Sample IRB

CCLASSS TOOLKIT

Sample IRB

he following IRB was developed by Jean Amaral from Borough of Manhattan Community

College as part of the Community College Libraries & Academic Support for Student Success

(CCLASSS) project. For more information on the project and additional resources, please see

https://sr.ithaka.org/our-work/cclasss-toolkit

University Integrated Institutional Review Board

205 East 42

Street

New York, NY 10017

http://www.cuny.edu/research/compliance html

Initial Application

2018-0133

Jean Amaral

Table of Contents

1. Summary..................................................................................................................................................................................1

2. Summary - Exemption.........................................................................................................................................................2

3. Research Personnel.............................................................................................................................................................3

4. Other Personnel.................................................................................................................................................................... 4

5. Research Sites...................................................................................................................................................................... 5

6. Research Design - Overview............................................................................................................................................7

7. Research Design - Procedures and Risks................................................................................................................... 9

8. Research Design - Risks and Benefits....................................................................................................................... 11

9. Funding - Sources..............................................................................................................................................................12

10. Funding - Federal Details..............................................................................................................................................13

11. Participants - Populations..............................................................................................................................................14

12. Participants - Projected Enrollment............................................................................................................................15

13. Participants - Eligibility................................................................................................................................................... 16

14. Participants - Recruitment.............................................................................................................................................17

15. Participants - Consent....................................................................................................................................................18

16. Participants - Compensation........................................................................................................................................ 19

17. Participants - Privacy and Confidentiality.................................................................................................................20

18. Attachments....................................................................................................................................................................... 21

University Integrated Institutional Review Board

205 East 42

Street

New York, NY 10017

http://www.cuny.edu/research/compliance html

2018-0133 Initial Application Jean Amaral

1. Summary

Protocol Title

Community College Libraries and Academic Support for Student Success (CCLASSS)

Primary College Borough of Manhattan Community College

PI relationship to CUNY Full-time Faculty

Application Initiated By Jean Amaral

Are you seeking an approval for

a project that is lacking definite

plans for involvement of human

subjects (45 CFR 46.118)?

Research Type Social Behavioral

Are you seeking an exemption from

IRB review?

Yes

Lay Summary

Through semi-structured interviews and surveys, the researchers will develop and assess a series of concepts for

innovative library services with the goal of improving support of community college success.

Do you have a scientific protocol or

a sponsors protocol?

Page 1 of 21

University Integrated Institutional Review Board

205 East 42

Street

New York, NY 10017

http://www.cuny.edu/research/compliance html

2018-0133 Initial Application Jean Amaral

3. Research Personnel

Name/Department Role/Status Contact Access Signature

Authority

Phone Email

Jean Amaral /

Borough of

Manhattan

Community College

PI / Yes

LaGuardia

Community College

Co-Investigator /

/ Temp

Department

Co-Investigator /

Queensborough

Community College

Co-Investigator /

Page 3 of 21

University Integrated Institutional Review Board

205 East 42

Street

New York, NY 10017

http://www.cuny.edu/research/compliance html

2018-0133 Initial Application Jean Amaral

4. Other Personnel

None

Page 4 of 21

University Integrated Institutional Review Board

205 East 42

Street

New York, NY 10017

http://www.cuny.edu/research/compliance html

2018-0133 Initial Application Jean Amaral

5. Research Sites

Name CUNY

Sub-Location LaGuardia Community College

Site PI

Role of the site in

research

9999999

Has IRB? No

Permission Granted? No

Name CUNY

Sub-Location Bronx Community College

Site PI

Role of the site in

research

9999999

Has IRB? No

Permission Granted? No

Name CUNY

Sub-Location Queensborough Community College

Site PI

Role of the site in

research

9999999

Has IRB? No

Permission Granted? No

Name Northern Virginia Community College

Sub-Location

Site PI

Role of the site in

research

data collection and analysis

Has IRB? No

Permission Granted? No

Name Monroe Community College

Sub-Location

Site PI

Role of the site in

research

data collection and analysis

Has IRB? No

Permission Granted? No

Name Pierce Community College District (Washington State)

Sub-Location

Site PI

Role of the site in

research

data collection and anaylsis

Has IRB? No

Permission Granted? No

Name Ithaka S+R

Sub-Location

Site PI

Role of the site in

research

data collection and analysis

Has IRB? No

Permission Granted? No

Name CUNY

Sub-Location Borough of Manhattan Community College

Site PI

Role of the site in

research

9999999

Has IRB? No

Permission Granted? No

Page 6 of 21

University Integrated Institutional Review Board

205 East 42

Street

New York, NY 10017

http://www.cuny.edu/research/compliance html

2018-0133 Initial Application Jean Amaral

6. Research Design - Overview

Research Purpose and Hypothesis

The vast majority of research on how to adapt library services to support new priorities has been conducted at

four year colleges and universities. And, the definitions of student success used in these projects have often

derived from higher education institutions, state boards of education, and the federal government, thus omitting

the perspective of the student in what defines success. This project will take an important step to address these

imbalances.This study is an exploratory qualitative analysis of the practices, perspectives, and needs of community

college students in order to understand and determine the resources and services these students need to be

successful. This information will be used to generate a series of concepts for services that community college

libraries might seek to offer.

