Augsburg College Institutional Review Board

EXEMPT Application

IMPORTANT: Please consult the instructions for completing this application as it provides helpful tips that will facilitate completion. It is located on the IRB website. This is the application is for the 2015-2016 academic year. Only the current application will be accepted for review as of September 1, 2015. Items in red represent materials that must be submitted.

This application is designed for EXEMPT RESEARCH ONLY. Please see the definition here:

Research is reviewed for Exempt status (Level I review) by an IRB member if it involves very minimal or no risk and is conducted on the general public (ie, does not involve the protected classes of participants). The exception here is observation of classroom behavior of minor children. In general, research which does not propose to disrupt or manipulate the normal life experiences of subjects, incorporate any form of intrusive procedures or sensitive topics, or involve deception will be exempt from full IRB review. Projects that involve more than very minimal risk, are conducted with protected class(es) of participants as defined by 46.102 and those that include any degree of deception do not qualify for Exempt status.

1. Project Title

2. Research Investigator Information

A. Principal Investigator:

Department:

Address:

Telephone number:

Campus Box:

Augsburg e-mail address:

Faculty

Staff

Student

Undergraduate Research

Graduate Research

Indicate the degree program:

Advisor’s name:

Address:

Department:

Telephone number:

Augsburg e-mail address:

B. Co-investigator(s) name: Not applicable, skip to C

Institution:

Address:

Telephone number:

e-mail address:

Are any of the co-investigators affiliated with a non-academic institution?

No (Skip to C)

Yes, identify the co-investigator(s):

I have submitted a signed Non-Academic Institution Affiliated Co-investigator Confidentiality Agreement

C. Do you plan to use a research assistant(s) to collect or analyze data?

No (go to question 3)

Yes, provide the research assistant’s contact information

Name:

Telephone number:

Augsburg e-mail address:

I have submitted a signed Research Assistant Confidentiality Agreement

3. Funding

A. External or Internal funding will be sought/has been obtained for this project

No (go to question 4)

Yes, answer the following questions

i. Identify the type of funding

Internal Funding, please identify:

External Funding, please identify:

4. Cooperating Agency/Organization And Other Needed Reviews

A. Is this research being conducted in cooperation with an agency/organization?

No (skip to B)

Yes, answer the following questions:

i. Identify the cooperating agency/organization:

ii. Describe the nature of the relationship(s) between the cooperating agency/organization and the principal investigator and/or co-investigator (if relevant), and/or research assistant (if relevant):

I have submitted an approval letter from the proper authority at the agency/organization to conduct this research

B. Is this research subject to review by another internal committee of the College?

No (skip to C)

Yes, indicate the committee and the reason for the review:

Status of review

Submission pending

Under review

If submission is pending or under review explain why you needed to submit the Augsburg IRB application before approval was obtained:

Approved

I have submitted a copy of the approval letter from the committee

C. Is this research subject to review by any other Institutional Review Board?

No (skip to 5)

Yes, identify the location of other IRB:

Status of review

Submission pending

Under review

If pending or under review explain why you needed to submit the Augsburg IRB application before approval was obtained:

Approved

I have submitted a copy of the IRB approval letter

5. Research Question/Hypothesis, Purpose, and Methodology

A. Describe your research question/hypothesis in lay language, provide the justification for the research, and how it fits with previous research in the field:

B. Methodology

i. Identify the type of methodology(ies) you will be using in your study:

Analyzing existing data, records, or specimens.

Explain the source and its location:

I have submitted an approval letter granting me access to the source

(If sole method, skip to #9—and only respond to the questions there; DO NOT respond to the rest of the form)

Observation of public behavior

Describe who will be observed, what behavior is being observed, and where the observations will occur:

(If sole method, skip to #9—and only respond to the questions there; DO NOT respond to the rest of the form)

Qualitative Research

The research involves the use of:

Interviews

Indicate where the interviews will take place:

Focus Groups

Indicate where the focus groups will take place:

Survey Research (not the use of surveys in an experimental methodology)

Check the delivery method for the survey:

Hard copy, indicate where the surveys will be completed:

On-line, provide the survey tool used to deliver the survey (e.g. survey monkey) :

Normal Educational setting (i.e., focuses on subjects who are enrolled in a specific class(es)?

a. Indicate the “grade(s)” being tested:

pre-school through high-school

post-secondary

b. Is the research conducted during class time?

No, indicate where and when the research will be conducted:

Yes, describe in detail the activity for non-subjects and indicate who will be supervising them:

c. Is there anything that all subjects need to do even if they chose not to participate in the study?

No (skip to D)

Yes, explain the specifics and the accommodations for the students who choose not to participate in the study:

ii. Will multiple phases be used in the study?

No, answer the following questions

Describe the one phase:

Identify the criteria for selecting someone to be a subject:

Yes, answer the following questions

Explain each phase of the study:

Identify the criteria for selecting someone to be a subject:

iii. Indicate how long it will take for the participant to complete the survey, interview, focus group, or observation:

6. Materials

A. I will be collecting data in the following manner (check all that may apply):

Audio recording

Video recording

Written notes

Photographs

Drawings

Interviews/focus group questions

Provide the initial interview/focus group questions with the understanding that additional questions may be asked based on subject responses to these initial questions:

Surveys

Provide the survey(s) or if not possible to cut and paste it, indicate that it is attached in a separate document:

Did you create the survey(s)?

