Researchers investigating phenomena in nursing education have faced many obstacles, including primarily the lack of substantive funding to support their work. Because of this, many studies are designed to merely be do-able—that is, small enough to be conducted with limited support. These small studies have resulted in a literature plagued with small sample sizes, single-site designs, potential conflict of interest (investigators evaluating their own practice), and poorly designed instruments. To address these limitations common in the literature, calls for multisite studies to improve the generalizability of findings and to advance the science of nursing education have become commonplace (Broome, 2009; Broome, Ironside, & McNelis, 2012; Flynn, Ironside, Yedidia, Tanner, & Valiga, 2016; Ironside & Spurlock, 2014).
Yet, designing and managing multisite studies can be costly and time consuming. For example, investigators conducting multisite studies must frequently navigate wide variations in the requirements and expectations among potential sites regarding whether local institutional review board (IRB) approval is required for a particular study, the type of IRB approval needed, and the information required by a local IRB to secure that approval. Of course, protecting students' and faculty members' rights when they become study participants is an appropriate concern for investigators and every participating site. Clearly understanding the nature of the proposed research, the specifics of the research protocol, and the role of the local site personnel in the conduct of the research can help investigators in nursing education communicate clearly with IRB representatives so that human subject protection is ensured, while avoiding redundant reviews that offer no increase in protection.
The National Nursing Education Research Network
To explore these issues, we will use our experience launching the initial faculty and student surveys for the National Nursing Education Research Network (NNERN) as an exemplar. NNERN was created to develop large, uniform, longitudinal, individual-level faculty and student data sets that can be used by faculty and doctoral students to investigate research questions of interest in a rigorous and cost-effective way. Twenty-eight schools of nursing representing all regions of the United States participated in the initial NNERN surveys (Flynn, Ironside, Yedidia, Valiga, & Tanner, 2016). The surveys were Web based, and responses were captured by Research Evidence Data Capture (REDCap). Thus, the responses were anonymous—neither investigators nor site coordinators at participating schools could link particular responses with a participant.
The study protocol was approved by the Colorado Multiple Institutional Review Board (COMIRB). Investigators then collaborated with a designated site coordinator at each of the 28 participating schools to determine the local IRB requirements. These requirements ranged from no additional IRB review to full IRB review. Two schools could not participate because they were unable to secure approval from their local IRB. In working with site coordinators to address local IRB requirements and expectations, we noticed significant inconsistency among participating sites regarding a variety of issues in conducting multisite research, such as submission type (exempt, expedited, not human subject research) and whether the participating schools' site coordinators were considered to be engaged in human subjects research. (Site coordinators verified the list of faculty members, which investigators obtained from their Web site, and either provided a list of students and e-mail addresses or circulated an e-mail invitation and reminders to students with an embedded survey link.) In addition, there was inconsistent knowledge by site coordinators or their IRB representatives of the new guidelines disseminated by the U.S. Department of Health and Human Services (DHHS), the National Institute of Health, and others in relation to the use of a central IRB in multisite studies.
The IRB Regulations
The role of an IRB and criteria for approval of research is defined by the DHHS (Protection of Human Subjects, 2009) and the Food and Drug Administration (Institutional Review Boards, 2016) under 45 C.F.R. 46.111 and 21 C.F.R. part 56, respectively. IRBs are charged with the responsibility of determining that risks to subjects are minimized, risks are reasonable in relation to documented, an adequate plan is in place to monitor data collection to ensure the safety of subjects, and provisions are adequate to protect the privacy and confidentiality of subjects and their data (Protection of Human Subjects, 2009). Obtaining multiple IRB approvals can be costly and can delay the process of conducting research whether it involves educational interventions, survey administration, or simply recruiting potential subjects from multiple sites. Further, although delays from the time of submission until the time of approval can be considerable, the review of multiple IRBs does not necessarily provide for increased protection of subjects (Family Educational Rights and Privacy Act [FERPA], 2015).
The Office for Human Research Protections (OHRP) released a guidance document in 2008 to describe the engagement of institutions in human subjects research that is conducted or supported by the DHHS. When engaged in human subjects research, an institution is required to satisfy the DHHS regulatory requirements related to holding assurance of compliance (Federalwide Assurance) and certifying IRB review and approval. Criteria exist to determine whether an institution is engaged in human subjects research. However, based on these scenarios, an institution may be considered not engaged in human subjects' research if the involvement of their employees or faculty is limited (see the Table for engagement scenarios; DHHS, 2008).
Engagement in Human Subjects' Research Criteria
Regulatory Inconsistencies With NNERN
In consideration of the IRB submission type and whether an institution is engaged in human subjects research, the following issues were encountered during the NNERN survey study.
