79C3C34C52B45572883A05D425EB0F82
Policy and Procedure Regarding Use of Human Subjects in Research
https://documents.aucegypt.edu/docs/research_ReviewBoard/IRB.pdf
http://leaux.net/URLS/ConvertAPI Text Files/D48E4F682AEF4378DCD7C86259D3B1D3.en.txt
Examining the file media/Synopses/D48E4F682AEF4378DCD7C86259D3B1D3.html:
This file was generated: 2021-02-09 23:04:57
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
Searching for indicator prisoners:
(return to top)
p.(None):
p.(None): (1) vital functions of the fetus will not be artificially maintained,
p.(None):
p.(None): (2) experimental activities which of themselves would terminate the heartbeat or respiration of the fetus will not be
p.(None): employed, and
p.(None):
p.(None): (3) the purpose of the activity is the development of important biomedical knowledge which cannot be obtained by other
p.(None): means.
p.(None):
p.(None): In the event the fetus ex utero is found to be viable, it may be included as a subject in the activity only to the
p.(None): extent permitted by and in accordance with the requirements of other parts of this section.
p.(None):
p.(None): An activity may be conducted only if the mother and father are legally competent and have given their informed consent,
p.(None): except that the father's informed consent need not be secured if:
p.(None):
p.(None): (1) his identity or whereabouts cannot reasonable be ascertained,
p.(None):
p.(None): (2) he is not reasonably available.
p.(None):
p.(None): Activities Involving the Dead Fetus, Fetal Material, or the Placenta Activities involving the dead fetus, mascerated
p.(None): fetal material, or cells, tissue, or organs excised from a dead fetus shall be conducted only in accordance with any
p.(None): applicable local laws regarding such activities.
p.(None):
p.(None): B. Prisoners
p.(None):
p.(None): Inasmuch as prisoners may be under constraints because of their incarceration which could affect their ability to make
p.(None): a truly voluntary and uncoerced decision whether or not to participate as subjects in research, it is AUC policy to
p.(None): avoid use of prisoners as research subjects. Where this cannot be avoided additional safeguards must be provided for
p.(None): the protection of prisoners involved in research. In this event Principal Investigators must contact the IRB through
p.(None): the Office of the Vice Provost to obtain guidance in regard to development of the research plan and the special
p.(None): requirements of the IRB for such cases.
p.(None):
p.(None): C. Children
p.(None):
p.(None): To What Does This Section Apply?
p.(None):
p.(None): The categories of research listed as "exempt" beginning on page 1 of this Handbook are generally applicable. However
p.(None): the exemption for research involving survey or interview procedures or observations of public behavior does not apply
p.(None): to research involving children, except for research involving observation of public behavior when the investigator(s)
p.(None): do not participate in the activities being observed.
p.(None):
p.(None): Definitions
p.(None):
p.(None): "Children" are persons who have not attained the legal age for consent to treatments or procedures involved in the
p.(None): research, under the applicable law of the jurisdiction in which the research will be conducted.
p.(None):
p.(None): "Assent" means a child's affirmative agreement to participate in research. Mere failure to object should not, absent
p.(None): affirmative agreement, be construed as assent.
p.(None):
p.(None): "Permission" means the agreement of parent(s) or guardian to the participation of their child or ward in research.
p.(None):
...
Political / criminal
Searching for indicator criminal:
(return to top)
p.(None): 2. TYPES OF REVIEW
p.(None):
p.(None): The IRB will review projects by one of three methods: Exempt, Expedited, and Full Board Review.
p.(None):
p.(None): A. Exempt Review:
p.(None):
p.(None): Certain categories of research qualify for exempt review. Exempt proposals are reviewed and certified by the Chair of
p.(None): the IRB, working through the Office of the Vice Provost. Please allow one week for exempt reviews. Research activities
p.(None): in which the only involvement of human subjects will be in one or more of the following categories qualify for review
p.(None): under the exempt category:
p.(None):
p.(None): (1) Research conducted in established or commonly accepted educational settings, involving normal educational
p.(None): practices, such as
p.(None): (a) research on regular and special education instructional strategies, or
p.(None): (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom
p.(None): management methods.
p.(None):
p.(None): (2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures,
p.(None): interview procedures or observation of public behavior, unless:
p.(None): (a) Information obtained is recorded in such a manner that human subjects can be identified, directly or through
p.(None): identifiers linked to the subjects; and
p.(None): (b) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of
p.(None): criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. (See
p.(None): however Section 11 below for special considerations required when children are involved.)
p.(None):
p.(None): (3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures,
p.(None): interview procedures or observation of public behavior that is not exempt under paragraph (2) of this section, if:
p.(None): (a) The human subjects are elected or appointed public officials or candidates for public office; or
p.(None): (b) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information
p.(None): will be maintained throughout the research and thereafter.
p.(None):
p.(None): (4) Research, involving the collection or study of existing data, documents, records, pathological specimens, or
p.(None): diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in
p.(None): such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
p.(None):
p.(None): (5) Research and demonstration projects which are conducted by or subject to the approval of department or agency
p.(None): heads, and which are designed to study, evaluate, or otherwise examine:
p.(None): (a) public benefit or service programs;
p.(None): (b) procedures for obtaining benefits or services under those programs;
p.(None): (c) possible changes in or alternatives to those programs or procedures; or
p.(None): (d) possible changes in methods or levels of payment for benefits or services under those programs.
p.(None):
...
Health / Cognitive Impairment
Searching for indicator cognitive:
(return to top)
p.(None): proposal. Full approval must be sought as soon as feasible, and must be obtained before the involvement of human
p.(None): subjects in the project begins.
p.(None):
p.(None): Students making proposals must specify the name of an AUC faculty supervisor responsible for overseeing the research.
p.(None): The same holds for researchers from outside AUC who run proposals through the IRB: they too should list an AUC faculty
p.(None): liaison when making their proposal.
p.(None):
p.(None):
p.(None):
p.(None): 2. TYPES OF REVIEW
p.(None):
p.(None): The IRB will review projects by one of three methods: Exempt, Expedited, and Full Board Review.
p.(None):
p.(None): A. Exempt Review:
p.(None):
p.(None): Certain categories of research qualify for exempt review. Exempt proposals are reviewed and certified by the Chair of
p.(None): the IRB, working through the Office of the Vice Provost. Please allow one week for exempt reviews. Research activities
p.(None): in which the only involvement of human subjects will be in one or more of the following categories qualify for review
p.(None): under the exempt category:
p.(None):
p.(None): (1) Research conducted in established or commonly accepted educational settings, involving normal educational
p.(None): practices, such as
p.(None): (a) research on regular and special education instructional strategies, or
p.(None): (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom
p.(None): management methods.
p.(None):
p.(None): (2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures,
p.(None): interview procedures or observation of public behavior, unless:
p.(None): (a) Information obtained is recorded in such a manner that human subjects can be identified, directly or through
p.(None): identifiers linked to the subjects; and
p.(None): (b) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of
p.(None): criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. (See
p.(None): however Section 11 below for special considerations required when children are involved.)
p.(None):
p.(None): (3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures,
p.(None): interview procedures or observation of public behavior that is not exempt under paragraph (2) of this section, if:
p.(None): (a) The human subjects are elected or appointed public officials or candidates for public office; or
p.(None): (b) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information
p.(None): will be maintained throughout the research and thereafter.
p.(None):
p.(None): (4) Research, involving the collection or study of existing data, documents, records, pathological specimens, or
p.(None): diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in
p.(None): such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
p.(None):
p.(None): (5) Research and demonstration projects which are conducted by or subject to the approval of department or agency
p.(None): heads, and which are designed to study, evaluate, or otherwise examine:
p.(None): (a) public benefit or service programs;
p.(None): (b) procedures for obtaining benefits or services under those programs;
p.(None): (c) possible changes in or alternatives to those programs or procedures; or
p.(None): (d) possible changes in methods or levels of payment for benefits or services under those programs.
p.(None):
p.(None): (6) Research which is conducted on a collaborative basis with one or more other institutions whose IRB has reviewed and
p.(None): approved the research project and AUC assists with the implementation of activities fully covered by that approval. If
p.(None): the AUC role results in new activity not fully covered by the collaborating institution's IRB approval, or if AUC
...
Health / Drug Usage
Searching for indicator drug:
(return to top)
p.(None): diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in
p.(None): such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
p.(None):
p.(None): (5) Research and demonstration projects which are conducted by or subject to the approval of department or agency
p.(None): heads, and which are designed to study, evaluate, or otherwise examine:
p.(None): (a) public benefit or service programs;
p.(None): (b) procedures for obtaining benefits or services under those programs;
p.(None): (c) possible changes in or alternatives to those programs or procedures; or
p.(None): (d) possible changes in methods or levels of payment for benefits or services under those programs.
p.(None):
p.(None): (6) Research which is conducted on a collaborative basis with one or more other institutions whose IRB has reviewed and
p.(None): approved the research project and AUC assists with the implementation of activities fully covered by that approval. If
p.(None): the AUC role results in new activity not fully covered by the collaborating institution's IRB approval, or if AUC
p.(None): actions require that informed consent not provided for under the procedures established by the collaborating
p.(None): institution, the activity is not eligible for exempt review by the AUC IRB.
p.(None):
p.(None): (7) Taste and food quality evaluation and consumer acceptance studies,
p.(None): (a) if wholesome foods without additives are consumed or
p.(None): (b) 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, by the Food and Drug
p.(None): Administration and approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the US
p.(None): Department of Agriculture. Where stricter requirements have been established by appropriate Egyptian Agencies these
p.(None): will be observed to ensure that safe levels are observed.
p.(None):
p.(None):
p.(None):
p.(None): B. Expedited Review:
p.(None):
p.(None): Expedited reviews do not require a convened meeting of the IRB. The chair of the IRB chooses a limited number of board
p.(None): members to review the proposal. The IRB members return their comments to the chair, who notifies the principal
p.(None): investigator of the results of the review.
p.(None): Please allow one month for an expedited review. Research activities involving no more than minimal risk and in which
p.(None): the only involvement of human subjects will be in one or more of the following categories may be reviewed through the
p.(None): expedited review procedure:
p.(None):
p.(None): (1) Collection of: hair and nail clippings, in a non-disfiguring manner; deciduous teeth; and permanent teeth if
p.(None): patient care indicates a need for extraction.
p.(None):
p.(None): (2) Collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery,
p.(None): and amniotic fluid at the time of rupture of the membrane prior to or during labor.
p.(None):
p.(None): (3) Recording of data from subjects 18 years of age or older using noninvasive procedures routinely employed at
p.(None): clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a
...
p.(None): electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and
p.(None): electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (for example,
p.(None): x-rays, microwaves).
p.(None):
p.(None): (4) Acquisition of blood samples by finger pricking for collection of blood droplets or smears, from subjects 18 years
p.(None): of age or older and who are in good health and not pregnant.
p.(None):
p.(None): (5) Collection of both supra- and subgingival dental plaque and calculus, provided the procedure is not more invasive
p.(None): than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic
p.(None): techniques.
p.(None):
p.(None): (6) Voice recordings made for research purposes such as investigations of speech defects.
p.(None):
p.(None): (7) Moderate exercise by healthy volunteers.
p.(None):
p.(None): (8) The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
p.(None):
p.(None): (9) Research on individual or group behavior or characteristics of individuals, such as studies of perception,
p.(None): cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the
p.(None): research will not involve stress to subjects.
p.(None):
p.(None): (10) Research on drugs or devices for which an investigational new drug exemption or an investigational device
p.(None): exemption is not required.
p.(None):
p.(None): C. Full Board Review:
p.(None):
p.(None): The IRB schedules meetings as needed to review all proposals which do not fall into the Exempt or Expedited categories.
p.(None): Principal investigators may be invited to attend the meeting to discuss their proposal. Please allow one month for full
p.(None): board review.
p.(None):
p.(None): 3. REVIEW CRITERIA
p.(None):
p.(None): In any review (expedited, exempt, or full board), the reviewers will determine that:
p.(None):
p.(None): (1) Participation of human subjects in the project is justified.
p.(None):
p.(None): (2) Risks to subjects are minimized by using appropriate procedures.
p.(None):
p.(None): (3) Risks are justified in view of anticipated benefits.
p.(None):
p.(None): (4) Selection of subjects is equitable. Justification is required if the subject population is restricted to one gender
p.(None): or ethnic group.
p.(None):
p.(None): (5) Adequate provision is made for confidentiality of data and anonymity of participants in any published record.
p.(None):
p.(None): (6) Adequate provision is made for the rights and welfare of participants who are mentally, physically, economically or
p.(None): educationally disadvantaged.
p.(None):
p.(None): (7) Adequate provision is made for obtaining informed consent of the subjects, including those who may not be literate.
p.(None):
p.(None):
p.(None):
...
Health / Healthy People
Searching for indicator healthy volunteers:
(return to top)
p.(None): and amniotic fluid at the time of rupture of the membrane prior to or during labor.
p.(None):
p.(None): (3) Recording of data from subjects 18 years of age or older using noninvasive procedures routinely employed at
p.(None): clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a
p.(None): distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the
p.(None): subject's privacy. It also includes such procedures as weighing, the testing of sensory acuity, electrocardiography,
p.(None): electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and
p.(None): electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (for example,
p.(None): x-rays, microwaves).
p.(None):
p.(None): (4) Acquisition of blood samples by finger pricking for collection of blood droplets or smears, from subjects 18 years
p.(None): of age or older and who are in good health and not pregnant.
p.(None):
p.(None): (5) Collection of both supra- and subgingival dental plaque and calculus, provided the procedure is not more invasive
p.(None): than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic
p.(None): techniques.
p.(None):
p.(None): (6) Voice recordings made for research purposes such as investigations of speech defects.
p.(None):
p.(None): (7) Moderate exercise by healthy volunteers.
p.(None):
p.(None): (8) The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
p.(None):
p.(None): (9) Research on individual or group behavior or characteristics of individuals, such as studies of perception,
p.(None): cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the
p.(None): research will not involve stress to subjects.
p.(None):
p.(None): (10) Research on drugs or devices for which an investigational new drug exemption or an investigational device
p.(None): exemption is not required.
p.(None):
p.(None): C. Full Board Review:
p.(None):
p.(None): The IRB schedules meetings as needed to review all proposals which do not fall into the Exempt or Expedited categories.
p.(None): Principal investigators may be invited to attend the meeting to discuss their proposal. Please allow one month for full
p.(None): board review.
p.(None):
p.(None): 3. REVIEW CRITERIA
p.(None):
p.(None): In any review (expedited, exempt, or full board), the reviewers will determine that:
p.(None):
p.(None): (1) Participation of human subjects in the project is justified.
p.(None):
p.(None): (2) Risks to subjects are minimized by using appropriate procedures.
p.(None):
p.(None): (3) Risks are justified in view of anticipated benefits.
p.(None):
p.(None): (4) Selection of subjects is equitable. Justification is required if the subject population is restricted to one gender
p.(None): or ethnic group.
p.(None):
p.(None): (5) Adequate provision is made for confidentiality of data and anonymity of participants in any published record.
