1. Give a brief summary of the purpose of the research in non-technical language. Be sure to include a statement of the research problem, its importance, and how your project will address it, i.e., briefly explain how your methodology will help to answer the research question(s). Cite two or three references directly relevant to the proposed inquiry.

2. Give details of procedures that relate to subjects’ participation.
(a) Subjects and Recruitment:
(i) Salient characteristics of subjects–number who will participate, age range, sex, institutional affiliation, other special inclusion and exclusion criteria (if children, prisoners or other vulnerable subjects are recruited, explain why their inclusion is necessary, append screening materials, if applicable):

(ii) How are subjects recruited? What inducement is offered? If participants are paid, what amount and when are they paid (investigator(s) must comply with University guidelines for compensating research subjects)? Is there partial pay for partial completion? (Append copy of letter, advertisement, poster, or recruitment text for online posting, if any.)

(b) Research Procedures:
(i) What do subjects do, or what is done to them, or what information is gathered? Is there an online component to your project, such as web-based surveys? (Append copies of instructions, tests, questionnaires, interview guides, etc. to be used. If applicable, include a link to the web-based survey.)

(ii) How many times will interviews, observations, tests, etc., be conducted? How long will their participation take? (Describe in terms of what the subject will experience.)

(iii) Are subjects to be:
AUDIO recorded: tape digital
VIDEO recorded: tape digital
3. Describe how permission has been obtained from cooperating institution(s)–school, hospital, company, prison, or other relevant organization(s). (Append letters on letterhead or emails.) Is the approval of other research compliance committees or another Institutional Review Board required?

4. Describe your research experience and your research ethics training.
(a) Cite your experience with this kind of research and/or this population.

(b) Provide the names of everyone working with human subjects and/or their identifiable data and human subjects (e.g., CITI) training.

Names of people working on this project Role Human Subjects Training
Investigator(s)

Others

(c) Describe experience and role(s) of others:

5. How do you inform subjects about your research and then obtain their consent? (For an explanation of the elements of informed consent and documenting it, please see https://www.unk.edu/academics/gradstudies/irb/consent-assent/process-for-obtaining-informed-consent.php
(a) Do subjects sign a written consent form and receive a copy for their records? If not, do they receive an information sheet that provides what they need to know before deciding to participate? (In addition to answering parts a. – e. of Question 5, append a copy of consent form, information sheet, or script for oral explanation to subject.)

(b) Where (in a lab? online?) , when (immediately before participation? at another time?), and by whom (anyone other than investigator?) is consent obtained?

(c) Are subjects children (persons younger than 19 years old), mentally infirm, or otherwise not legally competent to consent? If so, how is their assent obtained, and who consents on their behalf?

(d) If subjects are vulnerable due to legal status, economic status, illiteracy, impaired decision-making capacity, or other circumstance (such as relationship with the investigator(s)), describe steps to minimize the risk of coercion or undue influence. Include in your answer how you ensure subjects understand that participation is voluntary.

(e) Is there any language barrier that could affect the consent process (your explanation of the research and the subject’s agreement to participate)? If so, please provide details, such as plans for use of translators or translating documents.

6. Give details of possible risks of harm to participants.
(a) What are the possible risks—physical, psychological, legal, social?

(b) If there are any risks, why are they necessary? Is there any other way to conduct the research that would reduce the risk to subjects, and, if so, why have you not chosen that alternative?

(c) What steps will be taken to minimize the risk? (If the research may involve greater than minimal risk to participants, describe provisions for ensuring participant safety.)

(d) Should a subject be injured or otherwise harmed, or experience significant distress, what are your plans for addressing the problem? (e.g., referral for evaluation or treatment if there are significant psychological risks)

(e) If risks are anticipated to be no more than minimal, please state so here and in the consent form, if used.

7. Are subjects deliberately deceived in any way? If so, what is the nature of the deception? Are the subjects informed that the study involves deception during the informed consent process? Is it likely to be significant to subjects? Is there any other way to conduct the research that would not involve deception, and, if so, why have you not chosen that alternative? What explanation for the deception do you give to subjects following their participation?

8. How will participation in this research benefit subjects? If subjects will be “debriefed” or receive information about the research project following its conclusion, how do you ensure the educational value of the process? (Append copies of any debriefing or educational materials.)

9. How are confidentiality and/or anonymity assured? For online studies, will IP addresses or other potentially identifying information be collected? What host site will be used (i.e. Qualtrics, SurveyMonkey, etc.)? Will identifiers be removed from the data? If so, at what point, and if not, please explain why identifiers must be retained.

10. How is the privacy of subjects protected? (e.g., are questions tailored to the research question so subjects are not asked to provide unnecessary information?)

11. Will research data (written or otherwise recorded) be destroyed at the end of the study? If not, where and in what format and for how long will they be stored? To what uses–research, demonstration, public performance, archiving–might they be put in future? How will subjects’ permission for further use of their data be obtained? If there is a key code connecting subjects’ data to their identity, when will the link be destroyed? (Include this information in the consent form, information sheet, or consent script.)

12. Do you believe this research meets the criteria to be reviewed as Exempt or Expedited? If so, please state and justify the category number under which this proposal is submitted. (See https://www.unk.edu/academics/gradstudies/irb/human/exempt.php for information on categories of research that qualify for Exempt Status.)
Exempt Category Number
Expedited Category Number
Explanation:
13. Do you and/or any other investigators associated with the project described in this application have, or appear to have, any actual or potential conflict of interest with respect to this research? (See https://www.unk.edu/academic_affairs/conflict_of_interest.php for what may constitute a conflict of interest that must be disclosed.)