CU IRB
Revised November 2016 / 1

CU IRB Application Cover Sheet Form

Principal Investigator (PI) NAME

/ Last, First /

Date submitting this Cover Letter

/ mm/dd/yyyy

PI email

/

Department

CO-PI

/

CO-PI email

If PI is student,

Faculty Advisor:

/ Last, First

Proposed

Study Title

Key Investigators

/ If others will be key in the data and/or sample collection or analysis, list below: Last, First; Last, First;

Project Review Type

/ Check one: ☐New Project ; ☐Renewal, date study was FIRST approved ______

Sponsor Information

(if known)

/ Check one: ☐Not seeking funding;☐Seeking funding (but not funded yet); ☐FUNDED
Sponsor name: ______Funding dates: begin______end______

Proposed Start

/ mm/dd/yyyy /

Proposed End

/ mm/dd/yyyy

1.Provide a brief description of the proposed study. You can use, or use with modifications, your Research Description Form (RDF) text here. Limit your responses to 2-4 lines (detailed responses are not wanted, since this is a short summary cover sheet for the longer Research Project Narrative).

  1. 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).]
  1. 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.]
  1. 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. Your relationship/role with the participants you want to collect data from: [Click to delete this and describe why you have access to the people you want to recruit. Write if you are the instructor of student participants, supervisor of employee participants, or contractor of customer participants.]

2.Does the study include vulnerable subjects? Check here if “No” ☐ , or Check all that apply, below:

☐ Minors (Children, in the US this is under 18 years old);

☐ Pregnant Women or Fetuses; ☐ Individuals Incompetent to consent, and/or

☐ Students receiving a grade; ☐ Workers employed by the investigation/investigator/institution

☐ Prisoners or other institutionalized individuals who are under the authority of investigator/institution

If you are enrolling students, write your plan to reduce any feelings of coercion to participate or to remain (not withdraw) from the study? [Click to type your response]

3.The following Table will identify some major potential risks of this study.

Will individuals be participating in:(read each question and respond by checking the ‘yes’ or ‘no’ box)?

a. / The accidental disclosure of the information might risk the participants’ social standing, psychological well-being, health care options, employment or promotion opportunities, criminal liability, or financial vulnerability? In other words, personal information needs to be protected to a great extent since, if disclosed or revealed, it could cause harm. / Yes
☐ / No
☐
b. / Physical measurement/tests that is more entailed or strenuous than that at a routine physical? I.e., are the procedures or questions more stressful than what the participants would experience in their daily life/routine? / Yes
☐ / No
☐
c. / Health related, medical, information linked to personal identifying information that either requires a biologic specimen (blood, urine, or other) or impacts insurance cost or access to health care? / Yes
☐ / No
☐
d. / Procedures that induce physical discomfort, pain, averse stimuli, or the threat of any of these, even if not in the context of a biomedical procedure or physical? / Yes
☐ / No
☐
e. / Study topics/research themes that do not have prior literature (innovative, new “territory”) or procedures that are new and/or present a new use for a test/method, device, food, or drug? / Yes
☐ / No
☐
f. / Procedures that are designed to test responses to or induce embarrassment, humiliation, lowered self-esteem, guilt, conflict, bullying, anger, discouragement or other emotional reactions? / Yes
☐ / No
☐
g. / Procedures designed to induce participants to act contrary to their wishes (or act with different behavior)? / Yes
☐ / No
☐
h. / Procedures where participants will be deceived (actively mislead) in any manner? There could be many examples of this; including e.g., measuring by-stander reactions to a faked accident or not disclosing this is research question. / Yes
☐ / No
☐
i. / Research where information the participant might reasonably expect to receive is withheld from them? For example, not telling the participant that her/his test result suggests they have an illness that they would reasonably want to know about. / Yes
☐ / No
☐
j. / OTHER: If there are other risks that are specific in a way that cannot be sufficiently described/summarized by “a” – “i” above? If so, please describe below,
______
______/ Yes
☐ / No
☐

CU-02 IRB Cover Sheet for IRB Application.docx