...
Health / Mentally Disabled
Searching for indicator mentally:
(return to top)
p.(None): cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the
p.(None): research will not involve stress to subjects.
p.(None):
p.(None): (10) Research on drugs or devices for which an investigational new drug exemption or an investigational device
p.(None): exemption is not required.
p.(None):
p.(None): C. Full Board Review:
p.(None):
p.(None): The IRB schedules meetings as needed to review all proposals which do not fall into the Exempt or Expedited categories.
p.(None): Principal investigators may be invited to attend the meeting to discuss their proposal. Please allow one month for full
p.(None): board review.
p.(None):
p.(None): 3. REVIEW CRITERIA
p.(None):
p.(None): In any review (expedited, exempt, or full board), the reviewers will determine that:
p.(None):
p.(None): (1) Participation of human subjects in the project is justified.
p.(None):
p.(None): (2) Risks to subjects are minimized by using appropriate procedures.
p.(None):
p.(None): (3) Risks are justified in view of anticipated benefits.
p.(None):
p.(None): (4) Selection of subjects is equitable. Justification is required if the subject population is restricted to one gender
p.(None): or ethnic group.
p.(None):
p.(None): (5) Adequate provision is made for confidentiality of data and anonymity of participants in any published record.
p.(None):
p.(None): (6) Adequate provision is made for the rights and welfare of participants who are mentally, physically, economically or
p.(None): educationally disadvantaged.
p.(None):
p.(None): (7) Adequate provision is made for obtaining informed consent of the subjects, including those who may not be literate.
p.(None):
p.(None):
p.(None):
p.(None): 4. OBTAINING INFORMED CONSENT
p.(None):
p.(None): Informed consent will be sought from all prospective subjects (or their legally authorized representatives) unless
p.(None): waived by the IRB. The IRB may waive the requirement of a signed consent form if:
p.(None):
p.(None): (a) this consent form is the only record linking the subject with the research and the principal risk would be
p.(None): potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants
p.(None): documentation linking the subject with the research, and the subject's wishes will govern; or
p.(None): (b) the research presents no more than minimal risk of harm to subjects, involving no procedures for which written
p.(None): consent is normally required outside the context of the research. Such a waiver might be appropriate where the research
p.(None): involves minimal risk, the rights and
p.(None):
...
Health / Physically Disabled
Searching for indicator physically:
(return to top)
p.(None): research will not involve stress to subjects.
p.(None):
p.(None): (10) Research on drugs or devices for which an investigational new drug exemption or an investigational device
p.(None): exemption is not required.
p.(None):
p.(None): C. Full Board Review:
p.(None):
p.(None): The IRB schedules meetings as needed to review all proposals which do not fall into the Exempt or Expedited categories.
p.(None): Principal investigators may be invited to attend the meeting to discuss their proposal. Please allow one month for full
p.(None): board review.
p.(None):
p.(None): 3. REVIEW CRITERIA
p.(None):
p.(None): In any review (expedited, exempt, or full board), the reviewers will determine that:
p.(None):
p.(None): (1) Participation of human subjects in the project is justified.
p.(None):
p.(None): (2) Risks to subjects are minimized by using appropriate procedures.
p.(None):
p.(None): (3) Risks are justified in view of anticipated benefits.
p.(None):
p.(None): (4) Selection of subjects is equitable. Justification is required if the subject population is restricted to one gender
p.(None): or ethnic group.
p.(None):
p.(None): (5) Adequate provision is made for confidentiality of data and anonymity of participants in any published record.
p.(None):
p.(None): (6) Adequate provision is made for the rights and welfare of participants who are mentally, physically, economically or
p.(None): educationally disadvantaged.
p.(None):
p.(None): (7) Adequate provision is made for obtaining informed consent of the subjects, including those who may not be literate.
p.(None):
p.(None):
p.(None):
p.(None): 4. OBTAINING INFORMED CONSENT
p.(None):
p.(None): Informed consent will be sought from all prospective subjects (or their legally authorized representatives) unless
p.(None): waived by the IRB. The IRB may waive the requirement of a signed consent form if:
p.(None):
p.(None): (a) this consent form is the only record linking the subject with the research and the principal risk would be
p.(None): potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants
p.(None): documentation linking the subject with the research, and the subject's wishes will govern; or
p.(None): (b) the research presents no more than minimal risk of harm to subjects, involving no procedures for which written
p.(None): consent is normally required outside the context of the research. Such a waiver might be appropriate where the research
p.(None): involves minimal risk, the rights and
p.(None):
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.(None): the only involvement of human subjects will be in one or more of the following categories may be reviewed through the
p.(None): expedited review procedure:
p.(None):
p.(None): (1) Collection of: hair and nail clippings, in a non-disfiguring manner; deciduous teeth; and permanent teeth if
p.(None): patient care indicates a need for extraction.
p.(None):
p.(None): (2) Collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery,
p.(None): and amniotic fluid at the time of rupture of the membrane prior to or during labor.
p.(None):
p.(None): (3) Recording of data from subjects 18 years of age or older using noninvasive procedures routinely employed at
p.(None): clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a
p.(None): distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the
p.(None): subject's privacy. It also includes such procedures as weighing, the testing of sensory acuity, electrocardiography,
p.(None): electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and
p.(None): electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (for example,
p.(None): x-rays, microwaves).
p.(None):
p.(None): (4) Acquisition of blood samples by finger pricking for collection of blood droplets or smears, from subjects 18 years
p.(None): of age or older and who are in good health and not pregnant.
p.(None):
p.(None): (5) Collection of both supra- and subgingival dental plaque and calculus, provided the procedure is not more invasive
p.(None): than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic
p.(None): techniques.
p.(None):
p.(None): (6) Voice recordings made for research purposes such as investigations of speech defects.
p.(None):
p.(None): (7) Moderate exercise by healthy volunteers.
p.(None):
p.(None): (8) The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
p.(None):
p.(None): (9) Research on individual or group behavior or characteristics of individuals, such as studies of perception,
p.(None): cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the
p.(None): research will not involve stress to subjects.
p.(None):
p.(None): (10) Research on drugs or devices for which an investigational new drug exemption or an investigational device
p.(None): exemption is not required.
p.(None):
p.(None): C. Full Board Review:
p.(None):
p.(None): The IRB schedules meetings as needed to review all proposals which do not fall into the Exempt or Expedited categories.
p.(None): Principal investigators may be invited to attend the meeting to discuss their proposal. Please allow one month for full
p.(None): board review.
p.(None):
p.(None): 3. REVIEW CRITERIA
p.(None):
p.(None): In any review (expedited, exempt, or full board), the reviewers will determine that:
p.(None):
p.(None): (1) Participation of human subjects in the project is justified.
p.(None):
p.(None): (2) Risks to subjects are minimized by using appropriate procedures.
p.(None):
...
p.(None): maintained;
p.(None):
p.(None): (6) For research involving more than minimal risk, an explanation as to whether any compensation or medical treatments
p.(None): are available if injury occurs and, if so, what they consist of, or where further information may be obtained; for
p.(None): example: "I understand the University does not provide a research subject with compensation or medical treatment in the
p.(None): event the subject is injured as a result of participation in the research project."
p.(None):
p.(None): (7) An explanation of whom to contact for answers to pertinent questions about the research and research subject's
p.(None): rights, and whom to contact in the event of a research-related injury to the subject; for example: "Questions about the
p.(None): research, my rights, or research-related injuries should be directed to (PI name) at (telephone number)."
p.(None):
p.(None): (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to
p.(None): which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty
p.(None): or loss of benefits to which the subject is otherwise entitled.
p.(None):
p.(None): When appropriate, one or more of the following additional elements of informed consent shall also be provided to each
p.(None): subject:
p.(None):
p.(None): (1) A statement that a particular treatment or procedure may involve risks to the subject (or to the embryo or fetus,
p.(None): if the subject is or may become pregnant) which are currently unforeseeable;
p.(None):
p.(None): (2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without
p.(None): regard to the subject's consent;
p.(None):
p.(None): (3) Any additional costs to the subject that may result from participation in the research;
p.(None):
p.(None): (4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of
p.(None): participation by the subject;
p.(None):
p.(None): (5) A statement that significant new findings developed during the course of the research which may relate to the
p.(None): subject's willingness to continue participation will be provided to the subject; and
p.(None):
p.(None): (6) The approximate number of subjects involved in the study.
p.(None):
p.(None): 6. CONTINUING REVIEW
p.(None):
p.(None): In its initial review of a proposal, the IRB will consider the extent of continuing review needed. All ongoing projects
p.(None): shall be reviewed annually, but in certain research the subjects are exposed to more than usual risk; such projects
p.(None): will be reviewed at more frequent intervals consistent with the research. This review interval will be determined at
p.(None): the time the research is approved and may be changed at the discretion of the IRB. In each such review, the principal
p.(None):
p.(None): investigator will be required to promptly report the status of the research activity, and any proposed changes in the
p.(None): research activity. If the research is still in progress, the investigator will affirm that the approved research
p.(None): protocol involving human subjects is being followed.
p.(None):
p.(None): 7. NONCOMPLIANCE ACTION
p.(None):
...
p.(None):
p.(None): 8. ARBITRATION
p.(None):
p.(None): Any matters requiring arbitration between the IRB and a principal investigator, or questions not resolved by the IRB,
p.(None): will be referred to the Provost. The Provost or an ad hoc committee appointed by the Provost, will meet with the Board
p.(None): and the principal investigator, seeking a resolution of the differences. They will report their findings to the Board
p.(None): and principal investigator, after which the IRB will meet again to reconsider the matter and render a decision. In no
p.(None): instance may any official of the institution overrule an IRB decision for disapproval.
p.(None):
p.(None): 9. RECORDS RETENTION REQUIREMENTS
p.(None):
p.(None): All records must be retained for at least three years after completion of the research. Records may include such items
p.(None): as research proposals, informed consent documents, progress reports, reports of injuries to subjects, and all related
p.(None): correspondence concerning the use of human subjects.
p.(None):
p.(None): 10. PREPARATION INSTRUCTIONS
p.(None):
p.(None): All materials required by the IRB, including proposal and the AUC proposal application form should be submitted to the
p.(None): Office of the Vice Provost. All materials constituting the informed consent documents should use lay language and be
p.(None): prepared in a manner which will facilitate effective communication with those providing the consent.
p.(None):
p.(None): 11. ADDITIONAL PROTECTIONS FOR SPECIAL POPULATIONS OF SUBJECTS
p.(None):
p.(None): A. Fetuses, Pregnant Women, and Human In Vitro Fertilization
p.(None):
p.(None): General limitations. No activity may begin unless:
p.(None):
p.(None): (1) appropriate studies on animals and non-pregnant individuals have been completed;
p.(None):
p.(None): (2) except where the purpose of the activity is to meet the health needs of the mother or the particular fetus, the
p.(None): risk to the fetus is minimal and, in all cases, is the least possible risk for achieving the objectives of the
p.(None): activity;
p.(None):
p.(None): (3) individuals engaged in the activity will have no part in
p.(None): (i) any decisions as to the timing, method, and procedures used to terminate the pregnancy, and
p.(None): (ii) determining the viability of the fetus at the termination of the pregnancy; and
p.(None):
p.(None): (4) no procedural changes which may cause greater than minimal risk to the fetus or the pregnant woman will be
p.(None): introduced into the procedure for terminating the pregnancy solely in the interest of the activity. No inducements,
p.(None): monetary or otherwise, may be offered to terminate pregnancy for purposes of the activity.
p.(None):
p.(None): Activities directed toward pregnant women as subjects:
p.(None): No pregnant woman may be involved as a subject in an activity unless:
p.(None):
p.(None): (1) the purpose of the activity is to meet the health needs of the mother and the fetus will be placed at risk only to
p.(None): the minimum extent necessary to meet such needs, or (2) the risk to the fetus is minimal.
p.(None):
p.(None): A pregnant woman may be involved as a subject in an activity only if she and the fetus's father are legally competent
p.(None): and have given their informed consent after having been fully informed regarding possible impact on the fetus, except
p.(None): that the father's informed consent need not be secured if:
p.(None):
p.(None): (1) the purpose of the activity is to meet the health needs of the mother;
p.(None):
p.(None): (2) his identity or whereabouts cannot reasonably be ascertained;
p.(None):
p.(None): (3) he is not reasonably available.
p.(None):
p.(None): Activities directed toward fetuses in utero as subjects: no fetus in utero may be involved as a subject in any activity
p.(None): unless:
p.(None):
p.(None): (1) the purpose of the activity is to meet the health needs of the particular fetus and the fetus will be placed at
p.(None): risk only to the minimum extent necessary to meet such needs, or
p.(None):
p.(None): (2) the risk to the fetus imposed by the research is minimal and the purpose of the activity is the development of
p.(None): important biomedical knowledge which cannot be obtained by other means.
p.(None):
p.(None): An activity permitted under this section may be conducted only if the mother and father are legally competent and have
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Health / injured
Searching for indicator injured:
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p.(None): exculpatory language through which the subject is made to waive, or to appear to waive, any of the subject's legal
p.(None): rights, or to release the investigator, the sponsor, the institution or its agents from liability for negligence. The
p.(None): basic elements of informed consent are:
p.(None):
p.(None): (1) A statement that the study involves research, an explanation of the purposes of the research, and the expected
p.(None): duration of the subject's participation, a description of the procedures to be followed, and identification of any
p.(None): procedures which are experimental;
p.(None):
p.(None): (2) A description of any reasonably foreseeable risks or discomforts to the subject;
p.(None):
p.(None): (3) A description of any benefits to the subject or to others which may reasonably be expected from the research;
p.(None):
p.(None): (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to
p.(None): the subject;
p.(None):
p.(None): (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be
p.(None): maintained;
p.(None):
p.(None): (6) For research involving more than minimal risk, an explanation as to whether any compensation or medical treatments
p.(None): are available if injury occurs and, if so, what they consist of, or where further information may be obtained; for
p.(None): example: "I understand the University does not provide a research subject with compensation or medical treatment in the
p.(None): event the subject is injured as a result of participation in the research project."
