The Institutional Review Board (IRB) is a committee established according to federal regulations and charged with the protection of human research subjects. Guidelines for human subjects research and a description of the IRB are in the faculty handbook which can be accessed using wuinfo. All necessary information to submit a research proposal to the IRB may be obtained from the Chair of the IRB or by requesting it through E-Mail (Pine).
The IRB must assure that risks to subjects are minimized and are reasonable in relation to (1) anticipated benefits to subjects (if any) and (2) the importance of the knowledge that may reasonably be expected to result. Specifically, federal regulations require that risks to subjects are minimized "by using procedures which are consistent with sound research design", among other factors.
The following principles are followed regarding research to be conducted by individuals in which there is minimal risk to subjects: (1) "sound research design" means that the design of the project/study is reasonable and (2) that the individual is responsible for the "soundness" of the research design.
Research proposals (student or faculty) must clearly state how the researcher will assure the confidentiality or anonymity of the human subjects in the reporting of the results of the research. Research involving small numbers of subjects will undergo particular scrutiny in this regard.
| I. | The
Chairperson of the IRB will coordinate the distribution of forms to applicants
and proposals for review to IRB members. |
| II. | Normal
review process. |
| The
IRB meets the first Monday of each month. The Investigator is to submit nine
(9) copies of the application to the Chairperson of the IRB. | |
| Proposals
should be sent to the IRB two (2) weeks before the regular monthly meeting for
review. Proposals received less than two weeks before a regular meeting may be
subject to delay, however, every effort will be made to accommodate the
Investigator. | |
| The
application will be assigned a number, recorded and distributed to IRB members
for review. | |
| The
application will be evaluated, recorded and an "IRB PROPOSAL EVALUATION
form will be returned to the Principle Investigator or the Faculty Supervisor. | |
| The IRB keeps the original application on file along with a copy
of the IRB PROPOSAL EVALUATION. | |
| III. | Expedited
review process. |
| If the
Investigator requests an expedited review, he/she must submit three (3) copies
of the application. The Chairperson of the IRB and one other committee member
will make the evaluation and return the IRB PROPOSAL EVALUATION. If either one
or both decide that the proposal requires full committee review then the
Investigator is notified with a request for six (6) more copies of the proposal
and it will follow the normal review procedure. |
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| I. | All the below are eligible for expedited review
(functionally, this means that a proposal can be reviewed within a week or two
after receipt by the IRB). Research activities involving no more than minimal risk and in which the only involvement of human subjects will be in one or more of the following categories (carried out through standard methods) may be reviewed by the Institutional Review Board through the expedited review procedure authorized in ?46.110 of 45 CFR Part 46. | |
| (1) | Collection of: hair and nail clippings, in a nondisfiguring
manner; deciduous teeth; and permanent teeth if patient care indicates a need
for extraction. | |
| (2) | Collection of excreta and external secretions including sweat,
uncannulated saliva, placenta removed at delivery, and amniotic fluid at the
time of rupture of the membrane prior to or during labor. | |
| (3) | Recording of data
from subjects 18 years of age or older using noninvasive procedures routinely
employed in clinical practice. This includes the use of physical sensors that
are applied either to the surface of the body or at a distance and do not
involve input of matter or significant amounts of energy into the subject or an
invasion of the subject's privacy. It also includes such procedures as
weighing, testing sensory acuity, electrocardiography, electroencephalography,
thermography, detection of naturally occurring radioactivity, diagnostic
echography, and electroretinography. It does not include exposure to
electromagnetic radiation outside the visible range (for example, xrays,
microwaves). | |
| (4) | Collection of blood samples by venipuncture, in amounts not
exceeding 450 milliliters in an eight-week period and no more often than two
times per week, from subjects 18 years of age or older and who are in good
health and not pregnant. | |
| (5) | Collection of both supra- and
subgingival dental plaque and calculus, provided the procedure is not more
invasive than routine prophylactic scaling of the teeth and the process is
accomplished in accordance with accepted prophylactic techniques. | |
| (6) | Voice
recordings made for research purposes such as investigations of speech defects. | |
| (7) | Moderate exercise by healthy volunteers. | |
| (8) | The study of existing data, documents,
records, pathological specimens, or diagnostic specimens. | |
| (9) | Research on
individual or group behavior or characteristics of individuals, such as studies
of perception, cognition, game theory, or test development, where the
investigator does not manipulate subjects' behavior and the research will not
involve stress to subjects. | |
| (10) | Research on drugs or devices for which
an investigational new drug exemption or an investigational device is not
required. | |
| II. | The Institutional Review Board may expedite
research from the requirements of this policy which, in its judgement, involves: | ||
| A. | Normal educational practices, such as: | ||
| 1. | Research on regular and special education instructional strategies; or | ||
| 2. | Research
on the effectiveness of or the comparison among instructional techniques,
curricula, or classroom management methods. | ||
| B. | The use of educational tests (cognitive, diagnostic,
aptitude, achievement), if information taken from these sources is recorded in
such a manner that subjects cannot be identified, directly or through
identifiers linked to the subjects. | ||
| C. | Survey or interview procedures, unless the following conditions exist: | ||
| 1. | information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and | ||
| 2. | any
disclosure of the human subjects' responses outside the research could
reasonably place the subjects at risk of criminal or civil liability or be
damaging to the subjects' financial standing, employability, or reputation. | ||
| D. | The observation (including observation by participants) of public behavior, unless the following conditions exist: | ||
| 1. | Observations are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects; | ||
| 2. | The observations recorded about the individual, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability; and | ||
| 3. | The
research deals with sensitive aspects of the subject's own behavior such as
illegal conduct, drug use, sexual behavior, or use of alcohol. | ||
| E. | 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 by the investigator in such
a manner that subjects cannot be identified, directly or through identifiers
linked to the subjects. | ||
Note: Expedited review and IRB monitoring as described above may not apply to research involving vulnerable populations such as children, prisoners, pregnant women, mentally impaired individuals and fetuses.
