| Protocol Review Categories The
Administrative Review Application The
Informed Consent Form Consent of Agencies
PROTOCOL
REVIEW CATEGORIES
Research involving human subjects may not begin until it has been reviewed according to the nature of the risk involved to the human subject and approval is obtained from the institution sponsoring it.
Risk-free research with human subjects is normally reviewed administratively as "exempt from IRB review."
a program is available
to help you determine whether your research is eligible for
Administrative Review (exempt from IRB review); please use
it now if you have
any question about Administrative Review status .
research with minimal and more involved risks to human subjects
is reviewed by the CSULB Institutional Review Board for the
Protection of Human Subjects (IRB)in a Standard
Review or Expedited Review.
ADMINISTRATIVE REVIEW CATEGORY
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Research exempt from IRB Review is defined in Section 3900 of the University policy on the Protection of Human Subjects, as follows:
"Certain types of research activity in which the only involvement of human subjects is in one or more of the following categories are exempt from review by the IRB:
"3910 Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as
(a) research on regular and special education instructional strategies, or (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
"3920 Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless
(a) the information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (b) 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.
"3930 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 of this section, if
(a) the human subjects are elected or appointed public officials or candidates for public office; or (b) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
"3940 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 by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
"3950 Research and demonstration projects which are conducted by or subject to the approval of government agencies, and which are designed to study, evaluate, or otherwise examine
(a) public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternatives to those programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs.
"3960 Taste and food quality evaluation and consumer acceptance studies,
(a) if wholesome foods without additives are consumed or (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 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 Inspection Service of the U.S. Department of Agriculture. [45 CFR 46.101 (b) (1) through (6)]
"3970 Researchers who believe that their projects involving human subjects are exempt included in one or more of the categories enumerated above shall submit to the Director of Research a completed copy of the form developed by the IRB to document such exemption. The Director of Research shall review all such claims of exemption and either approve them or refer them to the chair of the IRB. If the chair of the IRB does not believe that the proposed research is exempt from IRB review, the researcher shall submit a complete protocol for regular or expedited IRB review, as appropriate."
Research under Administrative Review will be reviewed by the Director of Research on behalf of the IRB, and will be approved or referred to a more appropriate category, normally within three instructional days after receipt of one copy of a complete Application in the Office of University Research.
APPLICATION FOR APPROVAL OF ADMINISTRATIVE REVIEW RESEARCH PROTOCOL
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One copy of the Administrative Review Category application must be submitted to the IRB through the Office of University Research. This Application is to include the information described below. All materials must be typed. Incomplete Applications will not be evaluated.
You should obtain forms from the
IRB website . Obtain assistance
from the Office of Research in the Foundation Building, Room
310 (562-985-5314).
I. THE APPLICATION
A. The basis for review and approval of research involving human subjects will be an Application submitted by the researcher. The application is a legal document. Oral statements cannot be accepted for legal purposes. Nevertheless, the administrator \ may ask an applicant to attend a meeting to explain parts of the Application. Answer all questions on the Application fully and completely.
B. Administrative Review Applications are reviewed by the Director, Office of University Research usually within 72 hours of submission in the Office. Applicants who are pressed for time with their research are advised to check with the Office Secretary or the Sr. Assistant Director of University Research well in advance so that vacations and off-campus business do not unnecessarily impede review.
C. Changes or supplemental information added to the Application which are initiated by the researcher after the Application is in review may necessitate withdrawal of the original Application and submission of a new one.
II. INFORMED CONSENT
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A. Definition.1.Three major ethical concerns underlie the requirements for Informed Consent. All three must be dealt with in the documentation and process of obtaining Informed Consent from individuals or their legally authorized representatives. Informed Consent is necessary whether the research is designed primarily for the direct benefit of research participants or for the advancement of knowledge.
a. One concern is to respect the ability and desire of individuals to decide whether they want to participate in research. Adequate information about the research must be provided. Individuals who are to be subjects of research or experimentation must understand as completely as possible what will be done to or asked of them.
b. A second concern requires that individuals or their representatives understand the nature and extent of potential benefits and risks to themselves.
c. The third concern is that Informed Consent must be given freely, without pressure or inappropriate inducement. In other words, possible participants must be able to exercise free power of choice without unethical inducements or any element of force, fraud, deceit, duress, or other form of constraint or coercion.
B. Consent Form. 1.The informed consent of subjects is ordinarily to be documented by a signed consent form. See Special Circumstances, below, for exceptions.
2.The consent form must be written so that it is comprehensible to the subjects in their preferred language. The exact wording should be appropriate to the particular research situation as well as to the level of understanding of the subjects. Their age, maturity, status, and condition must be taken into account.
3.The information in the consent form must be consistent with the corresponding items in the Application.