p.(None):
p.(None): (7) An explanation of whom to contact for answers to pertinent questions about the research and research subject's
p.(None): rights, and whom to contact in the event of a research-related injury to the subject; for example: "Questions about the
p.(None): research, my rights, or research-related injuries should be directed to (PI name) at (telephone number)."
p.(None):
p.(None): (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to
p.(None): which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty
p.(None): or loss of benefits to which the subject is otherwise entitled.
p.(None):
p.(None): When appropriate, one or more of the following additional elements of informed consent shall also be provided to each
p.(None): subject:
p.(None):
p.(None): (1) A statement that a particular treatment or procedure may involve risks to the subject (or to the embryo or fetus,
p.(None): if the subject is or may become pregnant) which are currently unforeseeable;
p.(None):
p.(None): (2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without
p.(None): regard to the subject's consent;
p.(None):
p.(None): (3) Any additional costs to the subject that may result from participation in the research;
p.(None):
p.(None): (4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of
p.(None): participation by the subject;
p.(None):
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Health / sensory impairment
Searching for indicator sensory:
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p.(None): Department of Agriculture. Where stricter requirements have been established by appropriate Egyptian Agencies these
p.(None): will be observed to ensure that safe levels are observed.
p.(None):
p.(None):
p.(None):
p.(None): B. Expedited Review:
p.(None):
p.(None): Expedited reviews do not require a convened meeting of the IRB. The chair of the IRB chooses a limited number of board
p.(None): members to review the proposal. The IRB members return their comments to the chair, who notifies the principal
p.(None): investigator of the results of the review.
p.(None): Please allow one month for an expedited review. Research activities involving no more than minimal risk and in which
p.(None): the only involvement of human subjects will be in one or more of the following categories may be reviewed through the
p.(None): expedited review procedure:
p.(None):
p.(None): (1) Collection of: hair and nail clippings, in a non-disfiguring manner; deciduous teeth; and permanent teeth if
p.(None): patient care indicates a need for extraction.
p.(None):
p.(None): (2) Collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery,
p.(None): and amniotic fluid at the time of rupture of the membrane prior to or during labor.
p.(None):
p.(None): (3) Recording of data from subjects 18 years of age or older using noninvasive procedures routinely employed at
p.(None): clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a
p.(None): distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the
p.(None): subject's privacy. It also includes such procedures as weighing, the testing of sensory acuity, electrocardiography,
p.(None): electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and
p.(None): electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (for example,
p.(None): x-rays, microwaves).
p.(None):
p.(None): (4) Acquisition of blood samples by finger pricking for collection of blood droplets or smears, from subjects 18 years
p.(None): of age or older and who are in good health and not pregnant.
p.(None):
p.(None): (5) Collection of both supra- and subgingival dental plaque and calculus, provided the procedure is not more invasive
p.(None): than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic
p.(None): techniques.
p.(None):
p.(None): (6) Voice recordings made for research purposes such as investigations of speech defects.
p.(None):
p.(None): (7) Moderate exercise by healthy volunteers.
p.(None):
p.(None): (8) The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
p.(None):
p.(None): (9) Research on individual or group behavior or characteristics of individuals, such as studies of perception,
p.(None): cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the
p.(None): research will not involve stress to subjects.
p.(None):
p.(None): (10) Research on drugs or devices for which an investigational new drug exemption or an investigational device
p.(None): exemption is not required.
p.(None):
p.(None): C. Full Board Review:
p.(None):
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Social / Age
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p.(None): agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug
p.(None): Administration and approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the US
p.(None): Department of Agriculture. Where stricter requirements have been established by appropriate Egyptian Agencies these
p.(None): will be observed to ensure that safe levels are observed.
p.(None):
p.(None):
p.(None):
p.(None): B. Expedited Review:
p.(None):
p.(None): Expedited reviews do not require a convened meeting of the IRB. The chair of the IRB chooses a limited number of board
p.(None): members to review the proposal. The IRB members return their comments to the chair, who notifies the principal
p.(None): investigator of the results of the review.
p.(None): Please allow one month for an expedited review. Research activities involving no more than minimal risk and in which
p.(None): the only involvement of human subjects will be in one or more of the following categories may be reviewed through the
p.(None): expedited review procedure:
p.(None):
p.(None): (1) Collection of: hair and nail clippings, in a non-disfiguring manner; deciduous teeth; and permanent teeth if
p.(None): patient care indicates a need for extraction.
p.(None):
p.(None): (2) Collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery,
p.(None): and amniotic fluid at the time of rupture of the membrane prior to or during labor.
p.(None):
p.(None): (3) Recording of data from subjects 18 years of age or older using noninvasive procedures routinely employed at
p.(None): clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a
p.(None): distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the
p.(None): subject's privacy. It also includes such procedures as weighing, the testing of sensory acuity, electrocardiography,
p.(None): electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and
p.(None): electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (for example,
p.(None): x-rays, microwaves).
p.(None):
p.(None): (4) Acquisition of blood samples by finger pricking for collection of blood droplets or smears, from subjects 18 years
p.(None): of age or older and who are in good health and not pregnant.
p.(None):
p.(None): (5) Collection of both supra- and subgingival dental plaque and calculus, provided the procedure is not more invasive
p.(None): than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic
p.(None): techniques.
p.(None):
p.(None): (6) Voice recordings made for research purposes such as investigations of speech defects.
p.(None):
p.(None): (7) Moderate exercise by healthy volunteers.
p.(None):
p.(None): (8) The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
p.(None):
p.(None): (9) Research on individual or group behavior or characteristics of individuals, such as studies of perception,
p.(None): cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the
p.(None): research will not involve stress to subjects.
p.(None):
p.(None): (10) Research on drugs or devices for which an investigational new drug exemption or an investigational device
p.(None): exemption is not required.
p.(None):
p.(None): C. Full Board Review:
p.(None):
p.(None): The IRB schedules meetings as needed to review all proposals which do not fall into the Exempt or Expedited categories.
p.(None): Principal investigators may be invited to attend the meeting to discuss their proposal. Please allow one month for full
p.(None): board review.
p.(None):
p.(None): 3. REVIEW CRITERIA
p.(None):
p.(None): In any review (expedited, exempt, or full board), the reviewers will determine that:
p.(None):
p.(None): (1) Participation of human subjects in the project is justified.
p.(None):
...
p.(None):
p.(None): B. Prisoners
p.(None):
p.(None): Inasmuch as prisoners may be under constraints because of their incarceration which could affect their ability to make
p.(None): a truly voluntary and uncoerced decision whether or not to participate as subjects in research, it is AUC policy to
p.(None): avoid use of prisoners as research subjects. Where this cannot be avoided additional safeguards must be provided for
p.(None): the protection of prisoners involved in research. In this event Principal Investigators must contact the IRB through
p.(None): the Office of the Vice Provost to obtain guidance in regard to development of the research plan and the special
p.(None): requirements of the IRB for such cases.
p.(None):
p.(None): C. Children
p.(None):
p.(None): To What Does This Section Apply?
p.(None):
p.(None): The categories of research listed as "exempt" beginning on page 1 of this Handbook are generally applicable. However
p.(None): the exemption for research involving survey or interview procedures or observations of public behavior does not apply
p.(None): to research involving children, except for research involving observation of public behavior when the investigator(s)
p.(None): do not participate in the activities being observed.
p.(None):
p.(None): Definitions
p.(None):
p.(None): "Children" are persons who have not attained the legal age for consent to treatments or procedures involved in the
p.(None): research, under the applicable law of the jurisdiction in which the research will be conducted.
p.(None):
p.(None): "Assent" means a child's affirmative agreement to participate in research. Mere failure to object should not, absent
p.(None): affirmative agreement, be construed as assent.
p.(None):
p.(None): "Permission" means the agreement of parent(s) or guardian to the participation of their child or ward in research.
p.(None):
p.(None): "Parent" means a child's biological or adoptive parent.
p.(None):
p.(None): "Guardian" means an individual who is authorized under applicable State or local law to consent on behalf of a child to
p.(None): general medical care.
p.(None):
p.(None): Research Not Involving Greater than Minimal Risk
p.(None):
p.(None): The IRB will approve projects in which no greater than minimal risk to children is presented, only if adequate
p.(None): provisions are made for soliciting the assent of the children and the permission of their parents or guardians.
p.(None):
...
p.(None): prospect of direct benefit to the individual subjects. For research involving greater risk and no prospect of direct
p.(None): benefit to subjects, permission is to be obtained from both parents, unless one parent is deceased, unknown,
p.(None): incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of
p.(None): the child.
p.(None):
p.(None): If the IRB determines that a research protocol is designed for conditions or for a subject population for which
p.(None): parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or
p.(None): abused children), it may waive the consent requirements, provided an appropriate mechanism for protecting the children
p.(None): who will participate as subjects in the research is substituted, and provided further that the waiver is not
p.(None): inconsistent with Federal, State, or local law. The choice of an appropriate mechanism would depend upon the nature and
p.(None): purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and
p.(None): their age, maturity, status, and condition.
p.(None):
p.(None): Permission by parents or guardians shall be documented.
p.(None):
p.(None): When the IRB determines that assent is required, it shall also determine whether and how assent must be documented.
p.(None):
p.(None): Wards
p.(None):
p.(None): Children who are wards of the State or any other agency, institution, or entity can be included in research only if
p.(None): such research is:
p.(None):
p.(None): (1) related to their status as wards; or
p.(None):
p.(None): (2) conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children
p.(None): involved as subjects are not wards.
p.(None):
p.(None): If the research is approved, the IRB shall require appointment of an advocate for each child who is a ward, in addition
p.(None): to any other individual acting on behalf of the child as guardian or in loco parentis. One individual may serve as
p.(None): advocate for more than one child. The advocate shall be an individual who has the background and experience to act in,
p.(None): and agrees to act in, the best interests of the child for the duration of the child's participation in the research and
p.(None): who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the
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Social / Child
Searching for indicator child:
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p.(None): avoid use of prisoners as research subjects. Where this cannot be avoided additional safeguards must be provided for
p.(None): the protection of prisoners involved in research. In this event Principal Investigators must contact the IRB through
p.(None): the Office of the Vice Provost to obtain guidance in regard to development of the research plan and the special
p.(None): requirements of the IRB for such cases.
p.(None):
p.(None): C. Children
p.(None):
p.(None): To What Does This Section Apply?
p.(None):
p.(None): The categories of research listed as "exempt" beginning on page 1 of this Handbook are generally applicable. However
p.(None): the exemption for research involving survey or interview procedures or observations of public behavior does not apply
p.(None): to research involving children, except for research involving observation of public behavior when the investigator(s)
p.(None): do not participate in the activities being observed.
p.(None):
p.(None): Definitions
p.(None):
p.(None): "Children" are persons who have not attained the legal age for consent to treatments or procedures involved in the
p.(None): research, under the applicable law of the jurisdiction in which the research will be conducted.
p.(None):
p.(None): "Assent" means a child's affirmative agreement to participate in research. Mere failure to object should not, absent
p.(None): affirmative agreement, be construed as assent.
p.(None):
p.(None): "Permission" means the agreement of parent(s) or guardian to the participation of their child or ward in research.
p.(None):
p.(None): "Parent" means a child's biological or adoptive parent.
p.(None):
p.(None): "Guardian" means an individual who is authorized under applicable State or local law to consent on behalf of a child to
p.(None): general medical care.
p.(None):
p.(None): Research Not Involving Greater than Minimal Risk
p.(None):
p.(None): The IRB will approve projects in which no greater than minimal risk to children is presented, only if adequate
p.(None): provisions are made for soliciting the assent of the children and the permission of their parents or guardians.
p.(None):
p.(None): Research Involving Greater than Minimal Risk but Presenting the Prospect of Direct Benefit to the Individual Subjects
p.(None):
p.(None): The IRB will approve projects in which more than minimal risk to children is presented by an intervention or procedure
p.(None): that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely
p.(None): to contribute to the subject's well-being, only if:
p.(None):
p.(None): (1) the risk is justified by the anticipated benefit to the subjects;
p.(None):
p.(None): (2) the relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by
p.(None): available alternative approaches; and
p.(None):
...
p.(None): (ii) the research will be conducted in accordance with sound ethical principles;
p.(None): (iii) adequate provisions are made for soliciting the assent of children and the permission of their parents or
p.(None): guardians.
p.(None):
p.(None): Requirements for Permission by Parents or Guardians and for Assent by Children
p.(None):
p.(None): The IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the
p.(None): judgment of the IRB the children are capable of providing assent. In determining whether children are capable of
p.(None): assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This
p.(None): judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the
p.(None): IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they
p.(None): cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of
p.(None): direct benefit that is important to the health or well- being of the children and is available only in the context of
p.(None): the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the
p.(None): IRB determines that the subjects are capable of assenting, the IRB may still waive the assent
p.(None):
p.(None): requirement under circumstances in which consent may be waived in accordance with general informed consent provisions.
p.(None):
p.(None): In addition, the IRB shall determine that adequate provisions are made for soliciting the permission of each child's
p.(None): parents or guardian. Where parental permission is to be obtained, the IRB may find that permission of one parent is
p.(None): sufficient for research involving minimal risk or for research involving greater than minimal risk but presenting the
p.(None): prospect of direct benefit to the individual subjects. For research involving greater risk and no prospect of direct
p.(None): benefit to subjects, permission is to be obtained from both parents, unless one parent is deceased, unknown,
p.(None): incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of
p.(None): the child.
p.(None):
p.(None): If the IRB determines that a research protocol is designed for conditions or for a subject population for which
p.(None): parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or
...
...
