Understanding the NDNQI RN Survey Research Study
This research study led by Dr. C. Karen Jeans delves into the complexities of the National Database of Nursing Quality Indicators (NDNQI) RN Survey. The webinar aims to address key issues faced by VA Facilities participating in the survey, covering topics like regulatory requirements, IRB reviews, data security, and more. The NDNQI, established in 1998, provides valuable nursing quality measurement data through various data collection efforts. The study also explores whether the NDNQI RN Survey qualifies as human subjects research under the Common Rule.
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The Press Ganey RN Survey Research Study Lead Presenter: C. Karen Jeans, PhD, CCRN, CIP Director of Regulatory Affairs, ORPP&E Sponsored by the VA Office of Research and Development (ORD) and the VHA Office of Nursing Services (ONS) July 26, 2021
Issue Statement Questions were raised by different VA Facilities contracting with Press Ganey Associates LLC to conduct the 2021 Press Ganey/National Database of Nursing Quality Indicators (NDNQI) RN Survey. Is the NDNQI RN Survey a human subjects research activity? Can a national coordinated approach be used to address key issues common to any VA Facility participating in the NDNQI RN Survey? Both the VHA Offices of Research and Development (ORD) and Office of Nursing Services (ONS) have worked to identify and resolve issues, including communication with Press Ganey. Today s webinar will discuss these questions with strategies to assist VA Facilities who are participating or plan to contract with Press Ganey to conduct the 2021 Press Ganey/NDNQI RN Survey. 2
Key Discussion Topics Summary of the background of The National Database of Nursing Quality Indicators (NDNQI) Specific human research regulatory requirements to be followed by VA Facilities participating in the 2021 Press Ganey/NDNQI RN Survey VA Central Institutional Review Board (IRB) vs. local IRB reviews VA Facility Research and Development (R&D) Committee review Information Security and Privacy reviews Additional agreement and review topics related to the NDNQI RN Survey Research Study 3
The National Database of Nursing Quality Indicators (NDNQI): Purpose and Background Established by the American Nurses Association in 1998 and managed by the University of Kansas School of Nursing until it was acquired by Press Ganey Associates in 2014. It is a unit level nursing quality measurement product offered to client health care facilities primarily in the United States. Press Ganey/NDNQI collects data from nursing units in client health care facilities through two efforts: 1. They collect unit level nurse staffing data and nursing sensitive patient outcome indicator data on a quarterly schedule. 2. They annually collect RN Survey data from direct care registered nurses (RNs) evaluating RN job satisfaction and the nursing work environment. 4
NDNQI RN Survey: Human Subjects Research vs. Non-Human Subjects Research In order to be human subjects research under the Common Rule, the activity must meet both definitions: Is it Research? Does the Research Involve Human Subjects? 5
Common Rule Definitions: Research and Human Subject Human Subject Research Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. 38 CFR 16.102(e)(1) Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. . . 38 CFR 16.102(l) 6
NDNQI RN Survey: Is it a Human Subjects Research Activity? Yes. Press Ganey designed the NDNQI RN Survey as a systematic investigation designed to develop to generalizable knowledge by examining the relationship between the nursing work environment with nurse and patient outcomes. The overall Study Principal Investigator is Dr. Kris Morgan, Vice President, Research and Measure Science, Press Ganey. The study is an exempt human subjects study (category 2) requiring a limited IRB review. Research team members (site coordinators) are responsible for activities which make them involved in the conduct of the research. 7
NDNQI RN Survey Role of Site Coordinators Press Ganey has a specific protocol site coordinators must follow if the client institution wishes to enroll in the NDNQI RN Survey. The protocol requires the Site Coordinator to recruit study subjects and participate in data collection for submission to Press Ganey. All RNs completing the NDNQI RN Survey are research subjects. The Advarra IRB made a determination that the NDNQI RN Survey is an exempt human subjects research study (exempt category 2) and provided the limited IRB review for Press Ganey s Principal Investigator. Advarra IRB s approval review does not cover limited IRB approval requirements for any client institution involved in the conduct of the NDNQI RN Survey. 8
NDNQI RN Survey: Exempt Human Subjects Research Activity- Category 2 38 CFR 16.104(d) d. Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met: (i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; (ii) Any disclosure of the human subjects responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, educational advancement, or reputation; or (iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by 46.111(a)(7). 9
