Application for IRB Approval

  • Complete this form and attach any required or relevant documents. The IRB will determine the type of review required for the proposal. For studies that may be considered exempt, the IRB will communicate to the investigator within 2 business days. In expedited reviews, having minimal risk of harm, the investigators can expect to hear from the IRB within 5 business days. For studies that require a full board review, the IRB may need up to 10 business days to complete the review.
  • title of your research project.
  • name, department, email address, and telephone number of the project’s principal investigator.For PhD candidates the Principle Investigator is the student. For master’s level and undergraduate students the Principle Investigator is the Supervising Faculty Member.
  • names, departments, email addresses, and telephone numbers for all of the project’s co-investigators.
  • 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.

  • 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

  • Describe the demographic characteristics of the participants in your research.
  • 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?
  • From what population will the participants/sample be drawn?
  • What is the expected sample size?
  • Explain the rationale for intentional inclusion or exclusion of any subpopulation beyond convenience sampling (e.g., males only, females only).
  • 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.
  • Will any participants receive compensation or other incentives to participate in the research project? If yes, describe the incentive, including details of distribution.
  • 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 Appendix C for a sample consent form for individual participants.

  • 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.

  • 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 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, signed 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. Include copies of these documents in the attachment section of this form.

    See Appendix D for a sample consent form for organizational participants.

  • 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; existing data, publicly available; existing data, not publicly available; experiment(s); focus groups or group interviews; ingesting substances; observation of participants, and; surveys, questionnaires, or interviews).
  • 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).
  • 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.
  • 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.
  • 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?
  • 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.
  • 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).
  • Attachments

  • Include all relevant attachments.
    • Completed Training Certificate(s)
    • Conflict of Interest Forms
    • Consent/Assent Forms
    • Data Collection Forms
    • Data Collection Instruments
    • Debriefing Forms
    • Information Sheets, Instructions, Scripts
    • Letter to do Research at Location.
    • Protocol and/or Procedures
    • Recruitment Materials
    • Stimuli Materials
  • Drop files here or
    Accepted file types: pdf.
    • 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, local laws, 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.

      I/We will submit a new Petition for Review to the IRB in the case of any modifications in the research or informed consent process prior to changes being implemented.

      I/We understand that IRB approval expires in 12 months. If data collection is not complete I/we will seek an extension of IRB approval.

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

    • Investigators’ Signatures

    • Date Format: MM slash DD slash YYYY