Institutional Review Board

The United States Department of Health and Human Services (DHHS) and Ozarks Technical Community College (OTC) have established standards and guidelines to protect individuals who may be at risk as a consequence of participation in a research activity.  The Institutional Review Board for the Protection of Human Participants (IRB) is responsible for insuring that adequate safeguards are established to protect any individual who may be at risk as a consequence of participation in research activities. Standards for the committee’s review are based upon:

1. Protection of Human Subjects – Code of Federal Regulations, 45 CFR 46
2. Standards for Privacy of Individually Identifiable Health Information, 45 CFR 160 and 164

Researchers are encouraged to refer to these codes in planning their research.

All research undertaken by individuals involving human participants in any way, regardless of the source of funds, must be reviewed and approved by the IRB before activity is undertaken.  This includes activities in which an individual is supervising student research activities. According to 45 CFR 46, “Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” The Health Insurance Portability and Accountability Act (HIPAA) imposes additional requirements for those involved in the collection, use, retention and destruction of research data that includes protected health information (PHI).  According to 45 CFR 165.501, protected health information is defined, in part, as individually identifiable health information transmitted or maintained in electronic or any other form or medium. All research projects must be renewed annually.  Renewals (without changes) are sent directly to the IRB chairperson and typically require only a brief review.  Any meaningful changes in procedures must also be reviewed.

All individuals involved in the design, collection and/or analysis of data in projects involving human participants must complete the online training module entitled “Protecting Human Research Participants”, sponsored by the National Institute of Health.

Additional information on the ethical use of human participants is available in 45 CFR 46 and from the Office of Human Research Protections (OHRP).

The primary investigator for the research project must complete an Application for Review and Approval of Activity Involving Human Participants.

• All project-related documents (e.g., consent forms, surveys, etc.) must be included with the application.
• All required certificates of completion for the required human participant protection training must be included with the application.

The decision of the IRB regarding the proposed research project will be based on the content of the application, so care should be exercised to ensure that it is completed carefully and completely. Approval of an application which omits substantive information regarding procedures to be used cannot be construed as approval of the research project. Any substantive changes in the project must be approved by the IRB except those changes necessary to eliminate apparent immediate hazards to the participant which shall be promptly reported to the IRB.

Include a brief statement as to the goals for your research project.

1. What are the project procedures?
2. Name and description of any data-gathering instruments (attach copies, if possible)
3. How many participants are needed?
4. From where will participants be obtained?
5. How long will the procedure take?
6. Are there any special considerations (e.g., providing full disclosure prior to the research activity is not feasible to prevent biased results)?
7. If data collection is done in class, what will non-participants do during the research activity?
8. Attach letters or approval forms from any other agencies or organizations that will be involved in the data collection process.

1. Indicate whether the project will involve protected health information (PHI).
2. Describe the procedures that will be used to comply with the HIPAA policy.
3. Include all required information and forms.  Examples include the following:
   • Procedures to be used regarding the Notice of Privacy Practices
   • Authorization for Use and/or Disclosure of PHI
     • Procedures to be used in requesting Authorization for Use and Disclosure of PHI from Individuals, or
     • Procedures to be used in requesting a waiver of Authorization from the IRB or
     • Statement that only “de-identified” individual health information will be used.
   • Request for access to PHI from a Health Care Component within Ozarks Tech.
   • Request for access to PHI from an entity outside of Ozarks Tech.
     • Application to entity for access to PHI
     • Approval by entity enabling access to PHI
   • Plan for using other HIPAA procedures and forms, as applicable.

To ensure that the plan is complete, please review the HIPAA procedures.

Describe the benefits received by research participants and/or the general population.

Describe the physical, psychological, and/or sociological risks to participants.

1. Describe precautions that will be taken to minimize the physical, psychological, and/or sociological risks to participants.
2. How will confidentiality of data be maintained?
3. Describe how the data will be handled at the conclusion of the research project. (e.g., what will be done with questionnaires, inventories, audio/video recordings?)

Describe the procedures that will be taken to obtain informed consent of all research participants.