Application for IRB Approval

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Applicant Information

Principal Investigator*

Name of the project’s principal investigator. For PhD candidates the Principal Investigator is the student.

Principal Investigator Email Address*

Principal Investigator Phone*

How many co-investigators will take part in this research?*

Co-Investigator 1 Name*

Co-Investigator 1 Email*

Co-Investigator 1 Phone*

Co-Investigator 2 Name*

Co-Investigator 2 Email*

Co-Investigator 2 Phone*

Co-Investigator 3 Name*

Co-Investigator 3 Email*

Co-Investigator 3 Phone*

Co-Investigator 4 Name*

Co-Investigator 4 Email*

Co-Investigator 4 Phone*

Co-Investigator 5 Name*

Co-Investigator 5 Email*

Co-Investigator 5 Phone*

Have you verified that the email address on this form are correct?*

Yes

Have you actually verified that the email address on this form are correct?*

Yes, I have actually checked

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Co-investigators [[Retired]]*

names, departments, email addresses, and telephone numbers for all of the project’s co-investigators.

In what role are you conducting this research at Indiana Tech?*

Student

Faculty

Staff

External Researcher

Select the degree level you are pursuing*

Undergraduate

Graduate

Doctoral

Are you doing this research for a course?*

Yes

Enter the course for which you are doing this research.*

i.e., course code and name, master’s thesis, or dissertation

Explain why you are conducting this research*

e.g., professional development, personal research, etc.

Select the college or department in which you work or study*

College of Business

College of Arts and Sciences

College of Engineering and Computer Sciences

Other

Where do you work or study?*

e.g., external organization name

Project Information

Complete this form and attach any required or relevant documents. The IRB will determine the type of review required for the proposal and will communicate a decision within 20 business days.

As of January 1, 2020, all investigators must obtain a CITI certification for research ethics and compliance training. This certificate must be included as an attachment in the Application for IRB Approval. All Indiana Tech students, faculty, and staff may obtain the CITI Institutional Training free of charge through the Let Me In one-click apps.

When identifying the specific course to take to obtain the required certification, select “Biomedical Researchers” or “Social-Behavioral-Educational Researchers” under Question 1. Researchers can ignore Question 2 but may opt to take additional courses under Questions 3-8. However, the IRB only requires that researchers complete a training from Question 1. For more guidance on courses, please email IRB@IndianaTech.edu.

Is this application a revised application from a previous denial?*

If yes, describe what has been changed in this application from previous versions.*

Project Title*

Title of your research project.

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Exemption Status [[Retired]]*

Indicate whether the research should be exempt or non-exempt from further human subjects review, including which of the six exemption categories that apply for an exemption.

See Appendix A for a list of the six exemption categories.

Exemption Status*

Indicate whether the research should be exempt or non-exempt from further human subjects review, including which of the six exemption categories that apply for an exemption.

See Exemption Categories for a list of the six exemption categories.

Exempt

Non Exempt

Under which of the following categories is your research exempt? (select all that apply)*

Category 1

Category 2

Category 3

Category 4

Category 5

Category 6

Expedited Status

Indicate whether the research is considered expedited, which addresses protocols presenting no more than minimal risk to subjects. Identify which of the procedures described in Expedited Categories apply to the research.

Project Purpose*

Briefly describe the proposed research project, clearly stating its purpose, the nature of the research that will be conducted, and dates for the beginning and ending of data collection. Be sure to clarify if this research is a regular, standing part of participation in a specific course, continuing every semester or every year.

Participants – Individuals

Participants – Individuals*

Describe the demographic characteristics of the participants in your research.

Vulnerable Populations*

Will any children, prisoners, pregnant women, individuals diagnosed with developmental delays, individuals living with mental illness, or other potentially vulnerable populations be included in the research?

Participant Population*

From what population will the participants/sample be drawn? Why are you using this sample?

Sample Size*

How many people will you recruit? How many participants do you hope to have? Why do you plan to have this number of participants? What will happen if you do not get the desired amount of participants?

Purposeful Inclusion or Exclusion*

Explain the rationale for intentional inclusion or exclusion of any subpopulation beyond convenience sampling (e.g., males only, females only).

Identification of Participants*

How will potential participants be identified and recruited (including the setting or online environment in which recruitment will take place)? How will investigators gain access to this population and how will the process respect participants’ privacy? Be sure to include copies of all recruitment materials in the attachments section of this form.

Incentives*

Will any participants receive compensation or other incentives to participate in the research project? If yes, describe the incentive, including details of distribution.

Informed Consent – Individuals*

Describe the consent process. Explain when and where consent will be obtained and how participants or their legally authorized representatives will be provided sufficient opportunity to consider participation. If seeking approval to waive informed consent signature, provide rationale. Be sure to identify all consent processes and documents that will be used including informed consent form to be signed, verbal or online informed consent, assent form to be signed, verbal or online assent, parental consent form to be signed, request waiver from IRB, or other. Include copies of informed consent/assent forms with the submission of this petition in the attachments section of this form.

See Individual Informed Consent for a sample consent form for individual participants.

See Waiver of Informed Consent for a sample waiver of documentation of informed consent for individual participants. This form is to be used when asking participants to sign an informed consent is not possible. However, researchers still need to include an informed consent in the attachments that will be given to participants; the participants will not be required to sign it if this waiver is approved.

Participants – Organizations

Participants – Organizations*

Participant organizations refer to organizations where the research will be conducted. If a researcher is looking at populations at specific organizations, this section needs to be completed.

Describe the characteristics of the main organizations who will be participating in your research.

Organization Informed Consent*

If you are going to conduct research at a specific location, you must provide a copy of the Organization Informed Consent, which identifies that you have permission from an appropriate supervisor or administrator at the location, such as a principal or company supervisor.

Describe the consent process for including specific organizations in your research. Explain when and where consent will be obtained and how participants or their legally authorized representatives will be provided sufficient opportunity to consider participation. If seeking approval to waive the informed consent signature, provide rationale.

See Organization Informed Consent for a sample consent form for organizational participants.

Research Methods

Research Methods*

Identify all research activities that will be conducted during the project and include copies of all materials that will be used (including audio, video, digital, or image recording; collecting biological samples; experiments; focus groups or group interviews; ingesting substances; observation of participants; and surveys, questionnaires, or interviews).

Procedures/Protocols*

Describe your research procedures and protocols. Include each step that the researchers will take when interacting with participants and collecting the data (including interactions with different groups, such as a control group and an experimental group).

Participant Risk*

Since all research involves some risk to participants that may include physical distress, emotional distress, social distress, and/or financial distress, will the research expose participants to discomfort or distress beyond what is normally encountered in daily life? If yes, provide an explanation of the risks and the measures taken to minimize those risks.

Disclosure*

Does any part of the research require deception or incomplete disclosure of information to participants? If yes, please describe the nature of the deception, the rationale, and debriefing procedures/form.

Location*

Where will the research take place? Be as specific about the location of the data collection as possible (e.g., internet data collection, campus, another physical location with address).

Privacy

Privacy Protection*

How will participant privacy be protected?

Data Handling*

Research-related records must be retained for a period of at least three years after the research has been discontinued (i.e., no further data collection, long term follow-up, re-contact, or analysis of identifiable/coded data). If student investigators will be leaving the university within this timeframe, research-related records must be retained by the faculty advisor for the same time period. Explain how collected data (electronic and hard copy records) will be handled, including storage, security measures, and who will have access to the information.

Identifiable Data*

Does the research require access to or collection of personally identifiable information (e.g., name, contact information, signed consent forms)? If yes, please describe the personally identifiable data involved in the research and list the source(s) of information (e.g., participant-reported, educational records, surveys, medical records). Indicate what will happen to the identifiable data (including signed consent forms) at the end of the study (i.e. identifiers permanently removed from the data and destroyed (de-identified), identifiable/coded (linked) data are retained, identifiable data not collected).

Additional Information

Is there any other information that you would like the IRB to know that has not been asked in this application? If so, include that information here.*

Attachments

Include all relevant attachments.

Assent Form
CITI Certification for Research Ethics and Compliance (Required as of January 1, 2020)
Completed Training Certificate(s)
Data Collection Forms
Data Collection Instruments
Debriefing Forms
Individual Informed Consent
Information Sheets, Instructions, Scripts
Organization Informed Consent
Parent/Guardian Permission Form
Protocol and/or Procedures
Recruitment Materials
Stimuli Materials
Waiver of Informed Consent

Attachments

Drop files here or

Accepted file types: pdf, Max. file size: 25 MB, Max. files: 12.

Investigators’ Assurance

I/We certify that all project investigators listed above have navigated Indiana Tech’s IRB web site and have read its policies and procedures.

I/We agree to follow all applicable university policies and procedures of federal, state, and local guidance regarding the protection of human participants in research, professional practice standards, and generally accepted good research practice guidelines for investigators. This includes all pre- and post-approval processes and requirements.

I/We will initiate the research only after written approval has been received from the IRB.

I/We will promptly report to the IRB events that may represent unanticipated problems involving risks to participants or others within 48 hours, using the Adverse or Unexpected Event Report form, which can be found on the IRB web site.

I/We will submit a Post-Approval Change Form to the IRB in case of any modifications in the research or informed consent process prior to changes being implemented.

I/We understand that the IRB approval expires in 12 months. If data collection is not complete within that timeframe, I/We will seek an extension of IRB approval, using the Post-Approval Change Form, at least a month before the initial approval expires.

I/We will maintain and protect research-related records for at least three years after the research has ended.

Investigators’ Signatures

The Principal Investigator signs on behalf of all co-investigators.

Principal Investigator*

Date*

MM slash DD slash YYYY

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Email [[Retired]]*

A copy of this form will be sent to the email provided.

Once submitted, your in-progress form will no longer be available for further changes. Updates to your request will need to be submitted in a new application form.

Undergraduate or master’s students who are completing the application should hit the “Save and Continue Later” button below. The link can be sent to the instructor (or supervising faculty) to review and approve before submission.

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Application for IRB Approval

Applicant Information

Project Information

Participants – Individuals

Participants – Organizations

Research Methods

Privacy

Additional Information

Attachments

Investigators’ Assurance

Investigators’ Signatures