Human Subjects Research

Determining the appropriate review type

Before submitting your human subjects research for review, it's important to determine the appropriate review pathway based on the nature of your study. Research involving human subjects is classified into one of three categories—exempt, expedited, or full board review—each with its own criteria and level of scrutiny. This section will help you identify which type of review your study requires, ensuring that your research is reviewed efficiently and according to federal and institutional guidelines.

If your research involves no more than minimal risk

Research is reviewed for Exempt status by an IRB board member if it involves very minimal or no risk. There are several types of research that may qualify for Exempt status. In general, research which does not propose to disrupt or manipulate the normal life experiences of subjects, incorporate any form of intrusive procedures, or involve deception will be exempt from Full Board review. Projects that involve more than very minimal risk do not qualify for Exempt status.

Please note that all of the rights and protection afforded to human subjects in research are required in Exempt status cases. Researchers engaged in human subjects research that qualifies for Exempt status will need to complete an abbreviated application form and prepare an information sheet, not a full consent form. Researchers must engage in practices that minimize risk, maximize benefit and ensure privacy.

Any research involving protected classes or vulnerable populations of subjects (such as prisoners or mentally disabled persons) or research requiring the use of PHI (protected health information) is rarely Exempt.

If your research involves minimal risk and fits specific categories

Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the entire IRB. The term "expedited" can be misleading: reviews of this type are not quicker or conducted with less rigor, but fewer reviewers are required for approval.

In general, research may be considered for Expedited review if it involves no more than minimal risk*, does not include intentional deception, does not employ sensitive populations or topics, and includes appropriate consent procedures.

The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal risk*.

To qualify for review via expedited procedures, the research must not be greater than minimal risk* and fall into at least one of the expedited categories defined by the federal regulations.

Summary of Expedited Categories:

1. Clinical studies of drugs and medical devices only when certain conditions are met
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture in certain populations and within certain amounts
3. Prospective collection of biological specimens for research purposes by noninvasive means
4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.
5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes
6. Collection of data from voice, video, digital, or image recordings made for research purposes
7. Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies

Researchers engaged in human subjects research that qualifies for Expedited review will need to complete a full application form and prepare a consent form, using our template.

If your research involves more than minimal risk or protected populations

All research not qualifying for Exempt status or Expedited review and research involving protected classes of subjects requires Full review. In general research requiring Full review places the subject at greater than minimal risk. Full review means that the research protocol is read, discussed and voted upon by the full IRB board.

Special considerations apply to protecting the welfare of particularly vulnerable populations such as fetuses, children, prisoners, mentally disabled or cognitively impaired persons, terminally ill patients, the elderly, students and employees, survey research that involves AIDS information either with the general public or with vulnerable populations, or economically or educationally disadvantaged persons. Research involving a protected class is required to undergo Full review.