INSTITUTIONAL REVIEW BOARD – UNIVERSITY OF WEST GEORGIA |
BOARD MEMBERS |
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| Jane Simpson, Legal Advisor University Counsel |
Myrna Gantner College of Education |
| Kathryn Grams College of Arts and Sciences |
Cher Hendricks College of Education |
| Jack Jenkins, Special Associate to the President Minority Affairs |
Karen Kagiyama St. Andrews Methodist Church |
| Kareen Malone College of Arts and Sciences |
Abbot Packard College of Education |
| Michael Aldrich, Chair Academic Affairs |
John Storer, Director Sponsored Operations |
| Salil Talpade Richards College of Business |
Satyanarayana Swamy-Mruthinti College of Arts and Sciences |
| 1) the application clearly states the nature and purpose of
the study; |
| 2) the application clearly states the procedures that will be
used in conducting the study so that level of risk can be determined; |
| 3) the procedures are appropriate for the proposed study and
are designed to minimize risk of harm to participating subjects; |
| 4) any risks that do exist are reasonable in relation to the
anticipated benefits; |
| 5) safeguards are in place in the event that subjects may
experience harm (e.g., counselor on site, EMT or other health care
provider on site, researchers trained in emergency response procedures,
etc.); |
| 6) selection of subjects is equitable; |
| 7) procedures are in place to obtain and document informed
assent (agreement by the subject) and/or consent (agreement by someone
who legally speaks in the subject’s behalf, such as a parent or
guardian) from each participant and/or his/her parent or guardian; |
| 8) data collection procedures will be monitored to insure the
safety and well-being of subjects; |
| 9) subjects’ privacy will be protected and proper mechanisms
will be in place to protect the confidentiality of the data; and |
| 10) additional safeguards will be put in place as required by federal law to protect the rights, safety and welfare of subjects from “vulnerable populations,” defined as minor children, prisoners, pregnant women, disabled persons, and persons who are economically or educationally disadvantaged. |
1) research conducted in established educational settings
involving normal educational practices, such as research on regular and
special education instructional strategies or research on the
effectiveness of or the comparison among instructional techniques,
curricula, or classroom management methods.
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2) research involving the use of educational tests
(cognitive, diagnostic, aptitude, achievement), survey procedures,
interview procedures or observation of public behavior, unless the
information obtained is recorded in such a manner that human subjects
can be identified, directly or indirectly, and/or any disclosure of the
subjects’ responses outside the research project could reasonably place
the subjects at risk of criminal or civil liability or be damaging to
the subjects’ financial standing, employability, or reputation.
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| 3) research involving the use of educational tests
(cognitive, diagnostic, aptitude, achievement), survey procedures,
interview procedures, or observation of public behavior that is not
exempt under paragraph (2) if the subjects are elected or appointed
public officials or candidates for public office, or federal statutes
require without exception that the confidentiality of personally
identifiable information will be maintained during and after the
research. |
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| 4) research involving the collection or study of existing
data, documents, records, pathological specimens, or diagnostic
specimens if these sources are publicly available or if the information
is recorded in such a manner that subjects cannot be identified
directly or indirectly. |
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| 5) research and demonstration projects which are conducted by
or subject to the approval of agency heads and which are designed to
study, evaluate or otherwise examine public benefit or service
programs, procedures for obtaining benefits or services under those
programs, possible changes in or alternatives to those programs or
procedures, or possible changes in methods or levels of payment for
benefits or services under those programs. |
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| 6) research involving taste and food quality evaluation and consumer acceptance if wholesome foods without additives are consumed or if food is consumed that contains an ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspections Service of the U. S. Department of Agriculture. |
| 1) clinical studies of drugs and medical devices when an
investigational new drug application is not required or an
investigational device exemption application is not required, or the
medical device is cleared/approved for marketing and is being used in
accordance with its cleared/approved purpose. |
| 2) Collection of blood samples by finger stick, heel stick,
ear stick, or venipuncture from healthy, non-pregnant adults who weigh
at least 110 pounds, or from other adults and children, considering the
age, weight, and health of the subjects, the collection procedure, the
amount of blood to be collected, and the frequency with which it will
be collected. |
| 3) Collection of biological specimens for research purposes
by noninvasive means (ex: hair and nail clippings, extracted teeth,
sweat, saliva, etc.). |
| 4) Collection of data through noninvasive procedures
