DSRT-839: Advanced Research Methods : Week 1 - IRB/Research Proposal Draft - Part I

IRBChecklistChairsandStudentsV10.23.docx

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Use this checklist as a guide to review your IRB application to ensure all areas are addressed.

Study Title:_________________________________________________

IRB Application Evaluation

Q#

Application Question

Yes

No

Tips

3

Estimated Start Date of Study

4

CITI Certificate Uploaded

5

Background information is comprehensive.

Cite at least two sources justifying the need for the study.

6

Research questions are in alignment. Variables (quantitative) or phenomenon of interest (qualitative) are adequately described.

Research questions must align with the study background, study type, and the data collection instrument. Minimum of 2 questions.

7

Research procedures are summarized.

Brief summary from start to finish of study.

8

Potential Risks and Benefits are described.

Risks and Benefits text box should match information on the uploaded Informed Consent. Must state at least minimal risks. Include risks associated with your study.

9

Will human subjects be recruited for the study?

Yes, if student is sending the link to participants or contacting them for interviews, making the study= Expedited. No, if link is being forwarded to participants by a third party, data is being collected by third party, or archival or de-identified secondary data is being used, making the study = Exempt.

10

Will the researcher be collecting data by directly interacting with the participants?

Yes if collecting data directly or by electronic or paper means. No if secondary or archival data.

11

Will identifiable private information be collected?

Yes, if collecting any representation of information that permits the identity of an individual to whom the information applies to be reasonably inferred by either direct or indirect means, including name, address, social security number or other identifying number or code, telephone number, email address, etc.

Q#

Application Question

Yes

No

Tips

12

Description of the population and sampling procedure is equitable and justified.

For quantitative, include G*Power calculation and information.

13

Subject Recruitment Materials and Procedures are detailed. Recruitment materials (letters of initiation, recruiting scripts, etc.) are attached and appropriate.

Include text of flyers to be posted on social media and emails or letters to be sent to agencies and potential participants.

14

· Informed Consent procedures are described and the form is uploaded.

· For an electronic survey, the informed consent is on the first page and designed so that when participants choose "no," they are directed to the end of the survey, and when they choose "yes," they proceed to the first survey question.

All sections on the Informed Consent template must be included. Remove UC logo, red text, and highlights if still using old template. Include "Must be at least 18 years of age" as Inclusion Criteria.

15

Data Collection process is described.

Include details.

16

· Data Collection Instrument and Permission to Use are described.

· Data collection Instrument is uploaded.

· If the instrument is copyrighted, the author’s permission is attached. If it is a public domain instrument, a statement of public use is attached.

· If using an electronic survey, the “live” survey is set up, informed consent is in place, and the survey is error-free.

· If a student-created quantitative survey or new qualitative instrument (such as an interview protocol) is used, the summary data of pilot or field testing is attached or discussed.

Must upload permission to use each data collection instrument or information showing it is available for public use. Must upload field test or pilot study results if developing instrument. Data collection URL must be for the actual survey that will be used in the study. Informed Consent must be the only information on page 1. If "No" is chosen, it must exit the person from the survey. If no URL is needed for your study, insert the UC URL in the box.

17

Site Permission or Data Use Permission. Necessary approvals, agreements, and/or contracts with partners have been obtained and are uploaded.

Must upload permissions for all sites from which data will be collected.

18

Data Analysis process is described.

Statistical tests must match wording of research question. Include independent variables, dependent variables, and analysis method for each research question.

19

Correct study method is selected.

Mixed Methods and Applied Research require program director permission. An email screenshot will suffice.

Q#

Application Question

Yes

No

Tips

20

Correct study type is selected.

Exempt if student is having no contact with participants. Expedited if student is having contact with participants. Full if protected populations are involved in the study.

21

Correct category is selected.

Most Expedited are Category 7. Most Exempt are Survey or Instrument (2nd on list) or No Human Subject Recrutiment category if secondary or archival data (last on list).

