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Instructions for Completing the IRB Application Form

rev. 3/23/12

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.

There are three categories for review by the IRB under which researchers must choose to submit their application. These categories relate the nature and the level of potential risk to the subject.

Administrative Review

Risk free research is normally reviewed administratively as exempt from full IRB Review." An interactive module on this website is available to help you determine whether your research qualifies for Administrative Review; please use it now if you have any questions about Administrative Review status.

If your study will use existing human subject data only, please refer to the IRB Application for Use of Existing Human Subject Data. In some cases, IRB application may not be required, as detailed in the first two items of this form. If IRB application is required for studies using existing human subject data only, the application will be reviewed administratively.

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) at either:

  • Standard Review
  • Expedited Review

Any protocol deemed inappropriate for a given category will be transferred by the Office of University Research to the appropriate category.

  1. Standard Review Category

    1. Research is required to be submitted under the Standard Review category if one (or more) of the following conditions is involved:
      1. The principal and overriding characteristic is that there is the prospect of more than minimal legal, physical, or psychological risk.
      2. In addition, however, the use of human subjects who have less than full legal autonomy may require Standard Review:This includes children under the age of 18, unless:
        • the risk is only minimal, then Expedited Review; or unless
        • qualifying for Administrative Review where there is no appreciable risk. This includes adults who are under legal guardianship or for other reasons require special concern, such as the developmentally disabled, mentally ill, etc.
      3. Given that the risk is greater than minimal, the identity of subjects can be linked to information provided by them, by others, or by way of the research procedures.
    2. The IRB may request the researcher to discuss problems at a meeting; request an outside review of the application; and/or require significant modifications before approval is given.
  1. Expedited Review Category

    1. Research which does not require a Standard Review, but which may involve minimal risk , should be submitted under the Expedited Review category. Examples of activities appropriate for Expedited Review are given in the Federal Register, which is excerpted here. (Use your browser "Back" button to return here.)
    2. Research under Expedited Review may be raised to Standard Review or reduced to Administrative Review by the IRB. The IRB may request the researcher to discuss problems at a meeting; request an outside review of the application; and/or require significant modifications before approval is given.
    3. Research under Expedited Review uses the same application form. The application is forwarded to subcommittees of the IRB immediately for review, whereas Standard Review is done once a month in a meeting of the full IRB.
  1. Administrative Review Category

Research qualifying for Administrative Review (exempt from full IRB review) is defined in Section 3900 of the University policy on the Protection of Human Subjects (Academic Senate Policy #00-03).  The policy states that 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 full IRB:

"3910 Research conducted in established or commonly accepted educational settings, involving 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.

"3920 Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:

  1. The 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.

"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:

  1. The human subjects are elected or appointed public officials or candidates for public office; or
  2. 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

  1. Public benefit or service programs;
  2. Procedures for obtaining benefits or services under those programs;
  3. Possible changes in or alternatives to those programs or procedures; or
  4. 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,

  1. If wholesome foods without additives are consumed or
  2. 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 from IRB review because they are included in one or more of the categories enumerated above shall submit to the Director of Research Compliance a completed copy of the form developed by the IRB to document such exemption. The Director of Research Compliance 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, the researcher shall submit a complete protocol for regular or expedited IRB review, as appropriate."

Research under Exempt Review will be reviewed by the Director of Research Compliance 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 Research and Sponsored Programs.

The Application Forms

The basis for review and approval of research involving human subjects will be an Application submitted by the researcher to the IRB. There are two forms for IRB Application. The general IRB Application Form for studies that do not use existing data and the specialized IRB Application for studies that use existing data. The general IRB Application form is used for all three types of review: Standard, Expedited, and Administrative. The Existing Data IRB Application Form will be reviewed administratively.

Standard Applications are reviewed once a month in a meeting of the IRB. The deadline for submission of applications is the last Thursday of the month. The meeting is the second Thursday of the month.

Expedited Applications are reviewed by a subcommittee of IRB. Applications are mailed to members. They have five days in which to report their comments.

Administrative Applications are reviewed by the Office of Research and Sponsored Programs.

Once the review is completed, comments from the reviewers are collated and summarized. If revisions are required, the specific requirements are communicated to the applicant. Responses to revisions are typically reviewed administratively within the Office of University Research.

Applications must be complete when they are submitted. Typically, changes or supplemental information added to the Application which are initiated by the researcher after the Application is in review will necessitate withdrawal of the original Application and submission of a new one.

As of July 2, 2012 all IRB applications must be submitted electronically through IRBNet.It is no longer necessary to submit hard paper copies of your IRB application. Information on how to use IRBNet are available at: http://www.irbnetresources.org/tresources/training.html  (Username: csulb. Password: training1) When you have finished training, visit www.IRBNet.org to register. Be sure that the "irbnet.org" domain is identified as a "Safe Sender" in your email program. Otherwise important communications could get caught in your Junk Mail filter

.

You can obtain forms directly from the IRB website. If you need assistance, please call the Office of Research and Sponsored Programs in the FO5-111 (562-985-8147).

NOTES REGARDING THE GENERAL IRB APPLICATION FORM: Standard, Expedited or Administrative Review (separate “Notes” are provided below for the Existing Data Form).

Items 1-7. Provide the required information.