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The Department of ______________________ supports the practice of protection for human subjects participating in research. The following information is provided so that you can decide whether you wish to participate in the present study. You should be aware that even if you agree to participate you are free to withdraw at any time, without penalty.
(sample description)
| The study is concerned with the kinds of troubling experience people have had. You will be asked to write anonymously about one troubling experience. You will use 'I' for yourself and will change the names of other people in the narration so that anonymity can be preserved. Your account will be identified only by a code number. At a second session you will be asked to rate it and other people's troubling experiences in several different ways. |
*Insert Liability Statement*
Your participation is solicited, but strictly voluntary. Do not hesitate to ask any questions about the study. Be assured that your name will not be associated in any way with the research findings. We appreciate your cooperation very much.
Sincerely,
(signature)
Name
Principla Investigator
Phone Number |
______________________________________________ _____________ Signature of subject agreeing to participate Date
*Examples of liability statements:
If the investigator and/or IRB consider the subjects to be at physical risk, a statement regarding compensation for possible physical injury must be included in the consent statement. Following are suggested wordings:
| (1) | If the researcher is covered by the University's liability policy, the following: "In the event physical injury results from the research procedures, no medical treatment or monetary compensation is provided by the University. In a very limited number of cases, workers' compensation could be available to University employees injured while participating as subjects. However, generally participants must look to their own health insurance policies or to the Kansas Legislature for compensation for their injuries." |
| (2) | If the researcher is covered by a policy other than the University's, the statement may vary according to the stipulations of the policy. |
| (3) | If the researcher has no compensation available, it may be stated: "No compensation for physical injury that may result from the research is available." |
Tips for IRB Submission
| 1. | Access IRB forms from Department or request copy of
forms from IRB secretary or access by e-mail. | ||
| 2. | Complete Application. | ||
| Check: |
|||
| a. | Is the research proposal considered expedited, or does
it require a full review. | ||
| 1. | If
expedited, submit three copies.
| ||
| 2. | If
full review is necessary or probable, submit nine copies.
| ||
| b. | Check informed consent documentation to be sure: | ||
| 1. | reads
clearly and in a language understandable by the subject population. | ||
| 2. | iforms
subjects of risks and benefits. | ||
| 3. | informs
subject sufficiently of procedures and outcomes to allow an informed decision to
participate. | ||
| 4. | clearly
indicates that subjects may withdraw their participation/involvement at any time
without penalty. | ||
| c. | Procedures for the protection of client
confidentiality must be described in sufficient detail. (note: if anonymity is
indicated the researchers must provide evidence of how the subjects' identify
will be kept anonymous. Anonymity and confidentiality are not the same.
Anonymity requires special protective procedures.) | ||
| d. | If subjects are asked to respond to sensitive
material which could place some subjects at special risk, then it may be
necessary to provide or make available debriefing/referral services should the
subjects experience the need. | ||
| e. | If any organization or agency is involved in the
research (ie., supports the project, receives the information from the research,
sponsors all or part of the research project, provides subject access, provides
staff support, provides documentation used in the sudy, etc.) a letter of
support must accompany the application indicating the agency's commitment and
the nature of the cooperative relationship. | ||
| f. | Typically, agency staff are discouraged from
participating in survey/interview assessments where subjects receive direct
services essential to their well-being from the agency. The rational | ||
| 3. | The IRB committee meets on the 1st Monday of each
month. applications are reviewed which have been received five working days (?)
to the meeting. | ||
| Suggestions | |||
| 1. | If data are to be disseminated in aggregate form, then
the research should so indicate. To some degree the presentation of the
aggregate data provides protection of subject identity and reduces disclosure
where the population size is large.
| ||
| 2. | If single subject designs are to be used, names of
who will be knowledgeable of the subject's identity and how confidentiality will
be protected must be described.
| ||
| 3. | If there are concerns or questions, the researcher
should be aware that each School and the College has representatives as
committee members on the IRB. These individuals may be used as resources to
provide technical assistance in the development of the IRB application.
| ||
| 4. | Some special populations, considered to be at special
risk, may require the researcher to detail special protective procedures. For
example, research with children or developmentally delayed persons will require
special informed consent practices. In some cases it may be necessary to obtain
both guardian and subject consent. In others the use or both written and orally
presented informed consent statements will be necessary. The researcher is
responsible for providing evidence of subject protection and meeting both the
substantive and procedural requirements of informed consent. | ||
| 5. | The IRB reviews applications to insure the protection
of subjects. However, the actual interventions used still need to be described
in sufficient detail to satisfy the reviewers that subject risk is within
acceptable limits. If surveys or assessment instruments are used, these should
be included in the application. | ||
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