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IRB Category II/III Form

If your research does not fall under Category I, it falls under either Category II or Category III.

For Category II:

Expedited Review Research, research may begin after notification by the Office of Academic Affairs following the positive recommendation of two members of the IRB.

The primary difference between Categories II and III is the level of stress, discomfort, deception, etc., involved, and the characteristics of your participants. Your research is Category II if:

1. Your research does not involve special or protected populations (e.g., participants under 18 years of age, prisoners, in/outpatients, mentally/physically disabled, pregnant women), AND

2. Your research involves only minimal risk, minimal discomfort, moderate stress, etc.

For Category III:

Full Review Research, research may begin after notification by the Office of Academic Affairs following the positive recommendation from a vote of the entire IRB.

Your research is Category III if:

1. Your proposed research involves more than minimal risk, minimal discomfort, moderate stress, etc., OR

2. Your proposed research involves special or protected populations (participants under 18 years of age, prisoners, in/outpatients, mentally/physically disabled, pregnant women).

IMPORTANT NOTICE TO STUDENT RESEARCHERS:

Once your application is submitted, it will be sent to your academic supervisor who must review your submission and send an email to IRB@depauw.edu before the Committee will review it.

Proposed research is:

Category II

Category III

Project Title:

DePauw Status (check all that apply):

Faculty

Administrator

Staff

Student

Non DePauw Participant

Researcher Name(s):

Department:

Email Address(es):

Phone number(s):

If a student, provide faculty sponsor(s) name, department, email, phone

Is this research part of a course requirement or affiliated with a course?

Yes

No

If yes, give a course name and number:

Estimated inclusive dates for data collection:

Proposed number of participants: MALE

Proposed number of participants: FEMALE

Supplementary Information

Please prepare a document addressing the issues in items 1-12 below that also includes your study description, informed consent, debriefing, and ancillary materials. This will be uploaded in the appropriate place after item 12.

1.Will any of your participants be under 18 years of age? (If yes, your document should describe how you will obtain approval from parents or guardians. If you will be gathering data in a school or institutional setting, include your procedure for obtaining authorization from school officials and teachers.)

Yes

No

2.Will any of your participants fall under "protected" categories (eg., prison imates, mentally ill, pregnant women)? If yes, your document should describe the population, and how you will obtain consent/authorization.

Yes

No

3.Will you be obtaining data from records?

Yes

No

4.Will any of your participants receive inducements (e.g., money, course credit, or extra credit) for participation? If yes, your document should include a description of the inducements.

Yes

No

5.Will your study collect information on medical conditions and/or disease/disorder/disability status? If yes, your document should describe why this is necessary and how you will preserve confidentiality and/or anonymity.

Yes

No

6.Will you be collecting data from participants concerning sensitive personal information? If yes, your document should include a description of the sensitive information, including an explanation of why you need to obtain it, and how you will obtain/record it.

Yes

No

7.Will your experimental manipulations and/or your measurment techniques intentionally produce stress/discomfort beyond everyday levels, or might your manipulations and/or measurements reasonably be expected to induce more than everyday stress? If yes, your document should describe why and how. [Note: Procedures that result in high stress/discomfort require at least some level of immediate debriefing (where such debriefing would be expected to reduce stress or discomfort), and a full debriefing at some point in time.]

Yes

No

8.Will your study manipulate feelings of self-esteem and/or competence, or involve manipulations that might reasonably be expected to affect feelings of self-esteem and/or competance? If yes, your document should explain the level and nature of the manipulation, why it is necessary, and how it will be accomplished. [Note: Procedures that reduce feelings of self-esteem and/or competence require at least some level of immediate debriefing (where such debriefing would be expected to ameliorate the reductions in self esteem/competence), and a full debriefing later in the project.]

Yes

No

9.Will your study involve deception (beyond merely not informing participants fully about the full nature of the research)? If yes, your document should explain the level and nature of the deception, why it is necessary, and how it will be accomplished.

Yes

No

10.Will your study involve any risks/discomfort in addition to those asked about in this form? If yes, your document should describe those risks/discomforts.

Yes

No

11.Will the data you collect preserve participant anonymity? (Participant anonymity is preserved when a study is conducted in a manner that does not allow linkage of participant names with individual data; that is, no one, not even the researcher, can link participant identity with individual data.) If yes, please explain how you will preserve anonymity in your document.

Yes

No

12.Will the data you collect preserve participant confidentiality? (Participant confidentiality is preserved when results are presented in a manner that does not allow identification of individual participants and their data—that is, although the researcher may be able to identify individual participants and link names to data, results are not presented in a manner that allows others to identify individual participants and their data.) If yes, please explain how you will preserve confidentiality in your document.

Yes

No

For your submission you will need to upload a document that has the following items: answers to questions 1-12, description of the study, informed consent form, debriefing, and other supporting materials. For complete information on each of these, please access this link: http://www.depauw.edu/office/academic-affairs/research-at-depauw/guidelines-for-using-human-sub/

Upload the document containing the information listed in the previous section.

Upload any additional materials that cannot be included in your original document, such as separate pdf files (e.g., appendices, questionnaires).

Acknowledgement of Investigator(s):

By submitting this application I(we) acknowledge that this research is in keeping with the standards set by our discipline and that the principal investigator has met all IRB requirements for review and approval of this research.

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