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Exempt Review Process

Exempt Review Process

Although the category is called Exempt Review, this type of research does require IRB review and registration. There are no deadlines for IRB applications categorized as Exempt Review. Research Integrity and Compliance (RIC) or the IRB chairperson conducts Exempt Reviews to ensure the study meets the ethical standards of Texas State University using the following criteria:

 

  1. The research involves no more than minimal risk to subjects.
  2. If subjects will be enrolled, selection is equitable.
  3. If there are interactions with subjects, there will be a consent process that will disclose such information as:
    • Activity involving research
    • The purpose of the research
    • A description of the procedures
    • The amount of time required for the research
    • How data is maintained and secured
    • Risks of participating in the study
    • Benefits of participating in the study
    • Participation is voluntary
    • Name and contact information for the Investigator
    • Contact information for the Texas State IRB
    • Adequate provisions to maintain the privacy interests of subjects
  4. If the IRB Reviewer requires additional information or modifications, the IRB Reviewer will contact the PI via e-mail. The IRB Reviewer will review the PI’s response upon receipt. If the PI does not respond within 30 days, the study will be closed out.
  5. When the initial application or requested revisions are insufficient, RIC may request additional revisions.
  6. Once the review and/or revision process is complete, a letter will be sent to the researcher notifying him/her of the result of the Exempt Review. The letter will include the specific category of review.
  7. If it is determined that the study does not qualify for Exempt Review, the study will be referred for Expedited or Full Board Review as applicable.
  8. Exempt Review studies do not expire; therefore, Continuing Review Reports (Renewals) are not required.
  1. If a researcher wants to make a change to an Exempt study, the researcher must submit an Amendment to the IRB. RIC will review the proposed change to ensure that the activities in the study do not change the level of review.
  2. If the requested change does not fall within an Exempt category, the study will need to undergo an Expedited or Full Board Review prior to implementation.
  3. If the researcher has concerns about the IRB’s decision or recommendations, the researcher may address his/her concerns to the IRB in writing. This request should include a justification for changing the IRB’s decision. The researcher should send this request to RIC.

 

Exempt Review Categories

To qualify for review at the exempt level, the research must not be greater than minimal risk and must fall into one or more of the exempt categories described below.

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  • Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies; or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

     

    Examples:

    • Evaluating the use of accepted or revised standardized tests
    • Testing or comparing a curriculum or lesson
    • A program evaluation of pharmacy continuing education
  • Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview, procedures or observation of public behavior, unless:

    • information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
    • any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.

    Examples:

    • Surveying teachers, nurses, or doctors about a technique or an outcome
    • Interviewing managers about a management style or best practice
    • Conducting a focus group about an experience or an opinion of a community program
  • Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) of this section, if:

    • the human subjects are elected or appointed public officials or candidates for public office; or
    • federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

    Example:

    • Interviewing public officials about a local or global issue.
  • 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 identified, directly or through identifiers linked to the subjects.

    Example:

    • Analyzing existing tissue samples or data sets which are recorded by the investigator without identifiers

     

  • Research and demonstration projects which are 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.

    Additional information may be obtained on the Office for Human Research Protections webpage: Exemptions for Public Benefit and Service Programs

  • Taste and food quality evaluation and consumer acceptance studies if:

    • if wholesome foods without additives are consumed; or
    • if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant 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.

Research not Eligible for Exempt Review

Human subject research that does not apply to one of the Exempt Review categories will undergo an Expedited or Full Board Review Process.

Research is not eligible for an Exempt Review if it:

  • is greater than minimal risk
  • uses vulnerable populations as research subjects (less than 18 years of age)
  • involves collection of identifiable information from subjects
  • involves administration or use of drugs or devices
  • involves deception
  • involves the audio or video recording of research participants in a non- anonymous manner
  • involves exercise