EMU Research

UHSRC Exempt Review Procedures

Introduction

Not all human subject research is subject to Federal Regulation 45 CFR 46. If you are not sure if your study meets Federal criteria for human subject research, please consult this page.

Research studies in which all research procedures fall into at least one of eight categories can undergo Exempt review. “Exempt” does not mean that you do not have to submit an application to the UHSRC. Rather, Exempt means that the study does not meet criteria for a full regulatory review according to Federal Regulation 45 CFR 46. Your study still must be submitted to the UHSRC for an Exempt determination, and in some cases, to undergo a limited UHSRC review. EMU policy states that only the UHSRC can make an Exempt determination (investigators cannot determine their research Exempt).

Exempt studies are reviewed in the Office of Research Compliance. As such, there is no submission deadline for Exempt review. Turn-around time for Exempt research, from initial submission to approval letter generally takes 1 week.

Exempt Review Categories

In order to qualify for Exempt review, all research activities must fit into one or more of the eight categories below:

1. Research conducted in established or commonly accepted educational settings involving normal educational practices that are not likely to adversely affect students' opportunity to learn or the assessment of educators who provide instruction Examples include research on regular and special education instruction strategies, or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2. Research that only includes interactions involving educational tests, survey procedures, interview procedures, or observation of public behavior, if at least one of the following criteria is met:
   1. Information obtained is recorded in such a way that subjects cannot be directly or indirectly identified;
   2. Any disclosure of the human subjects’ responses outside the research would not reasonably place subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation; or
   3. The data are identifiable, either directly or indirectly through identifiers linked to subjects, and the UHSRC conducts a limited review of privacy and confidentiality procedures.
3. Research involving benign behavioral interventions, including all relevant data collection, if the subject agrees beforehand to the intervention and data collection and at least one of the following criteria is met:
   1. Information obtained is recorded in such a way that subjects cannot be directly or indirectly identified;
   2. Any disclosure of the human subjects’ responses outside the research would not reasonably place subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation; or
   3. The data are identifiable, either directly or indirectly through identifiers linked to subjects, and the UHSRC conducts a limited review of privacy and confidentiality procedures.
4. Secondary research for which consent is not required, including uses of identifiable data provided at least one of the following conditions is met:
   1. The identifiable data are publicly available;
   2. The information is identifiable at source but is recorded by the investigator, for research purposes, in such a way that the investigator's copy does not contain any identifiable information, cannot be linked to identifiable data through the use of study ID codes linked to subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
   3. The research is protected by HIPAA (conducted by a HIPAA-covered agency or agent); or
   4. The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research activities. All identifiable data are subject to additional federal regulation regarding data privacy and confidentiality.
5. Research and demonstration projects conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine public benefit or service programs; procedures for obtaining benefits or services under those programs; possible changes in or alternatives to those programs or procedures; or possible changes in methods or levels of payment for benefits or services under those programs.
   
   
   
   
   
6. Taste and food quality evaluation and consumer acceptance studies, if:
   1. Wholesome foods without additives are consumed; or
   2. Foods consumed contain food ingredients at or below the level and for a use found to be safe, or agricultural chemicals or environmental contaminants at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
7. Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable data in a repository for potential secondary research use provided that the UHSRC conducts a limited review. This category applies to the creation and maintenance of a repository only, not for other uses of such data. At this point, the EMU Human Subjects Review Committee does not support the use of broad consent.
8. Secondary research for which broad consent is required: Research using identifiable data for secondary data analysis if all of the following criteria are met:
   1. Broad consent for the storage, maintenance, and secondary research use was obtained. Note: While EMU does not currently support the use of broad consent, if the investigator obtains data from another institution and the data have been collected at the other institution using broad consent, the EMU Human Subjects Review Committee will apply this category;
   2. Broad consent was appropriately documented; 
   3. The UHSRC conducts a limited review and determines that the research is conducted within the scope of broad consent; and
   4. The investigator does not return individual research results to subjects.

Exempt Review Process

Exempt research is reviewed in the Office of Research Compliance. Human subjects must be protected and the principles outlined in the Belmont Report (respect for persons, benevolence, and justice) apply.

 

Exempt applications must provide a clear and coherent description of study methods. Additionally, recruitment and consent must be free of coercion, and the consent process must be clear and understandable to the subject population. As such, recruitment documents and a consent form or script are required. See the Consent section below for assistance in developing a consent form/script for Exempt research.

 

 

Consent for Exempt Research

Although Exempt research is not subject to Federal Regulations regarding informed consent, EMU policy still requires that an informed consent process be used in all human subject research, including Exempt research. However, the consent process for Exempt research may be less formal and does not require that the subject sign a consent form. For Exempt research, the consent form/script must contain the following elements:

1. A statement that you are a researcher conducting a research study.
2. A description of the study procedures
3. A description of the risks
4. An explanation of how you will keep data confidential, how data will be stored (and for how long), and how data will be disseminated. If you would like to identify the subject in publication or presentation, you must include this information and provide the subject with the option of not being identified.
5. A statement that participation is voluntary and that the subject can discontinue participation at any time.
6. Your contact information, your advisor’s contact information if you are a student, and the following statement: “For information about your rights as a participant in research, you can contact the EMU Human Subjects Review Committee at [email protected] or 734-487-3090.”

Post-Approval

Once you receive your Exempt Determination letter, you are all set to begin your research. Unlike Expedited and Full-Board reviewed research, your study does not have an expiration date. You do not need to submit for annual review, however, the UHSRC requests that you contact [email protected] when your study is complete.

Changes to Exempt Research: If you plan to make any changes to your study during the course of your approval period, you must submit a Modification Request in Cayuse IRB and obtain approval prior to implementation. Exempt Modification Requests are reviewed to ensure that the study still qualifies for Exempt review with the requested changes. Exempt Modification Requests are typically approved within one week from the submission date.

If you have any questions about Exempt review, contact the Office of Research Compliance at [email protected] or 734.487.3090.