Institutional Review Board

Graceland University is committed to the safety and protection of human participants involved in biomedical and social behavioral research. The IRB meets the highest ethical standards for human research required by local, state and federal laws and regulations. It is guided by the ethical principles of respect, beneficence and justice set forth in The Belmont Report from the U.S. Department of Health and Human Services.

In order to adequately protect the rights of human participants in research, an effective IRB requires an institutional organizational structure in which authority and responsibilities are clearly defined. Responsibility for ethical conduct rests with all parties involved in the review, oversight or conduct of research involving human subjects. Parties include the Vice President of Academic Affairs (VPAA), deans, associate deans, department chairs, faculty, staff, students and the IRB.

IRB Process

Federal regulations and university IRB guidelines require IRB approval for research conducted with human subjects by faculty or students. Examples of research activities that require IRB review include undergraduate theses that may be presented in the public or professional venue, Honor’s theses, master’s theses, DNP project. However, some class projects are conducted for educational purposes and do not meet the definition of research with human subjects, and thus, IRB approval is not required. When faculty and students are unsure, please consult with the IRB or submit the application for review. IRB Frequently Asked Question (IRB FAQ) is also available under “Helpful Links.”

Step 1. Complete a human subject protection tutorial found on the IRB website and document the source on the IRB application. Faculty and graduate students may apply as principal investigator (PI). Undergraduate students may apply as co-investigator under the supervision of a faculty member as PI. See the human subject tutorial links below for certification or proof of training.

Step 2. Complete consent form (if required) for subjects 18 years of age or older (.doc) and subjects less than 18 years of age (.doc).

Step 3. Obtain letter of support from the site where data will be collected (if applicable). Contact the IRB administrator for any questions about this. (hsrc@graceland.edu)

Step 4. Download the IRB application and complete it electronically in Microsoft Word.

Step 5. Send the completed IRB application (in Word format) as an email attachment to the IRB administrator (hsrc@graceland.edu). Additional documentation should be saved as one Word document and included in the same email message to the IRB administrator.

Step 6. The IRB administrator will deliver to the designated IRB reviewer. Please allow a minimum of two weeks for review and feedback. Applications will be reviewed in the order that they are submitted.

Step 7. You will receive electronic confirmation of approval or required revisions to be resubmitted to the IRB administrator (hsrc@graceland.edu). NO SUBJECTS MAY BE RECRUITED AND NO DATA MAY BE COLLECTED PRIOR TO IRB APPROVAL.

Quality Improvement (QI)

Quality Improvement (QI) is the process of evaluating using scientific methodology to bring immediate performance improvements in health care delivery. Performance can be measured in terms of clinical outcomes, patient satisfaction, error rates, productivity and other metrics. All health care institutions including hospitals and ambulatory clinics utilize QI projects to improve patient outcomes. Results are used locally to improve care by improving the process being monitored. This process does not require IRB approval.

However, if you are considering the publication or presentation of the results of this QI effort outside of Graceland University, then you must complete this form and submit to the IRB to verify that you will be conducting a QI effort and that it currently does not meet the definition of human research.

QI Determination Form (.docx)

Meeting and Application Review

IRB meetings are scheduled once per semester; September, January, and April, unless full reviews are necessary, requiring additional meetings.

Applications are reviewed in the order that they are submitted. Researchers can expect to hear back within two to four weeks of submitting their application for review. If additional time is required for the review, the principal investigator will be notified by the IRB Administrator.

Helpful Links

LINK	DESCRIPTION
HHS-FAQ	Health and Human Services Frequently Asked Questions
OHRP	Office of Human Research Protection
FDA – FAQ	Food and Drug Administration Frequently Asked Questions
GU-IRB (pdf)	Graceland University IRB Guidelines
Reviewer Checklist (doc)	Graceland University IRB Member’s Reviewer Checklist
HHS Training	Health and Human Services Training Website
PRIMR	Public responsibility in Medicine and Research
IRB FAQ (pdf)	Institutional Review Board Frequently Asked Questions

Human Subject Protection Training

Graceland University IRB will accept Human Subject Protection Training from any of these tutorial links:

Contact Us

IRB Administrator, hsrc@graceland.edu

Chair, Wilaiporn Rojjanasrirat, PhD, RN, IBCLC, FILCA, FAAN, rojjanas@graceland.edu

Committee Members:

Elise Hector, PhD, RN, CPN — Nursing
Keith Jenkins, DNP, PMHNP-BC, FNP-C, AGNP-C — Nursing
Evan Kennedy, PhD — Psychology
Rebecca Reish, PT, DPT, PhD — DPT
Mary Shawgo, PhD — Biology
Jeana Wilcox, PhD, APMHCNS-BC — Volunteer