Human Subjects

New Studies

For help determining the appropriate level of review, see the Level of Review page.

Full Board and Expedited Review

Any study involving greater than minimal risk, or which does not fit into an Exempt or Expedited research category, requires Full Board review. Full Board new studies are reviewed by the convened IRB, and are assigned a board based on the date that review by the Human Subjects Office is complete, expertise of the boards, and the preferences of the researcher.

Expedited new studies (those that fit into one of the seven categories for expedited review as outlined by the regulations) are reviewed by members of the IRB outside of the convened IRB setting.

Required Documents:

All studies requiring Full Board or Expedited review must be submitted with the following information/documents:

  • Completed Questionnaires in KC IRB
  • Protocol (for Full Board studies)
  • HIPAA Authorization (if HIPAA applies and a waiver has not been requested in the HIPAA Questionnaire)
  • Informed Consent Statement (unless a waiver has been requested in the Informed Consent Questionnaire)
  • If study teams anticipate enrolling subjects who speak a language other than English, a translated Informed Consent Statement (and/or Assent and Study Information Sheet, as appropriate)
  • Assent (if children are being enrolled and a waiver has not been requested in the Assent & Parental Consent Questionnaire)
  • Study Information Sheet (if a waiver of written documentation of informed consent is requested in the Informed Consent Questionnaire)
  • All recruitment materials (advertisements, flyers, phone scripts)
  • All study materials (surveys, questionnaires)
  • Copy of the grant application (if the study is federally funded)

Exempt Review

Under IU policy, ALL research involving human participants/subjects must be reviewed and approved prior to commencement of the research, including research that falls into one of the federal exempt categories.

In addition to the federal exempt categories, IU has added additional exempt categories of review under its Flexibility Option.

For further information regarding the categories of research that qualify for exempt review, please see the Exempt Studies Guidance page.

Investigators planning to conduct exempt research must complete all required documents and submit these to the Human Subjects Office for approval by office staff prior to beginning any research. The research cannot be conducted until exemption is granted and final documents are received by the Principal Investigator.

Federal regulations do not require signed informed consent for exempt research projects. However, subjects should be given information regarding the research project whenever possible. This can be accomplished through the use of a written Study Information Sheet (available on the IRB Forms & Templates page), or other appropriate methods may be used.

Required Documents:

  • Study Information Sheet (if applicable)
  • Other Supporting Documents (recruitment flyer, surveys, letter of cooperation)

Humanitarian Use Device (HUD)

An HUD, because of its small expected market (fewer than 4,000 cases per year), is not expected to generate the type of efficacy data required for approval of a new medical device, so the FDA grants a special humanitarian device exemption (HDE) from some of the requirements for marketing approval. However, the FDA does require IRB approval before physicians and patients can access HUDs. Below is a flowchart developed by the FDA in order to assist researchers in understanding this special review process:

In order to request IRB approve for use of an HUD, a new submission must be made in KC IRB that includes:

  • Completed Questionnaires in KC IRB
  • HUD manufacturer’s product labeling, clinical brochure, and/or other pertinent manufacturer informational materials
  • The FDA HDE approval letter

Student Research Projects

Student projects that are intended for discussion within the classroom only do not contribute to generalizable knowledge and IRB review is not required.  If the activity is a student project that may place individuals at risk and/or involves a vulnerable population, please submit the 'Application for Non-Research Student Projects' form.

Required Document:

Application for Non-Research Student Projects

Non-Human Subjects Research Projects

Projects that do not fit the regulatory definition of human subjects research do not require review by the IRB. Generally, these include:

  • Projects where IU is not considered engaged. Please see the HHS External Link Guidance on Engagement of Institutions in Human Subjects Research page for more information.
  • Research with deceased individuals
  • Research where the investigator will have access to only a limited data set or deidentified data set
  • Research on coded tissue or samples for which the investigator does not hold the code linking samples to identifiable information.

Investigators conducting research falling into these categories do not need to submit an application to the IRB unless specifically requested by a sponsor or collaborator. In such cases, the investigator may submit the Application for Non-Human Subjects Research.

Required Document:

  • Application for Non–Human Subjects Research
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