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 website.
  • All materials should be submitted via email to the Chair of the Institutional Review Board, Bryan Price, bprice@wlu.edu. Print copy submissions will not be accepted.
  • PLAN AHEAD. Reviews are processed in the order in which they are received except during academic terms when time constraints give student projects a higher priority.
  • PLAN AHEAD. IRB members are volunteers who have full-time responsibilities in other positions at W&L. Reviews are added to already full workloads, especially for the IRB Chair. Reviews cannot be rushed nor can they be processed ahead of others in the queue with the exception listed in the previous bullet point.
  • 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. Your member number only indicates that you have established an account with CITI.
  • 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

Introductory Section

Please complete all fields that are applicable. 

  • The submission date should reflect the date the proposal is forwarded to the IRB
  • Include the names of all investigators who actively participate in the research
  • Include your course completion record ID number (not your member number)
  • Complete all other appropriate fields. Be sure to sign the form. A typed name is a sufficient proxy for your signature.

Section I: PROJECT DESCRIPTION: please provide a brief and 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 PARTICIPANT GROUP(S):

  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 many 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 first-year students 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. Students under 18 will be considered minors.
  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." You may use this response if you believe it is likely to be true and if it was not true, you should remove refrain from including such participants or develop an appropriate protocol to ensure adequate safeguards for that population.
  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 a larger group is limited by geography and time." 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 specificity and detail. You may have discussed this section thoroughly in Section I: Project Description. If so, please feel free to 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.
  7. If the research is being conducted outside of the United States, please discuss in detail the social and cultural norms of the population that affect the way you interact with the population sample. Please be thorough in your discussion since international communities may interact in ways that are completely different than that experienced in the United States and you, as the researcher, must be sensitive to those norms. A study that might represent no foreseeable risk in the United States may represent significant risk to participants living in a theocratic, communistic, or patriarchal communities with vastly different societal norms. This applies even if you are a citizen from the country from which you propose to engage in human subjects research. Your discussion may need to include comments from campus experts. An inadequate discussion in this section will result in the proposal being returned for additional information.

Section III: Risks: This entire section must be considered and discussed, even if the risk is minimal or as simplistic as "boredom." 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. Most research at W&L has minimal risk associated with it but it still should be considered.

a - e: self -explanatory

  1. Debriefing - provide detail on the debriefing you will include in your research
  2. International Research: discuss in detail the cultural and geopolitical environment. This is critical if you are conducting international research. You are obligated to follow the laws of other countries and need to be aware of any circumstances that might heighten the risk to international participants. Moreover, some researchers propose to conduct research in countries where the governmental system significantly restricts and/or prohibits freedoms granted citizens of the United States. A study that might represent no foreseeable risk in the United States may represent significant risk to participants living in a theocratic or communistic country. This applies even if you are a citizen from the country from which you propose to engage in human subjects research. Your discussion may need to include comments from campus experts. An inadequate discussion in this section will result in the proposal being returned for additional information.

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 - e.

      • Debriefing: Please note that a debriefing must be utilized when deception is involved in the research. Please discuss it in IV.c - e.

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.