Yes

No, do you have permission to use the survey(s)?

Yes and I have submitted the approval letter giving me permission to use the survey

No, explain why approval is not needed:

Other, please identify:

B. If needed, provide additional information relevant to your materials:

7. Risk/Benefit Ratio

A.	Monetary Compensation; answer the following questions

I.	Will subjects receive some type of monetary compensation for participating in the study?

No (skip to B)

Yes, answer the following questions

Describe the type AND amount of compensation:

B.	Benefits; answer the following questions

I.	Direct Benefits; answer the following questions

a.	Will subjects receive a reward/incentive (other than monetary) for participating in the study?

No (skip to II)

Yes, answer the following questions

Is one of the direct benefits course credit/extra credit?

Yes, one of the direct benefits is course credit/extra credit: answer the following questions

Identify the course(s):

No, one of the direct benefits is not course/extra credit: answer the following questions

Describe the proposed reward/incentive:

Justify how the proposed incentive/reward is not coercive:

II.	Indirect benefits: answer the following question

a.	Indicate potential benefits to science or society, in general (e.g., adding to existing knowledge), or to the course objectives (if direct benefit is course credit), as a result of participating:

C. Risks:

Does this study involve more than minimal risks to subject(s) (please review all of the risks below before indicating no)?

No, justify why your study does not involve more than minimal risks and then skip to D:

Yes, then this is not exempt research and you must complete the Full/Expedited application.

D. Protection Procedures

In the final report

Will you be using direct quotes?

No, (skip to E)

Yes, answer the following question

I will be identifying the subjects by name

Yes (if granted permission by the subject and if requested will use a pseudonym),

Explain the reason for wanting to identify the subjects:

No and I will use pseudonyms when discussing the subject being quoted

E. Describe other precautions to protect against risks that are specific to your study:

F. If needed, provide additional information relevant to the risk/benefit ratio:

8. Subject Description and Identification

A. Indicate the maximum number of subjects who may participate in your study: .

1. Identify the criteria for selecting someone to be a subject:

2. Will multiple types of subjects (e.g., teachers and students) be included in the study?

No (skip to B)

Yes, answer the following questions

Identify the various types of subjects:

Indicate the maximum number of each type who may participate in your study:

B. Check any of the populations you are targeting in your study

Minors (under age 18)

College students

Non English speaking

Other characteristics, specify:

Provide your rationale for purposefully targeting any of the above populations:

C. Are you identifying potential subjects based on private records “owned” by a cooperating agency/organization

No (Skip to D)

Yes and I have submitted the approval letter(s) specifically granting me access to the private records

D. Does the primary investigator, co-investigator (if relevant), or research assistant (if relevant) have a relationship with potential subjects?

No, explain why there is no relationship(s):

Yes, describe the relationship(s):

Could the relationship(s) be considered particularly close as defined by a relationship that is personal, involves frequent contact, or one that involves a power differential?

No, explain your answer:

Yes, describe the steps taken to mitigate possible coercion:

E. If needed, provide additional information relevant to subject description and identification:

9. Confidentiality

A. In addition to the primary investigator, co-investigator (if relevant), research advisor, research assistant (if relevant), translator (if relevant) and transcriptionist (if relevant), the following individuals will have access to the raw data

Identify the individual(s), including title and agency/organization and reason why they will need access to the raw data:

B. My raw data includes identifying information

No (skip to C)

Yes, answer the following questions

I. Data will be kept in:

a locked file

password protected computer, database, or digital storage system

Is the computer/database/digital storage system located at a cooperating agency/organization?

No

Yes

II. Will the data be part of a subjects’ chart, student file, or other permanent record?

No

Yes, explain:

III. Will the data include audio or video recordings?

No (skip to C)

Yes, answer the following questions.

a. Provide the level/date of destruction/erasure of the recordings:

b. Will the recordings be transcribed?

No (skip to C)

Yes, answer the following questions

Who will be doing the transcription?

Primary investigator or co-investigator

Research assistant

Other person

Identify the person:

I have submitted a signed transcriptionist confidentiality agreement

C. The final report will be disseminated in the following ways

Possible publication in scholarly/professional journals

Possible publication in a book

Possible presentation at local, regional, national or international conferences via a poster or oral presentation

Subjects (must ensure that each subject receives a copy of the final report)

External funding agency

Cooperating agency/organization

Identify the name (with title and agency/organization) to whom the report will be given and in what form:

Other means of dissemination, describe:

For Graduate Research only

Paper to Faculty for completion of degree requirements

Oral presentation to Faculty for completion of degree requirements

Library

For Undergraduate Research only

URGO presentation and paper

McNair presentation and paper

LSAMP presentation and paper

Paper to Faculty for Departmental Honors

Presentation to Faculty for Departmental honors

D. If needed, provide additional information relevant to confidentiality:

10. Recruitment

IMPORTANT: In this section, you will be required to provide recruitment documents. Therefore, a helpful guideline for creating recruitment documents is available in the Supplemental Resources section on the IRB website.