Research Design and Methodology

The research methodology includes semi-structured interviews with students which will be used to develop service

concepts, and these service concepts will then be tested with a survey. Students will participate in one-on-one

semi-structured interviews with a researcher. The interviews will be approximately 45-60 minutes and take place at

a convenient location on campus or by telephone. These interviews will be conducted by Ithaka S+R Researcher

Ithaka S+R is a not-for-profit service that helps the academic and cultural communities

serve the public good and navigate economic, technological, and demographic change. The research team will use

the interview data to develop a survey testing service concepts that emerge from the interviews. The collected data

from the seven participating community colleges will be analyzed thematically, and the findings will be released in a

public research report on student perspectives, practices, and needs.

Retrospective Data Review ONLY No

Funding Requested/Obtained Yes

Will you obtain informed consent

from participants?

Yes

Compensation for participation Yes

Will participants incur any research

related costs?

Is compensation available for

research related injury?

Surveys or Questionnaires Yes

Will the survey or questionnaire

be self administered by the

participants?

Yes

Do you intend to give feedback

to participants based on survey/

questionnaire results?

Attach survey(s) / questionnaire(s)

Title Survey Information

Upload CCLASSS-survey.docx

Interviews Yes

Who will conduct the interview

Will any individual(s) other than

the research personnel be present

during the interview?

Attach interview questions

Title Interview Questions

Upload CCLASSS-interview-protocol.docx

Observation No

Audio or Video Recording or

Photograph

Yes

Please be sure to insert template language regarding recordings and/or photographs in the

consent document

Check all that apply

Audio Recording Yes

List the procedures that will be recorded

Semi-structured interviews will be recorded.

State the purpose of recording

Recordings will be transcribed in order to complete thematic coding.

Will participants be permitted

to review, edit and/or erase the

recording?

Yes

Will participants be identified in the

recording?

Who will have access to the

recordings?

Video Recording No

Photograph No

Deception No

Access to or use of pre-existing

non-medical records, including

student records

Access or use of medical records No

Will participants be screened? No

Prospective Biological Sample

Collection and Existing

Biospecimens

Drugs or Vaccines No

Devices No

Page 8 of 21

University Integrated Institutional Review Board

205 East 42

Street

New York, NY 10017

http://www.cuny.edu/research/compliance html

2018-0133 Initial Application Jean Amaral

7. Research Design - Procedures and Risks

Participant Group

List all research related

procedures/data

collection methods

involving interaction

or intervention with

participants; use the

Add New Procedure and

Risk button to add each

method.

Procedure Semi-structured interviews will be conducted with three to seven students at each of the

seven participating community colleges.

Where it will take place? In office or other private room on campuses of participating institutions.

When it will take place? Spring semester 2018, as scheduled with participants.

Frequency Each student will be interviewed once.

Is procedure optional for

participants?

Yes

Associated risk or

discomfort

There are no known risks associated with participating in this study.

Anticipated severity of

risk or discomfort

no anticipated risk

Expected frequency of

risk or discomfort

not applicable

Risk reduction or

mitigation method

not applicable

Participant Group

List all research related

procedures/data

collection methods

involving interaction

or intervention with

participants; use the

Add New Procedure and

Risk button to add each

method.

List all research related procedures/data collection methods involving interaction or

intervention with participants; use the Add New Procedure and Risk button to add each

method.

Procedure Survey will be administered by email at the seven participating community colleges.

Where it will take place? Online

When it will take place? Fall semester 2018

Frequency One time

Is procedure optional for

participants?

Yes

Associated risk or

discomfort

There are no known risks associated with participating in this study.

Anticipated severity of

risk or discomfort

no anticipated risk

Expected frequency of

risk or discomfort

not applicable

Risk reduction or

mitigation method

not applicable

Page 10 of 21

University Integrated Institutional Review Board

205 East 42

Street

New York, NY 10017

http://www.cuny.edu/research/compliance html

2018-0133 Initial Application Jean Amaral

8. Research Design - Risks and Benefits

Does your research claim to

present a therapeutic benefit to the

participants?