Searching for indicator children:
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p.(None): the IRB, working through the Office of the Vice Provost. Please allow one week for exempt reviews. Research activities
p.(None): in which the only involvement of human subjects will be in one or more of the following categories qualify for review
p.(None): under the exempt category:
p.(None):
p.(None): (1) Research conducted in established or commonly accepted educational settings, involving normal educational
p.(None): practices, such as
p.(None): (a) research on regular and special education instructional strategies, or
p.(None): (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom
p.(None): management methods.
p.(None):
p.(None): (2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures,
p.(None): interview procedures or observation of public behavior, unless:
p.(None): (a) Information obtained is recorded in such a manner that human subjects can be identified, directly or through
p.(None): identifiers linked to the subjects; and
p.(None): (b) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of
p.(None): criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. (See
p.(None): however Section 11 below for special considerations required when children are involved.)
p.(None):
p.(None): (3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures,
p.(None): interview procedures or observation of public behavior that is not exempt under paragraph (2) of this section, if:
p.(None): (a) The human subjects are elected or appointed public officials or candidates for public office; or
p.(None): (b) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information
p.(None): will be maintained throughout the research and thereafter.
p.(None):
p.(None): (4) Research, involving the collection or study of existing data, documents, records, pathological specimens, or
p.(None): diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in
p.(None): such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
p.(None):
p.(None): (5) Research and demonstration projects which are conducted by or subject to the approval of department or agency
p.(None): heads, and which are designed to study, evaluate, or otherwise examine:
p.(None): (a) public benefit or service programs;
p.(None): (b) procedures for obtaining benefits or services under those programs;
p.(None): (c) possible changes in or alternatives to those programs or procedures; or
p.(None): (d) possible changes in methods or levels of payment for benefits or services under those programs.
p.(None):
p.(None): (6) Research which is conducted on a collaborative basis with one or more other institutions whose IRB has reviewed and
p.(None): approved the research project and AUC assists with the implementation of activities fully covered by that approval. If
...
p.(None): except that the father's informed consent need not be secured if:
p.(None):
p.(None): (1) his identity or whereabouts cannot reasonable be ascertained,
p.(None):
p.(None): (2) he is not reasonably available.
p.(None):
p.(None): Activities Involving the Dead Fetus, Fetal Material, or the Placenta Activities involving the dead fetus, mascerated
p.(None): fetal material, or cells, tissue, or organs excised from a dead fetus shall be conducted only in accordance with any
p.(None): applicable local laws regarding such activities.
p.(None):
p.(None): B. Prisoners
p.(None):
p.(None): Inasmuch as prisoners may be under constraints because of their incarceration which could affect their ability to make
p.(None): a truly voluntary and uncoerced decision whether or not to participate as subjects in research, it is AUC policy to
p.(None): avoid use of prisoners as research subjects. Where this cannot be avoided additional safeguards must be provided for
p.(None): the protection of prisoners involved in research. In this event Principal Investigators must contact the IRB through
p.(None): the Office of the Vice Provost to obtain guidance in regard to development of the research plan and the special
p.(None): requirements of the IRB for such cases.
p.(None):
p.(None): C. Children
p.(None):
p.(None): To What Does This Section Apply?
p.(None):
p.(None): The categories of research listed as "exempt" beginning on page 1 of this Handbook are generally applicable. However
p.(None): the exemption for research involving survey or interview procedures or observations of public behavior does not apply
p.(None): to research involving children, except for research involving observation of public behavior when the investigator(s)
p.(None): do not participate in the activities being observed.
p.(None):
p.(None): Definitions
p.(None):
p.(None): "Children" are persons who have not attained the legal age for consent to treatments or procedures involved in the
p.(None): research, under the applicable law of the jurisdiction in which the research will be conducted.
p.(None):
p.(None): "Assent" means a child's affirmative agreement to participate in research. Mere failure to object should not, absent
p.(None): affirmative agreement, be construed as assent.
p.(None):
p.(None): "Permission" means the agreement of parent(s) or guardian to the participation of their child or ward in research.
p.(None):
p.(None): "Parent" means a child's biological or adoptive parent.
p.(None):
p.(None): "Guardian" means an individual who is authorized under applicable State or local law to consent on behalf of a child to
p.(None): general medical care.
p.(None):
p.(None): Research Not Involving Greater than Minimal Risk
p.(None):
p.(None): The IRB will approve projects in which no greater than minimal risk to children is presented, only if adequate
p.(None): provisions are made for soliciting the assent of the children and the permission of their parents or guardians.
p.(None):
p.(None): Research Involving Greater than Minimal Risk but Presenting the Prospect of Direct Benefit to the Individual Subjects
p.(None):
p.(None): The IRB will approve projects in which more than minimal risk to children is presented by an intervention or procedure
p.(None): that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely
p.(None): to contribute to the subject's well-being, only if:
p.(None):
p.(None): (1) the risk is justified by the anticipated benefit to the subjects;
p.(None):
p.(None): (2) the relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by
p.(None): available alternative approaches; and
p.(None):
p.(None): (3) adequate provisions are made for soliciting the assent of the children and permission of their parents or
p.(None): guardians.
p.(None):
p.(None): Research Involving Greater than Minimal Risk and No Prospect of Direct Benefit to Individual Subjects, but Likely to
p.(None): Yield Generalizable Knowledge about the Subject's Disorder or Condition
p.(None):
p.(None): The IRB will approve projects in which more than minimal risk to children is presented by an intervention or procedure
p.(None): that does not hold out the prospect of direct benefit for the individual
p.(None):
p.(None): subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject, only if:
p.(None):
p.(None): (1) the risk represents a minor increase over minimal risk;
p.(None):
p.(None): (2) the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent
p.(None): in their actual or expected medical, dental, psychological, social, or educational situations;
p.(None):
p.(None): (3) the intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition
p.(None): which is of vital importance for the understanding or amelioration of the subjects' disorder or condition; and
p.(None):
p.(None): (4) adequate provisions are made for soliciting assent of the children and permission of their parents or guardians.
p.(None):
p.(None): Research Not Otherwise Approvable which Presents an Opportunity to Understand, Prevent, or Alleviate a Serious Problem
p.(None): Affecting the Health or Welfare of Children
p.(None):
p.(None): The IRB will approve projects in this category only if:
p.(None):
p.(None): (1) the IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or
p.(None): alleviation of a serious problem affecting the health or welfare of children; and
p.(None):
p.(None): (2) when DHHS funding is sought, the Secretary of DHHS, after consultation with a panel of experts in pertinent
p.(None): disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and
p.(None): comment, has determined either:
p.(None): (a) that the research satisfies the conditions of the above categories, or
p.(None): (b) the following:
p.(None): (i) the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a
p.(None): serious problem affecting the health or welfare of children;
p.(None): (ii) the research will be conducted in accordance with sound ethical principles;
p.(None): (iii) adequate provisions are made for soliciting the assent of children and the permission of their parents or
p.(None): guardians.
p.(None):
p.(None): Requirements for Permission by Parents or Guardians and for Assent by Children
p.(None):
p.(None): The IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the
p.(None): judgment of the IRB the children are capable of providing assent. In determining whether children are capable of
p.(None): assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This
p.(None): judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the
p.(None): IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they
p.(None): cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of
p.(None): direct benefit that is important to the health or well- being of the children and is available only in the context of
p.(None): the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the
p.(None): IRB determines that the subjects are capable of assenting, the IRB may still waive the assent
p.(None):
p.(None): requirement under circumstances in which consent may be waived in accordance with general informed consent provisions.
p.(None):
p.(None): In addition, the IRB shall determine that adequate provisions are made for soliciting the permission of each child's
p.(None): parents or guardian. Where parental permission is to be obtained, the IRB may find that permission of one parent is
p.(None): sufficient for research involving minimal risk or for research involving greater than minimal risk but presenting the
p.(None): prospect of direct benefit to the individual subjects. For research involving greater risk and no prospect of direct
p.(None): benefit to subjects, permission is to be obtained from both parents, unless one parent is deceased, unknown,
p.(None): incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of
p.(None): the child.
p.(None):
p.(None): If the IRB determines that a research protocol is designed for conditions or for a subject population for which
p.(None): parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or
p.(None): abused children), it may waive the consent requirements, provided an appropriate mechanism for protecting the children
p.(None): who will participate as subjects in the research is substituted, and provided further that the waiver is not
p.(None): inconsistent with Federal, State, or local law. The choice of an appropriate mechanism would depend upon the nature and
p.(None): purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and
p.(None): their age, maturity, status, and condition.
p.(None):
p.(None): Permission by parents or guardians shall be documented.
p.(None):
p.(None): When the IRB determines that assent is required, it shall also determine whether and how assent must be documented.
p.(None):
p.(None): Wards
p.(None):
p.(None): Children who are wards of the State or any other agency, institution, or entity can be included in research only if
p.(None): such research is:
p.(None):
p.(None): (1) related to their status as wards; or
p.(None):
p.(None): (2) conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children
p.(None): involved as subjects are not wards.
p.(None):
p.(None): If the research is approved, the IRB shall require appointment of an advocate for each child who is a ward, in addition
p.(None): to any other individual acting on behalf of the child as guardian or in loco parentis. One individual may serve as
p.(None): advocate for more than one child. The advocate shall be an individual who has the background and experience to act in,
p.(None): and agrees to act in, the best interests of the child for the duration of the child's participation in the research and
p.(None): who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the
...
Social / Ethnicity
Searching for indicator ethnic:
(return to top)
p.(None):
p.(None): (7) Moderate exercise by healthy volunteers.
p.(None):
p.(None): (8) The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
p.(None):
p.(None): (9) Research on individual or group behavior or characteristics of individuals, such as studies of perception,
p.(None): cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the
p.(None): research will not involve stress to subjects.
p.(None):
p.(None): (10) Research on drugs or devices for which an investigational new drug exemption or an investigational device
p.(None): exemption is not required.
p.(None):
p.(None): C. Full Board Review:
p.(None):
p.(None): The IRB schedules meetings as needed to review all proposals which do not fall into the Exempt or Expedited categories.
p.(None): Principal investigators may be invited to attend the meeting to discuss their proposal. Please allow one month for full
p.(None): board review.
p.(None):
p.(None): 3. REVIEW CRITERIA
p.(None):
p.(None): In any review (expedited, exempt, or full board), the reviewers will determine that:
p.(None):
p.(None): (1) Participation of human subjects in the project is justified.
p.(None):
p.(None): (2) Risks to subjects are minimized by using appropriate procedures.
p.(None):
p.(None): (3) Risks are justified in view of anticipated benefits.
p.(None):
p.(None): (4) Selection of subjects is equitable. Justification is required if the subject population is restricted to one gender
p.(None): or ethnic group.
p.(None):
p.(None): (5) Adequate provision is made for confidentiality of data and anonymity of participants in any published record.
p.(None):
p.(None): (6) Adequate provision is made for the rights and welfare of participants who are mentally, physically, economically or
p.(None): educationally disadvantaged.
p.(None):
p.(None): (7) Adequate provision is made for obtaining informed consent of the subjects, including those who may not be literate.
p.(None):
p.(None):
p.(None):
p.(None): 4. OBTAINING INFORMED CONSENT
p.(None):
p.(None): Informed consent will be sought from all prospective subjects (or their legally authorized representatives) unless
p.(None): waived by the IRB. The IRB may waive the requirement of a signed consent form if:
p.(None):
p.(None): (a) this consent form is the only record linking the subject with the research and the principal risk would be
p.(None): potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants
p.(None): documentation linking the subject with the research, and the subject's wishes will govern; or
...
Social / Fetus/Neonate
Searching for indicator fetus:
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p.(None):
p.(None): (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be
p.(None): maintained;
p.(None):
p.(None): (6) For research involving more than minimal risk, an explanation as to whether any compensation or medical treatments
p.(None): are available if injury occurs and, if so, what they consist of, or where further information may be obtained; for
p.(None): example: "I understand the University does not provide a research subject with compensation or medical treatment in the
p.(None): event the subject is injured as a result of participation in the research project."
p.(None):
p.(None): (7) An explanation of whom to contact for answers to pertinent questions about the research and research subject's
p.(None): rights, and whom to contact in the event of a research-related injury to the subject; for example: "Questions about the
p.(None): research, my rights, or research-related injuries should be directed to (PI name) at (telephone number)."
p.(None):
p.(None): (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to
p.(None): which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty
p.(None): or loss of benefits to which the subject is otherwise entitled.
p.(None):
p.(None): When appropriate, one or more of the following additional elements of informed consent shall also be provided to each
p.(None): subject:
p.(None):
p.(None): (1) A statement that a particular treatment or procedure may involve risks to the subject (or to the embryo or fetus,
p.(None): if the subject is or may become pregnant) which are currently unforeseeable;
p.(None):
p.(None): (2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without
p.(None): regard to the subject's consent;
p.(None):
p.(None): (3) Any additional costs to the subject that may result from participation in the research;
p.(None):
p.(None): (4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of
p.(None): participation by the subject;
p.(None):
p.(None): (5) A statement that significant new findings developed during the course of the research which may relate to the
p.(None): subject's willingness to continue participation will be provided to the subject; and
p.(None):
p.(None): (6) The approximate number of subjects involved in the study.
p.(None):
p.(None): 6. CONTINUING REVIEW
p.(None):
p.(None): In its initial review of a proposal, the IRB will consider the extent of continuing review needed. All ongoing projects
p.(None): shall be reviewed annually, but in certain research the subjects are exposed to more than usual risk; such projects
p.(None): will be reviewed at more frequent intervals consistent with the research. This review interval will be determined at
p.(None): the time the research is approved and may be changed at the discretion of the IRB. In each such review, the principal
p.(None):
p.(None): investigator will be required to promptly report the status of the research activity, and any proposed changes in the
p.(None): research activity. If the research is still in progress, the investigator will affirm that the approved research
p.(None): protocol involving human subjects is being followed.
p.(None):
...
p.(None): instance may any official of the institution overrule an IRB decision for disapproval.
p.(None):
p.(None): 9. RECORDS RETENTION REQUIREMENTS
p.(None):
p.(None): All records must be retained for at least three years after completion of the research. Records may include such items
p.(None): as research proposals, informed consent documents, progress reports, reports of injuries to subjects, and all related
p.(None): correspondence concerning the use of human subjects.
p.(None):
p.(None): 10. PREPARATION INSTRUCTIONS
p.(None):
p.(None): All materials required by the IRB, including proposal and the AUC proposal application form should be submitted to the
p.(None): Office of the Vice Provost. All materials constituting the informed consent documents should use lay language and be
p.(None): prepared in a manner which will facilitate effective communication with those providing the consent.
