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Institutional Review Board

IRB Guidelines & Application Process

  • Researcher determines the type of approval requested:

    • Full IRB Review – requires full proposal
    • Expedited Review – requires justification of “expedited” status
    • Exempt Status – requires justification of “exempt” status
  • Researcher submits the [Application for Approval to Involve Human Subjects in Research].
  • IRB Administrator convenes the IRB committee, if necessary; for studies that are “exempt” or “expedited,” the IRB committee may review materials through electronic meetings.
  • Researcher is notified of the IRB decision. At times, the IRB may request changes in research procedures to comply with federal guidelines, appropriate research methodologies, or ethical standards.
  • Research cannot be conducted at Calhoun, physically or virtually, without written permission to use the premises. Request for permission to use the premises must be submitted to the office of the Vice President for Academic Affairs. This permission is separate and independent of the IRB.

IRB Exempt Categories

The following information is provided to researchers as a reference point for making determinations about IRB exempt categories. All research conducted at Calhoun Community College must receive written IRB approval. Those seeking exempt status must identify which category(s) apply. As per federal mandates, “Department or agency heads retain final judgment as to whether a particular activity is covered by this [exemption] policy.”

Student researchers may seek guidance from their research mentor or dissertation chair if uncertain about exemption status. Independent researchers who may require clarification concerning exempt categories may contact the Calhoun IRB chair directly at sara.sayle@calhoun.edu.

Exempt Categories as Defined by the U.S. Department of Health & Human Services, Office for Human Research Protections:

Category 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.

Category 2

Research involving the use of educational tests (cognitive, diagnostic, aptitude, or achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) 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.

Category 3

Research involving the use of educational tests (cognitive, diagnostic, aptitude, ad achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

Category 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.

Category 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: (i) Public benefit or service programs, (ii) procedures for obtaining benefits or services under those programs, (iii) possible changes in or alternatives to those programs or procedures, or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

Category 6

Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) 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.

Reference:

U.S. Department of Health and Human Services (2009, January 15). Protection of human subjects. Code of Federal Regulations, Title 45, Part 46. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#46.102

Reference:

U.S. Department of Health and Human Services (2009, January 15). Protection of human subjects. Code of Federal Regulations, Title 45, Part 46. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#46.102

Expedited Review Requirements

Student researchers may seek guidance from their research mentor or dissertation chair if uncertain about expedited review requirements. Independent researchers who may require clarification concerning expedited review requirements may contact the Calhoun IRB chair directly at sara.sayle@calhoun.edu.

As per the U.S. Department of Health and Human Services Title 45, Part 46, “In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied.”

Risks to subjects are minimized:

By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.

Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by §46.116.

Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117.

When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

Reference:

U.S. Department of Health and Human Services (2009, January 15). Protection of human subjects. Code of Federal Regulations, Title 45, Part 46. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#46.102