routinely employed in clinical practice, excluding x-rays or microwaves
(ex: physical sensors applied to the surface of the body or at a
distance, weighing, testing sensory acuity, MRI, EKG, EEG,
thermography, naturally occurring radioactivity, electroretinography,
ultrasound, diagnostic infrared imaging, Doppler blood flow,
echocardiography, moderate exercise, muscular strength testing, body
composition assessment, flexibility testing as appropriate to the age,
weight and health of the persoon). |
| 5) Research involving materials (data, documents, records, or
specimens) that have been collected or will be collected solely for
nonresearch purposes. |
| 6) Collection of data from voice, video, digital, or image
recordings made for research purposes. |
| 7) Research on individual or group characteristics or
behavior (ex: perception, cognition, motivation, identity, language,
communication, cultural beliefs or practices, and social behavior) or
research employing survey, interview, oral history, focus group,
program evaluation, human factors evaluation, or quality assurance
methodologies if such research is not exempt from human subjects review. |
| 8) Continuing review of research previously approved by the
IRB. |
| 9) Continuing review of research not conducted under an investigational new drug application or investigational device exemption where other categories do not apply but the IRB has determined that the research involves no greater than minimal risk. |
| 1) a statement that the study involves research, an
explanation of the purposes of such research, the expected duration of
the subject’s participation, a description of the procedures to be
followed, and identification of any procedures which are experimental; |
| 2) a description of any reasonably foreseeable risks or
discomforts to the subject; |
| 3) a description of any benefits to the subject or to others
which may reasonably be expected from the research; |
| 4) a disclosure of appropriate alternative procedures or
courses of treatment, if any, that might be beneficial to the subject; |
| 5) a statement describing the extent, if any, to which
confidentiality of records identifying the subject will be maintained; |
| 6) for research involving more than minimal risk, an
explanation as to whether any compensation and an explanation as to
whether any medical treatments are available if injury occurs, and, if
so, what they consist of, or where further information may be obtained; |
| 7) an explanation of whom to contact for answers to pertinent
questions about the research and research subjects’ rights, and whom to
contact in the event of a research-related injury; and |
| 8) a statement that participation is voluntary, refusal to
participate will involve no penalty or loss of benefits to which the
subject is otherwise entitled, and the subject may discontinue
participation at any time without penalty or loss of benefits to which
he/she is otherwise entitled. |
| 1) a statement that the particular treatment or procedure may
involve risks to the subject which are currently unforeseeable; |
| 2) anticipated circumstances under which the subject’s
participation may be terminated by the investigator without regard to
the subject’s consent; |
| 3) any additional costs to the subject that may result from
participation in the research; |
| 4) the consequences of a subject’s decision to withdraw from
the research and procedures for orderly termination of participation by
the subject; |
| 5) a statement that significant new findings developed during
the course of the research which may relate to the subject’s
willingness to continue participation will be provided to the subject;
and |
| 6) the approximate number of subjects involved in the study. |
| 1) the research is to be conducted by or subject to the
approval of state or local government officials and is designed to
study, evaluate, or otherwise examine public benefit or service
programs, procedures for obtaining benefits or services under those
programs, possible changes in or alternatives to those
programs/procedures, or possible changes in methods or levels of
payment for benefits or services under those programs; |
| 2) the research could not practicably be carried out without
the waiver or modification; |
| 3) the research involves no more than minimal risk to
subjects; |
| 4) the waiver or modification will not adversely affect the
rights and welfare of the subjects; |
| 5) when appropriate, the subjects will be provided with
additional pertinent information after participation; |
| 6) the only record linking the subject and the research would
be the consent document and the principal risk would be potential harm
resulting from a breach of confidentiality; and |
| 7) the research presents no more than minimal risk of harm to
subjects and involves no procedures for which written consent is
normally required outside of the research context. |
| 1) the activity is a one-time event or a series of events
(certain number of hours) engaged in to fulfill a course requirement
(ex: interview a resident in a nursing home, spend time tutoring
children in an after school program); |
| 2) the activity is systematic but does not require the
subjects to do anything different than what they would normally be
doing (ex: observe instructional technique in a particular classroom,
help teach a new curriculum and monitor scores on exams; observe a
group); |
| 3) the activity does not involve vulnerable populations, does
not involve invasive procedures, participation and stopping
participation are completely voluntary, topics covered are not of
sensitive nature, and participation is anonymous and confidential (ex:
