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The Research Protocol

The following information is required in each research proposal submitted to the OSDH Institutional Review Board (IRB) Committee. Summary submissions will be returned to the investigator without review.

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. If subjects are to be solicited through advertising, a copy of the ad must be submitted to the IRB for approval. For studies involving multiple sites, report the number of subjects at OSDH sites, and specify how many will be studied on an inpatient or an outpatient basis. Description of the study population should include the following: (1) inclusion/exclusion criteria, (2) duration of participation, and (3) early termination criteria.

Methods and Procedures
Describe research procedures involving human subjects in detail. 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, and (3) surgical procedures if they apply.

Data Collection, Analysis, and Confidentiality
Describe procedures for data collection, analysis, and maintaining confidentiality and subject privacy. 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.

Informed Consent
The written or oral (for telephone surveys) informed consent form must be submitted with the proposal. No investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.

Basic Elements of Informed Consent
The following information shall be provided to each subject: (1) a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental; (2) a description of any reasonably foreseeable risks or discomforts to the subject; (3) a description of any benefits to the subject or to others which may reasonably be expected from the research; (4) a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject; (5) a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; (6) for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained; (7) an explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and (8) a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Each informed consent form should specify the name and phone number of a person the subject can call for more details about the research. The consent form should also specify: for questions about your rights as a research subject, or to register concerns about your participation in this research, contact OSDH IRB Administrator, Malinda Douglas at 405-271-4072.

Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject: (1) a statement that the particular treatment, procedure, or survey may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable; (2) anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent; (3) any additional costs to the subject that may result from participation in the research; (4) the consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject; (5) A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and (6) the approximate number of subjects involved in the study.

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. This is in addition to agency approval for OSDH investigators.

Press releases, which include any phone numbers or imply solicitation for enrollment, must also be approved by the IRB prior to publication.

References
Provide a list of references, which support the protocol.

Appendices
Please include as appendices the investigator’s brochure 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.

Revised 11/02/2010

Submission Application Process.

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