4.The consent form should contain all of the following information. If it does not, the IRB is to be provided with an explanation as to why specific parts are missing:
a. A statement that the study involves research, and an explanation of the purpose of the research;
b. A description of the procedures to be followed; a description of the expected duration of the subject's participation; and identification of any procedures which are experimental;
c. A description of any reasonably foreseeable risks or discomforts to the subjects;
d. A description of any benefits to the subject or to others which may reasonably be expected from the research;
e. A statement describing the extent to which anonymity (subject identity not known) and/or confidentiality (subject identity known only to researcher) of participation and records will be maintained;
f. A statement to the effect that participation is voluntary, and that the individuals should not feel pressured in any way to participate by the researcher or anyone else. Furthermore, if they agree to participate, subjects are completely free to discontinue participation at any time. Indicate that agreeing or refusing to participate will have no effect on their usual position, status, or role in the setting from which they were recruited. If appropriate, indicate that there will be no gain or loss of benefits to which they would otherwise be entitled in that setting.
g. A statement of whom to contact for answers to pertinent questions about the research and about the rights of participants in research. That is: researcher and faculty member for questions regarding the study; CSULB Office of University Research for questions regarding the rights of research participants. Where applicable, the consent form should also include:
h. An explanation as to whether any compensation and/or medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
i. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
C. Special Circumstances.
1.Types of special circumstances
a. Oral presentation with short written version. In some circumstances, the elements of Informed Consent have to be presented orally (as in cases of illiteracy or visual impairment). A short version of the consent document should be substituted for the usual version, indicating that all of the elements of informed consent have been presented orally to subjects or their legally authorized representatives. The short version is to be signed by the subject or representative and by a witness to the oral presentation. (The proposed short version and the written verbatim script of the oral presentation must be part of the Application in order to receive IRB approval.)
b. No Prior Consent. Circumstances occasionally arise (especially in observational studies in the social sciences) in which obtaining prior written consent would defeat the purpose of the research, or in which participants would have no reasonable expectation of privacy.
c. Consent-Related Risk. In some cases in which the regular written Informed Consent form is used, signing the form would put the subject at risk (for reasons not directly related to the research).
d. Purpose not Revealed. In some special circumstances, revealing the purposes of the research can render it useless. For such research, indicate on the consent form that there is information about the research which the subjects will receive at its completion. It should be particularly noted that this refers to the informed consent requirements concerning explanation of the purpose of the research (item 4.a.,above). It is not an exception to the rule that all subjects must be informed about the research procedures that involve them directly. For example, the researcher studying people's behavior when they are startled must inform the subjects that they will be startled and by what means, but that (if it is the case) the startling events will occur at unexpected times.
2.Modified Procedures. In any of the above special circumstances, modified procedures may be proposed in the Application, if and only if all four of the following conditions exist. (A complete explanation must be included in the Application.) a. The research involves no more than minimal risk to the subjects; and b. The waiver or alteration will not adversely affect the rights and welfare of the subjects; and c. The research could not practicably be carried out without the waiver or alteration; and d. Whenever appropriate, subjects will be provided with additional pertinent information (debriefing) after participation.
D. Additional protections for all children, and for adults who are under legal guardianship or otherwise require special concern (for example, for those who are developmentally disabled, or mentally ill.)
1.Children (and adults described above) may not participate without prior informed consent of parent/guardian. However, parental consent while necessary is not sufficient. All children, and such adults, must themselves be given the opportunity freely to assent or to decline to participate in the research. Mere failure to object should not be construed as assent. Researchers are cautioned to be sensitive to the possible implied pressure of parental consent and/or the subject's relationship and rapport with the researcher.
2.In accordance with federal regulations (45 CFR 46, Subpart D- Additional Protection for Children Involved as Subjects in Research) the IRB may determine that the research is designed for conditions or subject population for which parental or guardian permission is not a reasonable requirement to protect he subjects, (for example, neglected or abused children). In such cases the IRB may choose to waive the consent requirements. However, an appropriate mechanism for protecting the subjects must be used and the researcher must document to the IRB that the waiver is not inconsistent with federal, state or local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the research, the risk and anticipated benefit to the research subjects, and their age, maturity, status and condition.
E. Retention of Records. Researchers must keep the signed Informed Consent forms for all subjects for three years to protect themselves in the event that future problems may arise with any research participants.
III. PERMISSION OF PARTICIPATING AGENCIES
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Prior to submitting your IRB application, you must obtain written permission from any agency, school, clinic, or other organizational entity whose cooperation is required in obtaining access to subjects and conducting the study. Such permission must be presented on printed agency letterhead and must be signed by an agency official. The letter of permission must indicate that the official approves of agency involvement as described in the IRB application. Include this letter of permission with your IRB application materials.
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