phone survey of adults in selected households regarding product
preferences); |
| 4) the activity involves traditional educational instruction,
educational testing, surveys, interviews, or observation of public
behavior and meets the requirements in # 3, where there are no
treatment and control groups or other system whereby any subject may
potentially be disadvantaged, and, if minor children are involved, the
activity is not one which would normally require parental consent; |
| 5) data, documents or other information is publicly available
or was collected for use other than research and no personal
identifiers will be attached; |
| 6) the project is being conducted by or has been approved by
an agency head for the purpose of studying or evaluating public benefit
programs and their associated procedures (ex: request by a local, state
or federal official for a study to evaluate the effectiveness of a
publicly funded program); and |
| 7) the study involves educational tests, surveys, interviews,
or observations of public behavior where individual subjects cannot be
identified, and if they were, such identification would not cause them
any harm, such as damage their reputation, negatively affect their
financial status or employability, or place them at risk for any type
of liability (ex: surveying classmates regarding meal plan preferences,
interviewing athletes regarding practice schedules, observing fan
behavior at an athletic event, etc.). |
| 1) the study involves a vulnerable population; |
| 2) the study involves the selection of treatment and control
groups or otherwise potentially places individuals and/or groups at a
disadvantage; |
| 3) the study involves minor children and procedures that
would require parental consent; |
| 4) the study involves questions of other than an instrumental
nature (ex: alcohol/drug use and abuse, sexual behavior, attitudes
about parental discipline, etc); |
| 5) the study is such that if participants’ involvement were
known it could possibly cause them harm, either physically, mentally,
emotionally, socially, financially, or legally; |
| 6) there is more than minimal risk of harm to subjects; and |
| 7) some degree of deception may be necessary in order to
conduct the study (ex: giving a control group a placebo drug, telling a
control group that a majority of students engage in X behavior when
that really isn’t true to see if it affects their own answers, etc.). |
| 8) the researcher may not be completely able to guarantee
confidentiality (ex: if there is disclosure of actual or potential
danger for self or other; disclosure of child abuse or neglect). |
| 1) Print off the IRB application checklist and be sure your
application packet is complete before submitting it for review. |
| 2) Print off the IRB application and complete every
section. Provide enough information so that it is clear to anyone
reading the application exactly what your study is about, how it will
be conducted, who will be the subjects and how they will be selected,
how confidentiality will be maintained, and how consent will be
obtained. Students and professors in the College of Education
need to check with the school system officials in the location where
they intend to conduct their research and complete any additional forms
and other requirements as instructed. These forms need to be
submitted with your application. |
| 3) Submit three or four copies of the application with
checklist on top to the Office of the Vice President for Academic
Affairs, depending on whether you are a student (four copies) or
independent investigator (three copies). After processing, one
copy is retained for the institution’s files in the Office of Sponsored
Operations, one copy is returned to the supervising professor if the
investigator is a student, and one copy is returned to the
investigator. If there are multiple investigators, please submit
as many extra copies so that each one can have a signed
application. In addition, if the participating agency requests a
copy, please submit an extra copy for that purpose and indicate where
it should be sent after a decision has been made. |
| 4) The VPAA’s Office staff will check in the application and
enter the identifying information into the IRB database. If any
information is missing, the investigator will be notified and asked to
submit the additional material. |
| 5) After the application has been checked in and cleared, it
will be sent to a member of the IRB committee for a preliminary
review. If the committee member determines that it is exempt or
can receive an expedited review, then he/she will indicate such and
return it to the IRB chair for a final review and signature. If
the committee member determines that the application requires a review
of the entire IRB committee, he/she will notify the chair and a meeting
will be scheduled. |
| 6) After a decision has been made by either the full
committee, or by the chair in consultation with another committee
member when a full committee review is not required, the investigator
will be sent a letter notifying him/her of the decision. |
| 7) At the completion of the study, the investigator is
required to submit a report to the IRB chair summarizing the study and
results. This report will be filed with the original application
in the Office of Sponsored Operations. |
| 1)Print off the IRB application checklist and be sure your
application packet is complete before submitting it for review. |
| 2)Print off the IRB application and complete every
section. Provide enough information so that it is clear to anyone
