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Studies that are Exempt from IRB Review

Like any research study the subjects in exempt research are human subjects who have rights that must be fully protected. If you think your research study may be exempt, send a summary of the study (design, tools, methods, data collected, etc.) to Amy Southerland in the NHRMC IRB Office at amy.southerland@nhrmc.org for a determination as to whether or not the study meets the requirements for exempt status. According to federal guidelines, researchers should not make this determination independently. The NHRMC IRB will issue an acknowledgement letter of determination for research studies that qualify for exempt status. Research studies that qualify for exempt status are not subject to continuing IRB reviews, but we ask that you let the IRB know when the study is completed/closed so that our records and files are kept current.

Department of Health and Human Services (DHHS) regulations describe 6 categories of research that may qualify for exempt status. Exempt status means that the study is exempt from the requirements of 45 CFR 46: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html. *Note that the HIPAA Privacy Rule regulations will still apply when protected health information is used for research.

The regulations do not specify a risk category for exempt study status, but it is implicit within the concept of exempt research that there must be very little, if any, associated risk. The six categories of exempt status are:

  1. 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.

  2. 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.

  3. 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 (b)(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.

  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 identified, directly or through identifiers linked to the subjects.

  5. 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.

  6. Taste and food quality evaluation and consumer acceptance studies,

    •  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.

References:
Code of Federal Regulations: TITLE 45 PUBLIC WELFARE,
Department of Health and Human Services, PART 46 PROTECTION OF HUMAN SUBJECTS

Amdur,MD, R. 2003. Institutional Review Board Member Handbook, Sudbury MA: Jones and Bartlett Publishers International

Bankert, E. and R. Amdur, MD. 2006 Institutional Review Board Management and Function. Sudbury MA: Jones and Bartlett Publishers International

 
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