Human Subjects Protections, Privacy, and Information Security Regulatory Requirements: VA Facilities Enrolling to Conduct the NDNQI 2021 RN Survey Will Conduct Prior to September 1, 2021 1. Limited IRB Approval: Use Primary IRB of Record Can be done using expedited procedures 2. VA Facility R&D Committee Approval: LOCAL Designated review is permitted as described in VHA Directive 1200.01, Paragraph 9.e.(4). 3. Privacy Officer Review: LOCAL 4.Information Systems Security Officer Review: LOCAL Will Conduct After September 1, 2021 1. Limited IRB Approval: Use VA Central IRB unless your primary IRB review is in process Can be done using expedited procedures 2. VA Facility R&D Committee Approval: LOCAL Designated review is permitted as described in VHA Directive 1200.01, Paragraph 9.e.(4). 3.Privacy Officer Review: Central unless already in process at site 4.Information Systems Security Officer Review: Central unless already in process at site 10
NDNQI RN Survey: VA Facilities without Research Programs or Initiated the RN Survey Without Required Research Approvals For VA Facilities without research programs, please email ONS and ORD: For ONS: Dr. Sheila Sullivan at Sheila.sullivan2@va.gov For ORD: Dr. Karen Jeans at c.karen.jeans@va.gov For VA Facilities with research programs: Obtain the required research approvals Inform your research compliance officer Email ONS and ORD 11
NDNQI RN Survey: Use of VA Central IRB to Conduct the Limited IRB Review: VA Facility must have a current IRB Memorandum of Understanding for use of the VA Central IRB. VA Study Chair/Lead PI will be Dr. Sheila Sullivan, Director of Evidence Based Practice and Analytics, ONS. The VA Central IRB limited IRB review approval is anticipated to occur approximately by late August or early September pending receipt of materials for the application materials. All participating VA sites using the VA Central IRB to conduct the limited IRB review will submit their names to Dr. Sullivan with the name of the VA Facility s Principal Investigator. The Study Chair/PI will make a copy of the approval to all participating sites using the VA Central IRB upon request by email or will give access for the study approval and approved documents through the Share function to all participating sites in VAIRRS. 12
NDNQI RN Survey: Centralized Privacy Reviews A centralized privacy review will be done by ORD s Privacy Officer for the NDNQI RN Survey when the limited IRB review is conducted by the VA Central IRB. A VA Form 10-250 will not be submitted by participating VA sites. If a HIPAA waiver of authorization is required, it will be approved by the VA Central IRB if the criteria are met during the limited IRB review. The written HIPAA authorization (VA Form 10-0493: Authorization for Use & Release of Individually Identifiable Health Information for Veterans Health Administration (VHA) Research)) will be reviewed by the ORD Privacy Officer. The Study Chair/PI will make a copy of the approval to all participating sites using the VA Central IRB upon request by email or will give access for the study approval and approved documents through the Share function to all participating sites in VAIRRS. 13
NDNQI RN Survey: Centralized Information Systems Security Reviews A centralized information systems security review will be done by the Research Support Division (RSD), Office of Information Security for the NDNQI RN Survey when the limited IRB review is conducted by the VA Central IRB. A consolidated Enterprise Research Data Security Plan (ERDSP) will be submitted by the VA Study Chair/Lead PI (Dr Sullivan). Participating VA sites will not submit individual ERDSP forms. The Study Chair/PI will make a copy of the approval to all participating sites using the VA Central IRB upon request by email or will give access for the study approval and approved documents through the Share function to all participating sites in VAIRRS. 14
NDNQI RN Survey: Other Approval and Review Issues Paperwork Reduction Act (PRA)/Office of Management and Budget (OMB) Clearance OMB approval is not required; the subjects are federal employees. Organizational Assessment Committee (OAC) Review approval: VA Facilities are not required to obtain OAC approval if your site has already begun the RN Survey research study. National approval will be obtained by ONS from OAC if needed. Contracts No national contract exists at the current time between VHA and Press Ganey to conduct the NDNQI RN Survey. Union Reviews 15
NDNQI RN Survey: Required ONS and ORD Notifications If your VA Facility has already conducted the 2021 NDNQI RN Survey or is planning on conducting the 2021 NDNQI RN Survey, please email both ONS and ORD at the following addresses: For ONS: Dr. Sheila Sullivan at Sheila.sullivan2@va.gov For ORD: Dr. Karen Jeans at c.karen.jeans@va.gov 16
Summary VHA and Press Ganey are working together to ensure that VA Facilities conducting the NDNQI RN Survey are given the information they need if the VA Facility wishes to enroll in the NDNQI RN Survey. If there are questions related to the NDNQI RN Survey requiring a response by Press Ganey, ONS requests that these questions be sent to the Study Chair/PI if it is related to study procedures. Additional information and updates will be sent to participating sites as it becomes available. Please ensure that both ONS and ORD are notified by email that your VA Facility is participating or is planning to participate in the 2021 NDNQI RN Survey. 17
Availability of Recording A recording of this session and the associated handouts will be available on ORPP&E s Education and Training website approximately one-week post-webinar. An archive of all ORPP&E-hosted webinars can be found here: https://www.research.va.gov/programs/orppe/education/w ebinars/archives.cfm
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