Institutional Review Board- Westmont College

Projects Involving Human Subjects

(Revised Oct 2013)

Keep all the information in this column as it is. Do NOT modify or delete anything from this column / Instructions for the cell to the immediate left are provided.
Once you have read the instructions for the row, delete them from the cellin this column and type in the information for your research project
Contact Info
  1. Principal Researcher
/ The person charged with responsibility for the project
  1. Faculty Sponsor (if student)
/ If a student, you must have a faculty member who will sponsor your project. The faculty member should review this completed form and send an email to the IRB chair stating the students’ name and project title and that the protocol is acceptable and the form is accurately/fully completed.
  1. Project Title
/ Provide a brief title for your project
  1. Department
/ Identify the academic department are you affiliated with
  1. Email
/ Westmont Email account
  1. Phone
/ Phone number you can be contacted at
  1. Co-Investigators (list all)
Provide: names/titles/depts / A person having a major role in the project
  1. Source of funds (if any)/& name of granting agency
/ The entity or individual providing financial support for the project/ The entity or person who sponsors an investigation, fiscally or otherwise
Research Project
  1. Brief Summary of Project
/ Provide a ONE paragraph summary of your project. This is an abstract of your research plan. It should include the purpose of the study (ex: "this exploratory study is designed to determine the variables relevant to learning in a particular setting"). You should also include the name of the population/samples and the data collection techniques (e.g., self report, observation, videotaped interviews, record review).
  1. Preferred START date:
  2. Preferred END date:
/ Start: identify the date you would like to start project
End: date this project will be completed (one year maximum from start date)
Subjects
  1. Number of subjects
/ How many people you want to participate in your study
  1. Will you be recruiting …

  1. Students at Westmont
/ Yes or No
  1. Minors (under 18 years old)
/ Yes or No
  1. Incompetent persons
/ Yes or No
Any person who has either been adjudged incompetent or who, in fact, lacks the capacity to understand that s/he is being asked to do and to thereafter give his/her consent.
  1. Low income persons
/ Yes or No
  1. Institutionalized persons
/ Yes or No
Any person who is confined to a prison, reformatory, or like institution or who is either voluntarily or involuntarily institutionalized as mentally infirm.
  1. Pregnant women
/ YES or NO. IF yes, do you anticipate any harm to the fetus from the study?
  1. Why ”protected class” subjects are needed for your study
/ If you answered “Yes” to 13b-13e, explain why you need these subjects for your research. These classes are “vulnerable” to coercion in research. Minors require signed parental consent and minor assent forms.
  1. Time commitment for subjects
/ State the total number of hours a subject will be involved in the study and how many times he/she will be required.
Research Protocol
  1. Research Procedures related to subjects’ participation
/ Provide a step-by-step breakdown of the research plan ofwhat are you going to do:
  • what variables are manipulated and how
  • who are your subjects and how you will recruit/select them
  • what are you going to measure & how will you measure it
Only include reference to the literature if they indicate previous successful protection of subjects in these research activities.
Flow charts/Outlines are helpful.
  1. Survey/Interview Measures/ Items/ Questions
/ Yes or No -- will you have subjects self-report anything to you?
If YES: Append all items/scales/measures that subjects self-report (from a survey, interview, or experimental design) at the end of this entire document.
Do so that it is saved as part of this IRB file, rather than as a separate document
  1. Blood draw?
/ Yes or No. If yes, identify method and quantity.
  1. Drugs/appliances/procedures that are FDA investigational or experimental?
/ Yes or No.
If Yes, Identify and be very specific how these items apply
Potential Risks to Subjects
  1. Anonymous data collection
/ Yes or No.
If subjects be identified by name; combo of demographic features unique to them; any audio/videotape; handwriting on papers; unique characteristics, then they are NOT anonymous, even if you are not collecting names.
If NOT anonymous, then you MUST identify how you:
  • will store the data without identifying features (how you might strip out all personally identifying data from your data before saving & analyzing data) to create “anonymity”in the data set OR
  • will insure confidentiality of the data by limiting who has access to it and how it will be stored in locked files

  1. Minimal Risk?
/ Yes or No.
A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
  1. Potential Risks to Subjects
/ Identify all potential Risks to subjects and for each, identify how you will protect your subjects in your research protocol.
Risks include potential physical or psychological risks (ex: Testing, all medical work, deception, any factor inhibiting the subject from withdrawing from the study…)
Identify all factors potentially causing anxiety or embarrassment for subjects and how you will minimize them.
If in doubt about any procedure and it’s risk, list it.
Sometimes there is no procedure that will minimize the risk (e.g., anxiety in a threatening situation). Since subjects are always protected from any risks by the ability to discontinue participation in the research, it is particularly important in these cases to describe the procedure to ensure subjects' understanding of their rights to drop out of the study.
  1. Any deception in this Research?
/ Yes or No
If yes you must:
a. Identify what explanations are made to subjects concerning their participation in the study: exactly what are subjects told, by whom, when (in relation to the research activities), and in what setting (group/individual, strangers about?).
b. Provide a complete debriefing scenario (copy and paste at the end where designated). Indicate how the experimenter will communicate and know that subjects fully understand why deception was necessary, or that subjects have full accurate information about what really occurred (when prior full consent is not feasible).
  1. Risk #1 and how you will protect
/ Identify risk and protocol to minimize it
  1. Risk #2 and how you will protect
/ Identify risk and protocol to minimize it
  1. Risk #3+ and how you will protect each of them
/ Identify remaining risks and protocol to minimize it…
  1. Identify Potential Benefits to Subjects
/ Identify all personal, social, scientific benefits.
The IRB weighs the risks of the study and its internal validity against these benefits.
Benefits may be to the subjects, populations, as well as to science.
  1. Informed Consent Form
/ All research must have an “informed consent” document that subjects sign.
Anonymous surveys classified as minimal risk do not need signatures. The email or opening section of the survey contains the Informed consent information.
There is a sample consent form on the IRB website for you to model after. Create your consent form in word and then paste it at the designated place below.
Use language appropriate for your sample. The committee should be told what will be said to the subjects (and parents/guardians), buy whom, and in what setting (a written script is helpful to the investigator and the committee). If working with minors, you will need a parents’ informed consent and a minors’ assent form.
Faculty: If you have any questions as to how to complete this form, please contact any member of the IRB.
Students: If you have any questions as to how to complete this form, please contact your faculty sponsor.

Required: Measures/Items/Scales/Questions pasted here (#17):

Required: Informed Consent Document pasted here (#24):

Debriefing Form pasted here (#22a):