p.(None):
p.(None): 11. ADDITIONAL PROTECTIONS FOR SPECIAL POPULATIONS OF SUBJECTS
p.(None):
p.(None): A. Fetuses, Pregnant Women, and Human In Vitro Fertilization
p.(None):
p.(None): General limitations. No activity may begin unless:
p.(None):
p.(None): (1) appropriate studies on animals and non-pregnant individuals have been completed;
p.(None):
p.(None): (2) except where the purpose of the activity is to meet the health needs of the mother or the particular fetus, the
p.(None): risk to the fetus is minimal and, in all cases, is the least possible risk for achieving the objectives of the
p.(None): activity;
p.(None):
p.(None): (3) individuals engaged in the activity will have no part in
p.(None): (i) any decisions as to the timing, method, and procedures used to terminate the pregnancy, and
p.(None): (ii) determining the viability of the fetus at the termination of the pregnancy; and
p.(None):
p.(None): (4) no procedural changes which may cause greater than minimal risk to the fetus or the pregnant woman will be
p.(None): introduced into the procedure for terminating the pregnancy solely in the interest of the activity. No inducements,
p.(None): monetary or otherwise, may be offered to terminate pregnancy for purposes of the activity.
p.(None):
p.(None): Activities directed toward pregnant women as subjects:
p.(None): No pregnant woman may be involved as a subject in an activity unless:
p.(None):
p.(None): (1) the purpose of the activity is to meet the health needs of the mother and the fetus will be placed at risk only to
p.(None): the minimum extent necessary to meet such needs, or (2) the risk to the fetus is minimal.
p.(None):
p.(None): A pregnant woman may be involved as a subject in an activity only if she and the fetus's father are legally competent
p.(None): and have given their informed consent after having been fully informed regarding possible impact on the fetus, except
p.(None): that the father's informed consent need not be secured if:
p.(None):
p.(None): (1) the purpose of the activity is to meet the health needs of the mother;
p.(None):
p.(None): (2) his identity or whereabouts cannot reasonably be ascertained;
p.(None):
p.(None): (3) he is not reasonably available.
p.(None):
p.(None): Activities directed toward fetuses in utero as subjects: no fetus in utero may be involved as a subject in any activity
p.(None): unless:
p.(None):
p.(None): (1) the purpose of the activity is to meet the health needs of the particular fetus and the fetus will be placed at
p.(None): risk only to the minimum extent necessary to meet such needs, or
p.(None):
p.(None): (2) the risk to the fetus imposed by the research is minimal and the purpose of the activity is the development of
p.(None): important biomedical knowledge which cannot be obtained by other means.
p.(None):
p.(None): An activity permitted under this section may be conducted only if the mother and father are legally competent and have
p.(None): given their informed consent, except that the father's consent need not be secured if:
p.(None):
p.(None): (1) his identity or whereabouts cannot reasonably be ascertained,
p.(None):
p.(None): (2) he is not reasonably available. Activities directed toward fetuses ex utero, including nonviable fetuses, as
p.(None): subjects:
p.(None):
p.(None): Until it has been ascertained whether or not a fetus ex utero is viable, a fetus ex utero may not be involved as a
p.(None): subject in an activity unless:
p.(None):
p.(None): (1) there will be no added risk to the fetus resulting from the activity, and the purpose of the activity is the
p.(None): development of important biomedical knowledge which cannot be obtained by other means, or
p.(None):
p.(None): (2) the purpose of the activity is to enhance the possibility of survival of the particular fetus to the point of
p.(None): viability.
p.(None):
p.(None): No nonviable fetus may be involved as a subject in an activity unless:
p.(None):
p.(None): (1) vital functions of the fetus will not be artificially maintained,
p.(None):
p.(None): (2) experimental activities which of themselves would terminate the heartbeat or respiration of the fetus will not be
p.(None): employed, and
p.(None):
p.(None): (3) the purpose of the activity is the development of important biomedical knowledge which cannot be obtained by other
p.(None): means.
p.(None):
p.(None): In the event the fetus ex utero is found to be viable, it may be included as a subject in the activity only to the
p.(None): extent permitted by and in accordance with the requirements of other parts of this section.
p.(None):
p.(None): An activity may be conducted only if the mother and father are legally competent and have given their informed consent,
p.(None): except that the father's informed consent need not be secured if:
p.(None):
p.(None): (1) his identity or whereabouts cannot reasonable be ascertained,
p.(None):
p.(None): (2) he is not reasonably available.
p.(None):
p.(None): Activities Involving the Dead Fetus, Fetal Material, or the Placenta Activities involving the dead fetus, mascerated
p.(None): fetal material, or cells, tissue, or organs excised from a dead fetus shall be conducted only in accordance with any
p.(None): applicable local laws regarding such activities.
p.(None):
p.(None): B. Prisoners
p.(None):
p.(None): Inasmuch as prisoners may be under constraints because of their incarceration which could affect their ability to make
p.(None): a truly voluntary and uncoerced decision whether or not to participate as subjects in research, it is AUC policy to
p.(None): avoid use of prisoners as research subjects. Where this cannot be avoided additional safeguards must be provided for
p.(None): the protection of prisoners involved in research. In this event Principal Investigators must contact the IRB through
p.(None): the Office of the Vice Provost to obtain guidance in regard to development of the research plan and the special
p.(None): requirements of the IRB for such cases.
p.(None):
p.(None): C. Children
p.(None):
p.(None): To What Does This Section Apply?
p.(None):
p.(None): The categories of research listed as "exempt" beginning on page 1 of this Handbook are generally applicable. However
p.(None): the exemption for research involving survey or interview procedures or observations of public behavior does not apply
p.(None): to research involving children, except for research involving observation of public behavior when the investigator(s)
p.(None): do not participate in the activities being observed.
p.(None):
p.(None): Definitions
p.(None):
...
Searching for indicator fetuses:
(return to top)
p.(None):
p.(None): 8. ARBITRATION
p.(None):
p.(None): Any matters requiring arbitration between the IRB and a principal investigator, or questions not resolved by the IRB,
p.(None): will be referred to the Provost. The Provost or an ad hoc committee appointed by the Provost, will meet with the Board
p.(None): and the principal investigator, seeking a resolution of the differences. They will report their findings to the Board
p.(None): and principal investigator, after which the IRB will meet again to reconsider the matter and render a decision. In no
p.(None): instance may any official of the institution overrule an IRB decision for disapproval.
p.(None):
p.(None): 9. RECORDS RETENTION REQUIREMENTS
p.(None):
p.(None): All records must be retained for at least three years after completion of the research. Records may include such items
p.(None): as research proposals, informed consent documents, progress reports, reports of injuries to subjects, and all related
p.(None): correspondence concerning the use of human subjects.
p.(None):
p.(None): 10. PREPARATION INSTRUCTIONS
p.(None):
p.(None): All materials required by the IRB, including proposal and the AUC proposal application form should be submitted to the
p.(None): Office of the Vice Provost. All materials constituting the informed consent documents should use lay language and be
p.(None): prepared in a manner which will facilitate effective communication with those providing the consent.
p.(None):
p.(None): 11. ADDITIONAL PROTECTIONS FOR SPECIAL POPULATIONS OF SUBJECTS
p.(None):
p.(None): A. Fetuses, Pregnant Women, and Human In Vitro Fertilization
p.(None):
p.(None): General limitations. No activity may begin unless:
p.(None):
p.(None): (1) appropriate studies on animals and non-pregnant individuals have been completed;
p.(None):
p.(None): (2) except where the purpose of the activity is to meet the health needs of the mother or the particular fetus, the
p.(None): risk to the fetus is minimal and, in all cases, is the least possible risk for achieving the objectives of the
p.(None): activity;
p.(None):
p.(None): (3) individuals engaged in the activity will have no part in
p.(None): (i) any decisions as to the timing, method, and procedures used to terminate the pregnancy, and
p.(None): (ii) determining the viability of the fetus at the termination of the pregnancy; and
p.(None):
p.(None): (4) no procedural changes which may cause greater than minimal risk to the fetus or the pregnant woman will be
p.(None): introduced into the procedure for terminating the pregnancy solely in the interest of the activity. No inducements,
...
p.(None): Activities directed toward pregnant women as subjects:
p.(None): No pregnant woman may be involved as a subject in an activity unless:
p.(None):
p.(None): (1) the purpose of the activity is to meet the health needs of the mother and the fetus will be placed at risk only to
p.(None): the minimum extent necessary to meet such needs, or (2) the risk to the fetus is minimal.
p.(None):
p.(None): A pregnant woman may be involved as a subject in an activity only if she and the fetus's father are legally competent
p.(None): and have given their informed consent after having been fully informed regarding possible impact on the fetus, except
p.(None): that the father's informed consent need not be secured if:
p.(None):
p.(None): (1) the purpose of the activity is to meet the health needs of the mother;
p.(None):
p.(None): (2) his identity or whereabouts cannot reasonably be ascertained;
p.(None):
p.(None): (3) he is not reasonably available.
p.(None):
p.(None): Activities directed toward fetuses in utero as subjects: no fetus in utero may be involved as a subject in any activity
p.(None): unless:
p.(None):
p.(None): (1) the purpose of the activity is to meet the health needs of the particular fetus and the fetus will be placed at
p.(None): risk only to the minimum extent necessary to meet such needs, or
p.(None):
p.(None): (2) the risk to the fetus imposed by the research is minimal and the purpose of the activity is the development of
p.(None): important biomedical knowledge which cannot be obtained by other means.
p.(None):
p.(None): An activity permitted under this section may be conducted only if the mother and father are legally competent and have
p.(None): given their informed consent, except that the father's consent need not be secured if:
p.(None):
p.(None): (1) his identity or whereabouts cannot reasonably be ascertained,
p.(None):
p.(None): (2) he is not reasonably available. Activities directed toward fetuses ex utero, including nonviable fetuses, as
p.(None): subjects:
p.(None):
p.(None): Until it has been ascertained whether or not a fetus ex utero is viable, a fetus ex utero may not be involved as a
p.(None): subject in an activity unless:
p.(None):
p.(None): (1) there will be no added risk to the fetus resulting from the activity, and the purpose of the activity is the
p.(None): development of important biomedical knowledge which cannot be obtained by other means, or
p.(None):
p.(None): (2) the purpose of the activity is to enhance the possibility of survival of the particular fetus to the point of
p.(None): viability.
p.(None):
p.(None): No nonviable fetus may be involved as a subject in an activity unless:
p.(None):
p.(None): (1) vital functions of the fetus will not be artificially maintained,
p.(None):
p.(None): (2) experimental activities which of themselves would terminate the heartbeat or respiration of the fetus will not be
p.(None): employed, and
p.(None):
p.(None): (3) the purpose of the activity is the development of important biomedical knowledge which cannot be obtained by other
p.(None): means.
p.(None):
...
Social / Incarcerated
Searching for indicator restricted:
(return to top)
p.(None): techniques.
p.(None):
p.(None): (6) Voice recordings made for research purposes such as investigations of speech defects.
p.(None):
p.(None): (7) Moderate exercise by healthy volunteers.
p.(None):
p.(None): (8) The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
p.(None):
p.(None): (9) Research on individual or group behavior or characteristics of individuals, such as studies of perception,
p.(None): cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the
p.(None): research will not involve stress to subjects.
p.(None):
p.(None): (10) Research on drugs or devices for which an investigational new drug exemption or an investigational device
p.(None): exemption is not required.
p.(None):
p.(None): C. Full Board Review:
p.(None):
p.(None): The IRB schedules meetings as needed to review all proposals which do not fall into the Exempt or Expedited categories.
p.(None): Principal investigators may be invited to attend the meeting to discuss their proposal. Please allow one month for full
p.(None): board review.
p.(None):
p.(None): 3. REVIEW CRITERIA
p.(None):
p.(None): In any review (expedited, exempt, or full board), the reviewers will determine that:
p.(None):
p.(None): (1) Participation of human subjects in the project is justified.
p.(None):
p.(None): (2) Risks to subjects are minimized by using appropriate procedures.
p.(None):
p.(None): (3) Risks are justified in view of anticipated benefits.
p.(None):
p.(None): (4) Selection of subjects is equitable. Justification is required if the subject population is restricted to one gender
p.(None): or ethnic group.
p.(None):
p.(None): (5) Adequate provision is made for confidentiality of data and anonymity of participants in any published record.
p.(None):
p.(None): (6) Adequate provision is made for the rights and welfare of participants who are mentally, physically, economically or
p.(None): educationally disadvantaged.
p.(None):
p.(None): (7) Adequate provision is made for obtaining informed consent of the subjects, including those who may not be literate.
p.(None):
p.(None):
p.(None):
p.(None): 4. OBTAINING INFORMED CONSENT
p.(None):
p.(None): Informed consent will be sought from all prospective subjects (or their legally authorized representatives) unless
p.(None): waived by the IRB. The IRB may waive the requirement of a signed consent form if:
p.(None):
p.(None): (a) this consent form is the only record linking the subject with the research and the principal risk would be
p.(None): potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants
p.(None): documentation linking the subject with the research, and the subject's wishes will govern; or
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.(None): the subject's legally authorized representative, but in any event, the investigator shall give either the subject or
p.(None): the representative adequate opportunity to read it before it is signed; or
p.(None):
p.(None): (b) A "short form" written consent document stating that the elements of informed consent have been presented orally to
p.(None): the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to
p.(None): the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the
p.(None): representative. Only the short form itself is to be signed by the subject or the representative. However, the witness
p.(None): shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy
p.(None): of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the
p.(None): "short form."
p.(None):
p.(None): 5. BASIC ELEMENTS OF INFORMED CONSENT
p.(None):
p.(None): The informed consent of subjects must be obtained by methods that are adequate and appropriate for the situation (see
p.(None): previous section). Informed consent is the agreement obtained from a subject, or from an authorized representative, for
p.(None): the subject's participation in an activity. The agreement, written or oral, entered into by the subject, may include no
p.(None): exculpatory language through which the subject is made to waive, or to appear to waive, any of the subject's legal
p.(None): rights, or to release the investigator, the sponsor, the institution or its agents from liability for negligence. The
p.(None): basic elements of informed consent are:
p.(None):
p.(None): (1) A statement that the study involves research, an explanation of the purposes of the research, and the expected
p.(None): duration of the subject's participation, a description of the procedures to be followed, and identification of any
p.(None): procedures which are experimental;
p.(None):
p.(None): (2) A description of any reasonably foreseeable risks or discomforts to the subject;
p.(None):
p.(None): (3) A description of any benefits to the subject or to others which may reasonably be expected from the research;
p.(None):
p.(None): (4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to
p.(None): the subject;
p.(None):
p.(None): (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be
p.(None): maintained;
p.(None):
p.(None): (6) For research involving more than minimal risk, an explanation as to whether any compensation or medical treatments
p.(None): are available if injury occurs and, if so, what they consist of, or where further information may be obtained; for
p.(None): example: "I understand the University does not provide a research subject with compensation or medical treatment in the
p.(None): event the subject is injured as a result of participation in the research project."
