1979 forms the basis of all human
p.(None): research regulation. The report sets three basic ethical principles, respect for persons, beneficence, and justice.
p.(None): These principles are accepted internationally as the three essential requirements for ethical conduct of
p.(None): research involving human participants. Most
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): recently, the Council for International Organizations of Medical Sciences (CIOMS), working with the World Health
p.(None): Organization, issued the third edition of biomedical research ethical guidelines in 2002 which feature
p.(None): recommendations on ethical review committees and the issue of safeguarding confidentiality.
p.(None): 6.1 Definition
p.(None): Human participant is a living human being participating in a dental research project from which a
p.(None): researcher can obtain data through (1) intervention (2) interaction (3) private information. Intervention
p.(None): includes dental procedures and/or manipulations of the environment for research purposes. Interaction
p.(None): includes communication or interpersonal contact between the dental researcher and the human participant. Private
p.(None): information includes information that is individually identifiable and not expected to be made public. Private
p.(None): information is identifiable when the identity of the human participant must be exposed or
p.(None): associated with the collected information. Thus, an interaction with or an intervention involving a living human
p.(None): being happening within the context of research experimentation must be in compliance with the ethical principles
p.(None): within the Kingdom of Saudi Arabia. The ethical principles that govern human subjects research apply no matter where,
p.(None): with what populations, and how the research is being conducted. All researchers should assure that their
p.(None): research methods maintain these principles and maximize human subjects’ protection. Beyond these ethical principles
p.(None): are rules and laws that govern research.
p.(None):
p.(None): 6.2 Ethics in Dental Research Involving Human Participants
p.(None): The dental researcher should strive for the ethical principles that identify good, desirable and
p.(None): acceptable conduct of research involving human participant. The researcher should protect the welfare and
p.(None): rights of research participants, and reflect the basic ethical values of respect, beneficence and justice for human.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.3 Code of ethics in Dental Research Involving Human Participants
p.(None): The codes of ethics in Dental Research Involving Human Participants are in addition to the general code of ethics in
p.(None): dental research stated in part 4.2, they are applicable but not limited to dental research conducted by
p.(None): students, interns, academic or clinical staff, or affiliated researcher of the College of Dentistry, King
p.(None): Saud University. This is true regardless of the location where the research is conducted. The codes of ethics in
p.(None): dental research involving humans are:
p.(None): 1) Respect for persons incorporates at least two fundamental ethical considerations, namely:
p.(None): a. Respect for autonomy which requires that those who are capable of self- determination about their choices
p.(None): should be treated with respect for their capacity of self-determination.
p.(None): b. Protection of persons with impaired or diminished autonomy, which requires that those who are dependent or
p.(None): vulnerable be afforded full security against harm or abuse.
p.(None): 2) Beneficence and non-maleficence refers to the ethical obligation to maximize benefits and to minimize harms.
p.(None): This gives rise to norms requiring the risks of research to be reasonable in the light of the expected benefits, that
p.(None): the research design be sound, and that the investigators be competent to conduct the research and to safeguard the
p.(None): welfare of the research subjects.
p.(None): 3) Justice refers to the ethical obligation to treat each person in accordance with what is morally right and
p.(None): proper; to give each person what is due to him or her. In the ethics of research involving human participants, the
p.(None): principle refers primarily to distributive justice, which requires equitable distribution of both the burdens and the
p.(None): benefits of participation in research.
p.(None):
p.(None):
p.(None):
p.(None): 6.4 Establishment of the Dental Ethics Review Board (DERB)
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): The Dean of the College of Dentistry, King Saud University is responsible for establishing the Dental
p.(None): Ethics Review Board (DERB) to review, approve and monitor research that involves human participants. The DERB
p.(None): consists of a chairman and members from the different specialties within the College of Dentistry.
p.(None):
p.(None): 6.5 Authorities of the Dental Ethics Review Board (DERB)
p.(None): DERB has the obligation to ensure that dental research is designed and conducted in such a manner that the rights and
p.(None): welfare of participating human subjects is well protected. The authorities of the DERB are the following:
p.(None): • Determination of the level of review required for the presented research proposal. This is, the
p.(None): authority of the DERB chairman.
p.(None): • Review, approve, and request modifications of a research proposal
p.(None): • Restrict or omit steps or parts of a research proposal for participants’ protection.
p.(None): • Follow-up of the approved research by conducting continuing ethical review for ongoing research at an
p.(None): appropriate interval.
p.(None): • Inspect research facilities, equipment, and data and other relevant information relating to
p.(None): the use of human participants in dental research
p.(None): • Observe or have a third party observe the informed consent process.
p.(None): • Suspend or terminate previously approved research that is not being conducted in accordance
p.(None): with the DERB’s required standards
p.(None): • Suspend or terminate previously approved research that is associated with unexpected serious harm to
p.(None): participants.
p.(None): • Review, accept, and/or reject reports, including but not limited to reports of serious adverse events
p.(None): and unanticipated problems involving risks to subjects and others.
p.(None): • Disapprove a research proposal that is expected to cause serious harm to participants.
