Parker University Research Center has a policy for the protection of human subjects from research risk as set forth in Title 45, Part 46, of the Code of Federal Regulations (45 CFR 46). The detailed and complete policy statement, “Guidelines for the Protection of Human Subjects in Research Studies” is on file in the office of the Dean of Research, as well as with the Vice-President of Administration and Accreditation Liaison. It is the policy of Parker University that, except for those categories specifically exempted by 45 CFR 46, all research covered by this policy will be reviewed and approved by the Institutional Review Board (IRB) established under the policy regardless of the source of funding of the research.

IRB approval must be obtained before initiation of the study.

The IRB functions as an institutional resource to meet the requirements of funding agencies, to safeguard the welfare of human subjects of research and to protect investigators and the University from legal action.

The IRB membership consists of ten individuals including the Chair. The membership includes faculty or professional personnel, and at least one member who is not otherwise affiliated with the University and who is not part of the immediate family of a person affiliated with the University.

The IRB does not evaluate the scientific merit of the research; nevertheless, scientific merit is a factor in weighing the risks against the benefits of the research. Upon approval, research on human subjects is authorized in most instances for one year renewal of the authorization must be requested annually by the Principal Investigator. An exception to the one year rule may be authorized for clinical trials where there will be no changes in the protocol and it is expected that subject recruitment will take longer than one year.

The form is available in MS Word can be obtained from the Director of Research or the Chair of the IRB. The investigator should prepare his or her information in plain text in bold lettering and insert directly below questions.

 The application for approval of a new project is to be submitted prior to initiation of the research. In particular, the National Institutes of Health (NIH) require that the approval by the IRB must have been obtained before a grant application is considered for review. Many of the items covered in the project application document correspond to those requested by the NIH in the grant application Form PHS 398.

One printed copy of the completed application, together with any supplemental documents, are to be submitted to the to the Chairman of the IRB for review and approval. Please allow two weeks for the review process to be completed. Invariably, delays in the review process or return of the application result from lack of completeness of the information provided in the application, deficiencies in the consent document or in other supplemental documents.

Supplemental documents must accompany an application to the IRB. The types of supplemental documents necessary will become apparent, as the application is completed by the investigator. One or more of the following supplemental documents will be needed:

Research project protocol: A research project protocol must be submitted at the time of a new application. Normally, this will be a grant application prepared by the Principal Investigator for submission to either an external funding source or to PCC.  Occasionally it might be a device study protocol prepared by the manufacturer or inventor of the device.

Manufacturer information on devices if they have an impact on human subject protection must be submitted to the IRB. Generally, such a document is made available by the manufacturer in conjunction with a clinical trial to be performed at PCC. In the case of an investigator-initiated trial, or of an “in-house” developed product, the investigator must prepare the document to provide the IRB with technical information sufficient to judge the benefits and risks involved with the use of the product.

Text of written informed consent documents: The text of the document must contain all of the necessary elements for informed consent as described in this Guideline and contained in the College policy on the protection of human subjects from research risk.

 More than one written informed consent document may have to be used in conjunction with some research projects, depending on the specific information to be given the individual groups of research subjects, and legal requirements. For example, in project involving healthy volunteer subjects as well as patients, the information given for each group may differ substantially. Another example is if the patients to be studied include both adults and children. This might occur if the investigator is studying asthma. In the case of children, the documents would differ in that consent would b given by the parent or legal guardian. The written consent documents must be submitted to the IRB for review and approval.

Text of oral informed consent: The verbatim text is to be prepared as a condensed version of a written consent document. It must be submitted to the IRB for review an approval.

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