The Research Protocol

Listed below are the required sections of the research protocol. If you have questions regarding the information provided below, please contact the IRB Office at 405-949-4184 or via e-mail at irb@integrisok.com.

Purpose and Objectives

Please explain briefly the purpose of the research project, including the importance of the knowledge that may reasonably be expected to result. The IRB must have sufficient information to determine that risks associated with the research are reasonable in relation to anticipated benefits.

Research Design

Please limit this section of the protocol to those aspects of the research project that deal specifically with human subjects.

Study Population

Describe the manner in which subjects will be selected. The IRB must have sufficient information to determine that selection of subjects is equitable and that adequate consideration has been given to potential consequences of participation for each subject. This section should verify that all appropriate populations are included in this study. This includes minorities, women and children as appropriate to the research being conducted. The study population must be chosen in accordance with all federal guidelines.

If subjects are to be solicited through advertising, a copy of the ad must be submitted to the IRB for approval.

Description of the study population should include the following:

  1. Inclusion/Exclusion Criteria
  2. Duration of Participation
  3. Early Termination Criteria

Methods and Procedures

Describe in detail research procedures involving human subjects. The IRB must have sufficient information to determine that procedures are consistent with sound research design and do not unnecessarily expose subjects to risk. Address each of the following:

  1. Drugs and Dosages
  2. Devices
  3. Surgical Procedures

Data Collection, Analysis and Confidentiality

Describe procedures for data collection and analysis. The IRB must have sufficient information to determine that the safety and the privacy of subjects will be protected, and that procedures will yield meaningful research findings to justify the use of human subjects.

References

Provide a list of references, which support the protocol.

Appendices

Please include as appendices the investigator's brochure (if applicable) for an investigational drug/device, instrument manuals, data collection forms, survey instruments, proposed advertisements to recruit research subjects and/or other supplemental material that will facilitate the review process.

Advertisements and Press Releases

The IRB is responsible for ensuring the equitable selection of research subjects and therefore must review methods that investigators use to recruit subjects. Prior IRB approval is required for all print, radio and television advertisements. The Food and Drug Administration requires that the following information be included in advertisements:

  • name and office address of principal investigator,
  • purpose of the research and, in summary form, the eligibility criteria that will be used to admit subjects into the study,
  • a straightforward and truthful description of benefits to the subject, and
  • location of the research and person to contact for further information.

For clinical trials, no claims should be made either explicitly or implicitly that the drug or device is safe or effective for the purposes under investigation or that the drug or device is in any way equivalent or superior to any other drug or device. Such representation is misleading and in violation of FDA's regulations concerning the promotion of investigational drugs and devices. The amount of payment may not be included in the advertisement; rather it may be stated that subjects will be compensated for their participation.