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
(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?