Institutional Review Board


Types of Research

Exempt

Exempt: EXEMPT DOES NOT MEAN THAT IRB REVIEW IS NOT REQUIRED. All research projects involving human subjects need to be reviewed to assure adherence to the ethical standards required by federal and University regulations. Park University Policy requires review of all levels of research that involves human subject, even projects that meet the federal definition of "exempt".

"Research" means a "systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge".  If you intend to publish your results, then you must complete the IRB Application Form.

"Human subject" means "a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

No "vulnerable populations" may be used in exempt research (e.g., vulnerable participants include children, mentally ill individuals, retarded individuals, persons who have been declared mentally incompetent by the courts, persons for whom another individual or legal entity holds power of attorney, criminals, pregnant women, terminally ill individuals, abuse victims, parolees, etc.)

Exempt research includes:

  • Research that receives no external funding and is about non-sensitive topics (e.g., sensitive topics include drug use, sexual practices, aggressive behavior, criminal activity, etc.)  Research that does involve any sensitive topics is either "Expedited" or "Full Board".  The proper forms must be submitted to Brian Shawver.
  • Research where data is collected without participant identifiers. (e.g., names, Social Security numbers, Student ID numbers, phone numbers, addresses, or any other information that could uniquely identify the individual, etc.) NOTE: Identification numbers that are assigned by the researcher and are not keyed to uniquely identifiable identification information are acceptable.
  • Research where participants are adults and data is limited to questionnaires, surveys, educational tests, and non-recorded interviews.
  • Research that is conducted in established or commonly accepted educational settings; including research on regular and special education instructional strategies or comparison of the effectiveness of various classroom instructional strategies.
  • Research involving elected or appointed public officials or candidates for public office.
  • Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens. Specifically, research is exempt if these sources of information are publicly available or if the information is recorded by the investigator in a manner that subjects cannot be identified.
  • Research and demonstration projects which are conducted by or subject to the approval of department heads, and which are designed to study, evaluate, or otherwise examine public benefit or service programs.
  • Taste and food quality evaluations and consumer acceptance studies.


Expedited

Expedited research does not need to be reviewed by the entire IRB. Please allow at least two weeks for a decision on expedited reviews. Expedited research includes:

  • Research involving minimal risk (e.g., providing no more stress to participants than they would encounter in normal life experiences) for non-vulnerable participants (e.g., vulnerable participants include children, mentally ill individuals, criminals, pregnant women, terminally ill individuals, abuse victims, etc.).
  • Minor changes in previously approved research during the period (of one year or less) for which approval is authorized

Note: If your research requires that you record identifying information (e.g., names, Social Security Numbers, etc.), then you will need to have each participant sign a "coded agreement" in order to protect the privacy and confidentiality of participants' forms.

Full Board

Full Board requires both departmental and full IRB approval. Full board reviews require the review and majority approval of the entire IRB. Full board research includes:

  • Any research receiving external funding.
  • Research that places participants in "higher than minimal risk."
  • Research that places vulnerable subjects at a minimal risk.

Required Training: If your research falls into the "Expedited" or "Full Board" categories (see above), then the investigator(s) are required to complete the following training modules before submitting anything to the IRB, and are required to submit a copy of their program completion certificate with their application.  The training modules can be accessed at the following Internet address: Investigator Education Program