p.(None):
p.(None): (7) An explanation of whom to contact for answers to pertinent questions about the research and research subject's
...
p.(None): research. Such action will be accompanied by a letter to the principal investigator, stating the reason for the action.
p.(None): If unanticipated problems, including noncompliance and termination, involving risks to subjects or others occur, these
p.(None): will be reported to the Secretary of the Department of Health and Human Services.
p.(None):
p.(None): 8. ARBITRATION
p.(None):
p.(None): Any matters requiring arbitration between the IRB and a principal investigator, or questions not resolved by the IRB,
p.(None): will be referred to the Provost. The Provost or an ad hoc committee appointed by the Provost, will meet with the Board
p.(None): and the principal investigator, seeking a resolution of the differences. They will report their findings to the Board
p.(None): and principal investigator, after which the IRB will meet again to reconsider the matter and render a decision. In no
p.(None): instance may any official of the institution overrule an IRB decision for disapproval.
p.(None):
p.(None): 9. RECORDS RETENTION REQUIREMENTS
p.(None):
p.(None): All records must be retained for at least three years after completion of the research. Records may include such items
p.(None): as research proposals, informed consent documents, progress reports, reports of injuries to subjects, and all related
p.(None): correspondence concerning the use of human subjects.
p.(None):
p.(None): 10. PREPARATION INSTRUCTIONS
p.(None):
p.(None): All materials required by the IRB, including proposal and the AUC proposal application form should be submitted to the
p.(None): Office of the Vice Provost. All materials constituting the informed consent documents should use lay language and be
p.(None): prepared in a manner which will facilitate effective communication with those providing the consent.
p.(None):
p.(None): 11. ADDITIONAL PROTECTIONS FOR SPECIAL POPULATIONS OF SUBJECTS
p.(None):
p.(None): A. Fetuses, Pregnant Women, and Human In Vitro Fertilization
p.(None):
p.(None): General limitations. No activity may begin unless:
p.(None):
p.(None): (1) appropriate studies on animals and non-pregnant individuals have been completed;
p.(None):
p.(None): (2) except where the purpose of the activity is to meet the health needs of the mother or the particular fetus, the
p.(None): risk to the fetus is minimal and, in all cases, is the least possible risk for achieving the objectives of the
p.(None): activity;
p.(None):
p.(None): (3) individuals engaged in the activity will have no part in
p.(None): (i) any decisions as to the timing, method, and procedures used to terminate the pregnancy, and
p.(None): (ii) determining the viability of the fetus at the termination of the pregnancy; and
p.(None):
p.(None): (4) no procedural changes which may cause greater than minimal risk to the fetus or the pregnant woman will be
...
Social / Literacy
Searching for indicator literate:
(return to top)
p.(None): exemption is not required.
p.(None):
p.(None): C. Full Board Review:
p.(None):
p.(None): The IRB schedules meetings as needed to review all proposals which do not fall into the Exempt or Expedited categories.
p.(None): Principal investigators may be invited to attend the meeting to discuss their proposal. Please allow one month for full
p.(None): board review.
p.(None):
p.(None): 3. REVIEW CRITERIA
p.(None):
p.(None): In any review (expedited, exempt, or full board), the reviewers will determine that:
p.(None):
p.(None): (1) Participation of human subjects in the project is justified.
p.(None):
p.(None): (2) Risks to subjects are minimized by using appropriate procedures.
p.(None):
p.(None): (3) Risks are justified in view of anticipated benefits.
p.(None):
p.(None): (4) Selection of subjects is equitable. Justification is required if the subject population is restricted to one gender
p.(None): or ethnic group.
p.(None):
p.(None): (5) Adequate provision is made for confidentiality of data and anonymity of participants in any published record.
p.(None):
p.(None): (6) Adequate provision is made for the rights and welfare of participants who are mentally, physically, economically or
p.(None): educationally disadvantaged.
p.(None):
p.(None): (7) Adequate provision is made for obtaining informed consent of the subjects, including those who may not be literate.
p.(None):
p.(None):
p.(None):
p.(None): 4. OBTAINING INFORMED CONSENT
p.(None):
p.(None): Informed consent will be sought from all prospective subjects (or their legally authorized representatives) unless
p.(None): waived by the IRB. The IRB may waive the requirement of a signed consent form if:
p.(None):
p.(None): (a) this consent form is the only record linking the subject with the research and the principal risk would be
p.(None): potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants
p.(None): documentation linking the subject with the research, and the subject's wishes will govern; or
p.(None): (b) the research presents no more than minimal risk of harm to subjects, involving no procedures for which written
p.(None): consent is normally required outside the context of the research. Such a waiver might be appropriate where the research
p.(None): involves minimal risk, the rights and
p.(None):
p.(None): welfare of the subjects are not adversely affected, and the research would not be feasible without the waiver.
p.(None):
...
Social / Women
Searching for indicator women:
(return to top)
p.(None): (Note: all queries about this policy may be directed to Dr. Graham Harman, Chair of the Institutional Review Board for
p.(None): the Protection of Human Subjects, at gharman@aucegypt.edu)
p.(None):
p.(None):
p.(None):
p.(None): Policy and Procedure Regarding Use of Human Subjects in Research
p.(None):
p.(None): 1. GENERAL GUIDELINES
p.(None):
p.(None): The American University in Cairo complies with regulations of the Department of Health and Human Services for the
p.(None): protection of human subjects involved in research (45 CFR 46 as amended and published in the Federal Register on June
p.(None): 18, 1991). AUC applies the principles of protection of human subjects whether or not the research is subject to US
p.(None): regulations or conducted using funding supplied by agencies of the US government.
p.(None):
p.(None): The AUC Institutional Review Board for the Protection of Human Subjects (IRB) is charged with the responsibility of
p.(None): reviewing, prior to its initiation, all research involving human subjects (whether or not funded). The IRB is concerned
p.(None): with justifying the participation of subjects in research and protecting the welfare, rights and privacy of subjects.
p.(None): The IRB is composed of seven members: five from the AUC, and one external community member.
p.(None): Members must be from varying backgrounds and disciplines, and must include both men and women. At least one member must
p.(None): have a primary career base in science and one should be primarily concerned with non-science areas. The members of the
p.(None): IRB will be appointed by the Provost. They will in so far as possible serve during two or more academic years.
p.(None): Institutional support for the work of the IRB is provided by the Office of the Vice Provost. The IRB will have the
p.(None): capacity to add individuals to its ranks as needed on a case-by-case basis to ensure its ability to review proposed
p.(None): research projects fully. Interested parties may obtain the names and qualifications of the current members of the IRB
p.(None): by request to the Office of the Provost.
p.(None):
p.(None): All research (including interviews, surveys, and questionnaires) involving humans as subjects must be reviewed by the
p.(None): IRB. Provisional approval may be granted by the IRB as needed during the design of a project or preparation of a
p.(None): proposal. Full approval must be sought as soon as feasible, and must be obtained before the involvement of human
p.(None): subjects in the project begins.
p.(None):
p.(None): Students making proposals must specify the name of an AUC faculty supervisor responsible for overseeing the research.
p.(None): The same holds for researchers from outside AUC who run proposals through the IRB: they too should list an AUC faculty
p.(None): liaison when making their proposal.
p.(None):
p.(None):
p.(None):
p.(None): 2. TYPES OF REVIEW
p.(None):
p.(None): The IRB will review projects by one of three methods: Exempt, Expedited, and Full Board Review.
p.(None):
p.(None): A. Exempt Review:
p.(None):
p.(None): Certain categories of research qualify for exempt review. Exempt proposals are reviewed and certified by the Chair of
...
p.(None): Any matters requiring arbitration between the IRB and a principal investigator, or questions not resolved by the IRB,
p.(None): will be referred to the Provost. The Provost or an ad hoc committee appointed by the Provost, will meet with the Board
p.(None): and the principal investigator, seeking a resolution of the differences. They will report their findings to the Board
p.(None): and principal investigator, after which the IRB will meet again to reconsider the matter and render a decision. In no
p.(None): instance may any official of the institution overrule an IRB decision for disapproval.
p.(None):
p.(None): 9. RECORDS RETENTION REQUIREMENTS
p.(None):
p.(None): All records must be retained for at least three years after completion of the research. Records may include such items
p.(None): as research proposals, informed consent documents, progress reports, reports of injuries to subjects, and all related
p.(None): correspondence concerning the use of human subjects.
p.(None):
p.(None): 10. PREPARATION INSTRUCTIONS
p.(None):
p.(None): All materials required by the IRB, including proposal and the AUC proposal application form should be submitted to the
p.(None): Office of the Vice Provost. All materials constituting the informed consent documents should use lay language and be
p.(None): prepared in a manner which will facilitate effective communication with those providing the consent.
p.(None):
p.(None): 11. ADDITIONAL PROTECTIONS FOR SPECIAL POPULATIONS OF SUBJECTS
p.(None):
p.(None): A. Fetuses, Pregnant Women, and Human In Vitro Fertilization
p.(None):
p.(None): General limitations. No activity may begin unless:
p.(None):
p.(None): (1) appropriate studies on animals and non-pregnant individuals have been completed;
p.(None):
p.(None): (2) except where the purpose of the activity is to meet the health needs of the mother or the particular fetus, the
p.(None): risk to the fetus is minimal and, in all cases, is the least possible risk for achieving the objectives of the
p.(None): activity;
p.(None):
p.(None): (3) individuals engaged in the activity will have no part in
p.(None): (i) any decisions as to the timing, method, and procedures used to terminate the pregnancy, and
p.(None): (ii) determining the viability of the fetus at the termination of the pregnancy; and
p.(None):
p.(None): (4) no procedural changes which may cause greater than minimal risk to the fetus or the pregnant woman will be
p.(None): introduced into the procedure for terminating the pregnancy solely in the interest of the activity. No inducements,
p.(None): monetary or otherwise, may be offered to terminate pregnancy for purposes of the activity.
p.(None):
p.(None): Activities directed toward pregnant women as subjects:
p.(None): No pregnant woman may be involved as a subject in an activity unless:
p.(None):
p.(None): (1) the purpose of the activity is to meet the health needs of the mother and the fetus will be placed at risk only to
p.(None): the minimum extent necessary to meet such needs, or (2) the risk to the fetus is minimal.
p.(None):
p.(None): A pregnant woman may be involved as a subject in an activity only if she and the fetus's father are legally competent
p.(None): and have given their informed consent after having been fully informed regarding possible impact on the fetus, except
p.(None): that the father's informed consent need not be secured if:
p.(None):
p.(None): (1) the purpose of the activity is to meet the health needs of the mother;
p.(None):
p.(None): (2) his identity or whereabouts cannot reasonably be ascertained;
p.(None):
p.(None): (3) he is not reasonably available.
p.(None):
p.(None): Activities directed toward fetuses in utero as subjects: no fetus in utero may be involved as a subject in any activity
p.(None): unless:
p.(None):
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.(None): that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely
p.(None): to contribute to the subject's well-being, only if:
p.(None):
p.(None): (1) the risk is justified by the anticipated benefit to the subjects;
p.(None):
p.(None): (2) the relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by
p.(None): available alternative approaches; and
p.(None):
p.(None): (3) adequate provisions are made for soliciting the assent of the children and permission of their parents or
p.(None): guardians.
p.(None):
p.(None): Research Involving Greater than Minimal Risk and No Prospect of Direct Benefit to Individual Subjects, but Likely to
p.(None): Yield Generalizable Knowledge about the Subject's Disorder or Condition
p.(None):
p.(None): The IRB will approve projects in which more than minimal risk to children is presented by an intervention or procedure
p.(None): that does not hold out the prospect of direct benefit for the individual
p.(None):
p.(None): subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject, only if:
p.(None):
p.(None): (1) the risk represents a minor increase over minimal risk;
p.(None):
p.(None): (2) the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent
p.(None): in their actual or expected medical, dental, psychological, social, or educational situations;
p.(None):
p.(None): (3) the intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition
p.(None): which is of vital importance for the understanding or amelioration of the subjects' disorder or condition; and
p.(None):
p.(None): (4) adequate provisions are made for soliciting assent of the children and permission of their parents or guardians.
p.(None):
p.(None): Research Not Otherwise Approvable which Presents an Opportunity to Understand, Prevent, or Alleviate a Serious Problem
p.(None): Affecting the Health or Welfare of Children
p.(None):
p.(None): The IRB will approve projects in this category only if:
p.(None):
p.(None): (1) the IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or
p.(None): alleviation of a serious problem affecting the health or welfare of children; and
p.(None):
p.(None): (2) when DHHS funding is sought, the Secretary of DHHS, after consultation with a panel of experts in pertinent
...
