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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 six 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 review according to Federal Regulation 45 CFR 46. Your study still must be submitted to the UHSRC for an Exempt determination. 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 to 2 weeks.

 

 

Categories for Exempt Review

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

  1. Research conducted in established or commonly accepted educational settings involving normal educational practices, such as 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 involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior, unless:
      1. Information obtained is recorded in a directly or indirectly identifiable manner; or
      2. Any disclosure of the human subjects’ responses outside the research could reasonably place subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
  3. Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior that is not exempt under Category 2 above, if: 
      1. The human subjects are elected or appointed public officials or candidates for public office; or
      2. Federal statutes require without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
  4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be directly or indirectly identified.

  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.

 

Exempt Review Process

Exempt research is reviewed in the Office of Research Compliance. Although Exempt research is not held to the standards of Federal Regulation 45 CFR 46, human subjects must still be protected and the principles outlined in the Belmont Report (respect for persons, benevolence, and justice) still 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 human.subjects@emich.edu 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 human.subjects@emich.edu 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 research_compliance@emich.edu or 734-487-3090.

 

Elevating Communities, Inspiring Generations

EMU Research, 200 Boone Phone: 734.487.3090 mail orda_dept@emich.edu