Best Practices for Completing the Request for Approval of Research

GENERAL INFORMATION

  • All materials can be accessed at the Institutional Review Board for Research with Human Subjects site located in SharePoint.
  • All materials should be submitted via email to the Chair of the Institutional Review Board, Bryan Price, bprice@wlu.edu. Hard copy submissions will not be accepted.
  • PLAN AHEAD. Reviews are processed in the order in which they are received. IRB members are volunteers who have full-time responsibilities elsewhere. Reviews are added to already full workloads. Reviews will not be rushed.
  • Please include your CITI Record ID Number. This is NOT your CITI member number. The Record ID Number is earned ONLY after successfully completing your CITI training. Do NOT provide your CITI member number.
  • If you are a student, please ensure that your instructor or faculty mentor reviews your proposal prior to submission.
  • If you are a student, you must affirm that your advisor, instructor, or supervisor has reviewed the proposal prior to submitting it to the IRB.
  • ALL investigators must include either a signature and date, or the typed names of the investigators and the date. Your typed name is considered an acceptable proxy for your signature and affirms your pledge to abide by the submitted IRB protocols and all directive by the IRB.

SECTIONS

Section I: PROJECT DESCRIPTION: please provide a brief, definitive explanation of your research proposal, data collection procedures, special conditions, and other pertinent details. You should include a discussion of the literature in order to provide context for the research. Although you may be using language and descriptions that are appropriate to your discipline, please ensure that the terminology can be understood by readers from varied backgrounds.

Section II: CHARACTERISTICS OF THE PARTICIPANTS:

  1. Demographics: please be specific regarding the expected demographics of your research subjects. If the subjects are to be 18 or older, please ensure that you state that fact. If any of your subjects are to be minors, please be aware that additional research protocols will be required. Additionally, since the majority of proposals aim to conduct research on college students as a sample of convenience, please note that, in any given year, the number of entering first-time freshmen includes a sizeable population of students who are 17 and under (i.e., minors) through the early months of the term. It has, on occasion been argued, unsuccessfully, that students in college who are 17 and under should be considered adults because their developmental abilities are college-level. This argument will be rejected - always.
  2. Affiliation: self-explanatory and required.
  3. Participants' general state of health (mental or physical): you are required to answer this question. For the majority of research, it is expected that "the mental and physical health of subjects is expected to be good."
  4. The necessity for using these particular groups: you are required to answer this question. Please simply explain why you are choosing this particular sample, for instance, "a sample of convenience" or "access to larger group is limited by geography and time." Please do NOT include a statement that "humans are required because the research is on humans" or something similarly obvious and flippant.
  5. Briefly explain how the participants will be recruited: Describe the procedure to the point of gaining consent. You should include a discussion relevant to each subject group that is the focus of your research.
  6. Explicitly describe what the participants will be asked to do: This section emphasizes explicit description. Please be specific and detailed. You may have discussed this section thoroughly in Section I: Project Description. If so, please reference that section. Otherwise, your explanation should be so detailed that everyone reviewing your proposal will understand all of the steps involved in your research and what the subject will/would expect to experience. More detail is better than less.

Section III: Risks: This entire section must be considered and discussed, even if the risk is minimal or as simple as "boredom." Even the most benign of studies has the potential to have risk. If there is risk, please identify how you are minimizing that risk in your research design. For instance, if you are collecting opinions on controversial subjects, you may be minimizing the risk to a respondent by a methodology that ensures confidentiality. You should detail that protocol.

Section IV: Deception: for the majority of research, deception is not employed. It if is present, please answer each question carefully. If it is not, simply answer "not applicable" for a, b, and e.

  • Debriefing: Please note that a debriefing is utilized in many research settings. If you are utilizing a debriefing, please discuss it in IV.c and IV.d.

Section V: Confidentiality of Data: Many proposals are returned to investigators because they have inadequately discussed the protocols associated with their data collection and storage. Please discuss your data collection and storage procedures in detail. You should discuss the long-term and immediate use of the data as well as how long the results will be stored before they are destroyed.

Section VI: Informed Consent: Please answer all questions as appropriate. Consent templates are provided on the IRB website to assist you with the composition of your informed consent. Please ensure that you attach and reference all necessary consent forms. More people have trouble with consent than any other single element.

Primary investigators must sign the Request for Research Form. A typed name of an investigator can be utilized in lieu of a signature.

Please be sure to include ALL appendices with your proposal. Each appendix should be started on its own page so that it is readily identifiable.