22

Principal Investigator Statement. Investigator certifies accuracy of information by typing name.

Version.Summer 2021

Page 2 of 2 V10.23

Q#	Application Question	Yes	No	Tips
3	Estimated Start Date of Study
4	CITI Certificate Uploaded
5	Background information is comprehensive.			Cite at least two sources justifying the need for the study.
6	Research questions are in alignment. Variables (quantitative) or phenomenon of interest (qualitative) are adequately described.			Research questions must align with the study background, study type, and the data collection instrument. Minimum of 2 questions.
7	Research procedures are summarized.			Brief summary from start to finish of study.
8	Potential Risks and Benefits are described.			Risks and Benefits text box should match information on the uploaded Informed Consent. Must state at least minimal risks. Include risks associated with your study.
9	Will human subjects be recruited for the study?			Yes, if student is sending the link to participants or contacting them for interviews, making the study= Expedited. No, if link is being forwarded to participants by a third party, data is being collected by third party, or archival or de-identified secondary data is being used, making the study = Exempt.
10	Will the researcher be collecting data by directly interacting with the participants?			Yes if collecting data directly or by electronic or paper means. No if secondary or archival data.
11	Will identifiable private information be collected?			Yes, if collecting any representation of information that permits the identity of an individual to whom the information applies to be reasonably inferred by either direct or indirect means, including name, address, social security number or other identifying number or code, telephone number, email address, etc.

Q#	Application Question	Yes	No	Tips

12	Description of the population and sampling procedure is equitable and justified.			For quantitative, include GPower calculation and information.*
13	Subject Recruitment Materials and Procedures are detailed. Recruitment materials (letters of initiation, recruiting scripts, etc.) are attached and appropriate.			Include text of flyers to be posted on social media and emails or letters to be sent to agencies and potential participants.
14	· Informed Consent procedures are described and the form is uploaded. · For an electronic survey, the informed consent is on the first page and designed so that when participants choose "no," they are directed to the end of the survey, and when they choose "yes," they proceed to the first survey question.			All sections on the Informed Consent template must be included. Remove UC logo, red text, and highlights if still using old template. Include "Must be at least 18 years of age" as Inclusion Criteria.
15	Data Collection process is described.			Include details.
16	· Data Collection Instrument and Permission to Use are described. · Data collection Instrument is uploaded. · If the instrument is copyrighted, the author’s permission is attached. If it is a public domain instrument, a statement of public use is attached. · If using an electronic survey, the “live” survey is set up, informed consent is in place, and the survey is error-free. · If a student-created quantitative survey or new qualitative instrument (such as an interview protocol) is used, the summary data of pilot or field testing is attached or discussed.			Must upload permission to use each data collection instrument or information showing it is available for public use. Must upload field test or pilot study results if developing instrument. Data collection URL must be for the actual survey that will be used in the study. Informed Consent must be the only information on page 1. If "No" is chosen, it must exit the person from the survey. If no URL is needed for your study, insert the UC URL in the box.
17	Site Permission or Data Use Permission. Necessary approvals, agreements, and/or contracts with partners have been obtained and are uploaded.			Must upload permissions for all sites from which data will be collected.
18	Data Analysis process is described.			Statistical tests must match wording of research question. Include independent variables, dependent variables, and analysis method for each research question.
19	Correct study method is selected.			Mixed Methods and Applied Research require program director permission. An email screenshot will suffice.

Q#	Application Question	Yes	No	Tips
20	Correct study type is selected.			Exempt if student is having no contact with participants. Expedited if student is having contact with participants. Full if protected populations are involved in the study.
21	Correct category is selected.			Most Expedited are Category 7. Most Exempt are Survey or Instrument (2nd on list) or No Human Subject Recrutiment category if secondary or archival data (last on list).
22	Principal Investigator Statement. Investigator certifies accuracy of information by typing name.