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): • Approve the inclusion of the college member in other research teams within or outside the premises of King
p.(None): Saud University.
p.(None): • Research that has been reviewed and approved by the DERB may be subject to disapproval by King Saud
p.(None): University officials or higher authorities.
p.(None): • King Saud University officials may not authorize or approve the conduct of dental research involving human
p.(None): participants that has not been approved by the DERB.
p.(None): • Research approved by the DERB may be subject, if requested by King Saud University officials or higher
p.(None): authorities, to further review and approval or disapproval by officials of the institution.
p.(None): • Members are expected to treat as confidential all applications, meeting deliberations, information
p.(None): on research participants/volunteers and related matters.
p.(None): • When a committee member believe that he/she has a conflict of interest on a subject which will compromise
p.(None): his/her ability to make a decision, he/she should declare that conflict of interest and withdraw him/herself from the
p.(None): discussion and/or decision making.
p.(None):
p.(None): The DERB has the mandate to act as an independent entity within the College of Dentistry, King Saud
p.(None): University. As such, the DERB is the final authority for all decisions regarding safeguarding the rights and
p.(None): welfare of humans who are subjects of dental research conducted under the auspices of the University.
p.(None):
p.(None): 6.7 Types of Review
p.(None): A dental research proposal involving human participation is reviewed initially by the DERB chairman to
p.(None): determine the appropriate level of review. The level of review is determined by the probability and
p.(None): magnitude of expected risk to the human. Risk is defined as the harm or injury that is expected to
p.(None): occur to the human resulted from
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): participating in the planned dental research. The probability of risk may vary from no or minimal risk to significant.
p.(None):
p.(None): 6.7.1 Minimal Risk
p.(None): Minimal risk is defined as follows: "The probability and magnitude of harm or discomfort
p.(None): anticipated in the research are not greater than those ordinarily encountered in daily life or during
p.(None): the performance of routine physical or psychological examinations or tests." For example, the risk of bleeding
p.(None): during the examination of gingival pocket depth in a healthy human participating in dental research is not greater
p.(None): than the risk of bleeding in a routine gingival examination of a healthy human. The risks of psychological, social,
p.(None): or economic harm are difficult to assess in dental research. However, unethical breaches of confidentiality
p.(None): such as HIV infection status or drug and alcohol intake can place the human participating in dental research
p.(None): at the risk of damage to their employability, or reputation. Many risks can be minimized considerably with careful
p.(None): planning.
p.(None):
p.(None): In broad terms, a project involves minimal risk if:
p.(None): 1) The participant experiences no pain or physical danger.
p.(None): 2) The participant experiences no emotional arousal or psychological stress beyond the levels normally to be expected
p.(None): in everyday life.
p.(None): 3) The project neither includes nor attempts to induce long-term significant change in the participant's behavior
p.(None): (including attitude towards self and others).
p.(None): 4) The data would not embarrass or socially disadvantage the participant, were confidentiality to
p.(None): be violated.
p.(None): 5) If the investigator conceals information about specific purpose of the project, there is no reason to believe
p.(None): the subject would choose not to participate if he or she had known that information initially.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.7.2 Determining the Level of Review
p.(None): There are three levels of review for a research proposal depending on the risk expected to the human participating in
p.(None): the planned research. The three levels are:
p.(None): (1) Full Dental Ethical Board Review.
p.(None): (2) Exempt from the full dental ethical board review.
p.(None): (3) Expedited from the full dental ethical board review.
p.(None):
p.(None):
p.(None): 6.7.2.1 Full Dental Ethical Board Review
p.(None): Any protocol that uses a methodology that is sensitive and of higher probability for causing harm or
p.(None): distress to participants is subject to full board review. Additionally, any protocol using prisoners as
p.(None): participants or involving pregnant women, fetuses, and human in vitro fertilization will be reviewed by
p.(None): the full board. Research in which the risks versus the expected benefits are relatively high is also likely to be
p.(None): reviewed by the full board.
