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Human Subjects Research

Submission Requirements for New Studies

All personnel on research projects involving human subjects who will interact with participants or have access to identifiable data must complete the CITI “Social & Behavioral Research - Basic/Refresher, Refresher Course” training program or provide documentation of equivalent training before beginning the research. 

A complete IRB application package must contain all of the following:

  1. A completed IRB application (DOC). This application must be signed by all investigators and by the faculty advisor if this is a student project. 
  2. The application must be reviewed and signed by an authorized departmental reviewer
  3. All materials used to recruit participants, such as flyers, advertisements, letters, and/or the text of any emails or oral presentations.
  4. A copy of any letters or emails that will be used to seek permission from research sites, such as schools or other institutions
  5. Copies of all consent forms, parent permission forms, and/or assent forms
  6. Copies of all surveys, questionnaires, focus group questions, and/or interview questions.
  7. A copy of any grant applications associated with the project, if applicable
  8. A copy of any debriefing procedures, if applicable
  9. A copy of any support service information that will be provided, if applicable

IRB applications should be submitted to the Office of Research Compliance and Integrity (ORCI) a minimum of 20 business days prior to the date when the research will begin. Please note that additional lead time is required for departmental review of applications prior to sending it to ORCI. Although it is often possible to receive IRB approval in less than 20 business days, approval times vary depending on the completeness of the application, the level of review required, and the volume of protocols under review.

The consent/assent/parent permission documents

Please keep in mind: audio and videotaping require a separate statement of consent and a separate signature/date line on the consent form.

*The focus group consent form includes a statement about the researcher's inability to guarantee confidentiality among the group members.

Protocols involving physical activity and exercise

All IRB applications for protocols involving physical activity and exercise need to provide sufficient information so IRB members can determine risk and understand precautions taken by researchers to protect subjects. Please refer to the guidance provided in the link below to help you complete your IRB application:

Guidelines for protocols involving physical activity and exercise 

Recruitment materials

All materials aimed at recruiting subjects into a research study (including the final copy of printed advertisements, scripts, audio or video tapes, or Web sites) must be reviewed and approved by the IRB prior to use.

Guidance on writing recruitment materials (PDF)

Research Involving Deception

Research may sometimes use deception if truthful disclosure is considered likely to produce biased responses by the subject. However, this means that the subjects are not giving fully informed consent prior to beginning their participation. Researchers using deception have additional responsibilities to the subjects, such as debriefing following participation.

Guidelines for the Use of Deception (PDF)

Support services

The following link provides a list of  DeKalb area counseling support services for research participants (if appropriate to the protocol)

Counseling Resources in DeKalb (suggested referral list (DOC)

Use of Compensation/Incentives

Research subjects may receive incentives or compensation for their participation. However, the level of compensation should not be so high as to cause a prospective subject to accept risks that he or she would not accept in the absence of the compensation. This same principle would apply to compensation offered to parents whose children are prospective subjects. Information about any compensation should be included in subject recruitment materials and informed consent/parental permission/assent forms. Compensation should not be described as a benefit of the study.

The University will not reimburse purchases of gift cards to be used for compensation in research.

Guidance on NIU Controller’s policy regarding incentives/compensation (DOC)