reading the application exactly what your study is about, how it will
be conducted, who will be the subjects and how they will be selected,
how confidentiality will be maintained, and how consent will be
obtained. Students and professors in the College of Education
need to check with the school system officials in the location where
they intend to conduct their research and complete any additional forms
and other requirements as instructed. These forms need to be
submitted with your application. |
| 3)Print off the Exempt Research Study Application, complete
the top part, and check the appropriate box depending on which of the
exempt criteria your study meets. |
| 4)Attach the Exempt Research Study Application to the IRB
Application and submit three or four copies of the application with
checklist on top to the Office of the Vice President for Academic
Affairs, depending on whether you are a student (four copies) or
independent investigator (three copies). After processing, one
copy is retained for the institution’s files in the Office of Sponsored
Operations, one copy is returned to the supervising professor if the
investigator is a student, and one copy is returned to the
investigator. If there are multiple investigators, please submit
as many extra copies so that each one can have a signed
application. In addition, if the participating agency requests a
copy, please submit an extra copy for that purpose and indicate where
it should be sent after a decision has been made. |
| 5) The VPAA’s Office staff will check in the application and
enter the identifying information into the IRB database. If any
information is missing, the investigator will be notified and asked to
submit the additional material. |
| 6) After the application has been checked in and cleared, it will be sent to the Chair of the IRB committee for review and a signature. |
| Informed Consent Form (School) | Adobe PDF | MS Word |
| Informed Consent Form (Minor) | Adobe PDF | MS Word |
| Application | Adobe PDF | MS Word |
| Exempt Research Study Application | Adobe PDF | MS Word |
| IRB Checklist | Adobe PDF | MS Word |
| Metro-Atlanta School System IRB Database | Adobe PDF | MS Word |
| Human Subject Regulations Decisions Chart | Adobe PDF | MS Word |
These guidelines are intended to assist instructors in differentiating pedagogical assignments/projects from research projects.
This differentiation is based on Title 45 Code of Federal Regulations (CFR) Part 46.102(d) where research is defined as a systematic investigation designed to develop or contribute to generalizable knowledge (Federal Register, 56, p. 28013). Dissemination of findings to a scientific audience is a sufficient, but not a necessary, criterion for defining research. Dissemination includes, but is not limited to, honor's, master's, and doctoral theses; presentation at a scientific meeting or conference; submission to or publication, paper or electronic, in a scientific journal; and Internet postings. If the project falls under this definition of research, review and approval of a human participants research protocol by the Institutional Review Board (IRB) is required. Contact the Office for Research Protections (ORP) for guidance regarding the appropriate level of human participants review that must be conducted.
Class-related instructional assignments/projects that do not fit the above criteria do not need to be submitted to the IRB for human participants protection review. If either knowledge contribution or dissemination is a possibility, IRB review and approval must be obtained prior to the involvement of human participants. IRB approval of a research protocol cannot be granted retroactively under any circumstances.
Computer- and internet-based methods of collecting, storing, utilizing, and transmitting data in research involving human participants are developing at a rapid rate. As these new methods become more widespread in research in the social, psychological, and social sciences, they present new challenges to the protection of research participants. The Institutional Review Board (IRB) believes that computer- and internet-based research protocols must address fundamentally the same risks (e.g., violation of privacy, legal risks, psychosocial stress) and provide the same level of protection as any other types of research involving human participants. All studies, including those using computer and internet technologies, must (a) ensure that the procedures fulfill the principles of voluntary participation and informed consent, (b) maintain the confidentiality of information obtained from or about human participants, and (c) adequately address possible risks to participants including psychosocial stress and related risks.
At the same time, the IRB recognizes that computer- and internet-based research presents unique problems and issues involving the protection of human participants. The IRB further recognizes that computer and internet technologies are evolving rapidly, that these advances may pose new challenges to the protection of human participants in research, and that both the IRB and researchers employing new technologies must maintain their diligence in addressing new problems, issues, and risks as they arise in the coming years.
The purpose of these guidelines is to help researchers plan, propose, and implement computer- and internet-based research protocols that provide the same level of protection of human participants as more traditional research methodologies. The guidelines are comprised of requirements and recommendations that are consistent with the basic IRB principles applied to all research involving human participants.