p.(None): Dental research proposals that require full dental ethical board review included, but are not necessarily limited to
p.(None): the following:
p.(None): 1) Clinical trials involving human participants
p.(None): 2) New treatments or interventions
p.(None): 3) Research involving human remains, cadavers, tissues, discarded tissue (e.g. placenta), biological
p.(None): fluids
p.(None): 4) Physiological studies
p.(None): 5) Comparing an established procedure, whether therapeutic, non-therapeutic or diagnostic, with other
p.(None): procedures which are not recognized as established by virtue of their recent development, discovery or use in a new or
p.(None): unfamiliar way
p.(None): 6) Innovative practices in health and disability services
p.(None): 7) Research conducted by students, which includes all activities that meet the definition of
p.(None): research with human participants (As supervised student research is conducted primarily for the purpose of
p.(None): educating students on research techniques and methodologies, DERB should review research protocols with
p.(None): a view to
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): contributing to the students’ education concerning scientific and ethical principles governing research).
p.(None): 8) Observational clinical research
p.(None): 9) Access to personal information by means of questionnaires, interviews or other techniques of information
p.(None): gathering
p.(None): 10) Research involving the secondary use of data (use of data not collected for that research purpose), if
p.(None): any form of identifier is involved and/or if health information pertaining to individuals is involved
p.(None): 11) Case studies, when a series of subject observations allow possible extrapolation of generalization of the
p.(None): results from the reported cases and when there is intent to publish or disseminate the data.
p.(None):
p.(None): 6.7.2.2 Exempt from the full ethical board review
p.(None): The determination of which proposals will be exempt from the full ethical board review is the sole authority of the
p.(None): DERB chairman. The exempt status of a research proposal means that the proposed protocol for the dental research is
p.(None): exempt from full authority of the DERB in research involving the participation of the human. Any change in
p.(None): the protocol of the approved proposal must be re-submitted to the DERB chairman to determine further
p.(None): exempt status. The dental researcher must submit to the DERB secretary the full documentations required
p.(None): for the review by the DERB, including the research proposal, informed consent and the CV’s of the investigators.
p.(None):
p.(None): To determine exempt status, the research must qualify as one or more of the categories listed below. To qualify for a
p.(None): category, the research must meet all of the conditions of that category.
p.(None):
p.(None): 1. Research conducted in established or commonly accepted educational settings involving normal educational
p.(None): practices such as (a) regular and special education
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): instructional strategies, or (b) research on the effectiveness of or the comparison among instructional
p.(None): techniques, curricula, or classroom management methods.
p.(None): 2. Research involving use of educational tests, survey or interview procedures, or observation of public
p.(None): behavior unless information obtained from these sources is recorded in such a manner that subjects can
p.(None): be identified, and disclosure of the subject’s responses outside the research could reasonably place the subject
p.(None): at risk of criminal or civil liability or be damaging to his or her financial standing,
p.(None): employability, or reputation.
p.(None): 3. Research involving the use of education tests, survey procedures, interview procedures, or observation of
p.(None): public behavior if (a) the human subjects are elected or appointed public officials or candidates for
p.(None): public office; or (b) federal statutes require, without exception, that the confidentiality of the
p.(None): personally identifiable information will be maintained throughout the research and thereafter. Children may
p.(None): not be involved in this research.
p.(None): 4. Research involving the collection or study of existing data, documents, records, pathological
p.(None): specimens, or diagnostic specimens, (a) if these sources are publicly available, or (b) if the information is
p.(None): recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers
p.(None): linked to the subjects.
p.(None): 5. Research and demonstration projects that are designed to study, evaluate, or otherwise examine (a) public benefit
p.(None): or service programs; (b) procedures for obtaining benefits or services under these programs; (c) possible changes or
p.(None): alternatives to those programs or procedures; or (d) possible changes in methods or levels of payments for benefits or
p.(None): services under those programs.
p.(None): 6. Tests and food quality evaluation and consumer studies (a) if wholesome food without additives is consumed, or (b)
p.(None): if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or
p.(None): agricultural chemical or environmental contaminant at or below the level found to be safe.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.7.2.3 Expedited from the full ethical board review
p.(None): The determination of the expedited status for any research proposal is the authority of the DERB chairman. A dental
p.(None): research proposal eligible expedited from the full ethical board review means that the proposed dental research
p.(None): is to be reviewed by a single member of the DERB panel. The single member is designated by the DERB
p.(None): chairman. Like the exempt review, the research must be of minimal risk or no more than minimal risk and all aspects of
p.(None): a protocol must fit within one or more expedited categories to be reviewed in this manner. The dental researcher must
p.(None): submit to the DERB secretary the full documentations required for the review by the DERB, including the
p.(None): research proposal, informed consent and the CV’s of the investigators.
