POLICY
A. Proposals that must be reviewed and approved by the Department of Nursing Research and Evidence-Based Practice Committee (NREC) include any of the following:
1. Studies that involve the participation of Department of Nursing Services and Patient Care staff members as participants.
2. Studies that involve employees within the Department of Nursing Services and Patient Care as principal investigator or co-investigator.
3. Studies that involve investigation or evaluation of nursing procedures, even if a part of the regular patient care or nursing activities of the unit or clinic (e.g. collecting data that is not part of usual care, administering nursing care in a manner that differs from standard care), must be reviewed to evaluate scientific merit, resources and burden for staff and patients.
4. Nursing research that evaluates nursing practice even if not a part of regular nursing care (e.g., accesses existing patient or staff related databases at UIHC).
5. Modifications to existing IRB approved research proposals that include changes in nursing or nursing resource involvement
B. Approval processes for Department of Nursing Services and Patient Care employees: Research conducted during working hours must be relevant to the staff member's practice. Research that is proposed as part of an academic requirement must be approved by the investigator's college or school before the proposal is brought before the NREC.
C. Approval process for investigators outside the Department of Nursing Services and Patient Care: Proposals must be approved by the appropriate committee of the researcher's college, department, or agency before the proposal is brought before the NREC.
D. Proposals should be submitted to the NREC prior to or concurrent to the Institutional Review Board (IRB).
E. It is the responsibility of the researcher to submit the proposal to the University of Iowa Institutional Review Board for protection of human subjects. If uncertain about the need for IRB approval, go to the Human Subjects Determination Form (http://research.uiowa.edu/hso/index.php?get=hsrd&view=1).
F. The NREC makes recommendation(s) on: research procedures, nursing resources required (including reimbursement/compensation requests for the investigators), education of nurses who will be asked to participate, and supplies/equipment that will be required to complete the research study. This committee provides a recommendation for approval or disapproval to the Associate Vice President for Nursing, UI Health Care / Chief Nursing Officer, UIHC, who has final approval.
G. Recommendation for approval of research studies by the NREC is dependent upon factors which might affect the specific unit and population involved in the study. Therefore, it is highly recommended that investigators consult with nurse managers to discuss factors, such as:
1. The complexity of care, condition of patients, number of personal contacts and the competing demands affecting the patients or staff.
2. The additional workload the study might create on the clinical nursing unit (e.g., data collection, communication with research personnel, monitoring for side effects, and/or in-servicing for staff).
3. The number of projects in which a group of patients or staff members is already involved.
4. Over all quality and relevance of the study.
5. The types of instruments to be used.
PROCEDURE
A. Complete an electronic copy of Form I (http://research.uiowa.edu/hso/index.php?get=comm_nrc), obtain the appropriate signature(s), and submit to the NREC secretary in the Nursing Research and Evidence-Based Practice offices along with the University of Iowa IRB Form (See Protocol Section of Form I) and other required information for distribution to the NREC members.
B. Once all the appropriate forms, materials and signatures are in place, the proposal will be added to the NREC agenda for review. Meetings are scheduled twice a month.
C. The NREC will review, discuss and solicit additional information as needed from the investigator.
D. Proposals approved by the NREC will be forwarded to the Associate Vice President for Nursing, UI Health Care / Chief Nursing Officer, UIHC, with a recommendation for approval. The Associate Vice President for Nursing, UI Health Care / Chief Nursing Officer gives final approval.
E. When final approval has been granted, the investigator will be notified by the Chair of the NREC via email.
OTHER CONSIDERATIONS
If additional information or help is needed, please contact the Chair of the Nursing Research and Evidence-Based Practice Committee at 319-384-9098.
Written: 2/74
Revised: 11/82, 1/83, 11/85, 3/91, 2/98, 6/01, 4/05, 8/05; 8/08; 4/09, 9/09, 10/09, 2/12
Reviewed: 9/84, 11/94, 9/09, 2/12, 6/16
N-A-12.001
The University of Iowa Hospitals and Clinics
Department of Nursing Services and Patient Care
FORM I
Request for Approval of Research
New StudyIRB ID#:
WIRB ID#: / Modifications to a previously approved study which changes nursing involvement, nursing resources or evaluates nursing practices. Indicate below which venue previously approved this study.
IRB ID#:
Nursing Research and Evidence-Based Practice Committee (NREC)
WIRB ID#:
Date:
Title of Project:
Principal Investigator (PI):
Co-Investigators:
PI Address:
PI Telephone: / PI Email Address:
Advisor Name:
Advisor Email Address:
Research Study Coordinator Name:
Research Study Coordinator Email Address:
Clinical Services Areas to be Used (list specific units/clinics):
· / · / ·
· / · / ·
· / · / ·
· Other (please specify):
Data Collection Period: / Start Date: / End Date:
The Department of Nursing Services and Patient Care’s Nursing Research and Evidence-Based Practice Committee (NREC) supports research and nurses involvement in research. Therefore, the NREC reviews all studies that involve the participation of nursing staff on protocols or procedures for research. Even if participation is part of regular patient care or nursing activities of the unit, clinic or setting (e.g., medication administration, blood draws or monitoring), the study still requires review.
