Concordia University–Portland IRBStep 1, Research Description Form

The purpose of this form is for you to describe your potential research project to determine if you need to have institutional review board (IRB) review. You complete this form while consulting with your Faculty Advisor, if you are a student. After youemail this completed form to , you will receive a letter stating your research is “exempt” from submitting an IRB Application or instructing you on how to submit your IRB Application.

Researcher; calledprincipal investigator / Last, First /

Date submitting this form

/ dd/mm/yyyy

email

/ x@x.x /

Institutionif notCU

telephone

/ ( ) xxx-xxxx /

Another key researcher, if applicable

Faculty Advisor

/ Last, First /

CUDepartment

Proposed Study Title

/ [Click To Type Your Proposed Title. This Is Title Can Be Changed Later, If You Wish.]
  1. In a few sentences, describe your proposed research purpose and geographic location

Purpose and/or problem to be investigated:[Click to delete this and write your research question or hypothesis. Limit to four lines. This is a general and basic statement of the question, hypothesis, or motivation for the study. Write using non-specialized language (use lay-person language).]

Population of study,geographic location and/or target population group and/or recruitment organization: [Click to delete this and write what human subjects will be recruited, from where, and why you have access to this location.]

Basic method(s)to collect data: [Click to delete this and write how you will collect or obtain data for this study. {e.g., computer survey, interview, physical procedure, and/or observation?)]

  1. Describe how you intend/hope to use the data/results.Type or write “X”on any and allthat apply.

☐Dissertation or Thesis ☐Journal or Article☐Conference or Seminar ☐Grant Application

IF none of the 4 boxes are checked above, then check if Concordia, News story, or No Publication, below:

☐Concordia University Assessment, check where assessment (or institutional survey) will be presented, below:

☐Internal (e.g., classroom or administrative reporting)☐External (e.g., accreditation)

☐News story, historical book, biography, or personal-opinion piece (not generalizable knowledge)

☐No Publication, not even internal to CU.

  1. Which describes the research data/sample collection type(s). Write answer:“True,” “false,” or “N/A”

You can answer “True” to more than one. If you are not certain, you can write “don’t know.” If not applicable, write “N/A.”

A0 / You collect data that could identify a specific persondue to information obtained, collected, observed, created or remotely accessed from recruitment, consent, or research procedures. Even if you promise to hold this in confidence, if you could identify the person, you mark this “True.” Personal identifying information include, but is not limited to, a name, address, email, employer+position title, etc.
A1 / Person-specific data is collected, as described in A0 above, but this collection is within an educational setting (school/college/university) in order to evaluate, develop curriculum, or improve teaching methods or service at that particular educational setting.
A2 / Your study is only for your institution’s use (an institutional evaluation or survey) in order to improve service, customer satisfaction, and/or employment benefits and the datawill not be published outside of your institution.
B / You use existing publically available data (e.g., census data) or collect data that is clearly in public display or broadcast by the person for 100% dissemination into the public at large.
C / You will only collect data in aggregate, in a tabulated manner, so you will never record a specific response to a specific person and you would not know his/her personal identity/address.
D / Your data collection will be conducted in a group or forum situation with co-attendance of other participants. This can be “true” whether person-specific (as described in “A” above) or in aggregate (as described in “C” above) data collection, since the co-participants or bystanders might discern the person-specific answer. Mark “this True” if data will be collected in a group.
E / You will have only DE-identified information, such as receiving a biologic specimens and/or data-files.

Answer Questions 4–7 by writing “Yes,” “No,” “N/A,” or “don’t know.”(It is okay to write “don’t know” at this stage of your research development. If the CU IRB requires more information, the CU IRB will contact you.)

  1. Does the research require secret ormisleading/ deceptive data collection?

4.1 / Will the individuals know you are collecting data on, from, or about them for a research study?
4.2 / Does the study require disguising the study purpose, why a participant is asked to participate, what is the real intent/question/broadcasting of a question or test, even if only for a short period time? E.g., staging a fake accident, incident, or question so as to get the natural response.
  1. Is there only a minimum risk to the participant in recruitment and/or study procedures?

5.1 / Is the study a minimal psychological and social risk? Answer “Yes” if procedure(s) or questions are NOT of a sensitivenatureand therelease of the data would NOT pose risks to social standing or bias, employment/promotion options, and/or legal liabilities.
5.2 / Is the study a minimal physical risk? “Yes” would mean that the procedures/questions are no more painful, stressful, embarrassing and/or time consuming than a physical exam. E.g., a tube of blood, a stress test, and/or questions that many doctors would ask in that culture.
5.3 / Is there a minimal recruitment and enrollment risk? “Yes” would mean that people who might benefit from the outcomes of the research are involved in an equitable way that is voluntary and free of coercion. Because it is difficult to ensure equity and freedom when studying vulnerable populations, you must answer “No” if your study includes vulnerable populations, such as prisoners, workers/students feeling coercion to participate, or children.
5.4 / Is there some literature published regarding this type of study and/or published test method(s) so that we can predict the risks involved? You must answer “No” if your study embarks upon an unprecedented line of research and/or explores a novel/new test, device, food, or drug.
  1. Is it reasonable to expect that the investigator might be compelled/forced/required to disclose a participant’s identity?

6.1 / Is there a significant chance, either because of the population being recruited or the questions being asked, that the investigator will learn that a participant is in serious immediate danger of abuse or neglect, of harming him/herself, or of harming someone else?
6.2 / Is there a significant chance that the investigator will hear (learn of, observe) a participant behavior/action that could lead to serious social, employment, or legal consequences
  1. If this is educational research (classroom research), answer the following questions?

7.1 / Will your study be conducted using standard and conventional educational tests that are in a simple “question-answer” form? If open-ended questions will occur (interview discussion or group interaction with investigator), then you would mark “No” to this question.
7.2 / If you marked “No” to 7.1, are any of the questions what might be considered sensitive, embarrassing, provoking stress, or questioning identity?
7.3 / Is there a significant chance that interactions could reveal abuse, bullying or neglect? This could occur if the study includes students considered in social-economic-performance at-risk groups. This is similar to and overlaps with issues described in question 6, above.
7.4 / Is the person undergoing the study procedures a child? The procedures might include assess-ing or collecting their records and/or taking tests, answering questions, and/or interacting with an investigator in an interview. A child is usually defined as a minor < 18 years old.
7.5 / Will your study be conducted within a Federally funded K-12 school educational setting? An example is any US Department of Education primary or secondary school.
7.6 / If your study will be conducted in a Federally funded K-12 school, can you reasonably expect and document the parents’/guardians’ permission (consent) to adding this assessment/evaluation to the child’s school work/activities?

Document: CU-00 IRB STEP1 research description FORM 2016 v3.docx Published: 20160108, OLB

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