Social / education
Searching for indicator education:
(return to top)
p.(None): by request to the Office of the Provost.
p.(None):
p.(None): All research (including interviews, surveys, and questionnaires) involving humans as subjects must be reviewed by the
p.(None): IRB. Provisional approval may be granted by the IRB as needed during the design of a project or preparation of a
p.(None): proposal. Full approval must be sought as soon as feasible, and must be obtained before the involvement of human
p.(None): subjects in the project begins.
p.(None):
p.(None): Students making proposals must specify the name of an AUC faculty supervisor responsible for overseeing the research.
p.(None): The same holds for researchers from outside AUC who run proposals through the IRB: they too should list an AUC faculty
p.(None): liaison when making their proposal.
p.(None):
p.(None):
p.(None):
p.(None): 2. TYPES OF REVIEW
p.(None):
p.(None): The IRB will review projects by one of three methods: Exempt, Expedited, and Full Board Review.
p.(None):
p.(None): A. Exempt Review:
p.(None):
p.(None): Certain categories of research qualify for exempt review. Exempt proposals are reviewed and certified by the Chair of
p.(None): the IRB, working through the Office of the Vice Provost. Please allow one week for exempt reviews. Research activities
p.(None): in which the only involvement of human subjects will be in one or more of the following categories qualify for review
p.(None): under the exempt category:
p.(None):
p.(None): (1) Research conducted in established or commonly accepted educational settings, involving normal educational
p.(None): practices, such as
p.(None): (a) research on regular and special education instructional strategies, or
p.(None): (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom
p.(None): management methods.
p.(None):
p.(None): (2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures,
p.(None): interview procedures or observation of public behavior, unless:
p.(None): (a) Information obtained is recorded in such a manner that human subjects can be identified, directly or through
p.(None): identifiers linked to the subjects; and
p.(None): (b) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of
p.(None): criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. (See
p.(None): however Section 11 below for special considerations required when children are involved.)
p.(None):
p.(None): (3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures,
p.(None): interview procedures or observation of public behavior that is not exempt under paragraph (2) of this section, if:
p.(None): (a) The human subjects are elected or appointed public officials or candidates for public office; or
p.(None): (b) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information
...
p.(None):
p.(None): (2) the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent
p.(None): in their actual or expected medical, dental, psychological, social, or educational situations;
p.(None):
p.(None): (3) the intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition
p.(None): which is of vital importance for the understanding or amelioration of the subjects' disorder or condition; and
p.(None):
p.(None): (4) adequate provisions are made for soliciting assent of the children and permission of their parents or guardians.
p.(None):
p.(None): Research Not Otherwise Approvable which Presents an Opportunity to Understand, Prevent, or Alleviate a Serious Problem
p.(None): Affecting the Health or Welfare of Children
p.(None):
p.(None): The IRB will approve projects in this category only if:
p.(None):
p.(None): (1) the IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or
p.(None): alleviation of a serious problem affecting the health or welfare of children; and
p.(None):
p.(None): (2) when DHHS funding is sought, the Secretary of DHHS, after consultation with a panel of experts in pertinent
p.(None): disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and
p.(None): comment, has determined either:
p.(None): (a) that the research satisfies the conditions of the above categories, or
p.(None): (b) the following:
p.(None): (i) the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a
p.(None): serious problem affecting the health or welfare of children;
p.(None): (ii) the research will be conducted in accordance with sound ethical principles;
p.(None): (iii) adequate provisions are made for soliciting the assent of children and the permission of their parents or
p.(None): guardians.
p.(None):
p.(None): Requirements for Permission by Parents or Guardians and for Assent by Children
p.(None):
p.(None): The IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the
p.(None): judgment of the IRB the children are capable of providing assent. In determining whether children are capable of
p.(None): assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This
...
Searching for indicator educational:
(return to top)
p.(None): capacity to add individuals to its ranks as needed on a case-by-case basis to ensure its ability to review proposed
p.(None): research projects fully. Interested parties may obtain the names and qualifications of the current members of the IRB
p.(None): by request to the Office of the Provost.
p.(None):
p.(None): All research (including interviews, surveys, and questionnaires) involving humans as subjects must be reviewed by the
p.(None): IRB. Provisional approval may be granted by the IRB as needed during the design of a project or preparation of a
p.(None): proposal. Full approval must be sought as soon as feasible, and must be obtained before the involvement of human
p.(None): subjects in the project begins.
p.(None):
p.(None): Students making proposals must specify the name of an AUC faculty supervisor responsible for overseeing the research.
p.(None): The same holds for researchers from outside AUC who run proposals through the IRB: they too should list an AUC faculty
p.(None): liaison when making their proposal.
p.(None):
p.(None):
p.(None):
p.(None): 2. TYPES OF REVIEW
p.(None):
p.(None): The IRB will review projects by one of three methods: Exempt, Expedited, and Full Board Review.
p.(None):
p.(None): A. Exempt Review:
p.(None):
p.(None): Certain categories of research qualify for exempt review. Exempt proposals are reviewed and certified by the Chair of
p.(None): the IRB, working through the Office of the Vice Provost. Please allow one week for exempt reviews. Research activities
p.(None): in which the only involvement of human subjects will be in one or more of the following categories qualify for review
p.(None): under the exempt category:
p.(None):
p.(None): (1) Research conducted in established or commonly accepted educational settings, involving normal educational
p.(None): practices, such as
p.(None): (a) research on regular and special education instructional strategies, or
p.(None): (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom
p.(None): management methods.
p.(None):
p.(None): (2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures,
p.(None): interview procedures or observation of public behavior, unless:
p.(None): (a) Information obtained is recorded in such a manner that human subjects can be identified, directly or through
p.(None): identifiers linked to the subjects; and
p.(None): (b) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of
p.(None): criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. (See
p.(None): however Section 11 below for special considerations required when children are involved.)
p.(None):
p.(None): (3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures,
p.(None): interview procedures or observation of public behavior that is not exempt under paragraph (2) of this section, if:
p.(None): (a) The human subjects are elected or appointed public officials or candidates for public office; or
p.(None): (b) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information
p.(None): will be maintained throughout the research and thereafter.
p.(None):
p.(None): (4) Research, involving the collection or study of existing data, documents, records, pathological specimens, or
p.(None): diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in
p.(None): such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
p.(None):
p.(None): (5) Research and demonstration projects which are conducted by or subject to the approval of department or agency
p.(None): heads, and which are designed to study, evaluate, or otherwise examine:
p.(None): (a) public benefit or service programs;
p.(None): (b) procedures for obtaining benefits or services under those programs;
p.(None): (c) possible changes in or alternatives to those programs or procedures; or
p.(None): (d) possible changes in methods or levels of payment for benefits or services under those programs.
p.(None):
p.(None): (6) Research which is conducted on a collaborative basis with one or more other institutions whose IRB has reviewed and
p.(None): approved the research project and AUC assists with the implementation of activities fully covered by that approval. If
p.(None): the AUC role results in new activity not fully covered by the collaborating institution's IRB approval, or if AUC
...
p.(None):
p.(None): (1) the risk is justified by the anticipated benefit to the subjects;
p.(None):
p.(None): (2) the relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by
p.(None): available alternative approaches; and
p.(None):
p.(None): (3) adequate provisions are made for soliciting the assent of the children and permission of their parents or
p.(None): guardians.
p.(None):
p.(None): Research Involving Greater than Minimal Risk and No Prospect of Direct Benefit to Individual Subjects, but Likely to
p.(None): Yield Generalizable Knowledge about the Subject's Disorder or Condition
p.(None):
p.(None): The IRB will approve projects in which more than minimal risk to children is presented by an intervention or procedure
p.(None): that does not hold out the prospect of direct benefit for the individual
p.(None):
p.(None): subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject, only if:
p.(None):
p.(None): (1) the risk represents a minor increase over minimal risk;
p.(None):
p.(None): (2) the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent
p.(None): in their actual or expected medical, dental, psychological, social, or educational situations;
p.(None):
p.(None): (3) the intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition
p.(None): which is of vital importance for the understanding or amelioration of the subjects' disorder or condition; and
p.(None):
p.(None): (4) adequate provisions are made for soliciting assent of the children and permission of their parents or guardians.
p.(None):
p.(None): Research Not Otherwise Approvable which Presents an Opportunity to Understand, Prevent, or Alleviate a Serious Problem
p.(None): Affecting the Health or Welfare of Children
p.(None):
p.(None): The IRB will approve projects in this category only if:
p.(None):
p.(None): (1) the IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or
p.(None): alleviation of a serious problem affecting the health or welfare of children; and
p.(None):
p.(None): (2) when DHHS funding is sought, the Secretary of DHHS, after consultation with a panel of experts in pertinent
p.(None): disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and
p.(None): comment, has determined either:
p.(None): (a) that the research satisfies the conditions of the above categories, or
p.(None): (b) the following:
...
Social / embryo
Searching for indicator embryo:
(return to top)
p.(None): the subject;
p.(None):
p.(None): (5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be
p.(None): maintained;
p.(None):
p.(None): (6) For research involving more than minimal risk, an explanation as to whether any compensation or medical treatments
p.(None): are available if injury occurs and, if so, what they consist of, or where further information may be obtained; for
p.(None): example: "I understand the University does not provide a research subject with compensation or medical treatment in the
p.(None): event the subject is injured as a result of participation in the research project."
p.(None):
p.(None): (7) An explanation of whom to contact for answers to pertinent questions about the research and research subject's
p.(None): rights, and whom to contact in the event of a research-related injury to the subject; for example: "Questions about the
p.(None): research, my rights, or research-related injuries should be directed to (PI name) at (telephone number)."
p.(None):
p.(None): (8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to
p.(None): which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty
p.(None): or loss of benefits to which the subject is otherwise entitled.
p.(None):
p.(None): When appropriate, one or more of the following additional elements of informed consent shall also be provided to each
p.(None): subject:
p.(None):
p.(None): (1) A statement that a particular treatment or procedure may involve risks to the subject (or to the embryo or fetus,
p.(None): if the subject is or may become pregnant) which are currently unforeseeable;
p.(None):
p.(None): (2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without
p.(None): regard to the subject's consent;
p.(None):
p.(None): (3) Any additional costs to the subject that may result from participation in the research;
p.(None):
p.(None): (4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of
p.(None): participation by the subject;
p.(None):
p.(None): (5) A statement that significant new findings developed during the course of the research which may relate to the
p.(None): subject's willingness to continue participation will be provided to the subject; and
p.(None):
p.(None): (6) The approximate number of subjects involved in the study.
p.(None):
p.(None): 6. CONTINUING REVIEW
p.(None):
p.(None): In its initial review of a proposal, the IRB will consider the extent of continuing review needed. All ongoing projects
p.(None): shall be reviewed annually, but in certain research the subjects are exposed to more than usual risk; such projects
p.(None): will be reviewed at more frequent intervals consistent with the research. This review interval will be determined at
p.(None): the time the research is approved and may be changed at the discretion of the IRB. In each such review, the principal
p.(None):
p.(None): investigator will be required to promptly report the status of the research activity, and any proposed changes in the
p.(None): research activity. If the research is still in progress, the investigator will affirm that the approved research
...
Social / gender
Searching for indicator gender:
(return to top)
p.(None):
p.(None): (6) Voice recordings made for research purposes such as investigations of speech defects.
p.(None):
p.(None): (7) Moderate exercise by healthy volunteers.
p.(None):
p.(None): (8) The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
p.(None):
p.(None): (9) Research on individual or group behavior or characteristics of individuals, such as studies of perception,
p.(None): cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the
p.(None): research will not involve stress to subjects.
p.(None):
p.(None): (10) Research on drugs or devices for which an investigational new drug exemption or an investigational device
p.(None): exemption is not required.
p.(None):
p.(None): C. Full Board Review:
p.(None):
p.(None): The IRB schedules meetings as needed to review all proposals which do not fall into the Exempt or Expedited categories.
p.(None): Principal investigators may be invited to attend the meeting to discuss their proposal. Please allow one month for full
p.(None): board review.
p.(None):
p.(None): 3. REVIEW CRITERIA
p.(None):
p.(None): In any review (expedited, exempt, or full board), the reviewers will determine that:
p.(None):
p.(None): (1) Participation of human subjects in the project is justified.
p.(None):
p.(None): (2) Risks to subjects are minimized by using appropriate procedures.
p.(None):
p.(None): (3) Risks are justified in view of anticipated benefits.
p.(None):
p.(None): (4) Selection of subjects is equitable. Justification is required if the subject population is restricted to one gender
p.(None): or ethnic group.
p.(None):
p.(None): (5) Adequate provision is made for confidentiality of data and anonymity of participants in any published record.
p.(None):
p.(None): (6) Adequate provision is made for the rights and welfare of participants who are mentally, physically, economically or
p.(None): educationally disadvantaged.
p.(None):
p.(None): (7) Adequate provision is made for obtaining informed consent of the subjects, including those who may not be literate.
p.(None):
p.(None):
p.(None):
p.(None): 4. OBTAINING INFORMED CONSENT
p.(None):
p.(None): Informed consent will be sought from all prospective subjects (or their legally authorized representatives) unless
p.(None): waived by the IRB. The IRB may waive the requirement of a signed consent form if:
p.(None):
p.(None): (a) this consent form is the only record linking the subject with the research and the principal risk would be
p.(None): potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants
p.(None): documentation linking the subject with the research, and the subject's wishes will govern; or
...
Social / parents
Searching for indicator parent:
(return to top)
p.(None): the protection of prisoners involved in research. In this event Principal Investigators must contact the IRB through
p.(None): the Office of the Vice Provost to obtain guidance in regard to development of the research plan and the special
p.(None): requirements of the IRB for such cases.
p.(None):
p.(None): C. Children
p.(None):
p.(None): To What Does This Section Apply?
p.(None):
p.(None): The categories of research listed as "exempt" beginning on page 1 of this Handbook are generally applicable. However
p.(None): the exemption for research involving survey or interview procedures or observations of public behavior does not apply
p.(None): to research involving children, except for research involving observation of public behavior when the investigator(s)
p.(None): do not participate in the activities being observed.
p.(None):
p.(None): Definitions
p.(None):
p.(None): "Children" are persons who have not attained the legal age for consent to treatments or procedures involved in the
p.(None): research, under the applicable law of the jurisdiction in which the research will be conducted.
p.(None):
p.(None): "Assent" means a child's affirmative agreement to participate in research. Mere failure to object should not, absent
p.(None): affirmative agreement, be construed as assent.
p.(None):
p.(None): "Permission" means the agreement of parent(s) or guardian to the participation of their child or ward in research.
p.(None):
p.(None): "Parent" means a child's biological or adoptive parent.
p.(None):
p.(None): "Guardian" means an individual who is authorized under applicable State or local law to consent on behalf of a child to
p.(None): general medical care.
p.(None):
p.(None): Research Not Involving Greater than Minimal Risk
p.(None):
p.(None): The IRB will approve projects in which no greater than minimal risk to children is presented, only if adequate
p.(None): provisions are made for soliciting the assent of the children and the permission of their parents or guardians.
p.(None):
p.(None): Research Involving Greater than Minimal Risk but Presenting the Prospect of Direct Benefit to the Individual Subjects
p.(None):
p.(None): The IRB will approve projects in which more than minimal risk to children is presented by an intervention or procedure
p.(None): that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely
p.(None): to contribute to the subject's well-being, only if:
p.(None):
p.(None): (1) the risk is justified by the anticipated benefit to the subjects;
p.(None):
p.(None): (2) the relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by
...
p.(None): assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This
p.(None): judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the
p.(None): IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they
p.(None): cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of
p.(None): direct benefit that is important to the health or well- being of the children and is available only in the context of
p.(None): the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the
p.(None): IRB determines that the subjects are capable of assenting, the IRB may still waive the assent
p.(None):
p.(None): requirement under circumstances in which consent may be waived in accordance with general informed consent provisions.
p.(None):
p.(None): In addition, the IRB shall determine that adequate provisions are made for soliciting the permission of each child's
p.(None): parents or guardian. Where parental permission is to be obtained, the IRB may find that permission of one parent is
p.(None): sufficient for research involving minimal risk or for research involving greater than minimal risk but presenting the
p.(None): prospect of direct benefit to the individual subjects. For research involving greater risk and no prospect of direct
p.(None): benefit to subjects, permission is to be obtained from both parents, unless one parent is deceased, unknown,
p.(None): incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of
p.(None): the child.
p.(None):
p.(None): If the IRB determines that a research protocol is designed for conditions or for a subject population for which
p.(None): parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or
p.(None): abused children), it may waive the consent requirements, provided an appropriate mechanism for protecting the children
p.(None): who will participate as subjects in the research is substituted, and provided further that the waiver is not
p.(None): inconsistent with Federal, State, or local law. The choice of an appropriate mechanism would depend upon the nature and
p.(None): purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and
p.(None): their age, maturity, status, and condition.
p.(None):
p.(None): Permission by parents or guardians shall be documented.
p.(None):
p.(None): When the IRB determines that assent is required, it shall also determine whether and how assent must be documented.
p.(None):
p.(None): Wards
p.(None):
p.(None): Children who are wards of the State or any other agency, institution, or entity can be included in research only if
p.(None): such research is:
p.(None):
p.(None): (1) related to their status as wards; or
p.(None):
...
