About CUConduct an Approved Research Study
at Cornerstone University

Research is defined by federal regulations at 45 CFR 46.102 (Protection of Human Subjects 2018), as “a systematic investigation including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” This definition was revised in the 2018 Requirements version of the Common Rule to specifically exclude the following activities:

• Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research and historical scholarship).
• Public health surveillance activities.
• Collection and analysis of information, biospecimens or records by or for a criminal justice agency for activities authorized by law or court order or criminal investigative purposes.
• Authorized intelligence, homeland security, defense or national security mission operational activities.

Types of Research Requiring Review

Any research involving human subjects must receive prior approval from the Institutional Review Board (IRB). The sole exceptions are for:

• Faculty supervised classroom projects on educational practices in which students volunteer to use themselves as the research subjects;
• Anonymous one-time educational tests limited to innocuous items such as perceptions of non-personal matters; and
• Demographic, marketing and program evaluation information routinely collected by the university.

Projects in these three categories do not require IRB approval as they are not considered research by the Code of Federal Regulations, 45 CFR 46.102d. It is important to note that the above exceptions do not apply to research whose participants include vulnerable persons. “Vulnerable persons” are considered to be those who may be less able to protect themselves and their interests relative to other persons in a given setting or situation. Such individuals have diminished autonomy (45 CFR 46 parts B, C and D).

Student Research and Class Projects

All student researchers who involve human subjects in a research project must have a member of the Cornerstone University faculty act as the faculty sponsor for the research. The faculty member is responsible for ensuring that the student researcher takes proper precautions to protect the rights and welfare of volunteer participants and assists with the IRB proposal completion and submission processes.

The collection of information from research participants for the purpose of class discussion or for the purpose of training students in research methods generally does not require IRB review. In general, if your project is classroom-based and is not designed to produce generalizable knowledge, then IRB approval is not required. Use the university’s definition of “what is research” above to help discern if IRB review is warranted.

The IRB Review Process at a Glance

The goal of the IRB is to make the proposal review process as quick and efficient as possible. If you are planning a project in the future in which you are the principle investigator (PI), the following are the basic steps you’ll need to take to get IRB approval:

1. PI accesses proposal forms on IRB website.
2. PI completes proposal forms and online training.
3. PI submits forms and training certificate to IRB Chair.
4. Proposal is reviewed by committee.
5. IRB Chair contacts PI regarding decision.

If one conducts his or her own research without IRB approval, it is not covered by Cornerstone’s liability insurance.

The role of the IRB in reviewing research is to monitor the protection of human subjects. Specifically, the IRB aims to ensure respect for persons, beneficence and justice in the recruitment process. To do so, the IRB assesses the transparency of the research process, the informed consent process and the overall management of risk to human subjects. The extent to which research proposals must be reviewed are determined by the nature of the risk associated with the student. In essence, the greater the risk to the participants, the greater the degree or extent to which the proposal must be reviewed.

The following categories of review range from research considered to be of minimal or lesser risk (i.e., exempt) to research that is considered higher risk and thereby requiring a greater level of review (i.e., full committee review).

Exempt

Exempt research involves no more than minimal risk to subjects; the same level of risk that we experience going about our daily lives. Although the category is called “exempt,” this type of research does require IRB review and registration. See 45 CFR 46.104 for a description of the types of research that fall into this category.

Under the four exempt categories 46.104(d)(2)(iii), (d)(3)(i)(C), (d)(7) and (d)(8), research may be required to undergo limited IRB review. Limited IRB review is reviewed by an IRB Chair or designated IRB member as a condition of exemption.

Expedited Review

To qualify for an expedited review, research must fall into nine federally-defined expedited categories. These categories involve the collection of samples and data in a manner that is not anonymous and that involves no more than minimal risk to subjects. See 45 CFR 46.110 for a description of the types of research that fall into this category.

Full Committee Review

Proposed human subject research which does not fall into either the exempt or expedited review categories must be submitted for full committee review. This is generally research that involves high risk to participants, vulnerable persons or research that requires deception.

Cornerstone University’s Institutional Review Board (IRB) strives to ensure adequate protection of the research subjects and also the researchers themselves. In order to perform a study at Cornerstone, you must submit an approval request and informed consent forms to the chair of the IRB for review and a certificate indicating your completion of an online training course.

Approved applications are good for only one year from the date of approval. For renewal options, contact the IRB chair.

Approval Process for Research Studies

The chair or a member of the IRB will review your research study application. During the approval process, changes to the application may be requested. If your request for approval is denied, it will be so only after careful consideration at a full CU IRB meeting. If the research involves vulnerable subjects or you have other questions, consult the IRB chair. Be aware that such research requires full CU IRB approval and may also require approval from other IRBs. Be prepared for lengthy delays before such studies receive approval.

If an online survey is connected with Cornerstone in any manner, subjects can participate only if the survey has CU IRB approval. In order to obtain such approval, follow the three steps above. A hard copy of the survey questions must be submitted to the chair. If the survey receives approval, a reference to “Cornerstone University—Institutional Review Board Approval” must be clearly stated in the explanatory paragraph (intro paragraph) of the survey.

1. Fill Out a Research Study Approval Request

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 the 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.

Research Study Approval Request

2. Obtain Informed Consent from All Research Study Participants

If IRB approval is granted, the consent form will receive a stamp of approval. Only copies of CU IRB approved consent forms are to be sent to participants, because participants may only sign the form if a stamp of approval is evident. 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 university’s 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.

Informed Consent Form

3. Complete the Online Training Course

Online training is required of all investigators. All CU faculty, staff and students can complete the training course in Moodle. After creating an account, begin with the “Introduction” module and follow the instructions. Once you’ve completed all modules and all quizzes, print out the certificate and submit it along with this proposal form to the university’s IRB chair.

Course Enrollment Guide