  1. Consider the nature of the information you will accumulate because of this research. Answer "yes" or "no" whether you will have access to or custody of records of, previous research data on, or other forms of information about the subjects of this research NOT produced by this research.
  2. Describe the sample set of human subjects by completing parts a-e. In part e, describe the unique characteristics of the subjects that differentiate them from a random sample.
  3. Describe the purpose(s) of the study (including research hypotheses, if applicable). This should be a succinct description.  The IRB does not want student thesis proposals attached. The purpose of the research must be stated more briefly than in such documents.
  4. Provide the required information if applicable.
  5. From what source(s) will the subjects be recruited, such as hospital, institution, school, class, shopping mall, etc.? Attach original letters of approval from all participating organizations (including campus classes) on their official letterhead. If you are asking faculty of this or other institutions for access to their classroom for any part of the class period, you must have separate approval from each faculty member. Letters approving access should state on letterhead that you have permission for a discrete period of time for research associated with your topic, as defined in the application subject title.
  6. Describe the process of obtaining informed consent from the initial contact of potential subjects until the point of obtaining informed consent. In this section do not describe your research procedures. You must attach a copy of each Informed Consent document in each language that will be used to obtain informed consent. The IRB assumes a bi-lingual situation in most southern California venues and classrooms, therefore research on single-language (e.g., English-only) persons should be explicitly stated as such. Please review and quote freely from the CSU Long Beach IRB Sample Informed Consent Form .
  7. What will you do with the human subjects? Describe the details of your research methods and procedures that involve the subjects. This is the place to describe the research fully in step-by-step chronological detail sufficient for replication of the study. Also, see Item 19 below, which asks that you attach a copy of each test, survey, handout, etc.
  8. What risks, if any, does this research present to the dignity, reputation, rights, health, welfare, or well-being of the subjects? There may be risks caused by the contact you have with the subjects, including the research methods employed. There may also be risks relating to the security of materials collected in the course of research and breach of confidentiality. Number each risk so that you can refer to the risks in item 16.
  9. Describe in this section the safeguards you have designed to protect against or to minimize both the risks incurred from research contact with the subjects and the risks arising from security concerns. You may state that Informed Consent is a safeguard, but please indicate how the specific statements in the informed consent serves this purpose of protecting against the risks.

In part b specify how the records will be stored, secured, and destroyed. Federal policy requires that in most cases the records relating to research which is conducted shall be retained for at least 3 years after completion of the research. In some cases, risk may be reduced by destroying records after data have been extracted. For example, destruction of audio or video recordings after transcription may be desireable.

Items 17 and 18. Provide the information requested.

  1. Identify (with full publication information), describe, and attach in an "Appendix C: Tests and Questionnaires" all tests, questionnaires, surveys, or other instruments and materials to be used. Most materials from books, journals, test publishers, theses, and dissertations are covered by copyright, and you may need to obtain written permission before using them. Indicate if you have adapted or made changes in any of these materials. Indicate which instruments you have created.
  2. Describe any debriefings or other post-research activity or contact with the human subjects. If debriefing is short, please provide a script that you or research assistants are to use. If debriefing is more extensive, please describe it.
  3. Briefly describe the training and experience that qualifies you to carry out the proposed research.
  4. & 23. Provide the required information.

When you have completed the application form, print a copy and assemble a complete application using the check list provided on the IRB web site. Duplicate the required number of copies as noted at the bottom of the application form and mail or hand carry to the Office of Research and Sponsored Programs.

Existing Human Subject Data IRB Application

This form should only be used for studies involving the use of existing human subject data for research purposes. If the data set is provided to the researcher with all identifiers that would link to an individual removed, then IRB application is not required. However, all other research use of existing data must be approved by the IRB. Because this research generally is less risky, a special form has been developed that is reviewed administratively by the Office of Office of Research and Sponsored Programs. The requirements are generally apparent from the questions asked on the form.  Please call the Office of Research and Sponsored Programs (562 985-8147) if you have questions.

  1. Informed Consent
    1. Definition. 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.
      1. 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.
      2. A second concern requires that individuals or their representatives understand the nature and extent of potential benefits and risks to themselves.
      3. 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.
    2. Consent Form. The informed consent of subjects is ordinarily to be documented by a signed consent form. See Special Circumstances, below, for exceptions.
      1. 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.
      2. The information in the consent form must be consistent with the corresponding items in the Application.
      3. 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:
        1. A statement that the study involves research, and an explanation of the purpose of the research;
        2. 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;
        3. A description of any reasonably foreseeable risks or discomforts to the subjects;
        4. A description of any benefits to the subject or to others which may reasonably be expected from the research;
        5. 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;
        6. 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.
        7. 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:
        8. 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.
        9. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
      4. Special Circumstances.
        1. Types of special circumstances
          1. 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.)
          2. 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.
          3. 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).
          4. 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.
  1. 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.
    1. 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 a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects, (for example, neglected or abused children). In such cases the IRB may choose to waive the (parental or guardian) 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.
  1. Retention of Records. Researchers must keep the signed Informed Consent forms for all subjects for three years after the study is completed to protect themselves in the event that future problems may arise with any research participants.
  1. Permission of Participating Agencies

Prior to submitting your IRB application, you must obtain written permission from any agency, school, clinic, business, 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 with their title. The letter of permission must indicate that the official approves of agency involvement as described in the IRB application. Include this original letter of permission with your IRB application materials.

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