Augsburg College Institutional Review Board 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.

Project Title

Review Category

Full review

Expedited Review

Research Investigator Information

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:

Is there a co-investigator(s) on the project?

No (skip to C)

Yes, answer the following question

Provide the contact information

Name:

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(s)

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

No (skip to D)

Yes, provide the research assistant’s contact information

Name:

Telephone number:

Augsburg e-mail address:

I have submitted a signed Research Assistant Confidentiality Agreement(s)

If needed provide additional information relevant to the research investigators:

4.	Funding

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

No (go to question 5)

Yes, answer the following questions

i. Identify the type of funding

Internal Funding, please identify:

External Funding, please identify:

B. If needed, provide additional information relevant to federal grant funding:

5.	Cooperating Agency/Organization And Other Needed Reviews

A.	Is this research being conducted in cooperation with an agency/organization (i.e., a place provides assistance in recruiting subjects or provides access to potential subjects)?

No (skip to B)

Yes, answer the following questions:

Identify the cooperating agency/organization:

Describe the nature of the relationship(s) (e.g., previous or current employer, intern, etc.) between the cooperating agency/organization and the principal investigator and if relevant the co-investigator and/or research assistant:

I have submitted a signed 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, answer the following questions

Indicate the committee:

Provide 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 D)

Yes, answer the following questions

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 the IRB approval letter

D.	If needed, provide additional information relevant to cooperating agency/organization and other needed reviews:

6.	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 methodology(ies) you will be using in your study (check all that apply):

Analyzing existing data, records, or specimens; answer the following questions

Identify the source of the existing data, records, or specimens:

Identify the location of the existing data, records, or specimens:

I have submitted a signed approval letter granting me access to the source

(If sole method, skip to #10 and complete that section; then the application is completed)

Observation of public behavior (i.e., naturally occurring behavior unaffected by the research); answer the following questions

Indicate who will be observed:

Describe the behavior being observed:

Identify where the observations will occur:

(If sole method, skip to #10 and complete that section; then the application is complete)

Qualitative Research; this 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 surveys used in experimental methodology); check delivery method for the survey:

Hard copy, indicate where the surveys will be completed:

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

Experimental Research; indicate where the experiment will be conducted?

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

Does the study have more than one phase?

No, answer the following questions

Describe the one phase:

Yes, answer the following questions

Explain each phase of the study:

7.	Materials

I will be collecting the following types of data:

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; answer the following questions

Provide the survey(s) or if not possible to cut and paste, 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 a signed 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:

8.	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, answer the following questions

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

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

Yes, answer the following questions (a and b)

Check all of the risks associated with participating in your study

Inability to guarantee anonymity

Provide the reason why anonymity cannot be guaranteed:

Use of private records (medical, agency, or educational)

Describe how the risk is involved in your study:

Possible invasion of privacy of subject or family

Describe how the risk is involved in your study:

Discussion of/questions about sensitive topics

Describe how the risk is involved in your study:

Social or economic risk (i.e., participation could lead to social or economic harm)

Describe how the risk is involved in your study:

Probing for personal information

Describe how the risk is involved in your study:

Physical injury

Describe how the risk is involved in your study:

Provide referral information:

Psychological distress

Describe how the risk is involved in your study:

Provide referral information:

Use of deception (including the inability to reveal true purpose in experimental method)

Describe how the risk is involved in your study:

Describe the “debriefing procedure” that will be followed at the completion of or withdrawal from the study:

Other potential risks,

i.	Specify the risk and describe how it is involved in your study:

ii.	Describe how the risk is involved in your study:

b. Explain how the potential risks to subjects are reasonable in relation to the anticipated benefits:

D.	Protection Procedures; answer the following questions

a.	Will you be using direct quotes in any published material?

No, (skip to E)

Yes, answer the following questions

Do you plan to identify the subjects by name?

Yes (you must request permission from the subject to do so on the consent form; if not granted permission, you will use pseudonyms when discussing the subject being quoted); answer the following question.

Explain the reason for wanting to identify the subjects:

No and I will use pseudonyms (e.g., fake names, subject 1, etc.) when discussing the subject being quoted

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

9.	Subject Description and Identification

A.	Subject Population

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

Minors (under age 18)

College students

Pregnant women

HIV/AIDS patients

Economically disadvantaged

Educationally disadvantaged

Hospital inpatients or outpatients

Elderly/aged persons (over age 65)

Minority groups

Prisoners

Cognitively impaired individuals

Physically impaired individuals

Non-English speakers

Immigrants

Other characteristics, specify:

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

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

Identify the criteria for selecting someone to be a subject:

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

No (Skip to D)

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

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

No, explain why there is no relationship(s) and then skip to E:

Yes, answer the following questions

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 why the relationship is not considered close:

Yes, answer the following questions:

Explain why the relationship is considered close:

Describe the steps taken to mitigate possible coercion:

Will multiple types of subjects be included in the study?

No (skip to G)

Yes, answer the following questions

Identify the various types of subjects:

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

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

10.	Confidentiality

A. In addition to the principal investigator, co-investigator, research advisor, research assistant, translator 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:

My raw data will include information that may allow subjects to be identified

No (skip to C)

Yes, answer the following questions

Data will be kept in (at least one of the two options must be checked):

a locked file cabinet

password protected computer, database, or digital storage system

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

No, skip to II

Yes, skip to II

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

No (skip to III)

Yes, explain:

III. Will the raw data include audio or video recordings?

No (skip to C)

Yes, answer the following question.

Provide the level/date of destruction of the recording(s).

Will the recordings be transcribed?

No (skip to C)

Yes, who will be doing the transcription?

Principal investigator or co-investigator

Research assistant

Other person; identify the person:

I have submitted a signed transcriptionist confidentiality agreement

The final report will be disseminated in the following ways (check all that apply)

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 (if checked, 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 (e.g., paper, oral presentation, etc.):

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

Lindell 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:

11.	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:

12.	Informed Consent Process

IMPORTANT: In this section, you will be required to provide consent information. All consent and assent forms must be provided to the IRB in their final format as an attached word document. 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, answer the following questions and then skip to B

Please explain the type AND level of cognitive impairment:

Indicate the “status” of the subjects. There are three options. Check the ones that apply.

Subjects are over 18 with no legal guardian. Answer the following questions and then skip to B

Explain why subjects do not have a legal guardian despite being cognitively impaired:

Provide a subject consent form, with modified language, if needed.

Subjects are over 18 with a legal guardian. Answer the following questions.

Is a guardian consent form with subject assent statements appropriate for subjects with this level of cognitive impairment (i.e., subjects are capable of understanding a subject consent form)?

Yes, answer the following questions and then skip to B.

Explain why:

Provide a parent/guardian consent form with subject assent statements as an attachment.

No, answer the following questions and then skip to B

Explain why not:

Provide a guardian consent form as an attachment.

Provide a subject assent form as an attachment.

Subjects are under 18 with a parent/legal guardian, answer the following questions

Is a parent/guardian consent form with subject assent statements appropriate for subjects with this level of cognitive impairment (i.e., subjects are capable of understanding a subject consent form)?

Yes, answer the following questions and then skip to B

Provide a parent/guardian consent form with subject assent statements:

No, answer the following questions and then skip to B

Provide a parent/guardian consent form:

Is an assent form appropriate for subjects at this age and with this level of cognitive impairment?

No, skip to B

Yes, provide a subject assent form as an attachment.

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 as an attachment.

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: