WVU-ES Policies & Procedures for Research Approval Under the IRB

University policy requires that all faculty research involving human subjects needs to be reviewed and approved prior to being initiated. This is to insure that such research follows ethical principles and that it is carried out in accordance with applicable regulations. University policies and procedures for human subjects research are governed by Institutional Review Board (IRB) guidelines.

"Research" is defined by the Institutional Review Board as "a systematic investigation designed to develop and contribute to generalizable knowledge." Examples of activities that constitute research include

• any study intended to result in publication or public presentation,
• any activity resulting in publication or public presentation, even though it involves only review of existing data that were collected with no intent to publish,
• any use of an investigational drug or device (see Chapter VIII).

As provided for in these guidelines certain types of research may be exempt from full board review although they do require an exemption approval. The purpose of this document is to establish policies and procedures for obtaining exemption approval within the Extension Service for research conducted by extension faculty.

1. Criteria for Exemption from Board Review

A project is exempt if all research activities belong in one or more of the following categories:

1. Research involving the collection or study of existing data--including documents, records, pathological specimens or diagnostic specimens--if
   • these sources are publicly available, or

   • the information is recorded by the investigator in such a manner that individual human subjects cannot be identified in any way.

2. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
   • research on regular and special education instructional strategies, or

   • research on the effectiveness of or the comparison among instructional techniques, curricula or classroom management methods.

3. Research involving only the use of educational tests (cognitive, diagnostic, aptitude, achievement) if
   • the data are recorded so that individual subjects cannot be identified in any way, and

   • none of the investigator's own current students are subjects. (If someone other than the investigator has contact with subjects, the study can be exempt.)

4. Research involving only observation of public behavior. If subjects can be identified in any way and if any of the following conditions apply, the study is not eligible for exemption approval and must undergo expedited or quorum review.
   • the subject's responses or conduct (if they became public) may place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability, or

   • the subject's responses deal with sensitive aspects of personal behavior (for example, illegal conduct, drug use, sexual behavior or use of alcohol), or

   • the investigator participates in the activities being observed.

5. Research involving only surveys or interviews. If subjects can be identified in any way and if any of the following conditions apply, the study is not eligible for exemption approval and must undergo expedited or quorum review.
   • the subject's responses or conduct (if they became public) may place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability, or

   • the subject's responses deal with sensitive aspects of personal behavior (for example, illegal conduct, drug use, sexual behavior or use of alcohol).

6. Research involving only surveys or interviews of elected or appointed public officials or candidates for public office is eligible for exemption approval without regard to item 5 above. (Public officials are defined as those individuals elected or appointed to local, state or federal office.)

Special Considerations:

Any research in which the subjects or their legal representatives sign a consent form can not qualify as exempt and must undergo expedited or quorum review.

Any research in which the subjects are filmed or videotaped can not qualify as exempt and must undergo expedited or quorum review. However, some begin studies in which subjects are audiotaped may qualify for exemption.

2. Exempt Research Involving Children

The exemptions in categories (1), (2), (3) and (4) above are applicable to research involving children and exempt research approval may be sought.

Category (5) above does not apply to research involving children and thus exemption approval may not be sought.

3. Procedures for Exempt Research

If a research study meets the criteria for exemption, the investigator needs to fill out an Application for Exemption and submit this application to the investigator's Center Leader for review and approval.

It is the Center Leader's responsibility to determine that the research is eligible for exemption and that the methods for data collection and storage are in accordance with IRB Guidelines. The Center Leader will either approve the application and forward it to the Associate Provost's office for final approval, or he/she will provide the investigator with a written explanation of why the application was denied. If the Associate Provost approved the application then the investigator will be given written permission to begin the research. If the application is not approved the investigator will be given a written explanation of why the application was denied. In some cases the investigator may be advised to make certain modifications and resubmit an Application for Exemption. In other cases the investigator may be required to seek an expedited or quorum review from the Institutional Review Board.

WVU Institutional Review Board (IRB) Website

For further information or assistance you can contact Peter Marshall at 293-6967 ext. 3427.