Parker University 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 (45CFR46). This information is detailed in the Parker University Standard Operating Procedure Manual, which is available at another link on this page. It is the policy of Parker University that, except for those categories specifically determined to be  exempt by the Parker University Human Protections Administrator or his/her designee under 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. It cannot be granted retrospectively.

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

The IRB membership consists of at least 5 individuals, including the Chair. The membership includes faculty or professional personnel, and at least 1 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 1 year but may be shorter if the project carries higher risk. Renewal of the authorization must be requested annually by the Principal Investigator.

The Standard Operating Procedural Manual for Parker's IRB and its human research participant activity can be obtained via the link immediately below. This manual incorporates the updates to the federal regulations (45CFR46 and 21CFR56) that took place in 2018 and represents the current procedures and policies used by the Parker University Institutional Review Board.

PU-IRB_SOPs_Common Rule Revisions-Final.docx

45CFR46

21CFR56

https://www.hhs.gov/ohrp/regulations-and-policy/guidance/research-involving-coded-private-information/index.html

Supplemental documents must accompany an application to the IRB via the Cayuse system. 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:

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. The new Standard Template is recommended for institutional use. Informed Consent Guide and Template_Final.docx

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 be 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.

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. For further information, please see: https://www.fda.gov/files/about%20fda/published/Frequently-Asked-Questions-About-Medical-Devices---Information-Sheet.pdf

From the Office of Human Research Protection (OHRP):

https://www.hhs.gov/ohrp/regulations-and-policy/guidance/research-involving-coded-private-information/index.html

Guidance on the Secondary Analysis of Existing Data Sets:

https://ovpr.uconn.edu/services/rics/irb-2/researcher-guide/secondary-analysis-of-data-sets/