p.(None):
p.(None): An expedited review process is available for research activities that present no more than minimal risk to
p.(None): human participants or that request a minor change in previously approved research that involves no additional risk and
p.(None): that involve only procedures in one or more of the categories listed below. Some of the categories overlap with those
p.(None): used to assess exempt status. The distinction between exempt and expedited review is based on the sensitivity of the
p.(None): data and/or the risk of compromised confidentiality (such as a relatively small sample size).
p.(None):
p.(None): The expedited review procedure may not be used where identification of the subjects and/or their responses would
p.(None): reasonably place them at risk of criminal or civil liability or be damaging to the subject’s financial standing,
p.(None): employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be
p.(None): implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
p.(None): Furthermore, the expedited review procedure may not be used for classified research involving human
p.(None): participants.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): To determine expedited status, the research must qualify as one or more of the categories listed below.
p.(None): To qualify for a category, the research must meet all of the conditions of that category.
p.(None):
p.(None): 1. Clinical studies of drugs and medical devices. (a) Research on drugs where the application for
p.(None): investigation of new drug is not required. (b) Research on medical devices where; (i) the application
p.(None): for investigation of new medical device is not required, (ii) the medical device is cleared/approved for
p.(None): marketing. Examples: Review of dental implant results to assess for indicators of successful outcome.
p.(None): 2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture. Example: (i)
p.(None): Measurement of CRP levels before and after treatment for gingivitis. Requires 10 mL of blood drawn twice over
p.(None): a 3-month period.
p.(None): 3. Prospective collection of biological specimens for research purposes by noninvasive means. Examples: (a)
p.(None): deciduous and permanent teeth if routine patient care indicates a need for extraction; (b)
p.(None): uncannulated saliva collected either in an un- stimulated fashion or stimulated by chewing gum base or wax or by
p.(None): applying a dilute citric solution to the tongue; (c) supra- and sub-gingival dental plaque and calculus, provided the
p.(None): collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process
p.(None): is accomplished in accordance with accepted prophylactic techniques; (d) mucosal and skin cells collected by
p.(None): buccal scraping or swab, skin swab, or mouth washings; (e) sputum collected after saline mist
p.(None): nebulization.
p.(None): 4. Collection of data through noninvasive procedures routinely employed in dental clinical practice,
p.(None): excluding procedures involving x-rays. The medical/dental devices employed must be cleared/approved
p.(None): for marketing. Example: Analysis of measurements of blood pressure and heart rate using an automated blood
p.(None): pressure monitor every 10 minutes during tooth extraction, a comparison between routine local anesthesia and
p.(None): routine local anesthesia with hypnosis.
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 5. Research involving materials (data, documents, records, or specimens) that have been collected, or
p.(None): will be collected solely for non-research purposes. Example: (i) Prospective review of dental records
p.(None): to determine the outcome of standard treatment of oral ulcers in HIV-positive patients. (ii) Review of
p.(None): medical records and pathology samples of patients with parotid tumors to determine predictors of malignancy.
p.(None): 6. Collection of data from voice, video, digital, or image recordings made for research purposes.
p.(None): 7. Research on individual or group characteristics or behavior employing survey, interview, oral history,
p.(None): focus group, program evaluation, human factors evaluation, or quality assurance methodologies. Examples: (i) Survey of
p.(None): children in a Headstart program to determine knowledge about dental care. (ii) Focus group of multiple
p.(None): ethnic groups to determine attitudes and practices about oral health.
p.(None): 8. Continuing review of research previously approved by the full DERB review as follows: (a) where (i) the
p.(None): research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related
p.(None): interventions; and (iii) the research remains active only for long-term follow-up of subjects; or (b) where no subjects
p.(None): have been enrolled and no additional risks have been identified; or (c) where the remaining research
p.(None): activities are limited to data analysis.
p.(None): 9. Continuing review of research, not conducted under an investigational new drug application or
p.(None): investigational device exemption where categories two (2) through eight (8) do not apply but the DERB has
p.(None): determined and documented at a convened meeting that the research involves no greater than minimal risk and no
p.(None): additional risks have been identified.
p.(None):
p.(None): 6.8 Conflict of Interest
p.(None): Dental researchers hold trustful relationships with research participants, research sponsors, their
p.(None): institution, professional bodies and society. This trust can be put at risk by a conflict of interest that
p.(None): influences their independent and objective judgment.
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): Conflict of Interest is when the professional judgment concerning research is influenced by a secondary interest such
p.(None): as personal or financial gain. The dental researchers and DERB members should disclose any actual, perceived or
p.(None): potential conflicts of interest to the DERB. The DERB should develop mechanisms to address and manage such conflicts of
p.(None): interest.
p.(None):
p.(None): 6.9 Informed Consent
p.(None): Informed consent means that a participant has been informed about the risks and benefits of the research,
p.(None): understands such risks and benefits and is able to give consent to participation, without coercion, undue
p.(None): influence or inappropriate incentives. It represents a signed agreement between the dental researcher
p.(None): and the human participant or their legally authorized representative to participate in the research
p.(None): before the start of the research. The informed consent process should provide the necessary information to
p.(None): the participants in simple, clear language that they understand and in terms they comprehend. It should provide the
p.(None): freedom of choice, the respect of participant’s autonomy, the voluntariness to participate and the protection
p.(None): of privacy and confidentiality. The information is given in a document known as the Informed Consent
p.(None): Form.
p.(None):
p.(None): The informed consent form should have the following as may be applicable:
p.(None): 1) Nature and purpose of study, stating it as research.
p.(None): 2) Duration of participation with number of participants.
p.(None): 3) Procedures to be followed.
p.(None): 4) Investigations, if any, to be performed.
p.(None): 5) Foreseeable risks and discomforts adequately described and whether the project involves more than minimal
p.(None): risk.
p.(None): 6) Benefits to participants, community or the dental profession as may be applicable.
p.(None): 7) Policy on compensation.
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 8) Availability of dental or alternative treatments if available for injuries or risk management.
p.(None): 9) Steps taken for ensuring confidentiality.
p.(None): 10) Freedom to withdraw without any consequences or loss of benefits.
p.(None): 11) Contact details of researchers for seeking more information related to the research or in case of injury.
p.(None): 12) Contact details for appeal against violation of rights.
p.(None): 13) Voluntary participation.
p.(None): 14) If test for genetics and HIV is to be done, counseling for consent for testing must be given as per Kingdom of
p.(None): Saudi Arabia guidelines.
p.(None): 15) Storage period of biological sample and related data with choice offered to participant
p.(None): regarding future use of samples, refusal for storage and receipt of its results.
p.(None):
p.(None): A copy of the informed consent form should be given to the participant for personal record. Note; in the
p.(None): UK we call the above ‘the patient information leaflet’ the last page of which being where the signatures of patient and
p.(None): consent taker are required
p.(None):
p.(None): 6.9.1 Re-consent
p.(None): Re-consent is taken in following conditions:
p.(None): 1) Availability of new information that necessitate changes in the research protocol.
p.(None): 2) When a research participant regains consciousness from an unconscious state or become mentally competent
p.(None): to understand the study.
p.(None): 3) Follow-up of the results of previous research.
p.(None): 4) Not finished research that requires extension of the allowed time.
p.(None): 5) When there is a change in treatment modality, procedures and site visits.
p.(None): 6) Before publication if there is possibility of disclosure of identity through data presentation or
p.(None): photographs that should be camouflaged adequately.
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 6.9.2 Waiver of consent
p.(None): Voluntary informed consent is a requirement for any research proposal that involves human participation.
p.(None): However, there are situations when the requirements for informed consent can be waived. If it is
p.(None): justified that the research involves not more than minimal risk or when the participant and the researcher do not
p.(None): come into contact or when it is necessitated in emergency situations. If such studies have the appropriate protection
p.(None): for both privacy and confidentiality, and do not violate the rights of the participants then the DERB
p.(None): may waive the requirement for informed consent in the following instances:
p.(None): a) When it is impractical to conduct research since confidentiality of personally identifiable
p.(None): information has to be maintained throughout the research.
p.(None): b) Research on publicly available information, documents, records, works, performances,
p.(None): reviews, quality assurance studies, archival materials or third party interviews, service programs for benefit
p.(None): of public having a bearing on public health programs, and consumer acceptance studies.
p.(None): c) Research on anonymised biological samples from left over samples after clinical investigation.
p.(None): d) In emergency situations when informed consent can be taken. Do you mean cannot be taken? (yes cannot, but I think
p.(None): we need to define the emergency situations)
p.(None):
p.(None): 7.0 Research Participants Requiring Additional Attention
p.(None): Humans with limited autonomy or in subordinate positions are considered participants that require additional
p.(None): attention and are in need of greater protection. These may include children, pregnant women and fetus, prisoners, and
p.(None): human highly dependent on medical care. Does this cover mentally impaired people?