Expected Direct Benefit(s)

Participants may experience benefits in the form of increased insight and awareness into their own practices and

needs.

Benefit to Society

Community colleges nationwide will have access to two research reports which will support the development of

new services to students: one on student perspectives, practices, and needs, and a second providing specific

assessments of service models.

Will data safety monitoring be

done?

Page 11 of 21

University Integrated Institutional Review Board

205 East 42

Street

New York, NY 10017

http://www.cuny.edu/research/compliance html

2018-0133 Initial Application Jean Amaral

9. Funding - Sources

Grant or Contract Title Community College Library Support for Student Success

Grant or Contract

Number

Funding Status: Funded

Grant/Contract PI:

Department Borough of Manhattan Community College

Division

Phone

Funding Source: Institute of Museum and Library Services

Contact

Funding Category: Federal

Do the protocol and

funding proposal

match?

Yes

Identify the substantive

differences

Page 12 of 21

University Integrated Institutional Review Board

205 East 42

Street

New York, NY 10017

http://www.cuny.edu/research/compliance html

2018-0133 Initial Application Jean Amaral

10. Funding - Federal Details

Is CUNY the prime awardee and/or

coordinating center?

Yes

Please outline your procedures for oversight of the conduct of this research at the external collaborating

sites:

The research at each site will be coordinated by the campus PI and conducted by Ithaka S+R. Oversight will be

jointly shared between the CUNY lead, Jean Amaral, and the grant lead, Dr. Braddlee. Ithaka S+R will be in close

contact with both the campus contacts and the leads as the research progresses.

Please outline your procedures for ensuring timely communication amongst the collaborating sites with

regards to i) modifications to the protocol & related documents; and ii) unanticipated problems involving

risks to participants or others:

The project team, which includes representatives of the seven colleges and Ithaka S+R, holds regularly scheduled

conference calls, and also communicates frequently through a project team email distribution list.

You will maintain with your research records for this study: Documentation of

Federalwide Assurance (FWA) for each of the collaborating sites engaged in human

participants research. Documentation of current IRB approval and IRB approved

documents from the designated IRB of all collaborating sites engaged in human

participants research. Collaborative agreements/contracts with all collaborating sites,

when applicable

I certify Yes

Will any participating sites or

individual investigators rely on

CUNY UI IRBs?

Yes

Attach letter from relying sites institutional official agreeing to comply with CUNY policies and procedures.

Attach executed IRB Authorization Agreement or Individual Investigator Agreement

Page 13 of 21

University Integrated Institutional Review Board

205 East 42

Street

New York, NY 10017

http://www.cuny.edu/research/compliance html

2018-0133 Initial Application Jean Amaral

11. Participants - Populations

Age Range(s) 18 years of age or older

Targeted Population(s) CUNY Students

Page 14 of 21

University Integrated Institutional Review Board

205 East 42

Street

New York, NY 10017

http://www.cuny.edu/research/compliance html

2018-0133 Initial Application Jean Amaral

12. Participants - Projected Enrollment

Please provide the upper limit of anticipated enrollment

Projected Enrollment 15,000

Page 15 of 21

University Integrated Institutional Review Board

205 East 42

Street

New York, NY 10017

http://www.cuny.edu/research/compliance html

2018-0133 Initial Application Jean Amaral

13. Participants - Eligibility

Inclusion Criteria and Rationale

Approximately 500 students (random sample) at each participating institution will receive an email invitation to

participate in the study. Students who are interested in participating will fill out a form to indicate their interest and

availability. From those who indicate interest in participating, approximately 3 to 7 will be randomly selected to

participate in the interviews. The data from the semi-structured interviews will be used to develop a survey. The

survey will be sent to a random sample of 10,000 to 15,000 students at each campus, with an anticipated response

rate of 15%. Students must indicate that they are 18 years or older to participate.

Exclusion Criteria and Rationale

Students must be at least 18 years of age to participate in the study.

Page 16 of 21

University Integrated Institutional Review Board

205 East 42

Street

New York, NY 10017

http://www.cuny.edu/research/compliance html

2018-0133 Initial Application Jean Amaral

14. Participants - Recruitment

Method(s) Broadcast emails

Outline the recruitment process in a step-by-step fashion

Approximately 500 students (random sample) at each participating institution will receive an email invitation to

participate in semi-structured interviews. Students who are interested in participating will fill out a form to indicate

their interest and availability. From those who indicate interest in participating, approximately 3 to 7 will be randomly

selected to participate in the interviews. An email invitation to participate in the survey developed from the interview

data will be sent to approximately 15,000 randomly selected students on each campus. The broadcast email text for

the survey will be uploaded when the survey is developed in summer 2018.