A.	Check which of the three (I-III) recruitment methods will apply to the study and/or identify another method of recruitment (IV).

I. Potential subjects will be recruited via e-mail postal mail letter telephone

a. Who will be doing the recruitment?

The principal/co-investigator and/or research assistant will be recruiting subjects (answer the following questions)

i. Check how the contact information (telephone number, e-mail address, postal address) for potential subjects will be obtained (check all that apply):

Principal/co-investigator personally possesses the contact information

Describe how/why the principal/co-investigator has personal access to the contact information:

Contact information for potential subjects is publically available

The cooperating agency/organization(s) will be asked to provide the contact information

People who the principal/co-investigator personally know will be asked to provide the contact information

Identify the type of people (e.g. friends, colleagues):

Describe how/why they have access to contact information:

A snowball method of recruitment will be used--subjects will be asked for the contact information

Describe how/why subjects have access to contact information:

Provide the recruitment e-mail, postal mail letter, or script for the telephone recruitment worded from the perspective of the researcher:

Someone other than the principal/co-investigator or research assistant will be recruiting subjects (answer the following questions)

Check all the ways in which recruiters will be identified:

Recruiters are employed at/”work for” the cooperating agency/organization(s)

Describe how recruiters will be identified:

Describe how/why they have access to subjects:

Principal/ co-investigator personally know the recruiters

Describe how the principal/co-investigator know the recruiters:

Describe how/why the recruiters have access to subjects:

Provide the recruitment e-mail, postal mail letter, or script for the telephone recruitment worded from the perspective of the recruiter:

II. Potential subjects will be recruited in person

Identify the location AND, the specific context in which the recruitment will take place:

Identify who will be doing the recruitment:

Indicate who is providing approval to do the recruitment at this location (check the one that applies):

I am the proper authority (e.g., your college classroom, your workshop)

I have submitted a signed approval letter granting me permission to recruit at the location

Provide the verbal script that will be used to recruit subjects and the handout given to potential subjects (if relevant). If someone other than the researcher is doing the recruitment be sure the recruitment information is worded from the recruiter’s perspective and not the researcher’s perspective:

III.	Potential subjects will be recruited via some type of posting

a.	Is.the posting in virtual space (e.g., facebook)?

Yes, answer the following questions, then skip to IV

Identify the specific venue:

Provide the exact wording that will be used in the posting:

No, it will be placed in a physical location (answer the following questions)

Describe the specific type of posting(s):

Provide the exact wording that will be used in the posting:

Is the physical location private property?

No, answer the two following questions

Describe the public place at which the posting will be placed:

Justify why it is public:

Yes, answer the following questions

Describe the private property at which posting will be placed:

I have submitted a signed approval letter granting me permission to post at the private location

IV. Potential subjects will be recruited by another method of recruitment

Explain the recruitment method:

B. If needed, provide additional information relevant to recruitment:

11. Informed Consent Process

IMPORTANT: In this section, you will be required to provide consent information as well as provide the final copy of the consent form as it will be presented to the subject. The consent form must be attached as a separate document and may not be copied into the application. Therefore, a helpful guideline for creating consent documents is located in the Supplemental Resources section on the IRB website.

Age and Ability Concerns. Answer the following questions

Are subjects cognitively impaired?

Yes, then this is not exempt research and you must complete the Full/Expedited application.

No, there is no level of cognitive impairment (answer the following questions)

Age Range of subjects

0-7 years (provide the information below and if sole age range, skip to B)

a. Provide a parent/guardian consent form:

b. Describe the process for obtaining parental/guardian consent, including when and where	it will occur and who will be obtaining consent:

8-17 years (provide the information below and if the sole age range, skip to B)

a. Provide a subject assent form (wording may vary depending on age):

b. Provide a parent/guardian consent form:

c. Describe the process for obtaining parental/guardian consent AND subject assent,	including when and where each will occur and who will be obtaining each:

18+ years

Is there contact with the subjects?

No

Yes, answer the following questions

Check all the type(s) of contact there will be with the subject

Subjects will be physically present

Subjects will be present via: phone or skype-like	technology, answer the following questions

Describe the process for obtaining and tracking consent:

Describe the process for getting subjects a copy of the consent form:

Provide a copy of the subject consent form as an attachment.

B. Questions asked to assess the subject’s understanding of the study and consent

There is no contact with the subject so no questions will be asked (if sole method skip to C)

There is contact with the subject (answer the following questions)

Required questions (All of the following must be present in the consent form)

Do you understand that you are free to withdraw from this study at any time?

Do you understand that you may skip any questions or tasks?

Do you have any questions about what you are being asked to do?

Is age-appropriate or ability-appropriate versions of the above questions needed?

No (skip to III)

Yes, provide the appropriate versions of the questions:

C. If needed, provide additional information relevant to the informed content process: