Most people come to the IRB Web site because they are interested in performing a research study and have to get “IRB approval” before they can get on with the study.
The intent of the site is to assist you in this process, in as user-friendly a manner as possible. You need to be aware that with the right to conduct research comes considerable responsibility. In some countries and under some political regimes atrocities to research subjects and in the name of research occur. Cornerstone University will only condone research studies of the highest ethical integrity. If you wish to conduct a research study at Cornerstone University you must capably demonstrate to its IRB that your research study both acknowledges and fulfills this essential requirement. The IRB strives to ensure adequate protection of the research subjects, and also the researchers themselves.
The IRB have set up this site in order to assist you in demonstrating ethical integrity. You have access here to various forms some of which you must fill out. In order to perform a study here at Cornerstone University you must submit two forms to the IRB for review. Then, send them to the chair of the IRB.
The first form examines the reasons for the study and provides the IRB with a summary of the study.
Of paramount importance is a clear description of any potential risk associated with the study and how these risks are effectively minimized to a level any average citizen might be exposed to on a day to day basis. An inability to recognize and to state these risks, as well as failure to indicate provision of appropriate safeguards, demonstrates to the IRB that the study has not been properly designed. It is highly unlikely that such a study will be granted approval.
The second form is the “Informed Consent” form. If IRB approval is granted, every copy of the consent form will carry an indication of this.
Each participant in your study is obligated to sign a copy of this “Informed Consent” form. By so doing they indicate three things.
- They have been adequately informed about the study and are aware of any potential risks involved.
- They have seen proof that the study has the approval of the Cornerstone University IRB.
- They will be participating in the study of their own free will.
Complete the two forms appropriate for your study; either for expedited or guarded study.
Cornerstone University does not condone any and all types of research study. Those studies which will be approved fall under two categories: expedited studies and guarded studies. Expedited studies require approval of either the chair or a designated member of the IRB. Guarded studies require full IRB approval (for instance because they involve vulnerable subjects; including children or animals).
If you sense the IRB will consider your study to be a guarded study it is strongly recommended that you contact the chair of the IRB as soon as possible. Be aware that guarded studies may require several months before a decision about approval is finally given. If possible, design of expedited studies is strongly recommended.
In cases of guarded studies, Study Summary Forms and Informed Consent Forms must be emailed electronically to the chair of the CU-IRB at least two weeks prior to full CU-IRB meetings. Contact the CU-IRB chair to confirm when the next CU-IRB will meet. It meets the last Thursday, 10 a.m., of various months during the traditional semesters.
Applications must include the following:
- CU-IRB Approval Request Form
- Informed Consent (guidelines and examples)
- On-line training certificate
- On-line training required of all investigators. Training can be found at http://ohrp-ed.od.nih.gov/CBTs/Assurance/login.asp. Login, read each page and click “continue” on the left side until you reach the Table of Contents. Choose module 2 “Investigator Responsibilities and Informed Consent. Complete the module and print out the certificate. The certificate must be forwarded to the Director of Institutional Research and Assessment.
- Approved applications are good for only one year from the date of approval. For renewal options, contact the chair of CU-IRB.