Identify the group(s) to whom email will be sent

For the interviews, 500 randomly selected students on each campus. For the survey, 15,000 randomly

selected students on each campus.

Indicate how you have access to these email addresses

Access will be through the campus institutional research offices.

Attach email text you will use

Type Broadcast emails

Title Recruitment Email

Page 17 of 21

University Integrated Institutional Review Board

205 East 42

Street

New York, NY 10017

http://www.cuny.edu/research/compliance html

2018-0133 Initial Application Jean Amaral

15. Participants - Consent

Documented informed consent and/

or parent or guardian permission

Yes

Are you requesting Broad Consent

Oral or internet based informed

consent and/or parent or guardian

permission

Yes

Waiver of Informed Consent

Involving Public Benefit and

Service Programs

Alteration of Informed Consent

Involving Public Benefit and

Service Programs

Documented informed consent and/or parent or guardian permission

Identify the research personnel who

will obtain consent

Jean Amaral

Identify where and when consent will be obtained from potential participants

For the semi-structured interviews, consent will be obtained at the time of the interview. For the surveys, consent will

be obtained online before participants begin filling out the survey. The interview consent form is attached. The survey

protocol will be provided when the survey is developed after the data from the interviews has been analyzed; this is

scheduled for summer 2018.

Attach Consent/Permission Document(s)

Title Interview Consent Form

Page 18 of 21

University Integrated Institutional Review Board

205 East 42

Street

New York, NY 10017

http://www.cuny.edu/research/compliance html

2018-0133 Initial Application Jean Amaral

16. Participants - Compensation

Type Monetary

Amount $50.00

Justification Time

Description (Address

the compensation

schedule for participants

that withdraw from the

research protocol.)

For the semi-structured interviews, there is no compensation for non-participation, as

the time spent would have been the interview itself.

When will participants be

compensated?

End of each visit

Explain when

Describe mechanism

in place to ensure

confidentiality

when distributing

compensation

Participants will receive an Amazon gift card at the end of the interview, which does not

include any identification.

Type Monetary

Amount $100.00

Justification Time

Description (Address

the compensation

schedule for participants

that withdraw from the

research protocol.)

As incentive to take the survey, students who complete will be entered in a raffle.

When will participants be

compensated?

Other

Explain when The raffle winners will be drawn after the survey has closed.

Describe mechanism

in place to ensure

confidentiality

when distributing

compensation

The collection of contact information for the raffle will be separate from the survey data.

Page 19 of 21

University Integrated Institutional Review Board

205 East 42

Street

New York, NY 10017

http://www.cuny.edu/research/compliance html

2018-0133 Initial Application Jean Amaral

17. Participants - Privacy and Confidentiality

Describe the mechanisms in place to protect the privacy of participants during recruitment, consent process

and research procedures

Participants will sign informed consent forms but these forms will in no way be linked to the collected data because

there will be no key that corresponds the participants to their responses. Informed consent forms will be stored as

paper copies in a locked file cabinet only accessible to the investigators. Ithaka S+R will store digital copies on a

private protected drive which will only be accessible to the Ithaka S+R project team and ITHAKA network domain

administrators.

Describe the mechanisms in place to maintain confidentiality of participant data

Interviews will be recorded and transcribed, and only the investigators will have access to the recordings and

transcriptions. Following the interviews, Ithaka S+R will store the recordings and transcriptions on a private

protected drive which will only be accessible to the Ithaka S+R project team and ITHAKA network domain

administrators.

How will you store participant data Without any identifiers or codes

What will you do with the data once

the research has been completed?

Retain data for three years, or longer when

required by the study sponsor, then destroy

it.

Page 20 of 21

University Integrated Institutional Review Board

205 East 42

Street

New York, NY 10017

http://www.cuny.edu/research/compliance html

2018-0133 Initial Application Jean Amaral

18. Attachments

Type Name Version Status Filename Uploaded

Date

Interview Question(s) CCLASSS-interview-

protocol.docx

1 New CCLASSS-interview-

protocol.docx

02/02/2018

Email Text CCLASSS-email-

recruitment.docx

1 New CCLASSS-email-

recruitment.docx

02/02/2018

Informed Consent

Document

CCLASSS-consent-

form.doc

1 New CCLASSS-consent-

form.doc

02/02/2018

Survey(s) CCLASSS-

survey.docx

1 New CCLASSS-

survey.docx

02/02/2018

Curriculum Vitae 1 New 02/09/2018

Curriculum Vitae 1 New

Curriculum Vitae 1 New 02/09/2018

Curriculum Vitae 1 New

Page 21 of 21

02/09/2018