p.(None):
p.(None): 7.1 Research involving children, adolescents and mentally impaired people
p.(None): Dental treatment and research on children, adolescents and mentally impaired person is part of the dental
p.(None): discipline. A child is a person who has not yet reached puberty
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): whereas an adolescent is a person who is reaching or has reached puberty. Mentally impaired person is a
p.(None): person who has impairment of intelligence and social functioning which appears to be permanent or temporary. Children,
p.(None): adolescents and mentally impaired person are considered participants who require additional attention because
p.(None): of their limited intellectual and emotional capacities. They cannot give a legal consent; therefore
p.(None): permission from the parent(s) is essential. Children, adolescents and mentally impaired person should
p.(None): participate in research only where their participation is indispensable to the research and where participation is
p.(None): not contrary to the individual's best interests. The research proposal must provide sufficient
p.(None): information to justify clearly why children, adolescents or mentally impaired person should be included
p.(None): as participants. Refusal of a child, adolescent or mentally impaired person to participate in the research must be
p.(None): respected.
p.(None):
p.(None): 7.1.1 Approval of research involving children and adolescents
p.(None): Research involving a child, adolescent or mentally impaired person should be approved only if:
p.(None): 1) The research, including observational research, places the child , adolescent or mentally impaired person at no
p.(None): more than minimal risk (that is, the risk commensurate with daily life or routine dental examinations – referred to as
p.(None): 'negligible risk' in some guidelines).
p.(None): 2) The research involves more than minimal risk but provides possible benefit for the child, adolescent or mentally
p.(None): impaired person participant. The degree of risk must be justified by the potential benefit.
p.(None): 3) The research involves greater than minimal risk, with no prospect of direct benefit to the child, adolescent or
p.(None): mentally impaired person, but has a high probability of providing significant knowledge. The risk should be justified
p.(None): by the risk-knowledge ratio and the risk must represent no more than a minor increase over minimal risk.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 7.1.2 Consent for children or adolescents
p.(None): Consent for children, adolescents or mentally impaired person to participate in research must be obtained from:
p.(None): a) The parents or legal guardian in all but exceptional circumstances such as emergencies.
p.(None): b) The child or adolescent that is competent to make the decision.
p.(None): c) Any organization or person required by authorization.
p.(None): d) No other caregiver can act on behalf of a child in providing consent to participate.
p.(None):
p.(None):
p.(None): 7.2 Research involving pregnant women
p.(None): The DERB must give extra attention to research that involves pregnant women or those who may become pregnant, because
p.(None): of the additional health concerns during pregnancy and the need to avoid unnecessary risk to the fetus. The policy of
p.(None): the college of dentistry research center is that; no pregnant woman may be involved as a participant in any dental
p.(None): research activity unless:
p.(None): • The purpose of the research is to meet the health needs of the mother and the fetus will be placed at no
p.(None): risk, or
p.(None): • The risk to the fetus is minimal.
p.(None): The DERB should consider the following regulatory protections before approval of the research proposal.
p.(None): • Appropriate studies conducted on animals and non-pregnant women have provided data for assessing potential risks.
p.(None): • Risks and prospects of benefit to the fetus and mother (separately or together) and the purpose of the research
p.(None): have been determined.
p.(None): • Any risk is the least possible for achieving the objectives of the research.
p.(None): The research activity may be permitted to be conducted only if the mother is legally competent and has given informed
p.(None): consent after having been fully informed about the possible impact on the fetus. The father's informed consent needs to
p.(None): be secured if the research has any risk to the fetus.
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None):
p.(None): 7.3 Research involving a fetus
p.(None): Dental research usually do not involve fetuses as participants, however, in research involve investigations on the
p.(None): craniofacial malformations such as cleft lip and palate the dental researcher may be involved as a member of a larger
p.(None): research group including medical researchers. The dental researcher must abide by the ethical codes and the regulatory
p.(None): procedures of the medical research team.
p.(None): The policy of the Research Center College of Dentistry for the dental research involving fetus is that; no fetus in
p.(None): utero may be involved as a participant in any dental research activity. The inclusion of any member of the college of
p.(None): dentistry in research activity involving fetuses as a member of larger team must be approved by the DERB. The approval
p.(None): of the DERB must be granted before the member start any research activity within the research team.