It is a requirement to obtain the NREC’s approval prior to or concurrently with review and final approval by the appropriate Institutional Review Board (IRB) for protection of human subjects. Studies must be reviewed by the NREC and approved before they are initiated. It is highly recommended that investigators talk to Nurse Managers to discuss factors that might affect the unit and populations involved in the study.
Investigators must complete the following checklist and submit required information listed below:
Materials Required for Review by the NREC:
New Study:
Description of Department of Nursing Services and Patient Care Personnel Involvement:
Specify the activity requested of Department of Nursing Services and Patient Care personnel contributing to the research protocol (i.e., data collection, recruitment of participants, communication with research personnel, monitoring of participants) by checking all that apply.
PI / Co-PI / Obtain participant consentInvestigator / Participant’s education (potentially)
Key personnel / Patient monitoring
Data collection / Identify potential participants
Intervention/treatment / Nurse consultant
Lab draws specifically for this study / Training of staff for research budget
Medication administration for this research study / Other (please specify: )
Describe the plan for educating Department of Nursing Services and Patient Care personnel about research study and the activity they are expected to perform (e.g., monitoring for adverse effects of medications).
Description:
Identify Department of Nursing Services and Patient Care supplies and equipment that will be required to complete this research study.
Description:
Protocol (a complete copy of The University of Iowa Human Subjects Review IRB application may be used for this):
Research question or hypothesis;
Sample selection with inclusion/exclusion criteria;
Sample size determination (if appropriate for study design);
Specific plan for recruitment of participants (who, how and when);
Study procedures;
Outcome evaluation (measures, statistical analysis);
Safety review, criteria for stopping accrual of participants (if appropriate)
All instruments to be used for data collection (include demographic forms, questionnaires and surveys).
All information summaries and consent/assent forms.
If investigational drugs are to be administered by Department of Nursing Services and patient care personnel, please see policy N-08.140 Investigational Drugs for additional instructions.
Modification:
Describe modifications being submitted for review that involves nursing, nursing resources or evaluates nursing practices; and any attachments (i.e., consent documents, letters of support, etc.).
Description:
Approval Process:
Review by appropriate UIHC physicians/medical directors, Directors for Clinical Services, and Nurse Managers who have management responsibilities for participants or areas involved. Signatures are required to document their reviews and give permission to conduct the research in their respective area(s). Research proposals will not be reviewed until all required signatures have been obtained and received.
I understand that this protocol titled “” will be conducted on (clinical area[s]) by (Principal Investigator). The project purpose is to . (N) participants with will be enrolled. UIHC Department of Nursing Services and Patient Care staff will participate in this study as indicated above.
Funding:
I understand that this study provides funding to the Department of Nursing Services and Patient Care for . The funding is provided by .
I understand that no funding is being provided
Reimbursement funding for training of unit nursing staff.
Required Signatures:
Director for Clinical Services for Specified Nursing Unit/Division / Nurse Manager for Specified Nursing Unit/DivisionDirector for Clinical Services for Specified Nursing Unit/Division / Nurse Manager for Specified Nursing Unit/Division
Director for Clinical Services for Specified Nursing Unit/Division / Nurse Manager for Specified Nursing Unit/Division
Physician / Other:
Physician / Other
Nurse Manager Resource (specific to this study) / Research Study Resource (specific to this study)
Submit an electronic copy of the signed Form I, the description of the Department of Nursing Services and Patient Care involvement, the University of Iowa Human Subjects Review Form and Application, and of the materials outlined on pages one and two to Kimberly Jordan, secretary for the Nursing Research and Evidence-Based Practice Committee at .
Final Approval by Department of Nursing Services and Patient Care:
Approved(Date) / (Associate VP for Nursing/Chief Nursing Officer)
Not Approved
(Date) / (Associate VP for Nursing/Chief Nursing Officer)
Comments:
IRB Approval Pending/Received:
New Study:
IRB-01 Approval Required(Received) / (Date)
IRB-02 Approval Required
(Received) / (Date)
IRB-03 Approval Required
(Received) / (Date)
WIRB Approval Required
(Received) / (Date)
Modification:
IRB-01 Approval Required(Received) / (Date)
IRB-02 Approval Required
(Received) / (Date)
IRB-03 Approval Required
(Received) / (Date)
WIRB Approval Required
(Received) / (Date)