Exempt Versus Expedited Submission Type
Two types of IRB approval are common in educational research, as defined by OHRP: exempt and expedited. The exempt approval type is actually not a true IRB approval category; under 45 CFR § 46.101(b), several types of research are exempt from the requirement of IRB approval based on the minimal risk these studies pose to subjects. Research conducted in educational settings (even interventional education research) and most forms of survey research are exempt from the requirement of IRB approval. The NNERN surveys would qualify as exempt (45 CFR 46.101) because subjects' identities could not be linked to their responses, and no potentially sensitive or stigmatizing questions were included in the surveys. Thus, the risks were deemed to be no more than minimal.
Educational or survey research in which subjects can be identified (usually via the collection of identifiers) and if disclosure of subjects' responses could reasonably put them at risk of criminal or civil liability or be damaging to employability, reputation, or financial standing is not exempt from IRB approval, although expedited approval procedures can be used. Expedited procedures, where IRB approval is granted after review by either the IRB Chair or a designee confirms the low-risk nature of the study, are appropriate when identifiers are collected but the risks to subjects are no more than minimal and the risks of identification of subjects and their responses outside the research could not reasonably put that subject at risk of criminal or civil liability or be damaging to employability, reputation, or financial standing.
Engagement in Human Subjects' Research
The participating institutions and site coordinators were external to the University of Colorado Denver and assisted investigators with the recruitment of participants by sending an e-mail recruitment invitation and reminders with the link to a REDCap survey. Although the coordinators disseminated information about the NNERN surveys to potential participants, they were not involved with data collection or analysis. Referring to the OHRP engagement criteria in the Table, although an institution may be communicating with subjects, communication is not synonymous with intervention, defined in regulation as “both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes” (DHHS, 2008, §I.2). DHHS guidelines (§II.B.4) are clear that an institution is not engaging in research when its employees inform potential subjects about the availability of a research study, provide information about the study (including consent or study information documents), provide an investigator with contact information, or even seek permission from potential subjects for the study investigators to contact them directly.
A separate concern related to some participating schools' desire to have a designated local investigator added to the protocol to protect their students and faculty and facilitate review and approval by the local IRB. In the context of the NNERN surveys, identifying a local investigator would be misleading given that local employees were not included in the collection or management of data. The NNERN team believed that not having a designated local investigator actually provided more student protection, and the recruitment e-mail stressed that school personnel would have no access to identifiable survey data. That said, having a local faculty member serve as a site coordinator at each site was helpful in navigating specific IRB requirements and communicating with local IRBs. In several cases in which the local IRB required a protocol submission, a local faculty member was needed to access the IRB forms and to submit the materials for review. In other similar cases, the NNERN team completed and submitted the required IRB materials. We found it was important to supply each site with the study protocol and IRB materials from the submission to the COMIRB so that when local faculty were submitting materials to their IRB, the study procedures were accurately described. Further, it allowed site coordinators to communicate their role and the protections for students to their IRB's personnel and to answer questions in a knowledgeable and accurate manner.
Many site coordinators shared with us their school's concern with providing investigators with student e-mail addresses, citing concerns about the privacy of student records under FERPA (20 U.S.C § 1232g, 34 CFR Part 99), which is a wide-ranging federal law that protects the privacy of student educational records from primary, secondary, and postsecondary educational settings. Although it provides many protections, FERPA specifically allows for schools to define what it considers directory information, individual student information that may be disclosed at its discretion and without further student consent unless a student has requested that directory information not be disclosed. FERPA also requires that each school publish a notice of its definition of directory information each year. Directory information includes (but is not limited to) name, address, telephone numbers, e-mail addresses, dates of attendance, program of study, place of birth, and any honors and awards received (U.S. Department of Education, 2015). Nonetheless, having each institution send a recruitment e-mail to potential student participants was an alternative some schools chose rather than disclosing e-mail addresses directly to an investigator.
In sum, the review of applicable regulations presented in this article clearly supports that merely providing directory information (e.g., a list of student names and e-mail addresses) to study investigators neither violates FERPA nor engages an institution in human subject research. This understanding of the interplay between FERPA and federal definitions of engagement in research could provide significant relief to educational researchers and the institutions in which educational research is conducted and, we believe, improve the quality of nursing education science.
Regulatory Changes Ahead
Recognizing the challenges created by the current federal regulatory scheme for all types of research, in 2015 the OHRP issued a Notice of Proposed Rule Making that would almost entirely revise the current system of research regulation covered by the Common Rule (45 C.F.R. 46.111). These changes include permitting or requiring a single IRB of record for U.S.-based multisite studies, eliminating continuing review for studies in which all study interventions have been completed, potentially expanding and revising the list of expedited review categories, and creating a procedure for exempt research where studies need only be registered with an IRB before commencement; exempt studies could begin as soon as the registration form is filed (DHHS, 2015). On January 19, 2017, the DHHS published final revisions to the Common Rule integrating many (but not all) of the changes outlined in the 2015 Notice of Proposed Rule Making (Federal Policy for the Protection of Human Subjects, 2017). The task of revising these regulations is gargantuan and progress has been slow, but the need has been clearly identified by researchers, institutions, and regulators. Unless the recent revisions to the Common Rule are reversed by Congress, IRBs will have until January 2020 to implement the rule in its entirety, with some provisions becoming effective in January 2018.