p.(None):
p.(None): 7.4 Research involving Prisoners
p.(None): A Prisoner is an individual involuntarily confined in a penal institution, including persons:
p.(None): (1) sentenced under a criminal or civil statute; (2) detained pending arraignment, trial, or sentencing; and (3)
p.(None): detained in other facilities such as treatment of addiction. The condition of imprisonment may make it difficult to
p.(None): ensure voluntary consent and confidentiality. There is a need for special consideration to provide protection to
p.(None): prisoner participating in research. The college of dentistry research center policy requires that all dental research
p.(None): involving prisoners should be reviewed by the full board.
p.(None):
p.(None): 7.4.1 Considerations regarding research involving prisoners
p.(None): The DERB will approve research proposals involving prisoners if:
p.(None): 1. Research will probably improve oral health or well‐being of the prisoners.
p.(None): 2. Minimal risk and no more than inconvenience caused and the research is a study of causes and effects.
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): 3. Minimal risk and no more than inconvenience caused and research is a study of prisons as institutional structures
p.(None): or of prisoners as incarcerated persons.
p.(None): 4. Research on conditions affecting prisoners as a class.
p.(None):
p.(None):
p.(None): 7.4.2 Approval of research involving prisoners
p.(None): 1) Advantages through participation compared to their current situation.
p.(None): 2) Risk of participation is the same as those that would be accepted by non‐prisoners.
p.(None): 3) Procedure of selection is fair to all prisoners.
p.(None): 4) Language for obtaining informed consent must be understandable to prisoners.
p.(None): 5) When studies need follow‐up, the provision for follow‐up must include a consideration of the length of individual
p.(None): sentences, and prisoners must be informed about follow‐up.
p.(None):
p.(None): 7.5 Research involving humans highly dependent on medical care
p.(None): Dental research on humans who are highly dependent on medical care raises ethical issues that deserve special
p.(None): attention. Researchers need to acknowledge that informed consent may be compromised by the effect of the medical
p.(None): condition or fear of affecting the level of medical care in case of refusal to participate. The following conditions
p.(None): are considered for possible dental research activities.
p.(None): 1. Research activities on humans under emergency care
p.(None): 2. Research activities on humans in the intensive care unit
p.(None): 3. Research activities on neonatals in the intensive care unit
p.(None): 4. Research activities on humans in the terminal care unit
p.(None): 5. Research activities on decisionallyXimpaired humans
p.(None): 6. Research activities on unconscious human
p.(None): The policy of the college of dentistry research center is that; no dental research should be carried out on the above
p.(None): mentioned conditions. However, The DERB, within its authority can approve dental research in the following conditions;
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): • The research is based on valid scientific hypotheses which support a reasonable possibility of benefit over
p.(None): standard care.
p.(None): • The research is intended to be therapeutic and the research intervention poses no more than a risk that is
p.(None): expected in alternative methods of treatment.
p.(None):
p.(None): 7.6 Other groups requiring additional attention
p.(None): The discussion of the dental research participants requiring additional attention should not be limited to those
p.(None): already mentioned. Other groups that require additional attention include: traumatized and comatose patients,
p.(None): terminally ill patients, elderly or aged patients, minorities, students, and employees. The DERB must ensure that
p.(None): special consideration is given to all these groups, especially with regard to the risks, benefits and obtaining
p.(None): informed consent.
p.(None):
p.(None): 8.0 EPIDEMIOLOGICAL RESEARCH
p.(None):
p.(None): Epidemiological research describes the health status in a population or subgroup of the population. Epidemiological
p.(None): research studies the distribution and determinants of health related problems in populations, and the application of
p.(None): the research results to prevent, control or eliminate such health problems. It is concerned with improvement of the
p.(None): health status and welfare in human populations and with the improvement in the efficiency and performance of health
p.(None): services. Epidemiological research is carried out with human participants, or data or biological samples from them,
p.(None): and such research provides important new knowledge that is not readily obtainable in other ways. Perhaps the second
p.(None): most significant dental discoveries, after local anesthesia, were the effects of naturally occurring fluoride on
p.(None): reducing the incidence of dental caries as revealed by epidemiological research. Such epidemiological studies provided
p.(None): the motive for several clinical and laboratory research studies on the relationships between fluoride and dental
p.(None): caries. The findings from these researches laid the ground for the current understanding of the relationship between
p.(None): fluoride and oral disease.
p.(None):
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): The main objective of epidemiological research is to collect information in order to throw light on the nature and
p.(None): occurrence of disease, and to suggest hypotheses that may be tested later through other research. Dental health
p.(None): problems suitable for epidemiological research include
p.(None):
p.(None): The measurement of dental disease prevalence and incidence within the population of Saudi Arabia,
p.(None):
p.(None): The identification of oral health care needs within the population of Saudi Arabia,
p.(None): The establishment of baseline information regarding the Saudi’s oral health and disease status, and
p.(None):
p.(None): The development and evaluation of various disease control procedures within the population of Saudi Arabia.