Searching for indicator parents:
(return to top)
p.(None): research, under the applicable law of the jurisdiction in which the research will be conducted.
p.(None):
p.(None): "Assent" means a child's affirmative agreement to participate in research. Mere failure to object should not, absent
p.(None): affirmative agreement, be construed as assent.
p.(None):
p.(None): "Permission" means the agreement of parent(s) or guardian to the participation of their child or ward in research.
p.(None):
p.(None): "Parent" means a child's biological or adoptive parent.
p.(None):
p.(None): "Guardian" means an individual who is authorized under applicable State or local law to consent on behalf of a child to
p.(None): general medical care.
p.(None):
p.(None): Research Not Involving Greater than Minimal Risk
p.(None):
p.(None): The IRB will approve projects in which no greater than minimal risk to children is presented, only if adequate
p.(None): provisions are made for soliciting the assent of the children and the permission of their parents or guardians.
p.(None):
p.(None): Research Involving Greater than Minimal Risk but Presenting the Prospect of Direct Benefit to the Individual Subjects
p.(None):
p.(None): The IRB will approve projects in which more than minimal risk to children is presented by an intervention or procedure
p.(None): that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely
p.(None): to contribute to the subject's well-being, only if:
p.(None):
p.(None): (1) the risk is justified by the anticipated benefit to the subjects;
p.(None):
p.(None): (2) the relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by
p.(None): available alternative approaches; and
p.(None):
p.(None): (3) adequate provisions are made for soliciting the assent of the children and permission of their parents or
p.(None): guardians.
p.(None):
p.(None): Research Involving Greater than Minimal Risk and No Prospect of Direct Benefit to Individual Subjects, but Likely to
p.(None): Yield Generalizable Knowledge about the Subject's Disorder or Condition
p.(None):
p.(None): The IRB will approve projects in which more than minimal risk to children is presented by an intervention or procedure
p.(None): that does not hold out the prospect of direct benefit for the individual
p.(None):
p.(None): subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject, only if:
p.(None):
p.(None): (1) the risk represents a minor increase over minimal risk;
p.(None):
p.(None): (2) the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent
p.(None): in their actual or expected medical, dental, psychological, social, or educational situations;
p.(None):
p.(None): (3) the intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition
p.(None): which is of vital importance for the understanding or amelioration of the subjects' disorder or condition; and
p.(None):
p.(None): (4) adequate provisions are made for soliciting assent of the children and permission of their parents or guardians.
p.(None):
p.(None): Research Not Otherwise Approvable which Presents an Opportunity to Understand, Prevent, or Alleviate a Serious Problem
p.(None): Affecting the Health or Welfare of Children
p.(None):
p.(None): The IRB will approve projects in this category only if:
p.(None):
p.(None): (1) the IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or
p.(None): alleviation of a serious problem affecting the health or welfare of children; and
p.(None):
p.(None): (2) when DHHS funding is sought, the Secretary of DHHS, after consultation with a panel of experts in pertinent
p.(None): disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and
p.(None): comment, has determined either:
p.(None): (a) that the research satisfies the conditions of the above categories, or
p.(None): (b) the following:
p.(None): (i) the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a
p.(None): serious problem affecting the health or welfare of children;
p.(None): (ii) the research will be conducted in accordance with sound ethical principles;
p.(None): (iii) adequate provisions are made for soliciting the assent of children and the permission of their parents or
p.(None): guardians.
p.(None):
p.(None): Requirements for Permission by Parents or Guardians and for Assent by Children
p.(None):
p.(None): The IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the
p.(None): judgment of the IRB the children are capable of providing assent. In determining whether children are capable of
p.(None): assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This
p.(None): judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the
p.(None): IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they
p.(None): cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of
p.(None): direct benefit that is important to the health or well- being of the children and is available only in the context of
p.(None): the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the
p.(None): IRB determines that the subjects are capable of assenting, the IRB may still waive the assent
p.(None):
p.(None): requirement under circumstances in which consent may be waived in accordance with general informed consent provisions.
p.(None):
p.(None): In addition, the IRB shall determine that adequate provisions are made for soliciting the permission of each child's
p.(None): parents or guardian. Where parental permission is to be obtained, the IRB may find that permission of one parent is
p.(None): sufficient for research involving minimal risk or for research involving greater than minimal risk but presenting the
p.(None): prospect of direct benefit to the individual subjects. For research involving greater risk and no prospect of direct
p.(None): benefit to subjects, permission is to be obtained from both parents, unless one parent is deceased, unknown,
p.(None): incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of
p.(None): the child.
p.(None):
p.(None): If the IRB determines that a research protocol is designed for conditions or for a subject population for which
p.(None): parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or
p.(None): abused children), it may waive the consent requirements, provided an appropriate mechanism for protecting the children
p.(None): who will participate as subjects in the research is substituted, and provided further that the waiver is not
p.(None): inconsistent with Federal, State, or local law. The choice of an appropriate mechanism would depend upon the nature and
p.(None): purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and
p.(None): their age, maturity, status, and condition.
p.(None):
p.(None): Permission by parents or guardians shall be documented.
p.(None):
p.(None): When the IRB determines that assent is required, it shall also determine whether and how assent must be documented.
p.(None):
p.(None): Wards
p.(None):
p.(None): Children who are wards of the State or any other agency, institution, or entity can be included in research only if
p.(None): such research is:
p.(None):
p.(None): (1) related to their status as wards; or
p.(None):
p.(None): (2) conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children
p.(None): involved as subjects are not wards.
p.(None):
p.(None): If the research is approved, the IRB shall require appointment of an advocate for each child who is a ward, in addition
p.(None): to any other individual acting on behalf of the child as guardian or in loco parentis. One individual may serve as
p.(None): advocate for more than one child. The advocate shall be an individual who has the background and experience to act in,
p.(None): and agrees to act in, the best interests of the child for the duration of the child's participation in the research and
p.(None): who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the
...
General/Other / Manipulable
Searching for indicator manipulate:
(return to top)
p.(None): distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the
p.(None): subject's privacy. It also includes such procedures as weighing, the testing of sensory acuity, electrocardiography,
p.(None): electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and
p.(None): electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (for example,
p.(None): x-rays, microwaves).
p.(None):
p.(None): (4) Acquisition of blood samples by finger pricking for collection of blood droplets or smears, from subjects 18 years
p.(None): of age or older and who are in good health and not pregnant.
p.(None):
p.(None): (5) Collection of both supra- and subgingival dental plaque and calculus, provided the procedure is not more invasive
p.(None): than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic
p.(None): techniques.
p.(None):
p.(None): (6) Voice recordings made for research purposes such as investigations of speech defects.
p.(None):
p.(None): (7) Moderate exercise by healthy volunteers.
p.(None):
p.(None): (8) The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
p.(None):
p.(None): (9) Research on individual or group behavior or characteristics of individuals, such as studies of perception,
p.(None): cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the
p.(None): research will not involve stress to subjects.
p.(None):
p.(None): (10) Research on drugs or devices for which an investigational new drug exemption or an investigational device
p.(None): exemption is not required.
p.(None):
p.(None): C. Full Board Review:
p.(None):
p.(None): The IRB schedules meetings as needed to review all proposals which do not fall into the Exempt or Expedited categories.
p.(None): Principal investigators may be invited to attend the meeting to discuss their proposal. Please allow one month for full
p.(None): board review.
p.(None):
p.(None): 3. REVIEW CRITERIA
p.(None):
p.(None): In any review (expedited, exempt, or full board), the reviewers will determine that:
p.(None):
p.(None): (1) Participation of human subjects in the project is justified.
p.(None):
p.(None): (2) Risks to subjects are minimized by using appropriate procedures.
p.(None):
p.(None): (3) Risks are justified in view of anticipated benefits.
p.(None):
p.(None): (4) Selection of subjects is equitable. Justification is required if the subject population is restricted to one gender
p.(None): or ethnic group.
p.(None):
p.(None): (5) Adequate provision is made for confidentiality of data and anonymity of participants in any published record.
p.(None):
p.(None): (6) Adequate provision is made for the rights and welfare of participants who are mentally, physically, economically or
p.(None): educationally disadvantaged.
p.(None):
...
General/Other / common rule
Searching for indicator 45XcfrX46:
(return to top)
p.(None): (Note: all queries about this policy may be directed to Dr. Graham Harman, Chair of the Institutional Review Board for
p.(None): the Protection of Human Subjects, at gharman@aucegypt.edu)
p.(None):
p.(None):
p.(None):
p.(None): Policy and Procedure Regarding Use of Human Subjects in Research
p.(None):
p.(None): 1. GENERAL GUIDELINES
p.(None):
p.(None): The American University in Cairo complies with regulations of the Department of Health and Human Services for the
p.(None): protection of human subjects involved in research (45 CFR 46 as amended and published in the Federal Register on June
p.(None): 18, 1991). AUC applies the principles of protection of human subjects whether or not the research is subject to US
p.(None): regulations or conducted using funding supplied by agencies of the US government.
p.(None):
p.(None): The AUC Institutional Review Board for the Protection of Human Subjects (IRB) is charged with the responsibility of
p.(None): reviewing, prior to its initiation, all research involving human subjects (whether or not funded). The IRB is concerned
p.(None): with justifying the participation of subjects in research and protecting the welfare, rights and privacy of subjects.
p.(None): The IRB is composed of seven members: five from the AUC, and one external community member.
p.(None): Members must be from varying backgrounds and disciplines, and must include both men and women. At least one member must
p.(None): have a primary career base in science and one should be primarily concerned with non-science areas. The members of the
p.(None): IRB will be appointed by the Provost. They will in so far as possible serve during two or more academic years.
p.(None): Institutional support for the work of the IRB is provided by the Office of the Vice Provost. The IRB will have the
p.(None): capacity to add individuals to its ranks as needed on a case-by-case basis to ensure its ability to review proposed
p.(None): research projects fully. Interested parties may obtain the names and qualifications of the current members of the IRB
p.(None): by request to the Office of the Provost.
p.(None):
...
Orphaned Trigger Words
p.(None):
p.(None):
p.(None):
p.(None): 4. OBTAINING INFORMED CONSENT
p.(None):
p.(None): Informed consent will be sought from all prospective subjects (or their legally authorized representatives) unless
p.(None): waived by the IRB. The IRB may waive the requirement of a signed consent form if:
p.(None):
p.(None): (a) this consent form is the only record linking the subject with the research and the principal risk would be
p.(None): potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants
p.(None): documentation linking the subject with the research, and the subject's wishes will govern; or
p.(None): (b) the research presents no more than minimal risk of harm to subjects, involving no procedures for which written
p.(None): consent is normally required outside the context of the research. Such a waiver might be appropriate where the research
p.(None): involves minimal risk, the rights and
p.(None):
p.(None): welfare of the subjects are not adversely affected, and the research would not be feasible without the waiver.
p.(None):
p.(None): The waiver of a written informed consent document does not waive the need for subjects to give their informed consent.
p.(None): Subjects should be presented with an oral description of the research and other pertinent items from "The Basic
p.(None): Elements of Informed Consent.”
p.(None):
p.(None): A description of the nature of the oral presentation must be submitted to the IRB. Documented informed consent will
p.(None): consist of a written consent form approved by the IRB and signed by the subject or the subject's authorized
p.(None): representative. A copy shall be given to the person signing the form.
p.(None):
p.(None): The signed consent forms and summaries shall be kept in the investigator's confidential file for at least three years
p.(None): beyond the end date of the project. The consent form may be either of the following:
p.(None):
p.(None): (a) A written consent document that embodies the elements of informed consent. This form may be read to the subject or
p.(None): the subject's legally authorized representative, but in any event, the investigator shall give either the subject or
p.(None): the representative adequate opportunity to read it before it is signed; or
p.(None):
p.(None): (b) A "short form" written consent document stating that the elements of informed consent have been presented orally to
p.(None): the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to
p.(None): the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the
p.(None): representative. Only the short form itself is to be signed by the subject or the representative. However, the witness
p.(None): shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy
p.(None): of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the
p.(None): "short form."
p.(None):
p.(None): 5. BASIC ELEMENTS OF INFORMED CONSENT
p.(None):
p.(None): The informed consent of subjects must be obtained by methods that are adequate and appropriate for the situation (see
p.(None): previous section). Informed consent is the agreement obtained from a subject, or from an authorized representative, for
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| 45XcfrX46 | common rule |
| age | Age |
| child | Child |
| children | Child |
| cognitive | Cognitive Impairment |
| criminal | criminal |
| drug | Drug Usage |
| education | education |
| educational | education |
| embryo | embryo |
| ethnic | Ethnicity |
| fetus | Fetus/Neonate |
| fetuses | Fetus/Neonate |
| gender | gender |
| healthy volunteers | Healthy People |
| injured | injured |
| language | Linguistic Proficiency |
| literate | Literacy |
| manipulate | Manipulable |
| mentally | Mentally Disabled |
| minor | Youth/Minors |
| parent | parents |
| parents | parents |
| physically | Physically Disabled |
| pregnant | Pregnant |
| prisoners | Criminal Convictions |
| restricted | Incarcerated |
| sensory | sensory impairment |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| child | ['children'] |
| children | ['child'] |
| education | ['educational'] |
| educational | ['education'] |
| fetus | ['fetuses'] |
| fetuses | ['fetus'] |
| parent | ['parents'] |
| parents | ['parent'] |
Trigger Words
capacity
consent
ethics
harm
protect
protection
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input