As investigators studying phenomena specific to nursing education continue to work toward more multisite studies, anticipating the time and costs associated with securing IRB approvals is important. Ensuring that representatives from each participating site are knowledgeable about the risks to subjects, the extent to which they will be engaged in the conduct of the research, and the nature of the data being collected can streamline the process and potentially avoid unneeded or redundant protocol review. Ultimately, IRB representatives at each site have the authority to determine local review processes and requirements, but communicating directly and knowledgably with these colleagues and asking questions to clarify differing views on or interpretations of the study protocol can prevent unnecessary or redundant work for investigators, local faculty, and IRB personnel who share a commitment to protecting study subjects.
- Broome, M.E. (2009). Building the science for nursing education: Vision or improbable dream?Nursing Outlook, 57, 177–179. doi:10.1016/j.outlook.2009.05.005 [CrossRef]
- Broome, M.E., Ironside, P.M. & McNelis, A.M. (2012). Research in nursing education: State of the Science. Journal of Nursing Education, 51, 521–524. doi:10.3928/01484834-20120820-10 [CrossRef]
- The Family Educational Rights and Privacy Act (FERPA), 20 U.S.C. § 1232g; 34 C.F.R. § 99 (2015).
- Federal Policy for the Protection of Human Subjects 82 Fed. Reg. 7149 (January 19, 2017) (to be codified at 10 C.F.R. § 745, 14 C.F.R. § 1230, 15 C.F.R. § 27, 20 C.F.R. § 431, 22 C.F.R. § 225, 24 C.F.R. § 60, 29 C.F.R. § 21, 32 C.F.R. § 219, 34 C.F.R. § 97, 38 C.F.R. § 16, 40 C.F.R. § 26, 45 C.F.R. § 46, 45 C.F.R. § 690, 49 C.F.R. § 11, 6 C.F.R. § 46, 7 C.F.R. § 1.)
- Flynn, L., Ironside, P., Yedidia, M., Tanner, C.A. & Valiga, T. (2016). The National Nursing Education Research Network. Journal of Nursing Education, 55, 363–364. doi:10.3928/01484834-20160615-01 [CrossRef]
- Institutional Review Boards, 21 C.F.R. § 56 (2016).
- Ironside, P.M. & Spurlock, D.R. (2014). Getting serious about building nursing education science. Journal of Nursing Education, 53, 667–669
- Protection of Human Subjects, 45 C.F.R. § 46 (2009).
- U.S. Department of Health and Human Services. (2008). Engagement of institutions in human subjects research. Retrieved from https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-engagement-of-institutions
- U.S. Department of Health and Human Services. (2015). Regulatory changes in ANPRM: Comparison of existing rules with some of the changes being considered. Retrieved from http://www.hhs.gov/ohrp/regulations-and-policy/regulations/regulatory-changes-in-anprm/index.html
Engagement in Human Subjects' Research Criteria
|Engaged in Human Subjects' Research: Criteria or Scenario|
|The institution is a direct award recipient from the U.S. Department of Health and Human Services for human subjects' research, even when all activities of the research occur by employees at another institution.|
|Intervening with a subject for research purposes. This may include intervening collecting blood, administering a behavioral or clinical intervention, and utilizing other measurement procedures.|
|Manipulating the environment for research purposes.|
|Interacting for research purposes with human subjects.|
|Obtaining informed consent for research purposes.|
|Obtaining identifiable private information or biological specimens for research purposes.|
|Not Engaged in Human Subjects' Research: Criteria or Scenario|
|Providing a service, whether commercial or not, as long as that service does not merit professional recognition such as a publication or conference presentation AND the services are typically performed by the entity or person AND the outside institution or employee are not administering a study intervention that is being evaluated by the research.|
|An institution that is not a research site but provide clinical trial–related medical services that are dictated by the protocol and would normally be done as part of routine clinical monitoring or follow-up of subjects enrolled at a study site.|
|Administering a study intervention being evaluated under the protocol provided it is on a one-time or short-term basis.|
|Informing potential subjects about the availability of research projects and providing a copy of the informed consent document, which provides contact information for the study team OR getting permission to allow the study team to contact a potential subject.|
|Permitting the use of space at an institution for an intervention or interaction with subjects by the study team from an approved research institution.|
|Releasing identifiable private information or biological specimens to an investigator at another institution.|
|Obtaining coded private information or biological samples from another institution involved in research but not being able to identify who the data or sample belongs to.|
|Accessing identifiable private information for the purposes of study auditing or source document verification.|
|Receiving identifiable private information to satisfy Food and Drug Administration reporting requirements.|
|Authoring a paper, article, or presentation describing a human subject research study.|