p.(None):
p.(None): The policy of the College of Dentistry Research Center is to encourage such epidemiological research that is expected
p.(None): to results in the prevention, control or elimination of dental diseases and oral health problems, such as caries,
p.(None): malocclusions, TMJ problems, oral cancer and other oral health related problems. Such research usually has priority in
p.(None): support and funding because of the expected local and national impact. The DERB should approve research proposal of
p.(None): dental epidemiological research provided that the ethical principles of respect, informed consent, confidentiality, and
p.(None): publication of the information are well covered.
p.(None):
p.(None): 9.0 Human genetic research
p.(None): Dental researches on human genetics involve the study of the inheritance pattern of the dento- facial trait and
p.(None): characteristics. Participation of families rather than individuals is required for genetic research studies.
p.(None): Genetic research enhances our understanding of how genes and environmental factors interact to influence the
p.(None): health of individuals and communities. Genetic research can reveal information about an individual's
p.(None): susceptibility to disease and future
p.(None):
p.(None):
p.(None): Copyright © College of Dentistry, King Saud University 2011. All Rights Reserved
p.(None):
p.(None): health. Such information may be of interest and benefit to research participants, especially where
p.(None): preventive strategies exist.
p.(None):
p.(None): In addition to ethical considerations applied to all research involving humans, there are ethical issues unique to
p.(None): genetic research. They arise from the nature of the information which may be shared with other family members and with
p.(None): unrelated individuals in the population. Research results may be of significance to the health of blood relatives and
p.(None): others not participating in the research. Individuals may have an interest in the genetic information that
p.(None): may create new options for life decisions. Participants may be at risk of harm, including unfair discrimination or
p.(None): exclusion. The results of genetic information about future health could be used, potentially, by third parties such as
p.(None): insurance companies and employers.
p.(None):
p.(None): Researcher must recognize that obtaining informed consent and the collection of genetic information from
p.(None): families require specific attention. The researcher must abide by the policy to protect the privacy, confidentiality,
p.(None): storage and publication of genetic information. The DERB within its authority should not approve any proposal for
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| HIV | HIV/AIDS |
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| belmont | belmont |
| cadavers | Cadavers |
| child | Child |
| children | Child |
| cioms | cioms guidelines |
| comatose | Comatose |
| criminal | criminal |
| decisionally impaired | decisionally impaired |
| dependent | Dependent |
| detained | person in detention center |
| diminished | Diminished Autonomy |
| disability | Mentally Disabled |
| disabled | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| educational | education |
| elderly | Elderly |
| emergencies | patients in emergency situations |
| emergency | Public Emergency |
| employees | employees |
| ethnic | Ethnicity |
| family | Motherhood/Family |
| fetus | Fetus/Neonate |
| fetuses | Fetus/Neonate |
| gender | gender |
| helsinki | declaration of helsinki |
| ill | ill |
| impaired | Cognitive Impairment |
| impairment | Cognitive Impairment |
| incarcerated | Incarcerated |
| influence | Drug Usage |
| language | Linguistic Proficiency |
| mentally | Mentally Disabled |
| military | Soldier |
| minor | Youth/Minors |
| parent | parents |
| parents | parents |
| party | political affiliation |
| pregnant | Pregnant |
| prisoners | Criminal Convictions |
| property | Property Ownership |
| racial | Racial Minority |
| religious | Religion |
| single | Marital Status |
| student | Student |
| terminal | Terminally Ill |
| terminally | Terminally Ill |
| tri-council | tri-council policy statement |
| unconscious | Unconscious People |
| volunteers | Healthy People |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| disability | ['disabled', 'mentally'] |
| disabled | ['mentally', 'disability'] |
| drug | ['influence'] |
| education | ['educational'] |
| educational | ['education'] |
| fetus | ['fetuses'] |
| fetuses | ['fetus'] |
| impaired | ['impairment'] |
| impairment | ['impaired'] |
| influence | ['drug'] |
| mentally | ['disabled', 'disability'] |
| parent | ['parents'] |
| parents | ['parent'] |
| terminal | ['terminally'] |
| terminally | ['terminal'] |
Trigger Words
capacity
coercion
consent
cultural
developing
ethics
harm
justice
protect
protection
risk
self-determination
sensitive
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input