V.04/06/2016

CSULB IRB Application Instructions

  1. Add the PI’s and Co-PI’s information (if applicable).
  1. Add your CITI Member ID number.
  1. Add your faculty advisor letter. Make sure that your faculty advisor letter is attached. The template for the faculty advisor letter is available on our website.
  1. The title stated on the protocol form must match the one entered on IRBnet.
  1. Select the type of review that you think best fits your study. Note that the selection might change as the IRB office will make the final determination for the type of review.
  1. Select the justification for Administrative review if you checked “administrative review” box in section 1. If Expedited or standard box was selected, select “not applicable.”
  1. Consider the nature of the information you will accumulate because of this research. Answer "yes" or "no."
  1. 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. Answer "yes" or "no." If yes, explain in the textbox and attach any applicable signed permission letter(s).
  1. 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. Note that the box on 9a can be edited to accommodate your study’s population.
  1. Describe the purpose(s) of the study (including research hypotheses, if applicable). This should be a brief description. The IRB does not want student thesis proposals attached. The purpose of the research must be stated more briefly than in such documents.
  1. Provide the required information.
  1. 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.
  1. Describe in chronological detail the process of obtaining informed consent from the initial contact of potential subjects until the point of obtaining the signed informed consent. Also, describe the process that will take place if a potential subject refuses to give 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 use the CSU Long Beach IRBInformed Consent FormTemplate and edit it to accommodate your study.
  1. Describe the step-by-step details in chronological order of your research methods and procedures that involve the subjects. Also, see item 20 below, which asks that you attach a copy of each test, survey, handout, links for online surveys etc.
  1. 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.
  1. 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.
  1. Number each safeguards you have designed to protect against or to minimize both the risks (mentioned in section 15) 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 desirable.
  1. Describe the benefits and/or compensation for the participants.Describe the benefits to society, as well as the expected gain in generalizable knowledge. Why are the mentioned risks to the participants worth taking in comparison to the potential gain of generalizable knowledge from your study?
  1. Provide the required information.
  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.
  1. Brieflydescribe the training and experience that qualifies you to carry out the proposed research in section a. In section b. list the name and email addresses of any other key personnel (research assistants) who will be assisting you with the research. All key personnel must be CITI training certified.
  1. Provide the required information.
  1. Provide the required information.